Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
The Medicare Beneficiary Complaint Process 
A Rusty Safety Valve 
AUGUST 2001 
OEI-01-00-00060  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. Principal OEI staff included:

BOSTON  HEADQUARTERS

Joyce M. Greenleaf, Project Leader  Bambi Straw, Program Specialist

Chaletta M. Clark, Program Analyst

Steven P. Keenan, 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  E X E C U T I V E   S U M M A R Y  
PURPOSE 
To reevaluate the effectiveness of the beneficiary complaint process of the Medicare Peer 
Review Organization program. 
BACKGROUND 
Complaints as a Means to Oversee Quality of Care 
Complaints can serve as a means of identifying practitioners and providers who pose harm 
and, if necessary, triggering interventions and follow-up. Since 1987, the Medicare 
beneficiary complaint process has been a statutory responsibility of Medicare Peer Review 
Organizations (PROs). 
Previous Office of Inspector General Report 
In 1995, the Office of Inspector General issued a report on the PROs beneficiary 
complaint process that identified three flaws: (1) Federal confidentiality regulations 
precluded the PROs from responding to complainants in a meaningful way, (2) PROs 
received too few complaints to identify patterns of poor care, and (3) the complaint 
process was lengthy. The Centers for Medicare and Medicaid Services (CMS, formerly 
the Health Care Financing Administration) responded positively to our report. It worked 
on revising the confidentiality regulations, but reports that it has been unable to publish a 
final rule. 
This Inquiry 
This inquiry reexamines the PROs complaint process. It is based on a mail survey to 
PROs, aggregate data on PRO complaints, site visits to 3 PROs, a review of 82 complaints 
at those 3 PROs, PRO budget data, and stakeholder discussions, among others. 
THE SIGNIFICANCE OF THE PROs COMPLAINT PROCESS 
Two main reasons underscore why the complaint process is an important safety valve: 
Identifying Instances of Poor Care.  On average, the PROs identified quality problems 
in 13 percent of medical record reviews initiated by complaints between August 1997 and 
July 1999. They identified such serious concerns as inappropriate transfer, delay in 
treatment, and missed medications, among others. 
Limits to Other Complaint Processes.  Professional licensing boards have historically 
struggled with quality-of-care complaints. The Joint Commission on Accreditation of 
i 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Healthcare Organizations gives complaints limited attention during its surveys. The 
medical malpractice system tends to have long delays and financial costs that work against 
Medicare beneficiaries in malpractice litigation. 
FINDINGS 
The PROs Complaint Process is an Ineffective Safety Valve for
Medicare Beneficiaries.  It Has Improved Little Over the Past 5 Years. 
Its accessibility is questionable.  We called 10 PROs and repeatedly reached busy 
signals at 2, reached recordings at 2, and were referred to a licensure board by another. 
PROs report that beneficiaries often lack a clear understanding of the complaint process. 
It rarely triggers any intervention beyond a letter for substantiated complaints. 
PROs called for a corrective action in 6 of 66 complaints with confirmed concerns that we 
reviewed. They involved clarifying policies or conducting in-service training. 
It fails to provide a meaningful response to complainants.  Current procedures 
requiring physician consent before PROs can share their review results with complainants 
continue to preclude the PROs from responding substantively to complainants. 
PROs Face Two Major Obstacles to Achieving a More Effective Beneficiary 
Complaint Process. 
CMS contracts with PROs treat complaints as a distinctly minor activity.  The 
contracts stress quality improvement and payment error reduction. 
The PROs tend to be more oriented toward the medical community than to the 
beneficiary community. This helps them in conducting quality improvement projects but 
can hinder them in developing a more effective beneficiary complaint process. 
RECOMMENDATION 
CMS should provide Medicare beneficiaries with an effective complaint process 
that meets the eight criteria identified in our template. 
In our draft report, we presented a series of recommendations on how CMS could achieve 
an effective complaint process. In this final report, we have revised our recommendations 
and present CMS with two options on how it can achieve this. 
Option 1:  CMS could fix the complaint process within the existing PRO program. 
Toward that end, CMS must make the beneficiary complaint process a prominent part of 
the PRO program, specify its expectations of an effective process through its contracts, 
consider different contracting approaches, and hold the PROs more accountable for 
providing an effective complaint process. 
ii 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Option 2:  CMS could establish a complaint process outside of the PRO program. 
This option represents a significant departure from how CMS has handled beneficiary 
complaints to date and would require legislative change. CMS could establish an entirely 
new program or contract mechanism focused on complaints and beneficiary outreach. It 
could develop new mechanisms, such as mediation, for dealing with certain types of 
complaints. Or it could build on existing entities that already conduct similar work, such 
as State survey and certification agencies, State medical licensure boards, and the State 
Health Insurance Partnership Program. 
. 
Issues for CMS to Consider 
The two options above have advantages and disadvantages for CMS to weigh as it 
considers how to best achieve effective complaint process for beneficiaries. Below we 
highlight those issues we consider as paramount. 
	 To what extent would establishing a complaint process outside of the PROs isolate the 
PROs from beneficiaries, who are the centerpiece of CMS programs? 
	 To what extent would fixing the complaint process within the PRO program exacerbate 
the tension between the quality improvement and complaint responsibilities of the 
PROs? 
	 To what extent does each option require legislative and regulatory changes to ensure 
that the complaint process functions with the appropriate authority and scope? 
  What are the resource implications of each option? 
COMMENTS 
CMS did not provide detailed comments on the recommendations in our draft report. We 
look forward to receiving such comments in response to this final report. We solicited and 
did receive comments from the American Health Quality Association, Citizen Advocacy 
Center, AARP (formerly the American Association of Retired Persons), and the American 
College of Physicians-American Society of Internal Medicine. All commenters agreed 
that an effective complaint process is important for Medicare beneficiaries and that the 
PRO programs focus on quality improvement is an appropriate one that can co-exist with 
a more effective complaint process. Some offered further recommendations, such as an 
informal complaint resolution process or options for contract changes. We urge CMS to 
consider these comments. 
iii 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  T A B L E   O F   C O N T E N T S  
PAGE

EXECUTIVE SUMMARY

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

SIGNIFICANCE OF THE PROs COMPLAINT PROCESS  . . . . . . . . . . . . . . . . . . . . . .  4

FINDINGS

Complaint Process is an Ineffective Safety Valve ............................... 6

Obstacles to a More Effective Complaint Process .............................. 14

RECOMMENDATION ........................................................ 16

COMMENTS on the DRAFT REPORT  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21

APPENDICES

A:  Profile of Complaints Reviewed  ........................................ 23

B:  Comments on the Draft Report  ......................................... 26

C: Endnotes ........................................................... 49

The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  I N T R O D U C T I O N  
PURPOSE 
To reevaluate the effectiveness of the beneficiary complaint process of the Medicare Peer 
Review Organization program. 
BACKGROUND 
The Complaint Process as a Means to Oversee Quality of Care 
The Centers for Medicare and Medicaid Services (CMS, formerly the Health Care 
Financing Administration) relies on a variety of quality oversight mechanisms to ensure 
that high quality health care and services are delivered to Medicare beneficiaries. One of 
these mechanisms is the complaint process, contractually administered by the Medicare 
Peer Review Organizations (PROs). The PROs complaint process provides Medicare 
beneficiaries and their families a forum to have their complaints taken seriously and 
investigated appropriately. It also complements other oversight efforts, ranging from 
surveying hospitals to collecting data on performance measures. 
Providing a complaint process specifically for Medicare beneficiaries has been a 
responsibility of the PROs since 1987, when Congress enacted the Omnibus Budget 
Reconciliation Act of 1986.1  That law mandates that PROs conduct an appropriate 
review of all written complaints about the quality of services paid for by Medicare, 
inform the beneficiary or representative of the final disposition of the complaint, and 
provide the practitioner and/or provider concerned with reasonable notice and opportunity 
for discussion.2 
Previous Office of Inspector General Report 
In 1995, the Office of Inspector General (OIG) issued a report on the PROs beneficiary 
complaint process.3  In that report we found the PROs complaint process to be flawed in 
three significant ways: (1) Federal confidentiality regulations precluded the PROs from 
responding to complainants in a meaningful, substantive way, (2) PROs received too few 
complaints to identify patterns of poor care, and (3) the process of investigating and 
responding to complaints was lengthy. Furthermore, we found that Medicare beneficiaries 
were often unaware of their opportunities to complain to PROs about the quality of their 
medical care. 
Based on those findings, we recommended that CMS give the highest priority to requiring 
PROs to respond in a substantive manner to the complainant. We also called for CMS to 
enhance Medicare beneficiaries awareness of PROs and the complaint process, and to 
streamline that process. 
1 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  CMS responded positively to our report. It assigned a taskforce (part of the Medicare 
Technical Advisory Group) the responsibility to improve the complaint process in light of 
the flaws we identified. That task force included representatives from CMS, the PROs, 
the American Medical Association, AARP (formerly the American Association of Retired 
Persons), the American Hospital Association, and the Citizen Advocacy Center, among 
others. The task met regularly in the period following the 1995 OIG report. 
As a result of recommendations made by the task force, CMS changed its guidelines for 
how long the complaint process should take, dropping the total days allowed from 250 to 
165 days and developing model letters to improve the readability of PRO responses to 
complainants.4  It also conducted three pilot programs to explore new approaches to 
different aspects of the complaint process (mediation to resolve complaints, structured 
implicit review to assess medical records, and various changes in investigating and 
managing complaints).5  However, it has yet to respond to the findings and 
recommendations from the pilot evaluation. 
CMS also began the process of revising the confidentiality regulations, but faced 
considerable hurdles in issuing a rule to allow a substantive response to complainants 
without explicit physician consent. CMS reports that it has been unable to publish the 
rule. It was on hold for over a year and withdrawn as of February 13, 2001, according to 
CMS Unified Agenda, the semiannual regulatory agenda published May 14, 2001.6 
This Inquiry and Report 
Having released our previous report 5 years ago, we now take a second look at the PROs 
beneficiary complaint process. This inquiry and report focus on the effectiveness of the 
complaint process and its role as a quality oversight mechanism. We exclude any 
examination of other major aspects of the PROs work, such as quality improvement 
projects and the payment error reduction program. 
Our inquiry drew on several data sources. We received national budget data for the fifth 
and sixth contract periods from CMS.7  We collected information from CMS data 
contractor on the volume and outcome of beneficiary complaint reviews as well as the 
type of and audience for PRO outreach efforts from August 1997 through July 1999. We 
also conducted a mail survey of the PROs in each State plus the District of Columbia, for 
which we achieved a 100 percent response rate.8  In addition to completing the survey, we 
asked each PRO to provide us with 3 examples of recent responses to beneficiary 
complaints; we received 101 such responses.9  We visited 3 PROs of different sizes in 
States representing 15 percent of the beneficiary population. While on site, we 
interviewed staff involved in complaints and reviewed 82 completed beneficiary 
complaint files, 16 of which involved no confirmed quality-of-care problems and 66 of 
which involved at least 1 confirmed quality-of-care problem. We also interviewed 
stakeholders in CMS, the American Health Quality Association (of which PROs are 
members), AARP, and the Citizen Advocacy Center (which represents public members of 
PRO boards, among others). Finally, we reviewed relevant laws and documents, such as 
the PRO manual and the pilot evaluation, The Medicare Beneficiary Complaint 
Alternative Methods Study, among others. 
2 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  We conducted this study in accordance with the Quality Standards for Inspections issued 
by the Presidents Council on Integrity and Efficiency. 
3 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  T H E   S I G N I F I C A N C E   O F  T H E
P R O s   C O M P L A I N T   P R O C E S S  
In 1995, CMS set forth its vision of the successful PRO in 5 years. CMS envisioned that 
the PROs will have earned a position of trust in the eyes of plans, providers, and 
practitioners and beneficiaries . . .based on responsive investigation of complaints and 
protection of consumers.10 
Five years have passed since CMS wrote this vision statement. The PROs complaint 
process, mandated by statute, continues to serve as the key instrument for protecting the 
38 million Medicare beneficiaries from practitioners and providers who pose harm. The 
complaint process can act as a means of identifying such practitioners and providers and, 
if necessary, triggering appropriate interventions and follow-up. This corresponds with 
one of the three purposes of the PRO program that CMS defined in its recent contract with 
the PROs: to protect Medicare beneficiaries. 11 
Below we identify two main reasons that underscore why the complaint process is an 
important safety valve in quality oversight. 
Identifying Instances of Poor Care 
Complaints can expose serious instances of substandard care. In the 2-year period from 
August 1997 through July 1999, PROs completed 9,099 medical record reviews in 
response to complaints. On average, PROs identified problems in 13 percent of those 
reviews. Our previous inquiry reported similar proportions of confirmed reviews: across 
all PROs, between 10 and 15 percent of reviews initiated by complaints led to at least 1 
confirmed problem.12  Notably, according to the more recent data, 3 PROs confirmed 
problems in as many as 29 percent of records reviewed. 
From our complaint file review, we found several examples of patient risk and harm that 
PROs identified and confirmed as problems through the complaint process. These 
examples represent technical quality concerns, which deal with clinical decisions and 
expertise: 
C	 Inappropriate transfer. During bladder surgery in an ambulatory surgical center, a 
beneficiary suffered complications that were improperly treated. The surgical center 
transferred him by wheelchair to a hospital six blocks away. A PRO physician 
reviewer called this transfer method repulsive and negligent because the ailing 
beneficiary was wheeled down the street dressed in a hospital gown with his family 
following him. 
C	 Delay in treatment. A beneficiary experienced a sharp decline in health due to a 
delay of treatment for an abdominal aortic aneurism. 
4 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  C	 Missed medications.  For 6 days after being transferred from a hospital to a skilled 
nursing facility, a beneficiary failed to receive his medications as ordered by his 
physician to treat his heart failure and lung problems, despite continued complaints to 
the nursing home staff from his wife. 
Each of the examples above concerned the technical quality of care. But we also found 
complaints that alleged problems with the quality of services, such as facility 
maintenance, communication, and staff attitudes. One PRO official characterized these 
service concerns in terms of beneficiaries perception of and overall satisfaction with their 
health care experience. For example, a beneficiarys daughter complained that her mother 
was confused about caring for her eye after cataract surgery because her physician failed 
to clearly communicate follow-up instructions. Another beneficiary complained that staff 
in his skilled nursing facility placed him in a wheelchair that was insufficiently cleaned of 
urine. Service quality concerns that are ongoing, particularly in long-term care, can affect 
residents and patients quality of life. 
See appendix A for more details on the complaints we reviewed. 
Limits to Other Complaint Processes 
Several entities other than PROs address quality-of-care complaints from Medicare 
beneficiaries as well as from the general population. But each entity has some limits. 
Hospitals and most other health facilities have their own internal complaint mechanisms, 
but are limited to those specific facilities. State survey agencies that certify facilities for 
Medicare consider complaints a priority, but focus on those that relate specifically to the 
Medicare conditions of participation and can only address provider concerns. The Joint 
Commission on Accreditation of Healthcare Organizations, which accredits most hospitals 
that participate in Medicare, gives complaints limited attention during its surveys and 
rarely schedules special surveys in response to complaints.13  Ombudsmen programs serve 
as advocates for residents in long-term care facilities and often investigate complaints, but 
generally lack clinical expertise to review medical records. Professional licensing boards, 
such as those that license physicians, routinely respond to complaints, but have 
historically struggled with quality-of-care complaints.14 
Medicare beneficiaries can also choose to pursue complaints through the courts. 
Malpractice court cases can address quality concerns, but memory lapses, pretrial delays, 
and limited finances tend to work against the elderly and ill in malpractice litigation, 
which is often lengthy and expensive. Moreover, malpractice attorneys working on a 
contingency fee basis have less incentive to accept retired or elderly clients such as 
Medicare beneficiaries who may receive minimal monetary awards from lost work 
earnings.15 
5 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  F I N D I N G S  
The PROs complaint process is an ineffective safety valve for
Medicare beneficiaries.  It has improved little over the past 5 
years. 
We developed a template for an effective complaint process based on prior inspection 
work on dialysis facility oversight.16  In testimony before Congress on dialysis facilities, 
CMS endorsed the elements as essential to an effective complaint system.17  We think it is 
just as relevant to the complaint process of Medicare PROs. The table below profiles the 
elements in our template and how well PROs fared in each element. 
Element  Characteristics of an  Characteristics of the 
Effective Complaint  PRO Complaint Process 
Process 
1.  Accessibility  Complainants are aware of the system  Hotline calls are inconsistently answered. 
and find it easy to use.  Success of PRO outreach is unknown. 
2.  Investigative  Appropriate experts, resources, and  PROs rely on medical record review, which is 
capacity  methods are available to assess  their strength, but they are unlikely to identify 
complaints and determine if they are  patterns. Medical record review is limited to 
part of an underlying pattern.  addressing technical quality concerns. 
3.  Interventions and  Substantiated complaints result in  Most common interventions are letters. 
follow-through  appropriate corrective action.  Corrective actions are rare. Few referrals to 
Monitoring assures compliance.  other entities. Little follow-up. 
4.  Quality  Complaints guide quality  Quality improvement projects rarely stem 
improvement  improvement efforts.  from complaints: only one PRO implemented 
orientation  a project based on complaints. 
5.  Responsiveness  Responses to complainants are  Current procedures continue to preclude 
regular, substantive, and clear.  PROs from responding substantively; 
physicians often fail to consent to disclosure. 
PROs vary in their responses; they report that 
beneficiaries are frustrated. 
6.  Timeliness  Each step is completed within an  Most complaints exceed the established 
established, reasonable time frame,  timeframes for reviewing complaints. 
and mechanisms exist to deal with 
emergent complaints in an expedited 
manner. 
7.  Objectivity  The review process is unbiased,  Information gathered suggests that the 
balancing the rights of each party.  process is fair. 
8.  Public  Complaint information is made  Little complaint information is publicly 
accountability  available to the public.  available. 
6 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Five years ago we examined the PROs beneficiary complaint process and found it to be 
seriously flawed. This time, we examined it more closely, gauging it by each element in 
our template. What we found was a complaint system that falls short in each element, with 
the exception of objectivity. Beneficiaries looking for an easy-to-use complaint system 
that will hold physicians and facilities accountable for quality-of-care problems and 
respond to beneficiaries in a meaningful way will be left frustrated and disappointed by the 
PROs beneficiary complaint process. Below we offer, in more detail, our assessments of 
the major elements in our template. 
Accessibility 
An effective complaint process is widely known and easy to use. 
Accessibility is questionable.  Our experience calling a sample of PROs raised 
concerns about how easily beneficiaries can access information through the toll-free 
numbers that PROs maintain. Though PROs train staff to assist beneficiaries in submitting 
complaints, we had trouble reaching such trained staff (see box). 
In addition to calling 10 PROs, we  Calls to 10 PROs 
called 1-800-MEDICARE, the phone 
number for a Medicare information  We called PROs in 10 States containing 54 percent 
of the Medicare population and asked operators to 
hotline, which is commonly included 
explain how a beneficiary with a quality-of-care 
on Medicare publications. The first 
complaint can use the PRO complaint process. 
day we reached a busy signal. 
Calling again the next day, we  2 Calls	 Reached Busy Signals. Repeated attempts 
reached a recording that presented no  over several hours resulted in busy signals. 
2 Calls 	 Reached Recordings. One requested an 
menu option for PROs or for quality-
access code, without explanation. One 
of-care concerns. Although CMS has 
recorded phone numbers for return calls. 
not measured the accuracy of PRO  6 Calls	 Reached Operators. One provided us with 
information provided by telephone, it  contact information for the State medical 
reported that in 1999 only two of  board, and explained that the board is the 
appropriate place for Medicare 
three Medicare beneficiaries received 
beneficiaries to bring quality-of-care 
responsive answers from Medicare 
complaints. One transferred us to a voice 
sources, meaning one of every three 
mail system without providing any 
received either no answer or an  information. Four provided accurate 
incorrect answer.18  information. 
According to our PRO survey, even 
beneficiaries who are aware of the PROs often lack a clear understanding of the complaint 
process. Many PROs identified inadequate beneficiary understanding of the complaint 
process as a barrier to achieving effectiveness.19 
All PROs conduct outreach to improve beneficiary awareness and understanding of the 
complaint process. The most common outreach activities are presentations at venues such 
7 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  as area agencies on aging and senior centers. Many PROs also coordinate outreach with 
State Health Insurance Partnership programs, Departments of Public Health, and the Social 
Security Administration, among others. However, PROs are not required to coordinate 
their outreach efforts with other relevant State entities. PRO contracts merely require them 
to take note of and avoid duplicating the outreach efforts of others.20 
The effectiveness of these outreach efforts, however, is unknown. For example, States 
conducting the highest rates of outreach do not necessarily have the highest rates of 
complaints, as measured by how many medical records they review.21  Outreach budgets 
are limited; under the fifth contract, average outreach spending constituted about 6 to 7 
percent of the total PRO budget.22  Despite CMS target to improve beneficiary education 
in its FY 2000 Performance Plan, the level of outreach funding did not change significantly 
under the sixth contract.23 
Investigative Capacity 
An effective complaint process has the appropriate experts, resources, and methods 
available to assess complaints. 
Strength in medical record review. PROs review medical records to investigate 
complaints. They have not only the expertise necessary for reviewing medical records, but 
also the authority to request the medical records, plus the access to the medical specialists 
needed for such reviews. PROs have a depth of experience in reviewing medical records 
that CMS, State survey agencies, and others are hard-pressed to match. 
PROs request only those medical records related to the complaints they receive. This often 
means they review multiple records. In our review of 82 complaints, 20 complaints 
involved 2 care settings and 5 involved 3 care settingswhich meant these PROs reviewed 
at least 55 records for those 25 complaints. 
Unlikely to review a sample of records. PROs tend to treat complaints as individual 
incidents, rather than as potential signs of systemic problems. When a PRO confirms a 
quality-of-care concern in a particular record, it is unlikely to pull extra records to 
determine whether an underlying pattern exists. PROs do have the authority to review 
extra records under such circumstances, but are unlikely to know whether the medical 
licensing board, State survey agency, or other overseer is investigating the same physicians 
or facilities. Without such knowledge or additional reviews, the likelihood of documenting 
a pattern based only on PRO data is low. One PRO medical director noted that identifying 
a pattern relies on corporate memory. According to the responses to our survey, just 9 of 
50 PROs identified a pattern of concerns based on reviewing complaints under their fifth 
contract, a period exceeding 3 years. 
Limits of medical record review.  While medical record review is well-suited to 
investigating complaints about technical quality of care, PROs also receive complaints 
8 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  concerning service quality. Medical records shed little light on those concerns. We asked 
officials at 24 PROs how they handled service quality, such as complaints about 
communication or facility maintenance. Twenty-two indicated they referred those 
complaints to others.24  They simply consider service-related complaints non-PRO issues. 
Among the 20 service-related concerns we identified during our on-site review of 
complaints, we saw documentation that PROs referred 2 to another entity. According to 
our site visits, PROs rarely hear back any results of investigations on referred complaints. 
Finally, PROs do little beyond the medical record review to investigate complaints, and are 
not expected to do more. They do not routinely conduct interviews with the parties 
involved, although in many cases, some semblance of a beneficiary interview occurs if a 
beneficiary complains to the PRO hotline staff, who then translate the complaint into 
writing.25 
Interventions and Follow-Through 
An effective complaint process triggers appropriate interventions and monitoring 
based on substantiated complaints. 
Most common interventions are letters. PROs rarely take any action beyond a 
notification letter to providers and practitioners in response to confirmed quality concerns 
based on complaints. PROs consider these letters to be educational interventions because 
they include references to how the care should have been handled by the physician or 
facility. PROs generally prefer these educational approaches, finding them more in line 
with the quality improvement orientation that is a centerpiece of their contracts. We 
reviewed 66 complaints with confirmed concerns. A PRO confirms a concern only after 
multiple layers of review, including an opportunity for the physician and provider in 
question to comment or provide additional information. In each of those 66 cases the PRO 
responded with such a letter.26 
Occasionally, PRO interventions exceeded the notification letter. In 6 of the 66 complaints 
with confirmed concerns, the PROs, based on the severity of the review findings, also 
called for a corrective action plan. In five of those six, the PRO found the facility 
responsible for the quality-of-care concern; in one case, the physician. PROs called for 
corrective action aimed at preventing further problems, including updating or clarifying 
policies or conducting in-service training. We saw no examples of a PRO calling for 
remedial training, coursework, or special supervision. Furthermore, we saw little evidence 
of particular follow-through by the PRO to ensure that the facilities had, in fact, changed 
their policies. We found no example of a PRO pulling extra records for review to 
determine if the problem persisted, for example. In each case, the PROs letters indicated 
that the problem would be entered into a database and tracked to determine whether a 
pattern developedbut one medical director told us that little tracking actually occurred.27 
9 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Referrals to licensing boards rare. More serious interventions, such as referring a 
physician to the State medical board based on the findings of a medical record review, were 
even rarer.28  We surveyed the PROs about such referrals based on beneficiary complaints. 
Just 9 of the 50 PROs that responded to our survey reported making such a referral at least 
once during their fifth contracta period that exceeded 3 years. Likewise, PRO referrals 
to State survey and certification agencies are uncommon: six PROs reported making such 
referrals for confirmed concerns during their fifth contracts.29 
Patterns difficult to establish. PROs cite the need for establishing a pattern of 
concerns through medical record review before applying an intervention beyond the 
traditional notification letter.30  Determining whether a concern is part of a larger pattern is 
crucial for the PROs to determine an appropriate intervention. However, establishing a 
pattern is increasingly difficult because they lack the volume of case review to identify a 
pattern. They do, however, have the authority to investigate whether a larger pattern exists 
by requesting additional cases to review.31  But they rarely invoke it. In responding to our 
survey, 9 out of 50 PROs reported identifying a pattern of quality concerns based on 
complaints during the whole fifth contract period. 
Occasional voluntary corrective actions.  Sometimes facilities took initiatives to 
implement corrective actions before the PROs even confirmed that a quality-of-care 
concern existed. In those cases, the facilities took action based on the PROs letter 
indicating that a potential quality-of-care concern existed. In those cases, the facilities 
were generally familiar with the PRO review process. In our review, we found six 
examples of such voluntary corrective actions. Four involved hospitals; one, an 
ambulatory surgical center, and; one, a skilled nursing facility. In each case, the voluntary 
actions involved improved or changed policies or in-service training. 
Mediation represents a questionable alternative intervention.  Five PROs 
piloted mediation as an alternative for resolving beneficiary complaints.32  In theory, 
mediation holds promise. It attempts to resolve disputes for beneficiaries by bringing 
together the beneficiary and provider or practitioner with a skilled mediator to foster 
agreement. However, the pilotwhich was very limited in scoperaises significant 
questions about its applicability to beneficiary complaints. It was labor-intensive, 
involving considerable outreach and education to all parties. In the end, 28 of 58 
beneficiaries accepted the PROs offer of mediation, and of these, only 11 providers agreed 
to mediate as well. Bringing together a beneficiary and provider or practitioner can present 
a burden to both parties, particularly a frail beneficiary. Furthermore, there is likely to be a 
perceived imbalance of power between the participants. The pilots experience in reaching 
resolutions between the parties was poor: just 3 of the 11 mediation cases ended up 
resolving their concerns to the beneficiaries satisfaction. 
The evaluation of the mediation pilot recommended that mediation be tested on a larger 
scale before implementation.33  Among the unanswered questions left by the pilot are: 
What types of complaints are appropriate/inappropriate for mediation? Should the severity 
of harm be considered? What role would medical record review have in mediation?  To 
what extent is mediation a burden to complainants who may be elderly or frail? How does 
mediation serve as a beneficiary protection if there is no intervention or follow-up? Do the 
10 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  benefits of mediation justify the resources spent on training PRO staff and educating 
providers and beneficiaries? 
Quality Improvement Orientation 
An effective complaint process guides quality improvement. 
Quality improvement projects rarely stem from complaints. Complaints have 
been a poor source of information on which to base quality improvement projects, which 
are the focus of the PROs contracts with CMS.34  The difficulties in identifying a pattern 
of complaints coupled with the PROs current contracts, which stress national quality 
improvement projects as opposed to local projects, make complaints an unlikely source for 
such projects. Even under their last contract, under which local projects played a larger 
role, just 1 of 50 PROs reported implementing a quality improvement project based on 
beneficiary complaints.35 
Responsiveness 
An effective complaint process provides regular, clear, and substantive responses to 
complainants. 
Limited responses. We found that beneficiaries generally received correspondence 
from the PRO twice: once at the beginning of the complaint process when the PRO 
acknowledges the complaint and explains the process, and again at the close of the review 
when the PRO sends a final letter(s). In our review of 82 complaints at 3 PROs, we found 
minimal documentation of ongoing written communication between PROs and 
beneficiaries during the review process, even though the PRO manual instructs PROs to 
recontact the complainant whenever you experience any delays with your review and 
provide the reason for the delay.36  We did, in fact, find delays in the review process to be 
common. In some cases, however, we did see evidence of beneficiaries calling and 
discussing their complaints with the PROs during the review process. 
Consent for disclosure remains problematic.  Current procedures require PROs to 
obtain consent from the physicians who provide the care in question before the PROs can 
share their review results with beneficiaries (however, on July 9, 2001, a Federal district 
court judge found that these procedures are contrary to Federal law).37  Without that 
consent, PROs can respond to beneficiaries complaints only in the most general way. But 
PROs have a difficult time obtaining physician consent, particularly when the medical 
record review identifies quality-of-care issues. PROs obtain consent in just 21 percent of 
complaints where a quality-of-care concern is confirmed. They obtain consent twice as 
often42 percentwhen no concern is confirmed.38  Because complaints often involve 
11 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  multiple care settings and physicians, obtaining consent can be complex if only some 
physicians consent. As a result of this consent requirement for complaints with several 
concerns, we also found that beneficiaries commonly receive multiple final response letters 
from the PRO, each letter dealing with a single aspect of the complaint. In one case, a 
beneficiary received eight final response letters from the PRO, all on the same day. 
Vague language. Our previous study defined a substantive response as including three 
components: (1) what the PRO did to investigate the complaint, (2) what the review 
revealed, including whether a quality-of-care problem was confirmed and, if so, the nature 
of the problem, and (3) if a quality-of-care problem was confirmed, what action the PRO 
took based on it.39  Overall, not all 
PROs are meeting all three 
Actual Language from Final
components. We reviewed over 
PRO Response to a Complainant 
100 final letters to beneficiaries 
from the PROs responding to our  THE FOLLOWING STATEMENT IS REQUIRED 
survey and found PROs vary  TO PROTECT CONFIDENTIALITY. . . 
UNAUTHORIZED DISCLOSURE OF PRO 
widely in the type and quality of 
CONFIDENTIAL INFORMATION MAY RESULT 
information they provide 
IN A $1000 FINE AND/OR 6 MONTHS 
beneficiaries. We often found the 
IMPRISONMENT IN A FEDERAL 
letters to lack plain language and  PENITENTIARY. 
even include intimidating 
references to statutes and 
regulations (see box). 
All letters did explain that PROs investigate complaints through medical record 
reviewinformation also spelled out in PROs initial letters acknowledging the receipt of 
the complaint. However, 24 percent of the final letters excluded a summary of the original 
complaint. We also found the responses to fall short of describing what the review 
revealed. Even when PROs received consent, some used language so vague that we had 
difficulty determining the nature of the problem.40  Likewise, the PROs used vague 
language in describing their follow-up of confirmed problems, offering explanations such 
as appropriate action has been or is in the process of being taken to prevent problems of 
this type from occurring in the future.41 
CMS does provide PROs with a manual to guide and standardize how they operate, 
including sample letters to complainants. Despite specific instructions for PROs not to use 
the samples as form letters, many PROs do just that, without providing any case specific 
details. Through our survey and site visits, many PRO officials reported finding the 
manual to be both confusing and of limited usefulness.42 
Beneficiaries frustrated.  PROs reported, both through our survey and site visits, that 
beneficiaries are often unsatisfied after the PRO completes its review and want closure 
after months of waiting. They want to know what specific actions the PRO took in 
response to their particular complaints. 
12 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Timeliness 
Each step in an effective complaint process is completed within an established, 
reasonable time frame, and mechanisms exist to deal with emergent complaints in 
an expedited manner. 
Established time frames difficult to achieve.  PROs continue to face difficulties in 
meeting CMS prescribed time frames for completing their reviews of beneficiary 
complaints. Since our 1995 inquiry, CMS shortened the target time frames considerably, 
from 220 to 150 days.43  Despite the reduced time frames from CMS, 43 of 55 complaints 
we reviewed that had complete date information exceeded the allowed time frames for 
review.44 
PRO officials identified a few major obstacles that prevent a more timely process. 
Collecting medical records from multiple care settings can cause delays, particularly when 
one of the settings is unaccustomed to working with the PRO. Unlike hospitals, settings 
such as physician offices and home health agencies have had less interaction with PROs, 
which means PROs may need to educate them to get records. Some PRO officials noted 
that their lack of authority to deny payments in certain settings can affect how responsive 
those places are in sending medical records. 
In recent pilots, a few PROs experimented with revised approaches to the complaint 
process, such as using a case manager to manage communications with the provider or 
beneficiary. The pilot evaluation found this approach to be more timely. 
Public Accountability 
An effective complaint process makes complaint information available to the public. 
Little information available.  Neither CMS nor the PROs make much complaint 
information available to Medicare beneficiaries and other interested parties, such as 
advocates. CMS does not release any aggregate national data on complaints. In fact, 
CMS own data system does not directly count actual complaints, though that number can 
be deduced through programming.45  The data system does count how many medical 
records were reviewed by PROs due to a complaint. Because one complaint can trigger 
multiple reviews, that number is a poor proxy for how many complaints PROs actually 
receive over a given period. 
Thirty-six out of 51 PROs reported that they release some complaint information, usually 
through their annual reports. The most commonly released piece of information was 
simply the number of complaints received. Fourteen of these PROs reported that they 
13 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  released information on the types of complaints they received and 15 on the outcome of 
review. 
PROs face two major obstacles to achieving a more effective
beneficiary complaint process. 
CMS contracts with PROs treat complaints as a distinctly minor activity.  The 
contracts stress quality improvement and payment error reduction. 
CMS current contract with the PROs divides their functions into six specific tasks. Half 
of those tasks relate to CMS Health 
Care Quality Improvement Program, 
which has been a major focus of the  Estimated PRO Budget for the 6th Contract Period, 
by Contract Task 
PROs over the past 7 years. Those 
tasks include quality improvement  Task  Budget  Percent 
projects that are national, local, and  (In millions) 
related to Medicare+Choice plans. 
1. National QI Projects  $237  36% 
The fourth task concerns CMS new  2. Local QI Projects  $ 81  12% 
Payment Error Prevention Program,  3. Medicare +Choice

QI Projects  $ 49  8%

which is designed to protect the 
4. Payment Error 

integrity of the Medicare Trust  Prevention Program  $148  23%

Funds. Together, these tasks  5. Other Contract Activities*  $122  18% 
6. Special Projects  $ 21  3% 
represent 79 percent of CMS 
estimated budget for all tasks in the 
* Mandatory case review is estimated to cost about $49 
sixth contract period (see box). The  million, which is 7 percent of the total estimated budget. 
Source: OIG Analysis of budget data provided by CMS for 
contract also calls for each PRO to 
the 6th scope of work (excludes information services). 
have two leadership positions: a 
director for the Health Care Quality 
Improvement Program (tasks 1 
through 3) and a director for the Payment Error Prevention Program (task 4). 
Despite beneficiary protection being identified elsewhere in the contract as one of three 
major functions of the PROs, the complaint process falls under task 5 of the contract, 
labeled Other Contract Activities.46  Representing 18 percent of the estimated budget, the 
Other Contract Activities section serves as a catch-all. It covers outreach and all 
mandatory review categories, which include complaints as well as hospital-issued notices 
of noncoverage, among others. Mandatory reviews, however, represent just 7 percent of 
the total estimated budget (see box). Unlike the requirements for the Quality Improvement 
and Payment Error Prevention Programs, the contract requires no director assigned to 
beneficiary protection or mandatory case review. 
CMS oversight of the PROs reflects the focus of the contract, with the most attention on 
the Health Care Quality Improvement (task 1) and Payment Error Prevention (task 4) 
Programs. The contract includes some performance expectations for those tasks. CMS did 
not publish its evaluation standards for the PROs until April 26, 2001, fully 21 months into 
14 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060   a contract period expected to last 36 months. Those criteria require little more than for 
CMS, through its regional project officers, to monitor electronically submitted data on the 
medical record reviews conducted by each PRO. Before those criteria were published (for 
the first 21 months of the contracts), CMS project officers, located in four regional offices, 
relied on checklists and site visits to monitor the PROs. We spoke with a project officer in 
each region, and while they vary in their approaches, they reported that their focus was on 
quality improvement and payment error prevention. For those that did review the 
beneficiary complaint process, their review was largely administrative and focused on 
documentation. 
PROs tend to be more oriented to the medical community than to the beneficiary 
community.  This helps them in conducting quality improvement projects but can 
hinder them in developing a more effective beneficiary complaint process. 
Investigating complaints thoroughlyseeking additional cases for review based on 
complaints and intervening with corrective actions in cases that fall short of the provider or 
practitioner grossly and flagrantly violating standards of carecan undermine the PROs 
relationships with the medical community.47  The focus of the PROs contracts puts a 
premium on those relationships. Without cooperation and support from the physicians and 
providers, the PROs would be hard-pressed to conduct any of their quality improvement 
projects. And given how significantly such projects figure in the PROs contracts and 
CMS evaluation of the PROs, those relationships become a priority. In fact, PROs are 
inherently tied to the medical community. CMS requires PROs to have the support of 
physicians in their States, which PROs must demonstrate at the start of each new contract. 
Furthermore, while PRO boards must have one consumer representativedefined as a 
Medicare beneficiaryall the other members may be physicians and other health care 
professionals.48 
The PROs orientation toward the provider community is not new. In fact, PROs 
traditionally have exhibited a reluctance to take on a more enforcement-oriented role that 
might undermine their relationships with the medical community. They have rarely, for 
example, referred physicians or providers for sanction. PROs have referred just six 
providers or practitioners for sanction in the past 5 years, and none in the past 2 years.49 
They prefer educational approaches, which are more in line with their quality improvement 
efforts, over punitive approaches. This reflects CMS view of the PRO program as 
operating in a penalty-free environment.50  The orientation toward the provider 
community was reinforced in 1993 with the onset of the Health Care Quality Improvement 
Program and the parallel decline in medical record review requirements. To date, the 
PROs preference for educational approaches remains strong, which leaves little room for a 
credible complaint process. 
15 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  R E C O M M E N D A T I O N  
This report focuses on the PROs complaint process. That process is available in each 
State for Medicare beneficiaries with concerns about the quality of care they receive. 
PROs bring a great deal of expertise to the process given their extensive experience in both 
reviewing medical records and working with beneficiaries. However, we found that the 
complaint process falls short of providing an effective safety valve for beneficiariesjust 
as we did 5 years ago. It has major shortcomings: it is hard-to-use, it rarely holds 
individual providers or practitioners accountable, and its responsiveness to beneficiaries is 
limited, leaving them frustrated and unsatisfied. Fundamentally, the complaint process 
represents a minor activity in a program more concerned with overall quality improvement. 
While fostering improvement represents an important goal, providing beneficiaries with a 
meaningful complaint process also serves an important goal of protecting beneficiaries 
from harm. 
CMS must exert strong leadership to address the shortcomings we identify and provide 
beneficiaries with an effective complaint process. In our draft report, we presented a series 
of recommendations on how CMS could achieve an effective complaint process. In this 
final report, we have revised our recommendations and present CMS with two options on 
how it can achieve an effective complaint process. The recommendations from the draft 
report are fully incorporated under the first option. 
CMS should provide Medicare beneficiaries with an effective
complaint process that meets the eight criteria identified in
our template. 
This is our core recommendation. Our template, which is on page 6, spells out the 
characteristics of an effective complaint process in each of the following eight elements: 
accessibility, investigative capacity, interventions and follow-through, quality 
improvement orientation, responsiveness, timeliness, objectivity, and public accountability. 
CMS has already endorsed these elements in Congressional testimony and in comments on 
a previous OIG report, calling them essential.51 
Below we present two options for CMS to consider in achieving an effective complaint 
process for Medicare beneficiaries. The first focuses on fixing the process within the PRO 
program; the second focuses on establishing a complaint process outside of the PRO 
program. Following the two options, we briefly identify some issues that CMS must 
address in pursuing either option. 
16 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Option 1: CMS could fix the complaint process within the existing PRO 
program.  Toward that end, it must 
Make the complaint process more prominent in the PRO program. Increasing 
the prominence of the complaint process is the first step toward achieving an effective 
beneficiary safety valve. To make a difference, CMS must give the beneficiary complaint 
process more stature in the contract. It must remove the complaint process from the 
category of Other and give it its own section. Without the fundamental commitment 
from CMS for those changes, any efforts to improve the complaint process through policy, 
contractual, or regulatory changes will be marginal at best. Indeed, CMS should look 
beyond the PRO program itself for ways to enhance the stature and support of the 
complaint process. CMS could, for example, enhance the 1-800-Medicare telephone 
service by adding a menu option about how to lodge a complaint with the PROs. 
Giving the complaint process more prominence as a beneficiary protection is in line with 
CMS own mission, vision, goals, and objectives, as spelled out in its Strategic Plan.52  In 
fact, CMS Strategic Plan includes a specific objective aimed at protecting beneficiaries 
from substandard care and identifies an effective complaint mechanism as a strategy for 
achieving that objective. Furthermore, it emphasizes the themes of 
accountability/stewardship and a renewed focus on the customer and a renewed 
Agency commitment to beneficiaries as the ultimate focus of all CMS activities, 
expenditures, and policies.53 
Specify its expectations through its contracts with the PROs. CMS should 
expect a basic level of performance from the PROs in each of the eight elements. It should 
articulate those expectations in its contracts. The contractsas opposed to the PRO 
manualrepresent CMS best mechanism for articulating those expectations. CMS could 
consult with the PROs and other stakeholders to develop the explicit expectations element 
by element. For example, under the accessibility element, CMS could expect that PRO 
hotlines are easier to find (e.g., by including the numbers in CMS publications and 
requiring better listings in phone books under the yellow pages or blue government pages). 
It should expect that those numbers are also answered appropriately. Under investigative 
capacity, it should clarify its expectations for referral relationships and follow-up with 
entities such as survey and certification agencies. Under responsiveness, it could expect 
the kind of substantive responses we called for in our report 5 years ago (which would also 
reflect the July 9, 2001 findings of a Federal district court judge, who ordered the 
Department to instruct PROs to disclose the results of PRO complaint investigations to 
beneficiaries).54 
Consider different contracting approaches for the complaint process. The 
shortcomings we identify in this report are serious. They undermine the ability of the 
complaint process to function as an effective safety valve. They may be so serious, in fact, 
as to warrant an overhaul of how the PRO program is structured, financed, and managed. 
It may be time to search for some creative solutions. For example, as PRO quality 
improvement projects tend toward more nationalas opposed to localapproaches to 
benchmarking, so too, perhaps, could complaint determinations. Below are three 
contracting options CMS could consider. 
17 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  First of all, CMS could modify the current contract with the PROs. In modifying the 
contract to give the complaint process more prominence, CMS could require each PRO to 
have a leadership position devoted to beneficiary protection, parallel to the directors called 
for in the contract to oversee the Quality Improvement and Payment Error Prevention 
programs. It should specify measurable performance expectations for the complaint 
process. Of the three options, this option would likely offer the most flexibility. But, 
because of the PROs existing orientation to providers, it could make achieving a more 
prominent complaint process difficult. 
Second, CMS could consider a separate contract with the PROs. Such a separate contract 
should focus on the whole complaint process, the related outreach activities such as the 
hotline, or some parts of each. Some PROs would likely develop into complaint specialists 
through this approach and compete for complaint contracts in multiple States. This 
approach has the advantage of a contract with a singular mission, but could result in some 
coordination problems within or among PROs. 
Third, CMS could consider a subcontract through the PROs. Like the second option, this 
approach gives the complaint process more prominence by allowing it to be the singular 
mission of the subcontract but shares the same potential problem with coordination. This 
approach would open the field of potential contractors to include any organizations capable 
of delivering the subcontracts requirements for an effective complaint process. Such 
organizations would compete to win the subcontract, which PROs would manage. 
We recognize that some legislative changes may be necessary to carry out some of these 
strategies.55 
Hold the PROs more accountable for providing an effective complaint 
process. CMS should revise and expand its criteria for evaluating the beneficiary 
complaint process. The current criteria, published in the Federal Register April 26, 2001, 
make no specific mention of that process. In the meantime, though, CMS should find ways 
to hold the PROs accountable for their contractual requirements, including developing 
relevant performance measures and performance incentives. Once again, our template 
could serve as a framework for CMS in defining such measures and incentives. CMS 
could work with the PRO community to develop them. 
Furthermore, CMS should make information publicly available on the numbers, nature, and 
outcomes of complaints investigated by the PROs. It could do this through its website and 
by requiring PROs to include their State-specific information in their own websites and in 
their annual reports. CMS could work with the PRO community to determine the scope of 
such information. 
18 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Option 2: CMS could establish a complaint process outside of the PRO 
program. 
This option represents a significant departure from how CMS has handled beneficiary 
complaints to date. It would require legislative change. 
As we have defined it, this option must include a mechanism to deal with complaints about 
facilities as well as individual practitioners. In other words, it must have the same scope as 
the existing PRO programs complaint authority. It must also have a mechanism to educate 
beneficiaries about how to register their complaints. CMS has some choices in how to 
establish a complaint system outside of the PRO program to achieve that. For example, it 
could establish an entirely new program or contract mechanism focused on complaints and 
reaching out to beneficiaries about their rights to complain. It could create new 
mechanisms to deal separately with complaints and outreach. It could even develop 
alternative mechanisms for mediating certain types of complaints. Or it could build on 
existing entities that conduct similar work. We explore the latter in more detail below. 
State survey and certification agencies already respond to complaints about care provided 
in certain facilities. Indeed, they are often the frontline responders to adverse events and 
complaints. They have agreements with CMS to respond to complaints about certain 
facilities that participate in the Medicare program.  These agencies usually have State 
licensure authorities for certain provider types in addition to the authority stemming from 
their agreements with CMS. Currently, CMS agreements with State survey and 
certification agencies emphasize nursing homes, home health agencies, and hospitals while 
excluding certain provider types, such as managed care organizations and physician 
offices. If CMS were to look to these agencies under this option, it would have to modify 
its agreements with them to ensure that complaints about all provider types would be 
equally covered. 
Medical licensure boards also already respond to complaints from the general public. 
Unlike State survey agencies, which focus on facilities, licensure boards focus on 
individual practitioners. In general, the mission of these boards is to protect the public by 
ensuring that practitioners have the appropriate skills, knowledge, and conduct to practice 
medicine safely. Responding to complaints about practitioners is a central function of 
these boards, which have the authority to intervene and take action against an individuals 
license to practice medicine. CMS already requires that practitioners who participate in 
Medicare be appropriately licensed by the medical board in their States of practice. 
Under this option, PROs would no longer be handling complaints, so the job of educating 
beneficiaries must also be placed elsewhere. Educating beneficiaries about their rights to 
complain as well as how to lodge a complaint is critical to ensuring an accessible complaint 
system. Many groups exist that provide support and outreach to Medicare beneficiaries. 
The State Health Insurance Partnership Program, for example, already receives funding 
from CMS to counsel and assist Medicare beneficiaries with health insurance-related 
concerns. This grant program exists in each State. 
19 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  Finally, just as we called for under the first option, CMS would have to specify its 
expectations for each of the elements in our template, hold the complaint system 
accountable for performance, and make information publicly available on the numbers, 
nature, and outcomes of complaints. How this would unfold would depend on what a 
complaint process outside of the PRO program would encompass. 
Issues for CMS to Consider 
The two options above have advantages and disadvantages for CMS to weigh as it 
considers how to best achieve our core recommendation, which is an effective complaint 
process for beneficiaries. Below we highlight those issues we consider paramount. 
 To what extent would establishing a complaint process outside of the PROs isolate the 
PROs from beneficiaries, who are the centerpiece of CMS programs? 
 To what extent would fixing the complaint process within the PRO program exacerbate 
the tension between the quality improvement and complaint responsibilities of the PROs? 
 To what extent does each option require legislative and regulatory changes to ensure that 
the complaint process functions with the appropriate authority and scope? 
 What are the resource implications of each option? 
The entities identified in each optionPROs, State survey and certification agencies, and 
medical licensure boardsall have performance track records in how well they respond to 
complaints. None of those records is without blemish.56  We urge CMS to carefully 
consider these issues, and others it identifies, as it deliberates on how to best achieve an 
effective complaint process for beneficiaries. 
20 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  C O M M E N T S  O N  T H E 
D R A F T   R E P O R T  
CMS did not provide detailed comments on the recommendations in our draft report. We 
look forward to receiving such comments in response to this final report. We solicited and 
did receive comments from the American Health Quality Association, Citizen Advocacy 
Center, the AARP (formerly the American Association of Retired Persons), and the 
American College of Physicians-American Society of Internal Medicine. Below, we 
summarize their comments. We urge CMS to consider the comments we received. 
Appendix B contains the full text of all the comments. 
The American Health Quality Association 
The American Health Quality Association agreed that CMS and the PROs should do more 
to make the complaint process more well-known and responsive to beneficiaries. To do so, 
the Association called for a reconfiguring of the complaint process and its funding to better 
integrate the principles of quality improvement within it. The Association called for CMS 
to implement a mediation and case management within the complaint process. 
Citizen Advocacy Center 
In its comments, the Citizen Advocacy Center emphasized that PROs are the appropriate 
entities to handle beneficiary complaints because of their unique expertise, access to 
records, and authority. It also emphasized beneficiaries rights to be heard and rights to 
redress. The Citizen Advocacy Center noted its support for the PROs focus on quality 
improvement and its view that a viable complaint process can be integrated into the quality 
improvement program. It identified further actions for CMS and the PROs to take to 
improve the complaint process. 
AARP 
AARP endorsed our template for an effective complaint process and found our 
recommendations useful. It noted that while it supports the quality improvement focus of 
the PROs, that focus does not preclude a more effective complaint process. It emphasized 
the importance of outreach and that PROs need to enhance their reputations as aggressive 
overseers of quality that value beneficiary input. AARP further recommended that CMS 
consider contract changes that would allow complaint reviews to be conducted by other 
regional PROs, thereby protecting the local quality improvement role. 
American College of Physicians-American Society of Internal Medicine 
Like the other commenters, the American College of Physicians-American Society of 
Internal Medicine agreed that an effective beneficiary complaint process is key to ensuring 
quality of care. It expressed its support for the current quality improvement focus of the 
PROs and emphasized that an improved complaint process can co-exist without 
21 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  compromising quality improvement. It further recommended that the complaint process be 
improved through making it more accessible and easier to use, including an informal 
complaint resolution process, and specifying more precisely what information a PRO can 
release that balances beneficiaries need for responsiveness as well as the trust of the 
medical community. 
22 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   A 
Profile of Complaints Reviewed 
Below we highlight information abstracted from the complaint files we reviewed at three 
PROs. We looked at 82 complaints in all, 16 of which had no confirmed quality-of-care 
concerns and 66 of which had at least 1 confirmed quality-of-care concern. Overall, we 
found complaints to be complex, ranging in types of concerns and care settings. 
Sources of Complaints.  PROs receive complaints from a variety of sources. 
Complainants either mail their written complaint directly to the PROs or allow PRO hotline 
staff to transcribe their complaint over the phone. While most complainants are Medicare 
beneficiaries or their representatives, some complaints are submitted anonymously. Of the 
82 complaints we reviewed, 13 were referrals from other entities. Most of these referred 
complaints came from CMS and Medicare fiscal intermediaries. 
Complaint Types. Complaints can raise a variety of allegations. Of the 82 complaints we 
reviewed, we identified 297 separate concerns that complainants wanted the PROs to 
investigate. On average, each complaint raised 3.6 concerns; one complaint had as many 
as 9 concerns. 
We organized these concerns into four main categories: 
1. Technical quality concerns, which question clinical expertise and decisions, such as 
the appropriate use of medications; 
2. Service quality concerns, which question facility maintenance and solicitude with 
patients, such as facility temperature and the friendliness of staff; 
3. Administrative concerns, which question general medical office management, such 
as errors in billing; 
4. Other concerns, which question issues beyond those of technical quality, service 
quality, and administrative concerns, such as instances of abuse and neglect. 
The table on the next page summarizes the number and percentage of each of those 
complaint types in the cases we reviewed. Overall, more complaints involved technical 
quality concerns than other types. 
23 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   A 
Type of Concern  Total Number of  Percent of Total 
Concerns  Number of Concerns 
Technical Quality  219  74% 
Service Quality  43  14% 
Administrative  11  4% 
Other  23  8% 
Unknown  1  <1%   
Total  297  100% 
Note: N=82 complaints

Source: OIG analysis of beneficiary complaints from three PROs, 2000.

One complaint can have a mix of these types of concerns, for example: 
C	 A beneficiary raised a technical quality concern that during his bladder surgery in an 
ambulatory surgical center he suffered complications that were improperly treated. 
The surgical center transferred him by wheelchair to a hospital six blocks away. He 
called this transfer method a traumatic ordeal as he was wheeled down the street 
dressed in a hospital gown with his family following him. This transfer method 
involved a service concern. 
C	 The wife of a Medicare beneficiary raised a quality concern that her husbands 
rehabilitation center discharged him to a skilled nursing facility still ill with an 
infection. She then questioned the service of the nursing staff who did not give her 
regular updates about her husbands health, especially about his decrease in appetite. 
C	 A Medicare+Choice beneficiary complained that he had used all of his lifetime 
inpatient mental health benefits because physicians in a hospitals alcohol and drug 
detoxification unit, psychiatric unit, and emergency room improperly admitted and 
treated him. This complaint raised not only administrative concerns that he was 
incorrectly billed for the care he received, but also technical quality concerns that he 
received unnecessary and harmful care. 
Care Setting. Complaints can also raise concerns about care given in multiple health 
care settings, such as hospitals, skilled nursing homes, emergency rooms, and physician 
offices, among others. From the 82 complaints we reviewed, 25 complaints concerned 
care given in 2 or more care settings. Five of these 25 complaints involved 3 care settings. 
24 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   A 
The table below summarizes the number of complaints that involved each care setting. 
Some complaints involved more than one care setting. Most complaints involved 
hospitals, but skilled nursing facilities and emergency rooms made up a significant 
number as well. 
Care Setting  Number 
Acute Care Hospital  44 
Skilled Nursing Facility  22 
Emergency Room  20 
Physician Office  16 
Home Health Agency  2 
Rehabilitation Center  2 
Ambulatory Surgical Center  1 
Psychiatric Unit in Acute Care  1 
Hospital 
Free-Standing Psychiatric  1 
Hospital 
Physical Therapy  1 
Radiological Center  1 
Hospice  1 
Outpatient Care Facility  1 
Note: N=82 complaints

Source: OIG analysis of beneficiary complaints from three PROs, 2000.

25 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
Detailed Comments on the Draft Report 
In this appendix we present the full text of the comments we received in response to our 
draft report. They include: 
C	 Centers for Medicare and Medicaid Services (formerly the Health Care Financing 
Administration) 
C  American Health Quality Association 
C  Citizen Advocacy Center 
C  AARP (formerly the American Association of Retired Persons) 
C  American College of Physicians-American Society of Internal Medicine 
26 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
27 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
28 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
29 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
30 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
31 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
32 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
33 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
34 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
35 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
36 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
37 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
38 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
39 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
40 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
41 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
42 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
43 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
44 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
45 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
46 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
47 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X   B 
48 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X  C  
Endnotes 
1. Omnibus Budget Reconciliation Act of 1986, Pub. L. No. 99-509. 
2. 42 U.S.C. sec 1320c-3 (a) (14). 
3. U.S. Department of Health and Human Services, Office of Inspector General, The Beneficiary 
Complaint Process of Medicare Peer Review Organizations, OEI-01-93-00250, November 1995. 
4. Health Care Financing Administration, Peer Review Organization Manual, 5020: 5-11 
through 5-12 and Exhibit 5-17 through Exhibit 5-18. 
5. The California PRO, California Medical Review Incorporated (CMRI), in collaboration with 
the University of California at San Francisco, RAND Corporation, and Center for Social 
Redesign, The Medicare Beneficiary Complaint Alternative Methods Study, 500-96-P535, 
Modification P00014, October 1999. 
6. 66 Fed. Reg. 93, 25389, May 14, 2001. 
7. The PROs fifth contract period began April 1996. The sixth contract period began in August 
1999 and is expected to last for 3 years. 
8. We excluded the PROs for Puerto Rico, American Samoa, Guam, and the Virgin Islands from 
this survey. 
9. We asked for final response letters where: (1) no quality-of-care concern was identified, (2) a 
quality-of-care concern was confirmed, and the practitioner consented to disclosure, and (3) a 
quality-of-care concern was confirmed, and the practitioner declined to disclosure. 
10. Health Care Financing Administration, The Successful PRO in 5 Years, Baltimore, MD, 
November 8, 1994. 
11. Sixth Scope of Work, R.F.P. No. CMS-99-001/ELH, March 1, 1999, p. 13. 
12. The Beneficiary Complaint Process of the Medicare Peer Review Organizations, 3. 
13. U.S. Department of Health and Human Services, Office of Inspector General, The External 
Review of Hospital Quality: A Call for Greater Accountability, OEI-01-97-00050, July 1999. 
14. For further discussion see: Mark R. Yessian, State Medical Boards and Quality Assurance, 
Federation Bulletin: The Journal of Medical Licensure and Discipline 79 (1992) 5: 126-135; 
How Can State Medical Boards Compete in the Quality Assurance Marketplace?, Federation 
Bulletin: The Journal of Medical Licensure and Discipline (1994) 2: 102-108;, From Self-
Regulation to Public Protection: Medical Licensure Authorities in an Age of Rising 
Consumerism, Federation Bulletin: The Journal of Medical Licensure and Discipline 81 (1994) 
3: 190-194. 
49 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X  C  
See also: Timothy S. Jost, Oversight of the Competence of Healthcare Professionals,: in 
Regulation of the Healthcare Professions, Timothy S. Jost, ed. (Chicago, IL: Health 
Administration Press, 1997); L. J. Finnocchio et al., Strengthening Consumer Protection: 
Priorities for Health Care Workforce Regulation (San Francisco, CA: Pew Health Professions 
Commission, 1998); and Carl F. Ameringer, State Medical Boards and the Politics of Public 
Protection (Baltimore, MD: The Johns Hopkins University Press, 1999). 
15. James T. OReilly, Elders, Surgeons, Regulators, Jurors: Are Medical Experimentations 
Mistakes Too Easily Buried? Loyola University Chicago Law Journal 31 (Spring 2000) 3: 355. 
16. U.S. Department of Health and Human Services, Office of Inspector General, The External 
Review of Dialysis Facilities: A Call for Greater Accountability, OEI-01-99-00050, June 2000. 
17. Medicare End Stage Renal Disease Program before the Senate Special Committee on Aging, 
106 Cong., 1st Sess. (June 26, 2000) (statement of Jeffrey Kang, Director, OCSQ). 
18. In 1999, 67 percent of beneficiaries who sought Medicare information from Medicare 
sources reported that the information they received answered their questions. See Health Care 
Financing Administration, FY 2000 Annual Performance Plan, Baltimore, MD, January 2000: 
150. 
19. In 1995, we found that 77 percent of Medicare beneficiaries were unaware of the PROs. 
Our current study revealed no evidence of increased awareness, a conclusion also reached by 
stakeholders with whom we spoke. 
20. Sixth Scope of Work, R.F.P. No. HCFA-99-001/ELH, March 1, 1999: 13. 
21. CMS method of tracking data from the PROs, the Standard Data Processing System (SDPS) 
indirectly counts the number of complaints each PRO receives. It counts how many medical 
records the PROs reviewed in response to complaints. One complaint can involve multiple 
settings of care, thus multiple records. Based on SDPS data reported by the PROs for the period 
between August 1997 and July 1999, we arrayed the PROs by the level of outreach activity and 
numbers of records reviewed due to complaints. Just 3 PROs appeared in the top 10 on both 
lists. 
22. PROs averaged less than 2 outreach activities per 10,000 beneficiaries between August 1997 
and July 1999. 
23. CMS lists Increasing the Effectiveness of Dissemination of Medicare Information to 
Beneficiaries as a target in its FY 2000 Annual Performance Plan. See Health Care Financing 
Administration, FY 2000 Annual Performance Plan, Baltimore, MD, January 2000: 150. 
24. The two PROs that reportedly did not refer service-related complaints handled them slightly 
differently. In one case, the PRO routinely reviewed the medical record for service complaints. 
As an example, the official from that PRO noted that a beneficiary might complain about her 
water pitcher being out of reach, which is a service quality issue. The medical record could, in 
fact, document that beneficiarys intake and output and potential dehydration related to an out-
50 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X  C  
of-reach water pitcher. The official from the other PRO noted that she considered service 
complaints as potentially the tip of the iceberg, and would generally at least skim the medical 
record. 
25. CMS recent pilot testing of alternative methods for handling beneficiary complaints 
included a recommendation for structured, in-depth telephone interviews of beneficiaries. See 
The Medicare Beneficiary Complaint Alternative Methods Study. 
26. We found a similar pattern when we examined the PROs responses to quality-of-care 
problems they identified through medical record review several years ago. In that study, we 
found the PROs most common response to providers and practitioners responsible for quality 
of-care problems to be letters, also considered to be educational. (Office of Inspector General, 
Educating Physicians Responsible for Poor Medical Care: A Review of the Peer Review 
Organizations Efforts, OEI-01-89-00020, February 1992.) 
27. There are exceptions, of course. At one PRO, the medical director told us about a surgeon 
whom the PRO had referred for sanction many years ago and who was just returning to the 
Medicare program. She told us that the PRO will monitor the quality of care given by the 
surgeon by pulling records for review. 
28. The lack of referrals between PROs and State medical boards has been well documented. 
See Office of Inspector General, Peer Review Organizations and State Medical Boards: A Vital 
Link, OEI-01-91-00530, April 1993 and Citizen Advocacy Center, Information Exchange 
Between Peer Review Organizations and Medical Licensing Boards: Report on 50 State Survey, 
November 1992. 
29. We found PRO referrals to State survey and certification agencies to be more common 
earlier in the complaint process. For example, PROs will refer complaints to such agencies when 
they deem the complaint to be about the quality of services rather than the quality of care. In 
those cases, the PRO would generally not conduct any kind of medical record review at all. 
30. This applies unless they identify a gross and flagrant problem. 
31. Sixth Scope of Work, R.F.P. No. HCFA-99-001/ELH, March 1, 1999: 32. 
32. The Medicare Beneficiary Complaint Alternative Methods Study. 
33. The small number of mediated beneficiary complaints and the inconsistent criteria for 
including beneficiaries in the mediation pilot limit the conclusions that can be drawn from the 
study. The study focused on 58 complaints, of which only 11 involved a provider and 
complainant who both agreed to mediate. Also, each of the five PROs used different criteria to 
select complaints for mediation. Inconsistency across PROs regarding whether to limit 
participation in mediation only to those cases where a medical record review had already been 
completed raises the question of whether mediation is intended to supplement or replace medical 
record review. Although a few complainants were satisfied with mediation, unless all complaints 
also undergo a medical record review, participants in mediation cannot be assured the same 
51 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X  C  
protection as those whose complaints undergo medical record review. 
34. CMS estimates that 51 percent of the PROs budgets in the sixth contract will be devoted to 
quality improvement activities through either national projects (33 percent), local projects (11 
percent), and managed care projects (7 percent). See Sixth Scope of Work, R.F.P. No. HCFA-
99-001/ELH, March 1, 1999. 
35. This quality improvement project concerned advanced directives. 
36. Health Care Financing Administration, Peer Review Organization Manual, 5020(A)(1). 
37. For current procedures, see Peer Review Organization Manual section 5035 and 42 C.F.R. 
476. For the recent court decision, see Public Citizen, Inc. v. Department of Health and Human 
Services, et al., Civil Action No. 00-00731, July 9, 2001. 
38. Based on Office of Inspector General review of SDPS data from August 1997 through July 
1999. 
39. The Beneficiary Complaint Process of the Medicare Peer Review Organizations. 
40. One PRO routinely provided a chronology of the care provided to the beneficiary during the 
time in question. While this conveyed that the PRO had indeed reviewed the case carefully, it 
also could suggest that the chronology represented the results of the medical record review. 
41. This is from a sample of final response letters with confirmed problems and consent for 
disclosure. 
42. In fact, after receiving questions from CMS regional office staff in May, CMS completely 
reversed its interpretation of the need for beneficiary consent to disclosure. Previously, if 
beneficiaries declined to have their names disclosed in the review process, CMS instructed the 
PROs to provide no final response whatsoever. Now, CMS allows a final responsewhich is 
required by the complaint statuteeven where the beneficiary fails to consent to disclosure. (See 
Health Care Financing Administration, Disclosure of Complainants Name in Beneficiary 
Complaint, OCSQ TOPS Control Number 2000-13, May 17, 2000.) 
43. This applies for complaints with confirmed concerns and no request for re-review. Health 
Care Financing Administration, Peer Review Organization Manual, exhibit 5-19. 
44. The 55 complaints included 16 without confirmed concerns, 20 with confirmed concerns but 
no re-review, and 19 with confirmed concerns and re-review. We used the timeframes 
appropriate to each category in measuring timeliness. Ten of the 16 complaints without 
confirmed concerns exceeded the 120 allowed days; 16 of the 20 confirmed concerns without re-
review exceeded the 150 allowed days, and; 17 of the 19 confirmed concerns with re-review 
exceeded the 165 allowed days. 
45. According to CMS, the SDPS data system can produce the number of actual complaints if 
someone programs it to count those records with the same beneficiary identifier and the same 
52 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060  A P P E N D I X  C  
start date as single complaints. 
46. Sixth Scope of Work, R.F.P. No. HCFA-99-001/ELH, March 1, 1999: 32. 
47. 42 U.S.C., sec. 1320c-5 (b) (1). 
48. 42 U.S.C., sec. 1320c-1 (3). 
49. Since 1986, PROs have referred 286 physicians and providers to the Office of Inspector 
General for sanction. PROs made no referrals for FY 1999 or FY 2000. See also Office of 
Inspector General, The Sanction Referral Authority of Peer Review Organizations, OEI-01-92-
00250, April 1993. 
50. Comments from the CMS Administrator in Office of Inspector General, The External 
Review of Hospital Quality: A Call for Greater Accountability, OEI-01-97-00050, July 1999. 
51. See The External Review of Dialysis Facilities: A Call for Greater Accountability and 
Medicare End Stage Renal Disease Program before the Senate Special Committee on Aging, 106 
Cong., 1st Sess. (June 26, 2000) (statement of Jeffrey Kang, Director, OCSQ). 
52. Health Care Financing Administration, Strategic Plan (September 1998). 
53. Strategic Plan, 7. 
54. In that 1995 report, we defined a substantive response as including three elements: (1) what 
the PRO did to investigate the complaint, (2) what the investigation revealed, including whether 
a quality-of-care concern was confirmed, and if so, the nature of the concern, and (3) if a quality-
of-care concern was confirmed, what action the PRO took based on it. See The Beneficiary 
Complaint Process of the Medicare Peer Review Organizations. For details on the Federal 
district court decision, see Public Citizen, Inc. v. Department of Health and Human Services, et 
al., Civil Action No. 00-00731, July 9, 2001. 
55. The Social Security Act calls for the Secretary to contract with a single PRO in each State 
(42 U.S.C. 1320c-2). Furthermore, it requires PROs to be the entities making final 
determinations on quality (42 U.S.C. 1320c-3). 
56. See the discussion on page 5 as well as The Beneficiary Complaint Process of Medicare 
Peer Review Organizations, November 1995; Office of Inspector General, Department of Health 
and Human Services, The External Review of Hospital Quality: A Call for Greater 
Accountability and The External Review of Hospital Quality: Medicare Certification, both July 
1999. 
53 
The Medicare Complaint Process: A Rusty Safety Valve  OEI-01-00-00060