Medicare
CMS Needs to Collect Consistent Information from Quality Improvement Organizations to Strengthen Its Establishment of Budgets for Quality of Care Reviews Gao ID: GAO-11-116R December 6, 2010Medicare funds health care services for more than 46 million beneficiaries. The Centers for Medicare & Medicaid Services (CMS)--the agency that administers Medicare--contracts with private organizations known as Quality Improvement Organizations (QIO) to, among other core functions, improve the quality of care for Medicare beneficiaries. CMS contracts with one QIO for each of the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. One of the QIOs' many responsibilities is to review quality of care concerns, raised by Medicare beneficiaries or others, to determine whether Medicare-financed medical services meet professionally recognized standards of health care. Quality of care reviews may address a range of issues, such as inappropriate treatment or hospital staff not administering medications on time; may involve a variety of health care services and settings; and may include a range of Medicare providers or practitioners. CMS enters into 3-year contracts with QIOs for a range of activities and reviews, including quality of care reviews. For each QIO contract, CMS establishes a budget reflecting the estimated costs of these activities and reviews. For the most recent contracts, which cover August 1, 2008, through July 31, 2011, CMS's budgets for the QIOs totaled about $1.1 billion, with approximately $208 million for all types of reviews, including QIOs' quality of care reviews, as well as some other activities. Questions have been raised about CMS's ability to set budgets appropriately for QIOs' quality of care reviews. A 2006 report by the Institute of Medicine (IOM) and a 2008 internal report commissioned by CMS identified weaknesses in CMS's ability to accurately compare costs across QIOs. Based on reports of wide variation in the costs that QIOs report for conducting these reviews, Congress raised questions about how CMS establishes QIOs' budgets. Ensuring that QIOs' budgets are based on accurate information is particularly important because CMS's contracts with the QIOs are funded from the Medicare Trust Funds, which are primarily used to support inpatient and outpatient health care services for Medicare beneficiaries. QIO contracts are funded from the Medicare Trust Funds in proportions from each that CMS determines to be fair and equitable, and the QIO program is not subject to the same kind of congressional oversight as other CMS programs, which are funded through the annual appropriations process. Policymakers are concerned about the long-term solvency of these Trust Funds and thus their ability to fund health care services for Medicare beneficiaries in the future. Congress raised questions about the information QIOs report to CMS for budgeting purposes and how CMS uses this information. To assist congressional consideration of this matter, this report describes and assesses the information CMS uses to establish the portion of QIOs' budgets for quality of care reviews.
To help establish QIOs' budgets for quality of care reviews for the current contract, the 9th Statement of Work, CMS used information that QIOs are required to provide to the agency about the volume of QIOs' quality of care reviews and the costs associated with conducting these reviews. CMS requires the QIOs to record information about the volume of their quality of care reviews in CMS's Case Review Information System (CRIS) and to record information about their labor costs in CMS's Financial Information and Vouchering System (FIVS). However, CMS has not established clear instructions for how QIOs should record volume and cost information in these systems. We found inconsistencies among some QIOs in the ways they record certain volume and cost information in CRIS and FIVS. As a result, the historical quality of care review volume and cost information CMS obtains is inconsistent across QIOs and CMS cannot be assured that the budgets it establishes for QIOs' quality of care reviews are appropriate.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Kathleen M. King Team: Government Accountability Office: Health Care Phone: No phone on recordGAO-11-116R, Medicare: CMS Needs to Collect Consistent Information from Quality Improvement Organizations to Strengthen Its Establishment of Budgets for Quality of Care Reviews
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GAO-11-116R:
United States Government Accountability Office:
Washington, DC 20548:
December 6, 2010:
The Honorable Max Baucus:
Chairman:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
Subject: Medicare: CMS Needs to Collect Consistent Information from
Quality Improvement Organizations to Strengthen Its Establishment of
Budgets for Quality of Care Reviews:
Medicare funds health care services for more than 46 million
beneficiaries.[Footnote 1] The Centers for Medicare & Medicaid
Services (CMS)--the agency that administers Medicare--contracts with
private organizations known as Quality Improvement Organizations (QIO)
to, among other core functions, improve the quality of care for
Medicare beneficiaries. CMS contracts with one QIO for each of the 50
states, the District of Columbia, Puerto Rico, and the U.S. Virgin
Islands. One of the QIOs' many responsibilities is to review quality
of care concerns, raised by Medicare beneficiaries or others, to
determine whether Medicare-financed medical services meet
professionally recognized standards of health care.[Footnote 2]
Quality of care reviews may address a range of issues, such as
inappropriate treatment or hospital staff not administering
medications on time; may involve a variety of health care services and
settings; and may include a range of Medicare providers or
practitioners.[Footnote 3]
CMS enters into 3-year contracts with QIOs for a range of activities
and reviews, including quality of care reviews.[Footnote 4] For each
QIO contract, CMS establishes a budget reflecting the estimated costs
of these activities and reviews.[Footnote 5] For the most recent
contracts, which cover August 1, 2008, through July 31, 2011, CMS's
budgets for the QIOs totaled about $1.1 billion, with approximately
$208 million for all types of reviews, including QIOs' quality of care
reviews, as well as some other activities. Questions have been raised
about CMS's ability to set budgets appropriately for QIOs' quality of
care reviews. A 2006 report by the Institute of Medicine (IOM)
[Footnote 6] and a 2008 internal report commissioned by CMS identified
weaknesses in CMS's ability to accurately compare costs across QIOs.
Based on reports of wide variation in the costs that QIOs report for
conducting these reviews, you raised questions about how CMS
establishes QIOs' budgets.
Ensuring that QIOs' budgets are based on accurate information is
particularly important because CMS's contracts with the QIOs are
funded from the Medicare Trust Funds, which are primarily used to
support inpatient and outpatient health care services for Medicare
beneficiaries.[Footnote 7] QIO contracts are funded from the Medicare
Trust Funds in proportions from each that CMS determines to be fair
and equitable,[Footnote 8] and the QIO program is not subject to the
same kind of congressional oversight as other CMS programs, which are
funded through the annual appropriations process. Policymakers are
concerned about the long-term solvency of these Trust Funds and thus
their ability to fund health care services for Medicare beneficiaries
in the future.
You raised questions about the information QIOs report to CMS for
budgeting purposes and how CMS uses this information. To assist
congressional consideration of this matter, this report describes and
assesses the information CMS uses to establish the portion of QIOs'
budgets for quality of care reviews.
To conduct this work, we reviewed CMS's current 3-year contract with
QIOs, and CMS policies, such as CMS's QIO policy manual[Footnote 9]
and relevant CMS policy memos. We reviewed these materials and
interviewed agency officials in order to identify the information that
CMS used, including information obtained from the QIOs, to establish
the QIOs' budgets for their quality of care reviews for the 9th
Statement of Work. We also reviewed these materials, as well as
relevant statutes and regulations, and interviewed agency officials in
order to understand the quality of care review process. We then
administered a Web-based pre-interview questionnaire and conducted
structured interviews with officials from a judgmental sample of seven
QIOs, in order to obtain information about how the QIOs conduct their
quality of care reviews, the variation in their implementation of
these reviews, and the information they regularly report to CMS about
these reviews. We selected these seven QIOs based on the number of
individuals eligible for Medicare residing in each of the 48
contiguous states and the District of Columbia using CMS's 2009
Medicare enrollment data and taking into account QIO corporate
affiliations and geographic distribution (see enclosure I for more
information about our scope and methodology). The information we
obtained from our selected QIOs cannot be generalized to all QIOs.
To assess the reliability of QIOs' responses to our Web-based pre-
interview questionnaire, we manually checked the responses to identify
illogical or inconsistent responses and other indications of possible
errors. We also conducted follow-up interviews with the officials we
interviewed from the selected QIOs in order to clarify their answers
and to gain a contextual understanding of their responses to certain
questions on our pre-interview questionnaire and to our interview
questions. To assess the reliability of CMS's 2009 Medicare enrollment
data, which we used to select the seven QIOs, we reviewed relevant
documentation about the data. We determined that the enrollment data
we used for our report were sufficiently reliable for our purposes.
We conducted this performance audit from October 2009 through December
2010 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
Results in Brief:
To help establish QIOs' budgets for quality of care reviews for the
current contract, the 9th Statement of Work, CMS used information that
QIOs are required to provide to the agency about the volume of QIOs'
quality of care reviews and the costs associated with conducting these
reviews. CMS requires the QIOs to record information about the volume
of their quality of care reviews in CMS's Case Review Information
System (CRIS) and to record information about their labor costs in
CMS's Financial Information and Vouchering System (FIVS). However, CMS
has not established clear instructions for how QIOs should record
volume and cost information in these systems. We found inconsistencies
among some QIOs in the ways they record certain volume and cost
information in CRIS and FIVS. As a result, the historical quality of
care review volume and cost information CMS obtains is inconsistent
across QIOs and CMS cannot be assured that the budgets it establishes
for QIOs' quality of care reviews are appropriate.
We obtained written comments on a draft of this report from the
Department of Health and Human Services (HHS). HHS agreed with our
recommendation that the Administrator of CMS develop clear
instructions for how QIOs are to record volume and cost information in
CRIS and FIVS. We incorporated HHS's technical comments as appropriate.
Background:
QIOs conduct quality of care reviews to determine if Medicare-financed
health services meet professionally recognized standards of health
care. Quality of care reviews are just one type of review QIOs are
required to conduct. QIOs also conduct what are known as utilization
reviews to determine whether Medicare services provided are medically
necessary, reviews of beneficiary appeals for denials of Medicare
coverage for certain health care services, and reviews of possible
violations of the Emergency Medical Treatment and Active Labor Act.
[Footnote 10] From August 1, 2008, through July 31, 2009--the first
year of the current QIO contract--CMS's data show that the QIOs
completed about 2,800 quality of care reviews initiated by
beneficiaries. The QIOs also completed about 16,000 quality of care
reviews initiated by non-beneficiary sources.[Footnote 11]
QIOs are required to conduct quality of care reviews for concerns
raised by Medicare beneficiaries.[Footnote 12] Beneficiaries may raise
their quality of care concerns[Footnote 13] by mailing a letter to a
QIO or by calling a QIO's helpline[Footnote 14] to register their
concerns orally,[Footnote 15] but QIOs can proceed with further steps
of the quality of care review only after beneficiaries submit written
descriptions of their concerns. Therefore, QIOs may proceed with
reviews for oral beneficiary concerns only if they obtain a written
concern from the beneficiary.[Footnote 16],[Footnote 17] QIOs are also
required by their contracts to conduct quality of care reviews for
quality of care concerns identified through non-beneficiary sources.
After receiving a written quality of care concern, QIOs review the
beneficiary's medical records. Specifically, CMS requires QIOs to
review the beneficiary's medical records held by the providers or
practitioners that delivered the Medicare services about which there
is a concern, in order to determine whether or not the Medicare
services delivered to the beneficiary met professionally recognized
standards of health care. QIOs are required to notify beneficiaries of
the QIOs' final determinations at the conclusion of a quality of care
review.[Footnote 18] (See enclosure II for additional information
about QIOs' processes for conducting quality of care reviews.)
CMS Uses Volume and Cost Information Provided by QIOs to Establish
Quality of Care Review Budgets, but CMS Has Not Provided Clear
Instructions for Recording This Information:
In order to help establish QIOs' budgets for quality of care reviews
for the current contract, the 9th Statement of Work, CMS used
information that QIOs are required to provide the agency about the
volume of QIOs' quality of care reviews and the costs associated with
conducting these reviews.[Footnote 19] However, CMS has not
established clear instructions for how QIOs should record volume and
cost information in the electronic systems used to provide CMS with
this information. We found inconsistencies among some QIOs in the ways
they record certain volume and cost information in these systems.
CMS Uses Information QIOs Provide about the Volume and Cost of Their
Quality of Care Reviews to Help Establish Budgets for These Reviews:
For every 3-year contract, CMS establishes a budget for each QIO
reflecting the estimated costs of the activities and reviews the QIO
is responsible for performing, including quality of care reviews. CMS
officials told us that, in order to establish the portion of a QIO's
budget for quality of care reviews for the current contract, the 9th
Statement of Work, the agency used information about the volume and
cost of these reviews the QIO performed under the previous 3-year
contract. Specifically, CMS used this historical information to
estimate each QIO's budgetary needs for performing quality of care
reviews from August 1, 2008, through July 31, 2011. CMS then added
these quality of care review estimates to estimates for performing
other contracted activities, in order to establish the current 3-year
budget for each QIO.
CMS obtained information about the volume of QIOs' quality of care
reviews from the Case Review Information System (CRIS), a CMS
electronic information system used to record information about QIO
activities and reviews, including quality of care reviews. CMS
requires QIOs to use CRIS to record information about quality of care
reviews and other types of reviews, such as utilization reviews,
within 3 days of performing a task, such as responding to a
beneficiary's oral concern. This information may include summaries of
oral and written beneficiary concerns received, notes about the
progress of medical record reviews, and information indicating whether
the QIO determined that Medicare services met professionally
recognized standards of health care. QIOs use two main categories--the
beneficiary complaint and case review categories--to record
information about their quality of care reviews in CRIS.
* Beneficiary Complaint Category. This category is used to record
information about written quality of care concerns QIOs receive from
beneficiaries. QIOs use this category to record information, such as
the date on which the QIO received the written beneficiary concern and
the date on which the QIO completed the medical record review. QIOs
also use this category to record information about their final
determinations about whether the Medicare services beneficiaries
received met professionally recognized standards of health care.
* Case Review Category. This category is used to document the type of
review the QIO is conducting--that is, whether the QIO is conducting a
quality of care review or another type of review, such as a
utilization review.
To calculate the volume of quality of care reviews that QIOs conducted
under the previous contract, CMS used the number of records that QIOs
created in the CRIS beneficiary complaint category and the number of
records marked as quality of care reviews in the CRIS case review
category.[Footnote 20]
To obtain information about the cost of QIOs' quality of care reviews,
CMS officials used information from another CMS electronic information
system, the Financial Information and Vouchering System (FIVS), which
is used to record information about the labor costs associated with
QIOs' various activities and reviews, including quality of care
reviews. QIOs are required, on a monthly basis, to record cost
information into FIVS, such as the number of hours QIO employees spend
conducting reviews and QIO employees' hourly rates of pay. CMS
established 18 cost codes for QIOs to use for recording their labor
costs related to conducting reviews, including quality of care
reviews, under the current contract.[Footnote 21] One of these codes--
the quality of care review cost code--is the primary code used to
record labor costs associated with quality of care reviews, such as
costs associated with conducting medical record reviews or
communicating with beneficiaries, providers, and practitioners about
the quality of care review process.
To establish the portion of QIOs' budgets for quality of care reviews,
CMS officials told us they use the volume and cost information QIOs
are required to record in CRIS and FIVS. Specifically, to establish
budgets for QIOs' quality of care reviews for the current 3-year
contract, the 9th Statement of Work, CMS officials used this volume
and cost information in a multistep process. First, using the volume
and cost information the QIOs recorded in CRIS and FIVS during the
previous 3-year contract period, CMS calculated a nationwide median
number of labor hours per quality of care review.[Footnote 22] Next,
CMS instructed the QIOs to use this nationwide median number of labor
hours or the QIO's own average number of labor hours per quality of
care review--whichever was lower--to develop proposed budgets to
conduct quality of care reviews under the 9th Statement of Work.
[Footnote 23] Further, the QIOs' proposed budgets were to be based on
the result of this labor hours calculation and the volume of quality
of care reviews the QIOs expected they would perform over the course
of the next 3 years.[Footnote 24] CMS officials told us that the QIOs
then added their estimates for quality of care reviews to their
estimates for other activities and reviews, and submitted their
proposed budgets to CMS about 4 months prior to the start of the
current contract.
After receiving each QIO's budget proposal, CMS officials reviewed the
proposals by comparing them to CMS's own estimates of funding each QIO
would likely need to conduct its activities and reviews for the 9th
Statement of Work, including quality of care reviews.[Footnote 25] As
part of this review, CMS determined whether each QIO's proposed budget
was higher or lower than CMS's own estimates for these reviews.
Officials then negotiated with each QIO to agree upon a total budget
for the current 3-year contract, which included an amount for
conducting quality of care and other reviews.
CMS's Instructions to QIOs for Recording Volume and Cost Information
for Quality of Care Reviews Lack Clarity:
Although CMS requires QIOs to record volume and cost information about
their quality of care reviews in CRIS and FIVS, the agency has not
provided clear instructions for how QIOs should record this
information in these systems. CMS has established basic requirements
for the quality of care review information QIOs must provide to the
agency; however, these requirements do not include specific
instructions about how QIOs should record volume and cost information
in CRIS and FIVS. CMS's requirements are outlined in CMS's current QIO
contract, a 2003 QIO policy manual, and a 2008 policy memo. According
to CMS's contract, QIOs must record all information about their
quality of care reviews in CRIS within 3 days. However, the contract
and policy manual do not specify which CRIS categories QIOs should use
to record certain types of information related to the volume of
quality of care reviews. In addition, CMS's 2008 policy memo
identifies the different cost codes QIOs should use to record their
labor costs in FIVS under the current contract.[Footnote 26] However,
CMS's memo does not specify exactly which quality of care review tasks
should be recorded with each cost code.
We found inconsistencies among some QIOs in the ways they record
volume and cost information in CRIS and FIVS, respectively. (See
enclosure III for examples of variation in the seven QIOs'
implementation of other quality of care review tasks, such as how QIOs
review medical records.) Among the seven QIOs we interviewed, we found
that all seven create a record in the CRIS beneficiary complaint
category when they receive a written beneficiary concern that relates
to the quality of Medicare services; however, some QIOs also create a
record in this category under other circumstances. Specifically, we
found:
* Three of the seven QIOs also create records in the beneficiary
complaint category when they receive oral beneficiary concerns that
they expect will eventually result in a written beneficiary concern.
However, in some cases beneficiaries ultimately do not submit written
concerns to the QIO, which means that the QIO cannot initiate a
quality of care review.[Footnote 27] Therefore, these three QIOs could
report a higher volume of beneficiary complaint records in CRIS,
relative to the four QIOs that do not create records in the CRIS
beneficiary complaint category for oral beneficiary concerns.
* Two of the seven QIOs also create records in the beneficiary
complaint category for written beneficiary concerns that may not
relate to the quality of care for Medicare services received by the
beneficiaries. The remaining five QIOs record this information in
another CRIS category. Therefore, the two QIOs could report a higher
volume of records in the beneficiary complaint category than the
remaining five QIOs report.
In addition, when conducting quality of care reviews initiated by
another type of review, such as a utilization review, QIOs vary as to
whether they create a record for a quality of care review in the CRIS
case review category. Specifically, we found:
* Three QIOs create records in the case review category for quality of
care reviews they perform, but only when they determine that Medicare
services did not meet professionally recognized standards of health
care.
* In contrast, the remaining four QIOs create records in the case
review category for quality of care reviews regardless of the QIOs'
final determinations about whether Medicare services met
professionally recognized standards of health care.
Similarly, while all seven QIOs in our review use FIVS to report cost
information to CMS, in some cases the QIOs vary in which of the FIVS
cost codes they use to classify labor costs associated with conducting
the quality of care review process. We found:
* QIOs do not always use the quality of care cost code to record their
labor costs when they identify a quality of care concern while
conducting other types of reviews, such as a utilization review. While
staff from two QIOs reported using the quality of care cost code,
staff from the remaining five QIOs reported using other cost codes. As
a result, these five QIOs could be reporting lower labor costs for
quality of care reviews relative to the remaining two QIOs.
* Four of seven QIOs record their labor costs under the quality of
care review cost code for activities associated with the helpline,
such as when following up with beneficiaries who express their
concerns orally through the QIO's helpline. As a result, labor costs
recorded under the quality of care review cost code for these four
could be higher when compared to the other three QIOs that record
their labor costs for activities associated with the helpline under
the helpline cost code.
Conclusions:
To set the QIOs' budgets for quality of care reviews, CMS depends on
historical volume and cost information the agency obtains from the
QIOs. However, because CMS does not provide clear instructions for how
the QIOs should record their volume and cost information in CMS's
information systems, CMS does not obtain consistent information across
the QIOs it oversees. Without consistent information on the volume and
costs for quality of care reviews, CMS cannot ensure that the budget
for these reviews that it establishes for each QIO is appropriate. By
providing clear, specific instructions for how the QIOs should record
information in CRIS and FIVS, CMS could improve the information it
obtains from the QIOs to establish budgets for quality of care reviews.
Recommendation for Executive Action:
To ensure that QIOs consistently record volume and cost information
for their quality of care reviews and to help ensure that the budgets
CMS establishes for these reviews are appropriate, the Administrator
of CMS should develop clear instructions specifying how QIOs should
record information about the volume and costs of their quality of care
reviews in CRIS and FIVS.
Agency and QIO Comments:
The Department of Health and Human Services provided us with written
comments on a draft of this report. The department's comments are
reprinted in enclosure IV. HHS agreed with our recommendation and
offered additional comments from CMS. In its comments, CMS indicated
that the agency is taking steps to improve the collection of volume
and cost information from QIOs. CMS said it would provide explicit and
clear guidance to QIOs about how to record this information prior to
the start of the 10th Statement of Work. HHS also provided technical
comments that we incorporated as appropriate.
We also provided the seven QIOs we interviewed the opportunity to
verify statements they made that were used to support our findings and
incorporated their comments as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 30
days from the report date. At that time, we will send copies to the
Secretary of Health and Human Services, the Administrator of the
Centers for Medicare & Medicaid Services, and other interested
parties. In addition, the report will be available at no charge on the
GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-7114 or kingk@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 members who made key
contributions to this report are listed in enclosure V.
Signed by:
Kathleen M. King:
Director, Health Care:
Enclosures - 5:
[End of section]
Enclosure I: Scope and Methodology:
This report describes and assesses the information CMS uses to
establish the portion of QIOs' budgets for quality of care reviews. To
conduct this work, we reviewed the Centers for Medicare and Medicaid
Services' (CMS) current 3-year contract with Quality Improvement
Organizations (QIO)--the 9th Statement of Work[Footnote 28]--and CMS
policies, such as CMS's Quality Improvement Organization (QIO) manual
[Footnote 29] and relevant CMS policy memos. We reviewed these
materials and interviewed agency officials in order to identify the
information CMS used, including information CMS obtained from the
QIOs, to establish the QIOs' budgets for their quality of care reviews
for the 9th Statement of Work. We also reviewed these materials, as
well as relevant statutes and regulations, and interviewed agency
officials in order to understand the quality of care review process.
We then administered a Web-based pre-interview questionnaire and
conducted structured interviews with officials from a judgmental
sample of seven QIOs that currently hold contracts with CMS, in order
to obtain information about how they conduct their quality of care
reviews, the variation in their implementation of these reviews, and
the information they regularly report to CMS about these reviews.
To identify the entities that hold QIO contracts for each state under
CMS's current contract, we accessed a comprehensive list of QIOs from
the QIO Directory on the QualityNet Web site [hyperlink,
http://www.qualitynet.org], a Web site established by CMS for QIOs.
The QIO Directory lists the name of each QIO, along with its telephone
number and Web site address. We used individual QIOs' Web sites to
gather contact information and information about whether the QIO is
part of a multistate QIO corporate affiliation.[Footnote 30] We
confirmed the QIO entities we identified as holding contracts in each
state, as well as which of those QIOs have multistate corporate
affiliations, with a QIO association.
To select our judgmental sample of seven QIOs, we ranked the 48
contiguous states and the District of Columbia[Footnote 31] by the
number of eligible Medicare beneficiaries[Footnote 32] residing in
each state, according to CMS's 2009 Medicare enrollment data. We then
selected three states with a high number of eligible Medicare
beneficiaries, two states with a medium number of eligible Medicare
beneficiaries, and two states with a low number of eligible Medicare
beneficiaries, in order to create our judgmental sample of seven
states. Our selection also took into account corporate affiliations
among QIOs as well as geographic distribution of the selected states.
We included more states with a high number of eligible Medicare
beneficiaries when selecting our judgmental sample of QIOs in order to
develop a sample that represented a greater proportion of the total
population of eligible Medicare beneficiaries nationwide. In all,
about 21 percent of the 2009 population of eligible Medicare
beneficiaries in the United States resided in the seven states
included in our sample. The information we obtained from our selected
QIOs cannot be generalized to all QIOs.
To assess the reliability of QIOs' responses to our Web-based pre-
interview questionnaire, we manually checked the responses to identify
illogical or inconsistent responses and other indications of possible
errors. We also conducted follow-up interviews with the officials we
interviewed from the selected QIOs in order to clarify their answers
and to gain a contextual understanding of their responses to certain
questions on our pre-interview questionnaire and to our interview
questions. To assess the reliability of CMS's 2009 Medicare enrollment
data, which we used to select the seven QIOs, we reviewed relevant
documentation about the data. We determined that the enrollment data
we used for our report were sufficiently reliable for our purposes.
We conducted this performance audit from October 2009 through December
2010 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
[End of section]
Enclosure II: Quality Improvement Organizations' (QIO) Processes for
Conducting Quality of Care Reviews:
There are four steps that QIOs should follow to conduct quality of
care reviews.[Footnote 33] Quality of care reviews are reviews of
concerns raised by Medicare beneficiaries and others[Footnote 34] to
determine whether the quality of medical services financed by Medicare
and delivered to beneficiaries met professionally recognized standards
of health care.[Footnote 35] The first key step in the quality of care
review process is for QIOs to receive quality of care concerns.
[Footnote 36] Beneficiaries may initiate their quality of care
concerns by mailing a letter to a QIO[Footnote 37] or by calling a
QIO's helpline[Footnote 38] to register their concerns orally.
[Footnote 39] QIOs may staff their helplines with clinicians, such as
nurses, or with non-clinical staff. However, QIOs can proceed with
further steps of the quality of care review only after the beneficiary
submits a written description of the concern. Therefore, QIOs can
proceed with reviews for oral beneficiary concerns only if they obtain
a written concern from the beneficiary.[Footnote 40] CMS instructs
QIOs to advise beneficiaries who registered their quality of care
concerns orally to submit their concerns in writing and to assist
beneficiaries in preparing written concerns when needed--for example,
by sending beneficiaries a form to complete--in order to proceed with
a quality of care review. QIOs may also follow-up with beneficiaries
who called the QIO but have not yet submitted written concerns.
[Footnote 41]
The second key step in the quality of care review process is for the
QIO, after receiving a quality of care concern, to request, receive,
and review the beneficiary's medical records.[Footnote 42]
Specifically, CMS requires the QIO to request the medical records held
by the providers or practitioners[Footnote 43] who delivered the
Medicare services about which there is a concern within 5 calendar
days of receipt of the concern and to allow 30 calendar days to
receive them.[Footnote 44] To conduct medical record reviews, QIOs use
physician reviewers[Footnote 45] to review the evidence documented in
the beneficiary's medical records and to determine whether or not the
Medicare services delivered to the beneficiary met professionally
recognized standards of health care.[Footnote 46] QIOs and their
physician reviewers may review medical records up to three times in
order to reach a final determination regarding whether Medicare
services met professionally recognized standards of health care.
[Footnote 47] QIOs may offer beneficiaries an opportunity to pursue an
alternative dispute resolution when they determine that Medicare
services met professionally recognized standards of health care.
[Footnote 48]
In the third key step of the quality of care review process, CMS
requires the QIO to notify involved providers or practitioners--
through written notices--of the QIO's final determination. In
instances where the QIO found that the care provided did not meet
professionally recognized standards of health care, the QIO may use
this written notice to inform the relevant providers or practitioners
that they must take steps to improve the quality of the Medicare
services they provide, referred to by CMS as a quality improvement
activity.[Footnote 49] In addition, for quality of care concerns
initiated by beneficiaries and involving practitioners, the QIO also
must seek the practitioners' consent to disclose details about the
QIO's findings to beneficiaries.[Footnote 50]
For the fourth and final key step of the quality of care review
process, the QIO is required to provide the beneficiary with a written
notification of its final determination about whether the Medicare
services delivered by the provider or practitioner met professionally
recognized standards of health care.[Footnote 51] CMS requires that
these written beneficiary notices include a brief explanation of QIOs'
quality of care review duties and functions, a brief summary of the
beneficiary's quality of care concern, a statement about whether the
Medicare services met professionally recognized standards of health
care, and contact information for a QIO staff person.[Footnote 52] In
instances involving providers and where involved practitioners provide
consent, CMS requires QIOs to provide additional details of their
findings to beneficiaries beyond the statement of whether the Medicare
services met professionally recognized standards of health care.
[Footnote 53]
[End of section]
Enclosure III: Selected Points of Variation among Quality Improvement
Organizations (QIO) in Their Implementation of the Quality of Care
Review Process for Quality of Care Concerns from Medicare
Beneficiaries:
This enclosure provides selected points of variation among the seven
QIOs we interviewed in their implementation of the four steps of the
quality of care review process.[Footnote 54] We interviewed the seven
QIOs about their quality of care review processes for quality of care
concerns received from Medicare beneficiaries.
Table 1:
Key step of quality of care review process: Step 1: Receive quality of
care concern.
Selected elements of the quality of care review process that vary
among QIOs: Professional background of staff who instruct
beneficiaries who register their concerns orally to submit written
quality of care concerns.[A];
Description of QIOs' variation:
* Three QIOs use non-clinical staff to instruct beneficiaries who
register their concerns orally to submit their quality of care
concerns in writing;
* Four QIOs use clinical staff, such as nurses, to instruct
beneficiaries who register their concerns orally to submit their
quality of care concerns in writing.
Selected elements of the quality of care review process that vary
among QIOs: Routinely assisting beneficiaries who register their
concerns orally in preparing written quality of care concerns;
Description of QIOs' variation:
* Three QIOs routinely assist beneficiaries who register their
concerns orally by preparing written quality of care concerns--such as
by composing a written summary on the beneficiary's behalf and
forwarding it to the beneficiary for signature;
* Three QIOs routinely assist beneficiaries who register their
concerns orally by completing the beneficiaries' demographic
information but do not routinely assist beneficiaries by preparing
written quality of care concerns on their behalf;
* One QIO does not routinely assist beneficiaries who register their
concerns orally either by completing the beneficiaries' demographic
information or by preparing written concerns on their behalf.
Selected elements of the quality of care review process that vary
among QIOs: Following up with beneficiaries who register their quality
of care concerns orally and do not submit written quality of care
concerns[B];
Description of QIOs' variation:
* Four QIOs contact beneficiaries who register their quality of care
concerns orally only once within 30 days to follow up when written
concerns are not received;
* Three QIOs contact beneficiaries who register their quality of care
concerns orally twice within 30 days to follow up when written
concerns are not received.
Key step of quality of care review process: Step 2: Review medical
record.
Selected elements of the quality of care review process that vary
among QIOs: Time given to relevant providers or practitioners to
supply medical records[C];
Description of QIOs' variation:
* Two QIOs initially request that relevant providers or practitioners
provide medical records to the QIO in fewer than 30 days;
* Five QIOs initially give relevant providers or practitioners a full
30 days to provide medical records to the QIO.
Selected elements of the quality of care review process that vary
among QIOs: Using specialists, such as orthopedists, as physician
reviewers when specialists are involved in the quality of care
concerns under review[D];
Description of QIOs' variation:
* Six QIOs almost always use specialists as physician reviewers when
specialists are involved in the quality of care concerns under review;
* One QIO uses generalists and specialists as physician reviewers when
specialists are involved in the quality of care concerns under review.
Selected elements of the quality of care review process that vary
among QIOs: Identifying and providing relevant professionally
recognized standards of health care[E] for physician reviewers to
consider when reviewing medical records;
Description of QIOs' variation:
* Five of the seven QIOs identify and provide relevant professionally
recognized standards of health care for the physician reviewers to
consider when reviewing medical records;
* Two QIOs do not identify and provide relevant standards of health
care for the physician reviewers.
Selected elements of the quality of care review process that vary
among QIOs: Medical Directors' involvement in accepting physician
reviewer decisions;
Description of QIOs' variation:
* Three QIOs told us that they generally accept their physician
reviewers' decisions as final;
* Three QIOs told us that on occasion, their Medical Directors may
change their physician reviewers' decisions;
* One QIO told us that its Medical Director may request another
physician reviewer's opinion in lieu of accepting a reviewer's
decision as final.
Selected elements of the quality of care review process that vary
among QIOs: Providing an opportunity for beneficiaries to participate
in alternative dispute resolution[F];
Description of QIOs' variation:
* Seven QIOs offer beneficiaries the opportunity to participate in
alternative dispute resolution.
Key step of quality of care review process: Step 3: Notify provider or
practitioner of final determination.
Selected elements of the quality of care review process that vary
among QIOs: Following up with practitioners concerning consent to
disclose the details of QIOs' final determinations to beneficiaries[G];
Description of QIOs' variation:
* Five QIOs follow up with practitioners by calling, mailing, or
faxing them reminders to return their consents for disclosure;
* Two QIOs do not follow up with practitioners from whom they have not
received responses to requests for consent for disclosure.
Selected elements of the quality of care review process that vary
among QIOs: Action taken to convince practitioners to disclose the
details of the QIOs' final determinations to beneficiaries;
Description of QIOs' variation:
* One QIO takes action to convince practitioners to disclose the
details of quality of care review findings to beneficiaries;
* Six QIOs do not take any action to convince practitioners to
disclose the details of quality of care review findings to
beneficiaries.
Selected elements of the quality of care review process that vary
among QIOs: Who determines the appropriate quality improvement
activity to initiate when Medicare services did not meet
professionally recognized standards of health care[H];
Description of QIOs' variation:
* Three QIOs rely on physician reviewers' recommendations about the
appropriate quality improvement activity to initiate;
* Two QIOs convene a committee of QIO staff to determine the
appropriate quality improvement activity to initiate;
* One QIO convenes a committee of physician reviewers to determine the
appropriate quality improvement activity to initiate;
* One QIO relies on its Medical Director to determine the appropriate
quality improvement activity to initiate.
Key step of quality of care review process: Step 4: Notify beneficiary
of final determination.
Selected elements of the quality of care review process that vary
among QIOs: Information provided to beneficiaries about QIOs' review
findings[I];
Description of QIOs' variation:
* Three of the seven QIOs generally adhere to CMS's model language for
the introduction, body, and closing paragraphs of their beneficiary
notification letters;
* Four of the seven QIOs include additional language in the
introduction, body or closing paragraphs of their beneficiary
notification letters, such as language to assure beneficiaries that
the submission of their quality of care concerns will help improve the
quality of health care for other Medicare beneficiaries--even in cases
where the QIO's medical record review found that delivered Medicare
services met professionally recognized standards of health care.
Source: GAO analysis of interviews with seven QIOs.
[A] Each QIO staffs a beneficiary helpline, a toll-free telephone
number that beneficiaries may call to voice their quality of care
concerns or to request other Medicare-related information or
assistance from the QIO. QIOs may staff their helplines with
clinicians, such as nurses, or with non-clinical staff.
[B] CMS, in the August 29, 2003, version of Chapter 5 of the QIO
policy manual, does not specify the time frame QIOs should follow up
with beneficiaries who express their quality of care concerns orally
but who subsequently do not submit a written record of their quality
of care concerns.
[C] For the purposes of quality of care reviews, a "provider" is
defined as a hospital or other health care facility, agency, or
organization and a "practitioner" is defined as a physician or other
health care professional licensed under state law to practice his or
her profession. See 42 C.F.R § 1004.1 (2009). CMS requires the QIO to
request the medical records held by the providers or practitioners who
delivered the Medicare services about which there is a concern within
5 calendar days of receipt of the concern and to allow 30 calendar
days to receive them for a retrospective quality of care review. See
42 C.F.R § 476.78(b)(2) (2009).
[D] Physician reviewers are practitioners who match, as closely as
possible, the variables of licensure, specialty, and practice setting
of a practitioner under review and maintain at least 20 hours a week
of active practice. Physician reviewers are generally specialists in
the same field as the physician under review. See CMS Publication 100-
10, Quality Improvement Organization Manual, Chapter 4: Case Review, §
4620 (Baltimore, Md. revised July 11, 2003).
[E] Professionally recognized standards of health care are defined as
statewide or national standards of care, whether in writing or not,
that professional peers, such as physicians, recognize as applying to
their fellow peers practicing or providing care within a state. See 42
C.F.R. § 1001.2 (2009).
[F] QIOs may offer beneficiaries an opportunity to pursue an
alternative dispute resolution when they determine that Medicare
services met professionally recognized standards of health care. An
example of an alternative dispute resolution is a facilitated
conversation where QIO staff talk separately with the beneficiary and
the provider and/or practitioner with the intent of obtaining
resolution of a beneficiary's quality of care concerns.
[GF] or quality of care concerns initiated by beneficiaries and
involving practitioners, the QIO must seek the practitioners' consent
to disclose details about the QIO's findings to beneficiaries. See 42
C.F.R. § 480.133(a)(2)(iii) (2009). QIOs are not required to obtain
such consent from providers that were found to deliver Medicare
services that did or did not meet professionally recognized standards
of health care because provider-specific information is not included
in the definition of confidential information. See 42 C.F.R. §
480.101(b) (2009). The QIOs' findings about Medicare services
delivered by providers are disclosed to beneficiaries.
[H] In its contract with QIOs, CMS defines a quality improvement
activity as an activity initiated by a QIO that requires the provider
or practitioner to articulate a plan or activity to improve an
identified quality of care concern. Examples of quality improvement
activities initiated by QIOs include requiring the provider or
practitioner to conduct staff training and requiring the provider or
practitioner to review a process and reduce unnecessary steps.
[I] CMS provides model language that QIOs may use in their final
beneficiary notification letters--the letters with QIOs' final
determinations regarding whether the Medicare services about which
there is a concern met professionally recognized standards of health
care. See CMS Publication #100-10, Quality Improvement Organization
Manual, Chapter 5: Quality of Care Review, § 5030, (Baltimore, Md.:
revised Aug. 29, 2003).
[End of table]
[End of section]
Enclosure IV: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office of the Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
November 15, 2010:
Kathleen King:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. King:
Attached are comments on the U.S. Government Accountability Office's
(GAO) correspondence entitled: "Medicare: CMS Needs to Collect
Consistent Information from Quality Improvement Organizations to
Strengthen Its Establishment of Budgets for Quality of Care Reviews"
(GAO 11-116R).
The Department appreciates the opportunity to review this
correspondence before its publication.
Sincerely,
Signed by:
Jim R. Esquea:
Assistant Secretary for Legislation:
Attachment:
[End of letter]
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Correspondence
Entitled, "Medicare: CMS Needs To Collect Consistent Information From
Quality Improvement Organizations To Strengthen Its Establishment Of
Budgets For Quality Of Care Reviews" (GAO-11-116R):
The Department appreciates the opportunity to review and comment on
this draft report. This report describes and assesses the information
that the Centers for Medicare and Medicaid Services (CMS) uses to
establish the portion of QIOs' budgets for quality of care reviews.
GAO Recommendation:
To ensure that QIOs consistently record volume and cost information
for their quality of care reviews and to help ensure that the budgets
CMS establishes for these reviews are appropriate, the Administrator
of CMS should develop clear instructions specifying how QIOs should
record information about the volume and costs of their quality of care
reviews in Case Review Information Systems (CRIS) and Financial
Information and Vouchering Systems (FIVS).
CMS Response:
We concur with the recommendation made in the report, that CMS should
develop clear instructions specifying how QIOs should record
information about the volume and costs of their quality of care
reviews in CRIS and FIVS.
The CMS acknowledges that there are differences in review processes
and practices across the QIOs. In April 2009, CMS began redesigning
the Beneficiary Protection Program case review processes and the
design and development of a new CRIS. The redesigned processes and
system will ensure standardization in the collection, analysis, and
reporting of information related to quality of care and other review
types, under the QIOs authority, to support budget decisions. In
preparation for the 10th Statement of Work (SOW), CMS has conducted a
review of case review operations identifying opportunities to improve
the consistency of case review volume and cost. Prior to the start of
the QIO 10th SOW, CMS will provide explicit and clear guidance to QIOs
on the recording and reporting of case review volume and cost
information.
We believe our actions to date demonstrate our success in addressing
the need to improve the collection of information from QIOs to better
establish the budgets for all case review functions. We look forward
to working with the GAO to further address this issue for the well-
being of all Medicare beneficiaries, and thank GAO for doing this work.
[End of section]
Enclosure V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Kathleen M. King, (202) 512-7114 or kingk@gao.gov:
Acknowledgments:
In addition to the contact named above, Mary Ann Curran, Assistant
Director; Julianne Flowers; Krister Friday; Regina Lohr; Alexis
MacDonald; Lisa Motley; and Lisa Rogers were major contributors to
this report.
[End of section]
Footnotes:
[1] Medicare is the federal health insurance program for people over
age 65, individuals under age 65 with certain disabilities, and
individuals diagnosed with end-stage renal disease.
[2] QIOs are required to conduct an appropriate review of all written
quality of care concerns from Medicare beneficiaries, or their
representatives, alleging that the quality of services they received
did not meet professionally recognized standards of health care. 42
U.S.C. § 1320c-3(a)(14); see also 42 C.F.R. § 476.71(a)(2) (2009).
QIOs are also required by their contracts to review such concerns from
CMS or CMS-designated entities, such as Medicare Administrative
Contractors, the CMS contractors whose responsibilities include
processing and paying Medicare claims. Professionally recognized
standards of health care are defined as statewide or national
standards of care, whether in writing or not, that professional peers,
such as physicians, recognize as applying to their fellow peers
practicing or providing care within a state. See 42 C.F.R. § 1001.2
(2009).
[3] For the purposes of quality of care reviews, a "provider" is
defined as a hospital or other health care facility, agency, or
organization and a "practitioner" is defined as a physician or other
health care professional licensed under state law to practice his or
her profession. See 42 C.F.R. § 1004.1 (2009).
[4] CMS's current contract, the 9TH Statement of Work, began on August
1, 2008, and will end on July 31, 2011. QIOs are responsible for
performing many other activities and reviews in addition to quality of
care reviews. For example, under their current contracts, QIOs are
also responsible for collecting and analyzing data about the rates of
health care associated infections in health care facilities and
reviewing beneficiary appeals of denial of Medicare coverage for
certain services.
[5] The budgets are not maximum amounts that QIOs can receive from
CMS. The amounts QIOs receive may be higher or lower than the budgeted
amounts. Amounts for which QIOs are reimbursed are determined by a
monthly review by CMS of vouchers of costs incurred by each QIO. CMS
officials reported that if a QIO thinks it will overspend its budgeted
amount, the QIO notifies CMS in writing to explain why it expects that
its costs will exceed budgeted amounts in order for CMS to determine
if it will provide the QIO additional funds.
[6] Institute of Medicine, Medicare's Quality Improvement Organization
Program: Maximizing Potential, (Washington, D.C.: 2006).
[7] The Hospital Insurance Trust Fund primarily finances hospital,
home health, skilled nursing facility, and hospice care for Medicare
beneficiaries, while the Supplementary Medical Insurance Trust Fund
primarily helps finance physician, outpatient hospital, home health,
and other services for Medicare beneficiaries.
[8] See 42 U.S.C. § 1320c-8.
[9] CMS Publication #100-10, Quality Improvement Organization Manual
(revised 2003, 2006).
[10] The Emergency Medical Treatment and Active Labor Act requires
Medicare participating hospitals with emergency departments to provide
emergency screening examinations and stabilization treatments to
individuals, including women in labor, regardless of individuals'
ability to pay for the services. 42 U.S.C. § 1395dd.
[11] These sources can include CMS or CMS-designated entities, such as
Medicare Administrative Contractors--CMS contractors whose
responsibilities include processing and paying claims--or the QIOs
themselves when they identify quality of care concerns during the
course of other types of reviews.
[12] A beneficiary's designated representative may also submit a
concern on his or her behalf. In this report, we use the term
"beneficiary" to refer to both beneficiaries and their representatives.
[13] If QIOs determine beneficiaries' concerns are unrelated to the
quality of Medicare services or other QIO responsibilities or
activities, they may refer beneficiaries' concerns to another entity
for resolution. For example, QIOs may refer beneficiaries' questions
about billing to the appropriate CMS contractor for resolution.
[14] A beneficiary helpline is a QIO-staffed, toll-free telephone
number that beneficiaries may call to voice quality of care concerns
or to request other Medicare-related information or assistance from
the QIO.
[15] Beneficiaries also may call 1-800-MEDICARE, a nationwide, toll-
free number that is operated by a CMS contractor. Beneficiaries can
call this number to inquire about any Medicare services or benefits.
If a 1-800-MEDICARE representative determines that a beneficiary's
call is related to the quality of Medicare services, he or she will
refer the beneficiary to the QIO in the beneficiary's state.
[16] Section 1154(a)(14) of the Social Security Act requires that QIOs
conduct an appropriate review of all written quality of care concerns
from Medicare beneficiaries alleging that the quality of services they
received did not meet professionally recognized standards of health
care. See 42 U.S.C. § 1320c-3(a)(14). Based on this requirement, CMS
does not permit QIOs to proceed with further steps of a quality of
care review unless beneficiaries submit a written description of their
concerns or if QIOs determine that the received oral concerns are of a
serious or urgent nature. See CMS Publication #100-10, Quality
Improvement Organization Manual, Chapter 5: Quality of Care Review, §
5010A (Baltimore, Md: revised Aug. 29, 2003). CMS instructs QIOs to
assist beneficiaries who voice their concerns orally in preparing
written descriptions of their quality of care concerns, in order to
proceed with quality of care reviews.
[17] As of December 3, 2010, CMS did not permit QIOs to initiate
quality of care reviews for concerns from beneficiaries transmitted by
e-mail or facsimile. CMS officials told us that the agency plans to
allow QIOs to accept quality of care concerns submitted by
beneficiaries via e-mail and facsimile, although as of December 3,
2010, CMS had not established a date for when it would begin accepting
these kinds of submissions.
[18] See 42 U.S.C. § 1320c-3(a)(14).
[19] The volume of QIOs' quality of care reviews refers to the number
of these reviews conducted by QIOs.
[20] In addition, QIOs also may record information about oral
beneficiary concerns they receive using the helpline category in CRIS.
In general, this category is used to record information such as
beneficiaries' names, addresses, and telephone numbers when they call
a QIO's helpline. QIOs also may use this category to record summary
information about the concern, document whether the QIO mailed any
written materials to the beneficiary, and track referrals to other
entities, such as other Medicare contractors, if the QIO determines
that the concern is not related to the quality of Medicare services or
other QIO responsibilities or activities.
[21] These 18 cost codes include a utilization review cost code to
record QIOs' costs when QIOs perform reviews to determine the
necessity and reasonableness of Medicare services provided to a
beneficiary, and a helpline cost code to record QIOs' costs for
helping beneficiaries who call a QIO's helpline.
[22] In order to develop the nationwide median number of labor hours
for a review, CMS officials told us they determined the average number
of labor hours per quality of care review for each QIO, using the
volume of reviews QIOs recorded in the CRIS case review category and
the total number of labor hours each QIO recorded for these reviews in
FIVS. CMS then sorted the average numbers for the 53 QIOs from
smallest to largest and determined the nationwide median number of
labor hours per quality of care review. The nationwide median number
of labor hours per quality of care review CMS used to estimate QIOs'
budgets for the current contract was 41.2 hours.
[23] CMS officials told us that the agency instructed QIOs to use the
lesser of the nationwide median or the QIOs' own average number of
labor hours per review in their budget proposals for quality of care
reviews as a means of limiting increases in spending on these reviews
between the previous contract and the current contract.
[24] To calculate their estimated labor costs for quality of care
reviews, QIOs multiplied either CMS's nationwide median number of
labor hours per quality of care review or their own average number of
labor hours per quality of care review--whichever was lower--by their
average hourly wage rates. QIOs' expected volume of quality of care
reviews was based on their historical volume of these reviews.
[25] CMS officials told us that their budget estimates for each QIO's
quality of care reviews were based on CMS's estimates for the volume
of quality of care reviews each QIO was expected to conduct. The
estimates were based on the QIO's historical volume of these reviews--
that is, the volume of these reviews the QIO recorded in the CRIS
beneficiary complaint category during the previous 3-year contract
period. CMS's budget estimates also included the nationwide median
number of labor hours per quality of care review and the QIO's
inflation-adjusted average hourly wage rates.
[26] CMS Standard Data Processing System Memo #08-191-F1, Financial
Information and Vouchering System (FIVS) 9th Statement of Work 719A
Cost Elements (issued July 10, 2008).
[27] In these cases, the three QIOs label these records as abandoned
in the CRIS beneficiary complaint category and do not perform a
medical record review. QIOs may proceed with a medical record review
if they determine that received oral concerns are of a serious or
urgent nature.
[28] CMS's current contract, the 9TH Statement of Work, began on
August 1, 2008, and will end on July 31, 2011.
[29] Centers for Medicare & Medicaid Services Publication #100-10,
Quality Improvement Organization Manual (revised 2003, 2006).
[30] For the purposes of this report, we define QIOs that have been
awarded contracts from CMS for more than one state as having
multistate corporate affiliations.
[31] For the purposes of QIO sample selection, we treated the District
of Columbia as a state.
[32] Individuals who are eligible for Medicare include those who are
age 65 or older, people under age 65 with certain disabilities, and
people of all ages with End-Stage Renal Disease (permanent kidney
failure requiring dialysis or a kidney transplant). Not all
individuals who are eligible for Medicare are enrolled in this
program. We ranked states based on the number of Medicare-eligible
individuals residing in each state, not the number of individuals who
are actually enrolled in the program.
[33] As of December 3, 2010, the Centers for Medicare & Medicaid
Services' (CMS) QIO policy manual listed nine steps for the quality of
care review process, which we simplified to four steps for this report.
[34] QIOs review quality of care concerns from Medicare beneficiaries,
their representatives, and from CMS or CMS-designated entities, such
as Medicare Administrative Contractors--the CMS contractors whose
responsibilities include processing and paying Medicare claims. This
enclosure focuses on QIOs' processes for conducting quality of care
reviews that were initiated by beneficiaries and their
representatives, and we use the term "beneficiaries" to refer to both
beneficiaries and their representatives.
[35] Professionally recognized standards of health care are defined as
statewide or national standards of care, whether in writing or not,
that professional peers, such as physicians, recognize as applying to
their fellow peers practicing or providing care within a state. See 42
C.F.R. § 1001.2 (2009).
[36] If QIOs determine beneficiaries' concerns are unrelated to the
quality of Medicare services or their other responsibilities or
activities, they may refer beneficiaries to another entity for
resolution. For example, QIOs may refer beneficiaries' questions about
billing to the appropriate CMS contractor for resolution.
[37] As of December 3, 2010, CMS did not permit QIOs to initiate
quality of care reviews for concerns from beneficiaries transmitted by
e-mail or facsimile. CMS officials told us that the agency plans to
allow QIOs to accept quality of care concerns submitted by
beneficiaries via e-mail and facsimile, although as of December 3,
2010, CMS had not established a date for when it would begin accepting
these kinds of submissions.
[38] A beneficiary helpline is a QIO-staffed, toll-free telephone
number that beneficiaries may call to voice quality of care concerns
or to request other Medicare-related information or assistance from
the QIO.
[39] Beneficiaries also may call 1-800-MEDICARE, a nationwide, toll-
free number that is operated by a CMS contractor. Beneficiaries can
call this number to inquire about any Medicare services or benefits.
If a 1-800-MEDICARE representative determines that a beneficiary's
call is related to the quality of Medicare services, he or she will
refer the beneficiary to the QIO in the beneficiary's state.
[40] Section 1154(a)(14) of the Social Security Act requires that QIOs
conduct an appropriate review of all written quality of care concerns
from Medicare beneficiaries alleging that the quality of services they
received did not meet professionally recognized standards of health
care. See 42 U.S.C. § 1320c-3(a)(14). Based on this requirement, CMS
does not permit QIOs to proceed with further steps of a quality of
care review unless beneficiaries submit a written description of their
concerns or QIOs determine that the received oral concerns are of a
serious or urgent nature. See CMS Publication #100-10, Quality
Improvement Organization Manual, Chapter 5: Quality of Care Review, §
5010A (Baltimore, Md.: revised Aug. 29, 2003).
[41] CMS, in the August 29, 2003, version of chapter 5 of the QIO
policy manual, does not specify the time frame in which QIOs should
follow up with beneficiaries who expressed their quality of care
concerns orally but who subsequently do not submit written records of
their quality of care concerns.
[42] QIOs may not request, receive, or review beneficiaries' medical
records when they determine that the beneficiaries' concerns are
unrelated to the quality of Medicare services.
[43] For the purposes of quality of care reviews, a "provider" is
defined as a hospital or other health care facility, agency, or
organization and a "practitioner" is defined as a physician or other
health care professional licensed under state law to practice his or
her profession. See 42 C.F.R. § 1004.1 (2009).
[44] These time frames apply to retrospective quality of care reviews.
[45] Physician reviewers are practitioners who generally match the
variables of licensure, specialty, and practice setting of a
practitioner under review and maintain at least 20 hours a week of
active practice. Physician reviewers are generally specialists in the
same field as a physician under review. See CMS Publication 100-10,
Quality Improvement Organization Manual, Chapter 4: Case Review, §
4620 (Baltimore, Md.: revised July 11, 2003).
[46] Some QIOs also have medical directors on staff, whose
responsibilities may include evaluating physician reviewers' decisions
about whether Medicare services met professionally recognized
standards of health care.
[47] If QIOs' physician reviewers initially determine that the
Medicare services provided did not meet professionally recognized
standards of health care, the QIOs are required to afford the involved
providers or practitioners an opportunity to provide additional
information for the QIO to review. See 42 U.S.C. § 1320c-3(a)(14). If,
after reviewing the medical record again with the additional
information, the QIOs' physician reviewers still determine that the
Medicare services did not meet professionally recognized standards of
health care, the involved providers or practitioners may request that
QIOs conduct one additional medical record review.
[48] An example of an alternative dispute resolution is a facilitated
conversation where QIO staff talk separately with the beneficiary and
the provider and/or practitioner with the intent of obtaining
resolution to a beneficiary's quality of care concerns.
[49] In its contract with QIOs, CMS defines a quality improvement
activity as an activity initiated by a QIO that requires the provider
or practitioner to articulate a plan or activity to improve an
identified quality of care concern and for the QIO to follow up to
ensure a plan is complete or an activity is undertaken. Examples of
quality improvement activities initiated by QIOs include requiring the
provider or practitioner to conduct staff training and requiring the
provider or practitioner to review a process and reduce unnecessary
steps.
[50] See 42 C.F.R. § 480.133(a)(2)(iii) (2009). QIOs are not required
to obtain such consent from involved providers that were found to
deliver Medicare services that did or did not meet professionally
recognized standards of health care since provider-specific
information is not included in the definition of confidential
information. In contrast, practitioner-specific information is
confidential. See 42 C.F.R. § 480.101(b) (2009).
[51] See 42 U.S.C. § 1320c-3(a)(14).
[52] CMS provides model language that QIOs may use in their final
beneficiary notification letters--the letters with QIOs' final
determinations regarding whether the Medicare services about which
there is a concern met professionally recognized standards of health
care. See CMS Publication #100-10, Quality Improvement Organization
Manual, Chapter 5: Quality of Care Review, § 5030, (Baltimore, Md.:
revised Aug. 29, 2003).
[53] The Department of Health and Human Services Office of Inspector
General reported in October 2010 that QIOs obtained consent for
disclosure from practitioners in 52 percent of the 2,768 requests for
practitioner consent for disclosure made between August 1, 2008, and
December 31, 2009. See Department of Health and Human Services Office
of Inspector General, Memorandum Report: Quality Improvement
Organizations' Final Responses to Beneficiary Complaints, OEI-01-09-
00620, (Washington, D.C.: October 2010).
[54] As of December 3, 2010, CMS's QIO policy manual listed nine steps
for the quality of care review process, which we simplified to four
steps for this report.
[End of section]
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