Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11035

or university approved by a State

department of education; or

(iii) Has 2 years of appropriate

experience as a physical therapist, and

has achieved a satisfactory grade on a

proficiency examination conducted,

approved, or sponsored by the U.S.

Public Health Service except that such

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking

qualification as a physical therapist after

December 31, 1977; or

(iv) Was licensed or registered prior to

January 1, 1966, and prior to January 1,

1970, had 15 years of full-time

experience in the treatment of illness or

injury through the practice of physical

therapy in which services were

rendered under the order and direction

of attending and referring doctors of

medicine or osteopathy; or

(v) If trained outside the United

States—

(A) Was graduated since 1928 from a

physical therapy curriculum approved

in the country in which the curriculum

was located and in which there is a

member organization of the World

Confederation for Physical Therapy;

(B) Meets the requirements for

membership in a member organization

of the World Confederation for Physical

Therapy,

(5) Physical therapist assistant. A

person who—

(i) Has graduated from a 2-year

college-level program approved by the

American Physical Therapy

Association; or

(ii) Has 2 years of appropriate

experience as a physical therapy

assistant, and has achieved a

satisfactory grade on a proficiency

examination conducted, approved, or

sponsored by the U.S. Public Health

Service, except that these

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking initial

qualification as a physical therapy

assistant after December 31, 1977.

(6) Public health nurse. A registered

nurse who has completed a

baccalaureate degree program approved

by the National League for Nursing for

public health nursing preparation or

postregistered nurse study that includes

content approved by the National

League for Nursing for public health

nursing preparation.

(7) Registered nurse. A graduate of a

school of professional nursing.

(8) Social work assistant. A person

who—

(i) Has a baccalaureate degree in

social work, psychology, sociology, or

other field related to social work, and

has had at least 1 year of social work

experience in a health care setting; or

(ii) Has 2 years of appropriate

experience as a social work assistant,

and has achieved a satisfactory grade on

a proficiency examination conducted,

approved, or sponsored by the U.S.

Public Health Service, except that these

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking initial

qualification as a social work assistant

after December 31, 1977.

(9) Social worker. A person who has

a master’s degree from a school of social

work accredited by the Council on

Social Work Education, and has 1 year

of social work experience in a health

care setting.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: July 15, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: August 16, 1996.

Donna E. Shalala,

Secretary.

[FR Doc. 97–5316 Filed 3–5–97; 9:45 am]

BILLING CODE 4120–01–P

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.
11036 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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/sul 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 onelevel 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 riskadjusting 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
11038 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

(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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 agencylevel performance improvement. As an

HHA improves over time across various

outcome dimensions, the aggregated

data will show improvement as well,

and average agency performance will

likewise continue to improve. Not only

will this be advantageous for Medicare

beneficiaries and other home care

clients, but it will be of value to the

home care industry in demonstrating its

effectiveness. We want to stress,

however, that in order for the OASIS

data to be helpful for all its purposes,

the OASIS items must be filled out

accurately. As they begin to collect the

OASIS items, HHAs should set up

procedures to monitor data accuracy

such as conducting validation visits to

verify accuracy, interdisciplinary

comparisons and record reviews. In fact,

data entry accuracy can, and should be,

an essential part of the HHA’s quality

assessment and improvement program,

since data accuracy is a fundamental

building block of an effective program.

We are aware that large numbers of

HHAs are using the OASIS in an

informal environment, without

direction or guidance from HCFA or the

University of Colorado. While we are

looking to the Medicare demonstration

to answer operational questions

regarding the aggregation of OASIS data

and their use to improve patient

outcomes, we are interested in the

experience of those HHAs that are using

the OASIS under their own initiative.

We are seeking public comments from

those HHAs on the following questions:

• How is the OASIS helpful in

determining changes in patient health

status between two points in time?

• How is the OASIS useful for

measuring the outcomes of patients who

are prescribed physical therapy,

occupational therapy, speech therapy,

skilled nursing services, or aide

services? How is the OASIS useful for

patient evaluation and management?

• How is the OASIS useful for care

planning and prescribing services?

Could the OASIS be made more useful

and, if so, how?

• How is the data in the OASIS useful

for identifying and interpreting

differences in both the severity and

complexity within agency caseloads?

Could the OASIS be made more useful

and, if so, how?

• What level and type of support (for

example, training, monitoring of staff) is

required to generate information from

the OASIS for use in assessment, care

planning, and quality assessment and

performance improvement?

• If you have used the OASIS data to

produce agency-level reports, are they

useful in identifying negative and

positive patient outcomes?

• Are there specific domains in

which the OASIS is particularly strong

or particularly weak?

• Are there other data items that

produce information that may be more

useful in measuring outcomes in a

particular domain?

3. Content and Planned Evolution of the

OASIS

For purposes of public comment, we

are reprinting the current version of the

OASIS in section II of this preamble.

The Center for Health Policy Research at

the University of Colorado has granted

permission for this sample OASIS

survey to be published and reproduced.

HCFA will provide HHAs with copies of

the OASIS and instructions for its use

as a manual issuance when the final

rule is published. All OASIS data items

were developed for outcome

measurement, risk adjustment, or

patient identifiers. Data items address

demographics and patient history, living

arrangements, supportive assistance,

sensory status, integumentary status,

respiratory status, elimination status,

neuro/emotional/behavioral status,

activities of daily living, medications,

equipment management, emergent care

and discharge information. While some

data items do not directly address

health status, they are vital

measurements of the context in which a

person’s health status exists. For

example, people with the same health

status but with different supports

(financial, caregiver, etc.) may

experience different health outcomes.

These characteristics should be part of

a comprehensive patient assessment,

but we again emphasize that the OASIS

was not developed to be a

comprehensive assessment instrument.

HHAs must supplement the OASIS

items to comprehensively assess the

health status and care needs of patients.

For example, the OASIS does not

include vital signs, which are a common

part of a patient’s assessment.

Most OASIS items require the same

information that the majority of care

providers currently gather in patient

assessment, but the OASIS requires the

information on a more precise scale. For

example, many care providers assess

each patient’s ability to bathe, but only

use three levels, independent, needs

moderate assistance, or dependent. The

OASIS items ask the care provider to

assess the same functional ability

(bathing) on a more precise six-level

scale. This greater precision results in

items that are more descriptive for

clinical purposes and more reliable and

valid statistically and, thereby,

improves their utility in an outcomes

improvement, database environment.

Consequently, items in clinical records

that have analogues in the OASIS

should be replaced by the

corresponding OASIS items so that all

certified agencies will be collecting

information using precisely the same

items to ultimately measure and risk

adjust outcomes.

When the final rule has been

promulgated, we will include the

instructions and definitions necessary to

use the OASIS in the notification to the

HHAs. At the present time, however, we

wish to clarify several items in the

current OASIS. These are:

• Overall Progress, Rehabilitative

Prognosis, and Life Expectancy
11040 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

While these are common assessment

items, they are included in this version

of the OASIS with the expectation that

they will be a part of the data we intend

to collect. They have been shown, thus,

far, to be highly predictive of health

status outcomes. In the controlled

environment of the reliability and

validity testing of these items where

data accuracy is verified, these items

correlated well with other items that

track functional status. In other words,

patients judged to have low

rehabilitation potential tend to show

less change in health status between two

points in time. If these items retain their

predictive power through the

demonstration and are retained in later

versions of the OASIS, they will be

useful items for ‘‘sorting’’ performance

or analysis and for searching for

opportunities for improvement. For

example, if an HHA reports many

patients with high rehabilitation

potential, but functional status measures

of these patients (risk-adjusted) show

poorer results than other high

rehabilitation potential patients in other

HHAs, an opportunity to improve is

presented to the HHA. We want to

emphasize that this item adds little or

no new burden, since HHAs routinely

use assessment items similar to, or the

same as, this item.

• Current Residence

We have included this item because it

is closely related to the sustainability of

an individual in community-based care

and, possibly, institutional services. For

example, a frail person who is able to

live successfully in the home of a family

member may not be able to do so if the

same person were living alone in a

rented room. The performance of the

HHA in relationship to such variables as

type of residence can make the

difference between staying out of a

nursing home and getting in to a nursing

home. Having this information in the

system enables the HHA (and HCFA) to

measure patient success in relationship

to residence.

• Supportive Assistance

The items in this section are intended

to sort out and distinguish among the

various types of caregiving that family

and others provide, and with what

frequency. As these items continue to be

analyzed for utility and predictive

power during the demonstration, they

may be consolidated or shortened. Their

importance, though, relates directly to

the balance that should be achieved

between the service the HHA provides

and the help family and others provide

to ensure the patient has the best chance

to remain at home for as long as possible

and to improve as much as possible.

To measure outcomes, OASIS data are

collected at uniformly defined time

points: start of care, every 57 to 62 days

until and including discharge, and

within 48 hours after return to home

from a hospital admission for any

reason other than diagnostic testing. We

are using a time frame of 57 to 62 days

to provide the HHA flexibility, and to

ensure that the reassessment will be

completed in time for the 62-day patient

recertification. We are requiring that the

OASIS be administered within 48 hours

of the patient’s return from a hospital

admission (except when the hospital

admission was for diagnostic tests)

because we believe hospital admissions

are predictive of likely changes in

patient status and, therefore, important

to capture for care planning and quality

assessment and performance purposes.

When HCFA asks HHAs to report

OASIS data, some information about the

patient at the time of admission to a

hospital may be included and, if so,

would be related to reasons for the

admission to the hospital. If home

health care is resumed after the hospital

admission and regardless of whether the

patient was formally discharged from

the HHA, the standard start-of-care

OASIS is completed, with supplemental

information on the length of hospital

stay. Under these circumstances, if the

patient was not formally discharged,

followup data collection continues at 57

to 62 day intervals in accord with the

original start-of-care date. If the patient

was formally discharged from the HHA,

the data collection proceeds on the basis

of the new start-of-care date that

followed the inpatient stay.

Some data items are unique to only

one time point (for example, discharge

information is only collected at patient

discharge), while other data are

collected at every time point. By

collecting data using uniform data items

and time points, individual patient data

are comparable. The data can be

aggregated to form agency-level

outcomes and to be used for

comparisons to a larger reference group

of agencies. As a result, uniformity of

data items and times points allows us to

compare ‘‘apples to apples.’’ Again, this

is why we are requiring as a condition

of participation that the HHA use the

OASIS exactly as specified by the

Secretary. The most current version of

the OASIS is published in this proposed

rule. It reflects minor adjustments to

various items that further testing in the

field has shown to increase the

precision and utility of the OASIS. This

version does not change the workload

associated with its use and there is some

indication it requires less

administration time than the earlier

version. We urge that agencies currently

using various versions of the OASIS,

including ‘‘partial’’ versions, now focus

on the use of the version of the OASIS

contained in this proposed notice.

As health care delivery is constantly

evolving, so will the OASIS continue to

evolve. Although the data set has

undergone extensive testing to date, it

will be necessary to test and refine the

data set on an ongoing basis. Further

reliability and validity testing is

occurring in the context of the national

demonstration noted above. As

experience is gained and as home care

continues to change, so too must the

OASIS. Modifications in items on the

OASIS or the addition or deletion of

data items from the OASIS as a result of

additional testing will be released to

HHAs periodically in manual updates,

so that HHAs will make the necessary

modifications and the OASIS can

continue to represent the best data set

for home health care outcome

measurement.

C. Expectations Regarding the Use of the

OASIS

We plan to implement full use of the

OASIS in stages. The first step, which

will begin when these proposed

regulations are published as a final rule,

is to require that all HHAs incorporate

the exact use of the OASIS into their

current comprehensive assessment

process. This requirement will help to

organize the assessment process around

a set of agreed-upon, valid and reliable

health status items that are known to be

of value in measuring quality outcomes

for patients. After HHAs have begun to

use the OASIS as specified by the final

rule, we intend to publish another

proposed rule that would require HHAs

to report OASIS data electronically into

a national database. We believe this step

will bring the use of the OASIS to its

full potential as described in section

I.C.2. ‘‘The Longer Run Use of the

OASIS’’ of this preamble.

1. The Near Future

The comprehensive needs of home

health patients are currently determined

in a wide variety of ways, using

numerous assessment tools. The utility

and effectiveness of the many ways of

completing a comprehensive assessment

also vary widely, from highly

sophisticated systems to little more than

general notes on the plan of care

submitted for payment. The first

critically important advantage of

requiring HHAS to incorporate the exact

use of the OASIS within their current

approach to a comprehensive

assessment process is that it helps to

organize the assessment process around
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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
11042 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 startof-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 patientspecific 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,
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 processof-care screen that investigates the

circumstances and processes leading to

outcomes. Such an investigation can, in

turn, lead to a plan of action that

focuses on specific changes in care

behaviors at the individual patient level.

This enables an HHA to identify and

apply ‘‘lessons learned’’ to its agency

operations to improve the outcomes of

the agency as a whole. Analogously, the

HHA can examine circumstances and

processes that produced superior or

exemplary outcomes to reinforce care

behaviors that produce such outcomes,

promulgating information on such care

behaviors within the agency.

Data from outcome reports not only

can be used by the HHA for continuous

quality improvement by monitoring

outcomes over time, but also can be

used to objectively assess the agency’s

strengths and weaknesses in the clinical

services it provides. Outcome reports

can inform the HHA what patients and

clinical conditions it best serves, what

areas of HHA-care behaviors or

activities correlate with patient

satisfaction, and what services need

improvement. Such information will be

of value to the HHA in its strategic

planning, financial planning, and

marketing.

Aggregate HHA outcome reports that

contain no patient-specific data may be

used by the industry for comparative

performance assessment. The home care

industry can identify those agencies

regarded as industry leaders in quality

of care for comparable services, care

domains, and/or patient populations.

Identified quality leaders can market

their services accordingly and can serve

as a reservoir of expertise for other

agencies in their efforts to improve

performance in selected areas.

The results of outcome measurement

also can provide useful information to

purchasers and consumers of home care

services. Such organizations and

individuals will be able to examine

reports of industry outcomes and

identify those agencies that will best

provide the services to meet the needs

of individual consumers or the

population needs of particular

purchasers. Improved access to

objective information on quality of care

for consumers and purchasers will also

drive quality improvement in the

industry as a whole. HHAs with records

of poor performance will be motivated

to improve their performances to

compete with better-performing HHAs.

Our managed care partners, as

purchasers of home health services,

would also be interested in such

outcome-based comparative

performance measurements of HHAs. A

standardized industry-wide instrument

would allow plans as purchasers to

make value-based purchasing decisions

of home health care. The ability to use

outcome measurement data is especially

important to us as a purchaser of

services on behalf of eligible

beneficiaries. For example, in addition

to comparing an HHA’s performance to

its own past performance, HCFA and

State survey agencies will be able to use

industry-wide performance data on a

continuous basis to identify HHAs that

are not performing to the norm, thereby

suggesting the possibility that poor

quality of care is occurring. This

information can trigger on-site

inspections to assess performance. At

the same time, the data can be used to

look for patterns of exemplary

performance that can be shared with

others to help improve outcomes of care

and satisfaction overall. Having these

data on a flow basis frees us up from

rigid survey schedules and enables us to

use scarce inspection resources more

productively. Of course, we would still

conduct initial inspections to ensure an

HHA is ready for participation. We

would also follow up, usually with an

on-site visit, on all complaints that

suggest quality of care problems.

Additionally, State survey agencies and

HCFA could use performance data to

identify opportunities for improvement

in national or local priority areas, such

as a project to improve medication

management for beneficiaries generally,

or to shorten the time necessary to

achieve a clinically important patient

outcome.

The availability of performance data

will also enable State survey agencies

and HCFA to evaluate more effectively

the HHA’s performance of its own

quality assessment and performance

improvement program. For example, an

HHA is receiving objective feedback

data that show that the HHA is

performing less well than other HHAs in

a particular clinical outcome area. The

HHA is not using the quality assessment

and performance improvement program

to address why its results are divergent

and to develop interventions to improve

its performance. Consequently, the

surveyors will have evidence that the

HHA is not responding the way it could

or should to improve outcomes of care

and satisfaction for patients.

Initially, since we are not yet

requiring HHAs to submit OASIS data,

surveyors will look at how the HHA has

used OASIS data internally, and ideally,

informally with other HHAs (for

example, either within its own

company, or through consortia of HHAs

in its geographic area). Likewise,

accreditation organizations with

deemed status can use the information

as part of their accreditation processes.

As we stated earlier in this preamble,

the Department of Health and Human

Services will, at a later date, issue a

separate notice of proposed rulemaking

identifying the specific data elements

that would be required to be reported to

HCFA, the timetable, and the intended

use of these data elements. At this time,

it has not been determined how

extensive or limited these requirements

will be. There will be extensive public

comment when the draft is issued. In

the meantime, however, we welcome

public comment on the question of what

would constitute appropriate reporting

requirements for the purposes of

monitoring progress toward meeting

performance outcome measures.

3. Other Potential Applications of

OASIS Data

We are presently investigating the

potential of the OASIS and information

on which clinical outcomes are based to
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assist in developing selected features of

a Medicare prospective payment system

for home health services. Specifically,

we have found that in identifying

factors that might be valuable in

developing case-mix adjustors for

payment purposes, traditional

characteristics such as patient diagnosis

account for little of the variation in

home health utilization. Our Office of

Research and Demonstrations is

currently researching home health casemix, including an investigation of the

use and applicability of the data items

contained within the OASIS for

developing a home health case-mix

adjustor for payment purposes. If such

data items are found to be a valid basis

for home health case-mix, the potential

of the OASIS would be further

maximized. At the same time, the

burden on HHAs in providing health

status information for purposes of

measuring outcomes, assessing patient

needs, care planning, and measuring

case mix would be minimized.

We believe the OASIS data have the

potential to be of significant benefit to

health professionals and professional

organizations. Objective, well-specified

data on home health outcomes can

assist professionals to determine those

practice areas needing improvement,

and help to identify inefficient or

ineffective practice standards or services

which do not contribute to improved

patient outcomes. Thus, the OASIS data

can inform and improve professional

practice standards and ultimately assist

in the development of clinical practice

guidelines and critical pathways. On a

broader scale, we are interested in

developing a capability of linking

beneficiary information across provider

settings with other administrative data

(for example, payment and utilization

data). Beneficiaries may have very

complex service delivery histories,

moving among various services and

benefits.

In order to effectively track outcomes

and to facilitate the administrative tasks

involved in integrating the care for

individuals, our data systems, including

the OASIS, minimum data set (MDS),

and others that may emerge, must be

able to be integrated. Since mandated

data sets have been implemented or are

being considered in other domains of

health care for which HCFA is

responsible (for example, the MDS for

nursing homes, and the Uniform Needs

Assessment instrument for hospital

discharge), we anticipate the evolution

of data items and data sets to occur so

that the degree of commonality among

such data sets can be maximized over

the course of time. Data sets have been

developed for selected fields such as

home care and nursing home care so

that the unique needs of patient and

Medicare beneficiaries that pertain to

each provider type can be adequately

taken into consideration in the context

of an initial data set such as OASIS or

MDS. Because of these unique needs, it

is unlikely that we can collectively

attain perfect overlap among the

different data sets. It is our goal

ultimately to attain as much

commonality across these data sets as

possible so that patient health status

might eventually be monitored across

provider settings using a core set of data

items within each data set.

Finally, we expect that the OASIS

data will help us in promoting more

efficient regulations and policies that

encourage good performance in the

home care industry. We will be able to

objectively examine the home health

industry in all its complexity, using

outcome data to support or refute

anecdotal information, unsubstantiated

opinion, or conjecture, thereby

facilitating consensus building and

more objective policy decisions. Most

important, home health outcomes

information will aid in shaping and

even creating the home health benefit of

the future. As we identify those

practices and services that contribute to

enhanced patient outcomes, the patient

populations that should be served by

home care can be better specified, and

the capacity of the home health industry

to provide the requisite services can be

strengthened, expanded, or refined in

keeping with beneficiary outcomes.

II. Sample OASIS Survey

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III. Provision of the Proposed

Regulations

This proposed rule would add further

requirements to the proposed

regulations regarding conditions of

participation for HHAs published

elsewhere in this issue of the Federal

Register. We would require that HHAs

incorporate the use of the OASIS in

their comprehensive assessment of their

patients, and that they use data from the

OASIS in their internal quality

assessment and performance

improvement programs. As we stated

previously in this preamble, we are not

yet proposing to require that HHAs

collect and report OASIS data to a

national data system or to use national

comparative OASIS data as a part of

their quality assessment and

performance improvement programs.

• We would revise proposed § 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 patientspecific, comprehensive assessment

* * * that incorporates the exact use of

the current version of the Outcomes and

Assessment Information Set (OASIS), as

specified by the Secretary.’’ We believe

that this is the only added regulatory

language necessary to require an HHA to

incorporate the OASIS into its already

existing comprehensive assessment

process. While not stated explicitly in

the language of the regulation, the

OASIS is inappropriate for use with

individuals under 21 years of age and is

not intended for use with maternity

cases. Information about the OASIS’’

clinical applicability is part of the

dataset procedures so we do not believe

it is necessary to state in the proposed

regulations that the use of the OASIS is

not applicable to maternity cases and

individuals under 21 years of age.

• We would also add language at

proposed § 484.55(d)(1) to state that the

comprehensive assessment must be

updated and revised as frequently as the

condition of the patient requires, but not

less frequently than every 62 days.

These updates must include the

administration of the OASIS within

every 57 to 62 days after the start of

care. We are proposing to add this

requirement to ensure that

reassessments would be completed in

time for the 62-day patient

recertification.

• We would revise proposed

§ 484.55(d) to require that an HHA

administer the OASIS ‘‘within 48 hours

of the patient’s return to the home from

a hospital admission for any reason

except diagnostic testing. (This update

includes the administration of the

OASIS.)’’ We are proposing to add the

requirement that an assessment using

the OASIS be administered after a

hospital admission for any reason

except diagnostic testing because we

know that, typically, such a hospital

admission can indicate a significant

change in a patient’s functional status.

We believe that the use of the OASIS

upon the patient’s return to the home

would be useful from a care planning

standpoint as part of the comprehensive

assessment and as a significant

functional status ‘‘data point’’ for

comparative purposes. This event will

trigger reporting of OASIS data as well

in the future.

• We would add new § 484.55(e) to

provide that the HHA must incorporate

into its own assessment instrument,

exactly as the OASIS is written, OASIS

data items that include information

regarding demographics and patient

history, living arrangements, supportive

assistance, sensory status,

integumentary status, respiratory status,

elimination status, neuro/emotional/

behavioral status, activities of daily

living, medications, equipment

management, emergent care, and

discharge.

• We would add language to

§ 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 companywide 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
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is included at Section VI.C.1. We

strongly believe that the benefits

associated with the use of OASIS data

will far outweigh its costs. As discussed

in detail above, OASIS data will

improve the delivery of quality care in

the nation’s HHAs in several ways.

HHAs will find the information helpful

in organizing their care planning. The

increased specificity in patient

assessment will assist agency staff to

uniquely tailor a treatment plan to each

individual patient.

On a more global scale, once data

from the OASIS are available in the

form of standardized outcome reports,

consumers, purchasers, providers, and

HCFA will be able to use information to

evaluate quality of care across the full

spectrum of HHAs. The home health

industry can use the data for

comparative performance assessment.

HCFA and the State survey agencies

will be able to use the data on a

continuous basis to identify providers

that are not performing to the norm.

This use will allow us to further

progress in our efforts to develop a more

efficient and targeted survey approach.

As we discussed above, these

proposed regulations would require that

each HHA use a standard core

assessment data set as part of its

assessment of most adult patients. The

impact of these proposed regulations

would vary from HHA to HHA

depending upon an HHA’s current

assessment process. The additional

impact on HHA workload centers

around collection of information and

paperwork burden and is discussed in

detail in the ‘‘Collection of Information

Requirements’’ section of this preamble.

There are no other requirements that

would impact HHAs in these proposed

regulations.

B. Rural Impact Statement

Section 1102(b) of the Social Security

Act (the Act) requires us to prepare a

regulatory impact analysis for any

proposed rule that may have a

significant impact on the operation of a

substantial number of small rural

hospitals. Such an analysis must

conform to the provisions of section 604

of the RFA. For purposes of section

1102(b) of the Act, we define a small

rural hospital as a hospital that is

outside of a Metropolitan Statistical

Area and has fewer than 50 beds. We are

not preparing a rural impact statement

since we have determined that this

proposed rule would not have a

significant impact on the operations of

a substantial number of small rural

hospitals.

C. Review by the Office of Management

and Budget

In accordance with the provisions of

Executive Order 12866, this proposed

regulation was reviewed by the Office of

Management and Budget.

V. Response to Comments

Because of the large number of items

of correspondence we normally receive

on Federal Register documents

published for comment, we are not able

to acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the DATES section of

this preamble, and, if we proceed with

a subsequent document, we will

respond to the comments in the

preamble to that document.

VI. Collection of Information

Requirements

Under the Paperwork Reduction Act

of 1995, agencies are required to provide

60-day notice in the Federal Register

and solicit public comment before a

collection of information requirement is

submitted to the Office of Management

and Budget (OMB) for review and

approval. In order to fairly evaluate

whether an information collection

should be approved, section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 requires that we

solicit comment on the following issues:

• Whether the information collection

is necessary and useful to carry out the

proper functions of the agency;

• The accuracy of the agency’s

estimate of the information collection

burden;

• The quality, utility, and clarity of

the information to be collected; and

• Recommendations to minimize the

information collection burden on the

affected public, including automated

collection techniques. Therefore, we are

soliciting public comment on each of

these issues for the proposed

information collection requirements

discussed below.

The proposed regulations at § 484.55

and § 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.
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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 agencylevel 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
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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 § 484.55 and § 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

Year*

Number of agencies

incurring start-up

costs

Start-up costs @

$2256 per HHA (in

millions)

Ongoing costs @

$2583 per HHA (in

millions)

Total costs (in millions)Medicare costs (in

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

Task Agency costs (in dollars)

National costs—historic growth rate of

9.3% (Agency costs

× 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

Task Hours Computation of average costs Average

cost

Intergration of OASIS into existing assessment forms:

Revision of intial assessment forms .............................................. 8

Revision of clinical forms (57–62 day assessment) ....................... 4

Revision of clinical forms (48 hours post-hospital admission) ....... 4

Total ........................................................................................ 16 16 hrs × $12.50 per hr (avg. clerical rate) .......... $200

Staff training:

Data collection for initial assessment ............................................. 2
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11063

3. HOURLY BREAKDOWN AND COMPUTATION OF THE AVERAGE OASIS START-UP COSTS PER HHA—Continued

Task Hours Computation of average costs Average

cost

Data collection for recertification assessment at follow-up ............ 0.3

Data collection at discharge ........................................................... 0.7

Data auditing .................................................................................. 0.5

Total ........................................................................................ 3.5 3.5 hrs × $24.05 per hr × 18 providers ............... 1,515

Learning curve:

Initial use of the OASIS data collection ......................................... 0.25

Next 4 uses of the OASIS data collection ( 4 × .25 hrs) ............... 1

Total ........................................................................................ 1.25 1.25 hrs × $24.05 per hr × 18 providers ............. 541

Total ........................................................................................ 19.75 2,256

4. HOURLY BREAKDOWN AND COMPUTATION OF ONGOING OASIS COST BURDENS PER HHA

Task Computation of hours Total

hours Computation of average cost Averagecost

Initial care ...................................... 486 admissions×2.5 min per admissions÷60

min.

20.3 20.3 hrs×$24.05 per hr .................. $488

Followup (57–62 days) .................. (42 percent of HHA patients×first followup×486 admissions) + (26 percent of

HHA patients×second follow-ups×486 admissions)+(17 percent×third followup×486 admissions)=413 follow-ups—

413 follow-ups×2.5 min per followup÷60

min.

17.2 Hrs×$24.05 per hr ......................... 414

Post-hospital admission ................. (486 admissions×.25 of HHA patients×2.5

min per admission)÷60 min.

5.1 5.1 hrs×$24.05 per hr .................... 123

Discharge ....................................... (486 admissions×8 min per admission)÷60

min.

64.8 64.8 hrs×$24.05 per hr .................. 1,558

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 § 484.55, the introductory

paragraph and paragraph (d) are revised

and new paragraph (e) is added to read

as follows:

§ 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 § 484.65, paragraph (a)(1) is

revised to read as follows:
11064 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

§ 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]

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