Nursing Homes
Federal Actions Needed to Improve Targeting and Evaluation of Assistance by Quality Improvement Organizations Gao ID: GAO-07-373 May 29, 2007In 2002, CMS contracted with Quality Improvement Organizations (QIO) to help nursing homes address quality problems such as pressure ulcers, a deficiency frequently identified during routine inspections conducted by state survey agencies. CMS awarded $117 million over a 3-year period to the QIOs to assist all homes and to work intensively with a subset of homes in each state. Homes' participation was voluntary. To evaluate QIO performance, CMS relied largely on changes in homes' quality measures (QM), data based on resident assessments routinely conducted by homes. GAO assessed QIO activities during the 3-year contract starting in 2002, focusing on (1) characteristics of homes assisted intensively, (2) types of assistance provided, and (3) effect of assistance on the quality of nursing home care. GAO conducted a Web-based survey of all 51 QIOs, visited QIOs and homes in five states, and interviewed experts on using QMs to evaluate QIOs.
Although more homes volunteered to work with the QIOs than CMS expected them to assist intensively, QIOs typically did not target their assistance to the low-performing homes that volunteered. Most QIOs' primary consideration in selecting homes was their commitment to working with the QIO. CMS did not specify selection criteria for intensive participants but contracted with a QIO that developed guidelines encouraging QIOs to select committed homes and exclude those with many survey deficiencies or QM scores that were too good to improve significantly. Consistent with the guidelines, few QIOs targeted homes with a high level of survey deficiencies, and eight QIOs explicitly excluded these homes. GAO's analysis of state survey data confirmed that selected homes were less likely than other homes to be low-performing in terms of identified deficiencies. Most state survey and nursing home trade association officials interviewed by GAO believed QIO resources should be targeted to low-performing homes. QIOs were provided flexibility both in the QMs on which they focused their work with nursing homes and in the interventions they used. Most QIOs chose to work on chronic pain and pressure ulcers, and most used the same interventions⎯conferences and distribution of educational materials⎯to assist homes statewide. The interventions used to assist individual homes intensively varied and included on-site visits, conferences, and small group meetings. Just over half the QIOs reported that they relied most on on-site visits to assist intensive participants. Sixty-three percent said such visits were their most effective intervention. Of the 15 QIOs that would have changed the interventions used, most would make on-site visits their primary intervention. Homes indicated that they were less satisfied with the program when their QIO experienced high staff turnover or when their QIO contact possessed insufficient expertise. Shortcomings in the QMs as measures of nursing home quality and other factors make it difficult to measure the overall impact of the QIOs on nursing home quality, although staff at most of the nursing homes GAO contacted attributed some improvements in the quality of resident care to their work with the QIOs. The extent to which changes in homes' QM scores reflect improvements in the quality of care is questionable, given the concerns raised by GAO and others about the validity of the QMs and the reliability of the resident assessment data used to calculate them. In addition, quality improvements cannot be attributed solely to the QIOs, in part because the homes that volunteered and were selected for intensive assistance may have differed from other homes in ways that would affect their scores; these homes may also have participated in other quality improvement initiatives. Ongoing CMS evaluation of QIO activities for the contract that began in August 2005 is being hampered by a 2005 Department of Health and Human Services decision that QIO program regulations prohibit QIOs from providing to CMS the identities of homes being assisted intensively.
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Director: Team: Phone:GAO-07-373, Nursing Homes: Federal Actions Needed to Improve Targeting and Evaluation of Assistance by Quality Improvement Organizations
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Report to the Ranking Member, Committee on Finance, U.S. Senate:
United States Government Accountability Office:
GAO:
May 2007:
Nursing Homes:
Federal Actions Needed to Improve Targeting and Evaluation of
Assistance by Quality Improvement Organizations:
Quality Improvement Organizations:
GAO-07-373:
GAO Highlights:
Highlights of GAO-07-373, a report to the Ranking Member, Committee on
Finance, U.S. Senate.
Why GAO Did This Study:
In 2002, CMS contracted with Quality Improvement Organizations (QIO) to
help nursing homes address quality problems such as pressure ulcers, a
deficiency frequently identified during routine inspections conducted
by state survey agencies. CMS awarded $117 million over a 3-year period
to the QIOs to assist all homes and to work intensively with a subset
of homes in each state. Homes‘ participation was voluntary. To evaluate
QIO performance, CMS relied largely on changes in homes‘ quality
measures (QM), data based on resident assessments routinely conducted
by homes. GAO assessed QIO activities during the 3-year contract
starting in 2002, focusing on (1) characteristics of homes assisted
intensively, (2) types of assistance provided, and (3) effect of
assistance on the quality of nursing home care. GAO conducted a Web-
based survey of all 51 QIOs, visited QIOs and homes in five states, and
interviewed experts on using QMs to evaluate QIOs.
What GAO Found:
Although more homes volunteered to work with the QIOs than CMS expected
them to assist intensively, QIOs typically did not target their
assistance to the low-performing homes that volunteered. Most QIOs‘
primary consideration in selecting homes was their commitment to
working with the QIO. CMS did not specify selection criteria for
intensive participants but contracted with a QIO that developed
guidelines encouraging QIOs to select committed homes and exclude those
with many survey deficiencies or QM scores that were too good to
improve significantly. Consistent with the guidelines, few QIOs
targeted homes with a high level of survey deficiencies, and eight QIOs
explicitly excluded these homes. GAO‘s analysis of state survey data
confirmed that selected homes were less likely than other homes to be
low-performing in terms of identified deficiencies. Most state survey
and nursing home trade association officials interviewed by GAO
believed QIO resources should be targeted to low-performing homes.
QIOs were provided flexibility both in the QMs on which they focused
their work with nursing homes and in the interventions they used. Most
QIOs chose to work on chronic pain and pressure ulcers, and most used
the same interventions?conferences and distribution of educational
materials?to assist homes statewide. The interventions used to assist
individual homes intensively varied and included on-site visits,
conferences, and small group meetings. Just over half the QIOs reported
that they relied most on on-site visits to assist intensive
participants. Sixty-three percent said such visits were their most
effective intervention. Of the 15 QIOs that would have changed the
interventions used, most would make on-site visits their primary
intervention. Homes indicated that they were less satisfied with the
program when their QIO experienced high staff turnover or when their
QIO contact possessed insufficient expertise.
Shortcomings in the QMs as measures of nursing home quality and other
factors make it difficult to measure the overall impact of the QIOs on
nursing home quality, although staff at most of the nursing homes GAO
contacted attributed some improvements in the quality of resident care
to their work with the QIOs. The extent to which changes in homes‘ QM
scores reflect improvements in the quality of care is questionable,
given the concerns raised by GAO and others about the validity of the
QMs and the reliability of the resident assessment data used to
calculate them. In addition, quality improvements cannot be attributed
solely to the QIOs, in part because the homes that volunteered and were
selected for intensive assistance may have differed from other homes in
ways that would affect their scores; these homes may also have
participated in other quality improvement initiatives. Ongoing CMS
evaluation of QIO activities for the contract that began in August 2005
is being hampered by a 2005 Department of Health and Human Services
decision that QIO program regulations prohibit QIOs from providing to
CMS the identities of homes being assisted intensively.
What GAO Recommends:
GAO recommends that the CMS Administrator (1) further increase the
number of low-performing homes that QIOs work with intensively, (2)
improve monitoring and evaluation of QIO activities, and (3) require
QIOs to share with CMS the identity of homes assisted intensively in
order to facilitate evaluation. CMS agreed with the first two
recommendations, but did not specifically indicate if it agreed with
the third.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-373].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Kathryn G. Allen, (202)
512-7118, allenk@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
QIOs Generally Had a Choice among Homes That Volunteered but Did Not
Target Assistance to Low-Performing Homes:
QIO Contract Flexibility Resulted in Variation in Assistance Provided
to Intensive Participants:
QIOs' Impact on Quality Is Not Clear, but Staff at Homes We Contacted
Attributed Some Improvements to QIOs:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Publicly Reported Quality Measures:
Appendix III: Comments from the Centers for Medicare & Medicaid
Services:
Appendix IV: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Quality Measures on Which QIOs Could Focus Their Quality
Improvement Efforts in the 7th SOW:
Table 2: Examples of Other Categories of Homes Stakeholders Suggested
QIOs Should Include as Intensive Participants:
Table 3: Examples of Resident Care Improvements Made by Homes as a
Result of Intensive Assistance Provided by QIOs, 7th SOW:
Table 4: QMs as of November 2002 and as of February 2007:
Figures:
Figure 1: Timeline for 7th SOW Contract and Concurrent Special Studies
by QIOs to Improve the Quality of Nursing Home Care:
Figure 2: Levels of QIO Assistance and Nursing Home Participation in
the 7th SOW:
Figure 3: QIO Contract Evaluation Scoring Methodology for the 7th SOW:
Figure 4: QIOs' Considerations in Choosing among Homes That Volunteered
for Intensive Assistance in the 7th SOW:
Figure 5: Comparison of Nonintensive and Intensive Participants'
Performance on State Surveys:
Figure 6: QMs Selected by QIOs for Statewide Interventions and QMs
Selected by Nursing Homes for Intensive Assistance, 7th SOW:
Figure 7: Statewide Interventions Most Relied on by QIOs, 7th SOW:
Figure 8: Intensive Interventions Most Relied on by QIOs and Frequency
of Interventions (Range and Median Number) during the 7th SOW:
Abbreviations:
CMS: Centers for Medicare & Medicaid Services:
FTE: full-time-equivalent:
HHS: Department of Health and Human Services:
IOM: Institute of Medicine:
MDS: minimum data set:
NQF: National Quality Forum:
OSCAR: On-Line Survey, Certification, and Reporting system:
PARTner: Program Activity Reporting Tool:
PRO: Peer Review Organization:
QIO: Quality Improvement Organization:
QM: quality measure:
SOW: statement of work:
United States Government Accountability Office:
Washington, DC 20548:
May 29, 2007:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
Dear Senator Grassley:
The federal government plays a major role in the financing and
oversight of nursing home care for individuals who are aged or
disabled. Medicare and Medicaid payments for nursing home services
totaled $67 billion in 2004, including a $46 billion federal
share.[Footnote 1] The Centers for Medicare & Medicaid Services (CMS)
defines quality standards that the nation's approximately 16,400
nursing homes must meet to participate in the Medicare and Medicaid
programs and contracts with state survey agencies to assess homes'
compliance through routine inspections, known as standard surveys, and
through complaint investigations. Under 3-year contracts beginning in
August 2002 and referred to as the 7th statement of work (SOW), CMS
directed Medicare Quality Improvement Organizations (QIO) to work with
nursing homes to improve the quality of care provided to residents in
the 50 states, the District of Columbia, and the territories.[Footnote
2]
As a condition of their contracts, QIOs were required to provide (1)
information to all Medicare-or Medicaid-certified nursing homes in each
state about systems-based approaches to improving resident care and
clinical outcomes and (2) intensive assistance to a subset of each
state's homes, typically 10 to 15 percent, that were selected by the
QIOs from among those homes that volunteered for assistance.
In a series of congressionally requested studies undertaken since 1998,
we have reported on the unacceptably high proportion of nursing homes
providing poor care to residents.[Footnote 3] Based in part on our
recommendations, CMS has undertaken a number of enforcement initiatives
to encourage nursing home compliance with federal quality standards,
including improved oversight by both state survey agencies and CMS, and
tougher enforcement measures to ensure that homes correct deficiencies
and maintain compliance with federal standards. For example, CMS
expanded its Special Focus Facility program in which state agencies
survey selected homes more frequently and terminate those that fail to
improve significantly within 18 months.
CMS's decision to offer direct assistance to nursing homes that
volunteer to work with QIOs represents a new strategy in the effort to
help address long-standing quality problems in nursing homes. To
evaluate QIO performance in improving nursing home care, CMS relied
primarily on changes in nursing homes' quality measures (QM) during the
contract period. QMs are numeric measures derived from resident
assessments--known as the minimum data set (MDS)--that nursing homes
routinely conduct and submit to CMS.[Footnote 4] The QMs were developed
to permit comparisons across nursing homes of the quality of care
provided to residents and have been publicly reported on CMS's Nursing
Home Compare Web site since 2002.[Footnote 5]
In 2005, CMS renewed the QIO contracts, including the nursing home
component, for another 3-year period, with a budget of $96 million to
assist nursing homes.[Footnote 6] Given the decision to continue the
program, you asked us to assess QIOs' work with nursing homes for the
7th SOW, covering the period August 2002 through January 2006. For this
report, we assessed (1) characteristics of nursing homes the QIOs
assisted intensively, (2) the assistance the QIOs provided to nursing
homes, and (3) the effect of QIOs' assistance on the quality of nursing
home care.
To assess the characteristics of nursing homes that the QIOs selected
to assist intensively from among the homes that volunteered, we
analyzed CMS data on deficiencies cited in standard surveys of nursing
homes and compared the results for homes assisted intensively by the
QIOs with homes that were not assisted intensively.[Footnote 7] To
gather information about the QIOs' criteria for selecting homes for
intensive assistance, we fielded a Web-based survey to the 37
organizations that held the 51 QIO contracts in the states and the
District of Columbia, achieving a 100 percent response rate.[Footnote
8] To determine the type of quality improvement assistance QIOs
provided to nursing homes, our Web-based survey collected data on the
types, frequency, and perceived effectiveness of specific interventions
used to assist homes both statewide and in the group assisted
intensively; interventions included activities such as on-site visits,
mailings, and conferences. To gather more detailed information about
QIOs' work with nursing homes, we conducted site visits to five states-
-Colorado, Florida, Iowa, Maine, and New York--where we interviewed QIO
personnel, staff from nursing homes that had received intensive
assistance, and key stakeholders.[Footnote 9] The five states accounted
for 15 percent of nursing home beds nationwide in 2002 and represented
a range in terms of such characteristics as number of nursing home
beds, region of the country, and QIOs' performance on the nursing home
component in the 7th SOW. In the five states, we interviewed staff from
28 nursing homesæ4 to 8 per state; in addition, we interviewed staff
from 4 homes in four other states for a total of 32 homes. We sought to
select a group of homes that represented a range in terms of state
survey deficiencies, improvement in QM scores during the 7th SOW,
distance from the QIO, and urban versus rural location. However, the
experiences of the 32 homes in our sample cannot be generalized to all
homes that received intensive assistance from the QIOs nationwide. To
assess the effect of QIOs' assistance on nursing home quality, we
reviewed performance requirements in the QIO contracts for both the 7th
and the 8th SOWs; reports on QIOs' work with nursing homes, including
the 2006 report on the QIO program by the Institute of Medicine
(IOM);[Footnote 10] and other documents. We also conducted interviews
with nursing homes, CMS officials, officials from state quality
assurance programs and state MDS accuracy review programs, and experts
on the nursing home QMs and the MDS data on which they are based. We
conducted our review from October 2005 through May 2007 in accordance
with generally accepted government auditing standards. (For a more
detailed description of our scope and methodology, see app. I.)
Results in Brief:
Although QIOs generally had a choice of homes to select for intensive
assistance because more homes volunteered than CMS expected QIOs to
assist, QIOs typically did not target the low-performing homes that
volunteered. Most QIOs reported in our Web-based survey that their
primary consideration in selecting homes was their commitment to
working with the QIO. CMS did not specify selection criteria for
intensive participants but contracted with a QIO to develop guidelines,
which encouraged QIOs to select homes that appeared committed to
quality improvement and to exclude homes with a high number of survey
deficiencies, high management turnover, or QM scores that were too good
to improve significantly. Consistent with the guidelines, only 2
percent of the QIOs that responded to our survey cited a high level of
survey deficiencies among their top three considerations in choosing
among homes that volunteered for assistance, and eight QIOs explicitly
excluded such homes. QIOs reasoned that these homes might be more
focused on improving their survey results than on committing time and
resources to quality improvement projects that might target other care
areas. Our analysis of state survey data showed that, nationwide,
intensive participants were less likely to be low-performing than other
homes in their state in terms of the number, scope, and severity of
deficiencies for which they were cited in standard surveys from 1999
through 2002. This result may reflect the nature of the homes that
volunteered for assistance, the QIOs' selection criteria, or a
combination of the two. Most of the stakeholders we interviewed who
expressed an opinion said that QIOs' resources should be targeted to
low-performing homes. CMS has directed a small share of QIO resources
to low-performing homes in the current 8th SOW. Specifically, each QIO
is required to provide intensive assistance to up to three
"persistently poor-performing homes" identified in consultation with
the state survey agency.
The 7th SOW contracts allowed QIOs flexibility in the QMs they focused
on and the interventions they used. While the majority of QIOs selected
the same QMs and most used the same interventions to assist homes
statewide, the interventions used to assist intensive participants and
staffing to accomplish program goals varied. Of eight possible QMs,
most QIOs and intensive participants worked on chronic pain and
pressure ulcers.[Footnote 11] While intensive participants were
supposed to have a choice of QMs to focus on, some intensive
participants told us that the QIO made the selection and that chronic
pain and pressure ulcers were not necessarily their greatest quality-
of-care challenges. The interventions QIOs relied on most for homes
statewide were conferences and the distribution of educational
materials; for intensive participants, they relied most on on-site
visits, conferences, and small group meetings.[Footnote 12] Although
the interventions QIOs used with intensive participants varied, most
QIOs (63 percent) considered on-site visits the most effective, and
some would make on-site visits their primary intervention if they had
the opportunity to change the interventions they used during the 7th
SOW. Insufficient experience or expertise and high turnover among QIO
personnel negatively affected homes' satisfaction with the program and
the extent of their quality improvements. Turnover was particularly
high at 24 of the 51 QIOs, where one-quarter or more of the QIO
personnel who assisted nursing homes worked less than half of the 36-
month contract. One intensive participant home had four QIO principal
contacts over the course of the 3-year contract.
The impact of QIOs on the quality of nursing home care cannot be
determined from available data, but at most nursing homes we contacted,
staff attributed some improvements in the quality of resident care to
their work with QIOs. Nursing homes' QM scores generally improved
enough for all of the QIOs to meet--and some to surpass widelyæthe
modest targets set by CMS for improvement among homes both statewide
and in the group assisted intensively. However, the overall impact of
the QIOs on the quality of nursing home care cannot be determined from
these data because of the shortcomings of the QMs as measures of
nursing home quality and because confounding factorsæincluding homes'
participation in other quality improvement efforts and any preexisting
differences between homes that volunteered and were selected for
intensive assistance and other homesæmake it difficult to attribute
quality improvements solely to the QIOs. Multiple long-term care
professionals we interviewed stated that QMs should not be used in
isolation to measure quality improvement, but combined with other
indicators, such as state survey data. In addition, the effectiveness
of the individual interventions QIOs used to assist homes cannot be
evaluated with the limited data CMS collected from the QIOs. CMS
planned to enhance evaluation of the program during the 8th SOW, but a
determination by the Department of Health and Human Services (HHS)
Office of General Counsel that the QIO program regulations prohibit
QIOs from providing to CMS the identities of the homes they are
assisting has hampered the agency's efforts to collect the necessary
data. Although we cannot determine the overall impact of the QIOs on
the quality of nursing home care, over two-thirds of the 32 nursing
homes we interviewed attributed some improvements in care to their work
with the QIOs.
We are recommending that the CMS Administrator increase the extent to
which QIOs target intensive assistance to low-performing homes and also
direct QIOs to focus intensive assistance on the quality-of-care areas
on which homes most need improvement. We are also recommending that the
CMS Administrator improve monitoring and evaluation of the QIO program
by revising program regulations to require QIOs to provide to CMS the
identities of the nursing homes they are assisting, collecting more
complete and detailed data on QIO interventions, and identifying a
broader spectrum of measures than QMs to evaluate changes in nursing
home quality. In commenting on a draft of this report, CMS concurred
with but did not indicate how it would implement our recommendations to
increase the number of homes that QIOs assist intensively and collect
more complete and detailed data on the interventions QIOs use to assist
homes. CMS did not specifically indicate if it agreed with our
recommendation to revise program regulations to allow QIOs to reveal to
CMS the identity of the nursing homes they are assisting, but did
indicate that it continues to explore options which would allow access
to such data in order to facilitate evaluation. CMS did not comment on
the remaining two recommendations.
Background:
Beginning in the late 1990s, CMS took steps to broaden the mechanisms
in place intended to help ensure that nursing home residents receive
quality care. To augment the periodic assessment of homes' compliance
with federal quality requirements, CMS contracted for the development
of QMs and tasked QIOs with providing assistance to homes to improve
quality. CMS used QMs both to provide the public with information on
nursing home quality of care and to help evaluate QIO efforts to
address quality-of-care issues, such as pressure ulcers. During the 7th
SOW, organizations other than QIOs were also working with nursing homes
to improve quality.
Indicators of Nursing Home Quality:
Two indicators used by CMS to assess the quality of care that nursing
homes provide to residents are (1) deficiencies identified during
standard surveys and complaint investigations and (2) QMs. Both
indicators are publicly reported on CMS's Nursing Home Compare Web site.
Survey Deficiencies:
Under contract with CMS, state agencies conduct standard surveys to
determine whether the care and services provided by nursing homes meet
the assessed needs of residents and whether nursing homes are in
compliance with federal quality standards.[Footnote 13] These standards
include preventing avoidable pressure ulcers; avoiding unnecessary
restraints, either physical or chemical; and averting a decline in a
resident's ability to perform activities of daily living, such as
toileting or walking.[Footnote 14] During a standard survey, a team
that includes registered nurses spends several days at a home reviewing
the quality of care provided to a sample of residents. States are also
required to investigate complaints filed against nursing homes by
residents, families, and others. Complaint investigations are less
comprehensive than standard surveys because they generally target
specific allegations raised by the complainants.
Any deficiencies identified during standard surveys or complaint
investigations are classified according to the number of residents
potentially or actually affected (isolated, pattern, or widespread) and
their severity (potential for minimal harm, potential for more than
minimal harm, actual harm, or immediate jeopardy). Deficiencies cited
at the actual harm and immediate jeopardy level are considered serious
and could trigger enforcement actions such as civil money penalties. We
have previously reported on the considerable interstate variation in
the proportion of homes cited for serious care problems, which ranged
during fiscal year 2005 from 4 percent of Florida's 691 homes to 44
percent of Connecticut's 247 homes.[Footnote 15] We reported that such
variability suggests inconsistency in states' interpretation and
application of federal regulations; in addition, both we and CMS have
found that state surveyors do not identify all serious
deficiencies.[Footnote 16]
Quality Measures:
QMs are relatively new indicators of nursing home quality. Although
survey deficiencies have been publicly reported since 1998, CMS did not
begin posting QMs on its Nursing Home Compare Web site until November
2002. QMs are derived from resident assessments known as the MDS that
nursing homes routinely collect on all residents at specified
intervals.[Footnote 17] Conducted by nursing home staff, MDS
assessments cover 17 areas, such as skin conditions, pain, and physical
functioning.
In developing QMs, CMS recognized that any publicly reported indicators
must pass a rigorous standard for validity and reliability. In October
2002, we reported that national implementation of QMs was premature
because of validity and reliability concerns.[Footnote 18] Valid QMs
would distinguish between good and poor care provided by nursing homes;
reliable QMs would do so consistently. One of our main concerns about
publicly reporting QMs was that the QM scores might be influenced by
other factors, such as residents' health status. As a result, the
specification of appropriate risk adjustment was a key requirement for
the validity of any QMs. Risk adjustment is important because it
provides consumers with an "apples-to-apples" comparison of nursing
homes by taking into consideration the characteristics of individual
residents and adjusting the QM scores accordingly. For example, a home
with a disproportionate number of residents who are bedfast or who
present a challenge for maintaining an adequate level of nutrition--
factors that contribute to the development of pressure ulcers--may have
a higher pressure ulcer score. Adjusting a home's QM score to fairly
represent to what extent a home does or does not admit such residents
is important for consumers who wish to compare one home to another.
Appendix II lists the 10 QMs initially adopted and publicly reported by
CMS--6 applicable to residents with chronic care problems (long-stay
residents) and 4 applicable to residents with post-acute-care needs
(short-stay residents).
MDS data are self-reported by nursing homes, and ensuring their
accuracy is critical for establishing resident care plans, setting
nursing home payments, and publicly reporting QM scores. In February
2002, we concluded that CMS efforts to ensure the accuracy of MDS data,
which are used to calculate the QMs, were inadequate because the agency
relied too much on off-site review activities by its contractor and
planned to conduct on-site reviews in only 10 percent of its data
accuracy assessments, representing fewer than 200 of the nation's then
approximately 17,000 nursing homes.[Footnote 19] Although we
recommended that CMS reorient its review program to complement ongoing
state MDS accuracy efforts as a more effective and efficient way to
ensure MDS data accuracy, CMS disagreed and continued to emphasize off-
site reviews.[Footnote 20]
Evolution of the QIO Program and the Quality Improvement Process:
Over the past 24 years, the QIO program has evolved from a focus on
quality assurance in the acute care setting to quality improvement in a
broader mix of settings, including physician offices, home health
agencies, and nursing homes. Established by the Peer Review Improvement
Act of 1982[Footnote 21] and originally known as Peer Review
Organizations (PRO), QIOs initially focused on ensuring minimum
standards by conducting retrospective hospital-based utilization
reviews that looked for inappropriate or unnecessary Medicare services.
According to the 2006 IOM report, as it became apparent that standards
of care themselves required attention, QIOs gradually shifted from
retrospective case reviews to collaboration with providers to improve
the overall delivery of care--a shift consistent with transformational
goals set by CMS's Office of Clinical Standards and Quality, which
oversees the QIO program.[Footnote 22]
In contrast to enforcing standards, quality improvement tries to ensure
that organizations have effective processes for continually measuring
and improving quality. The goal of quality improvement is to close the
gap between an organization's current performance and its ideal
performance, which is defined by either evidence-based research or best
practices demonstrated in high-performing organizations. According to
the quality improvement literature, successful quality improvement
requires a commitment on the part of an organization's leadership and
active involvement of the staff. The 2006 IOM report notes that QIOs
rely on various mechanisms to promote quality improvement, including
one-on-one consulting and collaboratives.[Footnote 23] While the former
provides direct and specialized attention, the latter relies on
workshops or meetings that offer opportunities for providers to share
experiences and best practices. Quality improvement often relies on the
involvement of early adopters of best practices--providers who are
highly regarded as leaders and can help convince others to change--for
the diffusion of best practices. Key tools for quality improvement
include (1) root cause analysis, a technique used to identify the
conditions that lead to an undesired outcome; (2) instruction on how to
collect, aggregate, and interpret data; and (3) guidance on bringing
about, sustaining, and diffusing internal system redesign and process
changes, particularly those related to use of information technology
for quality improvement. Quality improvement experts also emphasize the
importance of protecting the confidentiality of provider information,
not only to protect the privacy of personal health information but also
to encourage providers to evaluate their peers honestly and to prevent
the damage to providers' reputations that might occur through the
release of erroneous information.
Section 1160 of the Social Security Act provides that information
collected by QIOs during the performance of their contract with CMS
must be kept confidential and may not be disclosed except in specific
instances; it provides the Secretary of HHS with some discretion to
determine instances under which QIO information may be disclosed. The
regulations implementing the statute limit the circumstances under
which confidential information obtained during QIO quality review
studies, including the identities of the participants of those studies,
may be disclosed by the QIO. During the 7th SOW, QIOs submitted a list
of nursing home participants to CMS as a contract deliverable.
CMS Contract Funding and Requirements:
During the 7th SOW, CMS awarded a total of $117 million to QIOs to
improve the quality of care in nursing homes in all 50 states, the
District of Columbia, and the territories. The performance-based
contracts for QIO assistance to nursing homes delineated broad
expectations regarding QIO assistance to nursing homes, provided
deadlines for completing four contract deliverables, and laid out
criteria for evaluating QIO performance.[Footnote 24] For contracting
purposes, the QIOs were divided into three groups with staggered
contract cycles. The four contract deliverables, however, were all due
on the same dates, irrespective of the different contract cycles. The
contracts also required QIOs to work with a QIO support contractor
tasked to provide guidelines for recruiting and selecting nursing homes
as intensive participants, train QIOs in standard models of quality
improvement assistance, and provide tools and educational materials, as
well as individualized consultation if needed, to help QIOs meet
contractual requirements.[Footnote 25] QIOs and nursing homes were also
involved in other quality improvement special studies with budgets
separate from the QIO contracts for the 7th SOW. These studies varied
greatly in terms of length, the clinical issue(s) covered, the number
of QIOs involved, and the characteristics of the nursing homes that
participated. Figure 1 shows the 7th SOW contract cycles, deliverables
for the nursing home component, and the duration of the special studies.
Figure 1: Timeline for 7th SOW Contract and Concurrent Special Studies
by QIOs to Improve the Quality of Nursing Home Care:
[See PDF for image]
Source: GAO analysis of the 7th SOW and CMS descriptions of special
studies.
[A] In the 7th SOW, QIOs were divided into three groups with staggered
contract cycles. The four contract deliverables, however, were all due
on the same dates, irrespective of contract cycle.
[B] The term states includes the 50 United States and the District of
Columbia.
[C] QIOs could add--but not delete or change--QMs for their intensive
participants through September 2003.
[End of figure]
Contract funding. The $117 million awarded to QIOs to improve the
quality of care in nursing homes during the 7th SOW included (1) $106
million awarded to provide statewide and intensive assistance to
homes,[Footnote 26] (2) $5.6 million awarded to selected QIOs to
conduct eight special studies focused on nursing home care, and (3)
$5.3 million awarded to the QIO that served as the support contractor
for the nursing home component.[Footnote 27] CMS allocated a specific
amount for each component of the contracts, but allowed QIOs to move
funds among certain components.[Footnote 28] Just over half of the 51
QIOs did not spend all of the funds allocated to the nursing home
component, but on average the QIOs overspent the budget for the nursing
home work by 3 percent.
Contract requirements for quality improvement activities. Per the
contracts for the 7th SOW, QIOs were required to provide (1) all
Medicare-and Medicaid-certified homes with information about systems-
based approaches to improving patient care and clinical outcomes, and
(2) intensive assistance to a subset of homes in each state. The
contracts directed QIOs working in states with 100 or more nursing
homes to target 10 to 15 percent of the homes for intensive
assistance.[Footnote 29] Figure 2 illustrates that QIOs provided two
levels of assistance--statewide and intensive--and that homes'
participation was either nonintensive or intensive. Intensive
participants received both statewide and intensive assistance.
Selection of intensive participants from among the nursing homes that
volunteered was at the discretion of each QIO, but the SOW required the
QIO support contractor (the Rhode Island QIO) to provide guidelines and
criteria for QIOs to use in determining which homes to select.
Participation in the program was voluntary, and QIOs were prohibited
from releasing the names of participating nursing homes except as
permitted by statute and regulation.[Footnote 30]
Figure 2: Levels of QIO Assistance and Nursing Home Participation in
the 7th SOW:
[See PDF for image]
Source: GAO analysis of the 7th SOW.
[A] Nursing homes on the official list of intensive participants
submitted to CMS by the QIOs by February 3, 2003.
[End of figure]
Under the contracts, the quality improvement assistance provided by
QIOs focused on areas related to eight chronic care and post-acute-care
QMs publicly reported on the CMS Nursing Home Compare Web site. QIOs
were required to consult with relevant stakeholders and select from
three to five of the eight QMs on which QIOs' quality improvement
efforts would be evaluated (see table 1).[Footnote 31] Intensive
participant homes were also required to select one or more QMs on which
to work with the QIO. Although they could select one QM, they were
encouraged to select more than one.
Table 1: Quality Measures on Which QIOs Could Focus Their Quality
Improvement Efforts in the 7th SOW:
Chronic care QMs: Decline in activities of daily living; Post-acute-
care QMs: Failure to improve and manage delirium.
Chronic care QMs: Pressure ulcers; Post-acute-care QMs: Inadequate pain
management.
Chronic care QMs: Inadequate pain management; Post-acute-care QMs:
Improvement in walking.
Chronic care QMs: Physical restraints; Post-acute-care QMs: [Empty].
Chronic care QMs: Infections; Post-acute-care QMs: [Empty].
Source: CMS.
Note: Although CMS adopted 10 QMs, the QIOs were evaluated only on the
8 listed here (see app. II).
[End of table]
To improve QM scores, QIOs were expected to develop and implement
quality improvement projects focused on care processes known to improve
patient outcomes in a manner that utilized resources efficiently and
reduced burdens on providers. The QIO support contractor developed a
model for QIOs to facilitate systems change in nursing homes. This
model emphasized the importance of QIOs' statewide activities to form
and maintain partnerships, conduct workshops and seminars, and
disseminate information on interventions to improve quality. For
intensive participants, the model emphasized conducting one-on-one
quality improvement assistance as well as conferences and small group
meetings. According to contract language, QIOs were expected to
coordinate their projects with other stakeholders that were working on
similar improvement efforts or were interested in teaming with the QIO.
But ultimately, each QIO determined for itself the type, level,
duration, and intensity of support it would offer to nursing homes.
Evaluation of QIO contract performance. CMS evaluated QIOs' performance
on the nursing home component of the contract using nursing home
provider satisfaction with the QIO, QM improvement among intensive
participants, and QM improvement statewide (see fig. 3).[Footnote 32]
Nursing home provider satisfaction was assessed by surveying all
intensive participants and a sample of nonintensive participants around
the 28th month of each 36-month contract. CMS expected at least 80
percent of respondents to report that they were either satisfied or
very satisfied.
Figure 3: QIO Contract Evaluation Scoring Methodology for the 7th SOW:
[See PDF for image]
Note: QM improvement was calculated using the following formula:
(baseline rate minus remeasurement rate) / baseline rate. For example,
if a nursing home had a baseline rate of 20 percent for the pain
management QM (e.g., 20 percent of the home's residents had severe or
moderate pain), a 10 percent improvement would mean that 18 percent of
residents had moderate or severe pain at remeasurement [(20 percent -
18 percent) / 20 percent].
[A] All intensive participants and a sample of nonintensive
participants were surveyed to assess their satisfaction with the QIO.
[B] The weight (percentage of total score) given to this element
depended on the proportion of the state's homes that were included in
the intensive participant group; the weight ranged from 44 percent, if
10 percent of the homes were included, to 66 percent, if at least 15
percent of the homes were included.
[C] The weight (percentage of total score) given to this element was
the difference between 80 percent and the weight given to the intensive
participant element and ranged from 14 to 36 percent.
[End of figure]
QIOs were also expected to achieve an 8 percent improvement in QM
scores among both intensive participants and homes statewide. The term
improvement was defined mathematically to mean the relative change in
the QM score from when it was measured at baseline to when it was
remeasured. The statewide improvement score included the QM improvement
scores for intensive participants averaged with those of nonintensive
participants.
CMS established two scoring thresholds for the contracts that
encompassed scores from all components of the SOW. If a QIO scored
above the first threshold it was eligible for a noncompetitive contract
renewal; if it scored below that threshold, it was eligible for a
competitive renewal only upon providing information pertinent to its
performance to a CMS-wide panel that decided whether to allow the QIO
to bid again for another QIO contract.[Footnote 33]
CMS contract monitoring. CMS formally evaluated each QIO at months 9
and 18 of the 7th SOW. If CMS found that a QIO failed to meet contract
deliverables or appeared to be in danger of failing to meet contract
goals, it could require the QIO to make a performance improvement plan
or corrective plan of action to address any barriers to the QIOs
successfully fulfilling contract requirements. In addition, CMS
reviewed materials such as QIOs internal quality control plans, which
were intended to help QIOs monitor their own progress and to document
any project changes made to improve their performance.
Other Nursing Home Quality Improvement and Assurance Initiatives:
The QIO program operated in the context of other quality improvement
initiatives sponsored by federal and state governments and nursing home
trade associations. As stated earlier, CMS funded a number of special
nursing home studies involving subsets of the QIOs and nursing homes,
which addressed a variety of clinical quality-of-care issues and which
are summarized in figure 1. Under CMS's Special Focus Facility program,
state survey agencies were required to conduct enhanced monitoring of
nursing homes with histories of providing poor care. During the 7th
SOW, CMS revised the method for selecting homes for the Special Focus
Facility program to ensure that the homes performing most poorly were
included; increased the minimum number of homes that must be included,
from a minimum of two per state to a minimum of up to six, depending on
the number of homes in the state; and strengthened enforcement for
those nursing homes with an ongoing pattern of substandard
care.[Footnote 34] In addition, concurrent with the 7th SOW, at least
eight states had programs that provided quality assurance and technical
assistance to nursing homes in their states.[Footnote 35] These
programs varied in terms of whether they were voluntary or mandatory,
which homes received assistance, the focus and frequency of the
assistance provided, and the number and type of staff employed.
In addition to government-operated quality improvement initiatives,
three long-term care professional associations joined together in July
2002 to implement the Quality First Initiative.[Footnote 36] This
initiative was based on a publicly articulated pledge on the part of
the long-term care profession to establish an environment of continuous
quality improvement, openness, and leadership in participating homes.
QIOs Generally Had a Choice among Homes That Volunteered but Did Not
Target Assistance to Low-Performing Homes:
Although QIOs generally had a choice of homes to select for intensive
assistance because more homes volunteered than CMS expected QIOs to
assist, QIOs typically did not target the low-performing homes that
volunteered. Most QIOs reported in our Web-based survey that they did
not have difficulty recruiting homes, and their primary consideration
in selecting homes from the pool of volunteers was that the homes be
committed to working with the QIOs. In the 7th SOW, CMS did not specify
recruitment and selection criteria for intensive participants, leaving
the development of guidelines to the QIO support contractor, which
encouraged QIOs to select homes that seemed committed to quality
improvement and to exclude homes with a high number of survey
deficiencies, high management turnover, or QM scores that were too good
to improve significantly.[Footnote 37] Our analysis of state survey
data showed that, nationwide, intensive participants were less likely
to be low-performing than other homes in their state in terms of the
number, scope, and severity of deficiencies for which they were cited
in standard surveys from 1999 through 2002. This result may reflect the
nature of the homes that volunteered for assistance, the QIOs'
selection criteria, or a combination of the two. The stakeholders we
interviewed--including officials of state survey agencies and nursing
home trade associations--generally believed QIOs' resources should be
targeted to low-performing homes.
QIOs Generally Had a Choice of Which Nursing Homes to Assist
Intensively:
Most QIOs had a choice of which nursing homes to assist intensively, as
more homes volunteered than the QIOs could receive credit for serving
under the terms of their contracts.[Footnote 38] Of the 38 QIOs in
states with 100 or more homes, which were expected to work intensively
with 10 to 15 percent of the homes, 30 reported in our Web-based survey
that more than 15 percent of homes expressed interest in intensive
assistance, and 8 reported that more than 30 percent of homes expressed
interest.[Footnote 39] Most QIOs selected about as many intensive
participants as needed to get the maximum weight for the intensive
participant element of their contract evaluation score. Nationwide, the
intensive participant group included just under 15 percent (2,471) of
the 16,552 homes identified by CMS at the beginning of the 7th
SOW.[Footnote 40]
Most QIOs--82 percent of the 51 that responded to our survey--reported
that it was not difficult to recruit the target number of homes for
intensive assistance; the remainder reported that it was difficult (12
percent) or very difficult (4 percent) to recruit enough
volunteers.[Footnote 41] Among the QIOs we interviewed, personnel at
two that reported difficulties recruiting homes cited homes' lack of
familiarity with QIOs as a barrier. Personnel at one of these two QIOs
commented that the QIO's first task was to build trust among homes and
address confusion about its role, as some homes thought the QIO was a
regulatory authority charged with investigating complaints and citing
homes for deficiencies.
Commitment to Working with QIOs Was QIOs' Primary Consideration in
Selecting Homes from among Those That Volunteered:
QIOs that responded to our Web-based survey almost uniformly cited
homes' commitment to working with them as a key consideration in
choosing among the homes that volunteered to be intensive participants.
QIOs had wide latitude in choosing among homes because CMS did not
specify the characteristics of the homes they should recruit or select,
leaving it to the QIO support contractor to provide voluntary
guidelines. The QIO support contractor developed guidelines based on
input from a variety of sources, including QIOs that worked with
nursing homes during the 6TH SOW. Issued at the beginning of the 7th
SOW, the guidelines emphasized the important role the selected homes
would play in the QIOs' contract performance and encouraged QIOs to
select homes that demonstrated a willingness and ability to commit time
and resources to quality improvement. The QIO support contractor also
encouraged QIOs to exclude homes with a high number of survey
deficiencies, high management turnover, and QM scores that were too
good to improve significantly. With respect to homes' survey histories,
the QIO support contractor reasoned that homes with a high number of
deficiencies might be more focused on improving their survey results
than on committing time and resources to quality improvement projects.
For example, the care areas in which a home was cited for deficiencies
might not correspond with any of the eight QMs to which CMS limited the
QIOs' quality improvement activities (see table 1). In fact, the
quality of care area in which homes were most frequently cited for
serious deficiencies in surveys in 2006 was the provision of
supervision and devices to prevent accidents, which does not have a
corresponding QM.[Footnote 42]
Consistent with the guidelines, 76 percent of the 41 QIOs that reported
in our Web-based survey their considerations in selecting homes for the
intensive participant group ranked homes' commitment as their primary
consideration. Nearly all QIOs ranked commitment among their top three
considerations (see fig. 4).[Footnote 43]
Figure 4: QIOs' Considerations in Choosing among Homes That Volunteered
for Intensive Assistance in the 7th SOW:
[See PDF for image]
Note: Forty-one QIOs reported their considerations in choosing among
homes that volunteered for intensive assistance.
[End of figure]
Homes' QM scores were also an important consideration for QIOs. QIOs
were particularly interested in including homes that had poor QM scores
in areas where the QIO planned to focus or in assembling a group of
homes that represented a mix of QM scores. With respect to homes'
overall QM scores, the QIOs that responded to our survey were more
likely to seek homes with moderate overall scores than homes with poor
or good overall scores. Similarly, personnel at most QIOs we contacted
gave serious consideration to homes' QM scores, looking for homes that
appeared to need help and could demonstrate improvement. For example,
personnel at one QIO said that they tended to select homes whose QM
scores were worse than the statewide average; personnel at another QIO
said that this QIO selected homes with scores it thought could be
improved, eliminating homes with either very high or very low scores.
Personnel at one QIO acknowledged that some QIOs might "cherry pick"
homes in this way in order to satisfy CMS contract requirements but
argued that it was not possible for QIOs to predict which homes would
improve the most.
QIOs generally gave less consideration to the number of deficiencies
homes had on state surveys than to their QM scores. However, the 17
QIOs that ranked survey deficiencies among their top three
considerations in our survey were more likely to seek homes with
deficiencies in areas where they planned to focus or homes with an
overall low level (number and severity) of survey deficiencies than
homes with an overall high level. Moreover, of the 33 QIOs that
reported in our survey systematically excluding some of the homes that
volunteered from the intensive participant group, nearly one-quarter
(8) excluded homes with a high number of survey deficiencies. None
excluded homes with a low number of survey deficiencies.[Footnote 44]
Personnel at the QIOs we interviewed offered several reasons for
excluding homes with a high number of survey deficiencies from the
intensive participant group. Personnel at several QIOs concurred with
the QIO support contractor that such homes were likely to be too
consumed with correcting survey issues to focus on quality improvement.
Personnel at one QIO suggested that the kind of assistance very poor-
performing homes needæhelp improving the basic underlying structures of
operationæwas not the kind the QIO offered. Personnel at some QIOs said
they considered not just the level of deficiencies for which homes were
cited on recent surveys but the level over multiple years or the
specific categories of deficiencies. For example, personnel at one QIO
said that although the QIO excluded homes with long-standing histories
of poor performance, it actively recruited homes that had performed
poorly only on recent surveys. Personnel at another QIO stated that
their concern was to avoid homes with competing priorities. This QIO
sought to include homes with deficiencies in the areas it planned to
address but to exclude homes with deficiencies in other areas on the
assumption that these homes would not benefit from the assistance it
planned to offer. Personnel we interviewed at two QIOs said that they
worked with some extremely poor-performing homes but did not include
them on the official list of intensive participants submitted to CMS;
personnel at one of these QIOs explained that they did not want to be
held responsible if these homes were unable to improve.
QIOs Did Not Target Intensive Assistance to Low-Performing Homes:
Our analysis of homes' state survey histories from 1999 through 2002
indicates that QIOs did not target intensive assistance to homes that
had performed poorly in state surveys. Nationwide, the homes in the
intensive participant group were less likely than other homes in their
state to be low-performing in terms of the number, scope, and severity
of deficiencies for which they were cited in surveys during that time
frame. As illustrated in figure 5, the intensive participant group
included proportionately more homes in the middle of the performance
spectrum and proportionately fewer at either end. Although our analysis
focused on survey deficiencies rather than QMs, this result is
generally consistent with the results of our Web-based survey
concerning QIOs' use of QM scores as selection criteria, which showed
that QIOs were more likely to select homes with moderate overall scores
than homes with poor or good overall scores and to seek a mix of
performance levels among homes in the group. However, not knowing the
composition of the pool of homes that volunteered for assistance, we
cannot determine whether the composition of the intensive participant
groupæin particular, the disproportionately low number of low-
performing homes in the groupæwas a function of which homes
volunteered, which homes the QIOs selected from among the volunteers,
or a combination of both factors.
Figure 5: Comparison of Nonintensive and Intensive Participants'
Performance on State Surveys:
[See PDF for image]
Note: Homes are categorized as low-, moderately, or high-performing on
the basis of the number, scope, and severity of deficiencies for which
they were cited, relative to other homes in their state, in three
standard state surveys from 1999 through 2002. All differences are
statistically significant at p-value < 0.05 level.
[End of figure]
On a state-by-state basis, none of the QIOs targeted assistance to low-
performing homes by including proportionately more such homes in the
intensive participant group. Most QIOs (33 of 51) worked intensively
with homes that were generally representative of the range of homes in
their state in terms of performance on state surveys from 1999 through
2002. In these states, there was no significant difference in the
proportion of high-, moderately, or low-performing homes among
intensive participants compared with nonintensive participants.
However, 18 QIOs worked intensively with a group that differed
significantly from other homes in the state: 8 of these QIOs worked
with proportionately fewer low-performing homes, 5 worked with
proportionately more moderately performing homes, and 9 worked with
proportionately fewer high-performing homes.[Footnote 45]
Stakeholders Often Stated QIOs Should Target Intensive Assistance to
Low-Performing Homes:
Stakeholders we interviewed who expressed an opinion about the homes
QIOs should target for intensive assistance--11 of the 16 we
interviewed--almost uniformly said that the QIOs should concentrate on
low-performing homes.[Footnote 46] Survey officials in one state
suggested that QIOs should use state survey data to assess homes' need
for assistance because these data are often more current than QM data.
In their emphasis on low-performing homes, stakeholders echoed the
views expressed in the 2006 IOM report, which recommended that QIOs
give priority for assistance to providers, including nursing homes,
that most need improvement. Other stakeholder suggestions regarding the
homes QIOs should target are listed in table 2. Because the QIOs were
required to protect the confidentiality of QIO information about
nursing homes that agreed to work with them, stakeholders were
generally not informed which homes were receiving intensive assistance.
One exception was in Iowa, where the QIO obtained consent from the
selected homes to reveal their identities.
Table 2: Examples of Other Categories of Homes Stakeholders Suggested
QIOs Should Include as Intensive Participants:
Category of home: Special focus facilities; Explanation: One state
survey official suggested that CMS mandate that QIOs work with the low-
performing homes selected by state survey agencies for the Special
Focus Facility program.[A].
Category of home: Homes lacking resources for quality improvement;
Explanation: Stakeholders suggested targeting small rural facilities,
"stand-alone" facilities that lack the resources of corporate chains,
or facilities that are struggling financially..
Category of home: High-performing homes; Explanation: Several
stakeholders advocated including some high-performing homes. One
stakeholder group suggested that such homes could serve as models and
share their approaches with homes that were struggling. Another
suggested that QIOs may include homes at varying performance levels to
avoid stigmatizing the intensive participants as "bad homes.".
Source: GAO analysis.
Note: Eleven of the 16 stakeholders we interviewed expressed an opinion
about which homes the QIOs should include as intensive participants.
[A] Seventeen (13 percent) of the 129 facilities in the Special Focus
Facility program as of January 2005 were also among the QIOs' 2,471
intensive participants in the 7th SOW.
[End of table]
Several stakeholders said that low-performing homes can improve with
assistance. However, one suggested that QIOs might have to adapt their
approachæfor example, by streamlining their trainingæto avoid
overburdening homes that are struggling with competing demands. Another
agreed that low-performing homes can benefit from working with a QIO
but added that real improvements in the quality of care in these homes
would require attention to staffing, turnover, pay, and recognition for
staff. The results of one special study funded by CMS during the time
frame of the 7th SOW supported stakeholders' contention that low-
performing homes can improve, although the improvements documented in
these homes cannot be definitively attributed to the QIOs.[Footnote 47]
In this study, known as the Collaborative Focus Facility project, 17
QIOs worked intensively with one to five low-performing homes
identified in consultation with the state survey agency.[Footnote 48]
According to a QIO assessment of the project, the participating homes
showed improvement in areas related to the assistance provided by the
QIO in terms of both the number of serious state survey deficiencies
for which they were cited and their QM scores.[Footnote 49] CMS
officials pointed out that these improvements were hard-won: one-third
of the homes that were asked to participate in the Collaborative Focus
Facility project refused, and those that did participate required more
effort and resources from the QIOs to improve than did other homes
assisted by the QIOs.
Overall, CMS has specifically directed only a small share of QIO
resources to low-performing homes. In the current contracts (the 8th
SOW), CMS required QIOs to provide intensive assistance to some
"persistently poor-performing homes" identified in consultation with
each state survey agency. However, the number of such homes that the
QIOs must serve is smallæranging from one to three, depending on the
number of nursing homes in the stateæand accounts for less than 10
percent of the homes the QIOs are expected to assist intensively. Less
than 17 percent of the 144 persistently poor-performing homes the QIOs
selected in consultation with state survey agencies to assist in the
8th SOW were also special focus facilities in 2005 or 2006.
QIOs and stakeholders tended to disagree about whether participation in
the program should remain voluntary for all homes. QIO personnel we
interviewed who expressed an opinion generally supported voluntary
participation on the theory that homes that were forced to participate
would probably be less engaged and put forth only minimal effort.
Personnel at some QIOs that opposed mandatory participation suggested
that creating incentives for homes to improve their quality of careæfor
example, through pay for performanceæwould increase homes' interest in
working with the QIO. In contrast, most of the state survey agency and
trade association officials we interviewed who expressed an opinion
about the voluntary nature of the QIO program said that some homes
should be required to work with the QIO. Officials at one state survey
agency pointed out that the low-performing homes that really need
assistance rarely seek it; these officials believed that working with
the QIO should be mandatory for low-performing homes and voluntary for
moderately to high-performing homes. Another state survey agency
official recommended that 25 to 40 percent of the homes assisted
intensively be chosen from among the lower-performing homes in the
state and required to work with the QIO.
QIO Contract Flexibility Resulted in Variation in Assistance Provided
to Intensive Participants:
The 7th SOW contracts allowed QIOs flexibility in the QMs they focused
on and the interventions they used, and while the majority of QIOs
selected the same QMs and most used the same interventions to assist
homes statewide, the interventions for intensive participants and
staffing to accomplish program goals varied. Most QIOs and intensive
participants worked on the chronic pain and pressure ulcer QMs, but
these were not the QMs that some intensive participants believed
matched their greatest quality-of-care challenges. To assist all homes
statewide, QIOs generally relied on conferences and the distribution of
educational materials. The top three interventions for intensive
participants included on-site visits (87 percent), followed by
conferences (57 percent), and small group meetings (48 percent).
According to nursing home staff we interviewed, turnover and experience
levels of the QIO personnel that provided them assistance affected
their satisfaction with the program and the extent of their quality
improvements.
Most Quality Improvement Efforts Focused on Chronic Pain and Pressure
Ulcers:
Under the terms of the contracts, both QIOs and intensive participants
could select QMs to focus on, but most chose to work on two of the same
QMs.[Footnote 50] While nearly all QIOs chose to work statewide on
chronic pain and pressure ulcers, they differed on their selection of
additional QMs (see fig. 6). QIO personnel we interviewed told us they
based the choice of QMs for their statewide work on input from
stakeholders and nursing homes or QM data. For example, some
stakeholders told us that specific QMs selected addressed existing long-
term care challenges and were ones on which homes in the state ranked
below the national average. Personnel from two QIOs said they selected
QMs based on input from homes in their state about which QMs the homes
were interested in working on, and personnel from several QIOs stated
that they selected QMs on which their homes could improve. Personnel
from one QIO specifically mentioned that they selected QMs related to
the quality of life for nursing home residents.
Figure 6: QMs Selected by QIOs for Statewide Interventions and QMs
Selected by Nursing Homes for Intensive Assistance, 7th SOW:
[See PDF for image]
Source: GAO analysis of QIO support contractor data.
[End of figure]
Most intensive participants worked on a subset of the QMs selected by
their QIO--chronic pain and pressure ulcers (see fig. 6). The degree to
which intensive participants knew they had a choice of QMs was unclear.
Of the 14 intensive participants we interviewed that commented on
whether they had a choice, 9 said that they did. Staff from these homes
generally reported having selected QMs related to clinical issues on
which they could improve. However, the remaining 5 homes indicated that
their QIO selected the QMs on which they received assistance. Most of
these 5 homes' staff reported that they would have preferred to work on
different QMs from the list of eight that are publicly reported on the
CMS Nursing Home Compare Web site or other clinical issues that reflect
their greatest quality-of-care challenges.
Statewide Interventions Less Variable Than Those for Intensive
Participants:
The terms of the QIO contract with CMS allowed QIOs to determine the
kinds of quality improvement interventions they offered to homes, and
those selected by QIOs were consistent with an approach recommended by
the QIO support contractor: QIOs generally relied most on conferences
and the distribution of educational materials to assist homes statewide
and on on-site visits to assist intensive participants. However, there
was a greater variety of interventions frequently relied on to assist
intensive participants. In general, QIOs reported that the
interventions they relied on most were also the most effective for
improving the quality of resident care.
Statewide Assistance:
Almost three-quarters of the QIOs included conferences among the two
interventions they relied on most to provide quality improvement
assistance to homes statewide (see fig. 7). These QIOs held an average
of nine conferences over the course of the 7th SOW, typically in
various cities throughout the state to accommodate homes from different
regions. Sixty-eight percent of these QIOs reported that more than half
the homes in their state sent staff to least one conference, and 16
percent of QIOs reported that all or nearly all homes did so. QIO
personnel reported holding conferences to educate homes on quality
improvement, discuss the relationship between MDS assessments and the
QMs, and provide QM-specific clinical information or best practices.
Some conferences included presentations by state or national experts.
Figure 7: Statewide Interventions Most Relied on by QIOs, 7th SOW:
[See PDF for image]
Source: GAO survey of QIOs.
[End of figure]
Almost three-quarters of QIOs also ranked the distribution of
educational materials by mail, fax, or e-mail among their top two
statewide interventions. Thirty-two percent of these QIOs sent
materials four or fewer times per year, whereas 27 percent sent
materials 12 or more times per year to all or nearly all homes in the
state. For the QIOs we interviewed, these materials included
newsletters, QM-specific tools or clinical information related to the
QMs, and QM data progress reports for the home or state, overall.
Almost one-third of the QIOs (31 percent) reported that the type or
intensity of interventions they used to assist homes statewide changed
over the course of the 7th SOW.[Footnote 51] For example, two QIOs
reported that they concentrated much of their statewide efforts into
the first half of the 3-year period; one QIO specifically reported
doing so in the interest of ensuring that any improvements in QMs were
reflected in its evaluation scores, which, as specified by the
contract, were calculated near the mid-point of the contract
cycle.[Footnote 52] In contrast, five other QIOs reported that they
increased the intensity of their statewide work over time, in some
cases concentrating on homes whose performance was lagging.
For the 8th SOW, CMS has focused resources on assistance to intensive
participants by eliminating expectations for improvements in QMs
statewide. However, the contracts still contain statewide elements,
including a requirement to promote QM target-setting.
Intensive Assistance:
Fifty-one percent of QIOs ranked on-site visits as their most relied on
intervention with intensive participants and 87 percent ranked it among
their top three interventions (see fig. 8).[Footnote 53] Both the
number of visits and the time spent at sites varied considerably. The
median number of visits was 5 but ranged from 1 to 20.[Footnote 54]
Sixty-eight percent of QIOs that included on-site visits among their
top three interventions spent an average of 1 to 2 hours at sites each
time they visited, while 20 percent spent 3 to 4 hours. QIOs that
ranked on-site visits as their number one intervention made more and
longer visits to intensive participants than did QIOs that ranked them
lower. When surveyed about a typical on-site visit, the majority of QIO
respondents reported that they generally reviewed the homes' QM data,
provided education or best practices, or both. Approximately one-third
of QIOs that conducted site visits indicated that they had discussions
with the home about their systems or processes for care, homework
assignments, or quality improvement activities.[Footnote 55] Some QIOs
(26 percent) reported that they conducted team-building exercises with
the staff when on site.
Figure 8: Intensive Interventions Most Relied on by QIOs and Frequency
of Interventions (Range and Median Number) during the 7th SOW:
[See PDF for image]
Source: GAO survey of QIOs.
[A] The median number of times an intervention was provided is the
midpoint of all the times that an intervention was provided in the 7th
SOW, as reported by QIOs.
[End of figure]
QIOs varied in the interventions they used in addition to on-site
visits, with conferences, small group meetings emphasizing peer-to-peer
learning, and telephone calls being the three others most commonly
used. QIOs that included conferences among their three most relied on
interventions typically held between 3 and 10 during the 7th SOW, but
as with site visits, some variation existed. After conferences, QIOs
were most likely to rely on small group meetings and telephone calls
with individual homes. Nearly half of the QIOs ranked these two
interventions among their three most relied on, but few ranked them
highest. The number of homes that attended small group meetings varied.
An average of 6 to 10 homes was most common, but one-fifth of QIOs
reported having an average of 20 or more homes represented at each
meeting. As for telephone calls, the vast majority of QIOs (92 percent)
that ranked these calls among their three most relied on interventions
called all or nearly all of their intensive participants, typically on
a monthly basis.
Our interviews with QIOs and intensive participant homes suggested that
the small group meetings they held generally followed a similar format,
while telephone calls were used for a variety of purposes. For example,
personnel from several QIOs and intensive participant homes told us
that their small group meetings generally included a formal
presentation on the QMs or related best practices, as well as a time
for less formal information sharing and peer-to-peer learning among the
attendees. Participants shared stories about their successes and
challenges conducting quality improvement. Personnel from a number of
QIOs told us they used telephone calls to follow up after visits or
meetings, discuss the homes' progress on quality improvement, and to
decide on next steps.
Almost two-thirds of QIOs indicated that the type or intensity of
interventions for intensive participants varied over time. Of these
QIOs, 36 percent reduced the intensity of their interventions
(substituting small group meetings or telephone calls for on-site
visits), while 33 percent did the reverse (in some cases increasing the
frequency of on-site visits or substituting small group meetings for
conferences to increase participation). For example, personnel from a
few QIOs told us that while they initially relied on on-site visits to
begin the quality improvement process, they came to rely more on
telephone calls or on small group meetings where intensive participants
could share their success stories or ways to overcome barriers to
quality improvement. Seventy-nine percent of QIOs surveyed varied their
interventions based on the needs of intensive participants. Thus,
personnel from three QIOs told us they realized that some homes did not
need frequent on-site visits, while others needed more. The two
specific needs that QIOs cited most as having precipitated changes in
their interventions were nursing home staffing changes and turnover (23
percent) and poorer performance by some homes relative to others (15
percent). A few QIOs also noted that interventions varied by the
preferences or levels of readiness and participation of the homes with
which they were working.
QIO and Nursing Home Perspectives on the Interventions:
Most QIOs we surveyed deemed conferences the most effective statewide
intervention and on-site visits the most effective intensive
intervention; intensive participant homes we interviewed also found
these interventions valuable. For homes statewide, most QIOs (54
percent) reported that conferences were their most effective
intervention, followed by distribution of educational materials and on-
site visits. Of the one-quarter of QIOs that reported they would change
their statewide approach, the largest proportion (46 percent) would
make conferences their primary intervention. Staff from several nursing
homes we interviewed tended to concur that conferences were valuable
aspects of the program because conferences included expert presenters,
energized or motivated attendees, and were free.
For intensive participants, most QIOs (63 percent) deemed on-site
visits their most effective intervention, followed by conferences and
small group meetings. Of the 15 QIOs that said they would change their
approach with these homes, most (60 percent) would make on-site visits
their primary intervention, while fewer would rely on small group
meetings, conferences, and other interventions. One QIO began
conducting on-site visits and small group meetings when it became
apparent that telephone calls were less productive than had been
anticipated because of the difficulty of getting the right staff on the
telephone at the right time, the lack of speaker phones at many homes,
and the lack of staff engagement on the phone. Staff from a number of
nursing homes we interviewed agreed that visits by QIO personnel were
helpful. Some homes indicated that having someone from the QIO visit
the home maximized the number of staff that could take advantage of the
quality improvement training offered. Furthermore, the on-site visits
were motivating and kept staff on track with quality improvement
efforts. Regarding small group meetings, staff we interviewed from a
few homes stated that meeting with staff from other homes helped
validate their own efforts or facilitated the sharing of materials and
experiences. Staff from one nursing home specifically reported that
they were disappointed not to have formally participated in small group
meetings with other facilities in the state.
Homes also found particular types of assistance less helpful. Some
homes' staff reported that they did not feel they had the time or the
staff necessary to complete some of the homework assignments expected
of them, such as conducting chart reviews. Staff at some homes stated
that the QIO provided quality improvement information with which they
were already familiar.
QIO Staffing and Turnover Influenced Intensive Participants'
Satisfaction with Program:
Our interviews with nursing home staff who worked intensively with the
QIOs indicated that homes' satisfaction with the program was influenced
by the training and experience of the primary QIO personnel who served
as their principal contact with the QIOs, as well as by turnover among
these individuals during the course of the 7th SOW.[Footnote 56]
When a home's principal contact with the QIO was a nurse or someone
with long-term care or quality improvement experience, nursing home
staff tended to report that this person possessed the knowledge and
skills necessary to help them improve the quality of care in their
home. Interviewees also spoke appreciatively of QIO personnel who were
knowledgeable, motivating, and kept them on track with their efforts.
However, when the QIO principal contact lacked these qualifications or
characteristics, he or she was perceived as unable to effectively
address clinical topics with staff. Staff at one home said explicitly
that working with an experienced nurse, instead of a social worker who
seemed to lack knowledge of long-term care, would have led to greater
improvement in clinical quality.
The extent to which QIO primary personnel had the training or
experience that homes considered important varied. More than half (58
percent) of the primary QIO personnel who worked with nursing homes
during the 7th SOW were trained in nursing, and 42 percent held an
advanced degree. Nationwide, 27 percent of the primary personnel who
worked with nursing homes had less than 1 year of long-term care
experience, while 30 percent had more than 10 years of such
experience.[Footnote 57] Just over half of primary QIO personnel (54
percent) working with nursing homes had 4 or fewer years of quality
improvement experience. Nine percent of QIO personnel had more than 10
years' experience in both long-term care and quality improvement. Few
of the personnel working with nursing homes during the 7th SOW gained
any of their experience working for the QIO during the 6TH SOW because
there was little overlap in personnel across the two periods.
Our interviews with intensive participants suggested that turnover
among primary QIO personnel lowered nursing homes' satisfaction with
the program. Our survey revealed that turnover was particularly high at
some QIOs. At 24 QIOs, 25 percent or more of primary personnel who
worked with nursing homes did so for less than half of the 36-month
contract, and at 6 QIOs, the proportion was 50 percent or more. When a
nursing home's principal contact with a QIO changed frequently, nursing
home staff we interviewed reported that they received inconsistent
assistance that was disruptive to their efforts to improve quality of
care. For example, one nursing home we visited had four different
principal contacts over the course of the 7th SOW and found this to be
frustrating because, just as they were establishing a relationship with
a contact, the contact would leave. Staff at another home complained
that their interaction with QIO primary personnel turned out not to be
the learning experience that the staff thought it would be.
Staffing levels for the nursing home component also varied among QIOs.
As would be expected, given the wide variation in the number of nursing
homes per state, the number of full-time-equivalent (FTE) staff working
with nursing homes varied across the QIOs, ranging from 0.50 to 12.
However, the ratio of QIO staff FTEs to intensive participant homes
also showed significant variation. On average, the ratio was about 1 to
14; but for at least 9 QIOs, the ratio of staff FTEs to homes was 1 to
10 or fewer, and for at least 8 QIOs, the ratio was 1 to 18 or more.
QIOs' Impact on Quality Is Not Clear, but Staff at Homes We Contacted
Attributed Some Improvements to QIOs:
Although the QIOs' impact on the quality of nursing home care cannot be
determined from available data, staff we interviewed at most nursing
homes attributed some improvements in the quality of resident care to
their work with the QIOs. Nursing homes' QM scores generally improved
enough for the QIOs to surpass by a wide margin the modest contract
performance targets set by CMS; however, the overall impact of the QIOs
on the quality of nursing home care cannot be determined from these
data because of the shortcomings of the QMs as measures of nursing home
quality and because confounding factors make it difficult to attribute
quality improvements solely to the QIOs. Multiple long-term care
professionals we interviewed indicated that QMs should not be used in
isolation to measure quality improvement, but combined with other
indicators, such as state survey data. Moreover, the effectiveness of
the individual interventions QIOs used to assist homes also cannot be
evaluated with the available data. CMS planned to enhance evaluation of
the program during the 8th SOW, but a 2005 determination by HHS's
Office of General Counsel that the QIO program regulations prohibit
QIOs from providing to CMS the identities of the homes they are
assisting has hampered the agency's efforts to collect the necessary
data. Although the impact of the QIOs on the quality of nursing home
care is not known, over two-thirds of the 32 nursing homes we
interviewed attributed some improvements in care to their work with the
QIOs.
All QIOs Met Modest Targets for QM Improvement, but the Impact of the
QIOs on the Quality of Nursing Home Care Cannot Be Determined:
Although all of the QIOs met the modest targets CMS set for QM
improvement among homes both statewide and in the intensive participant
group, the impact of the QIOs on the quality of nursing home care
cannot be determined because of the limitations of the QMs and because
improvements cannot be definitively attributed to the QIOs. The
effectiveness of the specific interventions used by the QIOs to assist
homes also cannot be evaluated with the available data.
All QIOs Met CMS's Modest Targets for Improvement in Nursing Home QMs:
All QIOs met the CMS performance targets for the nursing home component
of the 7th SOW. In addition to receiving an overall passing score for
this component, nearly all QIOs surpassed expectations for each of the
three elements that contributed to the overall score: provider
satisfaction, improvement in QM scores among intensive participants,
and improvement in QM scores among homes statewide. In fact, about two-
thirds of the QIOs achieved at least five times the expected 8 percent
improvement among intensive participants, and nearly half achieved at
least twice the expected 8 percent improvement statewide.[Footnote 58]
CMS officials stated that the targets set for the nursing home
component of the contract were purposely modest. Because the 7th SOW
marked the first time all QIOs were required to work with nursing homes
on quality improvement, and little data existed to predict how much
improvement could be expected, CMS deliberately designed performance
criteria to limit QIOs' chances of failing. For example, expectations
for improvements in QM scores were set no higher for intensive
participants than for homes statewide. In addition, CMS modified the
evaluation plan so that if an intensive participant worked on more than
one QM, the QM that improved least was dropped before the home's
average improvement was calculated. CMS officials told us that, based
in large part on QIOs' performance in the 7th SOW, the agency raised
its expectations for the 8th SOW. For example, QIOs are required to
work with most intensive participants on four specified QMs and to
achieve an improvement rate of 15 to 60 percent, depending on the QM
and the homes' baseline scores. In addition, CMS will no longer drop
the QM that improved least when calculating homes' average
improvement.[Footnote 59]
CMS's Use of QMs to Evaluate QIO Performance Is Problematic:
Long-term care experts we interviewed generally agreed that CMS's use
of QMs to evaluate nursing home quality--and by extension, QIOs'
performanceæis problematic because of unresolved issues related to the
QMs and the MDS data used to calculate them.
QMs. As we reported in 2002, the validity of the QMs CMS proposed to
publicly report in November 2002 was unclear.[Footnote 60] Although the
validation study commissioned by CMS found that most of the publicly
reported QMs were valid and reflected the quality of care delivered by
facilities, long-term care experts have criticized the study on several
grounds. For example, a 2005 report concluded that (1) the statistical
criteria for the validity assessments were not stringent and (2) the
researchers did not attempt to determine whether QMs were associated
with quality of care at the resident level.[Footnote 61] As a result,
it is not clear whether a resident who triggers a QM (e.g., is assessed
as having his or her pain managed inadequately) is actually receiving
poor care.[Footnote 62] The lack of correlation among the QMsæa home
may score well on some QMs and poorly on othersæalso calls into
question their validity as measures of overall quality. Since 2002, CMS
has removed or replaced 5 of the original 10 QMsæincluding some of
those on which the QIOs were evaluated during the 7th SOW--to address
limitations in the QMs, such as reliability and measurement problems.
(See app. II for a list of the QMs as of November 2002 and February
2007).
Risk adjustment also impacts the validity of QMs. There is general
recognition that some QMs should be adjusted to account for the
characteristics of residents. However, there is disagreement about
which QMs to adjust, what risk factors should be used, or how the
adjustment should be made. For example, one expert we interviewed
suggested that in many cases pressure ulcers start in hospitals; the
pressure ulcer QM does not account for the origin of ulcers. Another
expert highlighted the difficulty of making an appropriate adjustment-
-noting, for example, that improperly risk-adjusting the pressure ulcer
QM could mask poor care that contributed to the development of ulcers.
MDS. We have also previously reported concerns about MDS
reliabilityæthat is, the consistency with which homes conduct and code
the assessments used to calculate the QMs.[Footnote 63] CMS awarded a
contract for an MDS accuracy review program in 2001 but revamped the
program in 2005, near the end of the QIOs' 7th SOW, acknowledging
weaknesses--mainly its reliance on off-site, rather than on-site,
accuracy and verification reviews--that we had previously
identified.[Footnote 64] Some states that sponsor on-site MDS accuracy
reviews continue to report troubling rates of errors in the data. For
example, officials of Iowa's program reported an average MDS error rate
of approximately 24 percent in 2005.
Our interviews with long-term care experts and nursing home staff
suggested that the chronic pain QMæwhich was selected as a focus of
quality improvement work by many QIOs and intensive participant nursing
homesæmay be particularly vulnerable to error in the underlying MDS
data. Possible sources of error are systematic differences in the
extent to which facilities identify and assess residents in pain and
misunderstandings about how to accurately code MDS questions specific
to pain. For example, staff from two nursing homes told us that their
pain management QM scores improved after staff realized that they had
been mistakenly coding residents as having pain even though their pain
was successfully managed. Moreover, experts we interviewed noted that
higher-quality homes may have worse pain QM scores because they do a
better job of identifying and reporting pain in residents.
The use of MDS data to measure the quality of care in nursing homes is
also problematic because the MDS was not designed as a quality
measurement tool and does not reflect advances in clinical practice.
CMS is updating the MDS now to address these limitations. For example,
instead of asking homes to classify the severity of a pressure ulcer on
the basis of a four-stage system, the draft MDS now under review
includes a measurement tool intended to more accurately classify the
severity of a pressure ulcer.[Footnote 65] In addition, facilities are
asked to indicate whether the pressure ulcer developed at the facility
or during a hospitalization. CMS does not yet have an official release
date for the revised MDS but anticipates that all validation and
reliability testing will be completed by December 2007.
Other Measures of Quality. Multiple long-term care professionals we
interviewed, including stakeholders and experts on quality measurement,
recommended both that the QMs undergo continued refinement and that
they not be used in isolation to assess the quality of care in nursing
homes. They suggested a number of other sources of information as
alternatives or complements to QMs for measuring quality. For example,
a representative of the National Quality Forum (NQF), a group with
which CMS contracted to provide recommendations on quality measures for
public reporting, stated that experts do not consider the QMs
sufficient in themselves to rate homes and that the other quality
markersæsuch as perceptions of care by family members, residents, and
staff; state survey data; and resident complaintsæalso provide useful
information about quality of care. Other long-term care professionals
we interviewed suggested these and other measures, including nursing
home staffing levels and staff turnover and retention rates.
Influence of Other Factors on Nursing Home Quality Makes It Difficult
to Evaluate QIOs' Impact:
Factors such as the existence of other quality improvement efforts make
it difficult to evaluate QIOs' work with nursing homes and attribute
quality improvement solely to QIOs. In an assessment of the QIO program
during the 7th SOW, CMS and QIO officials acknowledged this difficulty.
The assessment found that intensive participants improved more than
nonintensive participants on all five QMs studied, and for each QM,
intensive participants that worked on the QM improved more than
intensive participants that did not.[Footnote 66] However, the authors
noted that these results could not be definitively attributed to the
efforts of the QIOs because improvements may have been influenced by a
variety of factors, including preexisting differences between intensive
participants and nonintensive participants;[Footnote 67] public
reporting of the QMs, which may have focused homes' attention on
improving these measures; and other quality improvement efforts to
which homes may have been exposed. As noted earlier in this report,
these other efforts included, but were not necessarily limited to,
initiatives sponsored by state governments, nursing home trade
associations, and CMS. While these other efforts varied considerably in
the intensity of technical assistance offeredæranging from a trade
association-sponsored program that homes characterized as essentially
signing a quality improvement pledge, to state-sponsored programs that
involved on-site visits by experienced long-term care nurses who
provided best-practice guidelines, educational materials, and clinical
toolsæthe fact that the efforts were present made it impossible to
attribute quality improvements solely to the QIOs.
In its 2006 report on all aspects of the QIO program, IOM highlighted
similar shortcomings in previous studies of the QIO program and called
for more systematic and rigorous evaluations. IOM concluded that
although the QIOs may have contributed to improvements in the quality
of care, the existing evidence was inadequate to determine the extent
of their contribution. In its response to the IOM study, CMS
acknowledged the need to strengthen its methods of evaluating the
program and outlined plans to convene an evaluation expert advisory
panel to make recommendations on the framework for the next contracts
(the 9TH SOW, which will begin in 2008). CMS also stated that it will
collect information during the 8th SOW that will allow it to control
for differences in motivation between intensive and nonintensive
participants but did not specify the nature of this
information.[Footnote 68] Subsequently, HHS's Office of General Counsel
determined that QIO program regulations prohibited QIOs from providing
to CMS the identities of intensive participants.[Footnote 69] CMS
officials acknowledged that this prohibition posed a considerable
challenge to their evaluation plans and said that as a short-term
solution the agency might contract with one of the QIOs to evaluate the
program, with the possible stipulation that the findings be verified by
an independent auditor.
CMS Data Are Too Limited to Evaluate Effectiveness of Specific QIO
Interventions:
CMS collected little information about the specific interventions QIOs
used to assist nursing homes and acknowledged that the information it
did have was not sufficiently comprehensive or consistent to be used to
evaluate the interventions' effectiveness. In general, CMS's oversight
of QIOs' work on the nursing home component consisted of ensuring that
the QIOs produced the reports and deliverables specified in the
contracts and appeared on track to meet performance targets.
CMS's primary source of data about QIOs' interventions was the monthly
activity reports the QIOs were required to submit through the Program
Activity Reporting Tool (PARTner). In these reports, QIOs were to
document the specific interventions they provided to each home, using
such activity codes as "on-site support" and "stand-alone workshops on
quality improvement." However, with only seven activity codes for QIOs
to choose from, the level of detail in these reports was low. For
example, the same code would be used for a full-day visit as for an
hour visit. Moreover, because QIOs were not expected to enter any code
more than once per month for a home, a code for on-site support could
indicate a single visit or multiple visits. The system also captured no
information about the content of visits or other interventions. From
the perspective of the QIOs, the system was of limited use: More than
half of the 52 QIOs surveyed by IOM rated PARTner fair or poor in terms
of both value and ease of use. Staff at one QIO we interviewed reported
using tracking systems they developed themselves, rather than PARTner,
to monitor their work.
CMS regional offices and the nursing home satisfaction survey gathered
some additional information about the interventions used by QIOs. The
CMS regional offices gathered information through telephone calls and
visits to the QIOs and by participating in quarterly conference calls
during which QIOs and CMS regional and central offices discussed issues
related to the nursing home component of the contract. The regional
office staff also reviewed information entered into the PARTner data
system by QIOs, but they focused their evaluations on QIO contract
compliance and not on the effectiveness of specific interventions
because--as some regional staff emphasized--the contracts were
performance-based, and therefore it was not their place to
"micromanage" the QIOs or to advocate for or against specific
interventions. Feedback from nursing homes was gathered through the
nursing home satisfaction survey, conducted after the midpoint of the
contract cycle by a contractor for CMS.[Footnote 70] The survey
collected information about the frequency of, and homes' satisfaction
with, a range of interventions, including on-site visits, training
workshops, one-on-one telephone calls, conference calls, one-to-one e-
mails, and broadcast e-mails. However, the survey collected no
information about the content of these interventions or the aspects
that contributed to providers' satisfaction or dissatisfaction.
In its 2006 report on the QIO program, IOM emphasized the need for CMS
to gather more information about specific interventions and noted that
CMS was uniquely positioned to determine which interventions lead to
high levels of quality improvement. The agency responded that it will
collect information during the 8th SOW to better explore the
relationship between the intensity of assistance provided by the QIO
and the level of improvement, but did not specify the type of
information it will collect. As of March 2007, CMS had not yet
implemented a revamped PARTner system. In addition, the agency
cancelled its plans to conduct an initial survey of nursing homes early
in the contract period and now plans to conduct only one, later in the
contract period. CMS officials explained that the delay and
cancellation were due at least in part to the determination by HHS's
Office of General Counsel that QIOs could not provide to CMS the
identities of intensive participants to CMS.
Homes That Received Intensive Assistance Generally Attributed Some
Improvements in Quality of Care to Work with QIOs:
Although the impact of the QIOs on the overall quality of nursing home
care cannot be determined, staff we interviewed at over two-thirds of
the 32 nursing homes stated that they improved the care delivered to
residents as a result of working intensively with the QIOs. Staff at 23
of the 32 homes told us that they implemented new, or made changes to
existing, policies and procedures related to pain or pressure ulcers.
Of the 23 nursing homes, staff from 21 stated that they changed the way
they addressed resident pain. In general, these changes involved
implementing pain scales or new assessment forms. Staff at some
facilities noted that working with the QIO heightened staff awareness
of resident pain, including awareness of cultural differences in the
expression of pain. Staff at 8 of the 23 nursing homes stated that they
changed the way they addressed pressure ulcers. In general, these 8
homes implemented new assessment tools, changed assessment plans, or
revised facility policies using materials provided by the QIO. (Table 3
provides examples of resident care improvements related to pain
assessment and treatment and pressure ulcers.) Staff at 13 of the 32
nursing homes stated that the changes they made as a result of working
with the QIOs were sustainable, but staff from some nursing homes noted
that staffing turnover at their facilities could affect sustainability.
Table 3: Examples of Resident Care Improvements Made by Homes as a
Result of Intensive Assistance Provided by QIOs, 7th SOW:
Care area: Pain; Example: Had nurses evaluate acute pain management at
end of each shift with nurse aide involvement.
Care area: Pain; Example: Used interventions other than medications,
such as massage, compresses, and repositioning.
Care area: Pain; Example: Recorded signs of pain when providing care
for wounds such as pressure ulcers.
Care area: Pain; Example: Began using or resumed using pain scales to
assess resident pain.
Care area: Pain; Example: Implemented pain policy that addresses both
cognitively intact residents and residents who have dementia or are
nonverbal.
Care area: Pressure ulcers; Example: Increased skin assessments to four
times a week and had nurse aides document changes on a daily basis.
Care area: Pressure ulcers; Example: Established a wound care team.
Care area: Pressure ulcers; Example: Used a tracking tool to measure
depth and width of pressure ulcers.
Care area: Pressure ulcers; Example: Conducted skin checks when a
resident returned to the facility, such as after a hospitalization.
Source: GAO interviews with staff from nursing homes assisted
intensively by the QIOs.
[End of table]
Of the 32 nursing homes we contacted, staff from 4 specifically stated
that working with the QIO did not change their quality of care. For
example, staff from one home stated that the QIO did not offer their
facility any new or helpful information and did not offer feedback on
how the facility's processes could improve. Staff from another home
reported that the information provided by the QIO was on techniques
their facility had already implemented. Staff at a third home noted
that while the QIO was a good resource, the home could have done as
much on its own, without assistance from the QIO. Staff at three
facilities, none of which reported making any policy or procedural
changes, said the facilities experienced worse survey results while
working with their QIO; staff from two of the three reported being
cited for quality deficiencies in the specific areas they had been
addressing with the QIO. Staff at one of these facilities believed they
were cited because their work with the QIO had made the surveyor more
aware of the facility's problems in this area.
Conclusions:
Although it is difficult to evaluate the impact of QIO assistance, the
QIO program does have the potential to help improve the quality of
nursing home care. CMS program improvements for the 8th SOW, such as
the agency's decision to focus resources on intensive rather than
statewide assistance and its plans to improve evaluation, are positive
steps that could result in more effective use of available funds and
provide more insight into the program's impact. Our evaluation of
assistance provided during the 7th SOW, however, raised two major
questions about the future focus, oversight, and evaluation of the QIO
program, which we address below.
Given the available resources, which homes and quality-of-care areas
should CMS direct QIOs to target for intensive assistance? We found
that QIOs generally did not target intensive assistance to homes that
performed poorly in state surveys, partly because of concerns about the
willingness and ability of such homes to simultaneously focus on
quality improvement and cooperate with the QIOs. However, the
Collaborative Focus Facility project during the 7th SOW demonstrated
that low-performing homes could improve their survey results and QM
scores; subsequently, CMS required that during the 8th SOW each QIO
work with up to three such homes--about 10 percent of the total number
that QIOs are expected to assist intensively. Stakeholders we
interviewed believed that even more emphasis should be placed on
assisting low-performing homes. We found that there was little overlap
between homes that participated in the QIO Collaborative Focus Facility
project and in CMS's Special Focus Facility program, which is a program
involving about 130 nursing homes nationwide that, on the basis of
their survey results, receive increased scrutiny and enforcement by
state survey agencies. The limited overlap suggests that each state has
more than three low-performing facilities that could benefit from QIO
assistance.
Targeting assistance to low-performing homes could pose challenges
given the voluntary nature of the program--homes must agree to work
with a QIO. QIOs maintain that voluntary participation is critical to
ensuring homes' commitment to the program. However, the risk in this
approach is that some of the homes that need help most will not get it.
Indeed, in the Collaborative Focus Facility project, some of the low-
performing homes that were asked to participate refused QIO assistance.
In addition, QIOs expended more resources working to improve these low-
performing homes than were required to assist better-performing homes.
Thus, increasing the number of low-performing homes QIOs are required
to assist above the small number mandated for the 8th SOW might
necessitate decreasing the total number of homes assisted. However,
existing resources might be maximized if QIOs worked with each home
only on the quality-of-care areas that pose particular challenges for
that home.
Could interim steps be taken to improve oversight and evaluation of
QIOs' work with nursing homes before the contracting cycle that begins
in August 2008? Currently, CMS collects data primarily on QIO outcomes-
-specifically, changes in QM scores--and costs. CMS needs more detailed
data, particularly about the type and intensity of interventions used
to assist nursing homes, to improve its oversight and evaluation of the
QIO program. Without such data, CMS cannot hold QIOs fully accountable
for their performance under their contract with CMS. Some evaluation
activities are now scaled back or on hold because HHS determined early
in the 8th SOW that program regulations prohibited the QIOs from
providing to CMS the identities of the intensive participants. Such a
firewall presents a major impediment to improved oversight and
evaluation of the QIO program and prevented CMS from implementing
interim changes it planned to make. For example, for the 7th SOW, CMS
contracted for one nursing home satisfaction survey to be conducted
near the end of the contract period--too late to be of use in interim
monitoring of the QIOs' performance. For the 8th SOW, CMS had planned
to contract for two surveys but was forced to cancel the one planned
for early in the contract period because it was unable to provide the
names of intensive participants to its survey contractor. Moreover, the
lack of these data would preclude CMS from independently verifying QIO
compliance with such contract requirements as the geographic dispersion
of intensive participants in each state.
CMS evaluated QIOs' work with nursing homes primarily on the basis of
changes in QM scores; given the weaknesses of QM data, the current
reliance on these data appears unwarranted. While CMS actions to
improve the MDS instrument as a quality measurement tool are important,
the agency has not yet established an implementation date. Although
multiple long-term care professionals believe that multiple indicators
of quality, including deficiencies on homes' standard and complaint
surveys and residents' and family members' satisfaction with care,
should be used to measure quality improvement, CMS is not currently
drawing on these data sources to evaluate QIOs' efforts. Recognized
shortcomings in these other data sources--such as the understatement of
survey deficiencies by state surveyors--underscore the importance of
using multiple data sources to evaluate QIO outcomes.
Recommendations for Executive Action:
To ensure that available resources are better targeted to the nursing
homes and quality-of-care areas most in need of improvement, we
recommend that the Administrator of CMS take the following two actions:
* Further increase the number of low-performing homes that QIOs assist
intensively.
* Direct QIOs to focus intensive assistance on those quality-of-care
areas on which homes most need improvement.
To improve monitoring of QIO assistance to nursing homes and to
overcome limitations of the QMs as an evaluation tool, we recommend
that the Administrator of CMS take the following three actions:
* Revise the QIO program regulations to require QIOs to provide to CMS
the identities of the nursing homes they are assisting in order to
facilitate evaluation.
* Collect more complete and detailed data on the interventions QIOs are
using to assist homes.
* Identify a broader spectrum of measures than QMs to evaluate changes
in nursing home quality.
Agency Comments and Our Evaluation:
We obtained written comments from CMS on our draft report. CMS
addressed three of our five recommendations. It concurred with two of
the three recommendations but did not specify how it would implement
them, and it continues to explore options for implementing the third
recommendation. Our evaluation of CMS's comments follows the order we
presented each recommendation in the report. CMS's comments are
included in app. III.
Further increase the number of low-performing homes that QIOs assist
intensively. CMS agreed with this recommendation but did not specify a
time frame for addressing it or indicate how many low-performing homes
it will expect QIOs to assist in the future. Although our report
focused on the most recently completed contract period (the 7th SOW),
we acknowledged that in the current contract period, CMS required QIOs
to provide intensive assistance to some "persistently poor-performing"
homes identified in consultation with each state survey agency.
However, we pointed out that the number of these homes the QIOs were
required to serve was small, accounting for less than 10 percent of the
homes they were expected to assist intensively. CMS commented that
preliminary estimates from a special study conducted during the 7th SOW
indicated that assisting chronically poor-performing homes cost the
QIOs 5 to 10 times as much as assisting the "usual" home.[Footnote 71]
Our report acknowledged that additional resources were required for
QIOs to assist low-performing homes but suggested that CMS could
decrease the total number of homes assisted in order to increase the
number of low-performing homes beyond the small number mandated for the
8th SOW.
Direct QIOs to focus intensive assistance on those quality-of-care
areas on which homes most need improvement. CMS did not directly
respond to this recommendation, but did point out that about one-third
of QIOs were working primarily with homes on QMs on which the homes
scored worse than the national average during the 8th SOW. Our
recommendation was to direct all QIOs to focus intensive assistance on
QMs that reflect homes' greatest quality-of-care challenges. We had
reported that some nursing homes assisted intensively by QIOs did not
have a choice of QMs on which to work. We concluded that having QIOs
work intensively with homes only on the quality-of-care issues that
posed particular challenges to them would maximize program resources.
Revise QIO program regulations to require QIOs to provide CMS with the
identities of the homes assisted in order to facilitate evaluation. CMS
did not specifically indicate whether it agreed with this
recommendation, but did indicate that it continues to explore options
which would allow access to data on the homes assisted intensively in
order to facilitate evaluation. However, CMS expressed concern that
providing this access could potentially subject the information to laws
that could afford third parties similar access. We believe that CMS
should continue to evaluate how best to maintain an appropriate balance
between disclosure and confidentiality. If CMS's evaluation indicates
that it is unable to incorporate adequate confidentiality safeguards to
promote voluntary participation in QIOs' quality improvement
initiatives, the agency could seek legislation that would provide such
safeguards.
Collect more complete and detailed data on the interventions QIOs use
to assist homes. CMS responded to this recommendation, although it
labeled it "improve the monitoring of QIO activities," and agreed with
our recommendation. CMS noted that, in concert with HHS, it is
reviewing recommendations from the IOM's 2006 report on QIOs, which may
result in redesigning the program, including systems for evaluating QIO
activities in different care settings, such as nursing homes. CMS did
not discuss how it planned to collect additional data on QIO nursing
home interventions. Further, it stated that it may incorporate data-
handling and -reporting features of the nursing home subtask into
overall program improvements. We have reservations about this plan
because we found that CMS collected little information about specific
QIO interventions with nursing homes during the 7th SOW, the
information collected was not sufficiently comprehensive or consistent
to be used to evaluate the interventions' effectiveness, and QIOs
themselves reported that the data collection system was of limited use
to them.
Identify a broader spectrum of measures than QMs to evaluate changes in
nursing home quality. CMS did not directly address this recommendation.
However, the agency took issue with our judgment that the use of QMs to
evaluate nursing home quality--and by extension, QIOs' performance--is
problematic. CMS commented that the QMs have passed through rigorous
development, testing, deployment, and national consensus processes. We
reported that the study commissioned by CMS to validate the QMs has
been criticized by experts on several grounds, including a lack of
statistical rigor. We also noted that CMS has revised or is currently
revising both the QMs and the MDS data used to calculate them to
address limitations, such as reliability and measurement problems. For
example, CMS has removed or replaced 5 of the original 10 QMs since
2002, including some of those on which the QIOs were evaluated during
the 7th SOW. In addition, CMS is currently updating the MDS to reflect
advances in clinical practice and to improve its utility as a quality
measure tool. While we expect that these efforts will improve the QMs
as measures of nursing home quality, we believe that the QMs' current
limitations argue for the use of a broader spectrum of measures to
evaluate changes in nursing home quality. Multiple long-term care
professionals we interviewed recommended that the QMs not be used in
isolation to assess the quality of care in nursing homes; these
professionals suggested a range of measures that could be used to
supplement the QMs, including perceptions of care by family members,
residents, and staff; state survey data; and nursing home staffing
levels.
As arranged with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days
after its issue date. At that time, we will send copies to the
Administrator of the Centers for Medicare & Medicaid Services and
appropriate congressional committees. We will also make copies
available to others upon request. In addition, the report will be
available at no charge on the GAO Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please
contact me at (202) 512-7118 or allenk@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix IV.
Sincerely yours,
Signed by:
Kathryn G. Allen:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
Our analysis of QIOs' work with nursing homes had three major
components: (1) site visits to five QIOs, (2) analysis of state survey
data to compare homes that were assisted intensively with homes that
were not, and (3) a Web-based survey of 51 QIOs.
Site Visits:
We visited a QIO in each of five states to gather detailed information
about QIOs' work with nursing homes from the perspective of the QIOs,
nursing homes in the intensive participant group, and stakeholders; we
used this information to address all three objectives.[Footnote 72] We
selected the states-æand by extension, the QIOs that worked in those
states--on the basis of six criteria described in the following
section. After selecting the QIOs, we identified nursing homes that
received intensive assistance and stakeholders to contact for
interviews. We conducted most of our site visit interviews in March and
April 2006.
Selection of QIOs:
We based our selection of QIOs on the following criteria:
* Number of nursing home beds in the state. We divided the states into
three groups of 17 states each based on the number of nursing home beds
at the beginning of the 7th SOW (2002). We over-sampled states with
high numbers of nursing home beds by selecting one state with a low
number of beds, one state with a medium number, and three states with a
high number.
* Evaluation score for the nursing home component of the 7th SOW
relative to scores of other QIOs. We divided the states into three
groups of 17 based on the QIOs' evaluation scores for the 7th SOW. To
help us identify the possible determinants of scores, we selected more
states at each end of the spectrum than in the middle: two states with
scores in the bottom third, one state with a score in the middle third,
and two states with scores in the top third.
* State survey performance of homes selected for intensive assistance
relative to homes not selected. We also considered the extent to which
the homes selected for intensive assistance by a given QIO at the
beginning of the 7th SOW differed from the homes that were not
selected, in terms of serious deficiencies cited on state surveys (both
the proportion of homes cited in each group and the average number of
serious deficiencies per home). We chose one QIO that selected worse
homes, three QIOs that selected homes that were neither better nor
worse, and one QIO that selected better homes.
* Presence of a state-sponsored nursing home quality improvement
program. At the time we selected QIOs for site visits, we were aware of
four states that had state-sponsored quality improvement initiatives in
place during the 7th SOW.[Footnote 73] To learn more about these
efforts and how they interacted with and compared with efforts by the
QIOs, we included one state (Florida) with its own quality improvement
initiative.[Footnote 74] After we made our selection, we learned that
another state we had selected (Maine) had a state-sponsored quality
improvement program.
* QIO participation in the Collaborative Focus Facilities project. CMS
has funded QIOs to conduct several special studies with nursing homes,
including one in which the 17 participating QIOs each worked
intensively with up to five nursing homes identified by their state
survey agencies as having significant quality problems. To learn more
about the challenges involved in working with low-performing homes, we
selected two states whose QIOs participated in this project.
* Census region. We selected states from four different regions of the
country: Northeast, Midwest, South, and West.
Using these criteria, we selected the following five states: Colorado,
Florida, Iowa, Maine, and New York. Together these states represented
15 percent of nursing home beds nationwide at the beginning of the 7th
SOW (2002).
Selection of Nursing Homes:
Overall, we interviewed staff from 32 nursing homes in nine states. To
assist in the development of our site visit protocols, we interviewed
staff from 4 homes in four states. During the site visits to five
states, we interviewed staff from 28 nursing homes. In each state, we
interviewed staff from 4 to 8 nursing homes that received intensive
assistance from the QIO, for a total of 28 homes in these five states.
The number of homes we selected in each of the five states visited
varied depending on the number of homes the QIO was expected to select
for intensive assistance, an expectation based on the number of homes
in the state. Specifically, we selected either four homes or 7 percent
of the maximum number of homes that each of the five QIOs was expected
to assist intensively, whichever was greater.[Footnote 75]
We chose homes on the basis of four characteristics: number of serious
deficiencies in the standard state survey at the beginning of the 7th
SOW (2002), improvement in QM scores during the 7th SOW, distance from
the QIO (in order to include homes that were more difficult for QIOs to
visit), and urban versus rural location. Specifically, we sought to
include (1) at least one home that had one or more serious deficiencies
and that finished in the top third of the intensively assisted homes in
their state in terms of improvement on QM scores, and (2) at least one
home that had one or more serious deficiencies and that finished in the
bottom third of the intensively assisted homes in their state in terms
of improvement on QM scores. For the remaining homes, we sought a group
whose state survey deficiency levels and QM improvement scores were
representative of the range among intensive participants in their
state. However, the experiences of this sample of 32 homes cannot be
generalized to the entire group of homes that received intensive
assistance from the QIOs nationwide.
Selection of Stakeholders:
In each state we also interviewed officials from three stakeholder
groups: (1) the state survey agency; (2) the local affiliate of the
American Health Care Association, which generally represents for-profit
homes; and (3) the local affiliate of the American Association of Homes
and Services for the Aging, which represents not-for-profit homes.
Analysis of State Survey Data:
To assess the characteristics of the nursing homes that were selected
by the QIOs for intensive assistance from among the homes that
volunteered, we analyzed 3 years of standard state survey data on
deficiencies cited at nursing homes and compared the results for homes
that were assisted intensively with results for homes that were not; we
used this information to address our first objective.[Footnote 76] The
analysis involved three steps:
1. identifying nursing homes that had three standard state surveys from
1999 through 2002;
2. ranking nursing homes in each state in each year, based on the
number of serious and other deficiencies, and then classifying homes as
consistently low-, moderately, or high-performing; and:
3. identifying on a nationwide and state-by-state basis any
statistically significant differences between homes selected and not
selected by the QIO, in terms of the proportion of low-, moderately, or
high-performing nursing homes.
Identifying Homes with Three Standard Surveys:
To identify homes whose performance was consistently lower or higher
than other homes in their state prior to the selection of homes by the
QIOs, we included in our analysis only homes for which we were able to
identify three standard surveys from January 1, 1999, through November
1, 2002. Using the state survey calendar year summary files for 1999
through 2002 for the 50 states and the District of Columbia, we
obtained 3 years of deficiency data from standard surveys for 16,303
homes.[Footnote 77]
Classifying Homes as Low-, Moderately, or High-Performing:
CMS classifies deficiencies according to their scope and severity. For
each of the three surveys, we ranked all of the nursing homes in each
state based on the number of deficiencies in two categories: (1) actual
harm or immediate jeopardy and (2) potential for more than minimal
harm.[Footnote 78] Deficiencies in the first category are considered
serious deficiencies. We gave more weight to the serious deficiencies
by sorting the homes first on the number of deficiencies in the first
category and then on the number of deficiencies in the second category.
Homes with the same number of deficiencies in each category were
assigned the same rank. Based on these rankings, we identified homes in
the bottom and top quartile in each state in each survey.[Footnote 79]
We classified homes as low-performing if they ranked in the bottom
quartile in the most recent of the three surveys and in at least one of
the two preceding surveys. We classified homes as high-performing if
they ranked in the top quartile in the most recent of the three surveys
and in at least one of the two preceding surveys. We classified homes
as moderately performing if they did not meet the criteria for
inclusion in either the low-or high-performing group. Of the 16,303
homes with three standard state surveys during the period we specified,
we classified 15 percent as low-performing, 65 percent as moderately
performing, and 20 percent as high-performing.
To assess the stability of our categorization of homes as low-(or high-
) performing, we ran a logistic regression model to predict the
probability of a home being categorized as low-(or high-) performing in
the most recent of the three surveys given its categorization in the
two prior surveys. The regression results showed that homes that were
categorized as low-(or high-) performing in one survey were
significantly more likely to be categorized as low-(or high-)
performing in the other surveys as well.
Determining Statistically Significant Differences between Homes
Assisted Intensively and Homes Not Assisted Intensively by the QIOs:
Our final step was to determine, on both a nationwide and state-by-
state basis, whether there was a statistically significant difference
in the proportion of (1) low-performing homes, (2) moderately
performing homes, and (3) high-performing homes in the group assisted
intensively by the QIOs compared with the group not assisted
intensively.[Footnote 80]
Web-Based Survey of QIOs:
To gather information about the characteristics of the QIOs, including
their process for selecting homes for intensive assistance from the
pool of volunteers and the interventions they used, on July 19, 2006,
we launched a two-part Web-based survey of QIOs in all 50 states and
the District of Columbia; we used this information to address
objectives one and two.[Footnote 81] We achieved a 100 percent response
rate. The first part of the survey gathered information about the
primary personnel who worked with nursing homes during the 7th SOW,
including information about their employment with the QIO, and their
relevant credentials and experience.[Footnote 82] The second part of
the survey gathered information on a range of other topics, including
information about stakeholder involvement with the QIO, recruitment and
selection of nursing homes for intensive assistance, interventions used
with intensive participants, interventions used with homes statewide,
and QIOs' communication with CMS. We specifically inquired about QIOs'
use of six interventions: (1) mailings, faxes, and e-mails; (2)
conferences; (3) small group meetings; (4) conference calls and video
or Web conferences with multiple homes; (5) telephone conversations
with individual homes; and (6) on-site visits.[Footnote 83] We asked
QIOs to rank and provide information on the two interventions they
relied on most to assist homes statewide and on the three interventions
they relied on most to assist homes in the intensive participant
group.[Footnote 84] We also asked QIOs to rank the effectiveness of the
interventions they used and to identify the interventions they would
use if they could do the 7th SOW over again.
[End of section]
Appendix II: Publicly Reported Quality Measures:
In November 2002, CMS began a national Nursing Home Quality Initiative
that included the development of QMs that would be publicly reported on
the CMS Web site called Nursing Home Compare. CMS has continued to
refine the QMs and, as shown in table 4, has dropped some QMs and added
others.
Table 4: QMs as of November 2002 and as of February 2007:
QM: Chronic care QM; QM as of November 2002: [Empty]; QM as of February
2007: [Empty].
QM: Chronic care QM; Decline in activities of daily living; QM as of
November 2002: Yes; QM as of February 2007: Yes.
QM: Pressure ulcers; QM as of November 2002: Yes; QM as of February
2007: [Empty].
QM: Pressure ulcers[A]; QM as of November 2002: Yes; QM as of February
2007: [Empty].
QM: Pressure ulcers in high-risk residents; QM as of November 2002:
[Empty]; QM as of February 2007: Yes.
QM: Pressure ulcers in low-risk residents; QM as of November 2002:
[Empty]; QM as of February 2007: Yes.
QM: Inadequate pain management; QM as of November 2002: Yes; QM as of
February 2007: Yes.
QM: Physical restraints; QM as of November 2002: Yes; QM as of February
2007: Yes.
QM: Infections; QM as of November 2002: Yes; QM as of February 2007:
[Empty].
QM: Weight loss; QM as of November 2002: [Empty]; QM as of February
2007: Yes.
QM: Urinary tract infection; QM as of November 2002: [Empty]; QM as of
February 2007: Yes.
QM: Catheter insertion; QM as of November 2002: [Empty]; QM as of
February 2007: Yes.
QM: Depression; QM as of November 2002: [Empty]; QM as of February
2007: Yes.
QM: Bowel or bladder control in low-risk residents; QM as of November
2002: [Empty]; QM as of February 2007: Yes.
QM: Bedfast; QM as of November 2002: [Empty]; QM as of February 2007:
Yes.
QM: Worsening ability to move about room; QM as of November 2002:
[Empty]; QM as of February 2007: Yes.
QM: Administration of influenza vaccination during flu season; QM as of
November 2002: [Empty]; QM as of February 2007: Yes.
QM: Assessment for and administration of pneumococcal vaccination; QM
as of November 2002: [Empty]; QM as of February 2007: Yes.
QM: Post-acute-care QM; QM as of November 2002: [Empty]; QM as of
February 2007: [Empty].
QM: Failure to improve and manage delirium; QM as of November 2002:
Yes; QM as of February 2007: Yes.
QM: Failure to improve and manage delirium (facility-adjusted)[A]; QM
as of November 2002: Yes; QM as of February 2007: [Empty].
QM: Inadequate pain management; QM as of November 2002: Yes; QM as of
February 2007: Yes.
QM: Improvement in walking; QM as of November 2002: Yes; QM as of
February 2007: [Empty].
QM: Pressure ulcers; QM as of November 2002: [Empty]; QM as of February
2007: Yes.
QM: Administration of influenza vaccination during flu season; QM as of
November 2002: [Empty]; QM as of February 2007: Yes.
QM: Assessment for and administration of pneumococcal vaccination; QM
as of November 2002: [Empty]; QM as of February 2007: Yes.
Source: CMS.
[A] Facility-level risk adjustment was intended to take into account
the fact that some homes may admit frailer, sicker residents, or may
specialize in a particular area of care that may account for a larger
proportion of residents for a particular measure. CMS reported the
delirium measure both with and without facility adjustment.
[End of table]
[End of section]
Appendix III: Comments from the Centers for Medicare & Medicaid
Services:
[See PDF for image]
[End of figure]
Department Of Health & Human Services: Centers for Medicare & Medicaid
Services:
Administrator:
Washington, DC 20201:
Date: May 11, 2007:
To: Kathryn G. Allen:
Director, Health Care:
Government Accountability Office:
From: Leslie V. Norwalk, Esq.
Acting Administrator:
Subject: Government Accountability Office's (GAO) Draft Report:
"Federal Actions Needed to Improve Targeting and Evaluation of
Assistance By Quality Improvement Organizations" (GAO-07-373):
Background:
The Centers for Medicare & Medicaid Services (CMS) launched the
National Nursing Home Quality Initiative (NHQI) in November 2002,
marking the beginning of the first organized work with the Nation's
nursing homes on national quality improvement activities outside of the
Survey & Certification process. This coincided with the beginning of
the Quality Improvement Organizations' (QIOs) 7th Statement of Work
(SOW) contract cycle and marked the first time the QIOs were tasked
with "core" work in the nursing home setting in all 53 contract regions.
Since, up until this time, the entire CMS interface for nursing home
quality was through the Survey & Certification program, Senator
Grassley requested that the GAO collect data about the nursing home
task in the QIO contract ("Task 1A"). Specifically, Senator Grassley
requested that the GAO collect information about the nursing homes
which worked with the QIOs and the quality improvement outcome measures
associated with this work, especially in the 7th SOW (2002-2005).
The GAO conducted the study over an 18 month period from October 2005
to April 2007. During the course of the study, the GAO conducted a web-
based survey of 51 QIOs, conducted on-site reviews of QIOs and nursing
homes in five States (CO, FL, IA, ME, and NY), and interviewed experts
on "using quality measures to evaluate QIOs." The three initial
research questions were as follows:
1. What assistance are QIOs providing to nursing homes to help them
improve resident care?
2. Have nursing homes that have worked with QIOs improved their quality
of care?
3. How effective is CMS oversight of QIO assistance to nursing homes?
Page 2-Kathryn G. Allen:
GAO Recommendations:
The GAO made the following three recommendations for future QIO work in
the nursing home setting:
1. The CMS should further increase the number of low-performing homes
that QIOs work with intensively.
2. The CMS should improve the monitoring and evaluation of QIO
activities.
3. The CMS should require QIOs to share with CMS the identity of homes
assisted intensively in order to facilitate evaluation.
CMS Response: Executive Summary:
Recommendation 1: CMS agrees with the recommendation and points out
additional facts about the nursing home work of the QIO program. CMS
has already identified this as an issue from its own review, and has
taken steps to address it. For example, in the 8th SOW, 34 percent of
QIOs are working with an average of 56 percent of the nursing homes in
their states. However, there are significant cost implications for this
recommendation. A study conducted during the 7th SOW showed that
chronically poor performing nursing homes cost between five and tenfold
more to work with than nursing homes that are closer to average
performance.
Recommendation 2: CMS agrees with the recommendation, and has already
made progress toward re-designing the management of the Q10 program.
Recommendation 3: CMS continues to explore options which would allow
access to this data for evaluation of the QIOs individually and the
program as a whole, while maintaining appropriate safeguards necessary
to promote voluntary participation in quality improvement initiatives.
CMS will continue to seek a balance between disclosure and
confidentiality.
CMS Response to GAO Recommendations:
1. The CMS should further increase the number of low-performing homes
that QI0s work with intensively.
The CMS agrees with this recommendation. However, CMS notes that the
draft report does not draw enough attention to two important aspects of
this recommendation. 'the first is that CMS, in its own review of the
7'H SOW, identified this need and has already taken steps to address
it. CMS enhanced coordination between the Survey & Certification and
the Q10 Programs. As part of this effort, a CMS Long-Term Care
Coordinating Task Force was created to establish formal communication
lines within the Agency. CMS recently released the Task Force's second
annual report, "2007 Action Plan for (Further Improvement of) Nursing
Home Quality." This leadership activity translated into significant
exploration, both in Task IA core contract activities and with the Q10
Support Contractor, to find innovative ways for the new nursing home
teams in:
Page 3-Kathryn G. Allen:
QIOs and the State Survey Agencies to work collaboratively to assist
poorly performing nursing homes.
Secondly, the draft report identifies the special study awarded during
the 7th SOW to pilot this new approach (the "Collaborative Focus
Facility" Special Study), but draws insufficient attention to the fact
that preliminary analysis of cost data in that special study indicates
that it is very costly for QIOs to work intensively with chronically
poor performing nursing homes with multiple persistent survey
deficiencies. Preliminary estimates from the pilot are that additional
costs for this type of work run five to ten times the cost of helping
the "usual" nursing home. There is also significant controversy over
the best way to define a "low-performing" nursing home.
The draft report also fails to note where, for a large number of
states, the QIO is working intensively with either the great majority
of nursing homes in the state or a significant percentage of the homes.
In the 8th SOW, the QIO program operates in 53 contract regions. In
eight of these contract regions, the QIOs work intensively with 68
percent or more (up to 100 percent, for an average of 81 percent) of
the nursing homes in that state or territory. In ten additional
contract regions, the QIOs work intensively with more than one quarter
of the nursing homes in the state (up to 45 percent, for an average of
35 percent). Overall, for these 18 contract regions (34 percent of the
program) the QIOs work intensively with an average of 56 percent of the
nursing homes in the state. The overwhelming majority of these nursing
homes score worse (in most cases much worse) than the national average
on the quality measures they work to improve.
Finally, the draft report strongly suggests that use of the publicly
reported quality measures as the main metric for quality interventions
is "problematic". CMS disagrees with this opinion, as the publicly
reported quality measures in the nursing home setting have passed
through rigorous development, testing, deployment, and national
consensus processes involving the highest levels of technical expertise
on health care quality measurement in the country.
The CMS uses the Minimum Data Set (MDS), which nursing homes report
periodically for each resident, to generate publicly reported quality
measures (currently 14 for long-term care residents and five for
patients in short-stay skilled nursing facilities). Since 2002, the
Nursing Home Compare Web site has provided facility-level quality
measures to the public, along with the service array and other basic
descriptors of facilities, sorted by geography and other
characteristics. The nursing home industry regularly employs the
quality measures for quality management, alongside other quality
management tools such as Survey & Certification and internal quality
assessment and improvement. State Survey Agencies also regularly use
the quality measures to assist in their work. The quality measures
serve as a basis for improvement activities and research, and CMS
continues to update and improve the measures and their reporting
overtime. This ongoing process for revising measures has become a major
engine for generating tools and insights that substantially advance the
measurement and improvement of quality in Medicare.
'Nursing Home Compare at www.medicare.gov/nhcompare/ home.asp:
Page 4-Kathryn G. Allen:
2. The CMS should improve the monitoring and evaluation of Q10
activities.
The CMS agrees with this recommendation. The Institute of Medicine of
the National Academies, in its report released last year (Medicare's
Quality Improvement Organization Program: Maximizing Potential),
outlined I9 specific recommendations to CMS regarding the management,
cost accounting, and evaluation systems for the QIO contracts. Right
now, CMS, in concert with the Department of Health and Human Services,
is evaluating the recommendations from the IOM report and considering
ways to redesign the QIO Program. The IOM recommendations apply equally
to all aspects of the QIO Program, and all settings in which QIOs are
currently deployed (hospitals, physician offices, and home health
agencies, as well as nursing homes). 'thus, there are no
recommendations specific to the work QIOs do with nursing homes.
However, many of the aspects of the QIO nursing home work (especially
its data handling and reporting features) may be incorporated into the
redesigned QIO contract. In addition, CMS and the Department are
looking at a completely new approach to QIO evaluation for future
contract cycles.
3. The CMS should require QIOs to share with CMS the identity of homes
assisted intensively in order to facilitate evaluation.
The CMS is very much aware of the regulatory restrictions imposed upon
disclosure of the identities of the identified participant groups
(IPGs) and other identifiable data connected to the QIOs' quality
review study activity as defined in Federal regulations at 42 CFR
480.101. Given that the nature of the work with practitioners,
providers and institutions such as nursing homes is voluntary and most
often addresses poor performance in health care delivery, the
regulations implementing section 1 160 of the Social Security Act are
very restrictive in protecting highly sensitive identifying information
from disclosure. The GAO correctly notes that under the regulatory
provision at 42 CFR 480.140, CMS can only view the IPGs (which GAO
calls "intensive participants") on site at a QIO. The regulatory
provision allows for the on-site evaluation of the work of the QIO and
prevents the QIO from transferring this data to CMS where it would then
fall under potentially less restrictive disclosure rules (Health
Insurance Portability and Accountability Act and Privacy Act) and be
subject to the Freedom of Information Act. However, CMS is committed to
conducting effective and efficient oversight of program activities and,
therefore, continues to explore options which would allow access to
this data for evaluation of the QIOs individually and the program as a
whole, while maintaining appropriate safeguards necessary to promote
voluntary participation in quality improvement initiatives. The CMS
greatly appreciates the GAO's recommendation in this area and will
continue to seek a balance between disclosure and confidentiality.
Conclusion:
The CMS appreciates the GAO's efforts to study the QIOs' work with
nursing homes and will consider the GAO's recommendations in defining
future QIO work in this area and others.
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
Kathryn G. Allen, (202) 512-7118 or allenk@gao.gov:
Acknowledgments:
In addition to the contact named above, Walter Ochinko, Assistant
Director; Nancy Fasciano; Sara Imhof; Elizabeth T. Morrison; Colbie
Porter; and Andrea Richardson made key contributions to this report.
[End of section]
Related GAO Products:
Nursing Homes: Efforts to Strengthen Federal Enforcement Have Not
Deterred Some Homes from Repeatedly Harming Residents. GAO-07-241.
Washington, D.C.: March 26, 2007.
Nursing Homes: Despite Increased Oversight, Challenges Remain in
Ensuring High-Quality Care and Resident Safety. GAO-06-117. Washington,
D.C.: December 28, 2005.
Nursing Home Deaths: Arkansas Coroner Referrals Confirm Weaknesses in
State and Federal Oversight of Quality of Care. GAO-05-78. Washington,
D.C.: November 12, 2004.
Nursing Home Fire Safety: Recent Fires Highlight Weaknesses in Federal
Standards and Oversight. GAO-04-660. Washington D.C.: July 16, 2004.
Nursing Home Quality: Prevalence of Serious Problems, While Declining,
Reinforces Importance of Enhanced Oversight. GAO-03-561. Washington,
D.C.: July 15, 2003.
Nursing Homes: Public Reporting of Quality Indicators Has Merit, but
National Implementation Is Premature. GAO-03-187. Washington, D.C.:
October 31, 2002.
Nursing Homes: Quality of Care More Related to Staffing than Spending.
GAO-02-431R. Washington, D.C.: June 13, 2002.
Nursing Homes: More Can Be Done to Protect Residents from Abuse. GAO-
02-312. Washington, D.C.: March 1, 2002.
Nursing Homes: Federal Efforts to Monitor Resident Assessment Data
Should Complement State Activities. GAO-02-279. Washington, D.C.:
February 15, 2002.
Nursing Homes: Sustained Efforts Are Essential to Realize Potential of
the Quality Initiatives. GAO/HEHS-00-197. Washington, D.C.: September
28, 2000.
Nursing Home Care: Enhanced HCFA Oversight of State Programs Would
Better Ensure Quality. GAO/HEHS-00-6. Washington, D.C.: November 4,
1999.
Nursing Home Oversight: Industry Examples Do Not Demonstrate That
Regulatory Actions Were Unreasonable. GAO/HEHS-99-154R. Washington,
D.C.: August 13, 1999.
Nursing Homes: Proposal to Enhance Oversight of Poorly Performing Homes
Has Merit. GAO/HEHS-99-157. Washington, D.C.: June 30, 1999.
Nursing Homes: Complaint Investigation Processes Often Inadequate to
Protect Residents. GAO/HEHS-99-80. Washington, D.C.: March 22, 1999.
Nursing Homes: Additional Steps Needed to Strengthen Enforcement of
Federal Quality Standards. GAO/HEHS-99-46. Washington, D.C.: March 18,
1999.
California Nursing Homes: Care Problems Persist Despite Federal and
State Oversight. GAO/HEHS-98-202. Washington, D.C.: July 27, 1998.
FOOTNOTES
[1] Medicare is the federal health care program for elderly and certain
disabled individuals. Medicare may cover up to 100 days of skilled
nursing home care following a hospital stay. Medicaid is the joint
federal-state health care financing program for certain categories of
low-income individuals. Medicaid also pays for long-term care services,
including nursing home care.
[2] QIOs take a variety of forms. They can be for-or not-for-profit
organizations and can be either sponsored by a significant number of
actively practicing area physicians or have available to them a
sufficient number of these physicians to assure adequate peer review.
In general, QIOs cannot be health care facilities. Prior to 1999, QIOs
focused on quality improvement in the hospital setting. Beginning in
1999, CMS required QIOs to also work in an alternative setting; about
two-thirds selected nursing homes. The QIOs currently also work with
physician offices, home health agencies, rural or underserved
populations, and Medicare Advantage organizations to improve Medicare
beneficiaries' quality of care. For the 7th SOW, the 53 QIO contracts,
one for each state, the District of Columbia, and 2 territories (Puerto
Rico and the Virgin Islands) were held by 37 organizations. We excluded
the 2 territories from our study because of substantial differences in
health care financing between the territories and the states.
[3] See Related GAO Products at the end of this report.
[4] The minimum data set (MDS) consists of data that are periodically
collected to assess the care needs of residents in order to develop an
appropriate plan of care. State surveyors use MDS data to help assess
the quality of resident care, and Medicare and some state Medicaid
programs also use MDS data to adjust nursing home payments.
[5] The Web site can be accessed at www.Medicare.gov/NHCompare/
home.asp.
[6] The QIO contract is divided into tasks and subtasks; the nursing
home component is subtask 1a. The amount budgeted for this component in
the 8th SOW (the QIO contract covering the period from 2005 through
2008) was approximately $10 million less than was budgeted in the 7th
SOW.
[7] We ranked nursing homes as high-, moderately, or low-performing on
the basis of the number, scope, and severity of the deficiencies for
which they were cited (relative to other homes in their state) in three
standard state surveys from 1999 through 2002. We based our
classification of homes on their performance level relative to other
homes in the state to take into account the inconsistency in how states
conduct surveys, a problem we have reported on since 1998. A limitation
of our analysis is that we did not have information about all of the
homes that volunteered for intensive assistance, only those that were
selected by the QIOs, and therefore did not know the extent to which
low-performing homes volunteered for intensive assistance.
[8] Because a QIO is responsible for quality improvement activities in
each state and the District of Columbia, we refer to the 51 QIOs
throughout this report.
[9] To assist in the development of our site visit interview protocols,
we also interviewed personnel from three other QIOs. On each of our
five site visits, we interviewed officials from three stakeholder
groups: (1) the state survey agency; (2) the local affiliate for the
American Health Care Association, which generally represents for-profit
homes; and (3) the local affiliate for the American Association of
Homes and Services for the Aging, which represents not-for-profit
homes.
[10] IOM of The National Academies, Committee on Redesigning Health
Insurance Performance Measures, Payment, and Performance Improvement
Programs, Board on Health Care Services, Medicare's Quality Improvement
Organization Program: Maximizing Potential (Washington, D.C.: The
National Academies Press, 2006). The Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Pub. L. No. 108-173,
§109(d), 117 Stat. 2066, 2173-74, directed the Secretary of Health and
Human Services to ask the IOM to conduct an evaluation of the QIO
program administered by CMS. In 2006, the IOM issued a report that
examined performance within the entire QIO program, including the
nursing home component, during the 7th SOW.
[11] A pressure ulcer is an area of damaged skin and tissue that
results from constant pressure due to an individual's impaired
mobility. The pressure results in reduced blood flow and eventually
causes cell death, skin breakdown, and the development of an open
wound. Pressure ulcers can occur in individuals who are bed-or
wheelchair-bound, sometimes after only a few hours.
[12] In our survey of the QIOs, we asked them to identify the
interventions they relied on most and the interventions that were most
effective in improving the quality of nursing home care; we allowed the
QIOs to define these terms.
[13] CMS's Survey and Certification Group is responsible for oversight
of state survey agency activities.
[14] Surveys must be conducted at each home on average once every 12
months but no less than once every 15 months.
[15] This analysis excluded 13 states because fewer than 100 homes were
surveyed, and even a small increase or decrease in the number of homes
with serious deficiencies in such states could produce a relatively
large percentage-point change. In fiscal year 2005, about 17 percent of
the 16,337 homes surveyed had serious deficiencies. See GAO, Nursing
Homes: Efforts to Strengthen Federal Enforcement Have Not Deterred Some
Homes from Repeatedly Harming Residents, GAO-07-241 (Washington, D.C.:
Mar. 26, 2007).
[16] CMS is evaluating a new survey methodology to help ensure that
surveyors do not miss serious care problems. National implementation
will depend on the outcome of the evaluation.
[17] MDS assessments are conducted for all nursing home residents
within 14 days of admission and at quarterly and yearly intervals
unless there is a significant change in condition. In addition,
Medicare beneficiaries in a Medicare-covered stay are assessed through
MDS on or before the 5TH, 14TH, 30TH, 60TH, and 90TH day of their stays
to determine if their Medicare coverage should continue.
[18] GAO, Nursing Homes: Public Reporting of Quality Indicators Has
Merit, but National Implementation Is Premature, GAO-03-187
(Washington, D.C.: Oct. 31, 2002).
[19] See GAO-02-279.
[20] Some states that adjust nursing home payments to account for
variation in resident care needs have their own separate MDS review
programs.
[21] Pub. L. No. 97-248, §141-50, 96 Stat. 381-95. PROs were renamed
QIOs in 2002. Under the provisions of the Peer Review Improvement Act
of 1982 and implementing regulations, a QIO can be either a physician-
sponsored entity or a physician-access entity. See 42 C.F.R. §475.101
(2005). QIOs are allowed to be either for-or not-for-profit entities
and are required to include at least one consumer representative on the
QIO governing board. Funding for QIO activities comes from the Medicare
Trust Funds.
[22] IOM, Medicare's Quality Improvement Organization Program:
Maximizing Potential.
[23] IOM defines collaboratives as interventions designed to bring
together stakeholders working toward quality improvement for the same
clinical topic. Participants usually follow the same processes to reach
goals and interact on a regular basis to share knowledge, experiences,
and best practices.
[24] According to a CMS official, all QIO contracts prior to the 6th
SOW, which began in 2000, were considered "cost plus fixed fee" and
there were no deliverables, or set targets, that QIOs had to meet in
order to obtain payment. In the late 1990s, however, the Office of
Management and Budget instructed CMS to make QIO contracts performance-
based with deliverables and objectives that QIOs had to meet during the
contract cycle. In response, CMS changed the QIO contract so that part
of QIOs' fee was based on their performance.
[25] The Rhode Island QIO was awarded the support contract for nursing
homes for the 7th SOW. The contract defined roles for the QIO support
contractor, including (1) providing QIOs with information on clinical
topics and management systems' approaches and techniques for quality
improvement; (2) facilitating coordination and communication between
QIOs; (3) maintaining a nursing home informational clearinghouse Web
site with best practices, tools, and interventions; and (4) being
available for ongoing technical assistance.
[26] The $106 million represented 13 percent of the total amount ($809
million) awarded to QIOs for their base contracts. CMS did not budget
separately for statewide and intensive assistance.
[27] The QIO support contractor subcontracted with another QIO to
provide data analysis.
[28] For example, QIOs could move funds between the nursing home
component and the other components under task 1, which covered clinical
quality improvement efforts with home health agencies, hospitals,
physician offices, underserved and rural beneficiaries, and Medicare
Advantage organizations.
[29] QIOs working in the 13 states with fewer than 100 nursing homes
were expected to target at least 10 homes.
[30] See Social Security Act §1160; 42 C.F.R. §480.140 (2005).
[31] Stakeholders may include representatives of nursing homes, trade
associations, ombudsmen, state survey agencies, medical directors,
directors of nursing, geriatric nursing assistants, other licensed
professionals, academicians, and consumers.
[32] Under the 8th SOW contract, QIOs will not be held accountable for
QM improvement statewide.
[33] QIOs could fail to meet contract expectations for up to 2 of the
12 components and still remain eligible for noncompetitive renewal of
their contracts.
[34] Initiated in January 1999, the Special Focus Facility program was
expanded by CMS in December 2004. Expansion strengthened enforcement
authority so that if homes in the program fail to significantly improve
performance from one survey to the next, immediate sanctions must be
imposed; if homes show no significant improvement in 18 months and
three surveys, they must be terminated from participation in the
Medicare and Medicaid programs.
[35] The eight states are Florida, Maryland, Texas, Washington, Maine,
Michigan, Missouri, and North Carolina. We identified some of these
states by reviewing reports and asking officials in states that we knew
had quality assurance programs to identify other states with similar
programs. We did not attempt to determine if additional states had
similar programs.
[36] The organizations included the American Health Care Association,
the Alliance for Quality Nursing Home Care, and the American
Association of Homes and Services for the Aging, which are three of the
largest long-term care organizations and together represent the
majority of the approximately 16,400 nursing facilities in the United
States.
[37] In the 8th SOW contracts, CMS specified more selection parameters,
requiring QIOs to work with two groups of intensive participants,
including some "persistently poor-performing" homes identified in
consultation with state survey agencies; increasing the overall number
of intensive participants; and requiring geographic distribution of
these homes.
[38] QIOs could select more than 15 percent of the homes in their state
for intensive assistance. However, the weight given to this component
in a QIO's contract evaluation score could not exceed 66 percent--
generally, the weight given if the intensive participant group
comprised 15 percent of homes in the state.
[39] The 13 QIOs in states with fewer than 100 homes were expected to
work intensively with at least 10 homes.
[40] The 38 QIOs that were expected to work intensively with 10 to 15
percent of the homes in their state worked with an average of 15
percent. The other 13 QIOs worked with an average of 15 homes.
[41] The largest proportion of QIOs (27 percent) reported that their
most effective recruiting tactic was hosting statewide or regional
conferences for homes; however, 20 percent did not use this tactic at
all. The vast majority of QIOs (84 to 98 percent) also sent materials
to homes, contacted homes by telephone, and asked nursing home trade
associations or other groups to inform homes of the opportunity to
participate.
[42] Deficiencies are deemed serious if they constitute either actual
harm to residents or actual or potential for death/serious injury.
[43] Although many QIOs excluded some interested homes from the
official list of intensive participants submitted as a contract
deliverable, most QIOs (75 percent) reported that they gave these homes
more assistance than they did other homes in the state, and 37 percent
reported that they gave these homes as much assistance as they gave
intensive participants.
[44] Some QIOs also considered financial status and management
stability in making their selections. Among the 51 QIOs surveyed, 8
excluded homes that were struggling financially and 5 excluded homes
with recent management turnover. Personnel at one of the QIOs we
interviewed explained that the QIO excluded homes with known leadership
instability in order to avoid having to perform a great deal of
training and retraining as administrators came and went.
[45] These numbers do not sum to 18 because 4 of the 5 QIOs that
selected proportionately more moderately performing homes also selected
proportionately fewer low-or high-performing homes.
[46] Stakeholders included officials of state survey agencies and state
nursing home trade associations.
[47] One reason that improvements cannot be definitively attributed to
the QIOs is that homes may have benefited from other quality
improvement efforts as well.
[48] In most cases, the state survey agencies and QIOs issued joint
letters of invitation to the homes, and those that agreed to work with
the QIOs signed a participation agreement that addressed issues of
confidentiality and information sharing. The state survey agencies'
role was generally limited to identifying and helping recruit homes for
the project. As with homes in the intensive participant group, there
was little overlap between homes in the Collaborative Focus Facility
project and homes selected by state survey agencies for the Special
Focus Facility program. Although the Puerto Rico QIO participated in
the Collaborative Focus Facility project, our analysis focused on QIOs
in the 50 states and the District of Columbia.
[49] Over a 1-year period, the average number of survey deficiencies
the homes received in five areas (comprehensive assessment,
comprehensive care plan, pressure sore prevention/treatment, quality of
care, and physical restraints) changed little, going from 2.59 to 2.60,
but the average number of serious deficiencies they received in these
areas declined from 0.93 to 0.71. The homes' QM scores for physical
restraints and high-and low-risk pressure ulcers improved an average of
31 percent (or 38 percent when the score with the lowest improvement
was dropped from the average).
[50] For their statewide assistance, three-quarters of the QIOs
selected three QMs, the minimum number contractually allowed; the
remainder selected four QMs. No QIOs selected the maximum of five.
[51] The intensity of interventions varies by type of intervention (for
example, on-site versus telephone calls) and with the frequency of use.
[52] In its 2006 report on QIOs, the IOM recommended that Congress
permit extension of the contract from 3 to 5 years to allow for
measurement, refinement, and evaluation of technical assistance efforts.
[53] Because the largest component of the QIOs' contract evaluation
related to the intensive participants, we asked QIOs to rank and
provide detailed information on a greater number of interventions for
intensive participants than for statewide participants.
[54] The median number of times an intervention was provided is the
midpoint of all the times that an intervention was provided, as
reported by QIOs. Half the QIOs reported a number above the median and
half reported a number below.
[55] Nearly all QIOs (94 percent) also reported asking intensive
participants to complete homework assignments on their own. These
assignments most frequently involved conducting self audits, comparing
existing policies and procedures with checklists provided by the QIO,
and developing new practice protocols related to selected QMs. For
example, two homes told us they were given cause-and-effect analysis
exercises to complete to identify possible causes of and solutions to a
problem. Staff from another home told us that QIO personnel asked them
to conduct a mock survey to prepare for their next standard survey.
[56] We defined primary personnel as individuals who devoted more than
20 percent of a full-time work week to the nursing home component of
the contract. Some primary QIO personnel served as the principal
contacts, providing quality improvement assistance to homes. According
to our survey, 78 percent of QIOs also used outside experts
(consultants or subcontractors) for their quality improvement efforts.
The majority of QIOs reported using these experts to provide
presentations or training at conferences, participate in conference
calls, and develop or review materials. QIOs personnel we interviewed
told us they also used outside experts to train their primary personnel
or to provide technical assistance to intensive participant homes.
[57] Among individual QIOs, the extent of long-term care experience
spanned a wide spectrum. At five QIOs, 75 percent or more of the
primary personnel who worked with nursing homes had less than 1 year of
long-term care experience, while at two QIOs, all of the primary
personnel who worked with nursing homes had more than 10 years'
experience.
[58] The improvement, or relative change, in a home's QM scores is
calculated by subtracting its score at remeasurement from its score at
baseline and dividing by its score at baseline. For example, if the
number of residents with chronic pain in a 100-bed home decreased from
20 to 12æwhich translates to a change in scores from 0.20 to 0.12æthe
improvement in the home's pain QM would be 40 percent ([0.20-0.12]/
0.20).
[59] The four QMs specified in the contract are pressure ulcers among
high-risk patients, restraints, depression management, and chronic pain
management. With most intensive participants, QIOs are expected to work
on all four QMs and achieve a relative improvement rate of 15 to 60
percent. With the small group of persistently poor-performing homes
QIOs are now required to assist, they are expected to work on two QMs
(pressure ulcers among high-risk patients and restraints) and achieve
an improvement rate of 10 percent.
[60] GAO-03-187.
[61] Greg Arling and others, "Future Development of Nursing Home
Quality Indicators," The Gerontologist, vol. 45, no. 2 (2005).
[62] A resident who triggers a QM is included in both the numerator and
denominator when a facility's QM score is calculated.
[63] GAO-02-279 and GAO-03-187.
[64] In April 2005, CMS ended work under its data assessment and
verification contract but signed a new contract in September 2005 that
focused on on-site reviews of MDS accuracy.
[65] Stages of pressure ulcer formation are I--skin of involved area is
reddened, II--upper layer of skin is involved and blistered or abraded,
III--skin has an open sore and involves all layers of skin down to
underlying connective tissue, IV--tissue surrounding the sore has died,
exposing muscle and bone.
[66] William Rollow and others, "Assessment of the Medicare Quality
Improvement Organization Program," Annals of Internal Medicine, vol.
145, no. 5 (2006).
[67] Because homes must volunteer and be selected by the QIOs to
receive intensive assistance, intensive participants may differ from
nonintensive participants in ways that affect their capacity to improve
their QM scores, such as differences in motivation and commitment,
available resources, and competing priorities.
[68] At a meeting on October 31, 2006, of the Technical Expert Panel
convened by the contractor tasked to design an evaluation of the QIO
program for the Office of the Assistant Secretary for Planning and
Evaluation of HHS, panel members underscored the difficulty of
controlling for a subjective condition such as motivation to improve
the quality of care and noted the potential for biased assessments of
the impact of the QIOs if differences in motivation are not accounted
for appropriately.
[69] According to CMS guidance, the names of participants in
collaborative quality improvement projects constitute quality review
study information. See QIO Manual, §16005 (Rev. 07-11-03). Federal
regulations specify that quality review study information revealing the
identities of practitioners and institutions must be disclosed to CMS
"on site" or at the QIOs' place of operation. See 42 C.F.R. §480.140
(2005). That restriction does not apply to disclosures to certain other
federal agencies, such as HHS Office of Inspector General or GAO. See
42 C.F.R. §480.140(b)(2005).
[70] For the survey conducted during the 7th SOW, the response rate for
nursing homes was 95 percent.
[71] CMS did not provide this cost estimate during the course of our
work.
[72] To assist in the development of our site visit interview
protocols, we interviewed personnel from three additional QIOs
(Massachusetts, Rhode Island, and Washington) and staff from one
nursing home in each of four other states (Maryland, Massachusetts, New
Hampshire, and Virginia).
[73] The four states were Florida, Maryland, Texas, and Washington. We
subsequently learned that four other states, (Maine, Michigan,
Missouri, and North Carolina) also had state-sponsored quality
improvement programs.
[74] We contacted officials of programs in six states: Florida,
Maryland, Michigan, North Carolina, Texas, and Washington.
[75] QIOs working in states with at least 100 nursing homes were
expected to target 10 to 15 percent of all homes in the state for
intensive assistance. In the state we selected that had the highest
number of homes (Florida), 7 percent of the homes in the state equaled
approximately 8 homes.
[76] This analysis drew on data from the On-line Survey, Certification,
and Reporting system (OSCAR), a database maintained by CMS that
compiles the results of every state survey conducted at Medicare-and
Medicaid-certified facilities nationwide.
[77] We eliminated from the analysis 1,946 homes that had a standard
survey in the year prior to November 1, 2002, but for which we were
unable to identify two additional surveys during the period we
specified. The homes that we eliminated represented a larger proportion
of the group of homes not selected by the QIOs (11.8 percent) than of
the group of homes that were selected by the QIOs (3.4 percent).
[78] CMS defines immediate jeopardy as actual or potential for death/
serious injury.
[79] Because homes with the same number of deficiencies were assigned
the same rank, in some cases the top and bottom quartiles included more
than 25 percent of the homes in the state. We based our classification
of homes on their performance level relative to other homes in the
state to take into account the inconsistency in how states conduct
surveys, a problem we have reported on since 1998. An alternative
approach, which would not take into account the inconsistency in how
states conduct surveys, would be to classify homes based on the
absolute number of deficiencies they had receivedæfor example, to
classify all homes with five or more serious deficiencies as low-
performing homes. For data on inconsistencies, see GAO-06-117 and GAO-
07-241.
[80] We used the Satterthwaite t-test because it does not require the
variances of the two groups to be equal. We rejected the null
hypothesis that the proportions of two groups were equal when the p-
value from the Satterthwaite t-test was less than 0.05.
[81] We asked the QIOs to complete a separate survey for each state in
which they worked during the 7th SOW.
[82] We defined primary personnel as employees, subcontractors, or
consultants who worked with nursing homes or provided direct oversight
of those individuals, excluding administrative support staff and
individuals who worked less than 20 percent of a full-time work week on
the nursing home component.
[83] QIOs were also given the option of specifying other interventions
they used.
[84] Because QM improvement among intensive participants constituted
the largest part of the QIOs' contract evaluation score, we asked QIOs
to rank and provide detailed information on a greater number of
interventions for intensive participants than for statewide
participants.
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