[Federal Register Volume 62, Number 46 (Monday, March 10, 1997)]
[Proposed Rules]
[Pages 11005-11035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5316]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 484
[BPD-819-P]
RIN 0938-AG81
Medicare and Medicaid Programs; Conditions of Participation for
Home Health Agencies
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule revises the existing conditions of
participation that home health agencies must meet to participate in the
Medicare program. The proposed requirements focus on the actual care
delivered to patients by home health agencies and the results of that
care, reflect an interdisciplinary view of patient care, allow home
health agencies greater flexibility in meeting quality standards, and
eliminate unnecessary procedural requirements. 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, while at the same time reducing
procedural burdens on providers.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on June 9,
1997, except for comments on information collection requirements, which
must be received on or before May 9, 1997.
ADDRESSES: Mail written comments (one original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: BPD-819-P, P.O. Box 7519,
Baltimore, MD 21207-0519.
If you prefer, you may deliver your written comments (one original
and three copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-11-17, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code BPD-819-P. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue, SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
For comments that relate to information collection requirements,
mail a copy of comments to: Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building Washington, DC 20503, Attention Allison Herron Eydt,
HCFA Desk Officer.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 512-1800 or by faxing to (202) 512-
2250. The cost for each copy is $8.00.
[[Page 11006]]
As an alternative, you can view and photocopy the Federal Register
document at most libraries designated as Federal Depository Libraries
and at many other public and academic libraries throughout the country
that receive the Federal Register.
FOR FURTHER INFORMATION CONTACT: Susan Levy, (410) 786-9364 and Mary
Vienna, (410) 786-6940.
SUPPLEMENTARY INFORMATION:
I. Introduction
As the single largest payer for health care services in the United
States, the Federal Government has a critical responsibility for the
quality of care delivered under its programs. Historically, the Health
Care Financing Administration (HCFA) has adopted a quality assurance
approach that has been directed toward identifying health care
providers that furnish poor quality care or fail to meet minimum
Federal standards. These problems would either be corrected or would
lead to the exclusion of the provider from participation in the
Medicare or Medicaid programs. However, we have found that this
problem-focused approach has inherent limits. Trying to ensure quality
through the enforcement of prescriptive health and safety standards,
rather than trying to improve quality of care for all patients, has
resulted in HCFA expending much of its resources on dealing with
chronic problems with marginal providers, rather than on stimulating
broad-based improvements in quality of care.
We believe that a different approach toward achieving quality
health care for Federal beneficiaries is needed both to take advantage
of the continuing advances in the health care delivery field and to
keep up with growing demands for services. This approach necessitates
revising our requirements to focus on the expected patient-centered
outcomes of Medicare services. Thus, for home health services, we have
developed a core set of requirements encompassing patient rights,
comprehensive assessment, and patient care planning and coordination.
Tieing these requirements together is a fourth core requirement--
quality assessment and performance improvement--that rests on the
assumption that a provider's own quality management system is the key
to improved performance. Our objective is to achieve a balanced
approach combining HCFA's responsibility to ensure that essential
health and quality standards are achieved and maintained with a
provider's responsibility to monitor and improve its own performance.
To achieve this objective, we are now developing revised
requirements for several major health care provider types, including
the new HHA requirements set forth in this proposed rule as well as
revised requirements for hospitals, hospices, and end-stage renal
disease facilities. In addition, elsewhere in today's issue of the
Federal Register, we are publishing a proposed rule (Use of the OASIS
As Part of the Conditions of Participation for Home Health Agencies)
that describes the core standard assessment data set that we are
proposing to require HHAs to incorporate into the comprehensive
assessment process. This proposed rule is discussed below in section
II.D of this preamble. All of these proposals are directed at (1)
Improving outcomes of care and satisfaction for patients, (2) reducing
burden on providers while increasing flexibility and expectations for
continuous improvement, and (3) increasing the amount and quality of
information available on which to base health care choices and efforts
to improve quality.
We note that HCFA's revised approach to its quality assurance
responsibilities is linked closely both to the Administration's
commitment to reinventing health care regulations and to HCFA's own
strategic plan that sets forth our future goals. This regulation is a
regulatory reform initiative included in the President's and Vice
President's July 1995 report entitled ``Reinventing Health Care
Regulations''. In accordance with the President's Reinventing Health
Care Regulations initiative, HCFA is revising the HHA COPs to eliminate
unnecessary process regulations and focus on outcomes of care. Thus,
these initiatives share three common themes. First, they promote a
partnership between HCFA and the rest of the health care community,
including the provider industry, practitioners, health care consumers,
and the States. Second, they 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. Finally, 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. We believe that the
revised HHA requirements proposed below, and the revisions that will
follow for other providers, will provide the foundation for a health
care system in which this type of information is readily available. In
addition, certain provisions in this HHA COP rule support the
Administration's reinvention initiative combating fraud and abuse. Such
provisions are designated as serving this objective when appropriate.
II. Background
A. Home Health Care Benefit
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, be provided on a visiting basis to the
beneficiary's home, and 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)
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) and 1891 of the Act, the
Secretary has established in regulations the requirements that an HHA
must meet to participate in Medicare. These requirements are set forth
at 42 CFR Part 484, Conditions of Participation: Home
[[Page 11007]]
Health Agencies. The conditions of participation (COPs) apply to an HHA
as an entity as well as the services furnished to each individual under
the care of the HHA, unless a condition is specifically limited to
Medicare beneficiaries. 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.
B. Why Revise the Conditions of Participation?
The conditions of participation for HHAs were originally
promulgated in 1973 and have been revised in part on several occasions.
In particular, we made significant revisions to the COPs in 1989 (54 FR
33354) and 1991 (56 FR 32967), largely to implement provisions of
section 4021 of the Omnibus Budget Reconciliation Act of 1987 (OBRA
``87, Public Law 100-203), which added section 1891 of the Act. Most
recently, we made minor revisions to the HHA COPs on December 20, 1994
(59 FR 65482). However, many of the current COPs have remain unchanged
since their inception.
Our decision to propose major changes to the existing conditions is
based on several considerations. First, as discussed above, the
revision of the HHA requirements is part of a larger effort by HCFA to
bring about improvements in the quality of care furnished to Federal
beneficiaries through a new approach to our quality of care
responsibilities. Moreover, nowhere is the need for change more acute
than in home health services. During the 1980's and early 1990's, major
changes have taken place in the home health benefit, the provider
industry, home health care practices, and the characteristics of home
health care users that have combined to make home health services the
most rapidly growing segment of Medicare expenditures.
In response to challenges associated with the expanding use of home
health services, HCFA in 1994 began the Medicare Home Health Initiative
(Initiative) to identify opportunities for improvement in the Medicare
home health benefit. The Initiative is an agency-wide effort that
routinely solicits input and feedback on a wide variety of issues from
HCFA's partners in the home health care community. Representatives from
HCFA, consumer groups, the home health care industry, professional
associations, regional home health intermediaries, and States
(including State Medicaid agencies) have convened in a series of
collaborative meetings during 1994 and 1995. Among the Initiative's
primary recommendations is that HCFA develop HHA COPs that include a
core standard assessment data set and patient-centered, outcome-
oriented performance expectations that will stimulate continuous
quality improvement in home health care.
The existing HHA COPs do not provide patient-centered, outcome-
oriented standards, nor do they provide for the operation of a quality
assessment and performance improvement program. Historically, we set
requirements for participation in the Medicare program by establishing
requirements that address the structures and processes of health care.
These requirements are largely the result of professional consensus,
since there are no data supporting the link between structure and
process requirements and positive patient outcomes. The combination of
process-oriented requirements with an enforcement approach that focuses
on identifying providers that do not have the required structures and
procedures in place will not be adequate to meet the growing challenges
associated with the changing home health care environment. Thus, we
have concluded that significant revisions to the HHA conditions of
participation are essential.
C. Transforming the HHA Conditions of Participation
As we began to develop new proposed COPs for HHAs, we solicited the
advice and suggestions of the home health industry, professional
associations and practitioner communities, as well as consumer
advocates and State and other governmental agencies with an interest or
responsibility in HHA regulation and oversight. The fundamental
principles that guided the development of new COPs were the need to:
Focus on the continuous, integrated care process that a
patient experiences across all aspects of home health services,
centered around patient assessment, care planning, service delivery,
and quality assessment and performance improvement.
Adopt a patient-centered, interdisciplinary approach that
recognizes the contributions of various skilled professionals and how
they interact with each other to meet the patient's needs. A home care
patient encounters many services and is exposed to several disciplines,
given the interdisciplinary approach to home health care delivery. An
interdisciplinary team approach offers a more accurate portrayal of
overall patient care outcomes across interdependent functions. Thus, we
would eliminate requirements that encourage ``stovepipe''
administrative and enforcement structures.
Stress quality improvements, incorporating to the greatest
possible extent an outcome-oriented, data-driven quality assessment and
performance improvement program. Thus, the new COPs would invest our
principal expectations for performance in a powerful requirement that
each HHA participate in its own quality assessment and performance
improvement program.
Facilitate flexibility in how an HHA meets our performance
expectations, and eliminate outdated process requirements about which
there was little consensus or evidence that they were predictive of
good outcomes for patients or necessary to prevent harmful outcomes for
patients.
Require that patient rights are assured.
Finally, in order for the HHA conditions to move from a process/
structure orientation toward an outcome orientation, outcome measures
must be identified, developed, and validated. As discussed below, we
have already taken several steps toward the development and
implementation of a core standard assessment data set that will
ultimately provide home health consumers, providers, and the regulators
the data they need to improve quality and focus enforcement, as
detailed elsewhere in today's issue of the Federal Register.
Based on these principles, we are proposing new HHA conditions of
participation that revise or eliminate many existing requirements and
incorporate critical requirements into four ``core conditions.'' These
four COPs--Patient Rights, Patient Assessment, Care Planning and
Coordination of Services, and Quality Assessment and Performance
Improvement--would focus both provider and surveyor efforts on the
actual care delivered to the patient, the performance of the HHA as an
organization, and the impact of the treatment furnished by the HHA on
the health status of its patients. The first, Patient Rights,
emphasizes an HHA's responsibility to respect and promote the rights of
each home health patient. The second proposed core condition, Patient
Assessment, reflects the critical nature of a comprehensive assessment
in determining appropriate treatments and accomplishing desired health
outcomes. Third, the Care Planning and
[[Page 11008]]
Coordination of Services COP would incorporate the interdisciplinary
team approach to providing home health services. The fourth proposed
core COP, Quality Assessment and Performance Improvement, would then
charge each HHA with responsibility for carrying out a performance
improvement program of its own design to effect continuing improvement
in the quality of care furnished to its customers.
In the revised COPs, we are proposing to include process-oriented
requirements only where we believe they remain highly predictive of
ensuring desired outcomes and the prevention of harmful outcomes (for
example, home health aide competency and supervision and timeliness of
patient assessment). Far more frequently, however, we have eliminated
process details from the existing requirements and instead included the
related area of concern as a component that must be evaluated by the
HHA as part of the HHA's overall quality assessment and performance
improvement responsibilities. For example, we removed the process
requirements under existing Sec. 484.12(c) that an HHA and its staff
must comply with accepted professional standards and principles. We
transformed the approach by incorporating current clinical practice
guidelines and professional standards applicable to home care as a
factor to be considered in the HHA's overall quality assessment and
performance improvement program. The practical effect of this approach
would be to stimulate the HHA to find its own performance problems, fix
them, and continuously strive to improve patient outcomes and
satisfaction, as well as efficiency and economy.
We believe that the proposed COPs based on these principles reflect
a fundamental change in HCFA's regulatory approach, a change that to a
large extent establishes a shared commitment between HCFA and Medicare
providers to achieve improvements in the quality of care furnished to
HHA patients. The proposed COPs invest HHAs with internal
responsibility for improving their performance, rather than relying on
an externally-based approach in which prescriptive Federal requirements
are enforced through the punitive aspects of the survey process. This
change would enable HCFA and the States to use our resources
principally in joining with HHAs in partnerships for improvement. This
change in our regulations to a patient-centered, outcome-oriented
approach will also likely fundamentally change our approach to the
survey process. For example, since the proposed regulation sets a
performance expectation that an HHA constantly improve, it may be
possible to alter significantly, or possibly eliminate altogether, the
current Functional Assessment Instrument (FAI) that surveyors use to
assess the outcomes of care through home visits and some record review.
In an expanded review of the agency's approach to quality assessment
and performance improvement, we may approach this task differently,
with greater flexibility than the current FAI affords. We anticipate
fewer compliance surveys and the reduced need to threaten or take
adverse actions that could jeopardize a HHA's reputation, viability as
a going concern, and participation in the Medicare and Medicaid
programs. Yet these requirements provide the Secretary and State
Medicaid agencies with more than adequate regulatory basis for
compelling improved performance or termination of participation based
on failure to correct seriously deficient performance that can or does
threaten the health and safety of patients, or seriously impairs the
HHA's capacity to provide needed care and services to patients.
We recognize that the successful implementation of these proposed
regulations will depend largely on how effectively State and Federal
surveyors are able to learn, use, and internalize this patient-
centered, outcome-oriented approach and incorporate it into the survey
process. The approach embodied in these regulations, is consistent with
the approach that we have taken in survey and certification, beginning
as early as 1985 (in intermediate care facilities for the mentally
retarded) and 1986 (in nursing homes). In concert with the States, we
have trained surveyors to develop information from the survey process
that leads to conclusions about how the provider's performance has
impacted--positively and negatively--on patients, especially in terms
of the care and services that patients actually experience. For
example, for many years, in nursing homes surveyors have been trained
to interview residents and family members, seeking information that
contributes to their assessment of how the nursing home's performance
is experienced by the residents and their families. Before the use of
outcome oriented surveys, surveyors focused on record reviews and
observing care processes and organizational structures.
These proposed regulations contain two critical improvements that
support and extend our focus on patient-centered, outcome-oriented
surveys. First, the proposed regulations are designed to enable
surveyors to focus explicitly on assessing outcomes of care, because
the regulations would specify that each individual receiving the care,
his or her assessed needs demonstrate is necessary (rather than
focusing simply on the services and processes that must be in place).
Second, the addition of a strong quality assessment and performance
improvement requirement not only stimulates the provider to
continuously monitor its performance and find opportunities for
improvement, it also affords the surveyor the ability to assess how
effectively the provider has been pursuing a continuous quality
improvement agenda. All of the changes are directed toward improving
outcomes of care.
We have already begun the process of identifying the tasks
necessary to train surveyors and their supervisors and managers
effectively in this refined, expanded approach. In addition, HCFA is
implementing a new State survey agency quality improvement program that
is designed to help State survey agencies increase their focus on
improvement strategies in the survey and certification process. As more
sources of performance data and other performance information become
available, we will work with State survey agencies to determine how to
use the data effectively to target scarce survey resources and to
identify and implement opportunities for improvement (such as reduction
in pressure sores or improvements in medication management in home care
patients).
We believe that the proposed COPs would decrease the regulatory
burden on HHAs and provide them with greatly enhanced flexibility. At
the same time, the proposed requirement for a program of continuous
quality assessment and performance improvement would increase
performance expectations for HHAs in terms of achieving needed and
desired outcomes for patients and increasing patient satisfaction with
services provided.
We recognize that there are those who fundamentally believe that
regulations, particularly when they directly affect the health and
safety of people, should be prescriptive in their detail in order to
ensure that providers do not engage in practices that threaten patient
health and safety or to increase the clarity of intent, just as there
are those who support strongly our change in approach. We invite
comment on this fundamental shift in our regulatory approach and any
other concerns HHAS may have regarding their ability both operationally
and financially to undertake this new approach. We are
[[Page 11009]]
especially interested in comments that address how HCFA could improve
this approach, what additional flexibility could be provided, what (if
any) process requirements that are critical to patient care and safety
should be added, and how well HCFA's investment in the HHA's
participation in a strong continuous quality assessment and performance
improvement program of their own design will achieve our stated and
intended goal of improving the efficiency, effectiveness, and quality
of patient outcomes and satisfaction.
D. Incorporation of a Core Standard Assessment Data Set into the HHA
Conditions of Participation
Elsewhere in today's issue of the Federal Register, we are
proposing to require HHAs to incorporate a core standard assessment
data set, the Outcomes and Assessment Information Set (OASIS), into the
comprehensive assessment process and the quality assessment and
performance improvement programs. The incorporation of OASIS represents
the first step toward implementing HCFA's plans to use outcome-based
quality measures in home health services.
The details of how the OASIS was developed and tested, as well as
how it can be used are explained in the OASIS proposed rule, along with
the specific proposed regulatory language intended to achieve the
stated purpose of introducing the OASIS into the HHA program.
III. Provisions of the Proposed Regulations
A. Overview
Under our proposal, the HHA conditions of participation would
continue to be set forth in regulations under 42 CFR part 484. However,
since many of the existing requirements in part 484 would be revised,
consolidated with other requirements, or eliminated, we are proposing a
complete overhaul of the existing organizational scheme. The most
significant change would be our proposal to group together all COPs
directly related to patient care and place them near the beginning of
part 484. COPs concerning the organization and administration of an HHA
would follow in a separate subpart. We believe this organization is in
keeping with the patient-centered orientation of these regulations and
helps illustrate our view that patient assessment, care planning, and
quality assessment and improvement efforts are central to the delivery
of high quality care.
The proposed organizational format for part 484 is as follows:
PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES
Subpart A--General Provisions
Sec.
484.1 Basis and Scope
484.2 Definitions
Subpart B--Patient Care
484.50 Condition of Participation: Patient Rights
484.55 Condition of Participation: Comprehensive Assessment of
Patients
484.60 Condition of Participation: Care Planning and Coordination
of Services
484.65 Condition of Participation: Quality Assessment and
Performance Improvement
484.70 Condition of Participation: Skilled Professional Services
484.75 Condition of Participation: Home Health Aide Services
Subpart C--Organizational Environment
484.100 Condition of Participation: Compliance with Federal, State,
and Local Laws
484.105 Condition of Participation: Organization and Administration
of Services
484.110 Condition of Participation: Clinical Records
484.115 Personnel Qualifications for Skilled Professionals
B. Proposed Subpart A, General Provisions
Like the existing COPs, the revised conditions would begin with a
brief section (proposed Sec. 484.1) that would specify the statutory
authority for the ensuing regulations. The only change proposed in this
section would be the elimination of the reference to the statutory
authority for an HHA's institutional planning responsibilities
(existing Sec. 484.1(a)(2)). This change reflects our proposal to
eliminate from the HHA COPs a restatement of the statutory requirements
at section 1861(z) of the Act concerning institutional planning. See
section III.D of this proposed rule for a further discussion of this
issue.
Under proposed Sec. 484.2, we would set forth definitions for terms
used in the HHA COPs that we believe need clarification. We are
proposing to eliminate existing definitions for several terms for which
we believe meaning is self-evident, such as ``HHA,'' ``nonprofit
agency,'' or ``bylaws,'' as well as for terms that would not be
included in the revised COPs. We are proposing to delete the current
definitions for ``subdivision'' and ``subunit'' because the terms draw
distinctions for participation and payment for which there are no
differences. We are proposing to delete the current definitions for
``clinical note,'' and ``progress note,'' and ``summary report''
because the terms are commonly accepted as documentation requirements
reflecting good medical practice to assess the individual's reaction or
response to services furnished. We believe that the focus should be on
documentation of the actual care provided to the individual via the
interdisciplinary team within the comprehensive assessment, plan of
care, and clinical record rather than the term used to describe the
entry. We are deleting the definition for supervision from this section
and incorporating the concept under the proposed skilled professional
services COP. We are soliciting comments on the feasibility of a
consolidated definition section in the Code of Federal Regulations
(CFR) for definitions that are applied consistently throughout the
Medicare program.
The definitions that would be included under proposed Sec. 484.2
are as follows:
Branch means a location or site from which a home health agency
provides services within a portion of the total geographic area served
by the parent agency. The branch office is part of the home health
agency and is located sufficiently close to share administration,
supervision, and services in a manner that renders it unnecessary for
the branch independently to meet the conditions of participation as a
home health agency.
Parent HHA means the agency that develops and maintains
administrative control of branches.
Quality indicator means a specific, valid, and reliable measure of
access, care outcomes, or satisfaction, or a measure of a process of
care that has been empirically shown to be predictive of access, care
outcomes, or satisfaction.
With the exception of ``quality indicator,'' all of these terms are
defined in the same way as in existing Sec. 484.2. We are adding a
definition for the term ``quality indicator'' because, as discussed
above, the use of quality indicators is central to an HHA's successful
implementation of a quality assessment and performance improvement
program.
We note that we would not retain the provisions of existing
Sec. 484.4, Personnel qualifications, under proposed subpart A, General
Provisions. As discussed in detail in section III.D of this preamble,
we are proposing major modifications to the prescriptive personnel
qualification requirements now in place. Remaining requirements would
be set forth under proposed Sec. 484.115.
C. Proposed Subpart B, Patient Care
[[Page 11010]]
1. Patient Rights (Proposed Sec. 484.50)
Section 1891(a)(1) of the Act establishes as a Medicare COP that an
HHA must protect and promote the rights of each individual under its
care. These rights encompass being informed in advance regarding the
care to be provided and having an opportunity to participate in care
planning; voicing grievances; confidentiality of records; respect for
property; being informed about specific coverage and noncoverage of
services; and availability of information in writing and through a home
health services hotline. These statutory provisions are incorporated in
existing regulations at Sec. 484.10.
We would retain these statutory provisions in the proposed
regulations and redesignate existing Sec. 484.10 as proposed
Sec. 484.50, the first core COP, and also the first COP in proposed
Subpart B, Patient Care. We are proposing one substantive change to the
patient rights provisions. Specifically, we would expand the standard
under existing paragraph (c)(l) relating to informing the patient in
advance regarding care and treatment to be provided by the home health
agency. We propose to specify that the patient must also be informed
about ``expected outcomes'' of treatment and ``barriers'' to treatment.
We believe that these revisions represent an additional safeguard of
patient health and safety. Open communication between HHA staff and the
patient and access of the patient to treatment information are vital
tools for enhancing the patient's participation in his or her
coordinated care planning. In addition, there are many environmental
factors (for example, lack of nutrition and lack of family and
emotional support) that are barriers that could impact the
effectiveness of treatment decisions.
2. The Cycle of Care: Assessment, Planning, and Delivery
The patient care assessment, planning, and treatment process that
is embodied in the next three COPs can be seen as a cycle. Through the
use of a comprehensive assessment, accurate and timely patient
information is made available for use in the patient treatment process.
The treatment process is the actual interdisciplinary care furnished to
the patient. The patient treatment process results in an effect on the
patient's condition, whether it is positive, negative, or neutral. An
HHA's assessment of the effect of treatment then enters into subsequent
treatment decisions, and the cycle of comprehensive assessment
continues. Through this cycle, accurate patient information yielded
from each comprehensive assessment will result in more effective and
appropriate treatment decisions, thus generating a positive effect on
treatment decisions and yielding desired outcomes.
a. Comprehensive Assessment of Patients (Proposed Sec. 484.55)
Introduction The proposed Comprehensive Assessment of Patients COP
reflects the patient-centered, interdisciplinary approach of the
proposed COPs and underscores our view that systematic patient
assessment is essential to improving quality of care and patient
outcomes.
Patient assessment contributes to quality of care improvements in
three closely linked stages. First, the information generated from an
interdisciplinary, comprehensive assessment of each patient is a vital
tool for developing a patient's care plan and making individual
treatment decisions. An HHA would then track the patient's progress
towards achieving the desired care outcome and make appropriate changes
to the patient's plan of care and treatment. As an HHA carries out this
process on a repeated basis, the second contribution of patient
assessment becomes clear. That is, the HHA is able to evaluate the
results of its treatment decisions on an aggregate basis. Thirdly,
accurate patient information yielded from the comprehensive assessment
process would inform the HHA's future care planning process, generating
continuing improvements in an HHA's treatment decisions and ability to
produce desired patient outcomes. We believe that these internal
quality improvement strategies reflect contemporary standard practice
for many HHAs, and we are proposing to revise the COPs to support this
outcome-oriented approach.
These first two uses for comprehensive patient assessment data
basically involve short-term strategies that can be implemented by
individual HHAs. In this proposed rule, however, we are also laying the
foundation for a long-term strategy in which HCFA would use assessment
information from many HHAs to define and measure care outcomes for home
health care users. As discussed above, these quality indicators could
then be built into a national data system for use by HHAs to improve
the quality of care they provide and by HCFA to monitor patient
outcomes.
Proposed Patient Assessment Requirements
The primary requirement under the proposed COP would be 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 the assessment an individual's homebound
status. An individual's homebound status is a critical eligibility
requirement. This requirement would promote program integrity because
it is the first regulatory requirement that directly evaluates
homebound status.
Under our proposal, each HHA would have the responsibility and the
flexibility to determine the content and process of its own patient
assessment, within the broad requirement that it identifies the
patient's care and discharge planning needs. The intent of requiring
patient-specific comprehensive assessments is to avoid the use of
``canned'' patient assessments that do not reflect the individual needs
of each patient. The comprehensive assessment must fully reflect each
individual patient situation.
We are also proposing to require that the assessment must
incorporate the use of a core standard assessment data set that is
established by HCFA as a regulatory requirement under the comprehensive
assessment condition elsewhere in this issue of the Federal Register.
The data set includes only information necessary to measure outcomes of
care for quality indicators; thus, 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. That is, the incorporation of the core standard
assessment data set will complement the HHA's current approach to
comprehensive assessment.
The existing COPs contain several requirements that address the
need for patient assessment, including most notably a long and detailed
list of items under existing Sec. 484.18(a) that are required to be
covered in a plan of care, such as pertinent diagnoses, mental status,
and functional limitations. In place of this requirement, we would
emphasize the importance of the comprehensive assessment by
establishing patient assessment as a separate COP, specifying the
desired outcome of the assessment (that is, the identification of a
patient's care needs), and then allowing HHAs the flexibility to
determine how best to achieve this outcome. We believe that this
approach is consistent with current accepted practices in HHAs and that
most HHAs
[[Page 11011]]
now perform a comprehensive assessment for most of their patients.
The first standard under the proposed comprehensive assessment COP
concerns drug regimen review (proposed Sec. 484.55(a)). Under this
standard, we would retain the existing requirement of a drug regimen
review from Sec. 484.18(c), but would 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.
The second proposed standard sets forth the requirements for the
initial assessment visit. Specifically, at proposed Sec. 484.55(b), we
propose that a registered nurse must 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 or
within 48 hours after the patient's return home, or within 48 hours of
the physician-ordered start of care date, if that is later. If
rehabilitation therapy services are the only services ordered by the
physician, the initial assessment would be made by the appropriate
rehabilitation skilled professional. We welcome comments on the
appropriateness of using competent individuals other than a registered
nurse or appropriate therapist to perform initial patient assessments.
We also invite comments on the feasibility of permitting the delegation
of nursing responsibilities within the scope of State nurse practice
acts to competent individuals.
The third standard (proposed Sec. 484.55(c)) would specify the
timeframe in which the HHA must complete the comprehensive assessment.
We propose 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.
The fourth standard (proposed Sec. 484.55(d)) concerns updates of
the comprehensive assessment. We would provide that the comprehensive
assessment must discuss the patient's progress toward clinical outcomes
and be updated and revised as frequently as the patient requires, but
no less frequently than every 62 days from the start of care date,
which is when the patient's plan of care is revised for physician
review and when the patient is discharged.
These proposed standards essentially would replace the requirements
concerning the duties of the registered nurse under the existing
skilled nursing services COP (Sec. 484.30(a)). Currently, a registered
nurse must regularly reevaluate the patient's nursing needs, initiate
the plan of care and necessary revisions, prepare clinical and progress
notes, coordinate services, and inform the physician and other
personnel of changes in the patient's condition and needs. The existing
requirement emphasizes the patient information process. In contrast,
the proposed comprehensive assessment COP would focus on ensuring that
all critical information concerning a patient is routinely incorporated
through timely assessments that identify a patient's initial and
changing needs.
Under proposed Sec. 484.55 (b) and (c), we are proposing 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
being referred to a home health agency for initiation of services is at
a point of immediate and serious need, especially as patients are
returned home from hospital care sooner than ever before. Likewise, as
the complexity of the care needs of patients increases, so does the
need for comprehensive assessment of the patient, and the importance of
implementing an effective care plan promptly becomes paramount.
We believe that these requirements pose little or no burden for the
well-managed home health agency since they would in all likelihood be
performed in the absence of regulations. However, the proposed
timeframes serve as a strong performance expectation for HHAs that may
not have adequate resources (financial and human resources) by setting
the outside acceptable time for these activities to occur. If too many
patient referrals occur together, some patients might be neglected or
harmed by the HHA's inability to see the patient quickly or to conduct
and complete the needed comprehensive assessment so effective service
delivery can begin. Thus, if an HHA recognizes that its workload is
such that it is not capable of beginning work with a patient virtually
immediately upon referral, the patient should not be accepted for care.
Under proposed Sec. 484.55(d), we are proposing that the
comprehensive assessment be updated as frequently as the patients
condition requires but not less frequently than every 62 days, for
several reasons:
(1) Especially in the early stages of care, patient needs,
progress, and circumstances can change greatly, and changes in the
status of the patient can and should prompt changes in approaches to
care, so reassessment as needed helps to inform the revision of the
care plan and service delivery;
(2) When HCFA and the home health community are prepared to begin
collecting and utilizing quality indicator data (which will come from
the core standard assessment data set), it will be necessary for the
HHA to report the data on a regular basis. The developers of the core
standard assessment data set have found the roughly 2-month timeframe
to be an effective interval for data points for comparison purposes,
which also coincides well with the recertification timeframe in item
(3) below; and
(3) An HHA is required to have the patient recertified for
continued care every 62 days, which serves as a logical point for
updating an assessment if no updates have already been completed.
We welcome comments on whether the specific proposed timeframes in
the regulation text are reasonable and consistent with current medical
practice, and whether the timeframes should be used as benchmarks to
reflect patient health and safety concerns involving the timeliness of
the assessment components.
3. Care Planning and Coordination of Services (Proposed Section 484.60)
Currently, the condition of participation concerning the plan of
care is set forth at Sec. 484.18. We propose to revise the contents of
this section, and place them in a new condition, ``Care planning and
coordination of services'' (proposed Sec. 484.60). This condition would
contain four standards that reflect the interdisciplinary approach to
home health care delivery. The standards are discussed in detail below.
This proposed COP would first state the fundamental requirement
that the patient's plan of care must specify the care and services
necessary to meet the patient's specific needs as identified by the
physician and in the comprehensive assessment, and the measurable
clinical outcomes that the HHA expects will occur as a result of
implementing the plan of care. Again, a clinical outcome can be defined
as a change in an individual's health between two or more points in
time. We would retain the existing requirement that patients are
accepted for treatment on the basis of a
[[Page 11012]]
reasonable expectation that the patient's medical, nursing, and social
needs can be met adequately by the agency in the patient's place of
residence.
In accordance with our goal of eliminating prescriptive
requirements that do not directly relate to patient care, we have
simplified the plan of care standard at existing Sec. 484.18(a). The
first standard under this condition, ``Plan of Care,'' set forth at
proposed Sec. 484.60(a), would require that all home health services
must follow a written plan of care established and periodically
reviewed by a doctor of medicine, osteopathy, or podiatric medicine in
accordance with Sec. 409.42. We would specify that all patient care
orders must be included in the plan of care. We believe that our
proposal would decrease the burden on HHAs and would allow agency staff
to develop care plans that best suit the needs of the patients they
serve.
Under the second proposed standard, ``Review and revision of the
plan of care'', we would add to the language at existing
Sec. 484.18(b). The current requirement that the physician and the HHA
review the plan of care as frequently as the patient's condition
requires but not less than once every 62 days would be retained, with
the additional clarification that this period begins with the date of
start of care. We would continue to require that the HHA promptly alert
the physician to any changes in the patient's condition that suggest a
need to alter the plan of care. We would also extend the current
requirement to specify that the HHA must promptly alert the physician
if measurable outcomes are not being achieved. If measurable outcomes
are not being achieved, the HHA must review, assess, and document the
patient's responses to his or her current medical and environmental
situation (including barriers to care), and implement a physician's
revised plan of care as often as necessary to meet the patient's needs.
At a minimum, revised plans of care should be established and
implemented when a patient experiences significant changes in his or
her medical condition or functional capacity. An example of an
environmental situation that would be considered a barrier to care
would be a patient who was not receiving proper nutrition. In such a
case, the agency staff would document the situation and revise the plan
of care accordingly. We believe that these requirements would reflect
our outcome-oriented approach to patient care in that they would
require the HHA to focus on the patient's responses to treatment
decisions. Additionally, these requirements would not impose a burden
on HHAs since agencies are already required to complete a plan of care
for each patient. These requirements would be set forth at proposed
Sec. 484.60(b)(1). We are soliciting comments on the need for frequent
regular physician reviews of plans of care for patients who are only
receiving personal care services.
Under Sec. 484.60(b)(2), we propose to require that a revised plan
of care must include current information from the patient's
comprehensive assessment and information concerning the patient's
progress toward outcomes specified in the plan of care. We are
soliciting comments on the utility of adding an additional requirement
that would require the original plan of care that initiates care to be
reviewed and revised in a timely manner consistent with the patient's
immediate needs, but no later than 5 to 10 working days after the
completion of the comprehensive assessment. This would ensure that the
plan of care would be revised to reflect the incorporation of the
completed comprehensive assessment, which must be completed in a timely
manner consistent with the patient's immediate needs, but no later than
5 working days after the start of care. This additional requirement
would ensure the link between the completed comprehensive assessment
and a revised plan of care.
In the third standard, ``Conformance with physician orders'', we
would retain language at existing Sec. 484.18(c). In December 1994, we
revised this standard to require that oral orders be put in writing and
signed and dated with the date of receipt by the registered nurse or
qualified therapist responsible for furnishing or supervising the
ordered services (59 FR 65482). We also provided that oral 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.
We would include these standards in the Care planning and coordination
of services condition under proposed Sec. 484.60(c).
We propose to add a new standard, Coordination of care, at
Sec. 484.60(d). This standard would incorporate provisions at existing
Sec. 484.14(g) (Organization, services, and administration, Standard:
Coordination of patient services), which requires that all personnel
furnishing services maintain liaison to ensure that their efforts are
coordinated effectively and support the plan of care, and that the HHA
must document such liaison. Our proposed standard would go beyond this
requirement by linking the level of the coordination of services,
caregivers and the patient to identifiable care need and barriers to
care and by requiring HHAs to adjust the degree of coordination to meet
the needs of the patient. Specifically, we would require the HHA to
maintain a system of communication and integration of services, whether
provided directly or under arrangement, that ensures the identification
of patient needs and barriers to care, the ongoing liaison between all
disciplines providing care, and the contact of the physician for
relevant medical issues. Additionally, we would require the HHA to
identify the level of coordination necessary to deliver care to the
patient and involve the patient and the caregiver in the coordination
of care.
We believe that this standard is appropriate for a number of
reasons. Since a home care patient may encounter many services
delivered at different times by a variety of individuals with different
skills, efficient communication and integration among members of the
home health team is essential in responding to patient needs in a
timely and effective manner. Further, effective coordination of
services is necessary to avoid duplicative or conflicting services.
Finally, we recognize that an interdisciplinary approach to the
delivery of home health services reflects actual practice for most home
health agencies, and we believe that, when possible, our regulations
should coincide with current industry practice.
4. Quality Assessment and Performance Improvement (Proposed Section
484.65)
We are proposing to eliminate two conditions of participation,
existing Sec. 484.52, Evaluation of the agency's program, and existing
Sec. 484.16, Group of professional personnel, and replace them with a
single, new quality assessment and performance improvement condition of
participation. Existing regulations for HHAs do not provide for the
operation of a quality assessment and performance improvement program
whereby the HHA examines its methods and practices of providing care,
identifies opportunities to improve its performance, and then takes
actions that result in better outcomes of care and satisfaction for the
HHA's patients. In light of our intention to raise the performance
expectations for HHAs seeking entrance into the Medicare program as
well as those currently participating, HCFA is proposing that each HHA
develop, implement, and maintain an effective, data-driven quality
assessment and performance improvement program. We believe this
[[Page 11013]]
requirement would stimulate an HHA to continuously monitor and improve
its own performance and to be responsive to the needs, desires, and
satisfaction of its patients. This proposed new requirement epitomizes
the approach of these new COPs in that it provides a constant
expectation for improved performance, in contrast to the current
approach that only sets a floor of structural and procedural
requirements that are intended to be surrogate measures for ensuring
quality. This condition is intended to set up a self-sustaining system
for improvement, under which an HHA monitors its performance to a point
that surveyor findings would confirm an HHA's own assessment of where
performance improvements are needed.
We have not prescribed the structures and methods for implementing
this requirement, and have focused the condition of participation on
the expected results of the program, that is, quality indicators and
other outcome-oriented measures. This provides flexibility to the HHA,
as it is free to develop a creative program that meets the HHA's needs
and reflects the scope of its services.
Currently, the first COP that addresses quality of care (existing
Sec. 484.52, Evaluation of the agency's performance), provides for the
evaluation of the agency's total program at least once a year. The
agency must have written policies requiring the evaluation, the
evaluation must include a review of the HHA's policies and
administrative practices, and the results of the evaluation must be
separately recorded and maintained as administrative records. The
agency must also review a sample of open and closed clinical records at
least on a quarterly basis. The second condition of participation that
addresses quality of care (existing Sec. 484.16, Group of professional
personnel), requires a group of professional personnel, which includes
at least one physician and one registered nurse, to establish and
annually review the agency's policies governing the scope of services
offered, admission and discharge policies, medical supervision of plans
of care, clinical records, personnel qualifications and program
evaluation. This group is required to meet frequently to advise the
agency on professional issues, to participate in the evaluation of the
agency's program and assist in liaison functions. Minutes of the
group's meetings must be documented. These requirements focus on the
meetings and documentation of the agency's evaluation of their quality
of care and do not account for the outcome of these activities.
Instead of continuing to prescribe the structures and processes by
which an HHA evaluates its services, we have identified the outcomes
expected of an agency that assesses its performance and improves the
services that it provides to beneficiaries and set forth under proposed
Sec. 484.65 the required major components of an effective quality
assessment and performance improvement program. Our expectation is that
the HHA will successfully operate a continuous quality assessment and
performance improvement program on behalf of its beneficiaries. We
believe this is a reasonable expectation, for which the HHA can and
should be held accountable.
Previously, the only motivation for quality improvement for some
HHAs was the adverse effect of having been found by surveyors to be out
of compliance with one or more conditions of participation and
threatened with termination from the Medicare program. With an
effective quality assessment and performance improvement program, the
HHA can identify and reinforce the activities that it is doing well and
seek out and respond to opportunities for improvement on a continuous
basis. The desired outcome of this proposed requirement is that the HHA
itself, rather than the survey process, will be the driving force for
continuous improvements, enabling HCFA to focus its resources on
supporting that effort and on HHAs that fail to meet the requirements,
even after efforts have been made to improve performance.
The proposed condition requires the HHA to develop, implement, and
evaluate an effective, data-driven quality assessment and performance
improvement program. The program must reflect the complexity of HHA's
organization and services (including those provided directly or under
arrangement). The HHA must take actions that result in improvements in
the HHA's performance across the spectrum of care.
The first standard at proposed Sec. 484.65(a) requires that an
HHA's quality assessment and performance improvement program must
include, but not be limited to, the use of objective measures to
demonstrate improved performance with regard to:
(1) Quality indicator data (derived from patient assessments) to
determine if individual and aggregate measurable outcomes are achieved
compared to a specified previous time period. The terms ``quality
indicators,'' ``performance measures,'' and ``outcome measures'' are
often used interchangeably, though technically, they vary somewhat in
meaning. Regardless, they all refer to attributes of care and
satisfaction that can be used to gauge quality of care in specific
aspects of care. For example, the degree and rate of improvement in a
functional area (such as the ability to walk after a hip replacement)
can be shown to be a quality indicator. The method of defining and
measuring that improvement is the ``performance measure'' or ``outcome
measure.'' These measures assign a specific value to the care dimension
being measured. The appropriateness of the combination of services
reflected on the plan of care, the effectiveness of the communication
among the interdisciplinary team, or the competency of the mix of
professionals used on the team to implement the services could all be
possible indicators of the outcome-oriented performance expectations
that should stimulate ongoing quality improvement in home health care
delivery.
Some measures, though, are of processes of care that are predictive
of outcomes of care. These process measures quantify one or more
dimensions of the manner in which care is actually provided or
administered (or negatively, is not provided or administered). A
process measure such as the number of times a service is provided may
be directly related to the rate of improvement (or lack of improvement)
of the patient. So, a valid and reliable process measure can be shown
to be predictive of patient outcomes, therefore, a quality indicator.
The core standard assessment data set, described in detail
elsewhere in today's issue of the Federal Register, contains tested and
validated indices of functional status over time and satisfaction of
patients that have been shown to reflect quality of care. Once we have
completed the rulemaking necessary to implement the use of this data
set, each HHA will collect and evaluate these standard data as a part
of providing care and managing the quality assessment and improvement
program, but will not be required to report it. This information will
help the HHA to improve its services and the outcomes and satisfaction
that patients experience. Later, when we subsequently implement the
requirement to begin reporting the quality indicator data, the HHA will
be able to receive the aggregated and analyzed data from the universe
of HHAs to compare its performance with others.
(2) Current clinical practice guidelines and professional practice
standards applicable to home care. Contemporary care practices in an
increasingly complex and fragmented
[[Page 11014]]
health care environment are rapidly changing. Home care is now provided
routinely to very ill persons and persons with severe physical,
medical, and other challenges. We expect an HHA to pursue the latest
clinical practice guidelines and professional standards for use in its
quality assessment and performance improvement program. Continuous
improvement is only possible through the identification and use of
continuously improved information, techniques, and practices. Much of
this information also can be used by patients and their families to
enable them to be more independent and play a more effective role in
the home care process. While HCFA is not imposing any specific
standards of practice, this proposed requirement establishes the
expectation that the HHA will seek and utilize the latest standards as
a routine part of its daily business.
(3) Utilization data, as appropriate. HHAs currently collect and
monitor utilization data in order to evaluate their fiscal and
competitive well-being. This information can also be used to evaluate
the quality of care, as HHAs become aware of how their performance
compares with other HHAs. Eventually, we intend that the HHA will use
the utilization data from its own practices to compare with other HHAs
across the nation. The purpose of including utilization data in the
HHA's quality assessment and performance improvement program is to help
the HHA ensure the patient receives only the number of visits that are
necessary to achieve needed and desired outcomes. Utilization data will
also be used as part of HCFA's external quality assurance monitoring,
enabling the agency to target reviews of HHAs whose utilization data
suggest, for example, that patients may be receiving fewer (or more)
visits than necessary to achieve expected outcomes.
(4) Patient satisfaction measures. Beneficiary satisfaction with
home health services is an important element of a quality assessment
and performance improvement program. Under our proposal, an HHA would
develop and implement specific measures on an ongoing basis to
determine from patients and their families whether they are satisfied
with services provided and outcomes achieved and the extent to which
the HHA respected their rights. We expect that an HHA would use this
information to search for opportunities to improve services and patient
satisfaction. We do not intend to prescribe to specific tools for
measuring patient and family's views, but we do intend to ask the HHA
during a survey to demonstrate its patient rights and satisfaction
measurement system and how it is used as part of the overall internal
quality assessment and performance improvement program.
(5) Effectiveness and safety of services (including complex high
technology services, if provided), including competency of clinical
staff, promptness of services, and whether patients are achieving
treatment goals and measurable outcomes. For patients to experience the
needed and desired outcomes that the Medicare home health benefit is
intended to achieve, staff must be able to demonstrate the skills and
competencies necessary to enable patients to achieve needed and desired
outcomes. The HHA is expected to include data-based, criterion-
referenced performance measures of staff skills, to utilize that data
to ensure that staff maintain skills, and to provide training as new
techniques and technologies are introduced and as new staff arrive. We
intend that the HHA would be able to demonstrate that it has a system
of appropriate complexity for keeping track of the skills and
competencies of the staff and that effectively identifies and addresses
training needs. These ``data'' should be an integral part of the HHA's
internal quality assessment and performance improvement program,
providing continuous feedback on staff performance. The physicians and
other staff are in a unique position to provide the HHA's management
with structured feedback on the performance of the HHA and ways in
which the performance can be improved. The physicians and other staff
are customers also, whose needs and contributions to quality
improvements are significant. The HHA's internal quality assessment and
performance improvement program is expected to view staff as full
partners in quality improvement, and we expect the HHA to demonstrate
how physicians and staff contribute to the internal quality improvement
of the HHA. This proposed requirement is linked directly to the
proposed requirement that the HHA include in its quality assessment and
performance improvement program current clinical practice guidelines
and standards of practice.
Thus, we expect that the HHA will immediately correct problems that
are identified through the quality assessment and performance
improvement program that actually or potentially affect the health and
safety of patients. For example, if the quality assessment and
performance improvement program identifies problems with the accuracy
of medication administration, it is not enough for the HHA to consider
this area as a candidate for an improvement program that may or may not
be chosen from a list of potential projects. Rather, since the accuracy
of medication administration is critical to the health and safety of
patients, the HHA must intervene with a correction and improvement
approach immediately.
When we use the word ``measure,'' we mean that the HHA must use
objective means of tracking performance that enable both the HHA and
the survey agency to identify the differences in performance between
two, points in time. For example, a measure that states an HHA is
``doing better'' as a result of an improvement approach would be
unacceptable. There must be identifiable units of measure that any
reasonably knowledgeable person would be able to distinguish as
evidence of change. Not all objective measures must have been shown to
be valid and reliable (that is, subjected to scientific development),
to be useable in improvement approaches, but they must at least
identify a start point and end point stated in objective terms that
actually relate directly to the objectives and expected/desired
outcomes of the improvement program.
Under the second standard at Sec. 484.65(b), we are proposing that
the HHA must take actions that result in performance improvements and
must track performance to assure that improvements are sustained over
time. This requirement links the quality assessment and performance
improvement program to a pattern of actions over time. The focus is on
the pattern of behavior recognized by the HHA and how the HHA used its
own experience to continuously strive for improvements.
The third standard under the Quality Assessment and Performance
Improvement Program at proposed Sec. 484.65(c) states that the HHA must
set priorities for performance improvement, considering prevalence and
severity of identified problems, and giving priority to improvement
activities that affect clinical outcomes. However, any identified
problems that directly or potentially threaten the health and safety of
patients must be corrected immediately. Prioritizing areas of
improvement is essential for the HHA to gain a strategic view of its
operating environment and to ensure the consistent quality of care
provided over time. Overall, an HHA would be expected to give priority
to improvement activities that most affect clinical outcomes.
Conditions that may threaten the health and safety of patients must be
immediately and
[[Page 11015]]
directly addressed when they are identified.
The fourth standard under the Quality Assessment and Performance
Improvement COP, at proposed Sec. 484.65(d), would require the HHA to
participate in periodic, external quality improvement reporting
requirements as may be specified by HCFA. An example of participation
in an external quality improvement activity would be the future
requirement for the HHA to report quality indicator data (as discussed
elsewhere in today's issue of the Federal Register). Participation in
the survey process is another example. A different example might be
that the Secretary, reviewing the quality indicator data (or other
information), decides to embark on a national project to improve the
management of multiple medications from multiple doctors of HHA
patients. This proposal would require the HHA to participate in this
external quality improvement project. Another example might be a
national effort to increase the number of HHA patients who receive flu
shots each year. This proposed requirement is entirely consistent with
HCFA's strategic plan to improve the health status of Medicare and
Medicaid beneficiaries, and many of these projects will reach
beneficiaries well beyond individuals being served under specific
benefit programs such as home health.
Development of the revised COPs is part of the Administration's
reinventing government initiative. The COPs were revised to emphasize a
focus on outcomes of health care rather than process and procedural
requirements. Our revitalized approach reflecting the use of quality
indicators and outcome measures as part of future external quality
improvement reporting requirements as specified by the Secretary stem
from the statutory authority governing the HHA COPs. Section 1891(b) of
the Act states, ``It is the duty and responsibility of the Secretary to
assure that the conditions of participation * * * and the enforcement
of such conditions * * * are adequate to protect the health and safety
of individuals under the care of a home health agency and to promote
the effective and efficient use of public moneys.'' Congress mandated
broad authority to allow the Secretary to keep up with the myriad of
changes in quality health care delivery that reflect the state of the
art. The use of outcome measures is a significant feature of
accreditation for organizations such as the Joint Commission on
Accreditation of Healthcare Organizations' (JCAHO) Agenda for Change
and Community Health Accreditation Program's (CHAP) Benchmarks for
Excellence in Home Care.
The use of quality indicators and outcome measures as part of
external quality improvement reporting requirements stems, in part,
from the statutory requirement that surveys of HHAs employ quality
indicator data. Specifically, section 1891(c)(2)(C)(i)(II) of the Act
states, ``A standard survey conducted under this paragraph with respect
to an HHA shall include (to the extent practicable), for a case-mix
stratified sample of individuals furnished items or services by the
agency * * * a survey of the quality of care and services furnished by
the agency as measured by indicators of medical, nursing, and
rehabilitative care.''
Looking beyond the actual service delivered toward the outcome
resulting from that service allows the HHA the opportunity to
incorporate that information to change patterns of behavior or policies
and continually improve future performance. Although reaching the
desired outcome is beneficial, the revised approach focuses on
continuous change in an HHA's behavior over time. The regulatory
approach to outcome measures is not predicated on punishing those who
do not reach desired outcomes, but on examining how the HHA used its
own experience to change behavior and ultimately improve performance
over time.
Finally, this condition includes a standard about infection control
at proposed Sec. 484.75(e). We expect the HHA to maintain an effective
infection control program as part of its overall quality assessment and
performance improvement program. We recognize that an HHA cannot be
directly responsible for the maintenance of an infection free home
environment, especially since the HHA cannot be physically present in
the home at all times. However, it can be responsible for (1) ensuring
that all staff know and use current best practices themselves to ensure
they are not the source of the spread of infection in the course of
providing home health services, and (2) on educating families and other
caregivers on best practices for the control of the spread of
infections within the home during the course of the family/caregivers''
interactions with the patients. One example of the use of ``current
best practices'' is the universal precaution of the use of gloves when
handling blood or blood products. HCFA is not proposing any specific
approaches to meeting this requirement, but would expect to see clear
evidence that the HHA aggressively seeks to minimize the spread of
infection through the use of infection control techniques by its staff
and through the efforts made to help families and caregivers to
minimize the spread of infection.
5. Skilled Professional Services (Proposed Section 484.70)
Existing regulations at Secs. 484.16, 484.30, 484.32, and 484.36
specify standards that identify detailed tasks that must be performed
by agency staff in the provision of skilled nursing services, therapy
services, and medical social services respectively.
We propose to delete Secs. 484.16, 484.30, 484.32, and 484.36 and
replace them with a more simplified new condition on skilled
professional services. Instead of specifically identifying tasks, we
are broadly describing the expectations of the skilled professionals
who participate in the interdisciplinary team approach to home health
care delivery.
We would specify that skilled professionals who provide services to
HHA patients directly or under arrangement must participate in all
aspects of care, including an ongoing interdisciplinary evaluation and
development of the plan of care, and be actively involved in the HHA's
quality assessment and performance improvement plan. We are reducing
the concentration on process requirements and shifting the focus to
outcomes. The expected outcome is the coordinated, comprehensive,
interdisciplinary delivery of appropriate and effective skilled
professional services delivered and supervised by health care
professionals who practice under State licensure requirements and the
HHA's policies and procedures. Skilled professional services for
purposes of this section include: skilled nursing care, physical
therapy, speech language pathology, occupational therapy (as defined in
Sec. 409.44) and medical social services and home health aide services
(as defined in Sec. 409.45).
At proposed Sec. 484.70(a), we provide that skilled professional
services are authorized, delivered, and supervised (that is, given
authoritative procedural guidance) only by health care professionals
who meet the appropriate qualifications specified under Sec. 484.115
and who practice under the HHA's policies and procedures. We believe
that this approach to supervision provides clarity to the current
definition.
We are proposing to require that an HHA ensure that a majority of
at least 50 percent of the total skilled professional services are
routinely provided directly by the HHA. We are
[[Page 11016]]
proposing to phase in this new approach over 3 years. In the first
year, HHAs would be required to ensure that at least 30 percent of the
skilled professional services are provided directly. In the second
year, HHAs would be required to ensure that at least 40 percent of
skilled professional services are provided directly. By the third year
of enactment, HHAs would be required to ensure that at least 50 percent
of the skilled professional services are provided directly.
We are requesting comments on the use of a standard that would
limit the use of contract care by Medicare certified HHAs. We believe
such limits may be needed as a means of preventing the establishment of
``shell'' HHAs that are merely a fax machine and a nurse used as a
billing system. Further, we believe that this type of standard would
protect against provider fraud and abuse. Mass delegation of care has
led to problems in evaluating the accountability of providers. This is
a program integrity approach that seeks to ensure continuity of care
via the significant use of contractual care in the decentralized
environment of home health delivery.
Medicare makes a distinction between providing services directly,
as opposed to providing services under arrangement. The most common way
services are provided directly is through the use of employees. The
common law definition of ``employee'' fundamentally relates to whether
a person is under control by the entity or individual providing the
services, so by and large producing a W-2 form would constitute
providing the services directly. The ``Stark Provisions'' at section
1877(h)(2) of the Act references the IRS ``employee'' definition.
Section 1877(h)(2) provides that--
An individual is considered to be ``employed by'' or an ``employee
of'' an entity if the individual would be considered to be an employee
of the entity under the usual common law rules applicable in
determining the employer-employee relationship (as applied for purposes
of section 3121(d)(2) of the Internal Revenue Code of 1986).
We are exploring a more concise method of defining the provision of
direct services as opposed to services provided under arrangement.
We believe that the excessive use of contracting could be an
indication that an HHA may be exceeding its patient capacity, leading
to possible instability that can result in disruptions to patient care.
Excessive contracting is also a potential indication that the HHA may
not be exercising full control over quality of care. This performance
safeguard seeks to ensure continuity and quality of care through the
restriction of the significant use of contracted care in home care.
A major home health care association has supported the
establishment of limits on Medicare certified HHAs' use of contracted
care as a way to establish performance expectations for the quality of
care provided. The proposed direct services requirement is an attempt
to address our concerns with the growth in ``shell'' operations and
provider accountability. It is important to note that HHAs currently
report employment data on their cost reports. We welcome comments on
the percentage approach to the proposed direct services standard to
control the excessive use of the contracting of services. We welcome
comments on this shift in our approach and on any concerns HHAs may
have regarding their ability, both operationally and financially, to
undertake this new approach.
6. Home Health Aide Services (Proposed Section 484.75)
Section 1891(a) of the Act requires the Secretary to establish
minimum standards for home health aide training and competency
evaluation programs. Section 1861(m)(4) of the Act requires Medicare
covered home health aide services to be furnished by an individual who
has successfully completed a training and/or competency evaluation
program that meets the requirements established by the Secretary.
Currently, the condition of participation concerning home health
aide services is set forth at Sec. 484.36, (Condition of Participation:
Home health aide services). For the most part, we would retain the
existing requirements although in some cases we have made
organizational or editorial changes in the interest of brevity or
clarity. In addition, we are soliciting comments on some possible
alternatives for future revisions. Under our reorganization scheme,
this condition would be located at proposed Sec. 484.75.
Standard: Home Health Aide Qualifications
Currently, provisions concerning the qualifications for home health
aides are set forth at Sec. 484.4, Personnel Qualifications. As
discussed in detail below, we are proposing substantial revisions to
the personnel qualifications section. In light of our proposed
revisions and our reorganization of part 484, we believe that the
qualifications for home health aides would be more appropriately
located in this section. Thus, at proposed Sec. 484.75(a) we would
provide that a qualified home health aide is an individual who has
successfully completed a State-established or other training program
that meets the requirements of proposed Sec. 484.75(b) and a competency
evaluation program or State licensure program that meets the
requirements of proposed Sec. 484.75(c), or a competency evaluation
program or State licensure program that meets the requirements of
proposed Sec. 484.75(c), or has completed a nurse aide training and/or
competency evaluation program approved by the State as meeting the
requirements of existing Secs. 483.151 through 483.154 and is currently
listed in good standing on the State nurse aide registry. We are
soliciting comments on our proposed change to the home health aide
personnel qualification, which would include the interchangeable
paraprofessional training and/or competency standards for home health
aides and nurse aide requirements at requirements at existing
Secs. 483.151 through 483.154 (part of the Long-Term Care Facilities
Requirements for Participation). The home health aide workforce is
ridden with high turnover rates. We believe that the proposed changes
to the home health aide personnel qualifications yield flexibility to
HHAs in their ability to retain equally competent paraprofessionals
from a wider pool of employment prospects.
Under proposed Sec. 484.75(a)(2), we would retain (with
clarification) the current personnel qualification requirements
governing home health aide employment status during a continuous period
of 24 consecutive months. An individual is not considered to have
completed a training and competency evaluation program or a competency
evaluation program if, since the individual's most recent completion of
this program(s), there has been a continuous period of 24 consecutive
months during none of which the individual furnished services described
in Sec. 409.40 of this chapter for compensation. If an individual has
not furnished services described in Sec. 409.40 for compensation during
a continuous period of 24 consecutive months, then the individual must
complete another training and competency evaluation program or
competency evaluation program as described in paragraph (a)(1) of this
section.
Standard: Home Health Aide Training
We propose to retain the same requirements for content and duration
of training as those under the current requirements at
Sec. 484.36(a)(1). However, we propose more concise language.
[[Page 11017]]
Specifically, at proposed Sec. 484.75(b)(1), we would provide that the
home health aide training must include classroom and supervised
practical training that totals at least 75 hours. A minimum of 16 hours
of classroom training must precede a minimum of 16 hours of supervised
practical training.
Proposed Sec. 484.75(b)(1)(i) would clarify provisions regarding
communication skills currently located at Sec. 484.36(a)(1)(i)
(Standard: Home health aide training-(1) Content and duration of
training). We would provide that communication skills include the
ability to read, write, and make brief and accurate oral and written
presentations to patients, caregivers, and other HHA staff. We propose
to retain current requirements under Sec. 484.36(a)(1) (ii) through
(xii) at proposed Sec. 484.75(b)(1) (ii) through (xii) (Standard:
Content and duration of training). We propose to retain current
Sec. 484.36(a)(1)(xiii) with clarification at proposed
Sec. 484.75(b)(1)(xiii). We propose to modify the current language,
``Any other task that the HHA may choose to have the home health aide
perform'' by adding the following: ``The HHA is responsible for
training the home health aide, as needed, for skills not covered in the
basic checklist.''
At proposed Sec. 484.75(b)(2) and (3), we would essentially retain
the provisions governing conduct of training by organizations and
qualifications of instructors under existing Secs. 484.36(a)(2) (i) and
(ii).
At proposed Sec. 484.75(b)(4), we would essentially retain the
documentation of training requirement under existing Sec. 484.36(a)(3)
to include State approved nurse aide training and competency evaluation
as reflected in the definition of the personnel qualifications for home
health aides.
We propose to separate existing Sec. 484.36(b)(Standard: Competency
evaluation and inservice training) into two separate standards,
Competency Evaluation and Inservice Training. These standards would be
set forth at proposed Sec. 484.75(c) and (d) respectively.
Standard: Competency Evaluation
In order to simplify this standard, at proposed Sec. 484.75(c) we
would combine the current requirements for an HHA's responsibility for
the applicability of the competency evaluation requirements under
existing Sec. 484.36(b)(1) and the limitations on the applicability of
the competency evaluation requirements for personal care attendants
under a State Medicaid Personal Care benefit under existing
Sec. 484.36(e)(2). An individual may furnish home health services on
behalf of an HHA only after that individual has successfully completed
a competency evaluation program as described in this section. We
propose that the HHA must ensure that all individuals who furnish home
health aide services to patients meet the competency evaluation
requirements of this section. The only exception would be for personnel
care aides who exclusively provide personal care services to Medicaid
patients under a State Personal Care benefit.
We propose to combine the requirements for competency evaluation
under existing Sec. 484.36(b)(2) with the subject area requirements
under existing Sec. 484.36(b)(3)(iii). We propose the competency
evaluation must address each of the subjects listed in
Sec. 484.36(a)(1) (ii) through (xiii). Subject areas Sec. 484.36(a)(1)
(iii), (ix), (x), and (xi) must be evaluated by observing the aide's
performance with a patient. The remaining subject areas may be
evaluated through written examination, oral examination or after
observation of the home health aide with a patient. These provisions
would be set forth at proposed Sec. 484.75(c)(2).
At proposed Sec. 484.75(c)(3) we would to retain the current
requirements for the conduct of competency evaluations by organizations
under Sec. 484.36(b)(3)(i). A competency evaluation program may be
offered by any organization except as specified in existing
Sec. 484.36(a)(2)(i).
At proposed Sec. 484.75(c)(4) we would retain the current
requirement at Sec. 484.36(b)(3)(ii) that the competency evaluation
must be performed by a registered nurse. However, we recognize the
interdisciplinary approach to home health care and propose the
requirement that the registered nurse should perform the competency
evaluation in consultation with other skilled professionals, as
appropriate. At proposed Sec. 484.75(c)(5), we would retain the current
requirements for competency determinations under Sec. 484.36(b)(4).
At proposed Sec. 484.75(c)(6), we propose to retain the current
requirements for documentation of competency evaluation currently
located at Sec. 484.36(b)(5). We propose to delete the effective date
requirements under existing Sec. 484.36(b)(6) because they refer to a
timeframe in 1990 and are no longer necessary.
Standard: Inservice Training
At proposed Sec. 484.75(d) we would retain the requirements for the
amount of in-service training located at existing Secs. 484.36(b)(2)
(ii) and (iii). We propose to clarify the 12-month period to address
calendar year and anniversary date issues. We would combine the current
requirements to propose that the home health aide must receive at least
12 hours of inservice training in a 12-month period. During the first
12 months of employment, hours may be prorated based on the date of
hire. The in-service training may occur while the aide is furnishing
care to a patient.
At proposed Sec. 484.75(d)(2) we would revise the current
requirements for the conduct of inservice training by organizations
under Sec. 484.36(b)(3)(i). We would provide that an inservice training
program may be offered by any organization except as specified in
Sec. 484.75(b)(2).
We propose to revise the current requirement for instructors of
inservice training under Sec. 484.36(b)(3)(ii). The current requirement
states that inservice training generally must be supervised by a
registered nurse with specific experience requirements. Thus, at
proposed Sec. 484.75(d)(3), we would provide that the inservice
training must be supervised by a registered nurse. The revised language
does not include the current experience requirements because we believe
it is appropriate to give the HHA flexibility to utilize qualified
professionals to instruct and evaluate aides in an appropriate manner
in order to meet the outcome which is ensuring that the individuals who
furnish home health aide services on its behalf meet the competency
evaluation requirements of this section.
Standard: Home Health Aide Assignments
At proposed Sec. 484.75(e), we would retain the revisions to
existing Sec. 484.36(c), Standard: Assignments and duties of the home
health aide, published in December 1994 (59 FR 65482), with one
additional requirement. Specifically, at proposed Sec. 484.75(e)(3), we
propose to restore the requirement that home health aides must report
changes in the patient's medical, nursing, rehabilitative, and social
needs to the registered nurse or other appropriate skilled professional
and complete appropriate records in compliance with the HHA policies
and procedures. This requirement was inadvertently removed in the
December 1994 final rule. Home health aides may observe changes in
patient needs that are crucial to future treatment decisions and should
be reported to the appropriate professional in order to implement
effective and appropriate changes in care.
Standard: Supervision
At proposed Sec. 484.75(f), we would retain the home health aide
supervision
[[Page 11018]]
requirements under existing Secs. 484.36(d) (1), (2), (3), and (4).
We have concerns about whether quality supervision can be done
without the requirement of an aide's presence performing a direct
patient service. We have discussed several alternatives, including a
requirement that the registered nurse or appropriate skilled
professional must make an onsite visit to the patient's home while the
home health aide is providing patient care no less frequently than
every 30 days. We welcome comments on changing the current indirect
supervision requirement and will address the issue in the final rule.
We are also soliciting comments on the idea of focusing aide
supervision on individual aides rather than each patient. The purpose
of the supervisory visit is to determine if services are being
provided, to assess relationships with the patient, competency with
tasks, and evaluation of the employee's contribution to the
organization's goals to provide high quality care.
Generally, assessing patient needs, developing a plan of care, care
coordination, and other skilled visits are performed at a frequency
that generally exceeds a biweekly aide supervision schedule. These
visits traditionally encompass supervision functions by the nature of
being home and ascertaining whether the patient's needs are being met.
Therefore, the current supervisory requirements may not add the quality
measure of care and may duplicate functions that are inherently
provided by the interdisciplinary team. Aides who have performed well
and have satisfactory ratings may not need to be supervised as often as
new or unsatisfactory rated aides. Centering the supervisory visits on
an individual aide rather than on a patient would allow aides to be
included in the HHA's human resource management policies that apply to
all staff within the organization, and encourage the employer-employee
relationship to reflect quality of patient care.
We welcome comments on the following draft standard and will
address the issues in the final rule:
Standard: Paraprofessional Supervision
(1) If the patient receives skilled care and paraprofessional
services, or paraprofessional services without skilled care, the HHA
must not only ensure that the aide is competent to perform the
necessary skills (see competency evaluation), but also evaluate the
aide's ability to perform such functions on a continual basis.
Supervision must be provided by the appropriate professional to ensure
the health and safety of the patient, especially when specialized tasks
and delegated functions have been added to the competency subjects.
(2) The frequency of routine supervision is established by the
HHA's policies which promote high quality patient care through the
employment evaluation processes. These evaluation tools should begin at
the time of employment and are evaluated thereafter on a regular
employment basis, allowing for variations to accommodate time in
service with the hiring HHA and the employees' recorded evaluation
ratings with that HHA. Employment status should be calculated by the
most appropriate method for the organization to ensure regular
evaluations. HHAs who arrange for aide services through a non-Medicare
certified HHA must ensure equivalent supervision requirements in the
arrangement contract with the primary HHA responsible for compliance
with these requirements.
(3) The evaluation process includes, but is not limited to,
measuring the aide's continual ability to perform routine tasks,
specialized tasks, reporting problems to the HHA with care plan tasks,
recognizing and reporting barriers to the anticipated outcomes, and
patient satisfaction issues.
(4) Nonroutine supervision is also essential to monitor the need
for paraprofessional care plan revisions. For example, HHAs could
perform spot home visits (direct or indirect observation), telephone
interviews, and other mechanisms to ensure protection of the health and
safety of the patient and respect for patient's privacy and property.
Nonroutine supervisory techniques provide a forum for open and frequent
communication to obtain essential and timely feedback. Feedback can
also be obtained from other care providers (formal and informal),
significant family, and others deemed necessary to properly evaluate
the paraprofessional.
(5) In accordance with HHA policies, the aide should also provide
feedback on his or her employment environment and the evaluation
processes.
Additionally, we welcome comments on the efficacy of using
competent individuals other than a registered nurse to perform
training, competency evaluation, and assignment or supervision
functions for home health aides.
Standard: Medicaid Personal Care Aide Services--Medicaid Personal Care
Benefit
At proposed Sec. 484.75(g) we would retain the current requirements
under Sec. 484.36(e) (1) and (2). A Medicare certified HHA that
provides personal care aide services to Medicaid patients under a State
Medicaid Personal Care Benefit must determine and ensure the competency
of individuals who perform those Medicaid approved services.
Alternatives for Future Revisions
Home care patients are a vulnerable and confined population. It is
necessary to ensure the provision of safe quality care to patients in
their homes. We are proposing one specific measure in this proposed
rule--a criminal background check of home health aides as a condition
of employment (Sec. 484.75(h)). In addition, we are considering the
utility of several other process measures that could be included in
this regulation that are predictive of the desired outcome of
delivering safe quality care in the patient's home. One possibility
would be to adopt the language that is currently used in the Conditions
of Participation for Intermediate Care Facilities for the Mentally
Retarded (ICF/MR) at Sec. 483.420, modified to reflect the HHA
environment and population served. The ICF/MR provisions governing
client protections at Secs. 483.420(d)(1)(iii), (2), (3), and (4)
state:
The facility must prohibit the employment of individuals
with a conviction or prior employment history of child or client abuse,
neglect or mistreatment.
The facility must ensure that all allegations of
mistreatment, neglect or abuse, as well as injuries of unknown source,
are reported immediately to the administrator or to other officials in
accordance with State law through established procedures.
The facility must have evidence that all alleged
violations are thoroughly investigated and must prevent further
potential abuse while the investigation is in progress.
The results of all investigations must be reported to the
administrator or designated representative or to other officials in
accordance with State law within 5 working days of the incident and, if
the alleged violation is verified, appropriate corrective action must
be taken.
Proposing criminal background checks as a condition of employment
for home health aides is one vehicle to guard beneficiaries from
abusive practices in the sanctity of their homes.
[[Page 11019]]
We are soliciting comments on the costs and benefits of requiring
criminal background checks for home health aides and the possible
adoption of the additional patient safeguards modified to reflect the
HHA environment.
D. Proposed Subpart C--Organizational Environment
1. Compliance with Federal, State, and Local Laws (Proposed Section
484.100)
Currently, provisions concerning compliance with Federal, State,
and local laws are located at Sec. 484.12, Condition of Participation:
Compliance with Federal, State, and local laws, disclosure of ownership
information and accepted professional standards and principles. We
would retain most of the provisions contained in this condition with
minor changes, which are discussed in detail below. Under our proposed
reorganization scheme, discussed above, this condition would be set
forth at Sec. 484.100.
Under the first standard, compliance with Federal, State, and local
laws and regulations, at proposed Sec. 484.100(a), we would revise the
language at existing Sec. 484.12(a). That is, we would require that the
HHA and its staff must operate and furnish services in compliance with
all Federal, State, and local laws and regulations applicable to home
health agencies. If a State has established licensing requirements for
HHAs, all HHAs must be approved by the State licensing authority as
meeting those requirements whether or not they are required to be
licensed by the State. The Secretary may find an HHA to be out of
compliance with these conditions of participation if the HHA is found
out of compliance with any Federal, State, or local law or regulation
by the appropriate enforcement agency for that law or regulation and
the Secretary determines that the law or regulation affects the HHA's
ability to deliver home health services safely and effectively. When a
facility is actually found out of compliance and is cited by that
agency for a violation, HCFA will exercise discretion in determining
whether that violation should be cited as a violation under these
conditions. Clearly it is not in the interest of patients or providers
to decertify facilities or to require corrective action plans for
certain reasons (for example, a facility's failure to pay its local
property taxes on time or building a fence 3 feet over the property
line). We would not cite an agency whose problem was remedied (for
example, the facility paid its taxes). However, HCFA intends to cite
agencies when their violations of Federal, State, or local laws or
regulations affect the health and safety of patients, the ability of
HHAs to deliver quality services, the rights and well-being of
patients, and/or the management of the agency and its ability to
recruit qualified staff. We welcome comments on this interpretation.
Similarly, in the second standard, Disclosure of ownership and
management information, we propose to retain the requirements at
existing Sec. 484.12(b). We would continue to require that the HHA
comply with the requirements of Secs. 420.200 through 420.206 regarding
disclosure of ownership and control information. Additionally, the
second standard would continue to require that the HHA also disclose
the following information to the State survey agency at the time of the
HHA's initial request for certification, for each survey, and at the
time of any change in ownership or management:
The name and address of all persons with an ownership or
control interest in the HHA as defined in Secs. 420.201, 420.202, and
420.206.
The name and address of each person who is an officer, a
director, an agent, or a managing employee of the HHA as defined in
Secs. 420.201, 420.202, and 420.206.
The name and address of the corporation, association, or
other company that is responsible for the management of the HHA, and
the name and address of the chief executive officer and the chairperson
of the board of directors of that corporation, association, or other
company responsible for the management of the HHA.
Existing Sec. 484.12(c) provides that an HHA must comply with
accepted professional standards and principles. To reflect an emphasis
on the importance of continuity of care and our focus on quality,
regardless of the site of service, we propose to move the current
provisions at Sec. 484.12(c) and incorporate the performance
expectation of the provisions into the quality assessment and
performance improvement program. HCFA has long used the term ``in
accordance with accepted standards of practice'' in its various
provider and supplier requirements both to set a performance
expectation and to serve as an enforcement tool should grossly
divergent practices be identified in the survey process.
We believe that requiring an HHA to participate in a strong,
quality assessment and performance improvement program would stimulate
an aggressive effort to identify and use the best practices available
for all care providers in the HHA. As discussed above, for the HHA to
be successful in its quality assessment and performance improvement
program, it will be obliged to seek out best practices continuously.
HCFA's survey effort can then be devoted to assessing how the HHA has
sought out and adopted best practices in the field as part of the
surveyor's evaluation of the quality assessment and performance
improvement requirements, rather than HCFA prescriptively defining
``accepted professional standards''.
At proposed Sec. 484.100(c), we would provide that the HHA and its
branches must be licensed in accordance with State licensure laws, if
applicable, prior to providing Medicare reimbursed services. This
provision seeks to ensure that HHA patients receive the same level of
quality care from the appropriate personnel at all sites of service.
The requirement that HHAs comply with State licensure laws before
providing services to Medicare beneficiaries would apply to the HHA as
an entity as well as its staff furnishing services to HHA patients
directly or under arrangements.
Finally, we propose to move the current requirements at
Sec. 484.14(j), Organization, services and administration, Standard:
Laboratory services, to proposed Sec. 484.100(d). We believe that the
laboratory services standard is a Federal requirement that is better
suited under the revised condition of participation governing
compliance with Federal, State, and local laws.
2. Organization and Administration of Services (Proposed Section
484.105)
The proposed COP on organization and administration of services
would revise existing regulations at Sec. 484.14 (Condition of
participation: organization, services and administration) and replace
the existing regulations at Sec. 484.38 (Condition of participation:
Qualifying to furnish outpatient physical therapy or speech-language
pathology services). The proposed new condition simplifies the
structure of the current requirements and provides flexibility to the
HHA by replacing the current focus on organizational structures with
new performance expectations for the administration of an HHA as an
organizational entity. With the wide diffusion of home health
organization and management structures, it is imperative to ensure
accountability within HHAs by setting performance expectations for the
clear, unambiguous, and accountable operation of all
[[Page 11020]]
services. The overall goal of the proposed condition is clear,
accountable organization, management, and administration of an HHA's
resources to attain and maintain the highest practicable functional
capacity for each patient in terms of medical, nursing, and
rehabilitative needs as indicated on the plan of care.
One of the most critical responsibilities for the governing body of
the HHA to meet is stated explicitly at the beginning of proposed
Sec. 484.105: The HHA is expected to ``attain and maintain the highest
practicable functional capacity for each patient * * *'' This language
derives from section 1891(c)(2)(C)(i)(I) of the Act, which directs the
Secretary to devise a survey process that includes home visits to a
case-mix sample of patients ``for the purpose of evaluating * * * the
extent to which the quality and scope of items and services furnished
by the agency attained and maintained the highest practicable
functional capacity of [E]ach such individual * * * '' Thus, the
expectation for performance of the HHA, as stated throughout these
proposed rules, especially in the comprehensive assessment, care
planning and coordination, and quality assessment and performance
improvement COPs, is to achieve outcomes of care that are commensurate
with a patient's condition and expectations for returning to improved
functional status as much as possible. The placement of this
requirement in the COP that includes the governing body is intended to
express clearly our intention that the responsibility for achieving the
best outcomes possible for the patients served lies with the
administration of the HHA, including its governing body and
administrator.
This requirement lends support to the importance of the HHA using
current best practices within a strong quality assessment and
performance improvement program. It promotes the HHA's seeking out and
using comparative data where available and using its own data compared
to previous points in time to demonstrate internal improvements in
outcomes over time.
We recognize that there is no single test of this requirement; each
patient is unique and the expectations for outcomes vary in every case.
Yet, we will expect surveyors to determine that the HHA, overall, has
aggressively pursued this statutory expectation for outcomes for
patients and either achieves it, or demonstrates its efforts to achieve
it when desired outcomes are not successfully achieved.
In the proposed organization and administration of services
condition, we revise the current standard on governing body
(Sec. 484.14(b)), retain, with only minor changes, the current standard
on services furnished (Sec. 484.14(a)), retain, with only minor
editorial changes, the requirements with respect to services under
arrangements that are now stated in Sec. 484.14(h), delete the current
standards on administrator (484.14(c)), delete the current standards on
supervising physician or registered nurse (Sec. 484.14(d)), delete the
current standards on personnel policies (Sec. 484.14(e)), delete the
current standards on institutional planing (Sec. 484.14(i)), relocate
the existing condition, qualifying to furnish outpatient physical
therapy or speech-language (Sec. 484.38) under this condition, and
relocate the current standard on laboratory services (Sec. 484.14(j))
under the compliance with Federal, State and local laws COP.
In developing the proposed governing body standard, we emphasize
the responsibility of the HHA governing body (or designated persons so
functioning) for the management and provision of all home health
services, fiscal operations, quality assessment, performance
improvement, and the appointment of the administrator. We have retained
the necessary administrative features that promote and protect patient
health and safety from the current standard on governing body at
Sec. 484.14(b) while providing flexibility in the actual approach to
the performance expectation of the provision of quality care to all
patients. Thus, in the proposed governing body standard, the actual
approach to the administration of the HHA as an organization is left to
the discretion of the governing body of each HHA. The proposed
governing body standard reflects our goal of promoting the effective
management and administration of the HHA as an organizational entity
without dictating prescriptive requirements for how an HHA must meet
that goal.
In the proposed governing body standard, the HHA's governing body
(or designated persons so functioning) must assume the full legal
authority and responsibility to ensure the performance expectation of
the sound fiscal operation of the HHA, appoint a qualified
administrator who is responsible for the day-to-day operation of the
program, and may appoint designated persons to carry out those
functions. We believe the proposed standard on governing body
encompasses the performance expectation of an HHA administrator and of
organizational fiscal operations, and, therefore, propose to delete the
current prescriptive standards on the administrator at Sec. 484.14(c)
and on institutional planning at Sec. 484.14(i). We propose to replace
the current process-ridden institutional planning standard at
Sec. 484.14(i) with the performance expectation of the HHA governing
body's responsibility for the fiscal operation of the HHA.
We propose to remove the current statutorily based institutional
planning requirements from the HHA conditions of participation. Because
the HHA conditions of participation are primarily intended to reflect
patient health and safety standards, we feel the COPs are an
inappropriate location for the institutional planning provisions found
under section 1861(z) of the Act. The proposed standard requires the
governing body to assume full legal authority and responsibility for
fiscal operations and appointment of an administrator who is
responsible for the day-to-day operation of the program without
specifying the means to achieve the goal. This outcome-oriented
approach provides flexibility to the HHA in the administration of the
HHA as an organizational entity. However, it is important to note that
the statutory requirements of section 1861(z) of the Act continue to
apply to an HHA's institutional planning and capital expenditure
activities, even though we would not include them in the revised COPs.
The second proposed standard under the organization and
administration of services condition would specify that the HHA that
accepts the patient is the primary HHA and has the responsibility to
meet the care needs of the patient. Primary home health agency means
the agency that accepts the patient becomes the primary HHA and assumes
responsibility for the interdisciplinary coordination and provision of
services and continuity of care, whether the services are provided
directly or under arrangement. We are proposing the new primary HHA
standard to ensure continuity of quality care. Mass delegation of care
has led to problems in evaluating the accountability of providers and
quality of care. This standard was proposed to address the problem of
HHAs accepting patients for only specific services. For example, one
HHA accepts a patient, treats the patient for a specific condition, and
then refers the patient to several other agencies for the rest of his
or her treatment. Under our proposal, the HHA that accepts a patient
would become the primary HHA and would be held responsible for the
interdisciplinary coordination and provision of services ordered under
the patient's plan of care. We welcome
[[Page 11021]]
comments as to whether the primary HHA standard is an appropriate tool
to address the problem of mass delegation and fragmentation of care.
We are also proposing a new standard to address the parent/branch
relationship. We want to establish clear requirements regarding the
parent/branch relationship in order to protect patient health and
safety and to ensure a consistent level of care throughout the HHA as
an organizational entity. Although the existing regulations define
``branch office'' and ``parent HHA'', we have found that some HHAs have
several branch offices that are actually operating as full-fledged HHAs
while the parent offices are used as billing shells for the branches.
We have concerns about branches, which are not required to
independently meet the conditions of participation, acting as an
independent HHA and the effect on program integrity and the consistency
of quality care provided. We do not anticipate that this standard will
disrupt current business practice because the current definitions of
parent and branch provide a performance expectation for HHAs as
organizational entities as a condition of participation for Medicare
certification.
In the proposed rule, we have retained the current definitions, and
we are also incorporating the previous definition material into the
organization and administration of services COP in order to clarify
that this is a management responsibility of the organization. The
standard states that a parent home health agency provides direct
support and administrative control of branches. The branch office is
located sufficiently close to effectively share administration,
supervision, and services in a manner that renders it unnecessary for
the branch to separately meet the COPs as an HHA. We have added
``teeth'' to the current definition of the parent and branch by making
it a standard level requirement. This will enable surveyors to cite a
deficiency when the performance by an HHA's branch does not ensure that
the branch is meeting the HHA requirements applicable to its operation.
Since the parent/branch reference in the current rule is only a
definition, surveyors cannot presently cite a deficiency.
We are proposing at Sec. 484.105(e) to revise the current services
furnished requirement at existing Sec. 484.14(a). Specifically, we
would retain the current requirement that part-time or intermittent
skilled nursing services and at least one other therapeutic service
(physical therapy, speech-language pathology, or occupational therapy;
medical social services; or home health aide services) are made
available on a visiting basis in a place of residence used as a
patient's home. We would revise the second part of the standard to
state that an HHA must provide at least one of the qualifying services
directly, but may provide the second qualifying service and additional
services under arrangements with another agency or organization.
Medicare makes a distinction between services provided directly as
opposed to under arrangement. As discussed above, the most common way
services are provided directly is through the use of employees. The
common law definition of ``employee'' fundamentally relates to whether
a person is under control by the entity or individual providing the
services, so by and large producing a W-2 form would constitute
providing the services directly. We are exploring a straightforward way
to define the provision of direct services as opposed to services
provided under arrangement.
3. Clinical Records (Proposed section 484.110)
We are proposing a new COP, clinical records, that embodies several
of the requirements in existing Sec. 484.48, Condition of
participation: Clinical records. In this condition we would retain only
those process requirements that are essential to protect of patient
health and safety.
The primary requirement under the proposed clinical records
condition of participation is that a clinical record containing
pertinent past and current findings is maintained for every patient who
is accepted by the HHA for home health services. We propose to add the
requirement that the information contained in the clinical record must
be accurate, made available to the physician and appropriate HHA staff
and may be maintained electronically. The accuracy of the clinical
record must exhibit consistency between the diagnosed condition and the
actual experience of the patient. Accuracy can be reflected in the
appropriate link between patient assessment information and the
services and treatments ordered and furnished in the plan of care. In
light of the decentralized nature of HHAs, that is, patient care is not
furnished in a single location, we believe that members of the
interdisciplinary team must have access to patient information in order
to provide quality services. Many HHAs maintain electronic records and
we recognize this technological change in the home health environment.
The first standard of the condition, contents of the record, would
include several elements that we currently require HHAs to include in
the clinical record. We would retain the requirement that the record
include clinical/progress notes, a discharge summary, and the plan of
care. To give HHAs flexibility in maintaining clinical records, we
would no longer specify that the record must include appropriate
identifying information, name of physician, drug, dietary, treatment
and activity orders, and copies of summary reports sent to the
attending physician. Finally, we would add requirements to this
standard that reflect our outcome oriented approach to patient care.
Specifically at proposed Sec. 484.110(a), we would require that the
clinical record include: (1) The patient's current comprehensive
assessment, clinical/progress notes, and plan of care; (2) responses to
medications, treatments, and services; (3) a description of measurable
outcomes that have been achieved; and (4) a discharge summary that is
available to physicians upon request. We believe that these
requirements would give HHAs flexibility in maintaining clinical
records as well as ensure that the records contain information
necessary to provide high quality patient care.
We propose to add a new standard at proposed Sec. 484.110(b) to
provide for authentication of clinical records. We would require that
all entries be clear, complete, and appropriately authenticated.
Authentication must include signatures or a computer secure entry by a
unique identifier of a primary author who has reviewed and approved the
entry. The move to computerized records has resulted in transcription
of doctor's orders and electronic signatures. This standard is
currently in the COPs for hospitals, and addresses technological
changes in information management.
Under proposed Sec. 484.110(c) we would retain the current
requirement under Sec. 484.48(a) (Standard: Retention of records). That
is, we would continue to require that clinical records be retained for
5 years after the month the cost report to which the records apply is
filed with the intermediary, unless State law stipulates a longer
period of time. HHA policies provide for retention of records even if
the HHA discontinues operations. If the patient is transferred to
another health facility, a copy of the record or an abstract is sent
with the patient.
We also propose to incorporate into this condition the first
requirement under existing Sec. 484.48(b) (Standard: Protection of
records). At proposed Sec. 484.110(d) we would provide that patient
information and the record are safeguarded against loss or
[[Page 11022]]
unauthorized use. We believe the other requirements under existing
Sec. 484.48(b) concerning the release of clinical record information
are best incorporated into the new standard at proposed Sec. 484.50
(Patient Rights: Confidentiality of clinical records).
4. Personnel Qualifications (Proposed section 484.115)
Currently, provisions concerning the qualifications of HHA
personnel are located at Sec. 484.4. This section now includes very
specific credentialing requirements and provides that any staff
required to meet the conditions of participation must meet our
qualifications. In keeping with our goal of eliminating process
requirements that are not predictive of good outcomes for patients or
necessary to prevent harmful outcomes for patients, we are proposing
significant revisions to the personnel qualifications COP.
Specifically, we would provide that in cases where personnel
requirements are not statutory, or do not relate to a specific payment
provision we would apply State certification or State licensure
requirements. Under our proposal, the personnel qualifications would
fall into three basic categories, personnel for which there is a
statutory set of qualifications, personnel for which we have specified
requirements since all States do not have licensure or certification
requirements, and personnel for which all States have licensure or
certification requirements. Under our proposed reorganization of part
484, the personnel qualifications would be located at proposed
Sec. 484.115. We discuss the personnel qualifications in detail below.
The first category of personnel qualifications are those in which
we would defer to State law. At proposed Sec. 484.115(a), we would
specify that skilled professionals who provide services directly by or
under arrangements with the HHA must be legally authorized (licensed or
if applicable, certified or registered) to practice by the State in
which he or she performs, and must act only within the scope of his or
her State license or State certification.
The second category would consist of personnel for which there is a
statutory set of qualifications. Section 1861(r) of the Act essentially
defines a physician as a doctor of medicine, osteopathy, or podiatry
legally authorized to practice medicine and/or surgery by the State in
which such function or action is performed. We would refer to this
definition at proposed Sec. 484.115(b). The Act also contains a
definition of a speech language pathologist. Specifically, section
1861(ll)(3)(A) defines a qualified speech language pathologist as an
individual with a master's or doctoral degree in speech-language
pathology who is licensed as a speech-language pathologist by the State
in which the individual furnishes such services, or in the case of an
individual who furnishes services in a State which does not license
speech-language pathologists, has successfully completed 350 clock
hours of supervised clinical practicum (or is in the process of
accumulating such supervised clinical experience), performed not less
than 9 months of supervised full-time speech-language pathology
services after obtaining a master's or doctoral degree in speech-
language pathology or a related field, and successfully completed a
national examination in speech-language pathology approved by the
Secretary. The Act also defines the qualifications for home health
aides at section 1891(a). We believe that the description of
qualifications for home health aides would be more appropriately
located under the home health aide services COP. Thus, the requirement
will be cross-referenced at proposed Sec. 484.75(a).
The third category of personnel qualifications would include those
persons for whom all States do not currently have a licensing or
certification requirement. If a State has licensing or certification
requirements for a professional included in this section, then the
State qualifications would apply. If a State does not have licensing or
certification requirements, then the HHA would apply the qualifications
specified below. This category would consist of all current personnel
qualifications found under Sec. 484.4 with the exception of
audiologists and practical (vocational) nurses. We propose to delete
the current requirements for audiologists and practical (vocational)
nurses. The existing requirement for practical (vocational) nurses is
State licensure in the State practicing; thus it is self-explanatory in
our deference to State law. We believe the audiologist requirement is
no longer relevant to the home care environment.
We contemplated changing the current requirements for social
workers consistent with our approach to deferring to State licensing
laws, when applicable, but have not done so in this rule because of the
absence of data and outcome measures. We are requesting comments on
alternative approaches to personnel qualifications for social workers
and the submission of data that would support the retention or change
to the current personnel qualifications for social workers in this
rule.
We propose to revise the existing personnel qualifications for HHA
administrators. An administrator is a person who is licensed as a
physician; or holds an undergraduate degree and is a registered nurse;
or has education and experience in health service administration, with
at least one year of supervisory or administrative experience in home
health care or a related health care program and in financial
management.
We propose to revise the definition of administrator to provide
that an administrator who is a registered nurse must possess a
bachelor's degree. Additionally, we would specify the type of education
or experience that an administrator who is not a physician or a
registered nurse must have. Specifically, as stated above, such a
person would need education or experience in home health care or a
related health care program and in monitoring the financial aspects of
program management. In light of the fact that many HHAs experience
financial difficulties as a result of poor or inefficient management,
we believe that our proposed requirement that the administrator have
education or experience in financial management would be beneficial.
Additionally, we believe that this proposed requirement is necessary
since inefficient financial management of an HHA can ultimately lead to
low quality patient care. We note that States do not have licensing
requirements for HHA administrators; thus, as in the past, HHAs would
continue to apply our requirements.
In addition, in the event that a State does not have any licensure
or certification for the following professions, the HHA would apply the
qualifications specified below:
Occupational Therapist--A person who: (a) Is a graduate of an
occupational therapy curriculum accredited jointly by the Committee on
Allied Health Education and Accreditation of the American Medical
Association and the American Occupational Therapy Association; or (b)
is eligible for the National Registration Examination of the American
Occupational Therapy Association; or (c) has 2 years of appropriate
experience as an occupational therapist, and has achieved a
satisfactory grade on a proficiency examination conducted, approved, or
sponsored by the U.S. Public Health Service, except that such
determinations of proficiency do not apply with respect to persons
initially licensed by a State or seeking initial
[[Page 11023]]
qualification as an occupational therapist after December 31, 1977.
Occupational therapy assistant--A person who: (a) Meets the
requirements for certification as an occupational therapy assistant
established by the American Occupational Therapy Association; or (b)
has 2 years appropriate experience as an occupational therapy
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that such determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking
initial qualification as an occupational therapy assistant after
December 31, 1977.
Physical therapist--A person who: (a) Has graduated from a physical
therapy curriculum approved by: (1) The American Physical Therapy
Association; or (2) The Committee on Allied Health Education and
Accreditation of the American Medical Association; or (3) The Council
on Medical Education of the American Medical Association and the
American Physical Therapy Association; or (b) Prior to January 1, 1966
(1) Was admitted to membership by the American Physical Therapy
Association, or (2) was admitted to registration by the American
Registry of Physical Therapist, or (3) has graduated from a physical
therapy curriculum in a 4-year college or university approved by a
State department of education; or (c) has 2 years of appropriate
experience as a physical therapist, and has achieved a satisfactory
grade on a proficiency examination conducted, approved, or sponsored by
the U.S. Public Health Service except that such determinations of
proficiency do not apply with respect to persons initially licensed by
a State or seeking qualifications as a physical therapist after
December 31, 1977; or (d) was licensed or registered prior to January
1, 1966, and prior to January 1, 1970, had 15 years of full-time
experience in the treatment of illness or injury through the practice
of physical therapy in which the services were rendered under the order
and direction of attending and referring doctors of medicine or
osteopathy; or (e) if trained outside of the United States (1) Was
graduated since 1928 from a physical therapy curriculum approved in the
country in which the curriculum was located and in which there is a
member organization of the World Confederation for Physical Therapy;
(2) meets the requirements for membership in a member organization of
the World Confederation for Physical Therapy.
Physical therapy assistant--A person who: (1) Has graduated from a
2-year college-level program approved by the American Physical Therapy
Association; or (2) has 2 years of appropriate experience as a physical
therapy assistant, and has achieved a satisfactory grade on a
proficiency examination conducted, approved or sponsored by the U.S.
Public Health Service, except that these determinations of proficiency
do not apply to persons initially licensed by a State or seeking
initial qualification as a physical therapy assistant after December
31, 1977.
Public health nurse--A registered nurse who has completed a
baccalaureate degree program approved by the National League for
Nursing for public health nursing preparation or postregistered nurse
study that includes content approved by the National League for Nursing
for public health nursing preparation.
Registered nurse--A licensed graduate of an approved school of
professional nursing.
Social worker assistant--A person who: (1) Has a baccalaureate
degree in social work, psychology, sociology, or other field related to
social work, and has had at least 1 year of social work experience in a
health care setting; or (2) has 2 years of appropriate experience as a
social work assistant, and has achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service, except that these determinations of proficiency
do not apply with respect to persons initially licensed by a State or
seeking initial qualifications as a social work assistant after
December 31, 1977.
Social worker--A person who has a master's degree from a school of
social work accredited by the Council on Social Work Education, and has
1 year of social work experience in a health care setting.
Our approach to personnel credentialing would be as flexible as
possible. Our objective is to rely upon State licensure to the extent
that States license practitioners required under these conditions of
participation. However, the diverse nature of State licensure
provisions make it necessary for us to continue to write and apply
requirements in some cases. For example, where a State does not license
a type of practitioner required in these conditions of participation, a
Federal definition is needed to enable HHAs and surveyors to define and
meet the requirement. An example of this situation would be a State
that does not license occupational therapists. There are also instances
when the specific credential applicable to a practitioner is specified
in the law. An example of this is a physician, which is defined in
section 1861(r) of the Act. Finally, the credentialing philosophy that
we have described here would not apply under Medicare Part B, when a
specific level or education or training is specified as a pre-condition
for reimbursement. Thus, the definitions contained in this section
generally apply for HHA certification purposes only in States where
there are no State licensure or certification requirements.
IV. 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 proposed rule such as this would
not have a significant economic impact on a substantial number of small
entities. For purposes of the RFA, all home health agencies are
considered small entities. States and individuals are not considered
small entities.
In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis for any proposed rule that may
have a significant impact on the operation of a substantial number of
small rural hospitals. Such an analysis must conform to the provisions
of section 604 of the RFA. For purposes of section 1102(b) of the Act,
we define a small rural hospital as a hospital that is located outside
of a Metropolitan Statistical Area and has fewer than 50 beds. We are
not preparing a rural impact statement since we have determined, and
certify, that this proposed rule would not have a significant impact on
the operations of a substantial number of small rural hospitals.
Although the provisions proposed in this rule do not lend
themselves to a quantitative impact estimate, we do not anticipate that
they would have a substantial economic impact on home health agencies.
However, to the extent that our proposals may have significant effects
on providers or beneficiaries, be viewed as controversial, or be
mandated by statute, we believe it is desirable to inform the public of
our projections of the likely effects of the proposals.
As discussed in detail above, this proposed rule sets forth new HHA
COPs that revise or eliminate many existing requirements and
incorporate critical requirements into four ``core conditions.'' These
four COPs--Patient Rights, Patient Assessment, Care Planning and
Coordination of Services,
[[Page 11024]]
and Quality Assessment and Performance Improvement would focus both
provider and surveyor efforts on the actual care delivered to the
patient, the performance of the HHA as an organization, and the impact
of the treatment furnished by the HHA on the health status of its
patients. The impact of the proposed rule to incorporate OASIS into the
HHA COPs is separately detailed in that proposed rule (which is set
forth elsewhere in today's issue of the Federal Register). In
developing these proposed COPs, we have retained structure and process-
oriented requirements only where we believe they are essential to
achieving desired patient outcomes or preventing harmful outcomes (for
example, home health aide competency and supervision, timeliness of
patient assessment).
Under the proposed Comprehensive Assessment COP, we are proposing
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 being referred to a home health agency for initiation of
services is at a point of immediate and serious need, especially as
patients are returned home from hospital care sooner than ever before.
Likewise, as the complexity of the care needs of patients increases, so
does the need for comprehensive assessment of the patient. The
importance of coming to closure and implementing an effective care plan
becomes paramount.
We believe that these timeframe requirements pose little or no
burden for the HHA since they would in all likelihood be performed in
the absence of regulations. However, the proposed timeframes serve as a
strong performance expectation for HHAs that may not have adequate
resources (financial and human resources) by setting the outside
acceptable time for these activities to occur. If too many patient
referrals occur together, effective service delivery to some patients
might be delayed by the HHA's inability to see the patient quickly or
to conduct and complete the needed comprehensive assessment. Thus, if
an HHA recognizes that its workload is such that it is not capable of
beginning work with a patient virtually immediately upon referral, the
patient should not be accepted for care.
We welcome comments to address whether the specific proposed
timeframes in the regulation text are reasonable and consistent with
current medical practice, and whether the timeframes should be used as
benchmarks to reflect patient health and safety concerns involving the
timeliness of the assessment components.
Provision of an assessment would be necessary to provide the
appropriate information for compliance with the current plan of care
requirements. The existing COPs contain several requirements that
address the need for patient assessment, including most notably a long
and detailed list of items under existing Sec. 484.18(a) that are
required to be covered in a plan of care, such as pertinent diagnoses,
mental status, and functional limitations. In place of this
requirement, we would emphasize the importance of the comprehensive
assessment by establishing patient assessment as a separate COP,
specifying the desired outcome of the assessment (that is, the
identification of a patient's care needs), and then allowing HHAs the
flexibility to determine how best to achieve this outcome. We believe
that this approach is consistent with current accepted practices in
HHAs and that most HHAs now perform a comprehensive assessment for most
of their patients. 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. As stated above, we
are soliciting comments on the utility of specific timeframes for the
comprehensive assessment.
We are proposing to require that HHAs ensure a majority of at least
50 percent of the total skilled professional services are provided
directly. We are proposing to phase in this new approach over 3 years.
In the first year, HHAs would be required to ensure that at least 30
percent of the skilled professional services are provided directly. In
the second year, HHAs would be required to ensure that at least 40
percent of the skilled professional services are provided directly. By
the third year of enactment, HHAs would be required to ensure that at
least 50 percent of the skilled professional services are provided
directly.
Currently, an HHA must provide at least one of the qualifying
services directly, but may provide the second qualifying service and
additional services under arrangements with another agency or
organization. We believe that the excessive use of contracting could be
an indication that an HHA may be exceeding its patient capacity,
leading to possible instability that can result in disruptions to
patient care. Excessive contracting is also a potential indication that
the HHA may not be exercising full control over the provision of
quality care. Participants in a series of home health initiative
meetings agreed that this process requirement is a strong predictor of
appropriate management and in proposing this approach we are relying on
the judgement of the industry. This is a performance safeguard that
seeks to ensure continuity and quality of care through the restriction
of contracted care in the home care environment.
It is important to note that HHAs currently report employment data
on their cost reports (freestanding HHAs: Form-HCFA-1728-S-3 and
hospital-based HHAs: Form-HCFA-2552-H-S-4). We invite comment on this
shift in our approach and on any concerns HHAs may have regarding their
ability, both operationally and financially, to undertake this new
approach. We also invite comment on any other creative approaches that
could be used to limit the use of contracted care in the home care
industry.
We are proposing that HHAs conduct criminal background checks of
home health aides as a condition of employment to safeguard
beneficiaries from abusive practices in their home. This proposed
requirement may have some impact though not significant, on HHAs, which
are considered small entities. We already have similar patient
protection requirements in other rules governing other Medicare-
participating providers. These protections are especially necessary in
the decentralized environment of home health delivery. We are
soliciting comments on the impact on the HHA to operationally comply
with this requirement.
We are proposing a new standard to address the parent/branch
relationship to ensure a consistent level of care throughout the HHA as
an organizational entity. We added strength to the current definitions
by raising them to standard level requirements. This will enable
surveyors to cite a deficiency when the performance by an HHA's branch
does not ensure that the branch is meeting the HHA requirements
applicable to its operation. HCFA has concern about branches that are
not required to independently meet the conditions of participation, but
act as an independent HHA and the affect of that situation on the
consistency and quality of care provided. We estimate that this
standard will not disrupt current business practice because the current
definitions of parent and branch office provide a performance
[[Page 11025]]
expectation for the HHA as an organizational entity as a condition of
participation for Medicare certification. The current definitions
provide a clear expectation that the parent office develops and
maintains administrative controls of branches; and the branch office is
location or site from which a home health agency provides services
within a portion of the total geographic area served by the parent
agency and is part of the HHA and is located sufficiently close to
share administration, supervision and services in a manner that renders
it unnecessary for the branch to independently meet these conditions of
participation as a home health agency.
More often though, we have eliminated structural or process-
oriented requirements that we no longer believe are necessary (such as
personnel policies or the prescriptive details concerning the duties of
a registered nurse versus those of a licensed practical nurse), in
favor of an approach that, through the proposed core COP on quality
assessment and performance improvement, invests HHAs with internal
responsibility for improving their performance. This approach is
intended to incorporate into our regulations current best practices in
well-managed HHAs, relying on the HHA to identify and resolve its
performance problems in the most effective and efficient manner
possible.
We believe that the proposed COPs would decrease the administrative
burden on HHAs to comply with detailed Federal requirements, thus
reducing the costs incurred by the typical HHA in meeting the Medicare
conditions of participation. (See the information collection section
below for examples of specific changes in the recordkeeping and
paperwork burden of HHAs that would be associated with this proposed
rule.) Instead, the proposed COPs would provide HHAs with much more
flexibility to determine how best to pursue our shared quality of care
objectives in the most cost-effective manner. We expect HHAs to develop
different approaches to compliance based on their varying resources and
patient populations, differences in laws in various localities (such as
those concerning personnel standards), and other factors. Given the
uncertainties over the behavior of individual HHAs under the proposed
new COPs, quantitative analysis of the effects of these proposed
changes is not possible. However, even in situations where the proposed
requirements could result in some immediate costs to an individual HHA
(for example, for an HHA that would need to upgrade its existing
performance evaluation program), we believe that the changes that the
HHA would make would produce real but difficult to estimate long-term
economic benefits (such as more cost-effective performance practices or
higher patient satisfaction that could lead to increased business for
the HHA.)
We believe that the proposed COPs would decrease the regulatory
burden on HHAs and provide them with greatly enhanced flexibility. At
the same time, the proposed requirement for a program of continuous
quality assessment and performance improvement would increase
performance expectations for HHAs in terms of achieving needed and
desired outcomes for patients and increasing patient satisfaction with
services provided. This patient-centered, outcome oriented change in
approach to the regulation will also likely fundamentally change our
approach to the survey process. For example, since the proposed
regulation sets performance expectations for the HHA to constantly
improve, it may be possible to alter significantly, or possibly
eliminate altogether the current Functional Assessment Instrument
(FAI), which surveyors use to assess the outcomes of care through home
visits and some record review. In an expanded review of the agency's
approach to quality assessment and performance improvement, we may
approach this task differently, with greater flexibility than the
current FAI affords. We invite comment on this fundamental shift in our
regulatory approach and on any concerns HHAs may have regarding their
ability, both operationally and financially, to undertake this new
approach. We are especially interested in comments that address how
HCFA could improve this approach, what additional flexibility could be
provided, what (if any) process requirements that are critical to
patient care and safety should be added, and how well HCFA's investment
in the HHA's participation in a strong continuous quality assessment
and performance improvement program of their own design will achieve
our stated and intended goal of improving the efficiency, effectiveness
and quality of patient outcomes and satisfaction. We are especially
interested in comments that address how HCFA could improve this
approach, what additional flexibility could be provided, what (if any)
process requirements that are critical to patient care and safety
should be added, and how well HCFA's investment in the HHA's
participation in a strong continuous quality assessment and performance
improvement program of its own design will achieve our stated and
intended goal of improving the efficiency, effectiveness, and quality
of patient outcomes and satisfaction.
For the reasons given above, we certify that the proposed rule will
not have a significant effect on a substantial number of small entities
and that a regulatory flexibility analysis is not needed.
In accordance with the provisions of Executive Order 12866, this
proposed 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 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.
Therefore, we are soliciting comment on each of these issues for
the proposed information collection requirements discussed below.
The title and description of the individual information collection
requirements are shown below with an estimate of the annual reporting
and recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
As indicated earlier in this preamble, the current regulations
dealing with the HHA conditions of participation are contained in part
484 of the Code of Federal Regulations. The information collection
requirements for this part are currently approved under OMB approval
number 0983-0365 with an expiration date of May 31, 1998. Since we are
proposing to revise or delete many of the information collection
[[Page 11026]]
requirements in the existing HHA conditions of participation, we will
be seeking OMB approval for all of the information collection
requirements contained in the proposed part 484, including those that
are currently approved under OMB approval number 0983-0365. Many of
these requirements are performed only once by each HHA (such as the
development of a standard patient's right disclosure) or would normally
be performed by an HHA in the normal course of responsible business
practices in the absence of these requirements (such as the maintenance
of patient's records) and therefore represent a minimal, if any, burden
on HHAs. Following is a list of the specific information collection
requirements contained in the proposed 42 CFR Part 484.
Section 484.50 Patient's Rights
This section dealing with patient's rights mirrors those
information collection requirements in section 4021 of OBRA '87, which
specify the rights of patients receiving services from Medicare
certified HHAs. These requirements are necessary to ensure compliance
with statutory responsibilities at section 1891 of the Act. Current
requirements at Sec. 484.10 that are retained in the proposed rule
include:
a. A HHA must provide the patient with a written notice of the
patient's rights in advance of providing care and document that it has
complied with this requirement.
b. The HHA must document the existence and resolution of complaints
about care furnished by the HHA that were made by the patient, the
patient's family or guardian.
c. The HHA must advise the patient in advance of the disciplines
that will furnish the care, the plan of care, expected outcomes,
barriers to treatment, and any changes in the care to be furnished.
d. The HHA must advise the patient of the HHA's policies and
procedures regarding disclosure of patient records.
e. The HHA must advise the patient of his/her liability for
payment.
f. The HHA must advise the patient of the number, purpose, and
hours of operation of the State home health hotline.
Burden Estimate
We foresee that the HHAs will develop a standard notice of rights
that will fulfill the requirements contained in this section. The
standard notice will contain a checklist to be completed by the HHA in
a manner appropriate to each patient being accepted. A carbon copy of
the signed notice will serve as documentation of compliance. We
estimate that the completion of this form will impose a burden of
approximately 3 seconds per each current HHA patient for 1 year (3
seconds x 3.4 million patients) = 2,833 hours and each new admission
in succeeding years (3 seconds x 800,000 (approximate admission in
1995) = 666 hours.
In the rare circumstances to which paragraph (b) applies, it is
already common practice to have this information retained in the HHA's
record. Therefore, this requirement imposes no burden.
Section 484.55 Comprehensive Assessment
This new section on comprehensive assessment of the patient would
require HHAs to provide each patient with a comprehensive assessment
(including drug regimen review) of his or her needs which would be used
to develop expectations for treatment. We are proposing specific
timeframes for the initial assessment visit and completion of the
assessment of the patient because we believe that these requirements
are predictive of good patient care and safety and as well as the
prevention of harm to the patient. As many HHAs are already performing
a standardized patient assessment within their own internal policies,
we believe that these timeframes pose little or no burden since they
would in all likelihood be performed in the absence of regulations. In
addition, since HHAs already routinely obtain assessment information
from patients upon initiation of care and on an ongoing basis during
treatment, we believe this new requirement would not place an
information collection or paperwork burden on HHAs. The proposed
assessment timeframes serve as a strong performance expectation for
HHAs.
It is important to note that this proposed rule does not include
the requirement that HHAs participate in an external quality
improvement process incorporating the core standard assessment data
set. As discussed above, HCFA is proposing to require use of a core
standard assessment data set, as discussed elsewhere in today's issue
of the Federal Register. Reporting requirements associated with that
proposal are discussed separately in that Federal Register notice.
Section 484.60 Care Planning and Coordination of Services
This new section reflects an interdisciplinary, coordinated
approach to home health care delivery. The proposed new care planning
and coordination of services section sets forth the requirement that
each patient's written plan of care specifies the care and services
necessary to meet the patient specific needs identified in the
comprehensive assessment and the measurable outcomes that the HHA
anticipates will occur as a result of implementing and coordinating the
plan of care. This new section incorporates several of the existing
requirements under current Sec. 484.18. Section 484.18 consists of
longstanding requirements which implement statutory provisions found in
sections 1835 and 1814 of the Act, as well as section 1891(a) as
amended by OBRA `87 for non-Medicare patients. In addition, HCFA Forms
485-488 are currently approved under OMB No. 0938-0357.
Burden Estimate
We believe that these requirements are commonly accepted as good
medical practice. Therefore, they would impose little or no burden on
HHAs as they would in all likelihood be performed even in the absence
of these regulations. The only anticipated burden associated with this
requirement concerns the possible establishment and periodic review of
plans of care by doctors of osteopathy or podiatry. We estimate that
this will affect approximately 3 percent of home health patients,
resulting in a burden of 24,000 x 5 minutes = 2,000 hours for new
admissions and 102,000 x 3 minutes = 5,100 hours for existing
patients.
Section 484.65 Quality Assessment and Performance Improvement
This new section requires the HHA to develop, implement, maintain
and evaluate an effective, data driven quality assessment and
performance improvement program. Current requirements for HHAs do not
provide for the operation of an internal quality assessment and
performance improvement program, whereby the HHA examines its methods
and practices of providing care, identifies the opportunities to
improve its performance and then takes actions that result in higher
quality of care for HHA patients. We have not prescribed the structures
and methods for implementing this requirement and have focused the
condition toward the expected results of the program. This provides
flexibility to the HHA, as it is free to develop a creative program
that meets the HHA's needs and reflects the scope of its services. This
new provision would replace the current conditions at Sec. 484.16 Group
of professional
[[Page 11027]]
personnel and Sec. 484.52 Evaluation of an agency's program.
Burden Estimate
We believe the writing of internal policies governing the HHA's
approach to the development, implementation, maintenance, and
evaluation of the quality assessment and performance improvement
program will impose a burden. We want HHAs to utilize maximum
flexibility in their approach to quality assessment and performance
improvement programs. Flexibility is provided to HHAs to ensure that
each program reflects the scope of its services. We believe that this
requirement provides a performance expectation that HHAs will set their
own goals and use the information to continuously strive to improve
their performance over time. Given the variability across HHAs and the
flexibility provided, we believe that the burden associated with
writing the internal policies governing the approach to the
development, implementation, and evaluation of the quality assessment
and performance improvement program will reflect that diversity. Given
the variability, it is difficult to predict an exact burden. We want to
provide flexibility and do not want to be prescriptive in defining
hourly parameters. However, we need to quantify the burden associated
with this requirement. We estimate that the burden associated with
writing the internal policies would be an average of 4 hours annually
(although this figure may be much lower, since many HHAs have existing
internal quality improvement programs). We estimate on average:
4 hours x 9,058 (total number of Medicare-certified HHAs in calendar
year 1995) = 36,232 hours
4 hours x 1,145 (total number of newly certified HHAs in calendar
year 1995) = 4,580 hours
Section 484.70 Skilled Professional Services
This new section would require skilled professionals who provide
services to HHA patients as employees or under arrangement to
participate in all aspects of care, including an ongoing
interdisciplinary evaluation and development of the plan of care and be
actively involved in the HHA's quality assessment and performance
improvement program. In place of current provisions governing skilled
nursing services Sec. 484.30, therapy services Sec. 484.32, and medical
social services Sec. 484.34 we would consolidate all new requirements
under one new condition, Skilled professional services. We are broadly
describing the expectations of skilled professionals who participate in
the interdisciplinary approach to home health care delivery. The
current requirements are commonly accepted as good medical practice and
therefore impose little or no burden on the HHAs as they would in all
likelihood be performed in the absence of Federal regulations.
We are proposing a new standard that the HHA must ensure that a
majority of at least 50 percent of total skilled professional services
are routinely provided directly. We are proposing to phase in this new
approach over three years. In the first year, HHAs would be required to
ensure at least 30 percent of the total skilled professional services
are provided directly. In the second year, HHAs would be required to
ensure at least 40 percent of the total skilled professional services
are provided directly. In the third year, we would require at least 50
percent of the total skilled professional services are provided
directly. The requirement that the HHAs determine compliance with this
standard imposes a one-time annual burden of 2 minutes on existing HHAs
and any newly certified HHAs to determine the total number of skilled
professional visits that are provided directly. HHAs currently report
employment data (full-time equivalents) on their cost reports
(freestanding HHAs: Form HCFA-1728-S-3 currently approved under OMB
number 0938-0022 and hospital based HHAs: Form HCFA-2552-H-S-4
currently approved under OMB number 0938-0050).
Burden Estimate
2 minutes x 9,058 existing HHAs = 302 hours
2 minutes x 1,145 newly certified HHAs = 39 hours
Section 484.75 Home Health Aide Services
This section governs the requirements for home health aide
services. Many requirements in this section directly mirror the
statutory requirements of section 4021 of OBRA '87. The requirements
are longstanding and implement sections 1891 and 1861 of the Act: (1)
The HHA must maintain sufficient documentation to demonstrate that
training requirements are met; (2) The HHA's competency evaluation must
address all required subjects; (3) The HHA must maintain documentation
that demonstrates that requirements of competency evaluation are met;
and (4) A registered nurse or appropriate skilled professional prepares
written instructions for care to be provided by the home health aide.
In addition, this section requires the HHA to conduct criminal
background checks of home health aides as a condition of employment.
Burden Estimate
The first requirement imposes no additional burden as this
documentation will be included in personnel records. The second
requirement will impose a one time burden (to develop competency
evaluation) on all existing agencies and any newly certified agencies
in the future. We estimate that it will require approximately 2 hours
for each HHA to formulate this evaluation (although this figure may be
much lower in practice if agencies chose to adopt standardized
evaluation forms).
2 hours x 9,058 existing HHAs = 18,116 hours annually
2 hours x 1,145 newly certified HHAs each year = 2,290 hours annually
Maintaining documentation that demonstrates that each aide has met
the evaluation requirements imposes no burden as this information will
be retained in personnel records. The third requirement imposes a
burden of approximately 3 minutes for each newly admitted patient that
receives aide care, or 3 minutes x 260,000 (estimated number of
patients receiving aide care) = 13,000 hours.
We are not able at this time to estimate the burden associated with
the requirement that the HHA conduct criminal background checks of home
health aides. We solicit comments on whether HHAs believe this
requirement will impose an additional burden on them and what that
burden would be.
Section 484.100 Compliance With Federal, State, and Local Laws
Under this section, the HHA must disclose to the State Survey
Agency at the time of the HHA's initial request for certification the
name and address of all persons with an ownership or control interest
in the HHA, the name and address of all officers, directors, agents,
and managers of the HHA, as well as the name and address of the
corporation or association responsible for the management of the HHA
and the chief executive and chairman of that corporation or
association. This requirement directly implements section 4021 of OBRA
'87.
Burden Estimate
This provision expands upon a similar requirement currently
contained in Sec. 405.1221(b). It imposes a minimal burden of adding
the necessary additional information to the current disclosure used by
existing HHAs and
[[Page 11028]]
the creation of a new disclosure of ownership for newly certified HHAs.
The burden for supplementing the existing disclosure with the required
additional information is estimated at--
5 minutes x 9,058 (total number of Medicare certified HHAs in 1995) =
755 hours
5 minutes x 1,145 (number of newly certified HHAs in 1995) = 95 hours
Section 484.105 Organization and Administration of Services
The revised organization and administration of services condition
simplifies the structure of the current requirements and provides
flexibility to the HHA by replacing the current focus on organizational
structures with new performance expectations for the administration of
the HHA as an organizational entity. In the proposed condition we
revise the current standard on governing body Sec. 484.14(b), retain
with only minor editorial changes the current standard on services
furnished Sec. 484.12(a), retain with only minor editorial changes, the
requirements with respect to services furnished under arrangements
under existing Sec. 484.14(h), delete the current standards on the
administrator Sec. 484.14(c), delete the current standards on
supervising physician or registered nurse Sec. 484.14(d), delete the
current standards on personnel policies Sec. 484.14(e), delete the
current standards on institutional planning Sec. 484.14(i), relocate
current condition Sec. 484.38 under this condition and relocate the
current standard on laboratory services under the compliance with
Federal, State and local laws condition.
The current institutional planning requirements under
Sec. 484.14(i) impose 5,474.5 hours of burden under the current HHA
conditions of participation. We are proposing to delete that
requirement from the HHA conditions of participation, therefore,
reducing current burden associated with the institutional planning
requirements.
Section 484.110 Clinical Records
A clinical record containing pertinent past and current findings is
maintained for every patient receiving home health services. Clinical
records are retained for 5 years after the month the cost report to
which the records is filed with the intermediary. Written procedures
govern the use and removal of records and conditions for release of
information. This section contains longstanding provisions which are
specifically required in section 1861(o) of the Act and are necessary
to the preservation of the patient's privacy and the quality of care.
There is no burden associated with the retention of patient records as
this merely entails the filing of a copy of the record.
Total Burden Estimate
The total annual hourly burden for the information collection
requirements under the revisions proposed to the HHA conditions of
participation is estimated to be 86,008 hours. We estimate the annual
hourly burden under the revised COPs to be 8.4 hours per Medicare-
certified HHA (86,008 total hours/10,203 (total number of Medicare-
certified HHAs and newly certified HHAs in calendar year 1995). The
total annual hourly burden for the information collection requirements
under OMB approval number 0938-0365 (current HHA conditions of
participation) was estimated to be 7.7 hours per Medicare-certified HHA
(69,499 total hours/9,009 (total number of Medicare-certified HHAs and
newly certified HHAs as of November 1994).
Again, we welcome comments on all aspects of the above material.
Written comments on these information collection and recordkeeping
requirements should be mailed directly to the following:
Health Care Financing Administration, Office of Financial and Human
Resources, Management Planning and Analysis Staff, Room C2-26-17, 7500
Security Boulevard, Baltimore, Maryland 21244-1850; and Office of
Information and Regulatory Affairs, Office of Management and Budget,
Room 10235, New Executive Office Building Washington, DC 20503,
Attention: Allison Herron Eydt, HCFA Desk Officer.
Any comments submitted on these collection of information
requirements must be received by these two offices on or before May 9,
1997, to enable OMB to act promptly on HCFA's information collection
approval request.
VI. Crosswalk Current COPs/Revised COPs
------------------------------------------------------------------------
Current COPs Revised COPs
------------------------------------------------------------------------
Patient Rights 484.10:
484.10(a).......................... Intact 484.50(a).
484.10(b).......................... Revised 484.50(b).
484.10(c).......................... Revised 484.50(c).
484.10(d).......................... Revised 484.50(d).
484.10(e).......................... Intact 484.50(e).
484.10(f).......................... Intact 484.50(f).
Compliance with Federal, State and
local laws, disclosure of ownership
information 484.12:
484.12(a).......................... Intact with minor revisions
484.100(a).
484.12(b).......................... Intact 484.100(b).
484.12(c).......................... Incorporated into QAPI 484.65.
Organization, Services and
Administration 484.14:
484.14(a).......................... Revised 484.105(e).
484.14(b).......................... Revised 484.105(a).
484.14(c).......................... Revised 484.105(a).
484.14(d).......................... Deleted.
484.14(e).......................... Incorporated into QAPI 484.65.
484.14(f).......................... Deleted.
484.14(g).......................... Revised 484.60(d).
484.14(h).......................... Revised 484.105(d).
484.14(i).......................... Deleted.
484.14(j).......................... Intact 484.100(d).
Group of Professional Personnel 484.16. Deleted--QAPI approach 484.65.
Acceptance of patients, plan of care
and medical supervision 484.18:
484.18(a).......................... Revised 484.60(a).
484.18(b).......................... Revised 484.60(b).
484.18(c).......................... Revised 484.60(c) and
484.55(a).
[[Page 11029]]
Skilled Nursing Services 484.30........ Deleted--combined aspects
484.70.
Therapy Services 484.32................ Deleted--combined aspects
484.70.
Medical Social Services 484.34......... Deleted--combined aspects
484.70.
Home Health Aide Services 484.36:
484.36(a).......................... Intact 484.75(b).
484.36(a)(1)(i).................... Revised 484.75(b)(1)(i).
484.36(a)(1) (ii)-(xii)............ Intact 484.75(b)(1) (ii)-(xii).
484.36(a)(1)(xiii)................. Revised 484.75(b)(1)(xiii).
484.36(a)(2)(i).................... Intact 484.75(b)(2).
484.36(a)(2)(ii)................... Revised 484.75(b)(3).
484.36(a)(3)....................... Revised 484.75(b)(4).
484.36(b)(1)....................... Revised 484.75(c)(1).
484.36(b)(2)(i).................... Intact 484.75(c)(2).
484.36(b)(2)(ii)................... Deleted.
484.36(b)(2)(iii).................. Revised 484.75(d)(1).
484.36(b)(3)(i).................... Revised 484.75 (c)(3) and
(d)(2).
484.36(b)(3)(ii)................... Revised 484.75(c)(4).
484.36(b)(3)(iii).................. Revised 484.75(c)(2).
484.36(b)(4)(i).................... Intact 484.75(c)(5).
484.36(b)(4)(ii)................... Deleted.
484.36(b)(5)....................... Intact 484.75(c)(6).
484.36(b)(6)....................... Deleted.
484.36(c).......................... Revised 484.75(e).
484.36(d).......................... Revised 484.75(f).
484.36(e).......................... Intact 484.75(g).
Qualifying to furnish outpatient PT or Intact 484.105(f).
Speech language pathology 484.38.
Clinical Records 484.48................ Revised 484.110.
Evaluation of Agency's Program 484.52.. Deleted QAPI approach 484.65.
Definitions 484.2...................... Revised 484.2.
Personnel Qualifications 484.4......... Revised Approach 484.115.
------------------------------------------------------------------------
VII. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
HCFA proposes to amend 42 CFR chapter IV 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)).
2. Part 484 is revised to read as follows:
PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES
Subpart A--General Provisions
Sec.
484.1 Basis and scope.
484.2 Definitions.
Subpart B--Patient Care
484.50 Condition of participation: Patient rights.
484.55 Condition of participation: Comprehensive assessment of
patients.
484.60 Condition of participation: Care planning and coordination
of services.
484.65 Condition of participation: Quality assessment and
performance improvement.
484.70 Condition of participation: Skilled professional services.
484.75 Condition of participation: Home health aide services.
Subpart C--Organizational Environment
484.100 Condition of participation: Compliance with Federal, State,
and local laws.
484.105 Condition of participation: Organization and administration
of services.
484.110 Condition of participation: Clinical records.
484.115 Condition of participation: Personnel qualifications for
skilled professionals.
Subpart A--General Provisions
Sec. 484.1 Basis and scope.
(a) Basis. This part is based on sections 1861(o) and 1891 of the
Act, which establish the conditions that an HHA must meet in order to
participate in Medicare, and specify that the Secretary may impose
additional requirements that are considered necessary to ensure the
health and safety of patients.
(b) Scope. The provisions of this part serve as the basis for
survey activities for the purpose of determining whether an agency
meets the requirements for participation in Medicare.
Sec. 484.2 Definitions.
As used in this part--
Branch office means a location or site from which a home health
agency provides services within a portion of the total geographic area
served by the parent agency. The branch office is part of the home
health agency and is located sufficiently close to share
administration, supervision, and services in a manner that renders it
unnecessary for the branch independently to meet the conditions of
participation as a home health agency.
Parent home health agency means the agency that develops and
maintains administrative control of branches.
Quality indicator means a specific, valid, and reliable measure of
access, care outcomes, or satisfaction, or a measure of a process of
care that has been empirically shown to be predictive of access, care
outcomes, or satisfaction.
[[Page 11030]]
Subpart B--Patient Care
Sec. 484.50 Condition of participation: Patient rights.
The patient has the right to be informed of his or her rights. The
HHA must protect and promote the exercise of these rights.
(a) Standard: Notice of rights.
(1) The HHA must provide the patient with a written notice of the
patient's rights in advance of furnishing care to the patient or during
the initial evaluation visit before the initiation of treatment.
(2) The HHA must maintain documentation showing that it has
complied with the requirements of this section.
(b) Standard: Exercise of rights and respect for property and
person.
(1) The patient has the right to exercise his or her rights as a
patient of the HHA.
(2) The patient's family or guardian may exercise the patient's
rights when the patient has been judged incompetent.
(3) The patient has the right to have his or her property treated
with respect.
(4) The patient has the right to voice grievances regarding
treatment or care that is (or fails to be) furnished, or regarding the
lack of respect for property by anyone who is furnishing services on
behalf of the HHA and must not be subjected to discrimination or
reprisal for doing so.
(5) The HHA must investigate complaints made by a patient or the
patient's family or guardian regarding treatment or care that is (or
fails to be) furnished, or regarding the lack of respect for the
patient or the patient's property by anyone furnishing services on
behalf of the HHA, and must document both the existence of the
complaint and the resolution of the complaint.
(c) Standard: Right to be informed and to participate in planning
care and treatment.
(1) The patient has the right to be informed, in advance, about the
care to be furnished, the plan of care, expected outcomes, barriers to
treatment, and of any changes in the care to be furnished.
(i) The HHA must advise the patient in advance of the disciplines
that will furnish care, and the frequency of visits proposed to be
furnished.
(ii) The HHA must advise the patient in advance of any change in
the plan of care before the change is made.
(2) The patient has the right to participate in the planning of the
care.
(i) The HHA must advise the patient in advance of the right to
participate in planning the care or treatment and in planning changes
in the care or treatment.
(ii) The HHA must comply with the requirements of subpart I of part
489 of this chapter relating to maintaining written policies and
procedures regarding advance directives. The HHA must inform and
distribute written information to the patient, in advance, concerning
its policies on advance directives, including a description of
applicable State law.
(d) Standard: Confidentiality of medical clinical records. The
patient has the right to confidentiality of the clinical records
maintained by the HHA. The HHA must advise the patient of the agency's
policies and procedures regarding disclosure of clinical records.
(e) Standard: Patient liability for payment.
(1) The patient has the right to be advised, before care is
initiated, of the extent to which payment for the HHA services may be
expected from Medicare or other sources, and the extent to which
payment may be required from the patient. Before the plan of care is
initiated, the HHA must inform the patient orally and in writing of:
(i) The extent to which payment may be expected from Medicare,
Medicaid, or any other Federally funded or aided program known to the
HHA;
(ii) The charges for services that will not be covered by Medicare;
and
(iii) The charges that the individual may have to pay.
(2) The patient has the right to be advised orally and in writing
of any changes in the information provided in accordance with paragraph
(e)(1) of this section when they occur. The HHA must advise the patient
of these changes orally and in writing as soon as possible, but no
later than 30 calendar days from the date that the HHA becomes aware of
a change.
(f) Standard: Home health hotline. The patient has the right to be
advised of the availability of the toll-free home health hotline in the
State. When the agency accepts the patient for treatment or care, the
HHA must advise the patient in writing of the telephone number of the
home health hotline established by the State, the hours of its
operation, and that the purpose of the hotline is to receive complaints
or questions about local HHAs.
Sec. 484.55 Condition of participation: Comprehensive assessment of
patients.
Each patient must receive, and an HHA must provide, a patient-
specific, comprehensive assessment that identifies the patient's need
for home care and that meets the patient's medical, nursing,
rehabilitative, social, and discharge planning needs.
(a) Standard: Drug regimen review. The comprehensive assessment
must include a review of the patient's drug regimen 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.
(b) Standard: Initial assessment visit.
(1) Based on physician's orders, a registered nurse must perform an
initial assessment visit to determine the immediate care and support
needs of the patient. The initial assessment visit must be held either
within 48 hours of referral, or within 48 hours of the patient's return
home, or within 48 hours of the physician-ordered start of care date,
if that is later.
(2) When rehabilitation therapy service (speech language pathology
services, physical therapy, or occupational therapy) is the only
service ordered by the physician, the initial assessment visit may be
made by the appropriate rehabilitation skilled professional.
(c) Standard: Timeframe for completion of the comprehensive
assessment. 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.
(d) Standard: Update of comprehensive assessment. The comprehensive
assessment must include information on the patient's progress toward
clinical outcomes, and must be updated and revised--
(1) As frequently as the condition of the patient requires, but not
less frequently than every 62 days beginning with the start of care
date;
(2) When the plan of care is revised for physician review; and
(3) At discharge.
Sec. 484.60 Condition of participation: Care planning and coordination
of services.
Each patient must have a written plan of care that must specify the
care and services necessary to meet the patient-specific needs
identified by the physician or in the comprehensive assessment, or
both, and the measurable outcomes that the HHA anticipates will occur
as a result of implementing and coordinating the plan of care. Patients
are accepted for treatment on the basis of a reasonable expectation
that the patient's medical, nursing, and social needs can be met
adequately by the
[[Page 11031]]
agency in the patient's place of residence.
(a) Standard: Plan of care. All home health services furnished to
patients must follow a written plan of care established and
periodically reviewed by a doctor of medicine, osteopathy, or podiatric
in accordance with Sec. 409.42 of this chapter. All patient care orders
must be included in the plan of care.
(b) Standards: Review and revision of the plan of care.
(1) The plan of care must be reviewed and revised by the physician
and the HHA as frequently as the patient's condition requires, but no
less frequently than once every 62 days, beginning with the date of
start of care. The HHA must promptly alert the physician to any changes
in the patient's condition that suggest a need to alter the plan of
care or that suggest that measurable outcomes are not being achieved.
(2) A revised plan of care must include current information from
the patient's comprehensive assessment and information concerning the
patient's progress toward outcomes specified in the plan of care.
(c) Standard: Conformance with physician orders.
(1) Services and treatments must be administered by agency staff
only as ordered by the physician.
(2) Oral orders must be accepted only by personnel authorized to do
so by applicable State and Federal laws and regulations as well as by
the HHA's internal policies.
(3) When services are provided on the basis of a physician's oral
orders, a registered nurse or qualified therapist responsible for
furnishing or supervising the ordered services must put the orders in
writing and sign and date the orders with the date of receipt. Oral
orders must also be countersigned and dated by the physician.
(d) Standard: Coordination of care.
(l) The HHA must maintain a system of communication and integration
of services, whether provided directly or under arrangement, that
ensures the identification of patient needs and barriers to care, the
ongoing liaison of all disciplines providing care, and the contact of
the physician for relevant medical issues.
(2) The HHA identifies the level of coordination necessary to
deliver care to the patient and involves the patient and care giver in
coordination of care efforts.
Sec. 484.65 Condition of participation: Quality assessment and
performance improvement.
The HHA must develop, implement, maintain, and evaluate an
effective, data-driven quality assessment and performance improvement
program. The program must reflect the complexity of the HHA's
organization and services (including those services provided directly
or under arrangement). The HHA must take actions that result in
improvements in the HHA's performance across the spectrum of care.
(a) Standard: Components of quality assessment and performance
improvement program. The HHA's quality assessment and performance
improvement program must include, but not be limited to, the use of
objective measures to demonstrate improved performance with regard to:
(1) Quality indicator data (derived from patient assessments) to
determine if individual and aggregate measurable outcomes are achieved
compared to a specified previous time period.
(2) Current clinical practice guidelines and professional practice
standards applicable to home care.
(3) Utilization data, as appropriate (for example, numbers of
staff, types of visits, hours of services, etc.).
(4) Patient satisfaction measures.
(5) Effectiveness and safety of services (including complex high
technology services, if provided), including competency of clinical
staff, promptness of service delivery, and whether patients are
achieving treatment goals and measurable outcomes.
(b) Standard: Monitoring performance improvement. The HHA must take
actions that result in performance improvements and must track
performance to assure that improvements are sustained over time.
(c) Standard: Prioritizing improvement activities. The HHA must set
priorities for performance improvement, considering prevalence and
severity of identified problems and giving priority to improvement
activities that affect clinical outcomes. The HHA must immediately
correct any identified problems that directly or potentially threaten
the health and safety of patients.
(d) Standard: External quality assessment and performance
improvement program. The HHA must meet periodic external quality
assessment and performance improvement reporting requirements as
specified by HCFA.
(e) Standard: Infection control. The HHA must maintain an effective
infection control program in accordance with the policies and
procedures of the HHA and Federal and State requirements.
Sec. 484.70 Condition of participation: Skilled professional services.
Skilled professionals who provide services to HHA patients directly
or under arrangement must participate in all aspects of care, including
an ongoing multidisciplinary evaluation and development of the plan of
care, and be actively involved in the HHA's quality assessment and
performance improvement program. For purposes of this section, skilled
professional services include skilled nursing services, physical
therapy, speech language pathology services, and occupational therapy
as specified in Sec. 409.44, and medical social worker and home health
aide services as specified in Sec. 409.45.
(a) Standard: Services of skilled professionals. Skilled
professional services are authorized, delivered, and supervised (that
is, given authoritative procedural guidance) only by health care
professionals who meet the appropriate qualifications specified under
Sec. 484.115 and who practice under the HHA's policies and procedures.
(b) Standard: Provision of services. The HHA must ensure that a
majority, at least 50 percent, of total skilled professional services
are routinely provided directly by the HHA. An HHA may provide other
skilled professional visits under arrangement as needed.
Sec. 484.75 Condition of participation: Home health aide services.
All home health aide services must be provided by individuals who
meet the personnel requirements specified in paragraph (a) of this
section.
(a) Standard: Home health aide qualifications. A qualified home
health aide is a person who--
(1) Has successfully completed a State-established or other
training program that meets the requirements of paragraph (b) of this
section and a competency evaluation program or State licensure program
that meets the requirements of paragraph (c) of this section, or a
competency evaluation program or State licensure program that meets the
requirements of paragraph (c) of this section; or has completed a nurse
aide training or competency evaluation program approved by the State as
meeting the requirements of Secs. 483.151 through 483.154 of this
chapter and is currently listed in good standing on the State nurse
aide registry;
(2) Under paragraph (a)(1) of this section, an individual is not
considered to have completed a training and competency evaluation
program, or a competency evaluation program if, since the individual's
most recent completion of this program(s), there has been a
[[Page 11032]]
continuous period of 24 consecutive months during none of which the
individual furnished services described in Sec. 409.40 of this chapter
for compensation. If a 24-month lapse in furnishing services has
occurred, the individual must complete another training and competency
evaluation program or a competency evaluation program, as specified in
paragraph (a)(1) of this section, before providing services.
(b) Standard: Home health aide training.--(l) Content and duration
of training. The home health aide training must include classroom and
supervised practical training that totals at least 75 hours. A minimum
of 16 hours of classroom training must precede a minimum of l6 hours of
supervised practical training. ``Supervised practical training'' means
training in a practicum laboratory or other setting in which the
trainee demonstrates knowledge while performing tasks on an individual
under the direct supervision of a registered nurse or licensed
practical nurse. The home health aide training program must address
each of the following subject areas:
(i) Communication skills, including the ability to read, write, and
make brief and accurate oral and written presentations to patients,
care givers, and other HHA staff.
(ii) Observation, reporting, and documentation of patient status
and the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function
that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and knowledge of emergency
procedures. (viii) The physical, emotional, and developmental needs of
and ways to work with the populations served by the HHA, including the
need for respect for the patient, his or her privacy, and his or her
property.
(ix) Appropriate and safe techniques in personal hygiene and
grooming that include--
(A) Bed bath.
(B) Sponge, tub, or shower bath.
(C) Hair shampoo (sink, tub, or bed).
(D) Nail and skin care.
(E) Oral hygiene.
(F) Toileting and elimination.
(x) Safe transfer techniques and ambulation.
(xi) Normal range of motion and positioning.
(xii) Adequate nutrition and fluid intake.
(xiii) Any other task that the HHA may choose to have the home
health aide perform. The HHA is responsible for training the home
health aide, as needed, for skills not covered in this basic checklist.
(2) Conduct of training: Eligible training organizations. A home
health aide training program may be offered by any organization except
an HHA that, within the previous 2 years, has been found----
(i) Out of compliance with the requirements of paragraphs (b) or
(c) of this section;
(ii) To permit an individual that does not meet the definition of
``home health aide'' as specified in paragraph (a) of this section to
furnish home health aide services (with the exception of licensed
health professionals and volunteers);
(iii) Has been subject to an extended (or partial extended) survey
as a result of having been found to have furnished substandard care (or
for other reasons at the discretion of HCFA or the State);
(iv) Has been assessed a civil monetary penalty of not less than
$5,000 as an intermediate sanction;
(v) Has been found to have compliance deficiencies that endanger
the health and safety of the HHA's patients and has had a temporary
management appointed to oversee the management of the HHA;
(vi) Has had all or part of its Medicare payments suspended; or
(vii) Under any Federal or State law
(A) Has had its participation in the Medicare program terminated;
(B) Has been assessed a penalty of not less than $5,000 for
deficiencies in Federal or State standards for HHAs;
(C) Was subject to a suspension of Medicare payments to which it
otherwise would have been entitled;
(D) Had operated under a temporary management that was appointed to
oversee the operation of the HHA and to ensure the health and safety of
the HHA's patients; or
(E) Was closed or had its residents transferred by the State.
(3) Conduct of training: Qualifications for instructors. The
training of home health aides must be performed by or under the
supervision of a registered nurse. Other individuals may be used to
provide instruction under the general supervision of the registered
nurse.
(4) Documentation of training. The HHA must maintain documentation
of the aide's successful completion of a home health aide training and
competency evaluation program or competency evaluation program or State
approved nurse aide training and competency evaluation to demonstrate
that the requirements of this standard are met.
(c) Standard: Competency evaluation. An individual may furnish home
health services on behalf of an HHA only after that individual has
successfully completed a competency evaluation program as described in
this section.
(l) The HHA must ensure that all individuals who furnish home
health aide services to patients meet the competency evaluation
requirements of this section. Personal care aides who exclusively
provide personal care services to Medicaid patients under a State
Medicaid personal care benefit must meet the requirements specified in
paragraph (g) of this section.
(2) The competency evaluation must address each of the subjects
listed in paragraphs (b)(l)(ii) through (xiii) of this section. Subject
areas specified under paragraphs (b)(l)(iii), (ix), (x), and (xi) of
this section must be evaluated by observing the aide's performance of
the task with a patient. The remaining subject areas may be evaluated
through written examination, oral examination, or after observation of
the home health aide with a patient.
(3) A home health aide competency evaluation program may be offered
by any organization, except as specified in paragraph (b)(2) of this
section.
(4) The competency evaluation must be performed by a registered
nurse in consultation with other skilled professionals, as appropriate.
(5) A home health aide is not considered competent in any task for
which he or she is evaluated as ``unsatisfactory.'' The aide must not
perform that task without direct supervision by a licensed nurse until
after he or she received training in the task for which he or she was
evaluated as ``unsatisfactory'' and passes a subsequent evaluation with
``satisfactory.''
(6) The HHA must maintain documentation that demonstrates the
requirements of this standard are met.
(d) Standard: Inservice training.
(l) The home health aide must receive at least l2 hours of
inservice training in a l2-month period. During the first l2 months of
employment, hours may be prorated based on the date of hire. The in-
service training may occur while the aide is furnishing care to a
patient.
(2) Inservice training may be offered by any organization except
one that is excluded under paragraph (b)(2) of this section.
(3) The inservice training must be supervised by a registered
nurse.
(e) Standard: Home health aide assignments.
[[Page 11033]]
(l) The home health aide is assigned to a specific patient by the
registered nurse. Written patient care instructions for the home health
aide must be prepared by the registered nurse or other appropriate
skilled professional (that is, physical therapist, speech language
pathologist, or occupational therapist) who is responsible for the
supervision of the home health aide as specified under paragraph (f) of
this section.
(2) The home health aide provides services that are ordered by the
physician in the plan of care and that the aide is permitted to perform
under State law. The duties of a home health aide include the provision
of hands-on personal care, performance of simple procedures as an
extension of therapy or nursing services, assistance in ambulation or
exercises, and assistance in administering medications that are
ordinarily self-administered.
(3) Home health aides must report changes in the patient's medical,
nursing, rehabilitative, and social needs to the registered nurse or
other appropriate skilled professional, and complete appropriate
records in compliance with the HHA policies and procedures.
(f) Supervision.
(l) If the patient receives skilled nursing care, the registered
nurse must perform the supervisory visit required under paragraph
(f)(2) of this section. If the patient is not receiving skilled nursing
care, but is receiving another skilled service (that is, physical
therapy, occupational therapy, or speech-language pathology services),
supervision may be provided by the appropriate skilled professional.
Documentation of the supervisory visit must be made in the patient's
record.
(2) The registered nurse (or another professional described in
paragraph (f)(l) of this section) must make an onsite visit to the
patient's home no less frequently than every 2 weeks.
(3) If home health aide services are provided to a patient who is
not receiving skilled nursing care, physical or occupational therapy,
or speech-language pathology services, the registered nurse must make a
supervisory visit to the patient's home no less frequently than every
62 days. In these cases, each supervisory visit must occur while the
home health aide is providing patient care to ensure that the aide is
properly caring for the patient.
(4) If home health aide services are provided by an individual who
is not employed directly by the HHA, the services of the home health
aide must be provided under arrangement as defined in section
l86l(w)(l) of the Act (42 U.S.C. 1395 x(w)). If the HHA chooses to
provide home health aide services under arrangement with another
organization, the HHA's responsibilities include, but are not limited
to--
(i) Ensuring the overall quality of care provided by the aide;
(ii) Supervision of the aide's services as described in paragraphs
(f)(l) and (2) of this section; and
(iii) Ensuring that home health aides providing services under
arrangement have met the training or competency evaluation
requirements, or both, of this condition.
(g) Standard: Medicaid personal care aide services--Medicaid
personal care benefit.
(l) Applicability. This paragraph applies to individuals who are
employed by HHAs exclusively to furnish personal care attendant
services under a Medicaid personal care benefit.
(2) Rule. An individual may furnish personal care services, as
defined in Sec. 440.170 of this chapter, on behalf of an HHA after the
individual has been found competent by the State to furnish those
services for which a competency evaluation is required by this section
and which the individual is required to perform. The individual need
not be determined competent in those services listed in this section
that the individual is not required to furnish.
Subpart C--Organizational Environment
Sec. 484.100 Condition of participation: Compliance with Federal,
State, and local laws.
(a) Standard: Compliance with Federal, State, and local laws and
regulations. The HHA and its staff must operate and furnish services in
compliance with all Federal, State, and local laws and regulations
applicable to HHAs. If a State has established licensing requirements
for HHAs, all HHAs must be approved by the State licensing authority as
meeting those requirements whether or not they are required to be
licensed by the State.
(b) Standard: Disclosure of ownership and management information.
The HHA must comply with the requirements of part 420, subpart C of
this chapter. The HHA also must disclose the following information to
the State survey agency at the time of the HHA's initial request for
certification, for each survey, and at the time of any change in
ownership or management:
(l) The name and address of all persons with an ownership or
control interest in the HHA as defined in Secs. 420.20l, 420.202, and
420.206 of this chapter.
(2) The name and address of each person who is an officer, a
director, an agent, or a managing employee of the HHA as defined in
Secs. 420.20l, 420.202, and 420.206 of this chapter.
(3) The name and address of the corporation, association, or other
company that is responsible for the management of the HHA, and the name
and address of the chief executive officer and the chairperson of the
board of directors of that corporation, association, or other company
responsible for the management of the HHA.
(c) Standard: Licensing. The HHA and its branches must be licensed
in accordance with State licensure laws, if applicable, prior to
providing Medicare reimbursed services.
(d) Standard: Laboratory services.
(l) If the HHA engaged in laboratory testing outside of the context
of assisting an individual in self-administering a test with an
appliance that has been cleared for the purpose by the Food and Drug
Administration, such testing must be in compliance with all applicable
requirements of part 493 of this chapter.
(2) If the HHA chooses to refer specimens for laboratory testing to
another laboratory, the referral laboratory must be certified in the
appropriate specialties and subspecialties of services in accordance
with the applicable requirements of part 493 of this chapter.
Sec. 484.105 Condition of participation: Organization and
administration of services.
The HHA must organize, manage, and administer its resources to
attain and maintain the highest practicable functional capacity for
each patient regarding medical, nursing, and rehabilitative needs as
indicated by the plan of care.
(a) Standard: Governing body. A governing body (or designated
persons so functioning) must assume full legal authority and
responsibility for the management and provision of all home health
services, fiscal operations, quality assessment and performance
improvement, and appoints a qualified administrator who is responsible
for the day-to-day operation designated persons to carry out these
functions.
(b) Standard: Primary HHA. The HHA that accepts the patient becomes
the primary HHA and assumes responsibility for the interdisciplinary
coordination and provision of services ordered on the patient's plan of
care, and continuity of care, whether the services are provided
directly or under arrangement.
[[Page 11034]]
(c) Standard: Parent-branch relationship.
(1) The parent home health agency provides direct support and
administrative control of its branches.
(2) The branch office is located sufficiently close to the parent
home health agency to effectively share administration, supervision,
and services in a manner that renders it unnecessary for the branch
separately to meet the conditions of participation as an HHA.
(d) Standard: Services under arrangement.
(1) The HHA must ensure that all arranged services provided by
other entities or individuals meet the requirements of this part and
the requirements of section 1861(w) of the Act (42 U.S.C. 1395x(w)).
(2) An HHA that has a written agreement with another agency or
organization to furnish services to the HHA's patients maintains
overall responsibility for those services.
(e) Standard: Services furnished. Part-time or intermittent skilled
nursing services and at least one other therapeutic service (physical,
speech, or occupational therapy; medical social services; or home
health aide services) are made available on a visiting basis, in a
place of residence used as a patient's home. An HHA must provide at
least one of the qualifying services directly, but may provide the
second qualifying service and additional services under arrangement
with another agency or organization.
(f) Standard: Physical therapy or speech-language pathology
services. An HHA that furnishes outpatient physical therapy or speech
language pathology services must meet all of the applicable conditions
of this part and the additional health and safety requirements set
forth in Secs. 485.711, 485.713, 485.715, 485.719. 485.723, and 485.727
of this chapter.
Sec. 484.110 Condition of participation: Clinical records.
A clinical record containing past and current findings is
maintained for every patient who is accepted by the HHA for home health
service. Information contained in the clinical record must be accurate,
available to the patient's physician and appropriate HHA staff, and may
be maintained electronically.
(a) Standard: Contents of clinical record. The record must include:
(1) The patient's current comprehensive assessment, clinical/
progress notes, and plan of care;
(2) Responses to medications, treatments and services;
(3) A description of measurable outcomes relative to goals in the
patient's plan of care that have been achieved; and
(4) A discharge summary that is available to physicians upon
request.
(b) Standard: Authentication. All entries must be legible, clear,
complete, and appropriately authenticated and dated. Authentication
must include signatures or a secured computer entry by a unique
identifier of a primary author who has reviewed and approved the entry.
(c) Standard: Retention of records. Clinical records must be
retained for 5 years after the month the cost report to which the
records apply is filed with the intermediary, unless State law
stipulates a longer period of time. The HHA's internal policies must
provide for retention of the clinical records even if the HHA
discontinues operations. If a patient is transferred to another health
facility, a copy of the records or discharge summary must be sent with
the patient.
(d) Standard: Protection of records. Patient information and the
record must be safeguarded against loss or unauthorized use.
Sec. 484.115 Personnel qualifications for skilled professionals.
(a) General qualification requirements. Except as specified in
paragraphs (b) and (c) of this section, all skilled professionals who
provide services directly by or under arrangements with an HHA must be
legally authorized (licensed or, if applicable, certified or
registered) to practice by the State in which he or she performs the
functions or actions, and must act only within the scope of his or her
State license or State certification or registration.
(b) Exception for Federally defined qualifications. The following
Federally defined qualifications must be met:
(1) For physicians, the qualifications and conditions as defined in
section 1861(r) of the Act and implemented at Sec. 410.20 of this
chapter).
(2) For speech language pathologists, the qualifications specified
in section 1861(ll)(1) of the Act.
(3) For home health aides, the qualifications required by section
1891(a)(3) of the Act and implemented at Sec. 484.75.
(c) Exceptions when no State licensing laws or State certification
or registration requirements exist. If no State licensing laws or State
certification or registration requirements exist for the profession,
the following requirements must be met:
(1) The administrator of a home health agency must--
(i) Be a licensed physician; or
(ii) Hold an undergraduate degree and--
(A) Be a registered nurse; or
(B) Have education and experience in health service administration,
with at least one year of supervisory or administrative experience in
home health care or a related health care program, and in financial
management.
(2) An occupational therapist must--
(i) Be a graduate of an occupational therapy curriculum accredited
jointly by the Committee on Allied Health Education and Accreditation
of the American Medical Association and the American Occupational
Therapy Association; or
(ii) Be eligible for the National Registration Examination of the
American Occupational Therapy Association; or
(iii) Have 2 years of appropriate experience as an occupational
therapist, and have achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that such determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking
initial qualification as an occupational therapist after December 31,
1977.
(3) An occupational therapy assistant must--
(i) Meet the requirements for certification as an occupational
therapy assistant established by the American Occupational Therapy
Association; or
(ii) Have 2 years of appropriate experience as an occupational
therapy assistant, and have achieved a satisfactory grade on a
proficiency examination conducted, approved, or sponsored by the U.S.
Public Health Service, except that such determinations of proficiency
do not apply with respect to persons initially licensed by a State or
seeking initial qualification as an occupational therapy assistant
after December 31, 1977.
(4) Physical therapist. A person who--
(i) Has graduated from a physical therapy curriculum approved by--
(A) The American Physical Therapy Association;
(B) The Committee on Allied Health Education and Accreditation of
the American Medical Association; or
(C) The Council on Medical Education of the American Medical
Association and the American Physical Therapy Association; or
(ii) Prior to January 1, 1966--
(A) Was admitted to membership by the American Physical Therapy
Association;
(B) Was admitted to registration by the American Registry of
Physical Therapist; or
(C) Has graduated from a physical therapy curriculum in a 4-year
college
[[Page 11035]]
or university approved by a State department of education; or
(iii) Has 2 years of appropriate experience as a physical
therapist, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service except that such determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking
qualification as a physical therapist after December 31, 1977; or
(iv) Was licensed or registered prior to January 1, 1966, and prior
to January 1, 1970, had 15 years of full-time experience in the
treatment of illness or injury through the practice of physical therapy
in which services were rendered under the order and direction of
attending and referring doctors of medicine or osteopathy; or
(v) If trained outside the United States--
(A) Was graduated since 1928 from a physical therapy curriculum
approved in the country in which the curriculum was located and in
which there is a member organization of the World Confederation for
Physical Therapy;
(B) Meets the requirements for membership in a member organization
of the World Confederation for Physical Therapy,
(5) Physical therapist assistant. A person who--
(i) Has graduated from a 2-year college-level program approved by
the American Physical Therapy Association; or
(ii) Has 2 years of appropriate experience as a physical therapy
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that these determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking
initial qualification as a physical therapy assistant after December
31, 1977.
(6) Public health nurse. A registered nurse who has completed a
baccalaureate degree program approved by the National League for
Nursing for public health nursing preparation or postregistered nurse
study that includes content approved by the National League for Nursing
for public health nursing preparation.
(7) Registered nurse. A graduate of a school of professional
nursing.
(8) Social work assistant. A person who--
(i) Has a baccalaureate degree in social work, psychology,
sociology, or other field related to social work, and has had at least
1 year of social work experience in a health care setting; or
(ii) Has 2 years of appropriate experience as a social work
assistant, and has achieved a satisfactory grade on a proficiency
examination conducted, approved, or sponsored by the U.S. Public Health
Service, except that these determinations of proficiency do not apply
with respect to persons initially licensed by a State or seeking
initial qualification as a social work assistant after December 31,
1977.
(9) Social worker. A person who has a master's degree from a school
of social work accredited by the Council on Social Work Education, and
has 1 year of social work experience in a health care setting.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: July 15, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: August 16, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 97-5316 Filed 3-5-97; 9:45 am]
BILLING CODE 4120-01-P
