Department of Health and Human Services


OFFICE OF 

INSPECTOR GENERAL 

QUALITY CONCERNS IDENTIFIED 


THROUGH QUALITY 


IMPROVEMENT ORGANIZATION 


MEDICAL RECORD REVIEWS


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. 
Δ EXECUTIVE SUMMAR 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 noncoverage 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. 

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EXE CUTIVE S CUTIVE S U MMAR Y

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 paymentrelated 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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EXE CUTIVE S U MMAR Y 

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. 

CMS’s comments did not warrant any revisions to the results of our 

review. 

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Δ T ABLE OF CONTENTS 

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

INTR O D U C T I ON ........................................... 1

FINDI NGS ................................................ 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

CON C L U SION ............................................ 17

 Agency Comments...................................... 18

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

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

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

C: Agency Comments ................................... 24

ACKN O W LEDGMENTS .................................... 27
Δ INTRODU C TION 

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). 

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INTROD UCT ION 

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 noncoverage 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. 

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INTROD UCT ION 

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 thirdlevel 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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INTROD UCT ION

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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INTROD UCT ION

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 beneficiary’s 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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INTROD UCT ION

Table 1: Mandatory QIO Review Responsibilities 

Category Authority Description 

Written beneficiary 

complaints 

Social Security Act 

§ 1154(a)(14) 

Complaints filed by beneficiaries 

alleging poor quality of care 

Alleged antidumping 

violations (violations of the 

Emergency Medical 

Treatment and Labor Act 

(EMTALA) ) 

Social Security Act 

§ 1154(a)(16) 

Allegations of hospitals failing to 

provide appropriate medical 

screening examination, stabilizing 

treatment, or an appropriate 

transfer to another hospital, as 

required by law 

Beneficiary appeals of notices 

of noncoverage, including 

Hospital-Issued Notices of 

NonCoverage (HINN) and 

Notices of Discharge and 

Medicare Appeal Rights 

(NODMAR) 

HINN: Social Security Act 

§ 1154(e)(1) 

NODMAR: 42 CFR 

§ 422.622 

Appeals by beneficiaries of notices 

issued by hospitals (HINN) or 

Medicare + Choice (now Medicare 

Advantage) programs (NODMAR) 

indicating that there is no coverage 

in place for inpatient hospital care 

Hospital Payment 

Monitoring Program 

requirements 

QIO Manual, Chapter 11 – 

Hospital Payment 

Monitoring Program § 11010 

Referrals by special fraud 

contractors aimed at identifying 

area trends in inappropriate billing; 

review results are used to estimate 

State and national payment error 

rates 

Hospital-requested higherweighted diagnostic related 

group (DRG) validations 

42 CFR § 476.71(c)(2) Validations following all 

intermediary-approved requests by 

hospitals for higher weighted DRG 

adjustments 

Requests for assistants at 

cataract surgery 

Social Security Act 

§ 1154(a)(8) 

Preprocedural validation of the 

existence of a complicating medical 

condition warranting an assistant 

during a cataract surgery 

Requests by CMS, fiscal 

intermediaries, and other 

designated CMS contractors 

QIO Manual, Chapter 4 – 

Case Review § 4070 

Review requests varying in scope 

and setting 

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INTROD UCT ION

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, “Medicare’s 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 President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

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ΔF I NDING S 

 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 period. 

These reviews covered payment 

and utilization issues, notices of 

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 

DRG Assignments 

Referrals 

Primary Data Collection 

QIO Selected 

Appeals 

Beneficiary and 

Anonymous Complaints 

HINN 

Other* 

95,526 

89,773 

22,297 

20,932 

20,235 

20,175 

18,550 

17,287 

13,243 

30% 

28% 

7% 

7% 

6% 

6% 

6% 

5% 

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 

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F I NDING 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 

Complaints 

HPMP 

DRG Assignments 

Referrals 

Intensified Review 

HINN 

Other* 

13,679 

7,400 

5,737 

4,642 

1,622 

571 

1,117 

39% 

21% 

17% 

13% 

5% 

2% 

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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F I NDING S 

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 19 percent of 

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 

Reason for Selection 

Number of Cases 

That Received a 

Completed Quality 

Review 

Number of Cases 

With at Least One 

Confirmed Quality 

Concern 

Percentage of Cases 

With a Confirmed 

Quality Concern 

Beneficiary and 

Anonymous Complaints 

HPMP 

DRG Assignments 

Referrals 

Intensified Review 

HINN 

Other* 

13,679 

7,400 

5,737 

4,642 

1,622 

571 

1,117 

2,574 

1,335 

919 

779 

409 

163 

260 

19% 

18% 

16% 

17% 

25% 

29% 

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 

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F I NDING S 

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. 

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F I NDING 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 paymentrelated 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 

72 percent of cases with a confirmed quality 

concern 

In every case with a confirmed 

quality concern, QIOs must send a 

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). 

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F I NDING S 

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 beneficiary’s 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 patient’s 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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F I NDING S 

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 

Corrective Action 

Number of Times 

Recommended 

Percentage of All 

Recommended 

Corrective Actions 

Alternative Approach 

Offer Advice 

Quality Improvement Plan 

Intensified Review 

Referral to Licensing Body 

Initiation of Sanction Acitvity 

2,054 

1,439 

1,283 

264 

54 

31 

40% 

28% 

25% 

5% 

1% 

<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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ΔF I NDING S 

 CONCLUSION 

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 qualityof-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. 

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C O NCL USIO 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. CMS’s comments did not 

warrant any revisions to the results of our review. For the full text of 

CMS’s comments, see Appendix C. 

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Δ APPENDIX ~ A 

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 CMS’s 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 

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APP 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. 

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ΔAPP E N D I X B 

 APPENDIX ~ B 

Table B1: Cases by Original Reason for Selection 

Reason for Selection 

Number of 

Cases Percentage 

HPMP 

DRG Assignments 

Referrals 

Primary Data Collection 

QIO Reason 

Appeals 

Beneficiary and Anonymous 

Complaints 

HINN 

Intensified Review 

Long Term Care Hospital 

Sample 

EMTALA 

NODMAR 

Cost Outlier 

Readmission 

Sanction 

Fraud and Abuse 

Cataract Assistants 

95,526 

89,773 

22,297 

20,932 

20,235 

20,175 

18,550 

17,287 

4,155 

2,779 

2,751 

2,351 

796 

232 

106 

59 

14 

30% 

28% 

7% 

7% 

6% 

6% 

6% 

5% 

1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

Overall Total 318,018 100% 

Source: Office of Inspector General analysis of case review data, 2006. 

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APP E N D I X ~ B 

Table B2: Cases That Received a Quality Review by 

Reason for Selection 

Reason for Selection 

Number of 

Cases Percentage 

Beneficiary and 

Anonymous Complaints 

HPMP 

DRG Assignments 

Referrals 

Intensified Review 

HINN 

Primary Data Collection 

Appeals 

Long Term Care Hospital 

Sample 

Cost Outlier 

Readmission 

Sanction 

QIO Selected 

NODMAR 

EMTALA 

Fraud and Abuse 

Cataract Assistants 

13,679 

7,400 

5,737 

4,642 

1,622 

571 

306 

216 

204 

99 

95 

60 

54 

41 

39 

2 

1 

39% 

21% 

17% 

13% 

5% 

2% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

<1% 

Overall Total 34,768 100% 

Source: Office of Inspector General analysis of case review data, 2006. 

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APP E N D I X ~ B 

Table B3: Cases With at Least One Confirmed Quality Concern by Reason 

for Selection 

Reason for Selection 

Number of Cases 

That Received a 

Completed Quality 

Review 

Number of Cases 

With at Least One 

Confirmed Quality 

Concern 

Percentage of Cases 

With a Confirmed 

Quality Concern 

Fraud and Abuse 

EMTALA 

NODMAR 

Appeals 

QIO Reason 

HINN 

Sanction 

Intensified Review 

Readmission 

Long Term Care Hospital 

Sample 

Beneficiary and Anonymous 

Complaints 

HPMP 

Referrals 

DRG Assignments 

Cost Outlier 

Primary Data Collection 

Cataract Assistants 

2 

39 

41 

216 

54 

571 

60 

1,622 

95 

204 

13,679 

7,400 

4,642 

5,737 

99 

306 

1 

1 

19 

15 

77 

16 

163 

17 

409 

19 

40 

2,574 

1,335 

779 

919 

14 

42 

0 

50% 

49% 

37% 

36% 

30% 

29% 

28% 

25% 

20% 

20% 

19% 

18% 

17% 

16% 

14% 

14% 

0% 

Overall Total 34,768 6,439 18.5% 

Source: Office of Inspector General Analysis of case review data, 2006. 

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 O E I - 0 1 - 0 6 - 0 0 1 7 0 QUALITY C ONCERNS I DENTIFIED T HROUGH QIO MEDICAL RECORD REVIEWS 24 

Agency Comments 

Δ APPENDIX ~ C 
 

 

 O E I - 0 1 - 0 6 - 0 0 1 7 0 QUALITY C ONCERNS I DENTIFIED T HROUGH QIO MEDICAL RECORD REVIEWS 25 

APPENDIX ~ C 
 

 

 O E I - 0 1 - 0 6 - 0 0 1 7 0 QUALITY C ONCERNS I DENTIFIED T HROUGH QIO MEDICAL RECORD REVIEWS 26 

APPENDIX ~ C 
ΔAPP E N D I X B 

 ACKNOWLEDGMENTS 

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. 

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