Long-Term Care Hospitals
CMS Oversight Is Limited and Should Be Strengthened Gao ID: GAO-11-810 September 15, 2011Allegations about quality-of-care problems have raised questions about the oversight of long-term care hospitals (LTCH), which provide care to individuals with multiple acute or chronic conditions. Medicare pays for about 80 percent of LTCH patient care. To ensure compliance with federal quality standards, accrediting organizations (AO) and state survey agencies under contract with the Centers for Medicare & Medicaid Services (CMS) conduct routine and complaint surveys. One AO, The Joint Commission (TJC), surveys most LTCHs. In a November 2010 report, GAO compared oversight of LTCHs to that of other facilities. In this report, GAO examined the extent to which CMS collects data about LTCHs' quality of care and oversees LTCH survey activities. To do this work, GAO analyzed CMS data on the results of LTCH surveys and discussed oversight activities with both CMS and AO officials. GAO assessed the reliability of the survey data and took steps to ensure that the data presented were reliable.
CMS collects some data on the quality of care at LTCHs, but the data are limited for several reasons. First, CMS does not have detailed data on the results of surveys conducted by TJC prior to 2009 and has limited data on current surveys because TJC did not begin submitting detailed data to CMS until July 2009. CMS does have prior year and current survey data for state-surveyed LTCHs--about 16 percent of LTCHs. In addition, current survey results in CMS's databases may be incomplete because these databases do not always accurately identify (1) the organization responsible for surveying each LTCH and (2) whether a facility is, in fact, an LTCH. As of fiscal year 2010, CMS data showed a total of 447 LTCHs, but GAO identified 18 LTCHs incorrectly categorized in one CMS database as having been surveyed by state survey agencies. GAO also found 56 LTCHs either misidentified as acute care hospitals or missing from another CMS database that contains information on LTCHs surveyed by accrediting organizations. Second, CMS does not currently collect data on quality measures--information used to evaluate how health care is delivered--from LTCHs because, unlike other types of hospitals, LTCHs are not yet required to report them. The Patient Protection and Affordable Care Act enacted in 2010 requires LTCHs to report quality measures by 2014. CMS's oversight of state survey agency and AO survey activities of LTCHs is limited. Two of CMS's three oversight approaches do not focus on LTCHs specifically, but on hospitals in general. First, CMS established performance measures--expectations regarding survey activities or the reporting of survey results--for survey organizations, but reports the results of its assessments for hospitals in general rather than for LTCHs specifically. Second, state survey agencies conduct surveys annually in AO-accredited hospitals--known as validation surveys--to assess the effectiveness of the AO surveys, but have not systematically included some LTCHs in the sample of hospitals subject to validation surveys. Additional validation surveys are done based on complaints. State survey agencies conducted more than 1,000 validation surveys over a 5-year period based on complaints in LTCHs that had been surveyed by TJC. CMS does not refer such complaints to TJC for investigation. As a result, TJC conducted few complaint surveys. Although CMS has instructed its regional offices to provide TJC with the results of these surveys, GAO found that these data were not always shared. CMS's third oversight approach--collection and analysis of data on the results of survey organizations' activities--has not utilized all the available data to identify problems that may require further investigation. GAO identified several potential areas where the data may assist CMS in more effectively overseeing survey activities at LTCHs, such as how effectively states triage and conduct complaint validation surveys. GAO recommends that CMS strengthen its oversight of LTCHs by improving available data on quality of care and by improving oversight of LTCH survey activities. HHS concurred with all of the recommendations. TJC agreed with most of them, but disagreed with the value of state oversight surveys of AO-surveyed LTCHs. We continue to believe that such surveys are an important part of CMS oversight of LTCH survey activities.
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: Linda T. Kohn Team: Government Accountability Office: Health Care Phone: (202)512-3000GAO-11-810, Long-Term Care Hospitals: CMS Oversight Is Limited and Should Be Strengthened
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United States Government Accountability Office:
GAO:
Report to Congressional Requesters:
September 2011:
Long-Term Care Hospitals:
CMS Oversight Is Limited and Should Be Strengthened:
GAO-11-810:
GAO Highlights:
Highlights of GAO-11-810, a report to congressional requesters.
Why GAO Did This Study:
Allegations about quality-of-care problems have raised questions about
the oversight of long-term care hospitals (LTCH), which provide care
to individuals with multiple acute or chronic conditions. Medicare
pays for about 80 percent of LTCH patient care. To ensure compliance
with federal quality standards, accrediting organizations (AO) and
state survey agencies under contract with the Centers for Medicare &
Medicaid Services (CMS) conduct routine and complaint surveys. One AO,
The Joint Commission (TJC), surveys most LTCHs. In a November 2010
report, GAO compared oversight of LTCHs to that of other facilities.
In this report, GAO examined the extent to which CMS collects data
about LTCHs‘ quality of care and oversees LTCH survey activities. To
do this work, GAO analyzed CMS data on the results of LTCH surveys and
discussed oversight activities with both CMS and AO officials. GAO
assessed the reliability of the survey data and took steps to ensure
that the data presented were reliable.
What GAO Found:
CMS collects some data on the quality of care at LTCHs, but the data
are limited for several reasons. First, CMS does not have detailed
data on the results of surveys conducted by TJC prior to 2009 and has
limited data on current surveys because TJC did not begin submitting
detailed data to CMS until July 2009. CMS does have prior year and
current survey data for state-surveyed LTCHs-”about 16 percent of
LTCHs. In addition, current survey results in CMS‘s databases may be
incomplete because these databases do not always accurately identify
(1) the organization responsible for surveying each LTCH and (2)
whether a facility is, in fact, an LTCH. As of fiscal year 2010, CMS
data showed a total of 447 LTCHs, but GAO identified 18 LTCHs
incorrectly categorized in one CMS database as having been surveyed by
state survey agencies. GAO also found 56 LTCHs either misidentified as
acute care hospitals or missing from another CMS database that
contains information on LTCHs surveyed by accrediting organizations.
Second, CMS does not currently collect data on quality measures-”
information used to evaluate how health care is delivered”-from LTCHs
because, unlike other types of hospitals, LTCHs are not yet required
to report them. The Patient Protection and Affordable Care Act enacted
in 2010 requires LTCHs to report quality measures by 2014.
CMS‘s oversight of state survey agency and AO survey activities of
LTCHs is limited. Two of CMS‘s three oversight approaches do not focus
on LTCHs specifically, but on hospitals in general. First, CMS
established performance measures-”expectations regarding survey
activities or the reporting of survey results”-for survey
organizations, but reports the results of its assessments for
hospitals in general rather than for LTCHs specifically. Second, state
survey agencies conduct surveys annually in AO-accredited hospitals”-
known as validation surveys”-to assess the effectiveness of the AO
surveys, but have not systematically included some LTCHs in the sample
of hospitals subject to validation surveys. Additional validation
surveys are done based on complaints. State survey agencies conducted
more than 1,000 validation surveys over a 5-year period based on
complaints in LTCHs that had been surveyed by TJC. CMS does not refer
such complaints to TJC for investigation. As a result, TJC conducted
few complaint surveys. Although CMS has instructed its regional
offices to provide TJC with the results of these surveys, GAO found
that these data were not always shared. CMS‘s third oversight approach”
collection and analysis of data on the results of survey organizations‘
activities”has not utilized all the available data to identify
problems that may require further investigation. GAO identified
several potential areas where the data may assist CMS in more
effectively overseeing survey activities at LTCHs, such as how
effectively states triage and conduct complaint validation surveys.
What GAO Recommends:
GAO recommends that CMS strengthen its oversight of LTCHs by improving
available data on quality of care and by improving oversight of LTCH
survey activities. HHS concurred with all of the recommendations. TJC
agreed with most of them, but disagreed with the value of state
oversight surveys of AO-surveyed LTCHs. We continue to believe that
such surveys are an important part of CMS oversight of LTCH survey
activities.
View [hyperlink, http://www.gao.gov/products/GAO-11-810]. For more
information, contact Linda Kohn at (202) 512-7114 or kohnl@gao.gov.
[End of section]
Contents:
Letter:
Background:
CMS Has Data on the Quality of Care at LTCHs, but Currently the Data
Are Limited:
CMS Oversight of Survey Activities at LTCHs Is Limited:
Conclusions:
Recommendations for Executive Action:
Agency and Other External Comments and Our Evaluation:
Appendix I: Condition-Level Deficiencies Cited at Long-Term and Acute
Care Hospitals During Routine and Complaint Surveys:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: Comments from The Joint Commission:
Appendix IV: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: COP-Level Deficiencies Cited During Routine and Complaint
Surveys Conducted by State Survey Agencies at LTCHs, Fiscal Years 2005
through 2009:
Table 2: COP-Level Deficiencies Cited during Routine and Complaint
Surveys Conducted by State Survey Agencies and TJC at LTCHs and ACHs,
Fiscal Year 2010:
Table 3: COP-Level Deficiencies Most Commonly Cited by State Survey
Agencies during Routine and Complaint Surveys at LTCHs, Fiscal Year
2010:
Table 4: COP-Level Deficiencies Most Commonly Cited during Routine and
Complaint Surveys by State Survey Agencies at ACHs, Fiscal Year 2010:
Abbreviations:
ACH: acute care hospital:
AO: accreditation organization:
ASSURE: Accrediting Organization System for Storing User Recorded
Experiences:
CMS: Centers for Medicare & Medicaid Services:
COP: conditions of participation:
HHS: Department of Health and Human Services:
LTCH: long-term care hospital:
MedPAC: Medicare Payment Advisory Commission:
NQF: National Quality Forum:
OSCAR: On-line Survey, Certification, and Reporting system:
PPACA: Patient Protection and Affordable Care Act:
RFI: requirements for improvement:
TJC: The Joint Commission:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
September 15, 2011:
The Honorable Max Baucus:
Chairman:
Committee on Finance:
United States Senate:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on the Judiciary:
United States Senate:
Allegations about quality-of-care problems have raised questions about
the oversight of long-term care hospitals (LTCH).[Footnote 1] The more
than 400 LTCHs are a small subset of the approximately 4,800 acute
care, psychiatric, and rehabilitation hospitals that also provide post-
acute care services to clinically complex individuals who have
multiple acute or chronic conditions. Medicare is the predominant
payer for LTCHs.[Footnote 2] According to a recent report prepared for
the Centers for Medicare & Medicaid Services (CMS), about 80 percent
of patients admitted to LTCHs are covered by Medicare.[Footnote 3] CMS
is an agency within the Department of Health and Human Services (HHS).
As part of evaluating the quality of care provided to patients, CMS
requires all hospitals, including LTCHs, to demonstrate compliance
with federal Medicare quality standards. Compliance is assessed
through (1) routine surveys, which are unannounced, on-site
inspections conducted every 3 to 5 years, and (2) complaint surveys,
which may be conducted when a complaint is received. LTCHs are
surveyed using the same quality standards that are applied to acute
care hospitals (ACH)--there are currently no additional quality
standards that are specific to LTCHs.[Footnote 4] Although LTCHs are a
type of ACH, they do not necessarily provide the full range of
surgical, diagnostic, and emergency services and may not have the same
level of staffing provided in a typical ACH.[Footnote 5] During a
routine or complaint survey, surveyors may identify areas where a
quality standard is not being met and may cite a deficiency, which
demonstrates that the LTCH has failed to meet federal Medicare quality
standards. In general, LTCHs may choose who conducts their routine
surveys--a state survey agency under contract with CMS or a CMS-
approved accreditation organization (AO). Most LTCHs--about 80
percent--are surveyed by one AO, The Joint Commission (TJC).[Footnote
6] In turn, CMS is responsible for overseeing the survey activities of
both state survey agencies and AOs, which depends on the availability
of accurate and timely information. In our November 2010 report for
you, we noted that CMS's oversight focuses on hospitals in general and
not LTCHs specifically.[Footnote 7] In this report, we examine other
issues you raised. Specifically, we examine the extent to which CMS
(1) collects data about the quality of care at LTCHs and (2) oversees
survey activities at LTCHs.
To examine the extent to which CMS collects data about the quality of
care provided at LTCHs, we analyzed data on the results of routine and
complaint surveys from CMS databases, including the number of and most
commonly cited deficiencies. For state survey agencies, we analyzed
deficiency data for surveys conducted from fiscal year 2005 through
fiscal year 2010 to ensure that we had as many routine surveys for
state-surveyed LTCHs as possible. For TJC-surveyed LTCHs, we analyzed
deficiency data for surveys conducted in fiscal year 2010 because TJC
did not begin submitting detailed data to CMS on the deficiencies
identified during its surveys until July 2009. We compared the survey
results for LTCHs to those for ACHs because LTCHs are a type of ACH.
We also examined CMS efforts to develop quality measures. Quality
measures are used to evaluate how health care is delivered, and
information obtained from such measures can promote accountability
among health care providers and help consumers make informed choices
about their care.
To examine the extent to which CMS oversees survey activities at
LTCHs, we examined (1) federal statutes, as well as CMS regulations
and guidance, on state survey agency and AO survey activities; (2)
performance measures that are used to assess the activities of state
survey agencies and AOs; and (3) CMS's use of survey data to assess
the adequacy of survey processes, including the results of surveys
conducted by state survey agencies in TJC-surveyed LTCHs from fiscal
year 2005 through fiscal year 2010. To better understand the type and
quality of information that CMS and TJC share with each other, we
examined two judgmentally selected state survey agency complaint
surveys conducted at TJC-surveyed LTCHs. Criteria we used to select
these surveys included media coverage, the involvement of different
CMS regional offices, and complaint surveys that occurred both before
and after CMS issued guidance in 2008 intended to improve information
sharing between CMS and AOs. We interviewed officials at CMS
headquarters and two regional offices to obtain information on the
feedback provided to TJC on the results of these complaint surveys.
Additionally, we analyzed CMS data on the results of all types of
surveys, including the number of surveys, the number that cited
serious deficiencies, and the resources used to conduct the surveys.
For both objectives, we reviewed documents and interviewed officials
from CMS, including officials from CMS's Office of Survey and
Certification, Division of National Systems, Office of Clinical
Standards and Quality, and seven regional offices; TJC; National
Quality Forum (NQF);[Footnote 8] Medicare Payment Advisory Commission
(MedPAC); and the two LTCH associations--Acute Long Term Hospital
Association and National Association of Long Term Hospitals. We
excluded two of the three AOs that survey LTCHs from our analyses--the
American Osteopathic Association and Det Norske Veritas Healthcare,
Inc.--because, combined, they surveyed approximately 3 percent of
LTCHs in fiscal year 2010. To ensure the reliability of the data we
collected, we interviewed officials from CMS and TJC to verify
completeness and accuracy of our data and reviewed documentation
related to the data collected to identify obvious errors. We
identified data limitations involving accurate identification of the
survey organization responsible for surveying each LTCH, which we
discussed with CMS and the AOs. Based on these discussions and further
analyses, we made appropriate adjustments to ensure the reliability of
the data we report on LTCH quality of care. Based on these activities,
we determined that the data were sufficiently reliable for our
purposes.
We conducted this performance audit from November 2010 through
September 2011 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.
Background:
An LTCH is a type of ACH that specializes in treating critically ill
individuals who require an intense level of health care with frequent
physician and nurse visits for relatively extended periods--more than
25 days, on average.[Footnote 9] For example, a significant subset of
LTCH patients is dependent on a ventilator for breathing and receives
therapy to help them breathe on their own.[Footnote 10] Most LTCH
patients have been transferred from intensive or critical care units
of ACHs, which provide general, short-term care for a broad range of
medical conditions.[Footnote 11] LTCHs are not evenly distributed
across the nation and patients who could be treated by LTCHs might
instead receive care at ACHs, other types of hospitals, or nursing
homes. Medicare generally pays more for hospital stays in LTCHs than
in ACHs.[Footnote 12] In fiscal year 2010, Medicare paid an estimated
$4.7 billion for care provided in more than 400 LTCHs for about
138,000 discharges, which averages more than $34,000 per discharge.
Surveys, Survey Organizations, and Standards:
To assess whether LTCHs meet federal quality standards, state survey
agencies and AOs conduct two types of surveys--routine and complaint.
Routine surveys are unannounced and are conducted at specific
intervals. State survey frequencies are resource driven and depend on
CMS's annual funding level for such activities.[Footnote 13] CMS's
policy has been for state survey agencies to conduct surveys every 3
to 5 years since fiscal year 2001. In contrast, AO policy is to
conduct surveys every 3 years.[Footnote 14] Complaint surveys are
conducted in response to allegations of quality problems made by
families, patients, health care workers, or others and provide survey
organizations the opportunity to intervene promptly if problems arise
between routine surveys. Complaint surveys may be conducted either by
a state survey agency or an AO. However, most complaints are filed
with state survey agencies, which conduct complaint surveys both at
the LTCHs they survey as well as at AO-surveyed LTCHs. Complaint
surveys focus on the specific allegations made and surveyors generally
only assess the hospital's compliance with standards related to those
allegations.
In general, hospitals have a choice of who conducts their surveys--
state survey agencies using federal Medicare standards or CMS-approved
AOs that use requirements CMS has determined to be at least equivalent
to those standards.[Footnote 15] Federal Medicare standards consist of
74 standards that are organized under 23 conditions of participation
(COP), including categories such as Medical Staff, Infection Control,
and Emergency Services. TJC, one of three AOs approved by CMS to
survey hospitals, surveys the majority of LTCHs. TJC's standards for
hospitals are organized into 17 categories, such as Medication
Management, Leadership, and Medical Staff; each category consists of
numerous standards. Prior to the Medicare Improvements for Patients
and Providers Act of 2008, TJC had unique statutory deeming authority
for hospitals and did not need to apply to CMS to be recognized as a
national accreditation body for hospitals. This legislation revoked
TJC's statutory deeming authority effective July 15, 2010, and gave
CMS the authority to review and approve TJC's hospital accreditation
program. As a result, in 2009, CMS evaluated the standards and
processes used by TJC to conduct hospital surveys, including a
comparison of TJC's standards to Medicare's and a review of the
qualifications of its surveyors.[Footnote 16] CMS approved TJC's
hospital accreditation program effective July 15, 2010, through July
15, 2014.
When surveyors find quality problems during routine and complaint
surveys, they cite either deficiencies or requirements for improvement
(RFI), depending on the survey organization.
* State survey agencies cite deficiencies that are characterized as
either standard- or COP-level based on the seriousness of the
deficiency. Standard-level deficiencies denote less serious quality
problems, while COP-level deficiencies are cited when the problems are
serious or systemic in nature. A serious problem is defined as a
shortcoming in a hospital's quality of services that adversely
affects, or has the potential to adversely affect, the quality of
patient care. When deficiencies are found, a hospital may be required
to submit a plan of correction, detailing how and when it will address
the deficiencies. If a hospital does not correct the deficiencies
cited within the required time frame, CMS may terminate the hospital's
participation in the Medicare program.
* TJC cites direct and indirect RFIs when hospitals are found to be
out of compliance with TJC's standards on routine or complaint
surveys. According to TJC, direct RFIs are cited when compliance
issues are directly tied to quality, such as untreated pain; while
indirect RFIs are cited when compliance issues are indirectly related
to quality, such as hospital leadership. A hospital that does not
correct all of its RFIs may receive conditional or preliminary denial
of accreditation. A hospital may be denied accreditation if it has
exhausted all review and appeal opportunities, failed to pay the
accreditation fee, or refused to allow a survey. CMS may subsequently
terminate hospitals from Medicare participation if they lose their
accreditation.
CMS collects information on state survey results in its On-line
Survey, Certification, and Reporting system (OSCAR).[Footnote 17] To
collect data on the results of AO surveys, CMS established its
Accrediting Organization System for Storing User Recorded Experiences
(ASSURE) database in 2008. On a quarterly basis, all AOs update ASSURE
with survey results that are crosswalked from their own standards and
RFIs to federal Medicare quality standards and deficiencies.
Hospital Quality Measures:
The Medicare Prescription Drug, Improvement, and Modernization Act of
2003 provided for the establishment of hospital quality measures and
created a penalty for hospitals that do not report related data
beginning in 2005.[Footnote 18] Those hospitals that fail to report
quality data are subject to a 2.0 percent reduction in the hospital's
annual Medicare payment rate for the subsequent year.[Footnote 19]
This payment reduction applies to hospitals paid under Medicare's
inpatient prospective payment system, which covers most types of
hospitals but not LTCHs. ACHs began voluntarily reporting data for
quality measures in 2004. For fiscal year 2011, there are 60 quality
measures organized into six areas, including heart attack, heart
failure, and pneumonia. For example, the pneumonia quality measures
assess several aspects of care, including whether the patients
received an antibiotic within 6 hours of arriving at the hospital and
if the appropriate antibiotic was provided. In April 2005, CMS
launched a Web site called "Hospital Compare" to make information on
hospital data available to consumers.[Footnote 20] CMS posts
information for each hospital's quality measures on a quarterly basis.
CMS Survey Activity Oversight:
CMS and its 10 regional offices oversee state and AO survey activities
in order to monitor the performance of survey organizations and hold
them accountable for meeting CMS's survey requirements. To do so, CMS:
(1) established performance measures, (2) has states conduct
validation surveys of AO-surveyed hospitals, and (3) collects data
from survey results for all types of hospitals.
State survey agencies and AOs have separate performance measures.
State survey agency performance measures focus on states' ability to
meet the requirements for the survey and certification program.
[Footnote 21] These measures are organized into three sections:
frequency, quality, and enforcement. For example, state performance
measures assess states' abilities to prioritize and conduct complaint
surveys within specific time frames. AO performance measures focus on
their ability to provide CMS with consistent, accurate, complete, and
timely information on the facilities they survey. In October 2008, CMS
established three categories of performance measures for AOs: (1) use
of an electronic database to track accreditation and enforcement
activity; (2) submission of facility notification letters--which
contain information on individual facilities' accreditation status--
for all accreditation actions; and (3) submission of survey schedule
information. CMS monitors each AO's performance on the measures and
provides written feedback on a quarterly basis. CMS reports to the
Congress annually on the extent to which TJC and other AOs meet its
performance measures.[Footnote 22]
Validation surveys are conducted to measure the effectiveness of the
AO survey process in identifying areas of serious non-compliance with
federal Medicare quality standards in accredited facilities, such as
LTCHs. Validation surveys have consequences for both AOs and
facilities. State survey agencies conduct two types of validation
surveys. The first type is a full survey of a sample of AO-surveyed
facilities, known as traditional validation surveys. Traditional
validation surveys are generally conducted within 60 days following a
routine survey conducted by an AO. CMS selects a sample of hospitals
for these surveys based on the hospital's most recent routine survey
date and available resources. While CMS policy calls for approximately
1 percent of AO-surveyed hospitals to receive traditional validation
surveys each fiscal year, since fiscal year 2007 CMS has supplemented
the funding provided to states in order to increase the sample size to
2 percent or higher.[Footnote 23] Because of budgetary constraints,
the number has fluctuated from a 10-year high of 235 in fiscal year
1999 to about 90 in fiscal year 2009.[Footnote 24] The second type of
validation survey is a complaint validation survey, which occurs when
a state survey agency investigates a complaint for a hospital surveyed
by an AO. Unlike traditional validation surveys that are conducted
within 60 days of a routine survey, complaint validation surveys are
generally conducted when the complaint is received. Such surveys
initially focus on the condition(s) alleged to be out of compliance.
If the complaint validation survey cites one or more COP-level
deficiencies, the facility is placed under the jurisdiction of the
state survey agency. Subsequently, the state survey agency conducts a
full survey of all COPs.[Footnote 25] When all COP-level deficiencies
have been corrected, the facility again becomes the responsibility of
the AO.
CMS submits an annual report to Congress after the end of the fiscal
year--known as the CMS Financial Report--that includes information on
traditional validation surveys conducted at hospitals surveyed by AOs.
Based on such surveys, CMS calculates a hospital disparity rate for
each AO. The disparity rate measures the extent to which an AO has
failed to cite one or more deficiencies during its routine survey that
were later identified by a state survey agency during a traditional
validation survey. If the validation survey results for an AO indicate
a disparity rate that reaches the threshold of 20 percent or greater,
CMS is to notify the AO that its approval to survey and accredit
hospitals may be in jeopardy and that the agency may initiate a review.
CMS collects data on the results of state survey agency surveys in its
OSCAR database and AO surveys in its ASSURE database. The databases
include information such as the number and type of surveys conducted
and any deficiencies cited, including the specific standard or COP out
of compliance. In addition, OSCAR contains data on the number of
surveyors and amount of time devoted to the health portion of the
survey.[Footnote 26]
CMS Has Data on the Quality of Care at LTCHs, but Currently the Data
Are Limited:
Although CMS collects some data on the quality of care at LTCHs, the
data are currently limited. First, CMS does not have data on prior
survey results for the majority of LTCHs because TJC only recently
began submitting detailed deficiency data on the results of its
surveys to CMS.[Footnote 27] In addition, current survey results in
OSCAR and ASSURE may be incomplete because these databases do not
always accurately identify (1) which survey organization is
responsible for surveying each LTCH or (2) whether a facility is, in
fact, an LTCH. Second, CMS does not currently collect data for quality
measures because LTCHs are not yet required to report them.
CMS Has No Detailed Prior Survey Data and Incomplete Current Survey
Results on the Majority of LTCHs:
Because TJC only recently began submitting detailed survey data to
CMS, ASSURE has no prior data and limited current data--surveys
conducted since July 2009--for TJC-surveyed LTCHs, which constitute a
majority (about 80 percent) of such hospitals. As of December 2010,
TJC had surveyed and submitted data on about half of the LTCHs it
surveys.[Footnote 28] CMS has prior and current survey data in OSCAR
for state-surveyed LTCHs, which represent about 16 percent of LTCHs.
[Footnote 29] Appendix I reports prior and fiscal year 2010 data on
the proportion of LTCHs with COP-level deficiencies, lists the most
commonly cited deficiencies, and compares these results to those of
ACHs. Because fiscal year 2010 data does not include at least one
survey for each LTCH, these results may not reflect the quality of
care across all LTCHs.
We found that there were 447 LTCHs listed in OSCAR or ASSURE as of
fiscal year 2010.[Footnote 30] However, both the OSCAR and ASSURE
databases inaccurately identified the responsible survey organization
and the ASSURE database was incomplete. For example,
* OSCAR categorizes 89 LTCHs as state-surveyed, but we found that only
71 of these LTCHs are actually state-surveyed. The remaining 18 LTCHs
are surveyed by AOs. CMS officials told us that OSCAR data are not
always updated when LTCHs switch from being surveyed by an AO to being
surveyed by a state survey agency and vice versa.
* We found that 56 LTCHs were either misidentified in ASSURE as ACHs
or were missing from the database. LTCHs may initially be classified
as ACHs until they demonstrate their average length of stay is at
least 25 days and then need to be reclassified. According to a TJC
official, about 30 LTCHs submitted ACH identification numbers on their
TJC accreditation applications and were thus misidentified in ASSURE.
[Footnote 31] CMS subsequently issued new LTCH identification numbers
to these facilities, but TJC officials told us that neither CMS nor
the LTCHs had notified them. In a few cases, the LTCHs' initial survey
occurred after TJC's last quarterly ASSURE update, the LTCH had
submitted the identification number of a nearby facility with the same
owner, or the LTCH had closed. Finally, in a couple cases, TJC could
not explain why the LTCH was not listed in ASSURE.
CMS officials told us that they recognize these limitations, but have
not yet established an approach for addressing these issues.
CMS Does Not Require LTCHs to Report Data on Quality Measures, but
Will Do So Beginning in 2014:
CMS currently does not have quality measures for LTCHs because LTCHs
were not required to report on the quality measures developed for most
ACHs in 2003 or later. While LTCHs are not currently reporting on
quality measures, under the Patient Protection and Affordable Care Act
(PPACA) enacted in 2010, they must begin doing so by 2014. PPACA
directed HHS to publish measures for LTCHs and required the department
to consider measures endorsed by a consensus-based entity, such as
NQF.[Footnote 32] To identify these measures, CMS reviewed LTCH
measures currently used by the National Association of Long Term
Hospitals and TJC. CMS also has received feedback from MedPAC,
convened a technical expert panel, and held stakeholder information
sessions. In May 2011, CMS published a proposed rule on three
potential quality measures that LTCHs would be required to report on
from October 1, 2012, through December 31, 2012, for their fiscal year
2014 payment determination: (1) catheter-associated urinary tract
infection rate, (2) central-line associated blood stream infection
rate, and (3) new or worsened pressure ulcers.[Footnote 33] None of
the three measures have been endorsed by NQF for use by LTCHs, but NQF
has endorsed their use in other settings. CMS is working with NQF to
have these measures endorsed for the LTCH setting.[Footnote 34] The
proposed rule includes some additional quality measures that CMS may
require LTCHs to report in the future, some of which, such as patient
fall rate, also have been endorsed by NQF for other types of health
care facilities.
CMS Oversight of Survey Activities at LTCHs Is Limited:
CMS and its regional offices' oversight of state survey agency and AO
survey activities in LTCHs is limited because two of its oversight
strategies--performance measures and selection of hospitals for
traditional validation surveys--focus on hospitals in general rather
than LTCHs specifically. CMS's third oversight strategy--collection
and analysis of survey data--is also limited because the agency does
not utilize all of the available data to identify weaknesses in the
survey process that may require further investigation. As a result of
these oversight limitations, CMS cannot ensure that state survey
agencies and AOs are held accountable and that they meet CMS's survey
requirements.
CMS's Performance Measures for Survey Activities Do Not Focus on LTCHs:
None of the performance measures that CMS uses to assess the survey
activities of state survey agencies and AOs focus specifically on
LTCHs. Thus, CMS analyzes data on survey activities at LTCHs together
with data for other types of hospitals and facilities and does not
analyze or report the results separately for LTCHs.[Footnote 35] One
of CMS's performance measures for state survey agencies examines the
timeliness of state surveys. CMS's policy is for all hospitals to be
surveyed every 3 to 5 years. We used OSCAR data to analyze the
timeliness of routine surveys conducted by state survey agencies in
LTCHs. For LTCHs that had both a current and prior state survey (52 of
71), we found that more than 5 years had elapsed between surveys for
about 38 percent of LTCHs.[Footnote 36] About 19 percent of LTCHs were
surveyed by states within 3 years and about 42 percent were surveyed
from more than 3 up to 5 years after their prior surveys.[Footnote 37]
Similarly, CMS does not analyze the results of its AO performance
measures separately for LTCHs. CMS's performance measures for AOs
generally focus on the AOs' ability to provide the agency with timely,
complete, and accurate survey findings, facility notification letters,
and survey schedules for all of the types of facilities they survey
(such as hospitals, home health agencies, ambulatory surgery centers,
and hospices).[Footnote 38] In addition, CMS recently added a measure
that assesses whether AOs are conducting surveys of the accredited
facilities within a 3-year period. CMS provides feedback on its
analysis of performance measures to each AO, including TJC, on an
ongoing basis. These results are also reported to Congress in CMS's
annual financial report.[Footnote 39] However, CMS does not provide
feedback to AOs or publicly report on the performance measures for any
particular type of AO-surveyed facility, including LTCHs.
LTCHs Are Not Systematically Included in the Hospital Validation
Survey Sample, and Results from Complaint Validation Surveys Are Not
Always Shared with TJC:
CMS does not systematically include 1 percent of AO-surveyed LTCHs--
fewer than five--in its sample of traditional hospital validation
surveys conducted by state survey agencies. In contrast, state survey
agencies conduct a large number of complaint investigations at TJC-
surveyed LTCHs--known as complaint validation surveys. However, the
results are not always shared with TJC, limiting the effectiveness of
oversight.
Traditional Validation Surveys:
CMS's policy requires that approximately 1 percent of AO-surveyed
hospitals receive a traditional validation survey each year.[Footnote
40] While CMS has used this strategy to oversee AO survey activities
at hospitals generally, it has not done so for LTCHs specifically.
[Footnote 41] Agency officials told us that the sample was unlikely to
have included LTCHs prior to 2011 because they had not made LTCH
status a basis for assignment of validation surveys. However, using
OSCAR data, we found that about 1 percent or more of TJC-surveyed
LTCHs received a traditional validation survey each year from fiscal
years 2006 through 2010.[Footnote 42] The results of LTCH validation
surveys were included in CMS's annual calculations of TJC's hospital
disparity rates for fiscal years 2006 through 2009.
Following the publicized allegations of poor care at LTCHs, CMS
decided to have state survey agencies conduct validation surveys in
fiscal year 2011 at 34 AO-surveyed LTCHs.[Footnote 43] CMS selected
the LTCHs using a stratified random sample methodology that considered
the workload of the state survey agencies and the locations of the
LTCHs.[Footnote 44] CMS officials were not definitive in how they
would use the results of these LTCH validation surveys. They suggested
that they may compare the results of these surveys, including the
extent to which COP-level deficiencies are cited, to their prior
analysis of state LTCH survey data and to survey data for other types
of hospitals. However, these surveys do not constitute a solution to
CMS's lack of a systematic way of including LTCHs in its annual sample
of traditional validation surveys at hospitals because these surveys
are a one-time activity and will not be conducted within 60-days of a
routine survey. As a result, CMS will not be able to calculate a
disparity rate, which measures the effectiveness of the AOs' survey
process.
Complaint Validation Surveys:
Through state survey agencies, CMS conducts a significant number of
complaint validation surveys in TJC-surveyed LTCHs while TJC conducts
few complaint surveys in the LTCHs it surveys. From fiscal years 2006
through 2010, state survey agencies conducted 1,224 complaint
validation surveys at TJC-surveyed LTCHs compared with TJC's 67
complaint surveys at LTCHs it surveys. CMS officials told us that
state survey agencies receive more complaints than the TJC because
patients and their advocates may not always be aware that complaints
can be filed with an AO.[Footnote 45] They also told us that complaint
allegations, including the patients name and the name of the
complainant could not be referred to the appropriate AOs for
investigation because of privacy concerns unless the AO specifically
asked for each complaint.[Footnote 46] However, when we discussed this
issue with both CMS privacy and program officials, they concluded that
CMS regional offices could refer hospital complaints to AOs for
investigation or share complaint information with AOs prior to a state
complaint validation survey. TJC officials told us that they are
willing to conduct complaint surveys in response to referrals from CMS.
CMS told us that while it had not shared actual complaints with AOs it
had increased its communication with TJC, including the results of
complaint validation surveys. For example, CMS provided its regional
offices with the e-mail address of each AO in order to provide AOs
with copies of hospital correspondence and the results of surveys
conducted by state agencies in accredited facilities. However, TJC
officials told us that CMS regional offices do not consistently
provide the results of the complaint validation surveys and sometimes
the information provided is not timely. We spoke with officials from
two CMS regional offices that authorized two state agency complaint
validation surveys at TJC-surveyed LTCHs in fiscal year 2007 and
fiscal year 2009, respectively. Officials from one regional office
told us that not all of the information on the results of complaint
validation surveys was forwarded to TJC; thus, a letter might be sent
to TJC that outlined the COP-level deficiencies cited, but not the
standard-level deficiencies. TJC told us that they did not even know
that an additional complaint validation survey at this facility had
been conducted in 2009 until we informed them. Officials from the
other regional office said that they did not forward any information
from the complaint survey, including the official record of all the
deficiencies cited.[Footnote 47] TJC officials also said that
information on the findings from state complaint validation surveys
could lead them to conduct their own survey or could be used by TJC as
it prepares for the facility's next survey. Additionally, officials
from the CMS regional offices we contacted told us that state survey
agencies do not review the results of an AO's most recent routine
survey prior to conducting complaint validation surveys and therefore,
may not be familiar with any deficiencies cited by TJC. Given that
complaint validation surveys may provide insights into concerns that
occur between routine surveys, information sharing between CMS
regional offices and AOs is an important aspect of effective oversight.
CMS Is Not Using All Available ASSURE and OSCAR Survey Data to Oversee
Survey Activities at LTCHs:
CMS has not yet analyzed ASSURE survey data to oversee TJC's LTCH
survey activities or used these data in combination with OSCAR data to
identify issues that may warrant further examination and strengthen
oversight and accountability. By recognizing and adjusting for
limitations in these databases, we identified several areas where the
data may assist CMS in more effectively overseeing survey activities
at LTCHs. For example:
* CMS has data on the results of all surveys conducted by both state
survey agencies and TJC that could provide information on the
proportion of LTCHs and ACHs cited with COP-level deficiencies by
state survey agencies and TJC. Although CMS conducted an internal
analysis of the proportion of surveys at LTCHs and ACHs that cited COP-
level deficiencies, it used only OSCAR data, which primarily consists
of complaint surveys conducted by state survey agencies. We did our
own analysis using both ASSURE and OSCAR data and found that the
inclusion of ASSURE data influenced whether LTCHs or ACHs had more COP-
level deficiencies.[Footnote 48] See appendix I for the results of our
data analysis.
* CMS has data on complaint validation surveys conducted in LTCHs that
could provide information on how effectively states triage and conduct
complaint surveys at TJC-surveyed LTCHs. For example, our analysis
found that a small proportion of state complaint validation surveys
cited deficiencies. Specifically, we found that about 6 percent of the
1,224 complaint validation surveys conducted at TJC-surveyed LTCHs
between 2006 and 2010 had one or more COP-level deficiencies and about
66 percent did not cite any deficiencies.[Footnote 49] We also found
that two state agencies conducted nearly half (40 percent) of the
complaint validation surveys, but cited almost no COP-level
deficiencies.[Footnote 50] CMS and TJC officials told us that the
small proportion of state complaint validation surveys that cite COP-
level deficiencies indicated that state survey agencies may not be
adequately triaging complaints, that is, some of these complaints may
not have warranted on-site surveys. In addition, CMS officials
suggested that states may have cited deficiencies at the standard
level to avoid conducting a full survey and may not have reviewed all
standards related to the COP alleged by the complainant to have been
out of compliance.[Footnote 51]
* CMS has data to compare the results from routine and complaint
surveys that could provide information on the thoroughness of routine
surveys at LTCHs that also had complaint validation surveys. CMS has
not compared routine survey data for TJC-surveyed LTCHs it has in
ASSURE with complaint validation survey data it has in OSCAR. We
compared these two databases to determine if routine surveys by TJC
had missed COP-level deficiencies identified by state complaint
validation surveys. We identified 32 complaint validation surveys that
were conducted within 2 to 60 days of a TJC routine survey reported in
ASSURE. Four of the 32 surveys identified COP-level deficiencies that
were not identified on the LTCHs most recent survey by TJC. While
there may be reasonable explanations, further information could
improve CMS oversight of survey activities.
* CMS has data on the survey resources used during routine surveys by
state survey agencies and TJC that could provide information on the
efficiency and effectiveness of survey activities. We compared the
survey resources--number of surveyors and amount of time devoted to
conducting a survey--used by state surveyors and TJC for the health
portion of routine surveys at similar sized LTCHs between 2006 and
2010. We found that state surveyors spent about two times as many
hours per survey and utilized about two times more surveyors per
survey than TJC. The appropriate level of resources for an LTCH survey
is unclear and CMS, state survey agencies, and TJC may not be in
agreement.
CMS officials told us that they are not using all available ASSURE and
OSCAR survey data because they are currently focusing on obtaining
complete and accurate information from TJC and other AOs. They told us
that they intend to more fully use the available data in the future to
oversee LTCH survey activities; however, they have not developed a
plan to do so. One CMS official also told us that in the future the
agency might consider merging the information collected in ASSURE with
OSCAR, thereby establishing one database for hospital survey data.
Conclusions:
LTCHs are a specialized type of ACH that care for very sick and
clinically complex patients. Most patients in LTCHs have been
transferred from an intensive care unit of another hospital because
they need a continued intense level of care for an extended period of
time. Because these patients are so vulnerable, it is important that
oversight of the quality of care delivered by LTCHs is monitored and,
if shortcomings are identified, action is promptly taken. However, our
review found several limitations in the oversight of LTCHs that are
cause for concern, including weaknesses that affect the availability
of data to oversee the quality of care and the ability of CMS to hold
both state survey agencies and accrediting organizations accountable
for their survey activities.
We found several weaknesses in the availability of data on the quality
of care in LTCHs. The results of surveys are stored in more than one
database, which affects CMS's ability to use the data to understand
the quality of care in LTCHs. For example, CMS is unable to accurately
identify all LTCHs from these databases and which entity--state survey
agencies or AOs--is responsible for conducting routine surveys of the
facility. The inability to accurately identify all LTCHs has
implications, particularly when CMS implements a new COP for LTCHs and
when LTCHs have to begin reporting quality measures. The fragmentation
of data across different databases also affects CMS's ability to
review the data for LTCHs specifically and ensure that the data are
updated as needed and may inhibit the sharing of data between the
state survey agencies and AOs, both of which may have surveyors in the
same LTCHs at different times, conducting different types of surveys.
We also found weaknesses in CMS's ability to hold state survey
agencies and accrediting organizations accountable. CMS's traditional
strategies for holding these entities accountable--performance
measures and validation surveys--do not focus on LTCHs. Although CMS
conducts traditional validation surveys in hospitals in general as a
means for assessing the effectiveness of an AO's survey activities,
CMS cannot assure that LTCHs are systematically included in their
review; when such surveys have been conducted in LTCHs, CMS has not
separated out the LTCH surveys from surveys of all other hospitals and
so is unable to identify whether there may be areas of concern
specific to AO survey activities in LTCHs. Furthermore, CMS is not
effectively using the data it collects from surveys to review and
understand the activities conducted by state survey agencies and AOs.
For example, there are differences in the workload and resources
devoted to survey activities between state survey agencies and AOs;
however, the reasons for these differences were not clear. CMS
officials said they plan to more fully use the data in the future to
oversee survey activities in LTCHs, but have not yet developed a plan
for doing so.
CMS oversight of LTCHs is hampered by inaccurate data and ineffective
use of the data it currently collects. By increasing the use of its
existing databases and more effectively using the data it currently
collects, CMS has the opportunity to improve the accuracy of the data
it has and the effectiveness of its oversight. Unless CMS more
effectively uses the data it collects, the agency cannot provide
assurances that the quality of care in LTCHs meets federal quality
standards and ensure that vulnerable patients are not at risk.
Recommendations for Executive Action:
In order to improve the data available on the quality of care at
LTCHs, the Administrator of CMS should take the following two actions:
1. Improve the accuracy of the databases that track LTCH survey
results by:
* working with AOs and state survey agencies to develop a complete and
accurate list of the LTCHs that they each survey and an approach to
ensuring that the list is updated in a timely manner, and:
* expanding the OSCAR database to include the results of all LTCH
surveys, such as those conducted by TJC, which are currently stored in
the separate ASSURE database.
2. Improve information sharing with TJC regarding complaint validation
survey results for TJC-surveyed LTCHs, such as ensuring that all
survey findings are shared in a timely fashion.
In order to improve CMS's oversight of survey activities at LTCHs, the
Administrator of CMS should take the following three actions:
1. Conduct traditional validation surveys at a sample of LTCHs each
fiscal year and include an LTCH disparity rate in its annual financial
report to Congress.
2. Explore differences in survey workload and in the resources survey
organizations devote to LTCH surveys in order to:
* identify areas for efficiencies, and:
* determine whether the workload associated with complaint validation
surveys could be more equitably shared with TJC.
3. Develop a plan to use available data on survey activities to hold
survey organizations accountable for conducting surveys consistent
with CMS requirements for evaluating the quality of care provided by
LTCHs.
Agency and Other External Comments and Our Evaluation:
We provided a draft of this report to HHS and TJC for comment. In its
written comments, HHS concurred with our recommendations and
acknowledged that their implementation would further strengthen the
continued improvement in the oversight of AOs that CMS has undertaken
since fiscal year 2006. TJC agreed with most of our recommendations,
but disagreed with the recommendation related to traditional
validation surveys, that is, state oversight surveys at AO-surveyed
LTCHs. HHS's and TJC 's comments are reproduced in appendix II and
III, respectively.
HHS Comments:
HHS concurred with all five of our recommendations. With respect to
our recommendation to improve the accuracy of the databases that track
LTCH survey results, HHS noted that it had been working since 2007 to
identify and correct serious problems in both the AO and CMS databases
and had made significant progress. HHS acknowledged that one issue is
that LTCHs must enroll initially as acute care hospitals and are later
converted to LTCHs, which affects the identification of LTCHs in the
database. HHS outlined steps it had taken to address the fact that we
found many LTCHs identified as acute care hospitals in the ASSURE
database. HHS also said that it has begun the process of converting
ASSURE to a Web-enabled application, which would provide more
flexibility and allow it to explore methods to increase the accuracy
of the database.
HHS also concurred with our four other recommendations. HHS said that
it intends to:
* reinforce existing CMS policy on sharing information with AOs and
work with regional offices to enhance compliance,
* explore an option to increase its traditional validation survey
sample for hospitals, which would permit the inclusion of a stratified
sample of LTCHs annually,
* explore the differences in survey workload and resource allocation,
which it characterized as definitely meriting attention, while working
with regional offices to clarify the policy for triaging complaint
surveys at AO-surveyed LTCHs and for referring certain complaints to
the appropriate AO, and:
* review the available data to determine to what extent it can be used
to develop additional AO performance measures for evaluating quality
of care at hospitals, including LTCHs.
TJC Comments:
TJC agreed that there was room for improvement in CMS's oversight of
the quality of care provided by LTCHs and of survey activities at such
hospitals and noted that CMS had already taken positive steps toward
achieving these goals. However, it questioned our conclusion that CMS
oversight of LTCHs was limited. It suggested, instead, that a more
accurate conclusion was that CMS oversight was not separated in a
focused manner from that of other hospitals. We believe that our
report appropriately acknowledged CMS's progress in collecting data
from TJC since TJC's statutory deeming authority was revoked. We found
that CMS oversight of LTCHs was limited because it was (1) focused on
hospitals in general and not LTCHs specifically and (2) not
effectively using the survey data it collected to review and
understand the activities of state survey agencies and AOs at LTCHs.
TJC agreed with our recommendations to improve the accuracy of the
survey databases, improve information sharing, and use available data
to improve oversight. However, it disagreed with our recommendation to
conduct traditional validation surveys at a sample of LTCHs each
fiscal year and to include a LTCH-specific disparity rate in its
annual financial report to Congress. Specifically, TJC questioned the
value of LTCH-specific validation surveys for several reasons:
* TJC questioned whether validation surveys were the most appropriate
measure of AO performance because we had previously reported that
state surveyors understate (i.e., miss) serious deficiencies on
nursing home surveys. We do not believe that these findings are
directly applicable to traditional LTCH validation surveys because the
findings cited by TJC relate to routine nursing home surveys.
Moreover, understatement, if it did exist on validation surveys, would
not diminish the fact that state surveyors have identified serious
deficiencies that AOs should have, but did not cite. We agree with TJC
that CMS should monitor complaint validation survey findings as
another indicator of AOs performance. For example, we pointed out that
state survey agencies identified condition-level deficiencies not
cited by TJC on several complaint validation surveys that were
conducted within 60 days of TJC's routine survey.
* TJC stated that the inclusion of a representative number of LTCHs as
part of the annual validation survey schedule would require a
significant increase in the federal budget allocated to validation
surveys. TJC said this would be necessary in order to arrive at a
statistically valid sample size that would in turn support a LTCH-
specific disparity rate calculation. As we pointed out and HHS
comments noted, CMS has been conducting a small number of traditional
validation surveys at LTCHs each year--approximately 1 percent of
LTCHs. In addition, HHS noted that it would explore an option to
increase its traditional validation survey sample for hospitals,
thereby permitting the inclusion of a stratified sample of LTCHs each
year.
TJC noted that it had provided CMS with information such as the
accreditation status resulting from surveys, demographic information,
and up-to-date survey schedules prior to the establishment of ASSURE
in 2009 and, therefore, it was inaccurate to say that CMS has no prior
survey data on TJC-surveyed LTCHs. TJC's comments acknowledged that
the information provided to CMS prior to 2009 did not include detailed
information on the specific deficiencies identified. We added a
footnote to our report acknowledging the information that TJC did
provide to CMS before 2009 and clarified the report to make it clear
that the prior survey data we are referring to involved detailed data
on the deficiencies cited.
HHS and TJC also provided technical comments, which we incorporated as
appropriate.
As agreed with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution 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 your staff have any questions about this report, please contact me
at (202) 512-7114 or at kohnl@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 key contributions to this
report are listed in appendix IV.
Signed by:
Linda T. Kohn:
Director, Health Care:
[End of section]
Appendix I: Condition-Level Deficiencies Cited at Long-Term and Acute
Care Hospitals During Routine and Complaint Surveys:
This appendix presents the Centers for Medicare & Medicaid Services
(CMS) data on the results of surveys at long-term care hospitals
(LTCH). In the course of our analyses, we identified some data
limitations, which we discussed with both CMS and The Joint Commission
(TJC). We report only data that we determined to be reliable.
CMS has several years worth of data on condition of participation-
level (COP) deficiencies cited by state survey agencies at LTCHs, but
TJC only began submitting similar data in July 2009. Table 1 shows
data on COP-level deficiencies cited by state survey agencies from
fiscal years 2005 through 2009. Table 2 shows fiscal year 2010 survey
results for both state survey agencies and TJC for LTCHs and acute
care hospitals (ACH). Fiscal year 2010 is the first full year for
which data are available for both survey organizations. However, most
hospitals did not have a routine survey in fiscal year 2010 because
surveys are conducted every 3 to 5 years. Because fiscal year 2010
data does not include at least one survey for each LTCH, these results
may not reflect the quality of care across all LTCHs. Finally, tables
3 and 4 show the most commonly cited COP-level deficiencies at LTCHs
and ACHs surveyed by state survey agencies, during fiscal year 2010.
Table 1: COP-Level Deficiencies Cited During Routine and Complaint
Surveys Conducted by State Survey Agencies at LTCHs, Fiscal Years 2005
through 2009:
Survey organization: State survey agencies;
Routine surveys: Percentage of LTCHs with one or more COP-level
deficiencies (Number of LTCHs that were surveyed): 21.8% (55);
Complaint surveys[A]: Percentage of LTCHs with one or more COP-level
deficiencies (Number of LTCHs that were surveyed): 24.8% (282);
Total[B]: 25.4% (307).
Source: GAO analysis of OSCAR data.
[A] Both complaint and complaint validation surveys are included in
these data. Complaint surveys are conducted by survey organizations at
the LTCHs that they routinely survey. Complaint validation surveys are
conducted by state survey agencies at LTCHs that are surveyed by
accrediting organizations.
[B] Numbers may not add to totals because some LTCHs may have received
both a routine and complaint survey during fiscal years 2005 through
2009.
[End of table]
Table 2: COP-Level Deficiencies Cited during Routine and Complaint
Surveys Conducted by State Survey Agencies and TJC at LTCHs and ACHs,
Fiscal Year 2010:
Routine surveys:
Survey organization: State survey agencies;
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 18.5% (27);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 11.6% (268).
Survey organization: The Joint Commission;
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 9.8% (123);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 37.4% (911).
Survey organization: Total;
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 11.3% (150);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 31.6% (1,179).
Complaint surveys[A]:
Survey organization: State survey agencies;
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 14.7% (143);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 7.4% (1,256).
Survey organization: The Joint Commission;
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 12.5% (8);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 14.5% (138).
Survey organization: Total[B];
LTCHs: Percentage of LTCHs with one or more COP-level deficiencies
(Number of LTCHs that were surveyed): 14.6% (151);
ACHs: Percentage of ACHs with one or more COP-level deficiencies
(Number of ACHs that were surveyed): 8.1% (1,394).
Source: GAO analysis of OSCAR and ASSURE data.
Note: Our analysis included crosswalked LTCH and ACH survey results
submitted to ASSURE by TJC. CMS questioned the comparability between
state survey findings and TJC's crosswalked survey results because of
the different methods used.
[A] Both complaint and complaint validation surveys are included in
these data. Complaint surveys are conducted by survey organizations at
the LTCHs that they routinely survey. Complaint validation surveys are
conducted by state survey agencies at LTCHs that are surveyed by
accrediting organizations.
[B] Numbers may not add to totals because some LTCHs may have had one
or more complaint surveys conducted by a state survey agency, as well
as one or more complaint surveys conducted by TJC during the same year.
[End of table]
Table 3: COP-Level Deficiencies Most Commonly Cited by State Survey
Agencies during Routine and Complaint Surveys at LTCHs, Fiscal Year
2010:
COP-level deficiency: Nursing services;
Number of times cited: 15;
Percentage of all COP-level citations: 31.9%.
COP-level deficiency: Patient rights;
Number of times cited: 9;
Percentage of all COP-level citations: 19.2%.
COP-level deficiency: Infection control;
Number of times cited: 5;
Percentage of all COP-level citations: 10.6%.
COP-level deficiency: Pharmaceutical services;
Number of times cited: 4;
Percentage of all COP-level citations: 8.5%.
COP-level deficiency: Governing body;
Number of times cited: 3;
Percentage of all COP-level citations: 6.4%.
COP-level deficiency: Medical record services;
Number of times cited: 3;
Percentage of all COP-level citations: 6.4%.
COP-level deficiency: Food and dietetic services;
Number of times cited: 3;
Percentage of all COP-level citations: 6.4%.
COP-level deficiency: Physical environment;
Number of times cited: 2;
Percentage of all COP-level citations: 4.3%.
COP-level deficiency: Medical staff;
Number of times cited: 1;
Percentage of all COP-level citations: 2.1%.
COP-level deficiency: Discharge planning;
Number of times cited: 1;
Percentage of all COP-level citations: 2.1%.
COP-level deficiency: Surgical services;
Number of times cited: 1;
Percentage of all COP-level citations: 2.1%.
COP-level deficiency: Total;
Number of times cited: 47;
Percentage of all COP-level citations: 100%[A].
Source: GAO analysis of OSCAR data.
Note: Both complaint and complaint validation surveys are included in
these data. Complaint surveys are conducted by survey organizations at
the LTCHs that they routinely survey. Complaint validation surveys are
conducted by state survey agencies at LTCHs that are surveyed by
accrediting organizations.
[A] Numbers may not add to 100 due to rounding.
[End of table]
Table 4: COP-Level Deficiencies Most Commonly Cited during Routine and
Complaint Surveys by State Survey Agencies at ACHs, Fiscal Year 2010:
COP-level deficiency: Patient rights;
Number of times cited: 57;
Percentage of all COP-level citations: 24.0%.
COP-level deficiency: Governing body;
Number of times cited: 38;
Percentage of all COP-level citations: 16.0%.
COP-level deficiency: Nursing services;
Number of times cited: 37;
Percentage of all COP-level citations: 15.6%.
COP-level deficiency: Physical environment;
Number of times cited: 26;
Percentage of all COP-level citations: 10.9%.
COP-level deficiency: Medical staff;
Number of times cited: 18;
Percentage of all COP-level citations: 7.6%.
COP-level deficiency: Infection control;
Number of times cited: 13;
Percentage of all COP-level citations: 5.5%.
COP-level deficiency: Pharmaceutical services;
Number of times cited: 9;
Percentage of all COP-level citations: 3.8%.
COP-level deficiency: Surgical services;
Number of times cited: 8;
Percentage of all COP-level citations: 3.4%.
COP-level deficiency: Discharge planning;
Number of times cited: 7;
Percentage of all COP-level citations: 2.9%.
COP-level deficiency: Medical record services;
Number of times cited: 5;
Percentage of all COP-level citations: 2.1%.
COP-level deficiency: Radiologic services;
Number of times cited: 4;
Percentage of all COP-level citations: 1.7%.
COP-level deficiency: Respiratory care services;
Number of times cited: 4;
Percentage of all COP-level citations: 1.7%.
COP-level deficiency: Food and dietetic services;
Number of times cited: 3;
Percentage of all COP-level citations: 1.3%.
COP-level deficiency: Anesthesia services;
Number of times cited: 3;
Percentage of all COP-level citations: 1.3%.
COP-level deficiency: Compliance with federal laws;
Number of times cited: 2;
Percentage of all COP-level citations: 0.8%.
COP-level deficiency: Emergency services;
Number of times cited: 2;
Percentage of all COP-level citations: 0.8%.
COP-level deficiency: Utilization review;
Number of times cited: 1;
Percentage of all COP-level citations: 0.4%.
COP-level deficiency: Special conditions for hospitals;
Number of times cited: 1;
Percentage of all COP-level citations: 0.4%.
COP-level deficiency: Total;
Number of times cited: 238;
Percentage of all COP-level citations: 100%[A].
Source: GAO analysis of OSCAR data.
Note: Both complaint and complaint validation surveys are included in
these data. Complaint surveys are conducted by survey organizations at
the LTCHs that they routinely survey. Complaint validation surveys are
conducted by state survey agencies at LTCHs that are surveyed by
accrediting organizations.
[A] Numbers may not add to 100 due to rounding.
[End of table]
[End of section]
Appendix II: 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:
August 24, 2011:
Linda Kohn:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Kohn:
Attached are comments on the U.S. Government Accountability Office's
(GAO) draft report entitled: "Long-Term Care Hospitals: CMS Oversight
Is Limited and Should Be Strengthened" (GA0-11-810).
The Department appreciates the opportunity to review this report
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 Report Entitled.
"Long-Term Care Hospitals: CMS Oversight Is Limited And Should Be
Strengthened" (GA0-11-810)
Thank you for the opportunity to review and comment on this draft
report. GAO examined the extent to which the Centers for Medicare &
Medicaid Services (CMS) collects data about long-term care hospital's
(LTCHs) quality of care and oversees LTCH survey activities. However,
since about 84 percent of LTCHs are surveyed by accrediting
organizations (AOs) rather than by CMS or States, a major portion of
the study focuses on CMS oversight of AOs, principally The Joint
Commission (TJC).
Implementation of the GAO recommendations will further strengthen the
consistent improvement in the oversight of accrediting organizations
that CMS has undertaken since 2006. A few of the major milestones in
this improvement effort are:
* Dedicated Accreditation Team in CMS: Beginning in FY 2006, CMS
gradually built a small team of professionals in the CMS Survey &
Certification Group dedicated to the oversight of AOs.
* More Rigorous Review of AOs: AOs must demonstrate that they have
standards and survey processes that are equivalent or more stringent
than CMS standards for quality of care and safety in order to be
approved by Medicare. As a result of more rigorous CMS review, every
AO has recently upgraded its standards to ensure such equivalency. CMS
also increased the number and extent of reviews to match the 50
percent growth in the number of approved AO programs since FY 2007
(from 12 to 18 programs).
* More Validation Surveys: CMS (and States on behalf of CMS) conduct
surveys of a sample of facilities after an AO has conducted a survey
in those facilities. CMS compares the results of these validation
surveys with those of each AO to determine if the AO has missed any
deficiencies. The comparison allows CMS to calculate a useful measure
of performance (a disparity rate) for each AO. Each year CMS reports
these disparity rates to Congress. In recent years CMS has increased
the number of such validation surveys from 44 in FY 2004 to 223 in FY
2010.
* Improved Communications: CMS instituted annual conferences with all
AOs as well as quarterly conference calls, and in FY 2008 implemented
a dedicated e-mail address system for each CMS Regional Office for AOs
to submit their letters concerning facilities seeking to acquire or
retain accredited and deemed status.
* AO Performance Measures: In FY 2008, CMS began implementing a system
of performance measures for AOs. Results for the major performance
measures are reported to Congress each year.
* Oversight of TJC: Prior to July 15, 2010, CMS had no jurisdiction
over TJC's hospital accreditation program. The Medicare Improvements
for Patients and Providers Act of 2008 (MIPPA), enacted on July 15,
2008, removed the statutory standing of TJC's hospital accreditation
program and placed it on the same regulatory footing as all other
Medicare-approved AOs. The statute provided a two-year transition
period to allow TJC to submit its program for CMS review and receive
approval by July 15, 2010. Thus, a major portion of the GAO report is
focused on a comparatively new CMS oversight responsibility (i.e., the
oversight by CMS of TJC).
* Accreditation Organization System for Storing User Recorded
Experiences (ASSURE) Database: In late FY 2009, CMS began implementing
a new database designed to improve the accuracy of information
regarding the accreditation status of facilities. The new ASSURE
Database is currently a desktop application, populated by quarterly
electronic data submissions by all 17 of the currently-approved
national accreditation programs. In the future, we plan to migrate
ASSURE to a web-enabled application.
Much of GAO's report and recommendations focus on data extracted from
the ASSURE system. We recognize that ASSURE is very much a work in
progress, but also appreciate the GAO's confirmation that this new
database offers enormous potential to improve our oversight of AOs and
thereby improve oversight of the Medicare-participating health care
facilities that are subject to AO jurisdiction.
Despite the progress that CMS has made in the oversight of accrediting
organizations, a great deal remains to be done. The GAO
recommendations provide good examples of some of the possibilities for
improvement. Our response to each recommendation is provided in the
material that follows.
GAO Recommendation:
In order to improve the data available on the quality of care at
LTCHs, the Administrator of CMS should improve the accuracy of the
databases that track LTCH survey results by:
a. Working with AOs and State survey agencies to develop a complete
and accurate list of the LTCHs that they each survey and an approach
to ensuring that the list is updated in a timely manner.
CMS Response:
We concur. Prior to our development and introduction of ASSURE, AOs
submitted Excel spreadsheets of their lists of accredited facilities
that were deemed to comply with Medicare CoPs. In 2007, we attempted
to match the most recent AO Excel facility lists to the data in our
database. Only 30 percent of the facilities matched. These dismal
results highlighted the fact that there were serious problems in both
AO and CMS databases. Clearly the AOs were not identifying their
accredited facilities in a manner consistent with the way in which
those facilities enrolled in Medicare, i.e., according to the CMS
Certification Number (CCN – frequently also called the "Medicare
provider number"). Intensive, manual correction and reconciliation
efforts later managed to raise the match level to 82 percent in May
2008.
Figure: Confirmed Matches between CMS and AO Data for Deemed
Facilities:
[Refer to PDF for image: vertical bar graph]
FY 2007: 30%;
FY 2008: 82%;
FY 2011: 88%.
[End of figure]
These experiences led us to develop the electronic ASSURE database.
Under ASSURE there are upfront edits that preclude many of the errors
and omissions that were found in the prior Excel spreadsheets. We
utilize our ASSURE contractor to run largely automated matching to
identify and reconcile discrepancies. The contractor now refers to the
AOs (for correction) those discrepancies for which reconciliation is
not possible. The graph here shows our progress from FY2007 (when only
30 percent of the facilities matched) to the most recent ASSURE match
rate of 88 percent in FY 2011.
The identification of LTCHs in the system presents particular
challenges. Such facilities must enroll initially as short-term acute
care hospitals and are later converted to LTCHs. This requires a
manual notification of the AO by the CMS Regional Office (RO) at the
time of conversion. However, starting in FY 2010, the AOs have been
receiving quarterly notice from CMS via our ASSURE contractor of
errors in their CCN numbers that the contractor was able to correct,
and we expect the AOs to make these corrections before submitting
their next quarterly data.
We have also begun the process of converting ASSURE to a web-enabled
application. This process is expected to take several years to be
fully operational. Currently ASSURE is a desk-top application that
requires quarterly submissions by the AOs of an updated database that
is current as of the date 30 days prior to the quarterly submission.
There are a number of serious limitations in this batch mode, desktop
application. Once a web-enabled version is implemented we expect to
have more flexibility in the database operations and will explore
methods to use the enhanced flexibility to increase the accuracy of
the database.
It is inevitable that, even with improvements, there may always be
some areas of lag or discrepancy between AO and Quality Improvement
Evaluation System (QIES)-Certification And Survey Provider Enhanced
Reporting (CASPER) data. An AO may, for example, include information
on a new facility that it has accredited and which is seeking to
enroll in Medicare via accredited deemed status. New facilities in
ASSURE are not required to have a CCN number to be entered into the
system, since the CCN will likely not have been issued at the time of
the AO's data submission. It is possible that that facility might have
a significant delay in enrolling in Medicare, or may even have its
application rejected, due to a failure to comply with other Federal
requirements for enrollment. That facility will not be able to be
matched to one in QIES-CASPER, which consists only of facilities
enrolled in Medicare (or previously enrolled and terminated).
GAO Recommendation (continued):
b. Expanding the OSCAR database to include the results of all LTCH
surveys, such as those conducted by TJC, which are currently stored in
the separate assure database.
CMS Response:
We agree with the need for a combined database, and plan to accomplish
this through an alternate approach. We will extract and merge data
from QIES-CASPER and ASSURE into combined spreadsheets.
OSCAR itself is a legacy system that CMS is phasing out. The successor
to OSCAR is the Quality Improvement Evaluation System (QIES), which
consists of a suite of complex applications. A major component of
`QIES' is the Automated Survey Processing Environment (ASPEN), which
is housed on separate servers in each state to support State Survey
Agency and CMS RO daily operations. The QIES system also houses
patient-level data submitted by long-term care facilities (the Minimum
Data Set (MDS)) and home health agencies (the Outcome and Assessment
Information Set (OASIS)). CASPER is the national data repository that
supports QIES, and contains a more limited amount of data extracted on
a daily basis from the State ASPEN servers. There are clear
disadvantages to an effort to merge ASSURE and ASPEN, since the
business requirements for ASPEN are far more extensive and reflect the
certification and other functions that ASPEN supports in addition to
capturing survey results for States and CMS. In addition, neither
ASPEN nor CASPER is presently a web-based application, and integrating
ASSURE into ASPEN would impair or prevent our attempts to web-enable
ASSURE due to security concerns.
GAO Recommendation:
In order to improve the data available on the quality of care at
LTCHs, the Administrator of CMS should improve information sharing
with TJC regarding complaint validation survey results for TJC-
surveyed LTCHs, such as ensuring that all survey findings are shared
in a timely fashion.
CMS Response:
We concur. We intend to reinforce existing CMS policy on sharing of
information with AOs, including AOs that accredit LTCHs. Current CMS
policy calls for CMS ROs to copy the applicable AO on their
correspondence to the accredited hospital communicating survey results
and, if applicable, enforcement actions. We will clarify the existing
policy for the ROs and work with them to enhance compliance.
GAO Recommendation:
In order to improve CMS' oversight of survey activities at LTCHs, the
Administrator should conduct traditional validation surveys at a
sample of LTCHs each fiscal year and include a LTCH disparity rate in
its annual financial report to Congress.
CMS Response:
We concur. The primary purpose of a traditional validation survey is
to assess the survey process utilized by an AO through the calculation
of a disparity rate between findings of AO and SA surveys of the same
health care facilities within a 60-day timeframe. Between FY 2006 and
FY 2009 the number of LTCHs that were included in the traditional
validation sample assigned to SAs ranged between 4 and 8 LTCHs per
year. We will explore an option that would allow us to increase our
traditional validation survey sample for hospitals, thereby permitting
the inclusion of a stratified sample of LTCHs each year.
For FY 2011, we assigned the SAs to conduct non-traditional validation
surveys on a representative sample of approximately 34 LTCHs, without
regard to the AOs' survey schedules. We needed to disregard the AO
survey schedule in order to ensure that we would have a large enough
sample to compare LTCH survey results with those for non-accredited
LTCHs, as well as to hospitals in general. The results of these
surveys will assist us in making further plans with respect to this
GAO recommendation.
GAO Recommendation:
In order to improve CMS' oversight of survey activities at LTCHs, the
Administrator should explore differences in survey workload and in the
resources survey organizations devote to LTCH surveys in order to:
a. Identify areas for efficiencies, and;
b. Determine whether the workload associated with complaint validation
surveys could be more equitably shared with TJC.
CMS Response:
We concur. This is an area that definitely merits exploration.
Meanwhile, we will work with the CMS ROs to clarify (for consistent
national application) the policy for triaging complaints for deemed
facilities, and the policy for referring to the appropriate AOs those
complaints that do not allege substantial noncompliance with one or
more CoPs.
GAO Recommendation:
In order to improve CMS' oversight of survey activities at LTCHs, the
Administrator should develop a plan to use available data on survey
activities to hold survey organizations accountable for conducting
surveys consistent with CMS requirements for evaluating the quality of
care provided by LTCHs.
CMS Response:
We concur. We will review the various data available to us to
determine to what extent it can be used to develop and subsequently
implement additional AO performance measures for evaluating quality of
care at hospitals, including LTCHs.
[End of section]
Appendix III: Comments from The Joint Commission:
The Joint Commission:
August 24, 2011:
Linda T. Kohn:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Kohn:
The Joint Commission appreciates the opportunity to provide formal
comments on the report, Long-term Care Hospitals: CMS Oversight is
Limited and Should Be Strengthened Long-term care hospitals (LTCHs)
occupy an extremely important role in the United States' health care
delivery system. These hospitals specialize in delivering care to
critically-ill patients who have highly complex medical conditions.
Therefore, ensuring that these organizations provide safe, high-
quality health care is of utmost importance.
The Joint Commission takes seriously its responsibility to evaluate
the quality and safety of the care provided by America's health care
organizations. Since its founding in 1951, The Joint Commission has
been the leader in developing the highest standards for quality and
safety in the delivery of health care, and for evaluating organization
performance based on these standards. Today, more than 19,000 health
care organizations and programs use Joint Commission standards to
guide how they administer care and continuously improve performance.
Importantly, The Joint Commission evaluates health care organizations
across the continuum of care, including most of our Nation's
hospitals. Also in the family of Joint Commission accredited entities
are clinical laboratories, ambulatory care and office-based surgery
facilities; behavioral healthcare organizations; home care; hospice;
long term care organizations; and durable medical equipment suppliers.
Although accreditation is voluntary, the federal government and most
state regulatory bodies recognize and rely upon Joint Commission
accreditation evaluations and decisions for their certification or
licensure purposes.
Overall, The Joint Commission agrees with the GAO's recommendations to
improve the accuracy of the databases that track LTCH survey results
and improve information sharing with The Joint Commission regarding
complaint survey results. There is value in having accurate, complete
and timely data to inform policy and management decisions and to
evaluate organizational performance. Other government initiatives that
are underway or planned, such as implementing an LTCH quality measure
reporting system and developing LTCH-specific conditions of which the
GAO's November 2010 report cited as a CMS will participation, priority,
contribute greatly to improved oversight. The Joint Commission
welcomes strengthening its oversight partnership with CMS on quality
and safety performance of Medicare certified organizations.
The Joint Commission questions the conclusion that CMS oversight of
LTCHs is limited; a more accurate conclusion might be that CMS
oversight of LTCHs is not separated in a focused manner from that of
other hospitals. Currently, accountability for LTCH quality of care
and patient safety falls under the well-established acute care
hospital oversight framework. While LTCH-specific quality measures and
LTCH-specific conditions of participation would improve the existing
framework, the value of LTCH-specific validation surveys as the
GAO recommends is questionable on methodological, resource allocation,
and validity grounds. For instance, stratifying the annual validation
sample to include a representative number of LTCHs, or any other type
of specialty hospital, as part of the annual validation survey
schedule would require a significant increase in the federal budget
allocated to validation surveys in order to arrive at a statistically
valid sample size that would in turn support an LTCH specific
disparity rate calculation. As an alternative to stratifying the
validation sample, CMS could maintain complaint survey data by
hospital specialty type and monitor this information to determine when
the need may arise to perform additional focused oversight surveys of
LTCHs. This would be less costly and just as effective. Furthermore,
SA performance of survey activities has come under criticism,
particularly the wide variation in the number and severity of
deficiencies cited by different SAs.[Footnotes 1,2,3] This raises
questions as to whether validation surveys by SAs, as currently
conducted, are the most appropriate measure of AO performance of
Medicare related survey activities.
As noted in the report, The Joint Commission conducts surveys on a 3-
year interval; in contrast, State Survey Agencies (SAs) conduct
routine surveys every 3 to 5 years, likely due to resource
constraints. The Joint Commission is concerned that SA surveys for non-
accredited hospitals extends beyond 3 years.
We strongly agree with the GAO recommendation to use existing data to
improve oversight of LTCH quality of care. To accomplish this, SA
triaging of complaints needs improvement. For example, the report
reveals that only 6 percent of SA-conducted complaint surveys identify
one or more condition-level deficiencies, 66 percent did not cite any
deficiencies, and two State Survey Agencies accounted for nearly half
of all complaint surveys and cited almost no condition-level
deficiencies. This is consistent with GAO and OIG analyses about the
inconsistency of SA citation of deficiencies. It is difficult to avoid
the conclusion that federal dollars are not being well spent to
continue the current approach to conducting onsite complaint
investigations. In contrast, The Joint Commission's complaint triage
approach, which considers a number of factors including the
information contained in the complaint itself, and previous SA and
Joint Commission survey findings, prioritizes on-site evaluations for
only those allegations that could pose high risk to patient safety and
quality of care. This approach has yielded complaint substantiation
rates that range between 50 percent and 93 percent annually. Since
this approach relies heavily on accurate and timely information, we
would like to underscore our agreement with the GAO recommendation
that SAs share survey findings with The Joint Commission in a
consistent and timely manner. Working together, The Joint Commission
and CMS can forge a better public-private oversight framework for
LTCHs, by leveraging our respective activities.
While the GAO analysis identifies important areas for improvement,
there are areas where strides have been made to improve oversight of
health care providers and AOs. One such area involves the ASSURE
database. With the fairly recent implementation of ASSURE in October
2009, CMS was able for the first time to systematically collect and
compile survey data from all AOs. All AOs with deeming authority now
record their accreditation activities and enforcement actions in the
same database in a standardized manner. Prior to ASSURE, each AO
submitted an Excel spreadsheet that contained different information
about providers. Therefore, while improvements to ASSURE are still
necessary, as the GAO analysis reveals, it is important to applaud CMS
for developing ASSURE and evaluating and updating it on an ongoing
basis to improve the accuracy and relevance of the information.
Throughout the report, the GAO notes that "CMS does not have data on
the results of surveys conducted by TJC prior to 2009....." While The
Joint Commission did not report at the level of specificity that
included survey findings (i e., requirements for improvement or RFIs)
prior to implementation of ASSURE in 2009, we did provide to CMS the
outcome of surveys (i.e., accreditation status), demographic
information, and up-to-date survey schedules. Providing information at
the RFI level was not possible prior to the Medicare Improvements for
Patients and Providers Act of 2008, when a crosswalk that related
Joint Commission Standards to the Medicare hospital conditions of
participation was not required (and did not exist). Therefore, The Joint
Commission urges the GAO to reevaluate its use of this statement
throughout the report and ensure that the report reflects the full
context of the reporting landscape prior to implementation of ASSURE
in 2009.
Another area where recent and promising strides have been made to
improve oversight of LTCHs involves steps toward implementing LTCH
quality measures. The report notes that CMS does not have quality
measures for LTCHs, but will do so beginning in 2014. Prior to
enactment of the Patient Protection and Affordable Care Act (PPACA),
which requires LTCH quality reporting by 2014, The Joint Commission
initiated efforts to develop such measures. Since then, CMS with The
Joint Commission and other stakeholders have taken concrete steps
toward adoption of LTCH-relevant measures. Much work is yet to be
done, especially related to ensuring that any process measures that
are adopted meet The Joint Commission's criteria for "accountability"
measures. The Joint Commission is strongly urging CMS to adopt this
classification system for determining which process measures should be
reported by LTCHs. Accountability measures are defined according to
the following four criteria:
Research: Strong scientific evidence exists demonstrating that
compliance with a given process of care improves health outcomes
(either directly or by reducing risk of adverse outcomes).
Proximity: The process is closely connected to the outcome it impacts;
there are relatively few clinical processes that occur after the one
that is measured and before the improved outcome occurs.
Accuracy: The the That is, if the measure accurately assesses most
critical process components. measure construct does not support data
capture and assessment of the most essential process components, it is
a poor measure of quality, likely to be subject to workarounds that
induce unproductive work instead of work that directly improves
quality of care.
Adverse Effects: The measure construct is designed to minimize or
eliminate unintended adverse effects.
In conclusion, The Joint Commission believes there is room for
improvement in CMS's oversight of the quality of care provided by
LTCHs and their oversight of survey activities. However, it is also
important to recognize the positive strides CMS has already taken
toward these goals. Importantly, if we are to have a more effective
oversight framework in an environment of limited resources, one must
prioritize those oversight activities that are more likely to achieve
desired results such as 1) improving communication and information
exchange; 2) using appropriate, reliable, and valid quality measures;
and 3) effectively triaging complaints and using the results of
complaint surveys to determine the need to modify the validation
sampling methodology. This approach of leveraging existing and ongoing
activities is likely to be more effective and is sensitive to the
resource constraints of the current environment.
We appreciate the opportunity to review and comment on this report. If
you have any questions, don't hesitate to call me or you may contact
Margaret VanAmringe, Vice President for Public Policy and Government
Relations, at (202) 783-6655.
Sincerely,
Signed by:
Mark R. Chassis, MD., M.P.P., M.P.H.
President:
The Joint Commission:
Footnotes:
[1] Government Accountability Office. Nursing Homes: Addressing the
Factors Underlying Understatement of Serious Care Problems
Requires Sustained CMS and State Commitment (GAO-10-70). Washington,
D.C.: November 2009.
[2] Government Accountability Office. Nursing Homes: Federal
Monitoring Surveys Demonstrate Continued Understatement of Serious
Care Problems and CMS Oversight Weaknesses (GAO-08-517). Washington,
D.C.: May 2008.
[3] Office of Inspector General, US Department of Health and Human
Services. Nursing Home Deficiency Trends and Survey and
Certification Process Consistency (00-02-01-00600). Washington, D.C.:
March 2003.
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
Linda T. Kohn (202) 512-7114 or kohnl@gao.gov:
Staff Acknowledgments:
In addition to the contact name above, Walter Ochinko, Assistant
Director; Sarah Harvey; Kristin Helfer Koester; Dan Lee; Elizabeth T.
Morrison; Phillip J. Stadler; and Jennifer Whitworth made key
contributions to this report.
[End of section]
Footnotes:
[1] See, for example, Alex Berenson, "Long-Term Care Hospitals Face
Little Scrutiny," The New York Times, February 10, 2010.
[2] Medicare is the federal health insurance program for people aged
65 and older, certain individuals with disabilities, and individuals
with end stage renal disease. Among other things, Medicare covers
inpatient hospital stays and physician services.
[3] Communication from the Secretary of Health and Human Services
transmitting a CMS report to the U.S. Congress, Determining Medical
Necessity and Appropriateness of Care for Medicare Long Term Care
Hospitals, March 2011.
[4] According to CMS, the agency is developing LTCH-specific
regulations in response to requirements in the Medicare, Medicaid, and
SCHIP Extension Act of 2007. CMS officials told us that the changes to
the standards may reflect the patient admission and discharge process,
staffing requirements, and the level of patient care and that it plans
to release a notice of proposed rule making in September 2011.
[5] In this report, references to ACHs exclude those that are
classified as LTCHs.
[6] TJC is an independent, not-for-profit organization that accredits--
through surveys--more than 19,000 health care organizations and
programs in the United States.
[7] See GAO, Long-Term Care Hospitals: Differences in Their Oversight
Compared to Other Types of Hospitals and Nursing Homes, [hyperlink,
http://www.gao.gov/products/GAO-11-130R] (Washington, D.C.: Nov. 30,
2010).
[8] NQF is a nonprofit organization that fosters agreement on national
standards for measurement and public reporting of health care
performance data.
[9] LTCHs may initially be classified as an ACH until they demonstrate
their average length of stay is at least 25 days. The Social Security
Act permits certain LTCHs to maintain an average length of stay of
more than 20 days. See 42 U.S.C. §1395ww(d)(1)(B)(iv)(II).
[10] In fiscal year 2009, the most frequently occurring diagnosis was
respiratory diagnosis with ventilator support for 96 or more hours.
Eight of the top 20 diagnoses, representing 31 percent of LTCH
patients, were respiratory conditions. Patients treated by LTCHs vary
in age. Twenty-three percent of Medicare LTCH patients are under the
age of 65. See MedPAC, Report to the Congress: Medicare Payment Policy
(Washington, D.C., March 2011).
[11] The average length of stay in an ACH is about 5 days. See MedPAC,
Report to the Congress: Medicare Payment Policy (Washington, D.C.:
March 2009).
[12] ACHs are paid under the inpatient prospective payment system
whose rates are based on the average costs per case for each
diagnosis. LTCHs are paid under a different prospective payment system
that pays higher rates that reflect the resources required to treat
medically complex patients.
[13] For more information on CMS funding to survey the various types
of facilities that participate in Medicare, see GAO, Medicare and
Medicaid Participating Facilities: CMS Needs to Reexamine Its Approach
for Funding State Oversight of Health Care Facilities, [hyperlink,
http://www.gao.gov/products/GAO-09-64] (Washington, D.C.: Feb. 13,
2009).
[14] TJC's hospital accreditation survey interval ranges from 18 to 39
months.
[15] Appendixes I and II in GAO-11-130R summarize federal and TJC
hospital standards.
[16] CMS required TJC to make changes to its survey standards to
ensure consistency with federal quality standards for hospitals. For
example, TJC required the hospitals it surveys, including LTCHs, to
have an infection control officer, but did not spell out this
official's responsibilities; CMS required TJC to do so.
[17] OSCAR is an older database that CMS is phasing out. The successor
to OSCAR is the Quality Improvement Evaluation System.
[18] Pub. L. No. 108-173, §501(b), 117 Stat. 2066, 2289-90.
[19] 42 U.S.C. § 1395ww(b)(3)(B)(viii).
[20] See Hospital Compare, [hyperlink,
http://www.hospitalcompare.hhs.gov].
[21] CMS refers to the state survey agency performance measures as
performance standards.
[22] The facility types included in the performance measures are
hospitals, critical access hospitals, home health agencies, hospice
providers, and ambulatory surgical centers.
[23] CMS increased the total number of hospitals surveyed to 2 percent
for fiscal years 2008 and 2009 and 2.5 percent for fiscal year 2010.
[24] The approximately 90 traditional hospital validation surveys
represented an increase from a 10-year low of 44 in fiscal year 2004.
In addition, CMS began conducting traditional validation surveys of
other accredited facilities such as home health agencies and
ambulatory surgical centers in fiscal year 2007.
[25] In comparison, if a traditional validation survey cites one ore
more COP-level deficiencies, the subsequent survey conducted by the
state survey agency only reviews those COPs that were originally found
to be out of compliance.
[26] Surveys examine quality of care (the health portion of the
survey) as well as physical environment, which includes fire safety.
[27] While TJC did not report at the level of specificity that
included survey findings prior to implementation of ASSURE in 2009, it
did provide CMS the outcome of surveys, such as accreditation status,
demographic information, and up-to-date survey schedules.
[28] Because TJC surveys its hospitals about once every 3 years,
ASSURE has about 18 months of data.
[29] The remaining 3 percent of LTCHs were surveyed by other AOs.
[30] In November 2010, we reported that there were 434 LTCHs in fiscal
year 2009. See [hyperlink, http://www.gao.gov/products/GAO-11-130R].
Based on our current analysis, we found that there are 447 LTCHs.
[31] Hospital identification numbers consist of six digits. The first
two digits identify the state where the hospital is located. For
LTCHs, the remaining four digits range from 2000 to 2299. CMS
officials told us that, as of July 2011, AOs will be required to
identify the hospital subtype, such as ACH or LTCH, in ASSURE. We do
not believe that this requirement would have revealed the problem that
approximately 40 TJC-surveyed LTCHs were misidentified in ASSURE
because they had ACH identification numbers.
[32] The Secretary of Health and Human Services may specify measures
that are not endorsed in cases where existing endorsed measures are
not considered feasible or practical.
[33] Medicare Program: Hospital Inpatient Prospective Payment System
for Acute Care Hospitals and the Long Term Care Hospital Prospective
Payment System, 76 Fed. Reg. 25,788 (proposed May 5, 2011).
[34] The measure assessing catheter-associated urinary tract infection
rate has been endorsed for use in hospital intensive care units. The
central-line associated blood stream infection rate has been endorsed
for hospital intensive care units and high risk nursery patients. The
new or worsened pressure ulcer measures have been endorsed for short-
stay nursing home patients.
[35] CMS regional offices share the results of the hospital and
facility performance measures with the respective state survey agency
and CMS headquarters, which in turn shares each state's scores with
all of the other states.
[36] Survey information for about 17 of the LTCHs surveyed by states
only contained a recent, current survey; no prior survey data were
available. We removed these surveys from our analysis and report only
on those LTCHs that had both a current and prior state survey.
[37] These percentages do not total 100 percent because of rounding.
[38] In 2008, CMS adopted a policy of electronic information exchange
with the AOs, including TJC, in order to facilitate the timely receipt
of information, such as survey schedules and facility notification
letters, from the AOs. Previously, CMS had received information from
AOs, including TJC, through the U.S. Postal Service. Additionally, AOs
are required to immediately notify CMS of COP-level deficiencies that
pose an immediate jeopardy to patient(s) at accredited hospitals by
calling CMS as well as providing information about the immediate
jeopardy to CMS and the appropriate regional offices using the
electronic mailboxes. Regional offices generate 'alerts' for CMS when
an immediate jeopardy deficiency is cited.
[39] CMS Financial Report Fiscal Year 2010 [hyperlink,
http://www.cms.hhs.gov/CFOReport/].
[40] CMS has supplemented the funding provided to states since fiscal
year 2007 in order to increase the sample size to at least 2 percent.
[41] CMS does not conduct traditional validation surveys at state-
surveyed LTCHs.
[42] When we discussed these LTCH validation surveys with CMS
officials, they told us that they use a spreadsheet and not OSCAR to
track traditional validation surveys and to calculate each AO's
hospital disparity rate. However, we found that some of the surveys we
identified through OSCAR were not on CMS's spreadsheet, and that CMS
included a few surveys conducted outside the 60-day window. CMS
officials told us that surveys conducted outside of the 60-day window
are generally excluded from the agency's calculation of a disparity
rate. CMS officials explained that the spreadsheet is used to track
the assignment of validation surveys because OSCAR cannot be used to
determine which validation surveys were assigned to which state survey
agencies.
[43] CMS officials told us that of the 34 LTCHs, 33 LTCHs are TJC-
surveyed and 1 is surveyed by the American Osteopathic Association.
[44] According to CMS officials, they selected LTCHs in this way to
avoid overburdening certain state survey agencies. As noted earlier,
LTCHs are not evenly distributed across states.
[45] According to TJC, it has a hospital participation requirement
that hospitals notify the public they serve about how to contact
hospital management and TJC to report concerns about patient safety
and quality of care.
[46] Previously, when complaint information was forwarded to AOs, it
was redacted and, according to TJC officials, not useful.
[47] These officials and those at other CMS regional offices we
contacted told us that currently they do provide TJC and other AOs
information about surveys. However, one regional office we spoke with
forwards information from complaint validation surveys to TJC and
other AOs only when COP-level deficiencies are cited.
[48] Although our analysis included LTCH and ACH survey results that
were crosswalked and submitted to ASSURE by TJC, CMS questioned the
comparability between state survey findings and TJC's crosswalked
survey results because of the different methods used.
[49] The remaining surveys cited standard level deficiencies.
[50] For example, one state conducted 51 complaint validation surveys
at the same hospital over the 5-year period, but cited no COP-level
deficiencies.
[51] CMS's State Operations Manual requires state survey agencies to
conduct full surveys of an accredited facility when a COP-level
deficiency is cited. The appropriate regional office is to review and
approve a state survey agency's findings prior to the initiation of
the full survey.
[End of section]
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