Attachment G -- Federal Register Notice

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Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Notices

disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and strategies with regulatory
applicability and promotes the scientific
validation and regulatory acceptance of
toxicological and safety testing methods
that more accurately assess the safety
and hazards of chemicals and products.
ICCVAM evaluations include test
methods and strategies that will reduce
or replace animal use, or refine animal
use by enhancing animal welfare and
avoiding or lessening pain and distress.
The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) established
ICCVAM as a permanent interagency
committee of the NIEHS under
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
work collaboratively to evaluate new
and improved test methods and
strategies applicable to the needs of U.S.
Federal agencies.
NICEATM and ICCVAM welcome the
public nomination of new, revised, and
alternative test methods and strategies
for validation studies and technical
evaluations. Additional information
about NICEATM and ICCVAM can be
found on the NICEATM–ICCVAM Web
site (http://iccvam.niehs.nih.gov).
References
ICCVAM. 2008. The NICEATM–
ICCVAM Five-Year Plan (2008–2012). A
plan to advance alternative test methods
of high scientific quality to protect and
advance the health of people, animals,
and the environment. NIH Publication
No. 08–6410. Research Triangle Park,
NC: NIEHS.
Available: http://
iccvam.niehs.nih.gov/docs/
5yearplan.htm.
Dated: June 4, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Adapting Best Practices for Medicaid
Readmissions.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on March 28th, 2012 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by July 13, 2012.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
[email protected]
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

Proposed Project
Adapting Best Practices for Medicaid
Readmissions
One particular mission of AHRQ is to
improve the efficiency of health care
through reducing unnecessary health
care costs while maintaining or
improving quality. The proposed data
collection supports this goal through
developing strategies to assist safety net
hospitals in reducing readmissions for
Medicaid patients. Previous research
has shown that a focus on transitional
care, including needs assessment,
discharge planning, post-discharge

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intervention, and care coordination can
reduce avoidable readmissions. Based
on this evidence, there have been a
number of strategies and resources
developed for hospitals to reduce
avoidable readmissions, including:
• The Aging & Disability Resource
Centers Evidence-Based Care
Transitions program by the
Administration on Aging & CMS to
support state efforts in implementing
evidence-based care transition models
for older adults and individuals with
disabilities.
• The State Action on Avoidable
Rehospitalizations (STAAR) initiative
by the Institute for Healthcare
Improvement to improve care
transitions and care coordination
through state-based multi-stakeholder
collaborative efforts.
• The Hospital-to-Home (H2H)
initiative by the American College of
Cardiology to reduce readmissions for
patients with cardiovascular conditions.
• Project Re-Engineered Discharge
(RED), funded by AHRQ and the
National Institutes of Health (NIH)
National Heart, Lung, and Blood
Institute, to reduce re-hospitalizations
by improving hospital discharge
processes.
However, the majority of these
strategies and resources focuses on
general patient populations or
specifically targets the elderly and/or
disabled, primarily Medicare
populations. Recent research finds that
rates of readmission among Medicaidinsured non-elderly adults equals that of
the elderly, Medicare-insured
population and is 60 percent higher
than a privately-insured population. It is
not known whether existing resources
and strategies to reduce readmissions
address the circumstances and
characteristics of Medicaid-insured
patients. Particular socio-demographic
characteristics more prevalent in
populations insured through Medicaid,
such as low-income, racial and ethnic
minority, low literacy, housing
instability, mental illness, substance
abuse disorders, chronic and disabling
conditions, language barriers, and
discontinuous insurance coverage may
mean that strategies for reducing
readmissions need to be tailored
specifically to the unique needs of this
population.
Additionally, safety net hospitals,
which serve large populations of the
most vulnerable in society and where
Medicaid is often a major payer, face
unique conditions. Not only do they
serve more vulnerable populations, they
are often constrained by their financing
and governance structures. Safety net
hospitals generally operate on lower

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Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Notices
financial margins than other hospitals
because they are often underpaid for
many services provided to Medicaid
recipients and the uninsured. Faced
with declining contributions from state
and local governments and payment
reduction from both public and private
payers, many are struggling to meet the
growing demand for their services with
stagnant or declining revenues.
Resources addressing hospital
readmissions may also have to be
tailored to meet the unique
circumstances of safety net settings.
This project will recruit six safety net
hospitals to assess the existing resources
and strategies and suggest and test
modifications to address the particular
circumstances related to Medicaid
readmissions and safety net hospital
settings. The goals of this project are to:
• Identify factors at the patient,
provider, and community levels that
especially contribute to hospital
readmissions for Medicaid patients;
• Assess and test existing strategies to
reduce avoidable readmissions for their
adequacy and applicability to Medicaidinsured populations and safety net
hospital settings;
• Modify and test modifications of
existing strategies as necessary for
applicability to Medicaid-insured
populations and safety net hospital
settings; and
• Develop a package of revised
strategies for reducing avoidable
readmissions that are specific to the
factors contributing to Medicaid-insured
patient readmissions in safety net
settings.
Four cycles of testing will be
conducted to collect data on samples of
patient readmissions in each of the
participating hospitals. The data will be
collected and analyzed by the hospital
staff after each cycle. The first cycle will
identify factors related to Medicaid
readmissions, as well as establishing
baseline measures, while the next 3
cycles will be a quality improvement
effort to test the existing strategies, or
modifications to existing strategies, to
address the factors identified in the first
cycle. Each cycle will use a different
sample of Medicaid readmission
patients.
This study is being conducted by
AHRQ through its contractor, John
Snow, Inc. (JSI), pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and on
systems for the delivery of such care,
including activities with respect to the
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appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(1) Medical records review—The
medical records review will gather
background information about a
patient’s index admission and
readmission. Data to be abstracted from
the medical record includes patient
demographic information, living
arrangements, dates and timing of index
and readmissions, lengths of stay,
diagnoses on admission, source of
admission, discharge disposition, and
other transition factors, as well as the
name and setting of the patient’s
primary care provider (PCP), and
whether an appointment was made with
the PCP before discharge.
(2) Patient/family/caregiver
interview—After completion of the
patient’s medical record review,
interviews will be conducted with the
patient and a family member or
caretaker (using the same tool for all)
who has permission to discuss the
patient’s case. The purpose of the
patient/family/caregiver interviews is to
obtain the patient/family perspective, in
their own words, of their index
admission, their transition period, and
their readmission. Data to be collected
includes perspectives on reasons for
readmission, discharge experience,
extent to which they were able to follow
any discharge instructions provided,
setting to which they were discharged,
and any other assistance needed.
(3) Provider interview—Provider
interviews will complete the patient
readmission data. Two providers
involved in each readmission case will
be interviewed. Providers are likely to
be from the hospital setting (e.g.,
hospitalists, admitting physicians,
emergency room physicians) but also
may be from the larger care community
(e.g., primary care, skilled nursing
facility, home health). Providers
selected will change from case to case,
although any particular provider may be
asked about more than one readmission
over the course of the project. Providers
will be asked why they believe the
patient was readmitted and what they
think could have been done to avoid the
readmission.
The purpose of the primary data
collections is to add insight and direct

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35397

patient/family and provider input and
experience into all phases of the project.
The first data collection will provide
patient/family and provider insight into
the process of identifying factors related
to Medicaid readmissions. Based on
these factors, existing readmissions
strategies will be assessed for their
suitability in addressing these factors.
Participating hospitals will then select
existing or modified strategies to test in
their settings using a rapid cycle QI
process. Primary data collection will
occur during each of the three testing
cycles for purposes of gathering patient
and provider insight into the factors
associated with readmissions of
Medicaid patients and gauging the
extent to which the modified strategies
would be able to address those factors.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden for the respondent’s
time to participate in the project. The
medical records review will be
performed by one QI nurse at each of
the 6 participating hospitals for 80
readmission cases (20 from each of 4
cycles) and will take about 20 minutes
per case. In that the primary data
collections are intended to inform the
factors related to Medicaid readmissions
and inform the testing of existing or
modified strategies, there is no set
number of readmissions cases required
during each of the four data collection
cycles. Participating hospitals will be
instructed that it is a process that
should continue until patterns of
response converge and little new
information is being learned, with 20
cases as the maximum during any one
of the four cycles of data collection.
For each readmission case interviews
will be conducted by the QI nurse with
a total of 120 patients and family
member or care giver (20 of each from
each of the 6 hospitals) during each of
the 4 cycles of data collection. The
interviews are estimated to require 10
minutes each. The QI nurse will also
conduct interviews with 2 providers
associated with each readmission case
(a total of 240 providers across the 6
hospitals) during each of the 4 cycles
and will take about 5 minutes. The total
burden is estimated to be 640 hours
annually.
Exhibit 2 shows the estimated cost
burden associated with the respondent’s
time to participate in this project. The
total cost burden is estimated to be
$23,398 annually.

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Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

Medical records review ....................................................................................
Patient/family/caregiver interviews ..................................................................
Patient interview ..............................................................................................
Family/caregiver interview QI Nurse to conduct interviews ............................
Provider interviews:
Provider interviews
QI Nurse to conduct interviews ................................................................

6
120
120
6

80
4
4
160

20/60
10/60
10/60
10/60

160
80
80
160

240
6

4
160

5/60
5/60

80
80

Total ..........................................................................................................

498

na

na

640

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name
Medical records review ....................................................................................
Patient/family/caregiver interviews:
Patient interview .......................................................................................
Family/caregiver interview ........................................................................
QI Nurse to conduct interviews ................................................................
Provider interviews:
Provider interviews ...................................................................................
QI Nurse to conduct interviews ................................................................
Total ..........................................................................................................

Total burden
hours

Average
hourly wage
rate*

Total cost
burden

120

160

$32.56

$5,210

120
120
6

80
80
160

$21.35
$21.35
$32.56

$1,708
$1,708
$5,210

240
6

80
80

$86.96
$32.56

$6,957
$2,605

498

640

na

$23,398

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. Department of Labor, Bureau of Labor Statistics;’’ 29–1111 (Registered Nurse, $32.56/hr); 00–0000 (All Occupations, $21.35/hr); 29–1069 (Physicians and Surgeons, All Other, $86.96/hr).

Estimated Annual Costs to the Federal
Government
The total cost to the government is
estimated to be $253,033, which

includes costs for project development,
data collection, data analysis,
publication, project management, and
overhead as shown in Exhibit 3. The

data collection occurs throughout the
2.5 year project term (30 months); thus,
it has an estimated annual cost of
$101,212.

EXHIBIT 3—ESTIMATED ANNUAL AND TOTAL COSTS TO THE FEDERAL GOVERNMENT
Estimated annual
cost

Task/activity
Project Development ...................................................................................................................................
Data collection .............................................................................................................................................
Data analysis ...............................................................................................................................................
Publication ...................................................................................................................................................
Project Management ....................................................................................................................................
Overhead .....................................................................................................................................................

$7,438
30,866
9,470
5,606
15,086
32,746

$18,596
77,165
23,676
14,016
37,716
81,864

Total ......................................................................................................................................................

101,212

253,033

Request for Comments

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Estimated total
cost

In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed

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collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.

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Dated: June 1, 2012.
Carolyn M. Clancy,
Director.
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