Download Appendix B CARE Instrument

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE AND MEDICAID SERVICES
DATA COLLECTION FOR ADMINISTERING THE MEDICARE
CONTINUITY ASSESSMENT RECORD AND EVALUATION
(CARE) INSTRUMENT
OFFICE OF MANAGEMENT AND BUDGET
CLEARANCE PACKAGE SUPPORTING STATEMENT-PART A
July 17, 2007
CONTENTS
A.
BACKGROUND ....................................................................................................................1
JUSTIFICATION ............................................................................................................................2
A.1 Need and Legal Basis.....................................................................................................2
A.2 Information Users ..........................................................................................................3
A.3 Use of Information Technology .....................................................................................3
A.4 Duplication of Efforts ....................................................................................................4
A.5 Small Businesses ............................................................................................................4
A.6 Less Frequent Collection ...............................................................................................4
A.7 Special Circumstances ...................................................................................................4
A.8 Federal Register/Outside Consultation ..........................................................................4
A.9 Payment/Gifts to Respondents .......................................................................................5
A.10 Confidentiality ...............................................................................................................5
A.11 Sensitive Questions ........................................................................................................6
A.12 Burden Estimates (Hours & Wages) ..............................................................................6
A.13 Capital Costs ..................................................................................................................8
A.14 Cost to Federal Government ..........................................................................................8
A.15 Changes to Burden .........................................................................................................8
A.16 Publication/Tabulation Dates .........................................................................................8
A.17 Expiration Date ..............................................................................................................8
A.18 Certification Statement ..................................................................................................8
Appendix A Master List of CARE Items .........................................................................................9
Appendix B CARE Instrument ......................................................................................................10
Appendix C Deficit Reduction Act Section 5008 ..........................................................................11
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Supporting Statement for Administering the Medicare Continuity Assessment
Record and Evaluation (CARE) Instrument
A.
BACKGROUND
The Medicare Continuity Assessment Record and Evaluation (CARE) is a uniform
patient assessment instrument designed to measure differences in patient severity, resource
utilization, and outcomes for patients in acute and post-acute care settings. This tool will be used
to 1) standardize program information on Medicare beneficiaries’ acuity at discharge from acute
hospitals, 2) document medical severity, functional status and other factors related to outcomes
and resource utilization at admission, discharge, and interim times during post acute treatment,
and 3) understand the relationship between severity of illness, functional status, social support
factors, and resource utilization. The CARE instrument will be used in the Post-Acute Care
(PAC) Payment Reform Demonstration program mandated by Section 5008 of the Deficit
Reduction Act of 2005 to develop payment groups that reflect patient severity and related cost
and resource use across post acute settings. The Centers for Medicare and Medicaid Services
(CMS) awarded the contract for both the uniform patient assessment development and for the
payment reform demonstration to RTI, International (RTI) who teamed with experts from each
of the different levels of care, including acute, rehabilitation, and long term care hospitals;
skilled nursing facilities, and home health care.
The lack of a uniform post-acute assessment tool is one of the major limitations to
understanding variations in post-acute outcomes, cost-effectiveness, and Medicare payments.
The CARE instrument has been developed as a uniform assessment instrument and includes
items measuring case mix at hospital discharge and explaining expected resource use and
outcomes in each level of post-acute care, given the individual characteristics of the patient. The
major items collected on the CARE instrument include those related to:

Administrative information, such as provider, beneficiary, and payer data

Admission Information, including prior use and pre-morbid status

Current Medical items such as diagnoses, procedures, medications, allergies, skin
integrity, and physiologic factors related to the current admission

Cognitive Status and other interview-based items to measure risk of delirium,
depression, and pain

Physical Factors, including functional status and physical impairments

Factors affecting outcomes, such as engagement levels and Frailty or Life
Expectancy, and

Discharge Items, including discharge and caregiver information that might affect
these choices
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The instrument includes a core set of items to measure basic acuity on all patients and
screen for particular conditions. Most of these items are commonly collected in patient
assessments in all settings. A longer version containing supplemental items will be used in postacute settings to measure variations in functional status, impairments, and skin integrity for
patients having any of these problems. For cases with none of these deficits, the respondent will
skip some of the medical items, and all the impairment and functional status items. Each of
these sections have screening questions to determine whether the supplemental items are needed
(see Appendix A – Master List of Items).
The CARE tool is based on input from each of the different settings, including 4 clinical
workgroups with experts from each setting to discuss 1) medical, 2) functional, 3) cognitive, and
4) social support issues. These experts were charged with identifying items that effect resource
use, resource needs, or outcomes. The workgroups were also charged with building on the
current scientific evidence from each field to develop a tool that would effectively measure
resource needs and outcomes but still minimize the burden on providers. The workgroups began
with an examination of current assessment tools, including a sample of those used by acute and
long term acute hospitals, as well as the 3 Federally mandated assessment tools currently used in
the Medicare program: the IRF Patient Assessment Instrument (IRF-PAI), the Minimum Data
Set 2.0 used in skilled nursing facilities, and the Outcome and Assessment Information Set
(OASIS) used in home health agencies. Input from those revising the current Federal tools was
incorporated as well as recommendations from CMS based on other related efforts to measure
quality of care, and input from two Technical Expert Panels, on-going discussions with the
AHA, AMPRA, NALTH, ALTHA, AHCA, AANAC, AAHSA, VNAA, JCAHO, CARF, and
other associations. The team has been presenting early drafts at many of these association
meetings and inviting input to the demonstration website: [email protected]. This
process has lead to constant revisions and updates to develop a tool that measures basic case-mix
across the Medicare population, including types of conditions as well as severity of illness. The
tool has been designed to limit provider reporting burden, both conceptually and electronically.
The CARE tool will be an electronic, web-based tool that will allow providers to select
the items that are appropriate for the type of case being treated. The technology builds on item
response theory to develop an item bank for standardizing the types of items collected in the
Medicare program while allowing respondents to “skip” items not relevant for the type of case
being treated. Providers will be able to choose whether to submit their data electronically to
CMS or to continue to use their current vendors. The system is being developed as an
interoperable data system meeting CHI standards and allowing the limited CARE tool to later be
merged with other components of a provider’s record system. It contains only a subset of the
items currently in the IRFPAI, MDS, and OASIS but will be able, in the future, to merge with
the remaining care planning items a provider may be using.
JUSTIFICATION
A.1
Need and Legal Basis
CMS requires the use of standardized assessment instruments to collect and report
specified data on Medicare patients receiving post-acute services in skilled nursing facilities
(SNF), home health agencies (HHA) and inpatient rehabilitation facilities (IRF). There is no
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required instrument for long term care hospitals (LTCH) or acute care hospitals. The current
assessment instruments are used for payment purposes and contain many similar questions as
well as setting specific questions. However, the item definitions and rating scales differ across
settings, and instructions for data collection specify different time periods in each setting. These
differences in the existing assessment instrument make it difficult to compare patient function
and clinical characteristics across post-acute care settings.
Medicare policy makers have sought a means to compare patients cared for in the
different post-acute care settings. In 2005, Congress passed the Deficit Reduction Act (DRA)
which charged CMS with the development of a single comprehensive assessment to be used
across all post-acute settings. This instrument was also mandated for use in the Post-Acute Care
(PAC) Payment Demonstration program (Section 5008 of the DRA). Congress requires that this
single patient assessment instrument 1) detail the needs of the patient, 2) describe the clinical
characteristics of the patient’s diagnosis that determine the appropriate post-acute care setting for
treatment, and 3) be used across all post-acute care sites in order to measure functional status and
other factors during treatment and at discharge from each site of care. Appendix C contains the
legislative language for Section 5008 of the DRA.
The Post-Acute Care (PAC) Payment Demonstration will take place for a 3-year period
although data collection will be limited to the first 18 months. The purpose of the demonstration
is to collect data that will enable CMS to better understand the relationships among patient
needs, post-acute care placement, patient outcomes, and post-acute care costs and resource use in
the Medicare program. The demonstration includes the CARE instrument data collection which
will be combined with cost/resource use data and Medicare claims data to develop a post-acute
care payment reform model. CMS will deliver a Report to Congress on the demonstration
including results and recommendations for legislation and administrative action as the Secretary
determines to be appropriate.
A.2
Information Users
The data collected using the CARE instrument during the Post-Acute Care Payment
Demonstration will be used by CMS to develop a setting neutral post-acute care payment model
as mandated by Congress. The data will be used to characterize patient severity of illness and
level of function in order to predict resource use, post-acute care discharge placement, and
beneficiary outcomes. CMS will use the data from the CARE instrument to examine the degree
to which the items on the instrument can be used to predict beneficiary resource use and
outcomes. Internet-based software developed by CMS will be used to collect and transmit the
CARE data electronically.
A.3
Use of Information Technology
The CARE data will be collected electronically using an internet-based platform
developed through a CMS contract to Northrop Grumman. The goal of this data collection
method is to reduce provider burden. The instrument will be available at a secure CMSaddressed website and data will be transferred to CMS via the website once the data in each
CARE record has been finalized at the participating provider sites. All providers participating in
the demonstration will enter their data electronically. Internet access will be provided to
demonstration sites in areas without an internet connection.
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The CARE instrument is a new data collection tool and will be solely electronic. The data
collection does not require a signature from the respondent, but the electronic software will have
a place for respondents to finalize the data prior to submission.
A.4
Duplication of Efforts
This information collection does not duplicate any other effort and the information cannot
be obtained from any other source. There is no other assessment instrument that provides
standardized comparable information on patients admitted to the full range of post-acute
providers. Items on existing patient assessment instruments differ in their definitions and rating
scales preventing comparison of patient populations across post-acute care settings. The CARE
instrument is being designed to standardize the information collected across post-acute care
settings. Though the current assessment will continue to be collected during the demonstration,
the CARE instrument may eventually replace the current instruments and reduce provider
burden.
A.5
Small Businesses
Providers participating in the demonstration will potentially include small home health
agencies and skilled nursing facilities as well as larger hospitals and other post-acute providers.
Provider participation in the demonstration is voluntary. Small providers viewing the data
collection as a burden can refuse to participate.
A.6
Less Frequent Collection
This is a one-time data collection effort limited to the three-year study period of the PostAcute Care Payment Reform Demonstration as mandated by Congress under Section 5008 of the
Deficit Reduction Act of 2005. Data collection will be limited to providers volunteering to
participate in the demonstration.
A.7
Special Circumstances
The CARE instrument will be administered on all Medicare patients at discharge from
acute care hospitals, at admission and discharge from other post-acute care providers, and at
interim points during a patient admission for a nine month period during the Post-Acute Care
Payment Reform Demonstration. Data coordinators at participating demonstration providers will
review and finalize the CARE data for submission to CMS as patients are admitted to and
discharged from each setting. Frequency of data reporting to CMS will depend on the volume of
Medicare admissions and discharges at participating providers.
A.8
Federal Register/Outside Consultation
CMS developed the CARE tool in consultation with experts in patient assessment, item
development, Medicare payment policy, as well as clinicians and provider association
representatives. CMS held an Open Door Forum on the instrument development in December
2006 and invited input from the provider and beneficiary communities regarding issues they
would like to see addressed Two technical expert panels were convened to solicit feedback on
the feasibility of implementing this instrument in acute hospitals and the full range of post-acute
care providers. The first technical expert panel included representatives from post acute
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providers and provider associations and the second technical expert panel included clinicians and
researchers in post-acute care, item and scale development, and Medicare payment policy. The
panels were integral to item and scale development, and efforts to ensure that the tool is feasible
and can be implemented with minimum burden to providers. CMS also established an email
address inviting comments on the CARE instrument development and any other feedback from
post-acute care researchers and providers. Following the publication of the Federal Register
Notice, CMS will review and incorporate additional comments and feedback from the public.
Members of the CARE instrument development team outside of CMS include:
A.9

Barbara Gage, RTI International

Shulamit Bernard, RTI International

Roberta Constantine, RTI International

Anne Deutsch, Rehabilitation Institute of Chicago

Trudy Mallinson, Rehabilitation Institute of Chicago

Margaret Stineman, University of Pennsylvania

Christopher Murtaugh, Visiting Nurse Service of New York

Debra Saliba, RAND Corporation

Patrick Murray, Case Western Reserve University
Payment/Gifts to Respondents
There will be no payments/gifts to respondents to the CARE instrument.
A.10
Confidentiality
The data collected in the CARE instrument will be kept confidential by RTI and CMS.
Only authorized staff at participating demonstration providers and project staff at CMS and RTI
will have access to respondents’ data. Data will be stored in a secure format meeting all federal
privacy guidelines. Data will be collected using a secure internet-based platform for electronic
data entry and secure data transmission. The internet-based electronic system will be password
protected with access limited to project staff. To protect beneficiary confidentiality, the subject’s
name will not be linked to his/her individual data. For identification purposes, a unique ID
number will be assigned to each sample member.
All patient-level data are protected form public dissemination in accordance with the
Privacy Act of 1974, as amended. The information collected is protected and held confidential in
accordance with 20 CFR 401.3. Data will be treated in a confidential manner, unless otherwise
compelled by law.
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A.11
Sensitive Questions
The information collected in the CARE instrument is considered to be confidential
personal health information. This individual level data is considered sensitive and all necessary
protections will be employed to keep the data secure and confidential. Though this information is
considered to be personal health information, similar information is currently collected in other
CMS instruments. The items on the CARE instrument are being collected for CMS operational
purposes and the data will be used for analysis in the Post-Acute Care Payment Reform
Demonstration.
A.12
Burden Estimates (Hours & Wages)
The estimated time to complete the CARE instrument varies by patient severity of illness.
During limited pilot testing, CMS and RTI found that in took approximately 45 minutes to
complete the form in home health agencies, long term care hospitals, and inpatient rehabilitation
hospitals. In skilled nursing facilities, the time to complete the CARE instrument was closer to
60 minutes. The difference in time to complete across post-acute care settings is driven by
differences in the patient populations.
In acute care settings, the time to complete the form can be as short as 20 minutes for the
two-thirds of patients discharged home, but time to complete is longer, approximately 45
minutes, for the one-third of patients discharged to post acute settings. Patients discharged home
are less likely to have functional and cognitive impairments that require additional
documentation in the CARE form and therefore the time to complete the CARE instrument for
these patients is shorter.
Across all settings, the time to complete the form varies significantly depending on a
beneficiary’s severity of illness. The time to complete the instrument is shorter for beneficiaries
who are very healthy and can skip sections of the instrument and the time to complete the
instrument is longer for beneficiaries with some functional or cognitive limitations. A sample
calculation of the time burden associated with the CARE instrument is shown in Table A-1. This
table shows the estimated burden for each provider type participating in the demonstration. The
total burden associated with the 94,292 CARE assessments we expect to collect for the purposes
of the demonstration is 66,841 hours. The number of CARE assessments is based on estimates of
the number of Medicare beneficiaries admitted to participating providers during the
demonstration period.
In addition to the providers that will be participating in the demonstration, we expect that
there will be a number of other providers that will be interested in collecting data using the
electronic CARE instrument. Based on inquiries to participate thus far, we estimate that an
additional 238 providers may ask to test the system leading to the collection of an additional
150,000 assessments. We estimate that these 238 providers will include 25 acute hospitals, 17
long term care hospitals, 44 inpatient rehabilitation facilities, 76 skilled nursing facilities, and 76
home health agencies.
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Table A-1.
Estimated Response Burden for CARE
Target
Number of
Participating
Providers
Expected
Number of
Admission &
Discharge
Assessment
Patients
Number of
Admission &
Discharge
Assessments
Number of
Interim
Assessments
Total
Number of
Assessments
Average
Burden
Hours Per
Response
Total
Burden
Hours
Acute Hospitals (Excluding CAHs)
15
28,439
28,439
0
28,439
0.55
15,642
LTCHs
11
2,457
4,915
386
5,300
0.75
3,975
IRFs (Freestanding)
7
3,559
7,119
520
7,639
0.75
5,729
IRFs (Hospital Unit)
21
4,064
8,127
520
8,647
0.75
6,485
SNF (Freestanding)
42
3,002
6,004
504
6,509
1.00
6,509
SNF (Hospital Unit)
6
343
687
45
732
1.00
732
HHA (Freestanding)
39
14,632
29,263
2,245
31,508
0.75
23,631
HHA (Hospital-Based)
9
2,562
5,125
393
5,518
0.75
4,138
150
59,059
89,678
4,613
94,292
0.55-1.00 hours
66,841
150,000
0.75
112,500
Provider Type
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Total Demonstration Providers
Assessments from additional providers volunteering to collect data, but not part of the demonstration
238
93,750
142,662
7,338
NOTES:
The expected number of CARE assessment patients is equal to the average number of Medicare discharges (episodes for HHAs), excluding the top and bottom
deciles for each setting, multiplied by: the assumed fraction of each setting provider participating; the assumed fraction of the year for which CARE assessments
will be collected on Medicare patients (nine of twelve months, or 0.75); and the number of participating providers of that setting type. Acute hospitals will only
collect discharge assessments. HHAs will collect one interim assessment for each patient treated during each of three two-week periods coinciding with cost and
resource use data collection in their market.
A.13 Capital Costs
There are no additional capital costs to respondents or to record keepers.
A.14
Cost to Federal Government
There is not additional cost burden to the federal government beyond what Congress has
allocated for the demonstration.
A.15
Changes to Burden
There are no program changes or adjustments.
A.16
Publication/Tabulation Dates
There are no publications and tabulations associated with this collection.
A.17
Expiration Date
The OMB expiration date will be displayed on all disseminated data collection materials.
A.18
Certification Statement
There are no exceptions to the certifications statement.
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APPENDIX A
MASTER LIST OF CARE ITEMS
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APPENDIX B
CARE INSTRUMENT
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APPENDIX C
DEFICIT REDUCTION ACT SECTION 5008
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SEC. 5008. POST-ACUTE CARE PAYMENT REFORM DEMONSTRATION
PROGRAM.
(a) ESTABLISHMENT.— (1) IN GENERAL.—By not later than January 1, 2008, the Secretary
of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall establish a
demonstration program for purposes of understanding costs and outcomes across different postacute care sites. Under such program, with respect to diagnoses specified by the Secretary, an
individual who receives treatment from a provider for such a diagnosis shall receive a single
comprehensive assessment on the date of discharge from a subsection (d) hospital (as defined in
section 1886(d)(1)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(1)(B))) of the needs of
the patient and the clinical characteristics of the diagnosis to determine the appropriate
placement of such patient in a post-acute care site. The Secretary shall use a standardized patient
assessment instrument across all post-acute care sites to measure functional status and other
factors during the treatment and at discharge from each provider. Participants in the program
shall provide information on the fixed and variable costs for each individual. An additional
comprehensive assessment shall be provided at the end of the episode of care. (2) NUMBER OF
SITES.—The Secretary shall conduct the demonstration program under this section with
sufficient numbers to determine statistically reliable results. (3) DURATION.—The Secretary
shall conduct the demonstration program under this section for a 3-year period. (b) WAIVER
AUTHORITY.—The Secretary may waive such requirements of titles XI and XVIII of the
Social Security Act (42 U.S.C. 1301 et seq.; 42 U.S.C. 1395 et seq.) as may be necessary for the
purpose of carrying out the demonstration program under this section. (c) REPORT.—Not later
than 6 months after the completion of the demonstration program under this section, the
Secretary shall submit to Congress a report on such program, that includes the results of the
program and recommendations for such legislation and administrative action as the Secretary
determines to be appropriate. (d) FUNDING.—The Secretary shall provide for the transfer from
the Federal Hospital Insurance Trust Fund established under section 1817 of the Social Security
Act (42 U.S.C. 1395i), $6,000,000 for the costs of carrying out the demonstration program under
this section.
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