[Federal Register Volume 62, Number 46 (Monday, March 10, 1997)]
[Proposed Rules]
[Pages 11035-11064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5315]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 484
[HSQ-238-P]
RIN 0938-AH74
Medicare and Medicaid Programs: Use of the OASIS as Part of the
Conditions of Participation for Home Health Agencies
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would add additional requirements to the
proposed revision to the conditions of participation for home health
agencies (HHAs) which also appear in this issue of the Federal
Register. Specifically, this proposed rule would require that HHAs use
a standard core assessment data set, the ``Outcomes and Assessment
Information Set'' (OASIS), when evaluating adult, non-maternity
patients.
This proposed rule is an integral part of the Administration's
efforts to achieve broad-based, measurable improvement in the quality
of care furnished through Federal programs. It is a fundamental
component in the transition to a quality assessment and performance
improvement approach that focuses on stimulating measurable improved
outcomes of care and patient satisfaction in the Medicare and Medicaid
home health benefit while at the same time reducing burdens on
providers.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5:00 p.m. on June
9, 1997.
ADDRESSES: Mail written comments (one original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HSQ-238-P, P.O. Box 7518,
Baltimore, MD 21207-0519.
If you prefer, you may deliver your written comments (one original
and three copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW,
Washington, DC 20201, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments may also be submitted electronically to the following e-
mail address: hsq238phcfa.gov. E-mail comments must include the full
name and address of the sender and must be submitted to the referenced
address in order to be considered. All comments must be incorporated
into the e-mail message because we may not be able to access
attachments. Electronically submitted comments will be available for
public inspection at the Independence Avenue address below.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HSQ-238-P. Comments received timely will be available for
pubic inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue, SW, Washington,
D.C., on Monday through Friday of each week from 8:30 a.m. to 5:00 p.m.
(phone (202) 690-7890).
For comments that relate to information collection requirements,
mail a copy of the comments to: Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building, Washington, DC 20503, Attn: Allison Herron Eydt, HCFA
Desk Officer.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 37194, Pittsburgh, PA 15250-7954.
[[Page 11036]]
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FOR FURTHER INFORMATION CONTACT: Mary Vienna, (410) 786-6940.
SUPPLEMENTARY INFORMATION:
I. Background
A. Purpose of Proposed Regulation
Separately in this issue of the Federal Register, we are publishing
a notice of proposed rulemaking that would revise the current
conditions of participation that HHAs must meet to participate in the
Medicare program, the Medicaid program, or both programs. Those
proposed regulations would make the conditions of participation more
patient-centered and outcome-oriented and provide the HHAs with more
flexibility to operate their programs. As an important part of those
proposed revisions, we are introducing the proposed requirement that
each HHA develop, implement, and manage an outcome-based quality
assessment and performance improvement program. Such a program would
provide a foundation for enabling an HHA to monitor the impact of its
care on its customers' health status and satisfaction. The information
that the HHA derives from this program will enable the HHA to implement
real and lasting change to enhance outcomes of care.
In this proposed rule, we are proposing that Medicare-approved HHAs
and those HHAs that are required to meet Medicare conditions of
participation (which, by definition, includes Medicaid HHAs and managed
care organizations providing home health services to Medicare and
Medicaid beneficiaries) be required to incorporate the core standard
assessment data set included in this proposal, called the ``Outcomes
and Assessment Information Set'' (OASIS), into their comprehensive
assessment process. (The use of the term ``HHA'' will be used
throughout this discussion as a generic term to apply to all
environments in which this regulation would apply.)
We intend that the OASIS become one of the most important aspects
of the HHA's quality assessment and performance improvement efforts. By
integrating a core standard assessment data set into its own more
comprehensive assessment system, an HHA can use such a data set as the
foundation for valid and reliable information for patient assessment,
care planning, and service delivery, as well as to build a strong and
effective quality assessment and performance improvement program.
B. Background of the OASIS
1. How HHA Quality Indicators Were Developed
We have long been interested in the development of outcome measures
in health care. In 1988, we entered into a contract with the Center for
Health Policy Research and the Center for Health Services Research at
the University of Colorado Health Sciences Center to develop, test, and
refine a system of outcome measures that could be used for outcome-
based quality improvement in HHAs. The Robert Wood Johnson Foundation
provided funding to support work on additional, related tasks. The
system is intended to form the foundation for continuous quality
improvement (which we call in the proposed conditions of participation
published elsewhere in this issue of the Federal Register ``quality
assessment and performance improvement'') that could be used to enhance
care in agencies where quality is lacking, and to reinforce and further
improve patient outcomes and satisfactory in HHAs where care is already
exemplary.
Before the system could be constructed, numerous definitional and
methodological issues had to be addressed. We are presenting a brief
summary of those issues as part of this preamble. Anyone wishing a more
detailed explanation of the work that was necessary to develop this
system may request one of the publications referenced in this preamble.
We adopted the consensus definition of ``quality'' developed by the
Institute of Medicine that states ``quality is the degree to which
health services to individuals and populations increase the likelihood
of desired health outcomes and are consistent with current professional
knowledge.'' The usefulness of this definition is threefold. First, it
recognizes that ``quality'' can occur in varying amounts, not simply in
an all-or-nothing manner. Second, this definition encompasses the
beneficiary's desires and expectations for outcomes, and not just what
the ``professional'' decides. Third, it does not guarantee the desired
outcome will be achieved. Rather, quality care ``increases the
likelihood'' that needed or desired outcomes will be achieved. In this
regard, the implied relationship between quality care or quality of
services and outcomes highlights the fact that higher quality care
should produce better outcomes. Consequently, the most effective
indicator of the quality of care is the actual, consistent attainment
of desired health outcomes. As a result, we regard outcomes as central
to ensuring and improving care.
Overall, we define an ``outcome'' as a ``change in health status
over time.'' In using this definition, we recognize that ``health
status'' is a broad term, encompassing physiologic, functional,
cognitive, social, and mental health. To properly measure a specific
outcomes in any of these areas, it is necessary to collect precise
information on the health status indicator of interest at the start of
care and at followup points. Satisfaction, however, need only be
measured at discharge, though it can be measured at interim points as
well.
For our purposes, a patient- or consumer-level outcome can be
thought of as a change in health status that occurs during the timespan
that begins with the start of care and ends with either the discharge
from the HHA or some other followup point after the start of care.
Thus, changes in the status of a wound, ability to ambulate, shortness
of breath (dyspnea), or ability to manage oral medications are outcomes
when such changes are assessed between the start of care and followup
time points. Hospitalization and use of emergency care during the home
care interval can also be regarded as outcomes, since these events
usually occur as a result of a change in health status, typically of an
untoward nature. Indicators of consumer satisfaction are also outcomes
in that they may represent changes in
[[Page 11037]]
cognitive or emotional status in response to home health care.
Nonetheless, we sometimes speak of outcomes and satisfaction in this
proposal to emphasize the importance of beneficiary satisfaction as a
particular type of outcome.
A critical element of any quality assessment and performance
improvement program in home health care is precise information about
performance, particularly consumer outcomes. Such information must be
available to the HHA so it can identify and remedy poor outcomes,
identify and reinforce exemplary outcomes, and evaluate progress
resulting from remedied or reinforced actions. The most efficient way
in which HHAs can gather such information is by maximizing the overlap
between items needed to measure patient outcomes and those routinely
used for purposes of patient assessment, care planning, and service
delivery.
The terms ``quality indicators,'' ``performance measures,'' and
``outcome measures'' are often used interchangeably, though technically
they can vary somewhat in meaning. Regardless, they all refer to
attributes of care and satisfaction that can be used to gauge quality
in specific areas. For example, the degree of improvement in a
functional area (such as ability to walk after a hip replacement) is a
quality indicator. However, defining and quantifying that improvement
results in a ``performance measure'' or ``outcome measure'' that
assigns a numeric value to the attribute being evaluated. So, while it
is accurate to say that improvement in ambulation is a ``quality
indicator,'' the improvement becomes a precise and usable quantity
measurement when we assign numbers to the patient's performance.
The first step in the development of quality indicators was to
agree on outcomes that can be used as valid and reliable indicators of
quality care. In dealing with such issues as payment and utilization,
the outcomes of care and level of satisfaction the patient experiences
can be overlooked. Although outcomes are not yet being measured
systematically, we often assume that the care provided accomplishes
what we expect. Home health care is no exception. While we recognize
that patients have a strong preference for home care over most
alternatives, we know little about the effectiveness of home care.
Interest in the outcomes of home care, therefore, was arising from
payers, accrediting bodies, consumers, and the home care industry
itself. This interest provided impetus and credibility to the search
for outcomes that can be used a valid and reliable indicators of
quality care.
The way in which well-tested and established quality indicators are
developed is straightforward, although time consuming and resource
intensive. Clinical experts (especially those who actually deliver home
care services to people), researchers, patients, and others (for
example, administrators) ``nominate'' aspects of the total care process
and the outcomes of care across a variety of patient conditions and
problems. The list of candidate quality indicators can be very long,
including relevant indicators from research, applied literature, and
current use. From this list, expert panels group the nominees and
specify them more precisely as workable representations of attributes
of care, outcomes, or satisfaction that can be measured.
Once the set of nominated quality indicators (outcome indicators in
this case) is refined and defined, it is further tested for validity,
utility and reliability. When we test for validity and utility, we
consider such issues as whether or not the indicators actually reflect
what they purport to reflect in terms of patient outcomes, the ability
to detect differences among patient groups or types of agencies which
are expected to vary in terms of outcomes, utility for examining the
effectiveness of care, and acceptance among clinicians. When we test
for reliability, we consider such issues as whether or not the
information collected on the same patient by different evaluators
yields similar judgments about the performance indicators being
measured.
As an illustration, we know that improvement in ability to ambulate
is a quality indicator. During development of performance measures
based on the nominated quality indicators, the specific definition of
``ambulation/locomotion status,'' that was used in testing for validity
and reliability, included a six-level scale (0-5). This scale described
ambulation from completely bedfast to independence by using specific
and precise terminology associated with each of the six levels on the
scale. The wording for each level was carefully chosen and refined
through both expert review and empirical testing. For example, the one-
level in the scale states: ``Chair fast, unable to ambulate even with
assistance but is able to wheel self independently.'' The wording for
this particular level was specified, reviewed, and then tested by
having different care providers collect this information on the same
patients to assess the extent of agreement and reliability among
different raters. Appropriate changes were made and further testing was
conducted in terms of utility and clinical acceptability, with
additional refinements occurring as needed.
To properly measure outcomes as changes in health status between
two time points, reliable and precise health status scales such as the
ambulation scale are needed to render the outcome measures themselves
reliable and precise. All health status items in the OASIS underwent
such testing since these items will be used for either measuring
outcomes or for risk-adjusting outcomes for potential differences in
agency risk factors or case mix. The OASIS also contains items relating
to independence of functioning and available family and environmental
support. While not directly ``health status items,'' they are vital
measurements of the context in which a person's health status exists.
For example, people with the same health status but with different
supports may experience different outcomes.
The criteria the researchers used for selecting the outcome
measures included:
(1) Clinical meaningfulness in terms of perceived importance of the
measure for outcome-based quality improvement;
(2) Interrater reliability of the data items needed to compute the
measures as reflected by two or more reviewers rating a patient's
condition similarly;
(3) Diversity of the measures in terms of the different dimensions
of health status including functional, physiological, behavioral/
emotional, and cognitive status;
(4) Minimal redundancy in terms of clinical information content
within the entire measure set;
(5) Validity as reflected by the abilities of the measures to
detect agency-level differences in quality of care;
(6) Validity as indicated by the abilities of the measures to
detect differences between patient groups or types of agencies expected
to vary in terms of outcomes;
(7) Validity in terms of the clinical meaningfulness of
relationships among outcome measures;
(8) Validity as reflected by the clinical meaningfulness of the
relationships between outcome measures and risk factors or case mix
variables;
(9) Sufficient prevalence from a statistical perspective so that
the outcome measures would not signify extremely rare or extremely
common events;
(10) Minimal statistical redundancy among measures, so that
individual measures each can be shown to convey unique information; and
[[Page 11038]]
(11) Utility of the data items employed to define and compute
outcome measures in terms of the meaningfulness and face validity of
such items for assessment and care planning for home care patients.
As we discuss in detail in section I.B.2 of this preamble, the
individual items of the OASIS are valid and reliable in computing those
outcome measures of patient health status shown to be useful ``quality
indicators'' for home care. When the HHA staff who complete the
comprehensive assessment use the OASIS as part of the process, they
are, in fact, laying the groundwork for planning an effective course of
care for an individual patient and for a set of comparable performance
data aggregated across patients that can help to shape the agency's
agenda for continuous improvement.
We intend to require that HHAs use the OASIS exactly as specified.
This requirement is a necessary predicate to building a valid,
reliable, comparable data set of outcomes. The items on the OASIS
underwent rigorous validity and reliability testing, as discussed in
section I.B.2. of this preamble. Consequently, trained individuals can
have confidence in using the data items as part of their comprehensive
assessment of patients. This confidence extends, then, to the
comparability of the data acquired using the same items to amass
information from other patients, either in the same HHA or others, as
long as the assessments are conducted accurately, using the measurement
criteria spelled out for each item. Altering the items or using a
different tool and transposing the data onto the OASIS destroys the
essential validity and, therefore, the comparability of the data
collected. The HHA can rearrange and/or distribute the OASIS items
within the agency's comprehensive assessment system as long as the
items themselves remain exactly as written and specified by the
Secretary.
While this explanation of how the quality indicators were developed
is brief, the actual work to develop more than 150 indicators took most
of 5 years using expert clinical panels and volunteer HHAs for
empirical field testing. Further details on how the home health quality
indicators were developed, including validity and reliability testing,
are included in the final report of A Study to Develop Outcome-Based
Quality Measures for Home Care, available from the Center for Health
Policy Research and Center for Health Services Research, University of
Colorado, Health Sciences Center, 1355 S. Colorado Blvd., Suite 306,
Denver, CO 80222. Additional information on outcome-based quality
improvement can also be found in ``Measuring and Assuring the Quality
of Home Care,'' Health Care Financing Review, 16(1):35-67, Fall 1994,
and Outcome Based Quality Improvement: A Manual for Home Care Agencies
on How to Use Outcomes, August 1995, National Association for Home
Care, 228 South Street, SE., Washington, DC 20003.
2. Evolution of Medicare's Core Standard Assessment Data Set (OASIS)
As part of the Medicare Home Health Initiative started in 1994, we
began discussions with the industry, professional and consumer groups,
and enforcement agencies. These discussions articulated our desire that
the new conditions of participation serve both the clinical needs of
the agency and our emerging quality assessment and performance
improvement agenda.
In late 1994, we convened a workgroup of clinical assessment
experts representing HHAs and national associations of home care
providers along with other experts in assessment, including a
representative from the University of Colorado, to help shape the
development of an assessment tool. The group suggested it was
unnecessary to mandate a comprehensive assessment tool since the
majority of agencies are already using such tools. The understandable
diversity in such tools that arises from caring for special types of
patients (for example, pediatric, chronic, high technology, or Human
Immunodeficiency Virus patients) would render a single mandated
comprehensive tool unwieldy. The group agreed that the required
assessment set should be parsimonious, have maximal overlap with the
types of information agencies are already collecting at assessment (to
the extent possible), and be shorter and less complicated than the
Resident Assessment Instrument, another Federal assessment instrument
mandated for use by nursing homes.
The group recommended that we use the data items developed by the
University of Colorado for computing risk-adjusted patient outcomes.
The precision of the individual items in this data set makes them
particularly useful in patient assessment and care planning in addition
to their intended use in measuring outcomes. The workgroup recommended
the addition of a small number of assessment items for a total of 79
(plus 10 patient identifier items, for example Medicare number, that
are commonly used already for billing and other administrative
purposes), and the core standard assessment data set was completed. We
wish to make it clear that this data set is not, therefore, intended to
constitute a complete comprehensive assessment instrument. Rather, the
data set comprises items that are a necessary part of a complete
comprehensive assessment and are essential to uniformly and
consistently measuring patient outcomes. These items are already used
in one form or another by virtually all HHAs, and many more are usually
used by HHAs that conduct thorough assessments. Likewise, the OASIS
comprises fewer items than the Resident Assessment Instrument, another
Federal assessment instrument mandated for use by nursing homes.
The workgroup recommended that HCFA determine: (1) How the core
standard assessment data set could be incorporated into HHAs' patient
assessment processes (HHAs would need to include additional items for
the purpose of ``comprehensive'' patient assessment); and (2) if the
tool was effective in assisting home health clinical staff to assess
certain aspects of patient health and functional status, thus providing
information necessary for effective and efficient care planning and
service delivery. As the workgroup was concluding its work on the core
standard assessment data set in early 1995, the University of Colorado
was embarking on a new HCFA-funded project to demonstrate how the
quality indicators developed during the previous 5 years could be used.
The primary goal of the new project was to assess whether the data set
would be of value in targeting and guiding improvements in outcomes and
satisfaction for HHA patients. The researchers agreed to use the data
set as modified by HCFA and to pilot its effectiveness as the core
standard assessment data set. It was at this point that the data set
was named the Outcomes and ASsessment Information Set, or OASIS.
The demonstration currently underway involves the voluntary
participation of 50 HHAs distributed across the country. They have been
trained to use the OASIS and have begun collecting and transmitting
data to the Research Center at the University of Colorado. (The
Research Center is also testing a telephone satisfaction questionnaire
that is being administered to patients after HHA discharge. The results
will help assess the relationship between outcomes and satisfaction.)
Data are returned to the HHA as outcome reports, so that the HHA can
see how it is performing in terms of
[[Page 11039]]
patient outcomes compared with other HHAs in the project. As each data
reporting period passes, the database builds, providing additional
comparative data back to agencies for use in planning and implementing
performance improvement activities. Subsequent outcome reports can
assist in evaluating the effectiveness of such activities.
For example, a particular HHA receives an outcome report that shows
that 20 percent of its orthopedic patients improved in ability to
ambulate by either the 60th day of treatment or the date of discharge,
depending upon which came first. The HHA's 20-percent outcome compares
with a 40-percent aggregated outcome of the orthopedic patients from
all demonstration agencies. Because this 20-percent outcome finding is
significantly less than the 40-percent aggregated outcome, the staff
makes a determination that this is an outcome that should be
investigated further. Using record review, team evaluation and other
quality improvement techniques, the HHA staff determines that a
potential reason for the low rate of improvement is lack of
coordination between physical therapists and other care providers. This
lack of coordination, in turn, results in minimal reinforcement of
patient exercise programs by others on the care delivery team. The
agency staff, therefore, develops and implements a precise action plan
or performance improvement plan that strengthens team coordination of
specific and relevant caregiving actions. The next outcome report
indicates that the number of orthopedic patients improving in ability
to ambulate is 35 percent, suggesting that the performance improvement
activities resulted in better patient care, thereby producing improved
outcomes.
Thus, collection of OASIS data can be used not only in patient-
level applications (assessment, care planning, and care delivery) but
also for agency-level performance improvement. As an HHA improves over
time across various outcome dimensions, the aggregated data will show
improvement as well, and average agency performance will likewise
continue to improve. Not only will this be advantageous for Medicare
beneficiaries and other home care clients, but it will be of value to
the home care industry in demonstrating its effectiveness. We want to
stress, however, that in order for the OASIS data to be helpful for all
its purposes, the OASIS items must be filled out accurately. As they
begin to collect the OASIS items, HHAs should set up procedures to
monitor data accuracy such as conducting validation visits to verify
accuracy, interdisciplinary comparisons and record reviews. In fact,
data entry accuracy can, and should be, an essential part of the HHA's
quality assessment and improvement program, since data accuracy is a
fundamental building block of an effective program.
We are aware that large numbers of HHAs are using the OASIS in an
informal environment, without direction or guidance from HCFA or the
University of Colorado. While we are looking to the Medicare
demonstration to answer operational questions regarding the aggregation
of OASIS data and their use to improve patient outcomes, we are
interested in the experience of those HHAs that are using the OASIS
under their own initiative. We are seeking public comments from those
HHAs on the following questions:
How is the OASIS helpful in determining changes in patient
health status between two points in time?
How is the OASIS useful for measuring the outcomes of
patients who are prescribed physical therapy, occupational therapy,
speech therapy, skilled nursing services, or aide services? How is the
OASIS useful for patient evaluation and management?
How is the OASIS useful for care planning and prescribing
services? Could the OASIS be made more useful and, if so, how?
How is the data in the OASIS useful for identifying and
interpreting differences in both the severity and complexity within
agency caseloads? Could the OASIS be made more useful and, if so, how?
What level and type of support (for example, training,
monitoring of staff) is required to generate information from the OASIS
for use in assessment, care planning, and quality assessment and
performance improvement?
If you have used the OASIS data to produce agency-level
reports, are they useful in identifying negative and positive patient
outcomes?
Are there specific domains in which the OASIS is
particularly strong or particularly weak?
Are there other data items that produce information that
may be more useful in measuring outcomes in a particular domain?
3. Content and Planned Evolution of the OASIS
For purposes of public comment, we are reprinting the current
version of the OASIS in section II of this preamble. The Center for
Health Policy Research at the University of Colorado has granted
permission for this sample OASIS survey to be published and reproduced.
HCFA will provide HHAs with copies of the OASIS and instructions for
its use as a manual issuance when the final rule is published. All
OASIS data items were developed for outcome measurement, risk
adjustment, or patient identifiers. Data items address demographics and
patient history, living arrangements, supportive assistance, sensory
status, integumentary status, respiratory status, elimination status,
neuro/emotional/behavioral status, activities of daily living,
medications, equipment management, emergent care and discharge
information. While some data items do not directly address health
status, they are vital measurements of the context in which a person's
health status exists. For example, people with the same health status
but with different supports (financial, caregiver, etc.) may experience
different health outcomes. These characteristics should be part of a
comprehensive patient assessment, but we again emphasize that the OASIS
was not developed to be a comprehensive assessment instrument. HHAs
must supplement the OASIS items to comprehensively assess the health
status and care needs of patients. For example, the OASIS does not
include vital signs, which are a common part of a patient's assessment.
Most OASIS items require the same information that the majority of
care providers currently gather in patient assessment, but the OASIS
requires the information on a more precise scale. For example, many
care providers assess each patient's ability to bathe, but only use
three levels, independent, needs moderate assistance, or dependent. The
OASIS items ask the care provider to assess the same functional ability
(bathing) on a more precise six-level scale. This greater precision
results in items that are more descriptive for clinical purposes and
more reliable and valid statistically and, thereby, improves their
utility in an outcomes improvement, database environment. Consequently,
items in clinical records that have analogues in the OASIS should be
replaced by the corresponding OASIS items so that all certified
agencies will be collecting information using precisely the same items
to ultimately measure and risk adjust outcomes.
When the final rule has been promulgated, we will include the
instructions and definitions necessary to use the OASIS in the
notification to the HHAs. At the present time, however, we wish to
clarify several items in the current OASIS. These are:
Overall Progress, Rehabilitative Prognosis, and Life
Expectancy
[[Page 11040]]
While these are common assessment items, they are included in this
version of the OASIS with the expectation that they will be a part of
the data we intend to collect. They have been shown, thus, far, to be
highly predictive of health status outcomes. In the controlled
environment of the reliability and validity testing of these items
where data accuracy is verified, these items correlated well with other
items that track functional status. In other words, patients judged to
have low rehabilitation potential tend to show less change in health
status between two points in time. If these items retain their
predictive power through the demonstration and are retained in later
versions of the OASIS, they will be useful items for ``sorting''
performance or analysis and for searching for opportunities for
improvement. For example, if an HHA reports many patients with high
rehabilitation potential, but functional status measures of these
patients (risk-adjusted) show poorer results than other high
rehabilitation potential patients in other HHAs, an opportunity to
improve is presented to the HHA. We want to emphasize that this item
adds little or no new burden, since HHAs routinely use assessment items
similar to, or the same as, this item.
Current Residence
We have included this item because it is closely related to the
sustainability of an individual in community-based care and, possibly,
institutional services. For example, a frail person who is able to live
successfully in the home of a family member may not be able to do so if
the same person were living alone in a rented room. The performance of
the HHA in relationship to such variables as type of residence can make
the difference between staying out of a nursing home and getting in to
a nursing home. Having this information in the system enables the HHA
(and HCFA) to measure patient success in relationship to residence.
Supportive Assistance
The items in this section are intended to sort out and distinguish
among the various types of caregiving that family and others provide,
and with what frequency. As these items continue to be analyzed for
utility and predictive power during the demonstration, they may be
consolidated or shortened. Their importance, though, relates directly
to the balance that should be achieved between the service the HHA
provides and the help family and others provide to ensure the patient
has the best chance to remain at home for as long as possible and to
improve as much as possible.
To measure outcomes, OASIS data are collected at uniformly defined
time points: start of care, every 57 to 62 days until and including
discharge, and within 48 hours after return to home from a hospital
admission for any reason other than diagnostic testing. We are using a
time frame of 57 to 62 days to provide the HHA flexibility, and to
ensure that the reassessment will be completed in time for the 62-day
patient recertification. We are requiring that the OASIS be
administered within 48 hours of the patient's return from a hospital
admission (except when the hospital admission was for diagnostic tests)
because we believe hospital admissions are predictive of likely changes
in patient status and, therefore, important to capture for care
planning and quality assessment and performance purposes.
When HCFA asks HHAs to report OASIS data, some information about
the patient at the time of admission to a hospital may be included and,
if so, would be related to reasons for the admission to the hospital.
If home health care is resumed after the hospital admission and
regardless of whether the patient was formally discharged from the HHA,
the standard start-of-care OASIS is completed, with supplemental
information on the length of hospital stay. Under these circumstances,
if the patient was not formally discharged, followup data collection
continues at 57 to 62 day intervals in accord with the original start-
of-care date. If the patient was formally discharged from the HHA, the
data collection proceeds on the basis of the new start-of-care date
that followed the inpatient stay.
Some data items are unique to only one time point (for example,
discharge information is only collected at patient discharge), while
other data are collected at every time point. By collecting data using
uniform data items and time points, individual patient data are
comparable. The data can be aggregated to form agency-level outcomes
and to be used for comparisons to a larger reference group of agencies.
As a result, uniformity of data items and times points allows us to
compare ``apples to apples.'' Again, this is why we are requiring as a
condition of participation that the HHA use the OASIS exactly as
specified by the Secretary. The most current version of the OASIS is
published in this proposed rule. It reflects minor adjustments to
various items that further testing in the field has shown to increase
the precision and utility of the OASIS. This version does not change
the workload associated with its use and there is some indication it
requires less administration time than the earlier version. We urge
that agencies currently using various versions of the OASIS, including
``partial'' versions, now focus on the use of the version of the OASIS
contained in this proposed notice.
As health care delivery is constantly evolving, so will the OASIS
continue to evolve. Although the data set has undergone extensive
testing to date, it will be necessary to test and refine the data set
on an ongoing basis. Further reliability and validity testing is
occurring in the context of the national demonstration noted above. As
experience is gained and as home care continues to change, so too must
the OASIS. Modifications in items on the OASIS or the addition or
deletion of data items from the OASIS as a result of additional testing
will be released to HHAs periodically in manual updates, so that HHAs
will make the necessary modifications and the OASIS can continue to
represent the best data set for home health care outcome measurement.
C. Expectations Regarding the Use of the OASIS
We plan to implement full use of the OASIS in stages. The first
step, which will begin when these proposed regulations are published as
a final rule, is to require that all HHAs incorporate the exact use of
the OASIS into their current comprehensive assessment process. This
requirement will help to organize the assessment process around a set
of agreed-upon, valid and reliable health status items that are known
to be of value in measuring quality outcomes for patients. After HHAs
have begun to use the OASIS as specified by the final rule, we intend
to publish another proposed rule that would require HHAs to report
OASIS data electronically into a national database. We believe this
step will bring the use of the OASIS to its full potential as described
in section I.C.2. ``The Longer Run Use of the OASIS'' of this preamble.
1. The Near Future
The comprehensive needs of home health patients are currently
determined in a wide variety of ways, using numerous assessment tools.
The utility and effectiveness of the many ways of completing a
comprehensive assessment also vary widely, from highly sophisticated
systems to little more than general notes on the plan of care submitted
for payment. The first critically important advantage of requiring HHAS
to incorporate the exact use of the OASIS within their current approach
to a comprehensive assessment process is that it helps to organize the
assessment process around
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a set of agreed-upon, valid, and reliable health status items that are
known to be of value in measuring quality outcomes for patients.
The ease with which the items on the OASIS can be assimilated into
a comprehensive assessment process is apparent because all the items
must be accounted for in any effective, relevant, comprehensive
assessment. Hence, the information that is derived from the OASIS is
useful and essential to assessment and care planning, and to internal
performance improvement efforts. This fact is central to the rationale
for asking that each HHA use the OASIS exactly as specified as part of
its comprehensive assessment when the new home health conditions of
participation become effective. (Recall that the OASIS items can be
rearranged and distributed throughout an HHA's comprehensive
assessment, as long as the items are used exactly as written.)
Once the OASIS has been administered as part of the comprehensive
assessment, the results help to organize care planning with greater
precision than is currently possible, especially in HHAs that lack a
carefully structured approach to comprehensive assessment. The
increased specificity in patient assessment (in critical areas of
health and functional status) will assist agency staff to uniquely
tailor a treatment plan to each individual patient.
Once the assessment and care planning process has been completed,
and the provision of services has commenced for a specific patient, the
OASIS is readministered on a periodic basis. Since OASIS items have
been shown to be valid and reliable indicators of several dimensions of
health status, the results of accurately administering the OASIS
provide an effective measure of progress over time. As such, the OASIS
can contribute significant information that helps in reassessing
patient status, guiding changes in the plan of care, and developing
approaches to solving care problems.
In the day-to-day effort to competently deliver effective services
to a wide variety of patients with a panoply of needs, the HHA can
easily lose sight of the ``big picture'' or how the agency is
performing overall from the standpoint of effectiveness, efficiency,
and patient satisfaction. We would require HHAs to begin to use the
OASIS before final implementation of our request for HHAs to report
OASIS data that can be aggregated in a national database and fed back
to each HHA for use in its quality assessment and performance
improvement program. In fact, each HHA can collect and use OASIS data
on its own to compare the outcomes of similar patients to each other
and to compare its performance from one year to the next.
To implement OASIS data collection as part of the quality
assessment and performance improvement process, a HHA would ideally
proceed with three steps, all of which should occur under the
leadership of a team whose focus is to modify current assessment forms
and documentation. Because most HHAs are accustomed to revising patient
assessment instruments periodically as new clinical protocols become
known or as new requirements by accrediting bodies or regulators are
implemented, formation of teams or task forces often occurs at the
agency level. Clinical supervisors or managers, staff members of
various disciplines, and clerical staff are usually included on such
teams.
First, the team would review current clinical documentation,
comparing assessment items with similar OASIS data items. In some cases
(for example, start-of-care date, gender, date of birth, Medicare
number), minimal or no change to the current data item is needed. In
other situations (for example, dyspnea scale, bathing scale) the
precision of the OASIS item requires the HHA to substitute the OASIS
item for its current documentation. Next, the documentation team would
determine whether to adapt its current form, using a cut-and-paste
approach or to develop an entirely new form. Finally, the team would
take action. If the team chooses to develop a new form, sample clinical
forms are available from several sources to facilitate this
development, since this form is usually the most detailed document used
by the HHA. HHA documentation for recertification and discharge
assessments seldom are standardized, so these forms typically are
developed anew rather than modified. Once the forms are developed, the
implementation team oversees their pilot testing, modification,
finalization, and printing.
Any change in HHA forms, paper flow, and related activities
requires staff training to implement. The extent of the changes will
affect the amount of training required. Nearly all HHAs make some
modification to existing paperwork or internal procedures on
approximately an annual basis for reasons such as modifying forms,
internal paper flow, or current data entry processes. Consequently, the
HHAs are familiar with training staff to accomplish this task. In
addition, staff inservice, orientation, and training are routine parts
of ongoing HHA activities for both clinical and clerical personnel.
HHAs should also plan for two types of data accuracy checks. The
first check is for completeness of data; that is, whether all OASIS
items have been completed. This check can be done through a visual
check of clinical documentation submitted for data entry or through a
programmed data entry check. Other data accuracy checks can be
incorporated into a data entry program to examine logical
inconsistencies in the documentation (for example, a bedbound patient
who is independent in housekeeping, a patient with no pressure ulcers
whose pressure ulcers are not healing).
Software is becoming available from vendors and other sources for
this purpose. Clinical supervisory personnel are often alerted to
incomplete or logically inconsistent documentation, similar to what
occurs for HCFA-485 data which is the routine Medicare billing form.
To facilitate internal agency performance improvement activities,
it currently is possible for HHAs to create outcome reports for their
own patient populations using informal methods. Guidance in doing this
is provided in the aforementioned manual published by the National
Association for Home Care. For small HHAs or larger HHAs over a shorter
time interval, producing preliminary reports of this nature requires
only a paper-and-pencil data entry approach and a calculator. However,
we encourage computerization as soon as it is possible to do so. The
nearly universal move toward electronic information systems, including
the health care industry for areas such as billing and payment,
suggests that the sooner organizations learn how to use electronic
information systems for patient care and quality assessment and
performance improvement, the better positioned they will be to respond
when HCFA proposes to require electronic reporting of OASIS data in the
future.
If the HHA can be part of a reference database group or project,
participate in a reference data consortium, or is part of a
multiprovider company, such data can be collected and used as a
comparison database to assess performance among HHAs in the group, and
to search for opportunities that could contribute to improved outcomes
and satisfaction for patients. In this case, an individual HHA will be
considered relative to all HHAs in the group or database in terms of
the extent to which various outcome measures are indicative of high or
low quality of care relative to the standard represented by the mean
for all HHAs. Case-mix adjustment is necessary for outcome
[[Page 11042]]
comparisons across agencies or groups. The OASIS contains tested and
reliable data items that can be used for risk factor adjustment.
For example, an HHA generates an outcome report based on OASIS data
that indicates that 30 percent of all of the HHA's patients had
improved in ability to manage oral medications, compared with 45
percent of its patients from the previous time period. The HHA is
concerned about this decline in this outcome because a patient's
ability to manage oral medications is often critical to managing his or
her medical condition at home. An investigation into care processes
reveals that several of the HHA's care providers are not adequately
assessing fine motor ability and thus not addressing possible deficits
in fine motor skills when planning care. For a number of patients, this
appears to be resulting in inadequate assessment of the need for
occupational therapy involvement and teaching medication management.
The HHA develops a plan of action to improve care by incorporating a
more detailed fine motor evaluation into its comprehensive assessment
at the start of care, integrating findings from that evaluation into
the medication teaching guide, and enhancing nurse-occupational therapy
coordination with interdisciplinary care conferences on patients with
impaired fine motor function. The HHA's outcome report for the
following time period shows that 48 percent of discharged patients
improved in ability to manage oral medications. Thus, changes in care
processes resulting from an analysis of outcome findings subsequently
have a positive impact on patient outcomes.
While we recognize that some HHAs already are using fairly
sophisticated computer systems to collect and manage clinical as well
as financial data, we realize that many HHAs have not begun, or are
just beginning, to utilize electronic means of managing clinical and
programmatic information. We believe the contributions the OASIS can
make to the assessment, care planning, and implementation of
performance improvement activities will stimulate more HHAs to move to
an electronic format for managing patient clinical information. In
fact, we do not envision how an HHA can successfully move to a
continuous quality improvement approach without developing and using a
computer-based system to manage and use organizational and patient-
based data. In this regard, the OASIS will help guide the multiple
clinical record systems and electronic management information systems
under development at the present time, providing a foundation for
uniformity and precision in assessment, care planning, and outcome
monitoring. When we publish these requirements as a final rule, we are
committed to sharing data system specifications for the OASIS with the
HHA community.
A number of vendors have developed and are marketing various types
of software, including electronic clinical recordkeeping, to the home
care industry. We encourage such development because as information
technology continues to improve, it will increase the efficiency with
which the requisite information can be collected for home health care
administration, billing, assessment, and outcome monitoring.
Incorporating OASIS into electronic clinical records, including the
capability to adapt software to modest revisions of the OASIS
periodically is both a challenge and an opportunity. It is a challenge
because changes have to be made to current electronic clinical record
systems, replacing analogous items so that the total length of the
start-of-care assessment process for agencies is no greater (or only
marginally greater) in terms of time expended by the care providers.
Such changes will be reasonably straightforward for some vendors and
complex for others.
In many ways, the opportunities for software vendors serve to
offset the challenges because as we move toward national use of the
OASIS data set and subsequent updates as the OASIS evolves (as
explained in section I.C.2. of this preamble) nearly all HHAs will
require some type of software system. Such a system, at a minimum, will
be needed to perform initial computerization, those editing functions
necessary to ensure accurate OASIS and file development so that OASIS
data can be submitted to a central location for Medicare system
processing. Software conversion and marketing processes will, of
course, naturally accompany the increased demand for electronic
clinical recordkeeping in the home health care field. In all, we expect
there will be substantial opportunities to expand software applications
over the next few years.
We are also aware that some companies already exist that provide
both software management of assessment and other data as well as data
analysis and management services for quality improvement. We believe
the implementation of the proposed HHA conditions of participation,
published elsewhere in this issue of the Federal Register, which focus
on quality assessment and performance improvement, and this proposed
rule, which introduces the OASIS to the process, will only expand the
opportunities for quality management firms to flourish. While many HHAs
already have sophisticated quality improvement management programs, we
know a significant number do not. Since we encourage maximum
flexibility and creativity in these programs, we believe the
requirement that HHAs use the OASIS in no way inhibits these companies
from marketing their quality management services.
We are considering the possibility of using the OASIS in our
monitoring of managed care organizations in the future. For example, if
the OASIS were used, HCFA, HHAs, and managed care organizations would
be able to evaluate overall effectiveness of managed care home care and
make decisions and improvements based on beneficiary outcomes.
Another advantage of implementing the OASIS as part of the
comprehensive assessment at the time the new conditions of
participation become effective is that it provides HHAs with time to
learn how to use the OASIS effectively and accurately. HHAs can begin
to experiment with using OASIS data. This provides opportunities to
focus on specific areas for enhancing outcomes of care, patient
satisfaction, and organizational efficiencies. Such a learning period
would take place prior to HCFA implementing additional rule making that
would require HHAs to provide OASIS data electronically to a national
database.
2. The Longer Run Use of the OASIS
For informational purposes, we are discussing our long-range goals
for the use of the OASIS. While this proposed rule would not require
HHAs to report OASIS data to a national database, we intend to publish
such a rule when the system is developed. A national database would
allow HCFA to make these data available in the form of standardized,
risk-adjusted outcome reports. Aggregate OASIS-derived HHA outcome
reports that contain no patient-specific data will be in the public
domain, and consumers, purchasers, HHAs, and HCFA will be able to use
such information in a variety of ways. Additionally, HCFA as a
purchaser of managed care services is interested in the quality
oversight of home health services delivered by managed care
organizations.
When outcome reports become available, each HHA will be able to use
the outcome reports in its quality assessment and performance
improvement program. The HHA will be able to examine specific care
domains,
[[Page 11043]]
types of patients, or both and to compare present performance to past
performance and national performance norms. For example, the HHA could
compare its performance with other HHAs, locally, regionally, and
nationally. When these quality indicators are implemented and
evaluated, agency profiles could be used in the survey process to
compare the HHA's results with past performance. Objective data of this
nature can be an important validator of the HHA's improvement efforts
and also serve as a flag to the agency in terms of where to focus its
quality improvement priorities. The data will allow the HHA to focus
its quality improvement resources more efficiently by concentrating on
specific outcomes that require attention rather than investing in
systematic improvements in a broad range of areas that might presently
be satisfactory or even superior relative to other agencies throughout
the country. The ability of the HHA to efficiently and effectively
improve its individual performance would have the cumulative result of
the industry improving services to Medicare and Medicaid beneficiaries
at the same or lower cost. It may also further justify and highlight
the strengths of home care, thereby enhancing access for other types of
patients in the longer run.
An individual HHA can use the outcome reports to evaluate the
effectiveness of care provided to specific types of patients and, in
the context of investigating processes of care, to individual patients.
In order to investigate outcomes that might be judged inadequate by
agency staff, an individual patient's clinical records can be reviewed
in the context of a process-of-care screen that investigates the
circumstances and processes leading to outcomes. Such an investigation
can, in turn, lead to a plan of action that focuses on specific changes
in care behaviors at the individual patient level. This enables an HHA
to identify and apply ``lessons learned'' to its agency operations to
improve the outcomes of the agency as a whole. Analogously, the HHA can
examine circumstances and processes that produced superior or exemplary
outcomes to reinforce care behaviors that produce such outcomes,
promulgating information on such care behaviors within the agency.
Data from outcome reports not only can be used by the HHA for
continuous quality improvement by monitoring outcomes over time, but
also can be used to objectively assess the agency's strengths and
weaknesses in the clinical services it provides. Outcome reports can
inform the HHA what patients and clinical conditions it best serves,
what areas of HHA-care behaviors or activities correlate with patient
satisfaction, and what services need improvement. Such information will
be of value to the HHA in its strategic planning, financial planning,
and marketing.
Aggregate HHA outcome reports that contain no patient-specific data
may be used by the industry for comparative performance assessment. The
home care industry can identify those agencies regarded as industry
leaders in quality of care for comparable services, care domains, and/
or patient populations. Identified quality leaders can market their
services accordingly and can serve as a reservoir of expertise for
other agencies in their efforts to improve performance in selected
areas.
The results of outcome measurement also can provide useful
information to purchasers and consumers of home care services. Such
organizations and individuals will be able to examine reports of
industry outcomes and identify those agencies that will best provide
the services to meet the needs of individual consumers or the
population needs of particular purchasers. Improved access to objective
information on quality of care for consumers and purchasers will also
drive quality improvement in the industry as a whole. HHAs with records
of poor performance will be motivated to improve their performances to
compete with better-performing HHAs.
Our managed care partners, as purchasers of home health services,
would also be interested in such outcome-based comparative performance
measurements of HHAs. A standardized industry-wide instrument would
allow plans as purchasers to make value-based purchasing decisions of
home health care. The ability to use outcome measurement data is
especially important to us as a purchaser of services on behalf of
eligible beneficiaries. For example, in addition to comparing an HHA's
performance to its own past performance, HCFA and State survey agencies
will be able to use industry-wide performance data on a continuous
basis to identify HHAs that are not performing to the norm, thereby
suggesting the possibility that poor quality of care is occurring. This
information can trigger on-site inspections to assess performance. At
the same time, the data can be used to look for patterns of exemplary
performance that can be shared with others to help improve outcomes of
care and satisfaction overall. Having these data on a flow basis frees
us up from rigid survey schedules and enables us to use scarce
inspection resources more productively. Of course, we would still
conduct initial inspections to ensure an HHA is ready for
participation. We would also follow up, usually with an on-site visit,
on all complaints that suggest quality of care problems. Additionally,
State survey agencies and HCFA could use performance data to identify
opportunities for improvement in national or local priority areas, such
as a project to improve medication management for beneficiaries
generally, or to shorten the time necessary to achieve a clinically
important patient outcome.
The availability of performance data will also enable State survey
agencies and HCFA to evaluate more effectively the HHA's performance of
its own quality assessment and performance improvement program. For
example, an HHA is receiving objective feedback data that show that the
HHA is performing less well than other HHAs in a particular clinical
outcome area. The HHA is not using the quality assessment and
performance improvement program to address why its results are
divergent and to develop interventions to improve its performance.
Consequently, the surveyors will have evidence that the HHA is not
responding the way it could or should to improve outcomes of care and
satisfaction for patients.
Initially, since we are not yet requiring HHAs to submit OASIS
data, surveyors will look at how the HHA has used OASIS data
internally, and ideally, informally with other HHAs (for example,
either within its own company, or through consortia of HHAs in its
geographic area). Likewise, accreditation organizations with deemed
status can use the information as part of their accreditation
processes. As we stated earlier in this preamble, the Department of
Health and Human Services will, at a later date, issue a separate
notice of proposed rulemaking identifying the specific data elements
that would be required to be reported to HCFA, the timetable, and the
intended use of these data elements. At this time, it has not been
determined how extensive or limited these requirements will be. There
will be extensive public comment when the draft is issued. In the
meantime, however, we welcome public comment on the question of what
would constitute appropriate reporting requirements for the purposes of
monitoring progress toward meeting performance outcome measures.
3. Other Potential Applications of OASIS Data
We are presently investigating the potential of the OASIS and
information on which clinical outcomes are based to
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assist in developing selected features of a Medicare prospective
payment system for home health services. Specifically, we have found
that in identifying factors that might be valuable in developing case-
mix adjustors for payment purposes, traditional characteristics such as
patient diagnosis account for little of the variation in home health
utilization. Our Office of Research and Demonstrations is currently
researching home health case-mix, including an investigation of the use
and applicability of the data items contained within the OASIS for
developing a home health case-mix adjustor for payment purposes. If
such data items are found to be a valid basis for home health case-mix,
the potential of the OASIS would be further maximized. At the same
time, the burden on HHAs in providing health status information for
purposes of measuring outcomes, assessing patient needs, care planning,
and measuring case mix would be minimized.
We believe the OASIS data have the potential to be of significant
benefit to health professionals and professional organizations.
Objective, well-specified data on home health outcomes can assist
professionals to determine those practice areas needing improvement,
and help to identify inefficient or ineffective practice standards or
services which do not contribute to improved patient outcomes. Thus,
the OASIS data can inform and improve professional practice standards
and ultimately assist in the development of clinical practice
guidelines and critical pathways. On a broader scale, we are interested
in developing a capability of linking beneficiary information across
provider settings with other administrative data (for example, payment
and utilization data). Beneficiaries may have very complex service
delivery histories, moving among various services and benefits.
In order to effectively track outcomes and to facilitate the
administrative tasks involved in integrating the care for individuals,
our data systems, including the OASIS, minimum data set (MDS), and
others that may emerge, must be able to be integrated. Since mandated
data sets have been implemented or are being considered in other
domains of health care for which HCFA is responsible (for example, the
MDS for nursing homes, and the Uniform Needs Assessment instrument for
hospital discharge), we anticipate the evolution of data items and data
sets to occur so that the degree of commonality among such data sets
can be maximized over the course of time. Data sets have been developed
for selected fields such as home care and nursing home care so that the
unique needs of patient and Medicare beneficiaries that pertain to each
provider type can be adequately taken into consideration in the context
of an initial data set such as OASIS or MDS. Because of these unique
needs, it is unlikely that we can collectively attain perfect overlap
among the different data sets. It is our goal ultimately to attain as
much commonality across these data sets as possible so that patient
health status might eventually be monitored across provider settings
using a core set of data items within each data set.
Finally, we expect that the OASIS data will help us in promoting
more efficient regulations and policies that encourage good performance
in the home care industry. We will be able to objectively examine the
home health industry in all its complexity, using outcome data to
support or refute anecdotal information, unsubstantiated opinion, or
conjecture, thereby facilitating consensus building and more objective
policy decisions. Most important, home health outcomes information will
aid in shaping and even creating the home health benefit of the future.
As we identify those practices and services that contribute to enhanced
patient outcomes, the patient populations that should be served by home
care can be better specified, and the capacity of the home health
industry to provide the requisite services can be strengthened,
expanded, or refined in keeping with beneficiary outcomes.
II. Sample OASIS Survey
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III. Provision of the Proposed Regulations
This proposed rule would add further requirements to the proposed
regulations regarding conditions of participation for HHAs published
elsewhere in this issue of the Federal Register. We would require that
HHAs incorporate the use of the OASIS in their comprehensive assessment
of their patients, and that they use data from the OASIS in their
internal quality assessment and performance improvement programs. As we
stated previously in this preamble, we are not yet proposing to require
that HHAs collect and report OASIS data to a national data system or to
use national comparative OASIS data as a part of their quality
assessment and performance improvement programs.
We would revise proposed Sec. 484.55 ``Conditions of
participation: Comprehensive assessment of patients'' by adding
language to the introductory paragraph so that it would read as
follows: ``Each patient must receive, and an HHA must provide, a
patient-specific, comprehensive assessment * * * that incorporates the
exact use of the current version of the Outcomes and Assessment
Information Set (OASIS), as specified by the Secretary.'' We believe
that this is the only added regulatory language necessary to require an
HHA to incorporate the OASIS into its already existing comprehensive
assessment process. While not stated explicitly in the language of the
regulation, the OASIS is inappropriate for use with individuals under
21 years of age and is not intended for use with maternity cases.
Information about the OASIS'' clinical applicability is part of the
dataset procedures so we do not believe it is necessary to state in the
proposed regulations that the use of the OASIS is not applicable to
maternity cases and individuals under 21 years of age.
We would also add language at proposed Sec. 484.55(d)(1)
to state that the comprehensive assessment must be updated and revised
as frequently as the condition of the patient requires, but not less
frequently than every 62 days. These updates must include the
administration of the OASIS within every 57 to 62 days after the start
of care. We are proposing to add this requirement to ensure that
reassessments would be completed in time for the 62-day patient
recertification.
We would revise proposed Sec. 484.55(d) to require that an
HHA administer the OASIS ``within 48 hours of the patient's return to
the home from a hospital admission for any reason except diagnostic
testing. (This update includes the administration of the OASIS.)'' We
are proposing to add the requirement that an assessment using the OASIS
be administered after a hospital admission for any reason except
diagnostic testing because we know that, typically, such a hospital
admission can indicate a significant change in a patient's functional
status.
We believe that the use of the OASIS upon the patient's return to
the home would be useful from a care planning standpoint as part of the
comprehensive assessment and as a significant functional status ``data
point'' for comparative purposes. This event will trigger reporting of
OASIS data as well in the future.
We would add new Sec. 484.55(e) to provide that the HHA
must incorporate into its own assessment instrument, exactly as the
OASIS is written, OASIS data items that include information regarding
demographics and patient history, living arrangements, supportive
assistance, sensory status, integumentary status, respiratory status,
elimination status, neuro/emotional/behavioral status, activities of
daily living, medications, equipment management, emergent care, and
discharge.
We would add language to Sec. 484.65(a) ``Conditions of
participation: Quality assessment and performance improvement'' to
indicate that the HHA's quality assessment and performance improvement
program must include at a minimum, quality indicator data derived from
patient assessments, that must be included in data derived from the use
of the OASIS.
While we are not yet proposing to require that HHAs collect and
report OASIS data to a national data set, the incorporation of the
OASIS into the comprehensive patient assessment would provide the HHA
with a rich, internal database that it can begin to use for its
internal quality assessment and performance improvement programs. For a
home health company or a managed care organization, the availability of
OASIS data for company-wide or organization-wide use would be helpful
in measuring performance and identifying both those areas that need
improvement and those areas where performance is exemplary. This
information can be shared by HHAs throughout the company or
organization to improve performance. Small HHAs can enter into
arrangements with other HHAs to share data into a larger pool for the
same purposes as larger organizations. The net result of this
rulemaking, then, would be to require each HHA to use the OASIS as part
of its comprehensive assessment of patients and to use that information
not only for care planning and service delivery, but as a part of the
HHA's quality assessment and performance improvement program.
While we believe we have accurately summarized the history of the
development of quality indicators for home care, the potential uses of
them in the near and longer-term future, and our planned regulatory
approach to incorporating their use into the HHA conditions of
participation, we welcome comments on all aspects of both this
discussion and our regulatory approach to incorporating the use of
quality indicators into the Medicare HHA benefit. As with any system of
measurement, there are limitations to the home health care quality
indicators (and the OASIS), and we have tried to be sensitive to those
limitations. Commenters are urged to help us ensure that we have struck
the proper balance between what our proposed approach can and likely
cannot achieve.
IV. Impact Statement
A. Impact on HHAs
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless we certify that a proposed rule such as this would
not have a significant economic impact on a substantial number of small
entities. For purposes of the RFA, States and individuals are not
considered small entities.
All HHAs are considered small entities for the purposes of the RFA.
Consequently, we are including a statement of impact on the effect that
this proposed rule would have on HHAs. This impact statement reflects
only the impact of the provisions of this proposed rule. There are no
costs in this impact analysis that stem from the proposed regulations
regarding the HHA conditions of participation published elsewhere in
this issue of the Federal Register. Only the costs associated with the
introduction of the OASIS into the HHA conditions of participation are
included in this impact statement and in the Collection of Information
Requirements section of this preamble.
We anticipate that HHAs will incur some additional costs from
implementation of this proposed rule. These costs are Medicare and
Medicaid allowable costs and will be paid on a reasonable costs basis
subject to the applicable Medicare and Medicaid rules. A chart
projecting the costs to HHAs for the first five years of implementation
of the use of the OASIS
[[Page 11060]]
is included at Section VI.C.1. We strongly believe that the benefits
associated with the use of OASIS data will far outweigh its costs. As
discussed in detail above, OASIS data will improve the delivery of
quality care in the nation's HHAs in several ways. HHAs will find the
information helpful in organizing their care planning. The increased
specificity in patient assessment will assist agency staff to uniquely
tailor a treatment plan to each individual patient.
On a more global scale, once data from the OASIS are available in
the form of standardized outcome reports, consumers, purchasers,
providers, and HCFA will be able to use information to evaluate quality
of care across the full spectrum of HHAs. The home health industry can
use the data for comparative performance assessment. HCFA and the State
survey agencies will be able to use the data on a continuous basis to
identify providers that are not performing to the norm. This use will
allow us to further progress in our efforts to develop a more efficient
and targeted survey approach.
As we discussed above, these proposed regulations would require
that each HHA use a standard core assessment data set as part of its
assessment of most adult patients. The impact of these proposed
regulations would vary from HHA to HHA depending upon an HHA's current
assessment process. The additional impact on HHA workload centers
around collection of information and paperwork burden and is discussed
in detail in the ``Collection of Information Requirements'' section of
this preamble. There are no other requirements that would impact HHAs
in these proposed regulations.
B. Rural Impact Statement
Section 1102(b) of the Social Security Act (the Act) requires us to
prepare a regulatory impact analysis for any proposed rule that may
have a significant impact on the operation of a substantial number of
small rural hospitals. Such an analysis must conform to the provisions
of section 604 of the RFA. For purposes of section 1102(b) of the Act,
we define a small rural hospital as a hospital that is outside of a
Metropolitan Statistical Area and has fewer than 50 beds. We are not
preparing a rural impact statement since we have determined that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.
C. Review by the Office of Management and Budget
In accordance with the provisions of Executive Order 12866, this
proposed regulation was reviewed by the Office of Management and
Budget.
V. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, agencies are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques. Therefore, we are soliciting public comment on each of
these issues for the proposed information collection requirements
discussed below.
The proposed regulations at Sec. 484.55 and Sec. 484.65 would
require HHAs to use the OASIS as part of a comprehensive assessment of
the patient. The burden from requiring HHAs to collect the OASIS data
can be divided into two categories. The first category encompasses
activities that are required for startup. These activities include
incorporating the OASIS data into an HHA's clinical records, initial
acclimation to the OASIS, and training agency staff to use the OASIS
data. After these initial startup activities, the second burden arises
from the collection of the OASIS data on an ongoing basis.
A. Startup Activities: Time and Cost
We expect HHAs to incorporate the OASIS data into their clinical
records both to minimize the documentation burden (for example, by not
having to complete different forms with similar questions), and to
increase the precision of patient assessments. Once the data items are
incorporated into the clinical records, information can easily be
collected at start of care and at each followup time point (that is,
every 57 to 62 days; within 48 hours after the return home from a
hospital admission; and at discharge).
The time required to revise clinical records to include OASIS items
will vary for each agency, depending on the nature of their current
documentation. For example, HHAs that have developed their own forms
using word processing software may find it easier to merge or replace
items than those agencies without that capability. Most HHAs are
accustomed to revising patient assessment instruments periodically, as
new assessment protocols become available or as new requirements by
accrediting bodies or regulators are implemented. Once OASIS items are
included in clinical record forms, HHAs should have only minor
subsequent revisions to make with any future OASIS releases. The
following estimates are based on the actual experience of the HHAs that
participated in the development of the home health quality indicators.
1. Inclusion of OASIS Elements Into Assessment Forms
We define an average-size HHA as having 18 nurses and other service
providers and 486 admissions per year. We estimate that the time
required by an average-size HHA to revise assessment forms to
accommodate the OASIS is approximately 8 hours for revision of the
initial assessment forms. The HHA will also require an additional 4
hours for revision of clinical record forms at the 57 to 62 day
assessment, and for the assessment within 48 hours after a return to
home from a hospital admission. Many items in the discharge follow up
are identical to these 2 follow up points, but there are several
additional data elements associated with discharge that will result in
an additional 4 hours for revisions of discharge forms. Thus, the total
impact for clinical record forms revision is estimated to be 16 hours
per agency for integration of OASIS items for all data collection time
points. This estimate includes time associated with pilot testing the
revised forms and subsequent revisions as necessary.
[[Page 11061]]
We do not believe that nursing staff need to complete the
integration of OASIS data elements into an HHA's assessment forms.
Therefore, we estimate that the cost for an average-size HHA to revise
the clinical records will be $200, based on an hourly rate of $12.50 of
clerical time. The total national hours for revisions of patient
assessment forms is projected to be 146,992 hours for 9,187 HHAs (the
number of certified facilities as of March 1996), with an associated
national cost of $1.8 million.
2. Staff Training
We are assuming a total of 3.5 hours per nurse or other service
provider within each HHA for purposes of estimating staff training time
for the new OASIS recordkeeping. The Center for Health Services
Research at the University of Colorado has written a guide, ``Item-by-
Item Tips,'' for HHA use in training staff. This guide includes
responses for frequently asked questions about OASIS items, and should
be helpful to HHAs in the training of staff. Based on research
conducted by the University of Colorado, training for data collection
for initial assessments will require about 2 hours. Training for data
collection for recertification assessments at the follow up points
(that is, 57 to 62 day data collection and assessments within 48 hours
after the return home from a hospital admission for any reason except
diagnostic testing, includes a subset of admission items, but will
require an additional 20 minutes of training. Collecting patient status
data at discharge is likely to require the most significant
modification of current HHA practice. This training will require about
40 minutes of training and will encompass both an introduction to a few
specific data items and a discussion of revised agency procedures.
Part of the training described above would include an emphasis on
data accuracy to ensure the production of meaningful outcome reports.
Other procedures to be utilized by the agency to monitor data accuracy
(including follow-behind visits, interdisciplinary comparisons, record
reviews) require training as they are implemented. Several approaches
to data auditing could be included in training of approximately 30
minutes. The projected 3.5 hours of training time is expected to cost
an average HHA with 18 care providers about $1,515, based on an average
hourly rate of $24.05 for a registered nurse. The total national
training burden is projected to be 578,781 hours across all certified
HHAs, at a cost of $13.9 million.
Once care providers are familiar with the OASIS items, OASIS data
collection imposes a minimal burden above what care providers are
currently doing to assess their patients. OASIS data are collected
using a combination of staff observation and patient/care giver
interviews. Initially, the OASIS data collection may take additional
time until care providers become familiar with the precision and format
of the items. Estimates from providers using clinical records with
integrated OASIS items on the ``learning curve'' indicate that the use
of the OASIS initially adds approximately 15 minutes to the start of
care assessment. However, after using the OASIS approximately 5 times,
the time required beyond the routine patient assessment to complete the
OASIS decreases to approximately 2.5 minutes. Thus, the total
``startup'' or transitional burden until familiarity with OASIS for an
average HHA is estimated to be 22.5 hours and to cost about $541, based
on an average hourly rate of $24.05 for a registered nurse. This
results in a national burden of 206,708 hours for all HHAs, at a cost
of $5 million.
B. Ongoing Data Collection
Most items included in the OASIS require information that the
majority of care providers currently gather during patient assessments.
However, the OASIS employs a more precise scale. For instance, most
care providers assess a patient's ability to bathe in the course of an
assessment, but only using three levels (independent, needs moderate
assistance, or dependent). The OASIS item for bathing requires that the
care provider assess each patient's bathing ability on a more precise
six-level scale.
In order to measure outcomes, OASIS data are collected at uniformly
defined time points (start of care, every 57 to 62 days, within 48
hours after return to the home from a hospital admission for any reason
except diagnostic testing, and at discharge). Some data items are
unique to only one time point (for example, selected items are only
collected at patient discharge), while other data are collected at
every time point. By collecting data using uniform data items and time
points, specific information on individual patients is comparable and
can be aggregated to produce agency-level outcome reports that permit
comparisons between different groups of patients (for example, a given
HHA's patients relative to a national reference sample.)
OASIS data collection on an ongoing basis imposes a minimal burden
above the routine patient assessment. We estimate that providers using
clinical records with integrated OASIS items will need an additional
2.5 additional minutes for both start of care and for the followup
assessment at the 57 to 62 day interval. Therefore, when collecting
OASIS data, HHAs will spend an additional 2.5 minutes beyond what they
currently use to complete the patient assessment at start of care.
Similarly, at 57 to 62 day intervals, care providers currently conduct
detailed assessments in order to review any needed changes in the plan
of care for recertification. OASIS items are expected to require an
additional 2.5 minutes above the routine assessment currently performed
by home health agencies at 57 to 62 day intervals.
For home health episodes that began in 1992, HCFA billing data
indicate that 42 percent of HHA patients would have had at least one
60-day follow up. Data from 1992 also indicate that 26 percent of
patient home health episodes lasted more than 120 days requiring a
second follow up, while 17 percent had episodes lasting 180 days or
longer requiring a third follow up. Since the average HHA has 486
admissions per year, in conjunction with the episode length information
from 1992, we estimate an impact per HHA of 20.3 hours per year for
start-of-care assessments, and 17.2 hours per year for the 57 to 62 day
intervals.
Factoring in an additional 2.5 minutes beyond what agencies
currently do, we also estimate an additional burden of 5.1 hours per
HHA for assessments conducted within 48 hours after a patient's return
to home from a hospital admission for any reason except diagnostic
testing. This assumes that 25 percent of patients are admitted to
hospitals per year and require the resumption of home health services
upon return to the home.
At discharge, care providers currently conduct a fairly brief
assessment, only documenting significant changes in patients and the
reason for discharge. However, OASIS requires that care providers
conduct a more thorough patient assessment. This provides the
information necessary to measure changes in patient health status over
time and permits statistical analysis of patient outcomes (including
aggregation of patient data to produce agency-level outcome reports).
Therefore, while some additional burden is imposed on care providers,
data collection at discharge is necessary to measure outcomes. Based on
486 admissions for an average HHA, and applying an incremental time
increase of 8 minutes, the estimated total time necessary to complete
the OASIS items at patient discharge is
[[Page 11062]]
projected to be 64.8 hours per year per agency.
Finally, as we stated earlier in this preamble, the OASIS will be
updated and improved from time to time after implementation. We
anticipate these changes to be refinements of existing items and the
addition and deletion of items depending on utility or ineffectiveness.
On balance, we believe the implementation of later iterations of the
OASIS will result in a very small cost to HHAs. However, when such
revisions are made, we will detail the related costs.
In total, we project that the total incremental ongoing time for an
average HHA to complete OASIS data will be about 107.3 hours per year,
with an associated cost of $2,583. Nationally, this will result in
1,077,721 hours of incremental time based on historical growth rates of
9.3 percent for HHAs, at an estimated cost of $25.9 million.
Again, we welcome comments on all aspects of the above material.
Written comments on the information collection and recordkeeping
requirement should be mailed directly to the following:
Health Care Financing Administration, Office of Financial and Human
Resources, Management Planning and Analysis Staff, Room C2-26-17, 7500
Security Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503.
Attention: Allison Herron Eydt, HCFA Desk Officer.
Any comments submitted on the collection of information
requirements set forth in Sec. 484.55 and Sec. 484.65 must be received
by these two offices on or before May 9, 1997, to enable OMB to act
promptly on HCFA's information collection approval request.
C. Summary of Cost and Burden Estimates
The following tables summarize the total burden from the collection
of the OASIS items:
1. National Costs to HHAs for Implementation of the OASIS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of agencies Start-up costs @ Ongoing costs @
Year* incurring start-up $2256 per HHA (in $2583 per HHA (in Total costs (in Medicare costs (in
costs millions) millions) millions) millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................. 9,187 $20.73 $23.73 $44.46 $22.23
2.............................................. 864 1.93 25.94 27.86 13.93
3.............................................. 934 2.11 28.35 30.46 15.23
4.............................................. 1,021 2.30 30.99 33.29 16.64
5.............................................. 1,006 2.52 33.87 36.38 18.19
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These costs are based on the assumption that date of implementation will be in fiscal year 1997.
2. Breakdown of Agency Start Up and Ongoing Costs
----------------------------------------------------------------------------------------------------------------
National costs--
historic growth
rate of 9.3%
Task Agency costs (in (Agency costs x
dollars) 9,187 HHAs) (in
millions of
dollars)
----------------------------------------------------------------------------------------------------------------
Startup (one-time only) costs:
Integration of OASIS into existing assessment forms............... $200 $1.8
Staff training.................................................... 1515 13.9
Learning curve.................................................... 541 5.0
-----------------------------------------
Total start up costs.......................................... 2256 20.7
=========================================
Ongoing costs:
Initial care...................................................... 488 4.5
Follow up (57-62 days)............................................ 414 3.8
Post-hospital admission........................................... 120 1.1
Discharges........................................................ 1558 1.4
-----------------------------------------
Total ongoing costs........................................... 2583 25.9
=========================================
Total combined costs.......................................... 4839 46.6
----------------------------------------------------------------------------------------------------------------
3. Hourly Breakdown and Computation of the Average OASIS Start-Up Costs per HHA
----------------------------------------------------------------------------------------------------------------
Average
Task Hours Computation of average costs cost
----------------------------------------------------------------------------------------------------------------
Intergration of OASIS into
existing assessment forms:
Revision of intial 8
assessment forms.
Revision of clinical 4
forms (57-62 day
assessment).
Revision of clinical 4
forms (48 hours post-
hospital admission).
-----------
Total................ 16 16 hrs x $12.50 per hr (avg. clerical rate).............. $200
=========== ==========
Staff training:
Data collection for 2
initial assessment.
-----------
[[Page 11063]]
Data collection for 0.3
recertification
assessment at follow-up.
-----------
Data collection at 0.7
discharge.
-----------
Data auditing............ 0.5
-----------
Total................ 3.5 3.5 hrs x $24.05 per hr x 18 providers................. 1,515
=========== ==========
Learning curve:
Initial use of the OASIS 0.25
data collection.
-----------
Next 4 uses of the OASIS 1
data collection ( 4 x
.25 hrs).
-----------
Total................ 1.25 1.25 hrs x $24.05 per hr x 18 providers................ 541
=========== ==========
Total................ 19.75 2,256
----------------------------------------------------------------------------------------------------------------
4. Hourly Breakdown and Computation of Ongoing OASIS Cost Burdens per HHA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Average
Task Computation of hours hours Computation of average cost cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial care...................................... 486 admissions x 2.5 min 20.3 20.3 hrs x $24.05 per hr.......................... $488
per
admissions60
min.
Followup (57-62 days)............................. (42 percent of HHA 17.2 Hrs x $24.05 per hr............................... 414
patients x first follow-
up x 486 admissions) +
(26 percent of HHA
patients x second
follow-ups x 486
admissions)+(17 percent
x third follow-up x 486
admissions)=413 follow-
ups--413 follow-ups x
2.5 min per
followup60 min.
Post-hospital admission........................... (486 admissions x .25 of 5.1 5.1 hrs x $24.05 per hr........................... 123
HHA patients x 2.5 min
per
admission)60
min.
Discharge......................................... (486 admissions x 8 min 64.8 64.8 hrs x $24.05 per hr.......................... 1,558
per
admission)60
min.
----------- ------------
Total......................................... ........................ 107.4 .................................................. 2,583
--------------------------------------------------------------------------------------------------------------------------------------------------------
42 CFR Chapter IV would be amended as follows:
List of Subjects in 42 CFR Part 484
Health facilities, health professions, Medicare, Reporting and
record keeping requirements.
Note to readers: The following proposed regulations text
reflects changes to proposed regulation text published elsewhere in
this issue of the Federal Register and not to regulations text in
the existing Code of Federal Regulations.
HCFA proposes to amend 42 CFR Part 484 would be amended as set
forth below.
PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES
A. The authority citation for part 484 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).
B. In Sec. 484.55, the introductory paragraph and paragraph (d) are
revised and new paragraph (e) is added to read as follows:
Sec. 484.55 Condition of participation: Comprehensive assessment of
patients.
Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment that identifies the patient's need
for home care, that meets the patient's medical, nursing,
rehabilitative, social, and discharge planning needs, and that
incorporates the exact use of the current version of the Outcomes and
Assessment Information Set (OASIS), as specified by the Secretary.
* * * * *
(d) Standard: Update of comprehensive assessment. The comprehensive
assessment must include information on the patient's progress toward
clinical outcomes, and must be updated and revised--
(1) As frequently as the condition of the patient requires, but not
less frequently than every 62 days. These updates must include the
administration of the OASIS within every 57 to 62 days after the start
of care;
(2) When the plan is revised for physician review;
(3) Within 48 hours of the patient's return to the home from a
hospital admission for any reason except diagnostic testing (This
update includes the administration of the OASIS.); and
(4) At discharge. (This update includes the administration of the
OASIS.)
(e) Standard: Incorporation of OASIS data items. The OASIS data
items must be incorporated into the HHA's own assessment instrument and
must include, exactly as the OASIS is written, information regarding
demographics and patient history, living arrangements, supportive
assistance, sensory status, integumentary status, respiratory status,
elimination status, neuro/emotional/behavioral status, activities of
daily living, medications, equipment management, emergent care, and
discharge information.
C. In Sec. 484.65, paragraph (a)(1) is revised to read as follows:
[[Page 11064]]
Sec. 484.65 Condition of participation: Quality assessment and
performance improvement.
* * * * *
(a) * * *
(1) Quality indicator data derived from patient assessments,
including, at a minimum, data derived from the use of the OASIS, to
determine if individual and aggregate measurable outcomes are achieved
compared to a specified previous time period.
* * * * *
(Catalog of Federal Domestic Assistance Programs No 93.774,
Medicare--Supplementary Medical Insurance, and No. 93,778, Medical
Assistance Program)
Dated: January 21, 1997.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: January 30, 1997.
Donna E. Shalala,
Secretary.
[FR Doc. 97-5315 Filed 3-5-97; 9:45 am]
BILLING CODE 4120-01-P
