[Federal Register Volume 64, Number 15 (Monday, January 25, 1999)]
[Rules and Regulations]
[Pages 3764-3784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1449]



[[Page 3764]]

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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.

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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

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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

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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

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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

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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