[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]


-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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]]

Specify the date of the issue requested and enclose a check or money 
order payable to the Superintendent of Documents, or enclose your Visa 
or Master Card number and expiration date. Credit card orders can also 
be placed by calling the order desk at (202) 512-1800 or by faxing an 
order to (202) 512-2250. The cost for each copy is $8.00. As an 
alternative, you can view and photocopy the Federal Register document 
at most libraries designated as Federal Depository Libraries and at 
many other public and academic libraries throughout the country that 
receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. Free public access is available on a Wide 
Area Information Server (WAIS) through the Internet and via 
asynchronous dial-in. Internet users can access the database by using 
the World Wide Web; the Superintendent of Documents home page address 
is http://www.access.gpo.gov/su__ docs/, by using local WAIS client 
software, or by the telnet to SWAIS.access.gpo.gov, then log in as 
guest (no password required). Dial-in users should use communications 
software and modem to call (202) 512-1661; type swais, then log in as 
guest (no password required).

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:
    <bullet> How is the OASIS helpful in determining changes in patient 
health status between two points in time?
    <bullet> 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?
    <bullet> How is the OASIS useful for care planning and prescribing 
services? Could the OASIS be made more useful and, if so, how?
    <bullet> 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?
    <bullet> 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?
    <bullet> If you have used the OASIS data to produce agency-level 
reports, are they useful in identifying negative and positive patient 
outcomes?
    <bullet> Are there specific domains in which the OASIS is 
particularly strong or particularly weak?
    <bullet> 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:

<bullet> 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.

<bullet> 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.
<bullet> 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

[[Page 11041]]

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

[[Page 11044]]

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

BILLING CODE 4120-01-P

[[Page 11045]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.008



[[Page 11046]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.009



[[Page 11047]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.010



[[Page 11048]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.011



[[Page 11049]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.012



[[Page 11050]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.013



[[Page 11051]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.014



[[Page 11052]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.015



[[Page 11053]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.016



[[Page 11054]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.017



[[Page 11055]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.018



[[Page 11056]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.019



[[Page 11057]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.020



[[Page 11058]]

[GRAPHIC] [TIFF OMITTED] TP10MR97.021



BILLING CODE 4120-01-C

[[Page 11059]]

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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Whether the information collection is necessary and useful 
to carry out the proper functions of the agency;
    <bullet> The accuracy of the agency's estimate of the information 
collection burden;
    <bullet> The quality, utility, and clarity of the information to be 
collected; and
    <bullet> 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                                                                                                
                                                     admissions<divide>60                                                                               
                                                     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                                                                                        
                                                     followup<divide>60 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)<divide>60                                                                               
                                                     min.                                                                                               
Discharge.........................................  (486 admissions x 8 min        64.8  64.8 hrs x $24.05 per hr..........................        1,558
                                                     per                                                                                                
                                                     admission)<divide>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