Medicare and Medicaid Programs: Comprehensive Assessment and Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 484

[HCFA-3007-F]

RIN 0938-AJ11

Medicare and Medicaid Programs: Comprehensive Assessment and Use

of the OASIS as Part of the Conditions of Participation for Home Health

Agencies

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule.

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

SUMMARY: This final rule revises the existing conditions of

participation that home health agencies (HHAs) must meet to participate

in the Medicare program. Specifically, this rule requires that each

patient receive from the HHA a patient-specific, comprehensive

assessment that identifies the patient's need for home care and that

meets the patient's medical, nursing, rehabilitative, social and

discharge planning needs. In addition, this final rule requires that as

part of the comprehensive assessment, HHAs use a standard core

assessment data set, the ``Outcome and Assessment Information Set''

(OASIS) when evaluating adult, non-maternity patients. These changes

are an integral part of the Administration's efforts to achieve broad-

based improvements in the quality of care furnished through Federal

programs and in the measurement of that care.

EFFECTIVE DATE: These regulations are effective on February 24, 1999.

ADDRESSES: Mail written copies of comments related to information

collection requirements to the following addresses:

Health Care Financing Administration, Office of Information Services,

Security and Standards Group, Division of HCFA Enterprise Standards,

Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850,

Attention: John Burke HCFA-3007-F, Fax number: 410-786-0262 and,

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, D.C.

20503, Attention: Allison Herron Eydt, HCFA Desk Officer, Fax number:

202-395-6974 or 202-395-5167

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. 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 to (202) 512-

2250. The cost for each copy is $8. As an alternative, you can view and

photocopy the Federal Register document at most libraries designated as

Federal Deposit Libraries and at many other public and academic

libraries throughout the country that receive the Federal Register.

This Federal Register document is also available from the Federal

Register online database through GPO Access, a service of the U.S.

Government Printing Office. Free public access is available on a Wide

Area Information Server (WAIS) through the Internet and via

asynchronous dial-in. Internet users can access the database by using

the World Wide Web; the Superintendent of Documents home page address

is http://www.access.gpo.gov/su__docs/, by using local WAIS client

software, or by telnet to swais.access.gpo.gov, then login as guest (no

password required). Dial-in users should use communications software

and modem to call (202) 512-1661; type swais, then login as guest (no

password required).

FOR FURTHER INFORMATION CONTACT: Janice Stevenson at (410) 786-4882.

SUPPLEMENTARY INFORMATION:

I. Background

Home health services are covered for the elderly and disabled under

the Hospital Insurance (Part A) and Supplemental Medical Insurance

(Part B) benefits of the Medicare program and are described in section

1861(m) of the Social Security Act (the Act). These services must be

furnished by, or under arrangement with, an HHA that participates in

the Medicare program, and be provided on a visiting basis in the

beneficiary's home. Services may include the following:

Part-time or intermittent skilled nursing care furnished

by or under the supervision of a registered nurse.

Physical therapy, speech-language pathology, and

occupational therapy.

Medical social services under the direction of a

physician.

Part-time or intermittent home health aide services.

Medical supplies (other than drugs and biologicals) and

durable medical equipment.

Services of interns and residents if the HHA is owned by

or affiliated with a hospital that has an approved medical education

program.

Services at hospitals, SNFs, or rehabilitation centers

when they involve equipment too cumbersome to bring to the home.

Section 1861(o) of the Act specifies certain requirements that a

home health agency must meet to participate in the Medicare program.

(Existing regulations at 42 CFR 440.70(d) specify that HHAs

participating in the Medicaid program must also meet the Medicare

conditions of participation.) In particular, section 1861(o)(6) of the

Act provides that an HHA must meet the conditions of participation

specified in section 1891(a) of the Act and such other conditions of

participation as the Secretary finds necessary in the interest of the

health and safety of patients of HHAs. Section 1891(a) of the Act

establishes specific requirements for HHAs in several areas, including

patient rights, home health aide training and competency, and

compliance with applicable Federal, State, and local laws.

Under the authority of sections 1861(o), 1871 and 1891 of the Act,

the Secretary has established in regulations, the requirements that an

HHA must meet to participate in the Medicare program. These

requirements are set forth at 42 CFR Part 484, Conditions of

Participation: Home Health Agencies. Unless a condition is specifically

limited to Medicare beneficiaries, the conditions of participation

(COPs) apply to an HHA as an entity and to the services it furnishes to

an individual under its care. Under section 1891(b) of the Act, the

Secretary is responsible for assuring that the COPs, and their

enforcement, are adequate to protect the health and safety of

individuals under the care of an HHA and to promote the effective and

efficient use of Medicare funds. To implement this requirement, State

survey agencies generally conduct surveys of HHAs to determine whether

they are complying with the conditions of participation.

II. Provisions of the Proposed Rule and Discussion of Public

Comments

On March 10, 1997, we published two proposed rules in the Federal

Register that proposed significant changes to the HHA COPs. The first

proposed rule, Conditions of Participation for Home Health Agencies (62

FR 11004), set forth broad based revisions to the COPs with the goal of

eliminating cumbersome process regulations and focusing on outcomes of

care. In the preamble to that proposed rule, we discussed in detail our

rationale for revising the COPs and the principles underlying our

[[Page 3765]]

proposed revisions. Specifically, we stated that the revised COPs will

promote a partnership between HCFA and the rest of the health care

community, and are based on the belief that we should retain only those

regulations that represent the most cost-effective, least intrusive,

and most flexible means of meeting HCFA's quality of care

responsibilities. Also, they rely on the principle that making powerful

data available to consumers and providers can produce a strong

nonregulatory force to improve quality of care. One of the most

significant provisions of the HHA COPs proposed rule was the

requirement that each patient receive from the HHA a patient-specific,

comprehensive assessment that identifies the patient's continuing need

for home care, and that meets the patient's medical, nursing,

rehabilitative, social and discharge planning needs.

The second proposed rule published on March 10, 1997, Use of the

OASIS as Part of the Conditions of Participation for Home Health

Agencies (62 FR 11035), proposed that as part of the comprehensive

assessment, HHAs use a standard core assessment data set, the ``Outcome

and Assessment Information Set'' (OASIS), when evaluating adult, non-

maternity patients. In the preamble to that rule, we discussed in

detail the process we used to develop the OASIS including numerous

definitional and methodological issues that had to be addressed before

the OASIS was finalized. In addition, we also described expectations

regarding the use of the OASIS both in the near future and in the long

run. Both the proposal to revise the HHA COPs and the proposal

requiring use of the OASIS are integral parts of the Administration's

efforts to achieve broad-based improvements in the quality of care

furnished through the Medicare and Medicaid programs and in the

measurement of that care.

Subsequent to the publication of the two proposed rules discussed

above, the Balanced Budget Act (Public Law 105-33 (BBA)) was enacted on

August 5, 1997. It amended the Act to require the Secretary to

establish a prospective payment system for home health services.

Although the implementation of a prospective payment system will be

delayed until all related systems achieve year 2000 compliance, we will

still need to begin receiving the data to be used for standardizing the

payment amounts as soon as possible. In order to implement this

prospective payment system, it is necessary that we have data from HHAs

to develop a reliable case mix adjustment system. Case mix adjustment

modifies prospective payment rates to reflect the differences in the

amount of services required by patients of different diagnosis and

severity, and allows the payments to correspond more closely with

expected resource use by patients. Section 4602(e) of the BBA provides

that for cost reporting periods beginning on or after October 1, 1997,

the Secretary may require HHAs to submit additional information that

the Secretary considers necessary to develop reliable case mix

adjustments. We intend for the OASIS to be the vehicle through which

information for the case mix adjustments is collected. Thus, to

facilitate the implementation of the prospective payment system, in

this final rule, we are setting forth only that portion of the proposed

COPs concerning comprehensive assessment. In addition, we are

finalizing the proposed rule that requires use of the OASIS.

Specifically, as discussed in detail below, we are requiring that HHAs

complete a comprehensive assessment for each patient and that they

incorporate the OASIS into their comprehensive assessment process.

In addition to publishing this rule, in today's issue of the

Federal Register, we are also publishing regulations that require HHAs

to electronically report OASIS data as a condition of participation.

Because the prospective payment system must be implemented as soon as

possible, we will need to begin receiving the data to be used for

standardizing the payment amounts. The publication of this final rule

and the rule concerning reporting requirements for OASIS will allow us

enough lead time to be assured that the data we collect are consistent

and complete for the purposes of computing valid case mix adjusters.

Only then can we be confident that resulting payment levels are proper.

Should computations be flawed and payments improper, incentives would

be distorted and patient care could quite possibly suffer.

The immediate publication of rules requiring the collection and

reporting of OASIS data and OMB approval of these requirements pursuant

to the Paperwork Reduction Act of 1995 are essential because these data

are required for the development of the home health prospective payment

system, required by statute in October of 2000. Because OASIS data will

form the basis for the case mix adjustment component of the prospective

payment system, national OASIS data must be used in the extensive

statistical analyses needed to calculate standardized prospective

payment rates and estimate their impact. The process of rate

development must take place in the early spring of 1999 for

incorporation in a proposed rule. The proposed rule regarding the home

health prospective payment system must be published by the fall of 1999

to allow for necessary comments and revisions prior to the publication

of a final rule in the summer of 2000. Given the lag time between the

publication of the OASIS rules and the receipt of viable national data

by HCFA, we are already at the point where only two months of national

data will be potentially available for use in the proposed rule and

less than a year of data for the final rule. Further delays would

reduce the amount of national data available for development of the

prospective payment rates and thus seriously undermine the project plan

aimed at implementation of the prospective payment system on October 1,

2000.

Our commitment to revising the COPs for HHAs to focus on patient-

centered, outcome-oriented care remains unchanged. Once HHAs have

become familiar with collecting and reporting OASIS data, we expect to

publish a final rule that sets forth the remainder of the revisions to

the HHA COPs, which we proposed in March, 1997. Following is a

discussion of the provisions of the March 10, 1997 proposed rules

concerning comprehensive assessment and use of the OASIS as well as our

responses to public comments received on these issues. We will respond

to comments concerning the other home health conditions, which were

proposed in the March 10, 1997 Federal Register, in a separate

rulemaking document.

A. Comprehensive Assessment

The Comprehensive Assessment of Patients COP reflects the patient-

centered, interdisciplinary approach, and underscores our view that

systematic patient assessment is essential to improving quality of care

and patient outcomes. We believe that the comprehensive assessment

requirements reflect standard practice for most HHAs. In addition, this

condition requires HHAs to incorporate the use of OASIS in their

comprehensive assessment.

We proposed to add a new Sec. 484.55 to require that each patient

receive from the HHA a patient-specific, comprehensive assessment that

identifies the patient's need for home care and that meets the

patient's medical, nursing, rehabilitative, social and discharge

planning needs. For Medicare patients, identifying the need for home

care would include assessment of the patient's eligibility for the home

health benefit, including the patient's homebound status. (This

verification of a patient's eligibility for Medicare home

[[Page 3766]]

health benefit including homebound status does not apply to Medicaid

patients or private pay patients.) As a result of the utility of OASIS

as a case mix adjuster, we have slightly modified the appropriate

populations for whom the OASIS data should be collected. Because OASIS

data is necessary for payment purposes, it must be collected for all

Medicare beneficiaries except pediatric patients, including those

groups for whom OASIS is not as useful for outcome measurement as for

others. We expect HHAs will collect OASIS data on all patients served

by the HHA except prepartum and postpartum patients, patients under 18,

and patients who are not receiving personal care or health services

(that is patients who are receiving only services such as

housecleaning, cooking or laundry).

General Comments

Comment: One commenter expressed concern that the home care

industry is facing many major changes at one time including revised

COPs (which include a new set of standards requiring data driven

performance improvement), implementation of OASIS, and the

implementation of a prospective payment system that has not been

designed to consider the costs of outcome measurement and performance

improvement.

Response: We agree that change, even necessary change, is

difficult, and we have endeavored to make the transition as smooth as

possible. To that end, we published OASIS and the revised COPs in the

Federal Register in March, 1997, to give HHAs and the industry an

opportunity to begin familiarizing themselves with the data set and

developing strategies for complying with the proposed COPs. We

recognize that recent changes in the reimbursement system have made the

implementation of the OASIS requirements a challenging prospect for

some HHAs. However, as a result of the BBA, HCFA and HHAs are faced

with the rapid implementation of a prospective payment system. As

discussed above, OASIS data is critical to the development of case mix

adjustments for the prospective payment system for HHAs, which has been

mandated by the BBA. Without such data, there is a strong likelihood

that HCFA could not obtain the case mix information that is absolutely

essential for the establishment of a prospective payment system.

Although we recognize that it may be difficult for HHAs to cope with

the changes that would result from implementation of all the proposed

COPs at one time, we cannot delay implementation of the OASIS

requirements. Therefore, in this rule, we are finalizing only the

condition that requires collection of OASIS information. The reporting

requirements for OASIS data are published in a separate rule in today's

issue of the Federal Register. We plan to finalize the remainder of the

home health conditions in a later rulemaking document. We believe this

approach will give HHAs the opportunity to concentrate on OASIS

implementation.

Comment: One commenter suggested that assessment and care planning

are intertwined and should remain together in a single COP.

Response: We believe that assessment and care planning are

sequential steps in patient management, as one cannot develop a care

plan without first assessing the patient. By creating a separate

condition for the assessment process, we emphasize the importance of

this cornerstone of patient management. We provide specific assessment

requirements to support not only care planning, but also data critical

to the development and operation of a prospective payment system.

Comment: One commenter stated the belief that the requirement to

assess Medicare patients' homebound status when identifying patients'

need for home care is restricting. The commenter further stated the

belief that requiring a patient to be homebound in order to obtain

Medicare benefits limits them to the point of institutionalizing them.

Another commenter pointed out that the homebound criteria is not a

requirement for non-Medicare patients. The commenter recommended that

this be clearly stated in the surveyor interpretive guidelines.

Response: We recognize the commenters' concerns. However, sections

1814(a)(2)(C), and 1835(a)(2)(A) of the Act require a physician to

certify that an individual be homebound, or confined to the home, in

order to receive Medicare coverage for home health services. This

requirement is consistent with the statute, and promotes program

integrity because it requires HHAs to evaluate the Medicare patients'

eligibility for the home health benefit. We agree that homebound status

and other Medicare eligibility requirements do not apply to patients

served by the HHA who are not receiving Medicare home health benefits.

Therefore, we have revised the introductory text of Sec. 484.55 to

clarify that the HHA must verify the patient's eligibility for the

Medicare home health benefit including homebound status only for

Medicare home health beneficiaries. Verification of a patient's

eligibility for Medicare home health benefit including homebound status

does not apply to Medicaid patients, beneficiaries receiving Medicare

outpatient services or private pay patients. Because the comprehensive

assessment may not be completed at the time of the initial assessment

visit, we have also revised paragraphs (a) and (b) to require the HHA

to assess the patient's eligibility for the home health benefit at the

initial evaluation visit, and at the time the comprehensive assessment

is completed. In addition, we will ensure that HCFA guidance and

surveyor training reflect this distinction in accordance with the

commenter's request.

Comment: Many commenters favored the comprehensive assessment, but

requested clarification on the sequence of the assessment process as

specified in Sec. 484.55.

Response: We believe that commenters found the structure of the

condition confusing, as the requirements proposed at Sec. 484.55(a)

addressed drug regimen review as part of the comprehensive assessment,

Sec. 484.55(b) addressed the initial assessment visit, and Sec. 484.55

(c), (d) and (e) returned to the subject of the comprehensive

assessment. To improve clarity, we have revised the regulation to place

assessment requirements in sequential order within the condition. We

have also shortened the title of the proposed standard at

Sec. 484.55(c), Standard: Time frame for completion of the

comprehensive assessment to Standard: Completion of the comprehensive

assessment, in order to focus on the activity of completing the

comprehensive assessment, rather than to focus on the timing of the

activity. To further clarify the condition, we are removing language at

Sec. 484.55(d), which requires that the comprehensive assessment meet

the needs of the patient and include information on the patient's

progress toward clinical outcomes. We have incorporated this

requirement into the introductory text of Sec. 484.55.

The comprehensive assessment COP requires that a patient receive an

initial assessment in order to determine the immediate care and support

needs of the patient. The initial assessment visit corresponds to the

registered nurse initial evaluation visit required under the skilled

nursing condition of participation at Sec. 484.30. The initial

assessment visit is intended to ensure that the patient's most critical

needs for home care services are identified and met in a timely

fashion. We do not require that a comprehensive assessment be completed

at this visit, although the HHA may choose to do so. If the HHA does

not complete the

[[Page 3767]]

comprehensive assessment during the initial visit, then the

comprehensive assessment must be completed and updated according to the

time points at Sec. 484.55(b) and (d). Section 484.55(e) requires that

OASIS items be incorporated into the HHA's comprehensive assessment.

Therefore, in order to avoid misunderstandings regarding the

initial assessment, the comprehensive assessment and the OASIS, we have

rearranged the sequence of the process in Sec. 484.55 to read as

follows: Sec. 484.55(a) Initial assessment visit; Sec. 484.55(b)

Completion of the comprehensive assessment; Sec. 484.55(c) Drug regimen

review; Sec. 484.55(d) Update of comprehensive assessment; and

Sec. 484.55(e) Incorporation of OASIS data items.

Standard: Initial Assessment Visit

The regulation for the initial assessment visit set forth at

proposed Sec. 484.55(b) (now Sec. 484.55(a) in accordance with the

reorganization scheme discussed above) required that a registered nurse

perform an initial assessment visit based on physician's orders to

determine the immediate care and support needs of the patient either

within 48 hours of referral, within 48 hours after patient's return

home, or within 48 hours of the physician-ordered start of care date.

We proposed that when rehabilitation therapy services are the only

services ordered by the physician, the initial assessment would be made

by the appropriate rehabilitation skilled professional.

We solicited comments on the appropriateness of using competent

individuals other than a registered nurse or appropriate therapist to

perform initial patient assessments. We also invited comments on the

feasibility of permitting the delegation of nursing responsibilities

within the scope of State practice acts to competent individuals.

Comment: Several commenters questioned the requirement that the

initial assessment be completed within 48 hours. Commenters stated that

compliance would be difficult for home care providers who serve rural

areas, especially for weekend therapy coverage. Some commenters

suggested that the time frame be extended to 72 hours, others suggested

it be left up to the HHA. One commenter questioned how HHAs would

demonstrate that the patient was seen in the required amount of time.

However, another commenter pointed out that if a patient receives a

visit 48 hours after the physician orders those services to begin, then

the HHA is not complying with the plan of care.

Response: The requirement for the initial assessment to be

completed within a 48-hour time frame is imperative for the safety of

the patient. As the complexity of the care needs of patients increase,

so does the need for a comprehensive assessment of the patient, and the

importance of the development and implementation of an effective care

plan becomes paramount. In addition, HHAs are often providing services

that were once exclusively provided in a hospital or other

institutional settings (for example, chemotherapy, intravenous

treatments, and care for patients dependent on respirators). Thus, HHAs

are often caring for patients with severe and complex health care needs

who require high-tech services. Patients who are discharged from the

hospital or referred for home health services should not be left

unattended in the home for any extensive period of time, unless the

physician determines that a later start of care date is suitable. If

the physician orders that the patient begin receiving home health

services on a specific date, then it is reasonable to expect the HHA to

comply with that order. If there is no start of care date ordered, or

if access to the patient or provision of services are difficult to

provide within 48 hours of referral or discharge from the hospital,

then the HHA must communicate that difficulty to the physician. The

physician can then establish a start of care date that is appropriate

to meet the needs of the patient and is acceptable to the HHA.

We expect that HHAs will develop administrative processes to track

admissions and timeliness of service, and see such attention as a

positive outcome of this requirement. HHAs are free to choose the

method that works for them, given the size and patient population of

the HHA. We agree with the commenter that allowing the HHA to delay

services for 48 hours after the physician orders services to begin

would promote noncompliance with physician orders. As a result of this

comment, we have revised the requirement at Sec. 484.55(a)(1) to state

that the initial assessment visit must occur either within 48 hours of

referral, or within 48 hours of a patient's return home, or on the

start of care date ordered by the physician. To further clarify, if the

HHA is notified of a patient referral for home care on Monday, and the

patient is discharged from the hospital on Wednesday, we would expect

the initial assessment visit to occur by Friday, unless the physician

specifies an earlier time. However, if the physician orders the start

of care to begin on the following Monday (5 days after hospital

discharge and 7 days after the referral), the initial assessment must

be rendered on that day. We have also revised paragraph Sec. 484.55

(a)(1) to remove language that requires the registered nurse to

complete the initial assessment ``based on physician's orders''. We

believe this language is unnecessary, since all visits to the patient

are made based on physician orders.

Comment: One commenter indicated that most HHAs will not allow 48

hours or longer to complete the initial assessment. The commenter

stated that paperwork requirements, which differ from State to State,

mandate that all information be obtained and reduced to writing as

quickly as possible in order to obtain the physician's signature on the

document in the required time frames.

Response: In this final rule, we require specific time frames for

the initial assessment visit and completion of the comprehensive

assessment because we believe that these requirements are predictive of

good patient care, and proactive for the prevention of harm to the

patient. We recognize that States may have regulations that require

completion of the assessment earlier. However, we do not preclude

agencies from completing their assessments prior to the mandated

timeframes.

Comment: Two commenters suggested that we consider patient choice

and the patient's right to determine when the HHA will make the visit.

A commenter offered an example of a patient who would have help at home

until a designated point in time at which that help would cease. The

commenter suggested that the patient should be able to request that

home health services start as soon as help was no longer available.

Response: Section 1891(a)(1)(A) of the Act states that the patient

has the right to be fully informed in advance about the care and

treatment to be provided by the agency and the right to participate in

planning care. Section 1861(m) of the Act requires that the individual

receive services under a plan of care established and periodically

reviewed by the physician. Therefore, we expect that the patient, the

HHA and the physician will communicate in developing a plan of care

that meets the patient's health needs, is considerate of the patient's

concerns and can be delivered by the HHA. In the situation described by

the commenter, we would expect that a later start of care date would be

established by the physician if appropriate.

[[Page 3768]]

Comment: Several commenters disagreed with our proposed requirement

that therapists can perform initial assessment visits. Commenters

stated that, as the focal point for opening the case, the initial

assessment should be performed only by a registered nurse, because the

nurse has the broadest scope of clinical expertise. A few commenters

stated that therapists, including occupational therapists, (but not

therapy assistants) should be able to complete the initial assessment

visit. Several commenters questioned who should complete the

comprehensive assessment and asked that we clarify the requirement. One

commenter stated that updates of the comprehensive assessment and

completion of the OASIS at required intervals could be satisfactorily

performed by a licensed practical nurse under RN supervision.

Response: We received many comments recommending both restriction

(to registered nurses) and liberalization (to occupational therapists)

of our current requirements. Section 484.30(a) states that the

registered nurse make the initial evaluation visit; and, we agree that

the broad scope of clinical expertise of the registered nurse is

beneficial in conducting the initial evaluation. However, restricting

the initial evaluation to the registered nurse only (when only a

therapy service has been ordered by the physician) can be burdensome.

In these instances, in an endeavor to allow flexibility, a physical

therapist or speech language pathologist may conduct the initial

evaluation visit in accordance with physician orders. This policy has

been explained in interpretive guidelines, and is based on the proven

ability of the physical therapist and/or speech language pathologist to

conduct the initial visit.

At this time, we will make this policy explicit in regulation. As

we have said above, the initial assessment visit and comprehensive

assessment must be conducted by a registered nurse unless physical

therapy or speech language pathology is the only required service for

that patient. If that is the case, the physical therapist or speech-

language pathologist can conduct these assessments. The staff

requirements are the same for follow-up assessments and assessments at

the time of transfers and discharges.

With regard to occupational therapists completing the initial

assessment visit, we note that while Medicare pays for occupational

therapy, eligibility for the Medicare home health benefit cannot be

established based solely on the need for that service. The occupational

therapist may complete the comprehensive assessment and its updates if

the need for occupational therapy establishes program eligibility. The

need for occupational therapy would not establish eligibility for the

Medicare home health benefit, but could establish eligibility, for

example, in some States under the Medicaid program. Conversely, the

Medicare home health patient with multiple service needs can retain

eligibility if, over time, the only remaining need is for occupational

therapy. At that time, an occupational therapist can conduct the

follow-up assessment as well as those associated with transfers and

discharges. In the case of Medicaid patients, or Medicare patients

receiving outpatient services, if the need for a single therapy service

either establishes eligibility or allows eligibility to continue once

it is otherwise established, the corresponding practitioner, (including

a physical therapist, speech-language pathologist, or occupational

therapist) can conduct any of the designated assessments.

We do not believe the comprehensive assessment can be completed by

the licensed practical nurse in accordance with the COPs. The

introductory text to Sec. 484.55 requires that the comprehensive

assessment meet the needs of the patient and include information on the

patient's progress toward clinical outcomes. Thus, completing the

comprehensive assessment involves an evaluation of the patient. In the

current conditions of participation, patient evaluation is included in

the duties of the registered nurse at Sec. 484.30(a) and therapy

services at Sec. 484.32, but is not included in the duties of the

licensed practical nurse at Sec. 484.30(b). In response to comments, we

have revised Sec. 484.55(b)(2) to require that the registered nurse

complete the comprehensive assessment.

Comment: Several commenters requested that we clarify the term

``appropriate therapist''. Commenters indicated that surveyors apply

the Medicare restriction of occupational therapy as a qualifying

skilled service to non-Medicare patients or those Medicare patients

receiving outpatient services. Other commenters requested clarification

regarding the inclusion of the occupational therapist as one of the

disciplines to conduct the initial assessment visit.

Response: The appropriate therapist is the physical therapist or

speech language pathologist; and, in some cases as indicated above, the

occupational therapist. We have made this clarification in the

regulatory text at Sec. 484.55(a)(2). To further clarify, we have added

a new paragraph (b)(3) to provide that the comprehensive assessment may

be completed by the physical therapist, speech-language pathologist or

occupational therapist if the need for occupational therapy establishes

program eligibility.

Standard: Completion of the Comprehensive Assessment

At proposed Sec. 484.55(c) (now Sec. 484.55(b)) we specified the

timeframe in which the HHA must complete the comprehensive assessment.

We proposed that the HHA must complete the comprehensive assessment in

a timely manner consistent with the patient's immediate needs, but no

later than 5 working days after the start of care.

Comment: A few commenters questioned if the requirement for a

comprehensive assessment with OASIS data applies to all payment

sources, including managed care patients. Commenters also asked if

managed care organizations (MCOs) will be responsible for supplying the

follow-up to outcomes.

Response: The conditions of participation apply to the HHA, and

thus to all patients served by the agency. Therefore, we would expect

that managed care patients receive a comprehensive assessment,

including OASIS items, where required in the COPs. With regard to MCO

responsibility for follow-ups, we note that outcome reports generated

from OASIS data will be sent directly to the HHA providing the

services. At the discretion of the HHA, the HHA can work with the MCO

to develop a plan for follow-ups to the outcome reports.

Comment: Several commenters disagreed with the requirement that the

comprehensive assessment be completed within 5 working days after the

start of care. Some commenters suggested the requirement be changed to

7 days. Other commenters disliked the term ``working days'', stating

that every day is a working day for HHAs. These commenters suggested

changing the requirement to 5 calendar days.

Response: We agree with commenters that the term ``working days''

may be misleading. HHAs provide care to patients in accordance with

patient needs, and patient needs do not comply with the arbitrary

limits of ``working days''. Therefore, we have revised

Sec. 484.55(b)(1) to change the term ``working days'' to ``calendar

days'' in the requirement.

Comment: Two commenters requested that HCFA establish a

standardized comprehensive assessment that must be used for all HHAs.

The commenters felt

[[Page 3769]]

that this would improve efficiency for the HHA and the quality of

patient assessment. Another commenter pointed out that HHAs must

develop two comprehensive assessments; one for patients who require

collection of OASIS items, and one for patients who do not need to have

OASIS items included in their assessment. Commenters stated the belief

that this can be confusing and potentially burdensome for the HHA.

Response: We do not believe that a standardized comprehensive

assessment is necessary or useful to all HHAs. Our intent is that HHAs

have the flexibility to use a comprehensive assessment that reflects

the needs of their patient population. The standardized elements of the

comprehensive assessment are the OASIS items that must be incorporated

into the comprehensive assessment. We are aware that some provider,

vendor and academic organizations have developed standard comprehensive

assessments with the OASIS data set integrated into them. We expect

that the availability of such standard assessments would be attractive

to HHAs that do not want to develop their own. We do not require the

HHA to develop different comprehensive assessments in order to

accommodate OASIS data or varying clinical needs. The HHA is free to

establish assessment policy and to develop the number and type of

assessment forms that meet the individual HHA's needs.

Comment: One commenter stated that the OASIS follow-up must be

completed by the same discipline that completed the initial OASIS to

ensure reliability of the assessment.

Response: As discussed in the OASIS proposed rule, the University

of Colorado has found the OASIS to be valid and reliable even when

completed by different disciplines such as a nurse and physical

therapist or speech language pathologist at subsequent time points.

Therefore, we do not believe that the same discipline must complete the

OASIS at every time point.

Standard: Drug Regimen Review

Under Sec. 484.55(c) (proposed Sec. 484.55(a)) drug regimen review,

we proposed to incorporate the existing requirement concerning a drug

regimen review from Sec. 484.18(c). However, we clarify the

requirements by eliminating the identification of ``adverse actions''

and ``contraindicated medications'' and substituting the more concise

requirements of review for drug interactions, duplicative drug therapy

and noncompliance with drug therapy. This modification narrows the

scope of the drug regimen review, provides accountability, and focuses

the assessment toward data predictive of a significant patient outcome.

In this final rule, we are revising Sec. 484.18(c), by removing the

last sentence of the paragraph, which relates to review of the

patient's medications. This requirement has been incorporated into

Sec. 484.55(c) (proposed Sec. 484.55(a)).

Comment: Several commenters suggested that HCFA define the term

``drug regimen'' and questioned if this means all medications the

patient is taking or only medication prescribed for an episode of

treatment.

Response: We agree that the term ``drug regimen'' should be

clarified. Therefore, we have revised this standard to reflect that

drug regimen review is part of the comprehensive assessment of the

patient and includes all medications the patient is using at the time

of the assessment. This is an important safeguard for patients to

evaluate compliance with drug therapy, to recognize and reduce the risk

of complications from multiple medications, and prevent adverse drug

interactions and unnecessary medication. If an adverse drug reaction

should occur, the patient care provider should note the patient's side

effects and or adverse reaction in the medical record, notify the

patient's doctor, and, if possible, contact the pharmacy where the

prescriptions were filled.

Comment: One commenter stated that the review of drugs, drug

interactions, duplicative drug use, and noncompliance with the drug

regimen is not necessary for patients receiving only aide services, as

these patients are receiving their drug regimen from their physician

and pharmacist.

Response: All patients, whether receiving skilled services or only

aide services, receive their drug regimen from the physician. The drug

regimen review is an integral part of the comprehensive assessment, and

an important safeguard for patients who frequently receive medications

from a variety of physicians and pharmacies. We believe that patients

receiving aide services are likely to have multiple medications and

therefore require this health and safety protection.

Comment: Several commenters stated that the standard concerning

drug regimen review does not specify that the RN is responsible for the

drug regimen review as part of the comprehensive assessment. Commenters

were concerned that drug monitoring is beyond the scope of practice for

therapists and stated that it should be the ongoing responsibility of

the patient's physician and pharmacist in therapy-only cases. Another

commenter stated that the therapist was capable of completing the drug

regimen review and pointed out that therapists are currently doing so.

Response: Limiting the drug regimen review and completion of the

comprehensive assessment to the registered nurse would be burdensome to

the HHA, especially as the comprehensive assessment must be completed

periodically. If a therapy-only patient admission has a drug regimen,

we would expect the therapist to evaluate the patient's medications and

patient knowledge during the initial assessment visit and bring any

problems to the attention of the physician. We agree that management of

drug therapy is the responsibility of the physician, regardless of

whether the patient is receiving therapy-only services. We note that

this is a continuation of our policy since regulations previously

located at Sec. 484.18(c) allowed the drug regimen review to be

completed by the HHA nurse and therapist.

Standard: Update of the Comprehensive Assessment

Section 484.55(d) addresses the update of the comprehensive

assessment. In this standard, we proposed to require that the

comprehensive assessment must include information on the patient's

progress toward clinical outcomes, and be updated and revised (1) as

frequently as the patient requires but no less frequently than every 62

days from the start of care date, (2) when the patient's plan of care

is revised for physician review, (3) within 48 hours of the patient's

return home from the hospital, and (4) when the patient is discharged.

The comprehensive assessment updates must include the appropriate OASIS

items as indicated on the data set.

Comment: Several commenters objected to the requirement that the

OASIS be completed for patients who are seen infrequently (for example,

every two weeks, or monthly) in order to comply with the 57 to 62 day

requirement. Commenters stated that this standard would require HHAs to

provide additional skilled visits.

Response: In order to have data that is comparable across HHAs,

OASIS data must be collected at uniformly defined time points including

at recertification. We do not believe that this requirement will add to

the number of skilled visits provided by the HHA. We understand that

many HHAs arrange visit schedules to accommodate home health aide

supervisory requirements and patient and care giver schedules. We would

expect the HHA to similarly adjust the patient's visit schedule in

order to

[[Page 3770]]

accommodate OASIS time points. As discussed in detail below, we have

revised paragraph (d) by removing the proposed 62 day requirement.

Instead, we provide that the comprehensive assessment must be completed

every second calendar month beginning with the start of care date.

Comment: Several commenters objected to the requirement that the

OASIS be completed within 48 hours of a patient's return home from a

hospital, stating that this would be burdensome and duplicative of

assessment information in the clinical progress notes. Other commenters

stated that the comprehensive assessment and OASIS items should be

completed after a hospital stay of 24 hours or more, as this would be

more predictive of a significant patient event and less burdensome to

the HHA. A few commenters questioned the sequence of events regarding

collection of the OASIS data after the patient's return from the

hospital.

Response: Hospitalization as an event is generally a good predictor

of a deterioration in the patient's health status, and therefore should

be captured in the OASIS data. HHAs that do not account for

hospitalizations in their OASIS data collection may reflect poorer

outcomes than those that do. Patients frequently improve rapidly upon

returning home from the hospital, therefore it is important that the

patient's health status at the time of discharge from the hospital be

captured quickly. The 48-hour requirement is necessary, given the speed

of changes in a patient's status after hospitalization. In addition,

the importance of OASIS as a case mix adjuster makes it necessary, in

the interest of the accuracy of patient data, for the HHA to assess the

patient's true needs as quickly as possible upon discharge from the

hospital. This standard is intended to ensure the timely and accurate

assessment of patients who were not discharged from the HHA when they

were admitted to the hospital, and have returned home.

We do not intend that the comprehensive assessment be duplicative

of assessment information that is documented in the clinical progress

notes. Rather, we expect the comprehensive assessment to replace

assessment information that is transcribed in clinical progress notes.

For example, if a nurse assesses and documents the status of a

patient's surgical wound, ability to ambulate, presence of assistance

in the home and ability to manage medications during the comprehensive

assessment required upon return from a hospitalization, it is

unnecessary, burdensome and counterproductive for the nurse to also

document this information elsewhere in the clinical progress notes. We

agree with the commenter that requiring that the comprehensive

assessment (including the appropriate OASIS items) be completed after a

hospital admission of 24 hours or more would be predictive of a

significant patient event and less burdensome to the HHA. Therefore, we

have revised Sec. 484.55(d) to require that the comprehensive

assessment (including administration of OASIS) be completed within 48

hours of the patient's return home from a hospital admission of 24

hours or more for any reason except diagnostic testing.

If home health care is resumed after a hospital admission

(regardless of whether the patient was formally discharged from the

HHA), the comprehensive assessment must include the OASIS items

appropriate for assessment after a hospital admission. If the patient

was not formally discharged from the HHA, the HHA should establish the

next assessment time point at the end of the second calendar month

interval that corresponds to the original start-of-care date. For

example, if the start-of-care date is June 25th, the patient would be

reassessed on August 25th.

If the patient is formally discharged from the HHA, the data

collection proceeds on the basis of the new start-of-care date that

followed the inpatient stay. For purposes of OASIS data collection, the

HHA can establish its own internal policies regarding criteria for

formal discharge versus interrupting home care services but maintaining

the patient on the HHA admission roster.

Comment: Two commenters requested that HCFA define the update of

the comprehensive assessment. The commenters asked if it is necessary

to complete a full assessment and OASIS in the event that only one item

has changed, if the patient has a planned re-hospitalization, or if the

patient is chronically ill with frequent hospitalizations. Another

commenter suggested that the HHA should only complete OASIS data

related to the diagnostic or quality grouping of the patient, rather

than all OASIS items.

Response: The diagnostic and quality groupings to which the

commenter refers were made on aggregated patient data in the Medicare

demonstration and discussed in the OASIS proposed rule (62 FR 11038).

These groupings were created for research purposes and the HHAs in the

demonstration did not vary OASIS data collection in order to

accommodate these groupings. We believe the commenter misunderstood the

purpose and utility of the quality groupings and the methodology of the

Medicare demonstration. The update of the comprehensive assessment

must, at a minimum, include completion of all follow-up data items of

the OASIS and any changes in patient status. OASIS items must be re-

assessed and documented regardless of whether the patient's status has

changed.

It is only by doing an assessment that the caregiver can determine

if a change in condition has occurred or if a change in treatment is

warranted. For example, although a patient with testicular cancer may

continue to be incontinent, other factors may change that would warrant

a change in the care plan. Another example would be a diabetic patient

who continues to require insulin therapy. An assessment would still be

necessary to rule out any complications or other changes in the

patient's physical or mental health that would warrant revision of the

treatment plan.

For purposes of outcome measurement and case mix adjustment, it is

important to capture stabilization of the patient's health as well as

improved or deteriorated outcomes. Thus, the information must be

collected in order to measure the patient's complete health status, not

just to capture change. In addition, documentation of all the OASIS

items is an important safeguard for data accuracy. In the Medicare

demonstrations, HHAs with computer systems that allowed OASIS items to

``carry over'', rather than requiring re-entry every time, experienced

poorer outcomes. Upon examination of the data, it was discovered that

documenting OASIS by exception missed many of the subtle and

interrelated improvements in the patient's health status. For the

remainder of the comprehensive assessment that does not include the

OASIS items, limiting documentation to the changes in the patient's

assessment is acceptable. We have revised the introductory text of

paragraph (d) to clarify that all updates and revisions of the

comprehensive assessment include administration of the OASIS.

Comment: Several commenters expressed concern about the requirement

for gathering OASIS data when the plan of care is revised for physician

review, stating that this would require completion of a comprehensive

assessment each time the physician's orders are changed. Other

commenters stated that this requirement is duplicative of the

requirement to update the assessment every 57-62 days.

Response: We agree with the commenter that the requirement at

Sec. 484.55(d)(2) is duplicative and have

[[Page 3771]]

eliminated it. It was not our intent to require the HHA to complete a

comprehensive assessment whenever physician orders are changed, and

therefore, the HHA is not required to complete the OASIS data set

whenever the plan of care is revised. However, the HHA will still be

required to complete a comprehensive assessment when there is a

significant change (a major decline or improvement) in a patient's

health status.

Comment: Commenters indicated that the completion of the OASIS

should be based on the needs of the individual patient, rather than an

arbitrary time frame.

Response: While the frequency of ongoing patient assessment is

based on the needs of the individual patient, completion of the OASIS

items at standardized time points is critical for comparable

information and for a case mix system. To maintain a clear reporting

timeframe that eliminates the variations of days in a month, we have

revised the proposed 62 day requirement at paragraph (d)(1) to provide

that the HHA must update the comprehensive assessment no less

frequently than every second calendar month, beginning with the start

of care date. The allowable completion dates for the first assessment

and any subsequent follow-up assessments will be determined based on

the start of care date. Follow-up assessments must be completed every

two months that a patient is under care. For each month in which a

follow-up assessment is due, it must be completed no earlier than five

days before, and no later than one day before the calendar day on which

care began. The new rule defines the completion date relative to the

day of the month which marks every two-month anniversary of the start

of care. Please note the following two examples:

Example 1: If the start of care date is March 1st, the first

follow-up assessment must be completed between April 26th (five days

before May 1st) and April 30th (1 day before May 1st). The second

follow-up assessment must be completed between June 26th and June

30th.

Example 2: If the calendar day of the start of care exceeds the

last day of a month in which a follow-up assessment is due, the

completion dates are computed relative to the last day of the target

month. For example, if the start of care date is December 31st, the

first follow-up assessment must be completed between February 23

(five days before February 28th) and February 27th (one day before

February 28th). This example assumes that the year is not a leap

year. In a leap year, the completion date would fall between

February 24th and February 29th.

Comment: One commenter suggested that the terms ``discharge'' and

``transfer'' be defined by HCFA in order to improve the accuracy of

data. The commenter expressed concern over data accuracy issues, and

encouraged HCFA to require accuracy of OASIS data collected.

Response: We agree that the term ``discharge'' should be clarified,

since the COPs require update of the comprehensive assessment at

discharge. For purposes of this requirement, the term ``discharge''

applies when the patient is officially released from home health care

by the HHA, when the patient is transferred to another facility (such

as a nursing home or hospital), or when the patient dies. If any of

those events occur, then we would consider the patient to be discharged

from the HHA and we expect the HHA to update the comprehensive

assessment (including the appropriate OASIS items). A transfer occurs

when the physician orders that the patient's care be assumed by another

facility (for example, nursing home or rehabilitation hospital).

We also agree with the commenter that the data derived from the

comprehensive assessment and OASIS will be meaningless unless they

accurately reflect the patient's health status. Therefore, we have

revised the introductory text at Sec. 484.55 to require that the

comprehensive assessment accurately reflect the patient's current

status.

B. Use of the Outcome and Assessment Information Set (OASIS)

As discussed above, we published a proposed rule that proposed to

require HHAs to incorporate the core standard assessment data set,

called the ``Outcome and Assessment Information Set'' (OASIS), into

their comprehensive assessment process. This proposed rule added a new

paragraph (e), Standard: Incorporation of OASIS data items, to

Sec. 484.55. In the March 10, 1997 proposed rule (62 FR 11036), we

discussed in detail the methods we used to develop and validate the

OASIS items, as well as a demonstration project we established, which

was conducted by the University of Colorado, to assess the value of the

OASIS data set in targeting and guiding improvements in outcomes and

satisfaction for HHA patients. In addition, we described both the short

term and long term expectations for use of the data set. All public

comments, including those comments received on the impact of the OASIS

proposed rule have been summarized and are discussed below.

Standard: Incorporation of the OASIS Data Set

Section 484.55(e) provides that the HHA must incorporate the OASIS

data set into its own assessment, using the language and groupings of

the OASIS items. Integrating the OASIS items into the HHA's own

assessment system in the order presented in the OASIS form would

facilitate data entry of the items into data collection and reporting

software. However, it is not mandatory that agencies integrate the

items in any particular order. An HHA may integrate the OASIS items in

such a way that best suits the agency's own assessment. OASIS data

items 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. The OASIS data set

includes only information necessary to measure outcomes of care. Our

intent was not to develop a complete patient assessment but rather to

identify standardized data elements that fit within the HHA's overall

comprehensive assessment responsibilities; that is, the incorporation

of the core standard assessment data set will complement the HHA's

current approach to comprehensive assessment.

We intend that the OASIS become one of the most important aspects

of the HHA's activities in providing patient care. 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,

service delivery, and improvement efforts.

Comment: We received many comments in favor of OASIS, but some

commenters were concerned about the length of the assessment process if

OASIS items are included.

Response: We agree that the assessment would be lengthy if the

OASIS is added to the HHA's routine assessment form. However, we

emphasize the need to replace similar items/questions on the agency's

own assessment. It is our understanding that some HHAs have simply

appended the OASIS items to their current assessment without

considering which OASIS items could replace similar items on the

agency's assessment. Obviously this approach adds time to the

assessment process, and renders the comprehensive assessment burdensome

and

[[Page 3772]]

duplicative. We wish to make it clear that the OASIS is not intended to

constitute a complete comprehensive assessment. 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. The OASIS items are already used in one form or

another by virtually all HHAs that conduct thorough assessments. We

therefore believe that HHAs should replace similar items with OASIS

items to avoid lengthening the assessment unnecessarily. In fact, when

OASIS items have been used to replace similar assessment items, HHAs in

the demonstration project found that completing the integrated

assessment adds little to no net time increase to the visit. In

addition, HHAs have found it less burdensome to enter OASIS data items

into a data collection software program when they are inserted in order

into the HHA's comprehensive assessment. This approach increases the

speed and accuracy of data entry.

Comment: Several commenters applauded HCFA's effort to bring about

OASIS stating that, from experience, they had found that incorporating

the OASIS data set into their assessment process has proven to be very

beneficial in assisting health care professionals in identifying the

medical necessity and services that patients require. Commenters stated

the belief that the OASIS data set had been developed using sound

scientific processes, and will provide a useful minimal set of data

items for HHAs in assessing and demonstrating outcomes by promoting

systemization and completeness.

Response: We agree with the commenters that OASIS data will be

helpful to HHAs and assist them in planning and providing home health

services. We appreciate the positive comments and support for OASIS.

Comment: Several commenters stated that OASIS should have been

developed to be compatible with the Minimum Data Set (MDS) used in

Nursing Homes and/or the Uniform Needs Assessment that is under

development for use in hospitals. Commenters stated that such

compatibility or a crosswalk is crucial as we strive to develop

integrated systems and well coordinated care.

Response: The MDS and OASIS are different data sets, developed for

different purposes, for different patient care settings, and to

implement different statutory provisions. MDS was developed in 1990 to

implement sections 1819(f)(6) (A) and (B) of the Act for Medicare and

sections 1919(f)(6) (A) and (B) of the Act for Medicaid, which required

nursing homes to perform a comprehensive assessment of long term care

facility residents. The MDS was designed to function as a complete

assessment to promote decision making, care plan development, and care

plan implementation and evaluation. The structure of the MDS is

designed to enhance resident care and promote the quality of a

resident's life.

The OASIS data set was developed in 1993, in part to implement

sections 1891(c)(2)(C) and 1891(d)(1) of the Act, which require as part

of the home health assessment, a survey of the quality of care and

services furnished by the agency as measured by indicators of medical,

nursing, and rehabilitative care. OASIS is the designated assessment

instrument (or instruments) for use by an agency in complying with the

requirement. OASIS focuses on outcomes of care, and was developed as a

system of outcome measures that could be used specifically for outcome-

based quality improvement and evaluation in HHAs. OASIS, while helpful

for patient assessment, is not a care planning tool, and was not

designed to be a comprehensive patient assessment. In addition,

research has shown that there may be several uses for OASIS data, one

of which will provide HCFA with data for case mix adjustment and

grouping in the development of the home health prospective payment

system.

OASIS is the data set currently in use in many HHAs and is the

fundamental data set being evaluated for case mix adjustments for the

HHA prospective payment system. The OASIS data set reflects the care of

the patient populations in the home setting, and MDS reflects the care

and patient population of the nursing home setting. Therefore, it is

unlikely that we can collectively attain perfect overlap between the

MDS, OASIS, or other assessments under development. However, it is our

goal to ultimately 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.

HCFA is currently pursuing research that could ultimately help in

developing an assessment instrument that can support a common

assessment across settings. As our data sets are modified and improved

over time, our goal is to incorporate common data elements and

definitions within each of the instruments to the fullest extent

possible. This will improve HCFA's and States' ability to track the

characteristics and care needs of beneficiaries across the post-acute

and long term care service continuum. Use of common data elements will

also benefit patient care by facilitating transfer of information to

the continuing care provider and minimizing providers' data collection

burden.

We have already started the process of identifying areas in which

increased coordination of data elements is possible as part of our

uniform needs assessment instrument (UNAI) initiative. This activity

entails review of the item labels, definitions and reliabilities for

OASIS, the long term care minimum data set (MDS), and the MDS for post-

acute care (MDS-PAC), which incorporates items common to the MDS and is

currently being tested for potential implementation in rehabilitation

hospitals. We expect to be able to identify some areas in which

increased commonality is possible across OASIS and MDS items. Refined

item labels and definitions will be available for use within the next

versions of these instruments (e.g., construction of version 3.0 of the

MDS will begin in mid-1999.)

Comment: Several commenters requested that we add items to the

OASIS data set. Requests for additions included: data items tested

during the development of the OASIS data set; discipline-specific

services, interventions, the amount and frequency of visits and

outcomes; various ostomies for elimination status; surgical and V-

codes; and, additions to the answers listed for some items. Other

commenters suggested that we change or eliminate answers for some

items, or that we change the order of the OASIS items.

Response: At this time, any changes to the OASIS data set, or

changes in the order of existing items, would require further

validation and reliability testing, and revision of the outcome

measures. However, HHAs are reminded that OASIS is a core data set of

required items. While the OASIS items must be used as written, HHAs may

choose to collect additional data on discipline-specific services,

etc., as part of their comprehensive assessment, as long as the same

OASIS items, and the same answer choices as appear in the current

version of OASIS are incorporated into the agency's own assessment. We

have revised Sec. 484.55(e) to provide that the OASIS data items are

determined by the Secretary and must be used as they appear, and as set

forth in the current version of the OASIS.

Comment: One commenter expressed concern that client/caregiver

learning ability is not addressed in OASIS, when

[[Page 3773]]

a great deal of HHA's staff time is spent teaching clients.

Response: OASIS is a data set for gathering data that provides

valid, reliable information to measure selected home health outcomes.

Due to the lack of scientific measures that capture teaching outcomes

within the home health context, OASIS does not currently provide

outcome data on clients' learning ability, nor is it intended to gather

workload data on activities carried out by care givers. We agree that

patient education is a frequent service that HHAs provide, and we

remain interested in looking at pertinent measures at some point in the

future. In the interim, HHAs are at liberty to add these kinds of items

to their comprehensive assessment in order to capture those activities.

Comment: Several commenters stated that the OASIS primarily

measures outcomes that reflect skilled services, and does not address

the broad scope of patients served in home health. The commenter was

concerned that OASIS is a work in progress, and questioned the

appropriateness of mandating something that is not tested or finished.

Response: We agree that not all OASIS items address the needs of

patients receiving supportive services or specialized populations (such

as pediatric or maternal-child health), although many of the data items

are useful for comparison and to risk adjust outcomes. However,

contrary to this commenter's concern, OASIS has been extensively tested

in the field for validity, reliability and case mix adjustment for

almost a decade. Like any other data set (such as the MDS), the OASIS

will evolve to meet changing program needs and to reflect changes in

the health care environment and additional experience in program

administration.

We share the industry's interest in the adoption of a useful and

appropriate instrument with as little disruption to existing HHAs

operations as possible. We also share the industry's interest in

minimizing unnecessary paperwork and record keeping burdens, while at

the same time, ensuring quality of care for beneficiaries. Paperwork

and record keeping requirements must be cost effectively integrated

into HCFA's survey and enforcement processes (both from the balanced

perspectives of the public and private sectors), and must maximize

available information technologies. In particular, we may reevaluate

OASIS data and reporting needs for patient reassessments.

Comment: One commenter was concerned that in the future, HCFA may

wish to require the use of OASIS data for persons served in their new

Medicaid Managed Long Term Care plan.

Response: The requirements at Sec. 484.55 apply to HHAs that

participate in the Medicare and Medicaid programs, and the patients

served by that HHA. Requirements for Medicaid home and community-based

waiver programs vary from State to State, and are addressed by the

individual State.

Comment: A few commenters stated that the Joint Commission on

Accreditation of Healthcare Organizations (JCAHO) and the Community

Health Accreditation Program (CHAP) data collection requirements should

be considered, coordinated and approved by HCFA, which will minimize

the data collection burden on HHAs. Commenters further stated that the

relationship between JCAHO, CHAP and HCFA needs to be coordinated at

the Federal level to ensure that data requirements are not duplicative,

particularly since the goals of JCAHO, CHAP and HCFA are to foster and

support a data driven quality assessment and performance improvement

program in the home health care industry.

Response: HCFA has approved the deemed status option for use by HHA

accreditation organizations (JCAHO and CHAP). This deemed status

program ensures close coordination between HCFA and the HHA accrediting

bodies. Once OASIS requirements become final, JCAHO and CHAP must adopt

equivalent requirements for those HHAs that are accredited and

certified in the Medicare program. In fact, JCAHO's ORYX measures,

which have been approved by HCFA, contain the OASIS data set. CHAP has

also incorporated OASIS into their accreditation program. In fact, in

order for an accreditation organization to be granted deeming

authority, its requirements must be comparable to those of HCFA.

Therefore, there is no duplication of information.

Comment: One commenter suggested that Medicaid-eligible

individuals' State/Medicaid ID number should be collected to allow

analysis of data on dual eligible beneficiaries.

Response: The OASIS has a field that contains a patient ID number

that is unique to the patient. HCFA requires OASIS data to be encoded

and reported by the HHA, as provided in a separate rule in today's

Federal Register, Reporting Outcome and Assessment Information Set

(OASIS) Data as Part of the Conditions of Participation for Home Health

Agencies (HCFA-3006-IFC). In the interim, this rule does not preclude

HHAs and States from using Medicaid ID numbers to identify the patient.

Comment: One commenter requested that we clarify what is meant by

the ``current'' version of OASIS. The commenter asked if we were

referring to the OASIS-A, OASIS-B, or OASIS+.

Response: As stated in the preamble to the proposed regulation, we

urge HHAs currently using various versions of the OASIS, including

``partial'' versions, to focus on the version of the OASIS published in

the March 10, 1997 proposed rule. While the content of OASIS has not

changed, there may be a few changes in coding and identifier items as a

result of the OASIS reporting system. The version of OASIS approved by

the Secretary and for which we are seeking OMB approval is available on

HCFA's website on the Internet for HHAs to download at http://

www.hcfa.gov/medicare/hsqb/oasis/oasishmp.htm. As an alternative to

Internet access, which is the most efficient method of obtaining the

current version of the OASIS, agencies may contact their State agency

or HCFA regional office home health representatives to request a paper

copy of the data set for review. The current version of OASIS is a

proposed information collection requirement pending OMB approval. We

have summarized the Paperwork Reduction Act process below and have

described the timeframes associated with that process.

We note that some HHAs participating in research and demonstration

projects may be using other data collection data sets, which have been

approved by the Secretary. HHAs in research and demonstration projects

may be exempt from the requirement to use the OASIS as part of the

comprehensive assessment process for the duration of the project. We

intend to make these determinations on a case-by-case basis, depending

on several factors including, the nature of the demonstration project,

the data set used, payment implications for the HHA, quality concerns,

and burden issues.

Comment: Several commenters questioned the collection of OASIS data

for various types of patients. Some commenters recommended that the

comprehensive assessment be collected only on patients who were

medically unstable or require therapeutic treatment. Others suggested

that HHAs not be required to collect OASIS information for patients

receiving services for brief periods of time (with suggestions ranging

from two to eight days), for limited services (such as dressing

changes), for infrequent visits

[[Page 3774]]

(less frequently than every two weeks) and for long term patients.

Commenters stated that the financial burden to the HHA outweighs the

benefits of the data collected for these types of patients.

Response: We disagree. It is important that OASIS data be collected

on the entire spectrum of patients seen by the HHA (stable and

unstable, short-term and long-term, minimal services and extensive

services, frequent visits and infrequent visits). Eliminating an entire

subset of patients served by the HHA would harm the quality of care and

services to beneficiaries, and skew the case mix adjuster system which

could potentially result in undesirable payment incentives. In

addition, we would expect HHAs to be interested in evaluating the

quality, efficacy and efficiency of care delivered to all their

patients.

Comment: Several commenters recommended that consideration be given

to the type of patients for whom the OASIS is appropriate. Commenters

stated that the proposed conditions recognize that the OASIS data set

is not applicable to all populations served by the HHA (for 53 example,

pediatric and maternal/child), and all services such as non-personal

care, and educational services. Commenters suggested that we specify

for whom OASIS data must be collected.

Response: OASIS data will be used for two purposes. Specifically,

the data will be used as outcome measures to evaluate HHA quality of

care, and to provide data for a case mix adjustment and grouping for

the home health prospective payment system. When collection of the

OASIS information was proposed, we required the data to be collected

for those populations that were appropriate for outcome measurement.

Therefore, in the preamble of the OASIS proposed rule, we discussed

OASIS data collection for all patients except prepartum and postpartum

patients, pediatric patients, and patients who are not receiving

personal care or health services (that is, patients who are receiving

only services such as housecleaning, cooking, or laundry). We did not

exempt patients receiving educational services from OASIS collection,

as patient teaching is a skilled service and patient education can

affect outcomes of care such as medication management, pain management,

or equipment management.

As a result of the BBA and the utility of OASIS as a case mix

adjuster, OASIS must be collected on most patients, including public

and private pay patients, except prepartum and postpartum patients,

patients under age 18, and patients who are not receiving personal care

or health services (that is, patients who are receiving only services

such as cooking, housecleaning, or laundry services). Additionally,

HHAs must collect OASIS data on both public and private pay patients

because section 1891(b) of the Act requires the Secretary to assure

that the COPs and other requirements are adequate to protect all

individuals under the care of the HHA. As we gain experience with

OASIS, we will consider adjusting the patient populations and/or data

items collected, consistent with our statutory mandate.

Comment: One commenter had concerns regarding terminally ill

patients for whom a decline in status (a poor outcome) is expected, and

whether the HHA will be penalized because the outcomes show a decline

over the course of care.

Response: For terminally ill patients, death is an expected

outcome; thus, conclusions about the quality of care for a patient

cannot be made solely on the basis of whether or not the patient

improved. The OASIS collects information on the patient's prognosis

regarding recovery from illness, functional status improvement and life

expectancy, and outcome measures are adjusted to accommodate these

patient characteristics. Thus, HHAs that care for a large number of

patients with poor prognoses are not placed at a disadvantage when

their performance is compared to another HHA that serves a healthier

population. This process of adjusting for differences in patient

characteristics (case mix adjustment) is an important aspect of the

OASIS and is also an important function in a prospective payment

system.

Comment: One commenter stated that it would be helpful to know what

outcomes HCFA will want reported in the next set of rules, stating that

it seems a waste of time for everyone to set a data reporting system,

when HCFA may mandate electronic submission of the data. Another

commenter expressed concern that there is no approved software for the

OASIS data.

Response: As discussed above, as a result of the statutory

requirement that we develop a prospective payment system for home

health agencies, we expect that HHAs will begin reporting OASIS data to

HCFA in the very near future, as specified in the interim final rule

published separately in today's Federal Register. That regulation and

subsequent implementing manuals will outline the hardware and software

requirements for the transmission of OASIS data. Therefore, HHAs will

be aware of the OASIS reporting requirements as they integrate OASIS

data collection into the work of the HHA.

Comment: Two commenters expressed concern about patient privacy

issues. One commenter stated that OASIS contains personal information

that patients may be reluctant to provide. Another commenter expressed

concern about the confidentiality of OASIS data being used for

benchmarking among HHAs nationally. The commenter especially objected

to the information being shared with managed care organizations.

Response: We expect HHAs to protect the confidentiality of patient-

specific OASIS information in accordance with Federal and State privacy

requirements, just as they would any other part of the patient record.

The condition concerning patient rights at Sec. 484.10 provides that

the patient has the right to confidentiality of the clinical record. In

addition, the condition concerning clinical records at Sec. 484.48

requires HHAs to protect the clinical record against loss or

unauthorized use. Health professionals and HHAs have always had access

to personal information that is necessary to provide patient care, and

we expect the HHA to vigorously address confidentiality concerns in

compliance with State and Federal laws.

The OASIS data set contains assessment data that is normally

collected by the HHA in the course of delivering services. Disclosure

of this data must comport with both Federal and State privacy

protections.

Comment: One commenter stated that there is a need for HHAs to

track outcome data. Several commenters stated that OASIS appears well

conceived, and expressed support for the creation of a national

database for outcomes measurement and benchmarking.

Response: We appreciate support for our efforts to improve outcomes

of care in home health. As stated previously in this preamble, and as a

result of the BBA, we will develop the database supported by the

commenters.

III. Provisions of the Final Rule

We are adopting the provisions of the HHA COPs proposed rule

related to comprehensive assessment and the provisions of the OASIS

proposed rule, with the following revisions:

Section 484.18

We revised paragraph (c) by removing the last sentence of

the paragraph, which relates to review of the patient's medication.

[[Page 3775]]

Section 484.55, Reorganization

To clarify the condition, we have rearranged the order of

the standards in Sec. 484.55 as follows: Sec. 484.55(a) Initial

assessment visit; Sec. 484.55(b) Completion of the comprehensive

assessment; Sec. 484.55 Drug regimen review; Sec. 484.55(d) Update of

the comprehensive assessment; and Sec. 484.55(e) Incorporation of the

OASIS data set.

Section 484.55, Introductory text

We revised the introductory text to require that the

comprehensive assessment must accurately reflect the patient's current

health status; and, for Medicare patients, the home health agency must

verify the patient's eligibility for the Medicare home health benefit,

including homebound status at the time of the initial evaluation visit,

and at the time of the completion of the comprehensive assessment.

We have also incorporated into the introductory text

language from paragraph (d), which requires that the comprehensive

assessment include information regarding the patient's progress toward

desired outcomes.

Section 484.55(a) (Proposed Sec. 484.55(b))

In response to public comments, we revised paragraph

(a)(1) to provide that the initial assessment visit must occur either

within 48 hours of referral, or within 48 hours of the patient's return

home, or on the start of care date ordered by the physician.

We added, at paragraph (a)(1), the requirement that for

Medicare patients, the initial assessment visit must include a

determination of the patient's eligibility for the home health benefit,

including homebound status.

We removed the proposed requirement at paragraph (a)(1)

that the initial assessment visit must be performed based on

physician's orders.

We revised paragraph (a)(2) to clarify that when

rehabilitation therapy service (speech language pathology, physical

therapy, or occupational therapy) is the only service ordered by the

physician, and if the need for that service establishes program

eligibility, the initial assessment visit may be made by the

appropriate rehabilitation skilled professional.

Section 484.55(b) (Proposed Sec. 484.55(c))

We revised the title of the standard to read ``Completion

of the Comprehensive Assessment''.

We revised paragraph (b)(1) to provide that the

comprehensive assessment must be completed no later than 5 calendar

days after the start of care date.

We added a new paragraph, (b)(2), to provide that a

registered nurse must complete the comprehensive assessment, and for

Medicare patients determine eligibility for the Medicare home health

benefit.

We added a new paragraph (b)(3) to provide that when

physical therapy or speech language pathology is the only service

ordered by the physician, the physical therapist or speech language

pathologist may complete the comprehensive assessment and that

occupational therapists may complete the assessment when the need for

occupational therapy establishes program eligibility.

Section 484.55(c) (Proposed Sec. 484.55(a))

We revised this paragraph by removing the term ``drug regimen

review'' and providing that a comprehensive assessment must include a

review of all medications the patient is using at the time of the

assessment.

Section 484.55(d) (Same Paragraph Designation as Proposed)

For the purpose of clarity, we made editorial changes to

this paragraph. Specifically, we incorporated language previously

located in paragraph (d) into the introductory text of Sec. 485.55 and

we removed language from paragraph (d)(1) and included it in the

introductory text for paragraph (d).

We have revised the introductory text of paragraph (d) to

clarify that all updates and revisions of the comprehensive assessment

include administration of the OASIS, as frequently as the patient's

condition warrants, due to a major decline or improvement in the

patient's health status.

We revised paragraph (d)(1) to provide that the HHA must

update the comprehensive assessment every second calendar month

beginning with the start of care date.

We removed the proposed requirement at paragraph (d)(2)

that the comprehensive assessment must be updated when the care plan is

revised for physician review.

We redesignated proposed paragraph (d)(3) as (d)(2) and

proposed paragraph (d)(4) as (d)(3).

We revised redesignated paragraph (d)(2) to provide that

the comprehensive assessment must be completed within 48 hours of the

patient's return home from a hospital admission of 24 hours or more for

any reason other than diagnostic tests.

Section 484.55(e) (Same Paragraph Designation as Proposed)

We revised this paragraph to provide that the OASIS data

items determined by the Secretary must be incorporated into the HHA's

own assessment and must include: clinical record items, 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 data items

collected at inpatient facility admission or discharge only.

IV. Regulatory Impact Statement

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 final rule will 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. HHAs, on the other hand, are considered small entities

for the purposes of the RFA. Consequently, we are including a statement

of impact on the effect that this final rule will have on HHAs. Also,

we have discussed associated costs in detail in the Collection of

Information Requirements section of this preamble. The impact

associated with reporting of OASIS data will be in a separate rule in

today's Federal Register.

In addition, section 1102(b) of the Act requires us to prepare a

regulatory impact analysis for any final 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

final rule will not have a significant impact on the operations of a

substantial number of small rural hospitals.

We also have examined the impacts of this final rule as required by

section 202 of the Unfunded Mandates Reform Act. Section 202 of the

Unfunded Mandates Reform Act requires agencies to prepare an assessment

of anticipated costs and benefits before proposing any rule that may

result in an annual expenditure by State, local, or tribal governments,

in the aggregate, or by the private sector, of $100 million (adjusted

annually for

[[Page 3776]]

inflation). As discussed in detail in this preamble, we estimate that

the amount of the unfunded mandate associated with this final rule will

result in an annual expenditure of less than $100 million to these

governmental and private sectors. Therefore, we believe the law does

not apply.

In this final rule, under Sec. 484.55, we are requiring HHAs to use

the core assessment data set, the ``Outcome and Assessment Information

Set'' (OASIS) as part of the agency's comprehensive assessment;

specific timeframes for the initial assessment; completion of the

assessment; and, interim updates to the patient assessment. We believe

that these requirements, though process-oriented, are predictive of

good patient care and safety, as well as necessary to prevent harm to

the patient. Our rationale for these timeframes is that by definition,

a new patient who is referred to a home health agency for initiation of

services is at a point of immediate and serious need. Likewise, as the

complexity of the care needs of patients increase, so does the need for

comprehensive assessment of the patient. The importance of the

development and implementation of an effective care plan becomes

paramount.

We believe that the timeframe requirements pose little or no

additional burden on the HHA since assessments at these intervals would

in all likelihood be performed in the absence of regulations. However,

the timeframes serve as a strong performance expectation for HHAs that

may not have adequate resources. If too many patient referrals occur

together, effective service delivery to some patients could be delayed

by the HHA's inability to see the patient quickly and to complete the

needed comprehensive assessment. Thus, if an HHA recognizes that its

workload renders it incapable of assessing a patient upon referral, the

HHA must contact the patient's physician to arrange an appropriate

start of care date or to determine if the patient requires immediate

service.

In the March 10, 1997 proposed rule, we solicited comments on

whether the specific timeframe requirements in Sec. 484.55 are

reasonable and consistent with current medical practice, and whether

the timeframes should be used as benchmarks to ensure the timeliness of

the assessment components, and to protect patient health and safety. In

this final rule, we have addressed comments regarding timeframes in

section V.A. of this preamble.

The existing COPs contain several requirements that address the

need for patient assessment, including most notably an extensive,

detailed list of items that are required to be covered in a plan of

care, such as pertinent diagnoses, mental status, and functional

limitations. (See Sec. 484.18(a).) In this final rule, we emphasize the

importance of the comprehensive assessment by establishing

``Comprehensive assessment of patients'' as a separate COP. We have

specified the desired outcome of the assessment (that is, the

identification of a patient's care needs). We have required the use of

a specific assessment data set (OASIS) and we are allowing HHAs the

flexibility to determine how best to meet patients' care needs. We

believe that most HHAs now perform a comprehensive assessment for most

of their patients as a current accepted practice. We need to balance

the possible short-term increase in costs or other administrative

burden, if any, on the HHA with the long-term fundamental positive

effect on patient health resulting from an organized and timely

comprehensive assessment.

We anticipate that HHAs will incur some costs associated with the

implementation of this final rule. It is unknown at this time exactly

how many HHAs will receive an adjustment to the per visit limits

associated with these costs, which was announced in a Federal Register

notice on August 11, 1998. Only HHAs that have not already reached the

per beneficiary limits will benefit from these adjustments through the

HHA interim payment system. We estimate that approximately 70% of HHAs

will not receive an adjustment for the costs associated with

implementing this final rule. Because these HHAs have reached their per

beneficiary limits, they will not be reimbursed by Medicare for the

costs associated with OASIS collection start up activities. Those HHAs

still below these limits will be reimbursed by Medicare. However, we

also expect that the HHAs that will not be reimbursed by Medicare will,

to varying degrees, be reimbursed by a combination of the Medicaid

program, private insurers and beneficiaries. A table projecting the

costs to HHAs for the implementation of the use of the OASIS is

included at section V.C.3. of this preamble. These costs are based on

the assumption that implementation will be in fiscal years 1999 and

2000.

On August 11, 1998, we published in the Federal Register a notice

with comment period that set forth the per visit and per beneficiary

limitations for HHA costs (63 FR 42912). That notice included an OASIS

offset adjustment factor to the per visit limitation to address these

costs. In that notice, we asked for specific comments, including data,

that would impact future decision making on HHA cost limitations.

While, in the March 7, 1997 proposed rule, we indicated implementation

in 1998 and an estimated start-up cost for 5 years, we now realize that

implementation of the final rule will occur in fiscal years 1999 and

2000, and that the start-up costs associated with implementation of

this final rule will be incurred by HHAs in existence, and

participating in HCFA programs as of the effective date of the rule.

Therefore, HHAs that are certified after the effective date of this

final rule will not have established patient assessment protocols

requiring change to meet the HCFA requirements. Accordingly, these HHAs

will not have the corresponding start-up costs associated with a change

of protocols. (See table 1 in section V.C. of this preamble.) We

strongly believe that the benefits associated with the use of OASIS

data will far outweigh its costs.

As discussed 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 care planning, and the increased

specificity in patient assessment will assist agency staff to uniquely

tailor a treatment plan to each individual patient. Also, this data

will become an integral factor in the development of case mix adjusters

for a home health agency prospective payment system, as authorized by

sections 4602 and 4603 of BBA '97.

The Balanced Budget Act of 1997 requires HCFA to develop a

prospective payment system (PPS) for home health. A prospective payment

system pays providers based on the predicted costs of care, giving

providers the incentive to provide care efficiently. In the home health

PPS, beneficiaries will be classified into case mix groupings based on

their predicted resource use, with each group having a specific payment

rate.

In developing a sound classification system, HCFA must account for

the factors that would influence the beneficiary's use of services. In

the case of the hospital prospective payment system, this was done

using Medicare claims data linked to diagnosis data. Because the

majority of inpatient services are attributed to the medical diagnosis,

Medicare claims provide enough information to classify patients for

hospital payments.

Post-acute care services such as home health and skilled nursing

facility services are influenced in part by the medical diagnosis.

However, other factors have a strong influence in the use of post-acute

care, such as the severity of illness and functional abilities.

Therefore, a more comprehensive data source is needed

[[Page 3777]]

for proper patient classification. Because Medicare claims provide

information only about diagnosis, age, gender, and race, a claims-based

grouping would not adequately classify beneficiaries into payment

groups.

The first attempt to design a prospective payment system for post-

acute services was the case of skilled nursing facilities. Under this

payment system, HCFA has used data from both claims and the Minimum

Data Set (MDS) to classify patients into payment groups. Similarly,

HCFA plans to use OASIS data in addition to claims data to construct

the home health PPS. A classification system that takes into account

severity of illness as well as functional abilities will help to ensure

adequate payment for high-cost beneficiaries. If HCFA does not use

OASIS data to identify case mix groups, then, on average, prospective

payment amounts could be too low for beneficiaries who need assistance

with many activities of daily living and too high for beneficiaries who

need less assistance.

The Balanced Budget Act of 1997 also requires the amounts paid for

each case mix group under PPS to be based on a standardized payment

rate. HCFA is designing the case-mix classification system based on

OASIS and claims data from a stratified sample of 90 HHAs.

Standardization requires removing the effect of case mix from past

payment levels for these 90 HHAs and from national payment levels. This

helps to ensure that if case mix changes over time, or if resource use

varies from region to region, payments in the PPS are adjusted

accordingly. This process requires the same information that is used to

classify patients into payment groups. Therefore, we must collect OASIS

data from HHAs before HCFA can set standardized payment rates for a

PPS.

The OASIS instrument has been in development for the past ten

years. A large number of home health agencies have participated in its

development and testing. The instrument has demonstrated its validity

and reliability as an assessment and outcome measurement tool. In

addition to its use as the basis for PPS, OASIS will assist agencies in

improving their performance through outcomes-based assessment. The

quality component of OASIS is crucial to ensuring that beneficiaries

receive needed services under the home health PPS.

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 the 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 State survey agencies will be able to use the data on a continuous

basis to identify providers that are not performing as well as others.

This use will allow us to further progress in our efforts to develop a

more efficient and targeted survey approach.

The impact of these final regulations will 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. There are no other requirements in this final rule

that will impact HHAs. As discussed in detail and illustrated in the

tables in section V.C. of this preamble, implementation requirements of

Sec. 484.55, will not have a significant overall effect on the economy.

Section 804(2) of Title 5, United States Code (as added by section

251 of Pub. L. 104-121), specifies that a ``major rule'' is any rule

that OMB finds is likely to result in--

An annual effect on the economy of $100 million or more;

A major increase in costs or prices for consumers,

individual industries, Federal, State, or local government agencies, or

geographic regions; or

Significant adverse effects on competition, employment,

investment, productivity, innovation, or on the ability of United

States-based enterprises to compete with foreign-based enterprises in

domestic export markets.

Our estimation of the impact of this final rule does not meet the

above definition of a major rule in Title 5, United States Code,

section 804(2). Therefore it will not be forwarded to Congress for a

60-day review period.

In accordance with the provisions of Executive Order 12866, this

final rule was reviewed by the Office of Management and Budget.

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, agencies are required to

provide a 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 by OMB, 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.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction

Act of 1995, we are submitting to OMB the following requirements for

emergency review. We are requesting an emergency review because the

collection of this information is needed before the expiration of the

normal time limits under OMB's regulations at 5 CFR Part 1320. This is

to ensure the timely availability and reporting of data as necessary

for the development of a reliable case mix adjuster that is required by

section 4603(a) of BBA '97 for the establishment of a prospective

payment system for home health services in compliance with sections

4602 and 4603 of BBA '97. We cannot reasonably comply with normal

clearance procedures because public harm is likely to result if the

agency does not enforce the inclusion of OASIS elements into an HHA's

comprehensive assessment requirement early enough to permit training

and to enable HCFA to collect reliable OASIS data for the period

beginning on January 1, 1999. This timeframe is necessary because a key

aspect of creating a prospective payment rate system based on agency

cost experience is the need to ``standardize'' the rates. The overall

objective of standardization is to ensure that when the standardized

payment rate for an episode of care is adjusted by the case-mix and the

wage index, the results are consistent with the costs in the data base

used to construct the prospective payment amounts. That is, when the

average standardized payment rates are multiplied by the appropriate

wage and case mix adjustment factors, and summed for all relevant

episodes, the sum is equal to the total costs in the original data

base. We know of no reliable way to accomplish this result except by

using data from existing agencies. Because the payment system must be

implemented, we will need to begin receiving the OASIS data to be used

for standardizing the payment amounts as soon as possible.

The immediate publication of rules requiring the collection and

reporting of OASIS data and OMB approval of these requirements pursuant

to the Paperwork

[[Page 3778]]

Reduction Act of 1995 are essential because these data are required for

the development of the home health prospective payment system, required

by the BBA, in October of 2000. As stated earlier in this preamble, the

process of rate development must take place in the early spring of 1999

for incorporation in a proposed rule. The home health prospective

payment system proposed rule must be published by the fall of 1999 to

allow for necessary comments and revisions prior to the publication of

a final rule in the summer of 2000. Given the lag time between the

publication of the OASIS rules and the receipt of viable national data

by HCFA, we are already at the point where only two months of national

data will be potentially available for use in the proposed rule and

less than a year of data for the final rule. Further delays would

reduce the amount of national data available for prospective payment

rate development and thus seriously undermine the project plan aimed at

implementation of the prospective payment system on October 1, 2000.

This notice explicitly seeks OMB reapproval, with revisions, of

HCFA-R-39 (OMB # 0938-0365), ``Home Health Medicare Conditions of

Participation Information Collection Requirements as Outlined in

Regulation 42 CFR 484'', with a current expiration date of 11/30/2000.

It should be noted that this revision includes the OASIS protocol that

was proposed in HSQ-238-P, ``Use of the OASIS as Part of the Conditions

of Participation for Home Health Agencies'' (62 FR 11035). We are not

only asking for approval of OASIS but also reapproval of the existing

conditions of participation.

The version of OASIS approved by the Secretary and for which we are

seeking OMB approval is available on HCFA's website on the Internet for

HHAs to download at http://www.hcfa.gov/medicare/hsqb/oasis/

oasishmp.htm. As an alternative to Internet access, which is the most

efficient method of obtaining the current version of the OASIS,

agencies may contact their State agency or HCFA regional office home

health representatives to request a paper copy of the data set for

review. Any future changes to OASIS will be submitted to OMB to review

pursuant to the Paperwork Reduction Act of 1995, will be available on

the HCFA website, and, when approved by OMB, available in hard copy

from the National Technical Information Service (NTIS) at (703) 487-

4650.

We are requesting OMB review and approval of these collection

requirements within 16 working days from the date of publication of

this regulation, with a 180-day approval period. Written comments and

recommendations will be accepted from the public if received by the

addressees referenced in section V.A. of this preamble, within 15

working days from the date of publication of this regulation.

During this 180-day period, we will publish a separate Federal

Register notice announcing the initiation of an extensive 60-day agency

review and public comment period on these requirements. We will submit

the requirements for OMB review and an extension of this emergency

approval.

A. Responses to Public Comments on Collection of Information

Requirements

Comment: Commenters suggested that the proposed requirement at

Sec. 484.55(d)(2) to update comprehensive assessment forms on patients

each time the plan of care is revised, would be unnecessary,

burdensome, and costly.

Response: HCFA specified in the proposed regulation at

Sec. 484.55(d)(2) that the comprehensive assessment must be updated

whenever the plan of care is revised for physician review. However,

after further consideration, we agree with the commenter that the

requirement to update comprehensive assessment forms each time the plan

of care is revised, at proposed Sec. 484.55(d)(2), is unnecessary and

accordingly, we have not included the requirement in this final rule.

Comment: Some commenters suggested that OASIS data collection

requirements are excessive, both in terms of the number of items and

the frequency that the assessment must be performed. Commenters stated

that this could result in increased visits, particularly for rural

public health agencies.

Response: Findings from the Medicare OASIS demonstration indicate

that, after completion of the learning curve, this data collection

requirement does not impose ongoing burden on HHAs. Currently, it is

common practice for agencies to conduct ongoing assessments of

patients. While the frequency of ongoing patient assessment is based on

the needs of the individual patient, completion of the OASIS items,

which may be only part of the assessment, must be done at standardized

time points for comparable data and for the development of case mix

adjusters for use in the creation of prospective payment rates. We also

disagree that the data collection requirements will increase visits. We

have specified timeframes for assessment that are intended to provide

the HHA flexibility, and to diminish burden.

Comment: Several commenters stated concerns regarding increased

paperwork burden and the associated cost of producing new forms to

include the OASIS items.

Response: We acknowledge that developing and reproducing new forms

that incorporate the OASIS into an HHA's own comprehensive assessment

may create start-up costs for the HHA. Medicare OASIS demonstration

data indicates that an agency may incur costs of approximately $280 to

revise the start of care, assessment updates, and discharge forms. (See

table 2 below.) Therefore, in our start-up cost estimates, we have now

included a one time printing cost of $280 for the first year.

Comment: One commenter suggested that we have underestimated the

time for the learning curve as it relates to the OASIS. The commenter

stated that the HHA staff will not be proficient in using the OASIS

data after only 5 uses as estimated in the proposed rule.

Response: We recognize that learning curves may vary from HHA to

HHA, and person to person, and that some agencies may take longer than

our estimates to become familiar with the OASIS. Therefore, we have

adjusted our estimate of the number of uses required for the staff to

become proficient with OASIS to eight uses. Findings from the Medicare

OASIS demonstration indicate that use of the OASIS initially adds

approximately 15 minutes per person more than the time taken for an

HHA's existing assessment protocol. Then, rather than project a time

savings after the first 8 uses, as some research seems to suggest, we

have estimated neither a gain nor loss to the completion time.

Comment: Several commenters suggested that 2.5 minutes is an

underestimation of the additional time necessary, above the HHA's

routine patient assessment, for completion of the OASIS. Other

commenters recommended that HCFA's estimate of an additional 2.5

minutes to complete OASIS items should be increased to 3 minutes.

Response: We believe that our original estimate of 2.5 additional

minutes required to complete a comprehensive assessment that includes

the OASIS is inaccurate. We have heard from agencies that participated

in the OASIS demonstration about a time savings of 1 minute per

assessment. The ease with which OASIS items can be assimilated into a

comprehensive assessment process is apparent because all of the OASIS

items are typically included in any effective, relevant comprehensive

assessment of a patient.

[[Page 3779]]

Our analysis of data indicates that after the initial learning

curve, ongoing OASIS data collection poses no additional burden above

the routine patient assessment. In fact, agencies that participated in

the Medicare OASIS demonstration required one minute less overall for

completion of the patient assessment that included the OASIS than HHAs

that did not use OASIS-incorporated assessments. However, as stated

above, for the purpose of estimating burden on the provider community,

we have not factored in the time savings mentioned above.

Comment: Several commenters requested that HCFA guarantee the

availability of OASIS software prior to implementation of the

requirements for the use of OASIS as part of the Medicare conditions of

participation for home health agencies.

Response: The required OASIS form is available on our website at

the following address: http://www.hcfa.gov/medicare/hsqb/oasis/

oasishmp.htm. HHAs may access the HCFA website and download the

required OASIS for each data collection time point. For example, data

sets are available for start of care, resumption of care following an

inpatient facility stay, follow-up, discharge (not to an inpatient

facility), transfer to inpatient facility (with or without agency

discharge), and death at home. In addition, HCFA will provide software

on its website that can be downloaded and used to collect and report

OASIS data. This software, the Home Assessment Validation Entry

(HAVEN), will include the data specifications, data dictionaries,

OASIS, a user's manual for the OASIS, the HAVEN manual, and the HHA

submission manual. Other educational materials for the HHA will also be

posted on the HCFA website. This medium was chosen, and will be

supported by HCFA to provide for direct access by HHAs, State agencies,

software vendors, professional organizations, and other consumers. We

encourage vendors and agencies to regularly review the website for

information related to the computerization of OASIS and other HCFA-

related home health issues. We will continue to promote processes for

assuring accuracy in the software that we anticipate will evolve over

time.

Comment: Many commenters agreed that the OASIS items are similar to

those that most agencies assess for their patients and should impose a

minimal burden once they have been successfully incorporated into an

HHA's assessment process. However, commenters stated that HCFA

underestimated the time necessary to integrate OASIS into existing

assessment forms.

Response: We agree that OASIS items are similar to those that most

agencies use for their patients and that the OASIS should impose only a

minimal burden once successfully incorporated into the assessment

process. We stated in the proposed regulation that for each HHA a

clerical employee would take 16 hours to integrate the form. Ongoing

research indicates that revising assessment forms to incorporate the

OASIS items will require 12 hours of clinician expertise and

involvement, and 4 hours of clerical assistance (for a total of 16

hours). Therefore, we have revised the estimates accordingly. Further

discussion on the reassessment of the start-up requirements, along with

corresponding revisions to the summary tables, are below in section

V.C. of this preamble.

Various firms have developed an integrated clinical record (that

is, OASIS items integrated with other items necessary for good clinical

assessments) available for purchase. Based on an observation of the

Medicare OASIS demonstration, approximately one half to two-thirds of

agencies will purchase forms (to use ``as is'' or with minor

modifications). Since an agency will have the option of purchasing

integrated forms, or developing its own forms, we believe that the

burden for the average agency to integrate the OASIS into its existing

assessment forms will be less than the 16 hours we have estimated for

inclusion of OASIS elements into assessment forms.

Comment: Many commenters expressed concern that HCFA substantially

underestimated the time and cost required to train agency staff on

implementing OASIS. Commenters also stated that the proposed rule

referred to training only full time staff, did not consider the

training of part-time or contracted staff, nor did it consider the cost

of staff turnover.

Response: After careful consideration, we have re-estimated the

time and cost involved in training agency staff on the implementation

of OASIS. Based on additional information we received from the Medicare

OASIS demonstration, we have determined that training for OASIS data

collection is necessary for two categories of HHA employee, an agency

coordinator and the clinical staff. We estimate that the agency

coordinator, specified as the individual who conducts training or

clinical supervision for clinical staff, will need to read the OASIS

manual (4 hours) and attend an 8-hour training session (for a total of

12 hours to train the coordinator). We also estimate that each clinical

staff member in the agency will require an average of 3 hours of

training, to include practice and retraining, if indicated.

Additionally, we expect that training on data collection in general,

data collection for follow-up assessments, and data auditing will be

included within the 3 hours of staff training. In light of the Medicare

demonstration, we have also re-estimated the total number of training

hours stated in the March 10, 1997 proposed rule for the clinical staff

to 3 hours (3 hours per clinical staff member). The estimated average

training costs for each HHA have been increased to $1659 (that is, $144

more than the estimate of $1515 in the proposed rule). Training for

part-time and contracted staff was considered; however, we calculate

amounts for staff as full-time equivalents which encompasses HHAs'

flexible staffing practices. Training costs associated with staff

turnover should be considered part of an agency's normal operating

costs.

Comment: Several commenters stated that in the proposed rule, HCFA

did not accurately address the burden as it applies to the cost of

developing the necessary educational programs, or the costs associated

with preparing training materials.

Response: As part of the ongoing operating costs, an agency that

wants to develop training and educational programs is free to do so.

However, we have not developed cost estimates for additional training

because individual agency training policies and needs vary to such a

great degree.

Comment: Several commenters stated that the proposed rule provided

no transition time for incorporation of OASIS into an agency's

comprehensive patient assessment, or to develop related policies and

procedures.

Response: Although HCFA did not specify an exact transition period,

as discussed above in this preamble, requirements for a comprehensive

assessment as a COP for HHAs and for the incorporation of OASIS into an

HHA's patient assessment were published in the March 10, 1997 Federal

Register in separate proposed rules. This final rule will become

effective 30 days after the date of publication in the Federal

Register.

Comment: A few commenters indicated that the timeframes for

implementation will be cost prohibitive. Commenters also stated, that

HCFA's estimated national HHA cost of $50 million dollars, although

reimbursable, suggests a waste of taxpayer money and would

unnecessarily raise the cost of health care.

Response: Fifty million dollars is a misstatement of what we

estimated in the March 10, 1997 proposed rule. Our

[[Page 3780]]

final estimates of start-up costs indicate that HHA costs will decrease

with the implementation of OASIS. As stated above, in the August 11,

1998 notice, we included an OASIS offset adjustment factor to the per

visit limitation to address the costs. In that notice, we solicited

specific comments, including data, that would impact future decision

making on this issue. We believe the benefits of using the OASIS far

outweigh the burden since the OASIS will promote standardization of

information on patients. We believe that an HHA can integrate a core

standard assessment data set (OASIS) into its own more comprehensive

assessment system, then use that data set as the foundation for valid

and reliable information for patient assessment, care planning, and

service delivery. Also, we are using the OASIS data set to comply with

section 1891(d)(1) of the Act, which gives the Secretary the authority

to designate an assessment instrument for use by HHAs. As discussed

above, OASIS data will support the BBA `97 requirement that mandates

the implementation of a prospective payment system for HHAs. Therefore,

we need OASIS data to develop case mix adjusters for standardizing HHA

prospective payment amounts. To this end, we believe the prospective

payment system will save taxpayer dollars.

Comment: Commenters suggested that use of the HCFA-485 form in

conjunction with the OASIS is duplicative. They questioned whether

information from the HCFA-485 will be sent to HCFA for use in the OASIS

data base, whether the HCFA-485 form will be changed to a standardized

format to make the information more useful to HHAs, or whether the

HCFA-485 form will be discontinued.

Response: The HCFA-485 form and the OASIS are designed to serve two

different purposes. The HCFA-485 is the plan of care form developed for

payment purposes. It contains a certification statement that must be

signed by the patient's physician, and the HHA must continue to

maintain the HCFA-485 in the patient's medical records. The OASIS does

not provide for the physician certification needed to authorize

payments to HHAs for covered services.

B. Condition of Participation: Comprehensive Assessment of Patients

(Sec. 484.55)--Discussion and Summary

The HHA condition of participation for the comprehensive assessment

of patients at Sec. 484.55 requires that each patient receive a

comprehensive assessment that incorporates the exact use of the current

version of the OASIS as part of the HHA's patient assessment. The OASIS

includes only information necessary to measure outcomes of care for

quality indicators. Accordingly, our intent is not to develop a

complete patient assessment, but rather to identify standardized data

elements that fit within the HHA's overall comprehensive assessment

responsibilities. Therefore, we require that HHAs use the current

version of the OASIS as specified in Sec. 484.55(e). We believe this

requirement is necessary to build a valid, reliable, comparable data

set of outcomes. As discussed in the proposed rule, and elsewhere in

this preamble, the items on the OASIS have undergone rigorous validity

and reliability testing so that trained individuals can have confidence

in incorporating the data items as part of their comprehensive

assessment of patients. As long as the HHA staff conduct assessments

accurately and use the measurement criteria specified for each item, in

any HHA, the validity and reliability extend to the comparability of

the data acquired using the same items to collect information from

other patients. Altering the items or using a different data set,

destroys the essential validity and comparability of the data

collected. HHAs may distribute the OASIS items within the agency's own

comprehensive assessment system as long as the items remain within the

groupings as they appear in the current version, and as specified by

the Secretary.

We intend for the OASIS to become one of the most important tools

of the HHA's quality assessment and performance improvement efforts. By

integrating a core standard assessment data set into the HHA's own more

comprehensive assessment system, HHAs can use the data set as the

foundation for valid and reliable information for patient assessment,

care planning, and service delivery. Also, HHAs can use the data set to

build a strong and effective quality assessment and performance

improvement program. We believe, except as discussed below, that these

requirements pose little or no burden for well managed HHAs since a

comprehensive assessment would in all likelihood be performed in the

absence of regulations. However, we acknowledge that the timeframes

required by Sec. 484.55 serve as a strong performance expectation for

HHAs.

In summary, the information collection requirements in this final

rule ensure that HHAs increase the precision of patient assessments and

continue to demonstrate whether they meet the conditions of

participation in the Medicare and/or Medicaid programs. The frequency

of the revised information collection in the Medicare home health

conditions of participation remain on an ``as needed'' basis. The

affected public continues to be businesses or other for-profit and not-

for-profit institutions. Due to changes in the number of certified home

health agencies, as of March 1998, the number of respondents has

increased to 10,492.

Except for the specific information collection for the OASIS for

which we are requesting emergency approval from OMB (as discussed in

detail below) we do not anticipate an increase in burden as a result of

incorporating Sec. 484.55 Condition of participation: Comprehensive

assessment of patients into the HHA conditions of participation. In

section V.A. of this preamble, we address public comments on the

collection of information requirements of the comprehensive assessment

of patients COP combined with comments on the use of the OASIS.

However, we are interested in obtaining comments on the changes from

the proposed rule regarding the currently approved home health

conditions of participation information collection requirements, as

referenced in this regulation, and on modifications of the burden

discussed in detail in this section and summarized in tables below.

C. OASIS--Discussion and Summary

As discussed in section III. of this preamble, final regulations at

Sec. 484.55 will require HHAs to use the OASIS as part of a

comprehensive assessment of the patient. In the proposed rule, we

stated that the burden from requiring HHAs to collect OASIS data could

be divided into the two categories of activities: those activities

required for startup, and those required for ongoing data collection.

The first burden category of activities that are required for startup

include incorporating the OASIS data into an HHA's clinical records,

initial adaptation to use of the OASIS, and training agency staff.

After the initial startup activities, we stated that the second burden

category arose from the ongoing collection of the OASIS data. Based on

data obtained from the Medicare demonstration, we have reconsidered our

original estimates, in addition to making technical mathematical

corrections. While the overall actual burden has not increased from the

proposed rule, our reassessment indicates that since OASIS

implementation will occur in fiscal years 1999 and 2000, the burden

estimate for subsequent years is zero. After the initial startup costs,

HHAs will

[[Page 3781]]

have become familiar with OASIS, and its use will then be a common

business practice for HHAs.

1. Startup Activities: Time and Cost

We expect HHAs to incorporate the OASIS data into their clinical

records to minimize the documentation burden 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 follow-up time point (that is, every two calendar months;

within 48 hours after the return home from a hospital admission; and at

discharge).

Inclusion of OASIS Elements Into Assessment Forms

The following estimates are based on the experience of HHAs that

participated in the development of the home health quality indicators.

We define an average-size HHA as having 18 clinicians and other

service practitioners and 486 admissions per year. We estimate that the

time required by an average-sized HHA to integrate OASIS into the HHA's

assessment forms is approximately 16 hours. This 16 hours includes 8

hours required to revise the initial assessment forms, 4 hours to

revise the clinical record forms for follow-up visits, and post

hospital admissions. Many items in the discharge follow-up are

identical to the follow-up assessment and the assessment within 48

hours after hospital admission, but there are several data elements

associated with discharge that will result in an additional 4 hours for

revisions of discharge forms. Thus, the total burden for clinical

record forms revision is estimated to be 16 hours per agency for

integration of OASIS items for all 4 data collection time points. This

estimate includes time associated with pilot testing the revised forms

and subsequent revisions as necessary.

In the proposed rule, we based our estimates on the assumption that

only clerical staff would integrate the OASIS data elements into an

HHA's assessment forms. However, research from the Medicare OASIS

demonstration indicates that revising forms will require both clinical

involvement and clerical assistance. Therefore, we now estimate that

the cost for an average-size HHA to revise the clinical records will be

$339, based on 12 hours at an hourly rate of $24.05 for clinician time,

and 4 hours at an hourly rate of $12.50 for clerical time ((12 hrs. x

$24.05/hr.) and (4 hrs. x $12.50/hr.)). The total national hours for

revisions of patient assessment forms are now estimated to be 167,872

hours based on 10,492 Medicare certified HHAs as of March 1998 (16 hrs.

x 10,492 HHAs), with an associated national cost of $3.6 million ((12

hrs. x $24.05/hr. x 10,492 HHAs) and (4 hrs. x $12.50/hr. x

10,492 HHAs)).

Printing Forms

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. We stated in the

preamble to the proposed rule that most HHAs are accustomed to revising

patient assessments periodically, as new assessment protocols become

available or as new requirements are implemented by accrediting bodies

or regulators. Thus, we did not estimate costs for printing at that

time. However, based on the Medicare OASIS demonstration, research data

has shown that the need to revise the start of care, assessment

updates, and discharge forms may create startup costs. The inclusion of

OASIS items may add up to three pages to some of the HHA start of care

forms, and may also cause HHAs to revise assessment update and

discharge forms. HHAs participating in the demonstration estimated an

average of $280 in printing costs. Therefore, we have included an

additional one time estimated cost of $280 for the first year to print

the following forms:

New patient/start of care:

500 forms x 3 additional pages x .03/page....... $45.00

Follow-up:

250 forms x 9 total pages x .03/page............ 67.50

Discharge:

500 forms x 10 total pages x .03/page........... 150.00

Stapling Charges........................................ 17.50

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

Total............................................... 280.00

HHAs currently print their start of care assessment forms which,

prior to the implementation of this rule, have not been required to

include OASIS items. The average HHA conducts its comprehensive

assessment using forms that may vary in length from HHA to HHA. Based

on the Medicare OASIS demonstration, we are aware that in order to

comply with HCFA policy, an agency may need to print the start of care

forms when OASIS items have been integrated; the revised forms may

increase the length of an HHA's assessment form by 3 pages. Therefore,

we have estimated the cost to print an additional 3 pages. Once OASIS

items are included in an HHA's clinical record forms, we believe the

HHA will have only minor subsequent revisions for any future OASIS

releases.

Staff Training

In the proposed rule, we estimated 3.5 hours as the necessary

training time per nurse (or other clinical staff within each HHA) for

the new OASIS record keeping. We have revised this estimate to 3 hours

based on research conducted through the Medicare OASIS demonstration.

The 3 hours have been allocated for training on data collection for the

initial assessment, data collection for assessment at follow-up, data

collection at discharge, and data auditing. In the proposed rule, we

provided a breakout of the training hours. However, since training

needs may differ from agency to agency, we have not specified within

this final rule, a breakout of how the 3 hours of training should be

used.

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 used by the agency to monitor data accuracy

(including interdisciplinary comparisons and record reviews) require

training as they are implemented. Several approaches to data auditing

could be explained in 30 minute training sessions. The projected 3

hours of training time for staff is expected to cost an average HHA

with 18 clinicians approximately $1,299 (3 hrs. x $24.05/hr. x 18

clinicians). The projected 12 hours of training for the OASIS

coordinator is expected to cost $360 per HHA (12 hrs. x $30.00/hr.

x 1 coordinator). These estimates are based on an average hourly rate

of $24.05 for the clinical staff and of $30.00 for the

[[Page 3782]]

OASIS Coordinator. The total national training burden is estimated to

be 692,472 hours ((3 hrs. x 18 staff) and (12 hrs. x 1 coordinator)

x 10,492) across all certified HHAs, at a cost of $17.4 million ((3

hrs. x $24.05/hr. x 18 clinicians) and (12 hrs. x $30.00/hr. x

1 coordinator) x 10,492 HHAs).

Once HHA staff are familiar with the OASIS items, OASIS data

collection does not impose a burden above the current patient

assessments. 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 the HHA clinicians

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,

as discussed above, after using the OASIS approximately 8 times, the

additional time required to complete a comprehensive assessment that

incorporates the OASIS into an HHA's existing patient assessment is

eliminated. Thus, the total learning curve (of 8 uses until familiar

with OASIS) for an average HHA is estimated to be 36 hours (8 uses x

.25 hr. x 18 clinicians), at a cost of about $866 per HHA, based on

an average hourly rate of $24.05 per clinical staff for 18 clinicians

(36 hrs. x $24.05/hr.).

2. Data Collection

Most items included in the OASIS require information that the

majority of HHAs currently gather during patient assessments. However,

the OASIS employs a more precise scale. For instance, most HHAs assess

a patient's ability to bathe in the course of an assessment, but use

only three levels (independent, needs moderate assistance, or

dependent). The OASIS item for bathing requires that the clinician

assesses 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 two calendar months, and

within 48 hours after return to home from a hospital admission for any

reason except diagnostic testing). Some data items are unique to only

one point in time (for example, selected items are collected only at

patient discharge), while other data are collected at every time point.

By collecting data using uniform data items and time points, specific

information on individual patients is comparable and can be aggregated

to produce agency-level outcome reports that permit comparisons between

different groups of patients.

Since the proposed rule was published in the Federal Register on

March 10, 1997, we have collected data from the Medicare OASIS

demonstration that prompts us to revise our previous estimate of

ongoing costs for initial care, follow-ups, post hospital admissions,

and discharges. The data indicates that after the initial learning

curve, OASIS data collection on an ongoing basis poses no additional

burden above an HHA's routine patient assessment. Instead, agencies

that participated in the University of Colorado's OASIS Time Survey and

that completed comprehensive assessments incorporating the OASIS

required one minute less overall for completion of the assessment than

did the agencies that completed comprehensive assessments that did not

include OASIS. Therefore, we have determined that providers using

clinical records with integrated OASIS items will not need additional

time on an ongoing basis for initial care or discharges. We have

revised our estimates accordingly.

Based on the above findings, for the purposes of this analysis, it

will not take any additional time to complete OASIS for the follow-up

and post hospital admission items. In fact, we believe that the burden

associated with completing these assessments will diminish with the

incorporation of OASIS, after the learning curve.

Finally, as we stated earlier in this preamble, the OASIS will be

updated and improved periodically after implementation. We anticipate

these changes to be refinements of existing items and the addition and

deletion of items depending on their value. We believe the

implementation of later iterations of the OASIS will result in a very

small one-time cost to HHAs.

3. Summary of Cost and Burden Estimates

The estimated total national start-up costs across all certified

HHAs is $32,986,848. (See table 1 below). In this final rule, changes

from the proposed rule burden estimates are based on updated data that

show an increase in the number of certified HHAs, the addition of

clinician involvement in the integration of OASIS into existing

assessment forms, the addition of printing costs that research

identified, and the inclusion of OASIS coordinator training.

The following 3 tables provide a summary of the statistics for

start-up and ongoing costs, burden to the average HHA, and combined

cost for all HHAs for the collection of OASIS data. The tables are as

follows: (1) National Costs to HHAs for Implementation of the OASIS;

(2) Breakdown of Agency Start-Up Costs; and (3) Hourly Breakdown and

Computation of the Average OASIS Start-Up Costs per HHA.

1. National Costs for Implementation of the OASIS

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

Number of Start-up costs

agencies @ $3144 per Medicare costs Costs to other

Year FY incurring HHA (in (in millions) sources (in

start-up costs millions) millions)

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

1999 and 20001.................................. 10,492 $32.99 2 $9.89 2$23.10

2001............................................ 0 0 0 0

2002............................................ 0 0 0 0

2003............................................ 0 0 0 0

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

These costs are based on the following assumptions:

1 Implementation will be in fiscal years 1999 and 2000.

2 Medicare will reimburse approximately 30% of HHAs for their reasonable Medicare share of start-up costs, based

on the estimate that approximately 30% of HHAs will benefit from the add-on adjustment to per-visit cost

limits, published on August 11, 1998 in an Interim Payment System Notice. This estimate is reflected by

indicating that 30% of $32.99 million (or $9.89 million) will be reimbursed by Medicare. The remaining 70% of

$32.99 million ($23.10 million) will most likely be absorbed by a combination of the Medicaid program, private

insurers, and beneficiaries, to whom we expect the balance of HHAs to pass along these start-up costs. Because

approximately 23% of HHA patients are Medicaid beneficiaries, we expect HHAs to try to have the Medicaid

programs absorb up to 23% of this remaining $23.10 million.

[[Page 3783]]

2. Breakdown of Agency Start-Up Costs

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

National costs

(agency costs

Agency costs x 10,492

Task (in dollars) HHAs in

millions of

dollars)

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

Start-Up (One-Time Only) Costs

Integration of OASIS into existing

assessment forms:

Clinician Input--12 hrs. x $24.05/

hr................................. $289 $3.03

Clerical Input--4 hrs. x $12.50/hr 50 .52

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

Subtotal........................ 339 3.55

Staff Training:

Coordinator--

12 hrs. x $30.00/hr. x 1

coordinator.................... 360 3.78

Clinicians--

3 hrs. x $24.05/hr. x 18

clinicians..................... 1299 13.63

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

Subtotal.................... 1659 17.41

Learning Curve:

8 x .25 hr. x $24.05/hr. x 18

clinicians......................... 866 9.09

Printing Costs.......................... 280 2.94

===============================

Total Start-Up Costs................ 3144 32.99

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

3. Hourly Breakdown and Computation of the Average OASIS Start-Up Costs per HHA

[Does not include costs for printing]

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

Average cost

(rounded to

Task Hours Computation of average costs nearest

dollar)

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

Integration of OASIS into existing

assessment forms (revisions):

Initial assessment forms............... 8.0 12 hrs. x $24.05/hr. (Avg. $289

Clinician rate).

Clinical forms (57-62 day and 48 hours 4.0 4 hrs. x $12.50/hr. (Avg. 50

post-hospital admission). Clerical rate).

Discharge forms........................ 4.0

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

Sub-Total.......................... 16.0 Sub-Total........................ 339

Staff Training:

Coordinator Training for data 12.0 12 hrs. x $30/hr. x 1 360

collection at initial assessment, Coordinator.

assessment at follow-up, at discharge,

and data auditing.

Clinical Staff Training for data 54.0 3 hrs. x $24.05/hr. x 18 1299

collection at initial assessment, Clinicians.

assessment at follow-up, collection at

discharge, and data auditing.

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

Sub-Total.......................... 66.0 Sub-Total........................ 1659

Learning Curve:

Initial and next 7 Uses of the OASIS .............. 2 hrs. x $24.05/hr. x 18 Clinicians

Data Collection (.25 hr./use).

(8 x .25 hr. x 18 Clinicians)......

Sub-Total.......................... 36.0 ................................... 866

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

Per HHA Total...................... 118.0 Total............................ 2864

================ ===============

Total National Hours............... 1,238,056 Total Costs...................... 30,049,088

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

Note: HCFA has requested OMB approval of the Outcome and Assessment Information Set to support the use of

collecting patient information as part of the conditions of participation for HHAs. The average start-up costs

per HHA for the first years of implementation (FYs 1999 and 2000) is estimated to require 118.0 burden hours.

Subsequent years will require approximately 79 burden hours per year. The average burden over a 3-year period

is estimated to be 79 hours per year ((118.0 + 118.0 + 0) 3) for a national average of 828,862 burden

hours per year (79 hours x 10,492 HHAs). While the overall actual burden has not increased from the proposed

rule, the totals have been revised in the tables based on data from the Medicare OASIS demonstration, our

reassessment on ongoing burden, and technical corrections to the tables published in the proposed rule. We

estimate OASIS implementation will occur in fiscal years 1999 and 2000 at 118.0 hours each. The third year

burden estimate is zero by which time the OASIS will have become a common business practice for HHAs.

Therefore, we are requesting a three-year OMB approval for an average of 79 burden hours per year.

To obtain copies of the supporting statement and any related forms

for the proposed paperwork collections referenced above, E-mail your

request, including your address, phone number, and HCFA form number(s)

and/or OMB numbers referenced above, to [email protected], or call the

Reports Clearance Office on (410) 786-1326.

[[Page 3784]]

Interested persons are invited to send comments regarding the

burden or any other aspect of these collections of information

requirements. However, as noted above, comments on these information

collection and recordkeeping requirements must be mailed and/or faxed

to the designees referenced below, within 15 working days from the date

of this publication in the Federal Register to:

Health Care Financing Administration, Office of Information Services,

Security and Standards Group, Division of HCFA Enterprise Standards,

Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850,

Attention: John Burke HCFA-3007-F, Fax number: 410-786-0262, and

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, D.C.

20503, Attention: Allison Herron Eydt, HCFA Desk Officer, Fax number:

202-395-6974 or 202-395-5167

List of Subjects in 42 CFR Part 484

Health facilities, Health professions, Medicare, Reporting and

recordkeeping requirements.

42 CFR chapter IV is amended as follows:

PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES

1. 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)).

Subpart B--Administration

2. Section 484.18 is amended by revising paragraph (c) to read as

follows:

Sec. 484.18 Condition of participation: Acceptance of patients, plan

of care, and medical supervision.

* * * * *

(c) Standard: Conformance with physician orders. Drugs and

treatments are administered by agency staff only as ordered by the

physician. Verbal orders are put in writing and signed and dated with

the date of receipt by the registered nurse or qualified therapist (as

defined in Sec. 484.4 of this chapter) responsible for furnishing or

supervising the ordered services. Verbal orders are only accepted by

personnel authorized to do so by applicable State and Federal laws and

regulations as well as by the HHA's internal policies.

Subpart C--Furnishing of Services

3. Section 484.55 is added to subpart C to read as follows:

Sec. 484.55 Condition of participation: Comprehensive assessment of

patients.

Each patient must receive, and an HHA must provide, a patient-

specific, comprehensive assessment that accurately reflects the

patient's current health status and includes information that may be

used to demonstrate the patient's progress toward achievement of

desired outcomes. The comprehensive assessment must identify the

patient's continuing need for home care and meet the patient's medical,

nursing, rehabilitative, social, and discharge planning needs. For

Medicare beneficiaries, the HHA must verify the patient's eligibility

for the Medicare home health benefit including homebound status, both

at the time of the initial assessment visit and at the time of the

comprehensive assessment. The comprehensive assessment must also

incorporate the use of the current version of the Outcome and

Assessment Information Set (OASIS) items, using the language and

groupings of the OASIS items, as specified by the Secretary.

(a) Standard: Initial assessment visit. (1) A registered nurse must

conduct an initial assessment visit to determine the immediate care and

support needs of the patient; and, for Medicare patients, to determine

eligibility for the Medicare home health benefit, including homebound

status. The initial assessment visit must be held either within 48

hours of referral, or within 48 hours of the patient's return home, or

on the physician-ordered start of care date.

(2) When rehabilitation therapy service (speech language pathology,

physical therapy, or occupational therapy) is the only service ordered

by the physician, and if the need for that service establishes program

eligibility, the initial assessment visit may be made by the

appropriate rehabilitation skilled professional.

(b) Standard: Completion of the comprehensive assessment. (1) The

comprehensive assessment must be completed in a timely manner,

consistent with the patient's immediate needs, but no later than 5

calendar days after the start of care.

(2) Except as provided in paragraph (b)(3) of this section, a

registered nurse must complete the comprehensive assessment and for

Medicare patients, determine eligibility for the Medicare home health

benefit, including homebound status.

(3) When physical therapy, speech-language pathology, or

occupational therapy is the only service ordered by the physician, a

physical therapist, speech-language pathologist or occupational

therapist may complete the comprehensive assessment, and for Medicare

patients, determine eligibility for the Medicare home health benefit,

including homebound status. The occupational therapist may complete the

comprehensive assessment if the need for occupational therapy

establishes program eligibility.

(c) Standard: Drug regimen review. The comprehensive assessment

must include a review of all medications the patient is currently using

in order to identify any potential adverse effects and drug reactions,

including ineffective drug therapy, significant side effects,

significant drug interactions, duplicate drug therapy, and

noncompliance with drug therapy.

(d) Standard: Update of the comprehensive assessment. The

comprehensive assessment must be updated and revised (including the

administration of the OASIS) as frequently as the patient's condition

warrants due to a major decline or improvement in the patient's health

status, but not less frequently than--

(1) Every second calendar month beginning with the start of care

date;

(2) Within 48 hours of the patient's return to the home from a

hospital admission of 24 hours or more for any reason other than

diagnostic tests;

(3) At discharge.

(e) Standard: Incorporation of OASIS data items. The OASIS data

items determined by the Secretary must be incorporated into the HHA's

own assessment and must include: clinical record items, 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 data items

collected at inpatient facility admission or discharge only.

(Catalog of Federal Domestic Assistance Program No. 93.773,

Medicare--Hospital Insurance; and Program No. 93.778, Medical

Assistance Program)

Dated: November 3, 1998.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.

Dated: December 15, 1998.

Donna E. Shalala,

Secretary.

[FR Doc. 99-1449 Filed 1-22-99; 8:45 am]

BILLING CODE 4120-01-P