DEPARTMENT OF HEALTH &. HUMAN SERVICES 	 Office of Inspector General 
Washington. D.C.  20201 
()CT 122010 
TO: 	 Donald M. Berwick, M.D. 
Administrator 
Centers for Medicare & Medicaid Services 
FROM:  Stuart Wright 
Deputy Inspector General 
for Evaluation and Inspections 
SUBJECT: 	 Memoran~um Report:  Quality Improvement Organizations' Final Responses to 
Beneficiary Complaints, OEI-OI-09-00620 
This memorandum report provides information about Quality Improvement Organizations' 
(QIO) final responses to beneficiary complaints.  Specifically, it provides information on 
(1) the number ofQIO reviews of beneficiary complaints completed between August 1,2008, 
and December 31, 2009, that included practitioner consent for disclosure; and (2) whether the 
final responses from QIOs met requirements for responding to complainants. 
We found that QIOs completed 4,500 complaint reviews between August 1, 2008-when their 
current contracts began-and December 31, 2009.  As part ofthose reviews, QIOs made 
2,768 requests to practitioners for consent to disclosure, and 52 percent (1,449) of the 
practitioners consented. 
We also reviewed in detail 120 final responses that QIOs sent to beneficiaries to determine 
whether the responses met program requirements.  Sixty responses were cases in which the 
practitioners consented to disclosure, and 60 were cases in which practitioners declined to 
consent.  We determined whether each response met the requirement that it state whether the 
beneficiary's care met professional standards, a requirement arising from both the Centers for 
Medicare & Medicaid Services (CMS) policy and a 2003 U.S. Court of Appeals decision.  All 
60 of the responses with practitioner consent met this requirement.  Of the 60 responses without 
practitioner consent, all but 2 met the requirement.  Our.review showed that most QIO responses 
to complainants are meeting the terms of both the court decision and the CMS criteria regarding 
professional standards, as well as CMS's additional criteria. 
When a practitioner consents to disclosure, CMS has two additional requirements:  (1) the QIO 
response must contain a summary of the medical record, and (2) it must describe the corrective 
action that the QIO took in response to any confirmed quality-of-care concern.  All ofthe 
60 responses with practitioner consent contained a summary of the medical record, and 58 of 
OEI-OI-09~00620  QIOs' Final Responses to Beneficiary Complaints  Page 2  Donald M. Berwick, M.D. 
 
 
them described the corrective action taken.  Of the two responses that did not describe the 
corrective action, one stated that the QIO would work with the practitioner to improve future 
care, and the other stated only that appropriate action will be taken.   
 
Of the 60 responses without practitioner consent, 58 met the minimum standard (i.e., specifying 
whether care met professional standards).  Six of these fifty-eight responses, however, went 
beyond the minimumthey included information describing corrective actions that the QIOs 
took, even though CMS does not require such information for responses when the practitioner 
does not consent to disclosure.  According to one of the three QIOs that sent these responses, the 
practitioners involved had not objected to including this information. 
 
BACKGROUND 
 
Quality Improvement Organizations 
CMS contracts with QIOs to oversee and enhance the quality of care within the Medicare 
program and to protect over 40 million Medicare beneficiaries.  QIOs conduct different 
categories of medical record reviews and work with health care providers on quality 
improvement initiatives.  In carrying out these functions, QIOs serve as an essential frontline 
mechanism for beneficiary protection. 
 
QIOs sign 3-year contracts with CMS to work in the 50 States, the District of Columbia, Puerto 
Rico, and the U.S. Virgin Islands.  (Each State has one QIO, although a QIO can operate in more 
than one State.)  Each 3-year contract is governed by a scope of work (SOW).  The QIOs 
9th SOW began on August 1, 2008, and extends through July 31, 2011.  Funding for the 
9th SOW will total about $1.1 billion.1 
 
QIOs have a statutory responsibility to review all written complaints from Medicare beneficiaries 
(or their representatives) alleging that the quality of medical services does not meet 
professionally recognized standards of health care.2  The Office of Inspector General (OIG) 
examined this function twice in the past 15 years, and both times found that the QIOs final 
responses to complainants lacked substance.3   In its 1995 report, OIG recommended that QIOs 
respond substantively to complainants, and identified three elements that a response must 
describe to be substantive: 
 
1.  what the QIO did to investigate the complaint; 
2.  what the investigation revealed, including whether a quality-of-care problem was 
confirmed and, if so, the nature of the problem; and 
 
1 Department of Health & Human Services (the Department), Fiscal Year 2010 Budget in Brief.  Accessed at 
http://www.hhs.gov/asrt/ob/docbudget/2010budgetinbriefl.html on September 10, 2010. 
2 Social Security Act,  1154(a)(14). 
3 OIG, The Beneficiary Complaint Process of the Medicare Peer Review Organizations, OEI-01-93-00250, 
November 1995 and The Medicare Beneficiary Complaint Process:  A Rusty Safety Valve, OEI-01-00-00060, 
August 2001.  (Note that QIOs were previously known as peer review organizations.) 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 3  Donald M. Berwick, M.D. 
 
 
3.  what action the QIO took based on a confirmed quality concern.4 
 
In its comments on our 1995 report, CMS stated that it would take this recommendation under 
advisement, but expressed concerns about balancing these responses with the rights of providers 
to refuse to consent to disclosure.5   
 
Beneficiary Complaint Reviews 
Reviews.  For all written complaints, a QIO conducts a medical record review using 
nonphysician and physician reviewers.  If the nonphysician reviewer identifies a potential 
quality-of-care concern, he or she refers the case to a physician.  If the physician reviewer 
confirms a quality-of-care concern, the QIO offers the practitioner who rendered that care the 
opportunity to provide additional documentation and to request two additional levels of 
physician review.  The final reviewer examines all pertinent information and makes a 
determination regarding the care given.6   
 
If the final review confirms a quality-of-care concern, the QIO may take further action with the 
provider or practitioner, such as requiring a quality improvement plan or recommending 
alternative approaches to future care.  However, CMS does not require the QIO to take further 
action unless the QIO establishes a pattern of concerns.7  If the QIO establishes such a pattern, 
CMS instructs the QIO to work with the practitioner to identify remedial problems and develop 
an action plan.8 
 
Notice of disclosure.  When the case involves a specific practitioner, regardless of the outcome 
of the review, that practitioner may refuse to consent to the QIOs release of any information in 
its final response to the complainant that explicitly or implicitly identifies the practitioner.  After 
the QIO completes the review, but prior to notifying the complainant of the reviews outcome, it 
must provide notice of disclosure to the practitioner, who has 30 days to respond.9 
 
Final response to complainant.  The QIO must inform the complainant of its final disposition of 
the complaint.10  However, the content of the response (beyond a standard introduction, 
including a summary of the complaint) depends on whether the practitioner consented to 
disclosure. 
 
 
4 OIG, The Beneficiary Complaint Process of the Medicare Peer Review Organizations, OEI-01-93-00250, 
November 1995. 
5 Ibid. 
6 CMS, QIO Manual, Chapter 4Case Review, Rev. 2, 07-11-03,  43104320. 
7 Ibid.  4700. 
8 Ibid.  4705.  CMS guidance does not define what constitutes a pattern of concerns. 
9 42 CFR  480.133(a)(2)(iii) and CMS, QIO Manual, Chapter 5Quality of Care Review, Rev. 9, 08-29-03, 
 5025(B). 
10 Social Security Act,  1154(a)(14). 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 4  Donald M. Berwick, M.D. 
 
 
Final response when practitioner consents to disclosure.  If the practitioner consented to 
disclosure, the QIOs response indicates whether the care received by the complainant met 
recognized standards of quality.  The response also gives a complete summary of the reviews 
findings and the action taken in response to any confirmed quality-of-care concern.11 
 
Final response when practitioner declines to consent to disclosure.  If the practitioner did not 
consent to disclosure, CMS does not require the response to include a summary of the medical 
record or information on any corrective actions taken.  Until 2003, CMS instructed QIOs to state 
only that they had conducted a review but could not provide any information identifying the 
involved practitioner.12  Following a court decision, CMS changed its guidance (see below). 
 
Public Citizen v. Department of Health & Human Services 
In 2001, the advocacy group Public Citizen brought suit against the Department and CMS 
regarding the processes for notifying beneficiaries who submit complaints to a QIO.  Public 
Citizen maintained that CMSs regulations and manual sections regarding practitioner consent 
were contrary to the Peer Review Improvement Act of 1982,13 which requires QIOs to inform 
complainants of the final disposition of their complaints.  The court ruled that CMSs regulations 
and manual sections prohibiting disclosure of the results of investigations were invalid because 
they were contrary to section 1145(a)(14) of the Social Security Act.  The court ordered CMS to 
send a letter to QIOs informing them that they are required to disclose the results of reviews to 
complainants.14 
 
The Department appealed the decision, and in 2003 the U.S. Court of Appeals for the District of 
Columbia Circuit upheld the district courts decision.  The Court of Appeals stated that QIOs 
must notify complainants of the results of their reviews, meaning, at a minimum, the 
determination as to whether the quality of the services that the beneficiary received met 
professionally recognized standards of health care.15  The court did not require QIOs to 
include in the final response a summary of the medical record or to describe corrective actions 
taken.  Following the 2003 court decision, CMS required QIOs final responses to state whether 
a beneficiarys care met professional standards, regardless of whether the practitioner consented 
to disclosure.16   
 
See Table 1 for the criteria for QIO final responses to complainants.  The court decision 
mandates one element that QIOs must include in all final responses.  CMS requires three 
elements when the practitioner consents to disclosure and one when the practitioner does not.   
 
 
 
11 CMS, QIO Manual, Chapter 5Quality of Care Review, Rev. 9, 08-29-03,  5030(A). 
12 Ibid.,  5030(C). 
13 P.L. 97-248, Social Security Act,  11011183. 
14 Public Citizen, Inc. v. U.S. Department of Health & Human Services, 151 F. Supp. 2d 64 (D.D.C. 2001). 
15 Public Citizen, Inc. v. U.S. Department of Health & Human Services, 332 F.3d 654 (D.C. Cir. 2003). 
16 CMS, Transmission of Policy System, Control Number:  QIO 2003-08, August 11, 2003. 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 5  Donald M. Berwick, M.D. 
 
 
Table 1:  Summary of Criteria for QIO Final Responses 
 
Practitioner 
Practitioner 
Entity  Final Response to Complainant Includes:  Consent Not 
Consent Given 
Given 
Court of Appeals  Whether care met professional standards  Required  Required 
CMS  Whether care met professional standards  Required  Required 
CMS  Summary of the medical record  Required  Not Required 
CMS  Description of any corrective action taken  Required  Not Required 
Source:  Public Citizen, Inc. v. U.S. Department of Health & Human Services, 332 F.3d 654 (D.C. Cir. 2003); CMS, QIO Manual, 
Chapter 5Quality of Care Review, Rev. 9, 08-29-03,  5030(A) and 5030(c) and Transmission of Policy System Control Number: 
QIO 2003-08, August 11, 2003. 
 
METHODOLOGY 
 
Scope 
We analyzed data on the number of beneficiary complaint reviews from QIOs for 48 States and 
the District of Columbia.  We also analyzed final responses sent from QIOs for the 20 States 
with the largest Medicare populations.  Those States are (from largest to smallest Medicare 
population):  California, Florida, New York, Texas, Pennsylvania, Ohio, Illinois, Michigan, 
North Carolina, New Jersey, Georgia, Virginia, Massachusetts, Tennessee, Missouri, Indiana, 
Washington, Wisconsin, Arizona, and Alabama.  In 2008, these 20 States accounted for 
75 percent of the total Medicare population.   
 
Data Sources and Collection 
Number of complaint reviews.  We obtained from QIOs information on: 
 
  the number of complaint reviews that each QIO completed between August 1, 2008, 
when the current SOW began, and December 31, 2009; 
  the number of requests for practitioner consent to disclosure made as part of those 
reviews; and 
  the number of those practitioners who consented to disclosure.17 
 
We received data for QIOs representing 48 States and the District of Columbia.  Two QIOs did 
not respond to our request; we made three attempts to collect the data from them. 
 
Final responses.  For the 20 States with the largest Medicare populations, we obtained from each 
QIO 6 six recent final responses sent to beneficiaries at the conclusion of a complaint review.  
Specifically, we obtained the three most recent responses with practitioner consent to disclosure 
and the three most recent responses without practitioner consent for disclosure.  This gave us 
 
17 One QIO began the 9th SOW on December 22, 2008. 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 6  Donald M. Berwick, M.D. 
 
 
120 total responses, 60 of which included practitioner consent for disclosure and 60 of which did 
not. 
 
Data Analysis 
We calculated the total number of complaint reviews that QIOs completed and the total number 
of practitioner disclosure requests that QIOs made as part of those reviews.  We then calculated 
the percentage of complaint reviews in which the practitioner consented to disclosure.  We 
compared the contents of each final response with the 2003 Court of Appeals decision and 
CMSs criteria, as summarized in Table 1.   
 
Limitations 
We did not independently verify the QIO data on numbers of completed reviews, practitioners, 
and consent rate.  The results of our analysis of whether final responses met requirements are 
limited to the 120 letters we reviewed; we cannot project these results to the universe of final 
response letters. 
 
Standards 
This study was conducted in accordance with the Quality Standards for Inspections approved by 
the Council of the Inspectors General on Integrity and Efficiency. 
 
RESULTS 
 
QIOs Obtained Consent for Disclosure in About Half of Practitioner Requests 
Between August 1, 2008the start of the 9th SOWand December 31, 2009, QIOs completed 
4,500 complaint reviews.  As part of those 4,500 reviews, QIOs made 2,768 requests for 
practitioner consent to disclosure, and 52 percent (1,449) of those practitioners consented.18  
This means that in almost half of the cases involving specific practitioners, the beneficiaries 
received less information about the outcome of their complaint (e.g., no summary of their 
medical record) than in cases that had practitioner consent.  This consent rate is higher than the 
rate found in our 2001 report, which found that QIOs obtained practitioner consent in only 21 
percent of complaints when a quality-of-care concern was confirmed and in 42 percent of 
complaints when no concern was confirmed.19 
 
Of the 120 Total Responses we Reviewed, 116 Met Requirements 
 
One hundred and eighteen responses stated whether care met professional standards.  Both the 
2003 court decision and CMS require all QIO final responses, regardless of whether the 
practitioner consented to disclosure, to state whether the care under review met professional 
 
18 Not all beneficiary complaint reviews involve a specific practitioner.  Some concern only a facility; in these cases 
the QIO would not need to seek practitioner consent for disclosure.  Conversely, some complaints may involve more 
than one practitioner; in these cases, the QIO must seek consent from each involved practitioner. 
19 OIG, The Medicare Beneficiary Complaint Process:  A Rusty Safety Valve, OEI-01-00-00060, August 2001. 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 7  Donald M. Berwick, M.D. 
 
 
standards.  In meeting this criterion, 118 of 120 responses we reviewed stated that care met 
professionally recognized standards of care or that care was appropriate. 
 
The two responses that did not meet this requirement each concerned complaints in which the 
practitioner did not consent to disclosure, and both came from the same QIO.  Each response 
stated only that the QIO completed the review and would take appropriate action if warranted, 
omitting any mention of the QIOs findings.  This means that for these two complaints, the 
beneficiaries who complained did not learn whether the care they received met professional 
standards of quality. 
 
All 60 responses with consent for disclosure contained a summary of the medical record.  Each 
of the 60 responses for which the practitioner consented to disclosure contained a summary of 
the beneficiarys care as noted in the medical record.  This summary typically included any tests 
given, their results, and the course of treatment. 
 
All but 2 of the 60 responses with consent for disclosure described the corrective action taken in 
response to a confirmed quality-of-care concern.  Responses that met the criterion for a 
description of the corrective action listed specific actions that the QIO took.  For example, these 
responses stated that the QIO required the provider or practitioner to complete a quality 
improvement plan, or that the QIOs physician reviewer recommended alternative approaches to 
future care designed to address the quality-of-care concern.  Of the two responses that did not 
meet this criterion, one stated that the QIO would work with the practitioner to improve future 
care, and the other stated only that appropriate action will be taken. 
 
Six of the sixty responses in which the practitioner declined to consent to disclosure provided 
more information than CMS requires.  Each of these six responses included information 
describing corrective actions taken in response to a confirmed quality-of-care concern.  In these 
cases, a typical response required the practitioner to complete a quality improvement plan.  
When the practitioner does not consent to disclosure, CMS does not require QIOs to include 
information regarding the corrective actions the QIO took.  We spoke with staff at the QIO that 
sent three of these six responses.  According to staff, the involved practitioners had not objected 
to including that information. 
 
CONCLUSION 
 
Our review showed that most QIO responses to complainants are meeting the terms of both the 
court decision and CMS criteria regarding professional standards, as well as CMSs additional 
criteria.  However, QIOs do not obtain consent for disclosure from almost half of the 
practitioners involved (Medicare regulations allow practitioners to decline consent).  As similarly 
identified in previous OIG reports, requiring practitioner consent remains a barrier to providing 
beneficiaries with more complete information about their complaints. 
 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints  Page 8  Donald M. Berwick, M.D. 
 
 
Our review also showed that 6 of the 60 responses exceeded CMSs criteria by including 
information on corrective actions even when the practitioner did not consent to disclosure.  The 
fact that at least one QIO is already providing such a response to beneficiaries without adverse 
consequences suggests that disclosure might not impose an undue burden on practitioners and 
that other QIOs could make the complaint process more transparent to all beneficiaries.  
Responses providing information on corrective actions taken would likely provide some 
assurance to beneficiaries that their complaints and any underlying problems identified were 
being addressed.   
 
This report is being issued directly in final form because it contains no recommendations.  If you 
have comments or questions about this report, please provide them within 60 days.  Please refer 
to report number OEI-01-09-00620 in all correspondence.   
 
 
OEI-01-09-00620     QIOs Final Responses to Beneficiary Complaints