Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

Q C I
UALITY  ONCERNS  DENTIFIED 

T Q
HROUGH  UALITY 

I O
MPROVEMENT  RGANIZATION 

M R R
EDICAL  ECORD  EVIEWS

Daniel R. Levinson

Inspector General 

May 2007

OEI-01-06-00170
 Office of Inspector General 

http://oig.hhs.gov 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 
as amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides all auditing services for HHS, either by 
conducting audits with its own audit resources or by overseeing audit work done by others. 
Audits examine the performance of HHS programs and/or its grantees and contractors 
in carrying out their respective responsibilities and are intended to provide independent 
assessments of HHS programs and operations.  These assessments help reduce waste, 
abuse, and mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on 
significant issues.  Specifically, these evaluations focus on preventing fraud, waste, or 
abuse and promoting economy, efficiency, and effectiveness in departmental programs.  
To promote impact, the reports also present practical recommendations for improving 
program operations. 
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative 
investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 
and of unjust enrichment by providers.  The investigative efforts of OI lead to criminal 
convictions, administrative sanctions, or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support in OIG's internal operations. OCIG imposes program exclusions and civil 
monetary penalties on health care providers and litigates those actions within HHS. 
OCIG also represents OIG in the global settlement of cases arising under the Civil False 
Claims Act, develops and monitors corporate integrity agreements, develops compliance 
program guidances, renders advisory opinions on OIG sanctions to the health care 
community, and issues fraud alerts and other industry guidance.    E X E C U T I V E   S U M M A R Y  

OBJECTIVE 
To determine (1) the extent to which Quality Improvement 
Organizations (QIO) identify quality-of-care concerns through medical 
record reviews, and (2) what interventions QIOs take in response to 
confirmed concerns. 
BACKGROUND 
The Centers for Medicare & Medicaid Services (CMS) contracts with 
QIOs to oversee and enhance the quality of care within Medicare and to 
protect over 40 million Medicare beneficiaries.  QIOs are organizations 
that comprise medical professionals who work with health care 
providers on quality improvement initiatives and review medical 
records to ensure that care meets professional standards.  In December 
2005, the Senate Committee on Finance requested that the Office of 
Inspector General (OIG) evaluate the QIOs role in protecting 
beneficiaries from poor quality of care. 
QIOs review medical records for quality, payment, utilization, or non-
coverage concerns.  For quality concerns, QIO reviewers conduct a full 
quality review.  For other concerns, the reviewers screen for potential 
quality concerns. If this screening identifies a potential quality concern, 
the QIO conducts a subsequent full quality review on that case.  In the 
first step of a full quality review, a nonphysician reviewer examines the 
medical records for potential concerns.  CMS defines quality concerns as 
those in which care given results in a significant or potentially 
significant adverse effect on the patient.  If the nonphysician reviewer 
identifies a potential quality concern, a physician reviews the medical 
records to either confirm or resolve the concern. In cases with a 
confirmed concern, QIOs can recommend corrective actions meant to 
address the concern.  QIOs have discretion in determining whether to 
recommend a corrective action, which can range from offering advice to 
providers about care to recommending that OIG sanction the provider. 
We analyzed QIO-reported case review data for all cases that QIOs 
selected for review between February 1, 2003, and January 31, 2006.  
We also reviewed documentation and interviewed staff from three QIOs. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  i  EEE XXX EEE CCC UUU TTT III VVV EEE     SSS UUU MMM MMM AAA RRR YYY

FINDINGS 
QIOs selected over 300,000 cases for review between February 1, 
2003, and January 31, 2006, and reviewed about 11 percent of them 
for quality of care. QIOs selected 318,018 cases for review during this 
time. The most common reasons QIOs selected cases were for payment-
related reviews. QIOs completed full quality-of-care reviews on 
34,768 cases. Beneficiary and anonymous complaints were the most 
common reasons QIOs performed quality reviews, accounting for 
39 percent of all completed quality reviews. 
QIOs confirmed a quality concern in about 19 percent of those 
cases that received a quality-of-care review. QIOs confirmed one or 
more quality concerns in 6,439 cases. QIOs assigned one of the two 
lowest classifications, care could reasonably have been expected to be 
better, or care failed to follow generally accepted guidelines and usual 
practice to more than 80 percent of the cases with a confirmed quality 
concern. Cases that did not originally require a quality review proved to 
be a rich source of confirmed quality concerns. These cases, most of 
which were originally selected for payment-related reviews, comprised 
61 percent of all cases with a confirmed quality concern. 
QIOs recommended a corrective action in 72 percent of those cases 
with a confirmed quality concern. QIOs recommended 
5,125 corrective actions in 4,645 cases with a confirmed concern (a 
single case can have multiple corrective actions). The two least severe 
corrective actions accounted for almost 70 percent of all recommended 
corrective actions. QIOs rarely initiated sanction activity in response to 
a confirmed concern. QIOs imposed no corrective actions in 1,794 cases 
(28 percent) with a confirmed quality concern. 
CONCLUSION 
Our evaluation documents the scope of QIOs quality review activities 
between February 1, 2003, and January 31, 2006. QIOs have long had 
the potential to be an essential frontline mechanism through which 
Medicare can oversee the quality of care for which it pays. 
However, QIOs assigned more than 80 percent of confirmed quality 
concerns to one of the two least serious classifications, care could 
reasonably have been expected to be better or care failed to follow 
generally accepted guidelines or usual practice. Likewise, 70 percent of 
the corrective actions that QIOs recommended either called for 
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providers to consider an alternative approach to future care or offered 
advice.  These are the two least severe corrective actions available to 
QIOs. QIOs recommended the two most severe actions, initiation of 
sanction referral and referral to a licensing board, in less than 2 percent 
of the corrective actions during this 3-year period.   
Outside the QIO program and its authorities, Medicare has no other 
single mechanism with a comparable scope to perform case reviews and 
take such a range of corrective actions with providers.  However, this 
review raises questions for CMS to consider in its administration of the 
QIO program.  CMS should consider whether it needs to revisit its 
guidance regarding classifications of confirmed quality concerns and 
corrective actions. 
AGENCY COMMENTS 
CMS noted that it is currently evaluating the QIO case review process 
for reviewing and classifying quality-of-care concerns.  CMS also 
recently implemented a revised array of quality improvement activities 
(formerly known as corrective action plans) for QIOs to recommend to 
providers. QIOs can recommend these new improvement activities even 
in cases where they did not identify quality-of-care concerns.  CMS now 
requires QIOs to implement quality improvement activities in a certain 
percentage of cases in which QIOs do identify quality-of-care concerns.  
CMSs comments did not warrant any revisions to the results of our 
review. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  iii    T A B L E   O F   C O N T E N T S  

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

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

F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10

QIOs performed quality reviews on 34,768 cases . . . . . . . . . . . . .  10

QIOs confirmed a quality concern in 6,439 cases . . . . . . . . . . . . .  12

QIOs recommended a corrective action in 4,645 cases . . . . . . . . .  14

CONC LUSION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17

  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18

APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19

A:  Methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19

B:  Data Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21

C:  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  24

A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  27
   I N T R O D U C T I O N  

OBJECTIVE 
To determine (1) the extent to which Quality Improvement 
Organizations (QIO) identify quality-of-care concerns through medical 
record reviews, and (2) what interventions QIOs take in response to 
confirmed concerns. 
BACKGROUND 
Quality Improvement Organizations 
The Centers for Medicare & Medicaid Services (CMS) contracts with 
QIOs, formerly known as Peer Review Organizations, to oversee and 
enhance the quality of care within the Medicare program and to protect 
over 40 million Medicare beneficiaries.  QIOs are organizations that 
comprise medical professionals (largely physicians and nurses), 
epidemiologists and statisticians.  In addition to contracting as 
Medicare QIOs, these 39 organizations often hold contracts to conduct 
medical review and quality improvement activities for States, the 
Department of Veterans Affairs, private health plans, and other 
entities.  Further, CMS frequently contracts with QIOs to conduct 
special initiatives and demonstration projects. 
Within Medicare, QIOs work with health care providers on quality 
improvement initiatives and review medical records to ensure that care 
meets professionally recognized standards.  Pursuant to statute, QIOs 
must review the medical services rendered by individual practitioners 
and institutional providers to determine whether: 
	 services were reasonable and medically necessary and whether 
they were reimbursable under program guidelines, 
	 the quality of services met professionally recognized health care 
standards, and 
	 inpatient services could be effectively provided more

economically in another setting.1

QIOs sign 3-year contracts, called statements of work, with CMS to 
provide services in the 50 States, the District of Columbia, Puerto Rico, 
1 Social Security Act  1154(a)(1)(A-C). 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  1  I N T R O D U C T I O N  
and the U.S. Virgin Islands.  Funding for the QIO program totaled  
$1.15 billion in the Seventh Statement of Work (from 2002-2005).2 
In August 2005, QIOs began implementing the Eighth Statement of 
Work, which emphasizes broad activities aimed at improving the overall 
level of care provided by all Medicare providers but also retains their 
beneficiary protection role.  Funding for the Eighth Statement of Work 
(2005-2008) is projected to increase to about $1.2 billion.3 
Mandatory Review Responsibilities 
In addition to having a contractual emphasis on improving the overall 
quality of care, QIOs also have a statutory and contractual 
responsibility to review individual instances of care provided to 
Medicare beneficiaries.4  QIOs meet this mandate by reviewing medical 
records.  See Table 1 on page 6 for a list of QIO review responsibilities. 
Care provided by both institutional providers and individual 
practitioners can be subject to the medical record review process. In 
this report we use the term provider to include one or both of these 
groups unless specified otherwise. 
Overview of the QIO Medical Record Review Process 
QIOs review medical records for quality, payment, utilization, or non-
coverage concerns.  For quality concerns, QIO reviewers conduct a full 
quality review.  For other concerns, the reviewers screen for potential 
quality concerns. If this screening identifies a potential quality concern, 
the QIO conducts a subsequent full quality review on that case.  
Quality concerns are those in which the care given results in a 
significant or potentially significant adverse effect on the patient.5 
In the first step of a full quality review, a nonphysician reviewer 
examines the medical records for potential concerns.  If the reviewer 
identifies a potential quality concern, he or she refers the case to a 
physician reviewer who analyzes the clinical decisions made during 
2 The American Health Quality Association, Medicare Beneficiary Protection by the 
Numbers. Available online at http://www.ahqa.org/pub/189_1085_5234.cfm.       
Accessed February 16, 2007. 
3 Ibid. 
4 Social Security Act  1154(a)(4)(A) and QIO Seventh Statement of Work, Task 3: 
Improving Beneficiary Safety and Health Through Medicare Beneficiary Protection 
Activities. 
5 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 4  Case Review (4105), rev. 2, July 11, 2003. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  2  I N T R O D U C T I O N  
care.  If the nonphysician reviewer does not identify a potential quality 
concern, the quality review is completed.  If the first-level physician 
review finds that care did not meet professional standards, the QIO 
offers the provider who rendered that care the opportunity to discuss 
the case and offer additional documentation.  If the provider does not 
respond to this opportunity, the QIO reviewer makes a determination 
based on available data and the initial review.  If the provider does 
respond with additional information, the QIO conducts a second-level 
physician review.  If this review confirms the quality concern, providers 
who disagree can request a reconsideration.  In this case, another QIO 
physician reviewer not involved in the prior reviews conducts a third-
level review. 
Following the review of all pertinent information in the final level of 
review, the reviewer makes a determination regarding the care given.6 
Once a quality concern is identified, the physician reviewer may 
determine that no substantial improvement opportunities could be 
identified, or that care could have been better.  If the reviewer 
determines that care could have been better (confirms a quality 
concern), he or she classifies the care into one of three categories, based 
on CMS instructions: 
	 Care provided was a gross and flagrant violation;7 
	 Care failed to follow generally accepted guidelines/usual 
practice;8 or 
	 Care could reasonably have been expected to be better.9 
The governing statute, regulations, and the QIO Manual also require 
the reviewer to determine if the care constitutes a substantial 
6 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 4  Case Review (4310-4320), rev. 2, July 11, 2003. 
7 42 CFR  1004.1(b) defines a gross and flagrant violation as one that occurred in one or 
more instances which presents an imminent danger to the health, safety, or well-being of a 
program patient or places the program patient unnecessarily in high-risk situations.   
8 Centers for Medicare & Medicaid Services, Transmission of Policy System Control 
Number:  QIO 2003-14, December 22, 2003.  CMS instructs QIOs that a concern given this 
classification may support a determination that a substantial violation in a substantial 
number of cases occurred as described in 42 CFR  1004.1. 
9 Centers for Medicare & Medicaid Services, Transmission of Policy System Control 
Number:  QIO 2003-14, December 22, 2003. 
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violation in a substantial number of cases.10 The QIO database we 
analyzed does not indicate whether a particular case is part of such a 
violation. If the reviewer does not confirm a quality concern, no 
further action is necessary. 
Corrective Actions Following Confirmed Concerns 
When QIOs confirm a quality concern in the medical record review 
process, they must notify the provider(s) involved. Unless the concern 
poses severe risk, is a gross and flagrant violation, or is indicative of a 
pattern of poor care that would indicate a substantial violation in a 
substantial number of cases, CMS does not require the QIO to take 
further action.11 CMS provides guidance to QIOs regarding corrective 
actions their physician reviewers can recommend in response to a 
confirmed quality-of-care concern.12 
One corrective action QIOs can take is to recommend that the provider 
develop a quality improvement plan. Such plans are meant to improve 
the system or process of delivering care.13 In contrast to the corrective 
action plans described below, the quality improvement plans are not 
identified in any statute or regulation or the QIO Manual, and CMS 
provides no guidance on their structure or requirements. QIOs may 
offer providers suggestions and guidelines for the plans; providers then 
develop and submit their plans to QIOs for approval. Providers must 
also evaluate the effectiveness of the plans and send results to the QIO. 
QIOs may request additional medical records for review to determine if 
the plan has been effective in addressing the concern. 
For cases in which the QIO determines there is a gross and flagrant 
violation, or a substantial failure to comply with any obligation in a 
substantial number of cases, the QIO must determine if a corrective 
action plan is appropriate. If a corrective action plan is not appropriate, 
or if a provider has not successfully completed one, the QIO must 
recommend to the Office of Inspector General (OIG) that the provider be 
10 Social Security Act  1156(a)(1)(A); 42 CFR  1004.30(c); Quality Improvement 
Organization Manual, Chapter 4  Case Review (4000, 4105), rev. 2, July 11, 2003; 
Chapter 9  Sanction and Abuse Issues (9000), rev. 12, October 3, 2003. 
11 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 4  Case Review (4700), rev. 2, July 11, 2003. 
12 Centers for Medicare & Medicaid Services, Transmission of Policy System Control 
Number: QIO 2003-14, December 22, 2003. 
13 Ibid. 
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sanctioned.14  If OIG agrees with the sanction recommendation, it will 
either exclude the provider from Federal health care programs for no 
less than 1 year or impose civil monetary penalties.15 
Among other factors, QIOs consider the severity of the case, previous 
problems, and previous attempts to resolve the issues to determine if a 
sanction referral is appropriate. A corrective action plan is specific to 
the sanction process, while quality improvement plans are used in less 
severe cases. Pursuant to statute, QIOs must also notify the State 
medical board or other appropriate licensing board when they 
determine that a physician or practitioner should enter into a corrective 
action plan.16 
To determine which corrective action to take in response to concerns 
that are not classified as gross and flagrant, CMS instructs QIOs to 
weigh the probable benefit to the beneficiarys care against the cost of 
the action.17 However, this instruction to weigh the cost and benefits 
does not exclude quality concerns that constitute a substantial violation 
in a substantial number of cases, which by statute and regulation must 
be treated the same as those concerns classified as gross and flagrant.18 
CMS requires QIOs to enter their review findings into their data 
systems for pattern analysis. CMS instructs QIOs to analyze data on an 
ongoing basis to identify opportunities for improvement.19 
14 Social Security Act  1156(b)(1) and 42 CFR  1004.70. 

15 42 CFR  1004.20. 

16 Social Security Act  1154(a)(9)(B). 

17 Centers for Medicare & Medicaid Services, Transmission of Policy System Control 

Number: QIO 2003-14, December 22, 2003. 
18 Social Security Act  1156(a)(1); 42 CFR  1004.30(c), 1004.40(a), 1004.80(c)(6). 
19 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 5  Quality of Care Review (5050), rev. 9, August 29, 2003. 
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Table 1: Mandatory QIO Review Responsibilities 
Category  Authority  Description 
Written beneficiary  Social Security Act   Complaints filed by beneficiaries 
complaints   1154(a)(14)  alleging poor quality of care  
Alleged antidumping  Social Security Act   Allegations of hospitals failing to 
violations (violations of the   1154(a)(16)  provide appropriate medical 
Emergency Medical  screening examination, stabilizing 
Treatment and Labor Act  treatment, or an appropriate 
(EMTALA) )  transfer to another hospital, as 
required by law 
Beneficiary appeals of notices  HINN: Social Security Act   Appeals by beneficiaries of notices 
of noncoverage, including   1154(e)(1)  issued by hospitals (HINN) or 
Hospital-Issued Notices of  Medicare + Choice (now Medicare 
NonCoverage (HINN) and  NODMAR:  42 CFR  Advantage) programs (NODMAR) 
Notices of Discharge and   422.622  indicating that there is no coverage 
Medicare Appeal Rights  in place for inpatient hospital care 
(NODMAR) 
Hospital Payment  QIO Manual, Chapter 11   Referrals by special fraud 
Monitoring Program  Hospital Payment  contractors aimed at identifying 
requirements  Monitoring Program  11010  area trends in inappropriate billing;  
review results are used to estimate 
State and national payment error 
rates 
Hospital-requested higher- 42 CFR  476.71(c)(2)  Validations following all 
weighted diagnostic related  intermediary-approved requests by 
group (DRG) validations  hospitals for higher weighted DRG 
adjustments 
Requests for assistants at  Social Security Act  Preprocedural validation of the 
cataract surgery   1154(a)(8)  existence of a complicating medical 
condition warranting an assistant 
during a cataract surgery  
Requests by CMS, fiscal  QIO Manual, Chapter 4   Review requests varying in scope 
intermediaries, and other  Case Review  4070  and setting  
designated CMS contractors 
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Recent Interest in QIOs 
In 2003, Congress directed the Institute of Medicine of the National 
Academy of Sciences (IOM) to conduct an evaluation of QIOs. This 
mandate included reviewing the extent to which QIOs improve the 
quality of care for Medicare beneficiaries and the extent to which other 
entities could perform such functions as well as or better than QIOs.20 
IOM released a preliminary version of its report in February 2006. The 
report found that the quality of care received by Medicare beneficiaries 
has improved over time but that existing evidence was inadequate to 
determine the extent to which QIOs have contributed directly to that 
improvement. IOM recommended that case reviews be continued but 
that CMS consider removing this function from QIOs. CMS could 
instead contract at the national or regional level with a smaller number 
of organizations.21 
A July 2005 Washington Post article criticized QIOs for lack of 
meaningful responses to beneficiary complaints and cited a decline in 
sanction recommendations made by QIOs over the past 2 decades.22 In 
December 2005, the Senate Committee on Finance requested that OIG 
evaluate the QIOs role in protecting Medicare beneficiaries from poor 
quality of care. 
Previous Work 
OIG has conducted several evaluations of QIOs activities since their 
establishment in 1982. Past inspection reports covered topics such as 
the QIOs role in identifying poorly performing providers, their sanction 
recommendation authority, and the beneficiary complaint process.23 
20 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 
P.L. 108-173  109(d). 
21 Institute of Medicine of the National Academies, Medicares Quality Improvement 
Organization Program: Maximizing Potential, 2006. 
22 Gilbert M. Gaul, Once Regulators, Now Partners, The Washington Post, 
July 26, 2005, p. A01. 
23 Department of Health and Human Services, Office of Inspector General, The Sanction 
Referral Authority of Peer Review Organizations, OEI-01-92-00250, April 1993. 
Department of Health and Human Services, Office of Inspector General, The Medicare 
Peer Review Organizations Role in Identifying and Responding to Poor Performers, 
OEI-01-93-00251, December 1995. 
Department of Health and Human Services, Office of Inspector General, The Medicare 
Beneficiary Complaint Process: A Rusty Safety Valve, OEI-01-00-00060, August 2001. 
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METHODOLOGY 
Scope 
We analyzed all cases QIOs selected for review between February 1, 
2003, and January 31, 2006.  This date range largely corresponds to the 
QIOs Seventh Statement of Work.  QIOs started to transition to the 
Eighth Statement of Work on August 1, 2005, and finished the 
transition on February 1, 2006.  During this transitional period their 
case review responsibilities did not change. 
Analysis 
We use the term case to refer to a unique Medicare claim that a QIO 
selected for any type of review.  We counted a case as receiving a quality 
review if the QIO completed the quality review process for that case 
(i.e., the case would receive no further reviews because of a provider 
appeal or request for rereview).24  We also counted a case as receiving a 
quality review if, in the first step of a quality review, the nonphysician 
reviewer did not identify any potential quality concerns.  This review is 
separate from the quality screening that QIO reviewers perform on 
payment, utilization, or noncoverage cases.  We did not count this 
screening as a quality review. 
We counted a quality concern as confirmed if the highest level of 
physician review resulted in a confirmed concern.  We counted a case as 
having a confirmed quality concern if the QIO confirmed at least one 
quality concern from it. We counted a corrective action as recommended 
if the QIO recommended that action in response to a case with a 
confirmed quality concern. 
We reviewed documentation detailing examples of recommended 
corrective actions and interviewed staff from three QIOs.  We 
purposively selected the QIOs based on geographic diversity and size.  
Please see Appendix A for a full discussion of our methodology. 
Limitations 
We relied on case review data that were self-reported by QIOs for our 
analysis. We did not independently verify these data. 
24 We identified 606 cases in which the outcome of the review process was pending.  We 
excluded these cases from our analysis. 
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Standards 
We conducted this study in accordance with the Quality Standards for 
Inspections issued by the Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
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  F I N D I N G S

QIOs selected over 300,000 cases for review  QIOs selected 318,018 cases for 
between February 1, 2003, and January 31, 2006,  review during this time period. 
These reviews covered payment 
and reviewed about 11 percent of them for 
and utilization issues, notices of 
quality of care 
noncoverage, and quality of care. 
The most common reasons QIOs selected a case were for payment 
issues.  Cases selected as part of the Hospital Payment Monitoring 
Program (HPMP) and for higher weighted DRG requests accounted for 
almost 60 percent of all cases.  No other single review category 
accounted for more than 7 percent of cases. See Table 2 below for the 
number of cases selected for review, arrayed by the original reason for 
their selection.  (See Table B1 in Appendix B for a complete array of 
reasons for selection.) 
Table 2:  Cases by Original Reason for Selection 
Reason for Selection  Number of Cases  Percentage 
HPMP  95,526  30% 
DRG Assignments  89,773  28% 
Referrals  22,297  7% 
Primary Data Collection  20,932  7% 
QIO Selected  20,235  6% 
Appeals  20,175  6% 
Beneficiary and 
18,550  6% 
Anonymous Complaints 
HINN  17,287  5% 
Other*  13,243  5% 
Overall Total  318,018  100% 
Source:  Office of Inspector General analysis of case review data, 2006. 
* Comprises nine reasons for selection. 
Of the 318,018 cases, QIOs completed quality-of-care reviews on 
11 percent of them (34,768 cases).  The two most common reasons QIOs 
selected cases for review, HPMP and higher weighted DRG requests, do 
not require a full quality review.  In these and most other types of cases, 
QIO reviewers must screen for potential quality concerns during the 
course of the original review.  If the reviewer identifies a potential 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  10  F I N D I N G S  
quality concern, that case receives a subsequent full quality review.  
Some cases, such as most of those originating from written beneficiary 
complaints, automatically require a quality review.25 Sixty-two percent 
of the cases that received a completed quality review did not originally 
require one (21,570 of 34,768 cases).  See Table 3 below for the number 
of cases that received a quality review, arrayed by the original reason 
for their selection.  (See Table B2 in Appendix B for a complete array of 
reasons for selection.) 
Table 3:  Cases That Received a Quality Review by 
Original Reason for Selection 
Reason for Selection  Number of Cases  Percentage 
Beneficiary and Anonymous 
13,679  39% 
Complaints 
HPMP  7,400  21% 
DRG Assignments  5,737  17% 
Referrals  4,642  13% 
Intensified Review  1,622  5% 
HINN  571  2% 
Other*  1,117  3% 
Overall Total  34,768  100% 
Source:  Office of Inspector General analysis of case review data, 2006. 
* Comprises 11 reasons for selection. 
25 As shown in Table 3, not all beneficiary complaint cases selected for review received a 
completed quality review.  We identified 625 cases in which the quality review had not 
started at the time we received the case review data, 234 cases in which the review was not 
yet completed, and 507 cases that the QIO determined did not require a quality review.  We 
identified 1,610 cases for which we can not accurately determine the reason the QIO did not 
complete a quality review. 
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QIOs confirmed a quality concern in about 
QIOs confirmed one or more 
19 percent of those cases that received a  quality concerns in 19 percent of 
quality-of-care review  the cases on which they 
completed a quality review 
(6,439 of 34,768 cases). In these cases one or more physician reviewers 
confirmed a quality concern. QIOs confirmed 10,110 individual quality 
concerns in these cases (a single case can have multiple confirmed 
quality concerns). See Table 4 below for the number of cases that had a 
quality concern, arrayed by the original reason for their selection. (See 
Table B3 in Appendix B for a complete array of cases by reason for 
selection.) 
Table 4: Cases With at Least One Confirmed Quality Concern by 
Reason for Selection 
Number of Cases  Number of Cases 
That Received a  With at Least One  Percentage of Cases 
Completed Quality  Confirmed Quality  With a Confirmed 
Reason for Selection  Review  Concern  Quality Concern 
Beneficiary and 
13,679  2,574  19% 
Anonymous Complaints 
HPMP  7,400  1,335  18% 
DRG Assignments  5,737  919  16% 
Referrals  4,642  779  17% 
Intensified Review  1,622  409  25% 
HINN  571  163  29% 
Other*  1,117  260  23% 
Overall Total  34,768  6,439  19% 
Source: Office of Inspector General Analysis of case review data, 2006. 
* Comprises 11 reasons for selection. 
Physicians were the source of the confirmed concern in 4,451 cases, and 
facilities were the source in 1,935 cases. Medicare Advantage plans 
were the source in 25 cases, and 28 cases had no attributed source. A 
specific physician or facility was the source of a confirmed concern in 
multiple cases in the time period we examined. For example, 
282 physicians and 620 facilities were the source of a confirmed quality 
concern in more than one case. Because no classification exists in the 
database we analyzed regarding care that constituted a substantial 
OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  12  FFF III NNN DDD III NNN GGG
 SSS  
violation in a substantial number of cases, we were unable to learn 
whether QIOs determined if these providers met this condition. 
QIOs assigned the lowest level of concern to half of the cases with a 
confirmed quality concern; rarely did QIOs assign the most severe level of 
concern 
In 50 percent of the cases with a confirmed concern, QIOs assigned the 
lowest concern classification, care could reasonably have been expected 
to be better. For example, we reviewed such a concern that dealt with 
a beneficiary who did not receive adequate pain management. 
QIOs assigned the next level of classification, care failed to follow 
generally accepted guidelines or usual practice, to concerns in about 
31 percent of cases. For example, we reviewed a concern with this 
classification that involved a beneficiary who was inappropriately 
medicated, for which a QIO reviewer determined that the beneficiary 
received duplicate beta blocker medication. 
QIOs assigned the most severe classification, care provided was a gross 
and flagrant violation, in about 2 percent of cases. One example of 
such a concern we reviewed dealt with a beneficiary who died after 
being given an anesthesia drug to which she was allergic. While the 
allergy was known prior to surgery, that information was not noted on 
records used during the surgery. The QIO case review database did not 
record data on quality concerns classified as substantial violations in a 
substantial number of cases. These types of cases are described in the 
statute, regulations, and QIO Manual as being equivalent to the gross 
and flagrant violations that are given the most severe classification.26 
The data did not contain classifications for about 17 percent of cases. 
Cases that did not originally require a quality review proved to be a rich 
source of confirmed concerns 
Cases that did not originally require a quality review comprised 
61 percent of the cases with a confirmed quality concern (3,927 of 
6,439 cases). In these cases, a QIO reviewer identified a potential 
quality concern during a payment or other type of nonquality review, 
and the QIO subsequently performed a full quality review. 
26 Social Security Act  1156(a)(1); 42 CFR  1004.30(c), 1004.40(a), 1004.80(c)(6); 
Quality Improvement Organization Manual, Chapter 4  Case Review (4000, 4105), rev. 2, 
July 11, 2003; Chapter 9  Sanction and Abuse Issues (9000), rev. 12, October 3, 2003. 
OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  13  F I N D I N G S  
QIOs originally selected most of these cases for payment-related 
reviews. Cases from the HPMP and higher weighted DRG assignments 
comprised 57 percent of these cases (2,254 of 3,927 cases).  Because 
these two categories comprised the greatest number of all the cases 
QIOs selected for review, it is not surprising that they resulted in a 
large number of confirmed concerns.  However, the number of payment-
related cases that also received quality reviews does show that QIO 
reviewers are looking for and finding quality concerns in nonquality 
reviews. 
Cases that did require a quality review accounted for 39 percent of all 
cases with a quality concern (2,512 of 6,439 cases).  From this group, 
cases resulting from beneficiary complaints comprised the greatest 
number of cases with a quality concern.  
QIOs recommended a corrective action in      In every case with a confirmed 
72 percent of cases with a confirmed quality  quality concern, QIOs must send a 
concern  notification of their findings to the 
provider.  Unless the concern 
poses severe risk, is a gross and flagrant violation, or is indicative of a 
pattern of poor care, CMS does not require the QIO to take further 
action.27 QIOs did recommend 5,125 corrective actions in 
4,645 (72 percent) of the cases with a confirmed concern.  One case can 
have multiple corrective actions (e.g., a QIO may require a provider to 
implement a quality improvement plan and may also initiate intensified 
review on that provider).  See Table 5 on page 15 for the frequency of 
QIO-recommended corrective actions. 
The two least severe corrective actions accounted for almost 70 percent of 
all recommended corrective actions 
The two most commonly recommended corrective actions, considering 
an alternative approach to future care and offering advice, comprised  
68 percent of all recommended actions.  QIOs can recommend that 
providers consider an alternative approach for any classification of a 
confirmed quality concern.  This action is designed to communicate to 
the provider guidelines, usual practice, or advice regarding best 
27 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 4  Case Review (4700). 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  14  FF II NN DD II NN GG SS  
practices. Offering advice is similar to recommending an alternative 
approach but is used to address less serious concerns.28 
In our review, an example of an alternative approach was a case in 
which the QIO questioned whether a beneficiarys course of treatment 
was aggressive enough. After the provider in question explained the 
rationale for this treatment more fully, the QIO deemed the concern 
resolved. It recommended to the provider that, in future cases, such 
explanations should be contained in the medical records so that all 
relevant personnel would be aware of the treatment plan. 
A more intensive measure to address a confirmed concern is for 
providers to implement a quality improvement plan. QIOs instructed 
that providers implement quality improvement plans 1,283 times. 
Representatives from QIOs whom we interviewed told us that their 
QIOs typically let the provider develop the plan and then submit it for 
approval. The QIOs offer guidance to the provider on elements the plan 
must contain, such as the specific steps the provider will take to address 
the concern, how the provider will monitor the plan, and how it will be 
evaluated. Some QIOs send a tip sheet to the provider that lists and 
describes these elements. 
In one quality improvement plan we reviewed, a provider developed 
education programs for staff that focused on increasing knowledge and 
critical thinking skills. The provider also revised policies and 
procedures and developed staff competency assessments. The case 
involved nursing staff not reporting a patients deteriorating status to 
the physician timely. Other quality improvement plans we reviewed 
similarly consisted of staff training programs. 
QIOs rarely initiated sanction activity in response to a confirmed concern 
QIOs recommended the two most severe actions, initiation of sanction 
activity and referral to licensing boards, 31 and 54 times, respectively.29 
The initiation of sanction activity does not automatically mean that a 
QIO will make a sanction referral to OIG. The successful completion of 
a corrective action plan could resolve the case without the need for a 
sanction referral. QIOs classified care as a gross and flagrant violation 
28 Centers for Medicare & Medicaid Services, Transmission of Policy System Control 
Number: QIO 2003-14, December 22, 2003. 
29 When a QIO refers a case to OIG, the QIO must also provide notice to the State 
medical board or other appropriate licensing board. 42 CFR  1004.70(c). However, not all 
cases referred to a licensing board are referred to OIG for sanctions. 
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in 19 of the 31 cases in which they initiated sanction activity. They 
classified care as a gross and flagrant violation in 17 of the 54 cases 
involving referral to licensing boards and as failing to follow generally 
accepted guidelines or usual practice in 33 of those cases. 
Finally, QIOs initiated intensified review 264 times. QIOs can take this 
action when a confirmed quality concern appears to be the result of a 
systemic issue that spreads beyond that particular case.30 
QIOs imposed no corrective actions in 1,794 (28 percent) cases with a 
confirmed quality concern 
If a quality concern does not pose a severe risk or is not a gross and 
flagrant violation, CMS does not require QIOs to take further action 
unless a pattern of poor care emerges that would indicate a substantial 
violation in a substantial number of cases.31 For example, we reviewed 
documentation from two cases in which a QIO confirmed a quality 
concern and did not take a corrective action. The QIO did not classify 
care in either case as a gross and flagrant violation. In both cases, the 
QIO stated that because the concern was a single instance of a problem 
and not indicative of a pattern of poor care, it would take no further 
action beyond notifying the provider of its findings. 
Table 5: Number and Type of Recommended Corrective 
Actions 
Percentage of All 
Number of Times  Recommended 
Corrective Action  Recommended  Corrective Actions 
Alternative Approach  2,054  40% 
Offer Advice  1,439  28% 
Quality Improvement Plan  1,283  25% 
Intensified Review  264  5% 
Referral to Licensing Body  54  1% 
Initiation of Sanction Acitvity  31  <1% 
Overall Total  5,125  100% 
Source: Office of Inspector General analysis of case review data, 2006. 
30 Ibid. 
31 Centers for Medicare & Medicaid Services, Quality Improvement Organization 
Manual, Chapter 4  Case Review (4700). 
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  C O N C L U S I O N  

Our evaluation documents the scope of QIOs quality review activities 
between February 1, 2003, and January 31, 2006.  We found that QIOs 
selected more than 300,000 cases for review, for issues ranging from 
hospital payments to beneficiary complaints.  They found sufficient 
concern about quality of care to perform quality reviews on nearly 
35,000 of those cases.  QIO physician reviewers confirmed that quality-
of-care concerns existed in about 6,500 cases.  In response, QIOs 
recommended corrective actions to address the concerns in 72 percent of 
those cases. 
These numbers show that QIOs are using their statutory authority to 
perform case reviews.  In fact, QIOs have long had the potential to be an 
essential frontline mechanism through which Medicare can oversee the 
quality of care for which it pays. 
However, QIOs assigned more than 80 percent of confirmed quality 
concerns to one of the two least serious classifications, care could 
reasonably have been expected to be better or care failed to follow 
generally accepted guidelines or usual practice. QIOs assigned the 
most severe classification, care provided was a gross and flagrant 
violation, in about 2 percent of cases.  In addition, we could not 
determine from the data whether any case constituted a substantial 
violation in a substantial number of cases. 
Likewise, 70 percent of the corrective actions that QIOs recommended 
either called for providers to consider an alternative approach to future 
care or offered advice.  These are the least severe corrective actions 
available to QIOs.  Further, QIOs recommended no corrective actions in 
28 percent of the cases with a confirmed quality concern. QIOs 
recommended the two most severe actions, initiation of sanction referral 
and referral to a licensing board, in less than 2 percent of the corrective 
actions during this 3-year period. 
Outside the QIO program and its authorities, Medicare has no other 
single mechanism with a comparable scope to perform case reviews and 
take such a range of corrective actions with providers.  However, this 
review raises questions for CMS to consider in its administration of the 
QIO program.  It should consider whether it needs to revisit its 
guidance regarding classifications of confirmed quality concerns, 
particularly with respect to care that might constitute a substantial 
violation in a substantial number of cases.  CMS could also examine 
whether it needs to revise its guidance on corrective actions. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  17  C O N C L U S I O N  

AGENCY COMMENTS 
In its comments on our draft report, CMS noted that it is currently 
evaluating the QIO case review process for reviewing and classifying 
quality-of-care concerns.  CMS also recently implemented a revised 
array of quality improvement activities (formerly known as corrective 
action plans) for QIOs to recommend to providers. QIOs can 
recommend these new improvement activities even in cases where they 
did not identify quality-of-care concerns.  These cases would include 
such issues as poor communication with beneficiaries or insufficient 
billing and coding practices. CMS now requires QIOs to implement 
quality improvement activities in a certain percentage of cases in which 
QIOs do identify quality-of-care concerns.  CMSs comments did not 
warrant any revisions to the results of our review.  For the full text of 
CMSs comments, see Appendix C. 
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METHODOLOGY 
Analysis of Case Review Data 
QIOs collect and report case review data.  For each case given a quality 
review, reviewers record the initial reason for the medical record review 
(e.g., a beneficiary complaint), their determination about the quality of 
care provided, the corrective action recommended to address any quality 
concerns, and the Medicare identification number of the provider under 
review, among other items.  QIO reviewers enter these and other data 
into a database called the Case Review Information System (CRIS).  
CMS implemented this system during the QIOs Seventh Statement of 
Work.  (The CRIS is a module of CMSs Standard Data Processing 
System.  The system is developed and maintained, under contract, by 
the Iowa Foundation for Medical Care QIO.) 
We analyzed all cases QIOs selected for review between February 1, 
2003, and January 31, 2006.  This date range largely corresponds to the 
QIOs Seventh Statement of Work.  Although QIOs first transitioned to 
the Seventh Statement of Work on August 1, 2002, CMS did not require 
them to submit case review data to the CRIS until February 1, 2003.  
QIOs started to transition to the Eighth Statement of Work on  
August 1, 2005, and finished this transition on February 1, 2006.  
During this transitional period their case review responsibilities did not 
change. 
We use the term case to refer to a unique Medicare claim that a QIO 
selected for review.  Because a QIO can review one case for multiple 
reasons, we identified, by date, the original reason the QIO selected the 
case.  From this reason for selection, we determined whether or not the 
case originally required a quality review. 
We counted a case as receiving a quality review if the QIO completed 
the quality review process for that case (i.e., the case would receive no 
further reviews because of a provider appeal or request for rereview). 
We also counted a case as receiving a quality review if, in the first step 
of a quality review, the nonphysician reviewer did not identify any 
potential quality concerns. 
We counted a quality concern as confirmed if its highest level of 
physician review confirmed the concern.  That means any second- or 
third-level physician review had to uphold the initial finding of a 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  19  A P P E N D I X   ~   A  
confirmed quality concern.  We counted a case as having a confirmed 
quality concern if the QIO confirmed at least one quality concern from 
that case.  We then counted only those cases for which the QIO 
completed the review process. 
We counted a corrective action as recommended if the QIO 
recommended that action in response to a case with a confirmed quality 
concern. To identify cases that had no recommended corrective actions, 
we analyzed all confirmed quality concerns for a case and identified 
cases for which none of those confirmed concerns had a recommended 
action. 
To determine how many providers rendered care in multiple cases with 
a confirmed quality concern, we analyzed all cases for which a physician 
or facility was the source of the concern and then identified physician or 
facility identification numbers that appeared in more than one case. 
Data Request and Interviews with QIOs 
We reviewed documentation and interviewed staff from three QIOs.  We 
purposively selected the QIOs based on geographic diversity and size.  
We reviewed examples of corrective actions the QIOs recommended in 
response to both confirmed and resolved quality concerns. Our 
interviews covered how the QIOs performed pattern analysis, how their 
reviewers screened for quality concerns in nonquality reviews, and 
general topics pertaining to their case review activities. 
Limitations 
We relied on case review data that were self-reported by QIOs to the 
CRIS for our analysis.  We did not independently verify these data. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  20  A P P E N D I X   B  
  A P P E N D I X   ~   B  

Table B1:  Cases by Original Reason for Selection 
Number of 
Reason for Selection  Cases  Percentage 
HPMP  95,526  30% 
DRG Assignments  89,773  28% 
Referrals  22,297  7% 
Primary Data Collection  20,932  7% 
QIO Reason  20,235  6% 
Appeals  20,175  6% 
Beneficiary and Anonymous 
18,550  6% 
Complaints 
HINN  17,287  5% 
Intensified Review  4,155  1% 
Long Term Care Hospital 
2,779  <1% 
Sample 
EMTALA  2,751  <1% 
NODMAR  2,351  <1% 
Cost Outlier  796  <1% 
Readmission  232  <1% 
Sanction  106  <1% 
Fraud and Abuse  59  <1% 
Cataract Assistants  14  <1% 
Overall Total  318,018  100% 
Source:  Office of Inspector General analysis of case review data, 2006. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  21  A P P E N D I X   ~   B  

Table B2:  Cases That Received a Quality Review by 
Reason for Selection 
Number of 
Reason for Selection  Cases  Percentage 
Beneficiary and 
13,679  39% 
Anonymous Complaints 
HPMP  7,400  21% 
DRG Assignments  5,737  17% 
Referrals  4,642  13% 
Intensified Review  1,622  5% 
HINN  571  2% 
Primary Data Collection  306  <1% 
Appeals  216  <1% 
Long Term Care Hospital 
204  <1% 
Sample 
Cost Outlier  99  <1% 
Readmission  95  <1% 
Sanction  60  <1% 
QIO Selected  54  <1% 
NODMAR  41  <1% 
EMTALA  39  <1% 
Fraud and Abuse  2  <1% 
Cataract Assistants  1  <1% 
Overall Total  34,768  100% 
Source: Office ofInspector General analysisof case reviewdata, 2006. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  22  A P P E N D I X   ~   B  

Table B3:  Cases With at Least One Confirmed Quality Concern by Reason 
for Selection 
Number of Cases  Number of Cases 
That Received a  With at Least One  Percentage of Cases 
Completed Quality  Confirmed Quality  With a Confirmed 
Reason for Selection  Review  Concern  Quality Concern 
Fraud and Abuse  2  1  50% 
EMTALA  39  19  49% 
NODMAR  41  15  37% 
Appeals  216  77  36% 
QIO Reason  54  16  30% 
HINN  571  163  29% 
Sanction  60  17  28% 
Intensified Review  1,622  409  25% 
Readmission  95  19  20% 
Long Term Care Hospital 
204  40  20% 
Sample 
Beneficiary and Anonymous 
13,679  2,574  19% 
Complaints 
HPMP  7,400  1,335  18% 
Referrals  4,642  779  17% 
DRG Assignments  5,737  919  16% 
Cost Outlier  99  14  14% 
Primary Data Collection  306  42  14% 
Cataract Assistants  1  0  0% 
Overall Total  34,768  6,439  18.5% 
Source:  Office of Inspector General Analysis of case review data, 2006. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  23   
  
   
 A P P E N D I X   ~   C  
 
Agency Comments 
 
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A P P E N D I X   ~   C  
 
 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  25   
  
   
A P P E N D I X   ~   C  
 
 
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  A C K N O W L E D G M E N T S  

This report was prepared under the direction of Joyce M. Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the 
Boston regional office, and Russell W. Hereford, Deputy Regional 
Inspector General. 
Kenneth R. Price served as the team leader for this study and Ivan E. 
Troy served as the lead analyst.  Central office staff who contributed 
includes Doris Jackson. 
  OEI-01-06-00170  QUALITY CONCERNS IDENTIFIED THROUGH QIO MEDICAL RECORD REVIEWS  27