Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11005

would apply only in States without a

licensing requirement.

• Eliminate unnecessary

administrative requirements. Process

oriented requirements are included only

where we believe they remain highly

predictive of ensuring desired patient

outcomes and protect patient safety.

• Assure patients rights.

• Focus on continuous, integrated

care centered around patient

assessment, care planning, coordination

of service delivery, and quality

assessment and performance

improvement. The four ‘‘core

conditions’’ are Patient Rights, Patient

Assessment, Care Planning and

Coordination of Services, and Quality

Assessment and Performance

Improvement.

• Incorporate the program integrity

approaches.

2. The Proposed Implementation of

the Outcomes and Assessment

Information Set (OASIS).

This proposed rule would revise the

new conditions of participation for

HHAs by requiring an HHA to

incorporate the 79-item, core standard

assessment data set, referred to as the

OASIS, into its comprehensive patient

assessment, as well as use OASIS

information as part of its internal

quality assessment and performance

improvement program. The OASIS will

serve as the foundation for future

reliance on patient outcomes in

provider decision making, regulatory

oversight and consumer choice. This

proposed rule does not require the HHA

to collect and report OASIS to a national

data system.

This proposed rule is an integral part

of the Administration’s larger efforts to

achieve broad-based, measurable

improvement in the quality of care

furnished through Federal programs. It

is a fundamental component in the

transition to a quality assessment and

performance improvement approach

based on measurable patient outcomes

of care and satisfaction with the

Medicare home health benefit. In order

to reach the point where we can build

and use a national data set of measures

of outcomes and satisfaction, we must

begin with a requirement that all HHAs

use the same valid and reliable core

standard assessment data set. By

integrating a core standard assessment

data set into its own more

comprehensive assessment system, an

HHA can use such a valid and reliable

data set as the foundation for its quality

assessment and performance

improvement program.

We expect to receive positive and

constructive comments on both of these

documents. We have published these

documents as separate rules. They

reflect discreet steps in the transition

toward a regulatory system based on

patient outcomes. While linked in

important ways, they have different

impacts on the provider community. We

have published them in the same

Federal Register because together they

reflect a more complete picture of the

Department’s patient outcome based

strategy.

We have published the description of

the OASIS as a separate proposed rule

following the proposed HHA COP in

this Part of this issue of the Federal

Register. Please note that the

implementation of OASIS would change

only §§ 484.55 and 484.65 of the revised

HHA COP. We have included several

notes in the HHA COP to direct the

reader to the OASIS notice for more

comprehensive information.

(Catalog of Federal Domestic Assistance

Programs No 93.774, Medicare—

Supplementary Medical Insurance, and No.

93,778, Medical Assistance Program)

Dated: January 21, 1997.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: January 30, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–5314 Filed 3–5–97; 9:45 am]

BILLING CODE 4120–01–P

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.

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.
11006 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 patientcentered 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 patientcentered, outcome-oriented performance

expectations that will stimulate

continuous quality improvement in

home health care.

The existing HHA COPs do not

provide patient-centered, outcomeoriented 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
11008 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 § 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 patientcentered, 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 patientcentered, 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 § 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 § 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 § 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 § 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 § 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 § 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 § 484.115.

C. Proposed Subpart B, Patient Care
11010 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

1. Patient Rights (Proposed § 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 § 484.10.

We would retain these statutory

provisions in the proposed regulations

and redesignate existing § 484.10 as

proposed § 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 § 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 patientspecific, 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 § 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 § 484.55(a)). Under this

standard, we would retain the existing

requirement of a drug regimen review

from § 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 § 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 physicianordered 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

§ 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

§ 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 (§ 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 § 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 processoriented, 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 wellmanaged 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 § 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 § 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 § 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
11012 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 § 484.18(a). The first

standard under this condition, ‘‘Plan of

Care,’’ set forth at proposed § 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 § 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 § 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 § 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 § 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 § 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 § 484.60(c).

We propose to add a new standard,

Coordination of care, at § 484.60(d).

This standard would incorporate

provisions at existing § 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

§ 484.52, Evaluation of the agency’s

program, and existing § 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 selfsustaining 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 outcomeoriented 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 § 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

§ 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 § 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

§ 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
11014 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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, criterionreferenced 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

§ 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

§ 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11015

directly addressed when they are

identified.

The fourth standard under the Quality

Assessment and Performance

Improvement COP, at proposed

§ 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 § 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 §§ 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 §§ 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 § 409.44) and medical social

services and home health aide services

(as defined in § 409.45).

At proposed § 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 § 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
11016 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 § 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 § 484.75.

Standard: Home Health Aide

Qualifications

Currently, provisions concerning the

qualifications for home health aides are

set forth at § 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 § 484.75(a) we would

provide that a qualified home health

aide is an individual who has

successfully completed a Stateestablished or other training program

that meets the requirements of proposed

§ 484.75(b) and a competency

evaluation program or State licensure

program that meets the requirements of

proposed § 484.75(c), or a competency

evaluation program or State licensure

program that meets the requirements of

proposed § 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 §§ 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 §§ 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 § 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 § 409.40 of this chapter for

compensation. If an individual has not

furnished services described in § 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 § 484.36(a)(1). However,

we propose more concise language.
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11017

Specifically, at proposed § 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 § 484.75(b)(1)(i) would

clarify provisions regarding

communication skills currently located

at § 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

§ 484.36(a)(1) (ii) through (xii) at

proposed § 484.75(b)(1) (ii) through (xii)

(Standard: Content and duration of

training). We propose to retain current

§ 484.36(a)(1)(xiii) with clarification at

proposed § 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 § 484.75(b)(2) and (3), we

would essentially retain the provisions

governing conduct of training by

organizations and qualifications of

instructors under existing

§§ 484.36(a)(2) (i) and (ii).

At proposed § 484.75(b)(4), we would

essentially retain the documentation of

training requirement under existing

§ 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

§ 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 § 484.75(c) and (d)

respectively.

Standard: Competency Evaluation

In order to simplify this standard, at

proposed § 484.75(c) we would combine

the current requirements for an HHA’s

responsibility for the applicability of the

competency evaluation requirements

under existing § 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 § 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 § 484.36(b)(2) with the

subject area requirements under existing

§ 484.36(b)(3)(iii). We propose the

competency evaluation must address

each of the subjects listed in

§ 484.36(a)(1) (ii) through (xiii). Subject

areas § 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 § 484.75(c)(2).

At proposed § 484.75(c)(3) we would

to retain the current requirements for

the conduct of competency evaluations

by organizations under § 484.36(b)(3)(i).

A competency evaluation program may

be offered by any organization except as

specified in existing § 484.36(a)(2)(i).

At proposed § 484.75(c)(4) we would

retain the current requirement at

§ 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 § 484.75(c)(5), we would

retain the current requirements for

competency determinations under

§ 484.36(b)(4).

At proposed § 484.75(c)(6), we

propose to retain the current

requirements for documentation of

competency evaluation currently

located at § 484.36(b)(5). We propose to

delete the effective date requirements

under existing § 484.36(b)(6) because

they refer to a timeframe in 1990 and are

no longer necessary.

Standard: Inservice Training

At proposed § 484.75(d) we would

retain the requirements for the amount

of in-service training located at existing

§§ 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 § 484.75(d)(2) we would

revise the current requirements for the

conduct of inservice training by

organizations under § 484.36(b)(3)(i).

We would provide that an inservice

training program may be offered by any

organization except as specified in

§ 484.75(b)(2).

We propose to revise the current

requirement for instructors of inservice

training under § 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 § 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 § 484.75(e), we would

retain the revisions to existing

§ 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

§ 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 § 484.75(f), we would

retain the home health aide supervision
11018 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

requirements under existing

§§ 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 nonMedicare 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 § 484.75(g) we would

retain the current requirements under

§ 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 (§ 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 § 483.420, modified to

reflect the HHA environment and

population served. The ICF/MR

provisions governing client protections

at §§ 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.
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 § 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 § 484.100.

Under the first standard, compliance

with Federal, State, and local laws and

regulations, at proposed § 484.100(a),

we would revise the language at existing

§ 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

§ 484.12(b). We would continue to

require that the HHA comply with the

requirements of §§ 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

§§ 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 §§ 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 § 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 § 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 § 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 § 484.14(j),

Organization, services and

administration, Standard: Laboratory

services, to proposed § 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 § 484.14

(Condition of participation:

organization, services and

administration) and replace the existing

regulations at § 484.38 (Condition of

participation: Qualifying to furnish

outpatient physical therapy or speechlanguage 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
11020 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 § 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 (§ 484.14(b)), retain, with only

minor changes, the current standard on

services furnished (§ 484.14(a)), retain,

with only minor editorial changes, the

requirements with respect to services

under arrangements that are now stated

in § 484.14(h), delete the current

standards on administrator (484.14(c)),

delete the current standards on

supervising physician or registered

nurse (§ 484.14(d)), delete the current

standards on personnel policies

(§ 484.14(e)), delete the current

standards on institutional planing

(§ 484.14(i)), relocate the existing

condition, qualifying to furnish

outpatient physical therapy or speechlanguage (§ 484.38) under this

condition, and relocate the current

standard on laboratory services

(§ 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 § 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 § 484.14(c) and on

institutional planning at § 484.14(i). We

propose to replace the current processridden institutional planning standard

at § 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 § 484.105(e) to

revise the current services furnished

requirement at existing § 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 § 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 § 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 § 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 § 484.110(c) we

would retain the current requirement

under § 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 § 484.48(b) (Standard:

Protection of records). At proposed

§ 484.110(d) we would provide that

patient information and the record are

safeguarded against loss or
11022 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

unauthorized use. We believe the other

requirements under existing § 484.48(b)

concerning the release of clinical record

information are best incorporated into

the new standard at proposed § 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 § 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 § 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

§ 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 § 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 speechlanguage 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 speechlanguage 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 § 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

§ 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 selfexplanatory 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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,
11024 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 processoriented, 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 § 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 shortterm 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 hospitalbased 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
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 processoriented 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 costeffective 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 patientcentered, 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
11026 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 § 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 × 3.4 million patients) = 2,833

hours and each new admission in

succeeding years (3 seconds × 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 § 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 × 5 minutes = 2,000

hours for new admissions and 102,000

× 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

§ 484.16 Group of professional
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11027

personnel and § 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 × 9,058 (total number of

Medicare-certified HHAs in

calendar year 1995) = 36,232 hours

4 hours × 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 § 484.30, therapy

services § 484.32, and medical social

services § 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 × 9,058 existing HHAs = 302

hours

2 minutes × 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 × 9,058 existing HHAs = 18,116

hours annually

2 hours × 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 × 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 § 405.1221(b). It imposes a minimal

burden of adding the necessary

additional information to the current

disclosure used by existing HHAs and
11028 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

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 × 9,058 (total number of

Medicare certified HHAs in 1995) =

755 hours

5 minutes × 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 § 484.14(b), retain

with only minor editorial changes the

current standard on services furnished

§ 484.12(a), retain with only minor

editorial changes, the requirements with

respect to services furnished under

arrangements under existing § 484.14(h),

delete the current standards on the

administrator § 484.14(c), delete the

current standards on supervising

physician or registered nurse

§ 484.14(d), delete the current standards

on personnel policies § 484.14(e), delete

the current standards on institutional

planning § 484.14(i), relocate current

condition § 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 § 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).
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 11029

Current COPs Revised COPs

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 Speech language pathology

484.38.

Intact 484.105(f).

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

§ 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.

§ 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.
11030 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

Subpart B—Patient Care

§ 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.

§ 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.

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

§ 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.

§ 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

§ 409.44, and medical social worker and

home health aide services as specified

in § 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 § 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.

§ 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 §§ 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
11032 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

continuous period of 24 consecutive

months during none of which the

individual furnished services described

in § 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.
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules 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 speechlanguage 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 speechlanguage 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

§ 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

§ 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

§§ 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 §§ 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.

§ 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.
11034 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

(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. Parttime 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 §§ 485.711,

485.713, 485.715, 485.719. 485.723, and

485.727 of this chapter.

§ 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.

§ 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

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

or university approved by a State

department of education; or

(iii) Has 2 years of appropriate

experience as a physical therapist, and

has achieved a satisfactory grade on a

proficiency examination conducted,

approved, or sponsored by the U.S.

Public Health Service except that such

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking

qualification as a physical therapist after

December 31, 1977; or

(iv) Was licensed or registered prior to

January 1, 1966, and prior to January 1,

1970, had 15 years of full-time

experience in the treatment of illness or

injury through the practice of physical

therapy in which services were

rendered under the order and direction

of attending and referring doctors of

medicine or osteopathy; or

(v) If trained outside the United

States—

(A) Was graduated since 1928 from a

physical therapy curriculum approved

in the country in which the curriculum

was located and in which there is a

member organization of the World

Confederation for Physical Therapy;

(B) Meets the requirements for

membership in a member organization

of the World Confederation for Physical

Therapy,

(5) Physical therapist assistant. A

person who—

(i) Has graduated from a 2-year

college-level program approved by the

American Physical Therapy

Association; or

(ii) Has 2 years of appropriate

experience as a physical therapy

assistant, and has achieved a

satisfactory grade on a proficiency

examination conducted, approved, or

sponsored by the U.S. Public Health

Service, except that these

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking initial

qualification as a physical therapy

assistant after December 31, 1977.

(6) Public health nurse. A registered

nurse who has completed a

baccalaureate degree program approved

by the National League for Nursing for

public health nursing preparation or

postregistered nurse study that includes

content approved by the National

League for Nursing for public health

nursing preparation.

(7) Registered nurse. A graduate of a

school of professional nursing.

(8) Social work assistant. A person

who—

(i) Has a baccalaureate degree in

social work, psychology, sociology, or

other field related to social work, and

has had at least 1 year of social work

experience in a health care setting; or

(ii) Has 2 years of appropriate

experience as a social work assistant,

and has achieved a satisfactory grade on

a proficiency examination conducted,

approved, or sponsored by the U.S.

Public Health Service, except that these

determinations of proficiency do not

apply with respect to persons initially

licensed by a State or seeking initial

qualification as a social work assistant

after December 31, 1977.

(9) Social worker. A person who has

a master’s degree from a school of social

work accredited by the Council on

Social Work Education, and has 1 year

of social work experience in a health

care setting.

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: July 15, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: August 16, 1996.

Donna E. Shalala,

Secretary.

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

BILLING CODE 4120–01–P

42 CFR Part 484

[HSQ–238–P]

RIN 0938–AH74

Medicare and Medicaid Programs: Use

of the OASIS as Part of the Conditions

of Participation for Home Health

Agencies

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would add

additional requirements to the proposed

revision to the conditions of

participation for home health agencies

(HHAs) which also appear in this issue

of the Federal Register. Specifically,

this proposed rule would require that

HHAs use a standard core assessment

data set, the ‘‘Outcomes and Assessment

Information Set’’ (OASIS), when

evaluating adult, non-maternity

patients.

This proposed rule is an integral part

of the Administration’s efforts to

achieve broad-based, measurable

improvement in the quality of care

furnished through Federal programs. It

is a fundamental component in the

transition to a quality assessment and

performance improvement approach

that focuses on stimulating measurable

improved outcomes of care and patient

satisfaction in the Medicare and

Medicaid home health benefit while at

the same time reducing burdens on

providers.

DATES: Comments will be considered if

we receive them at the appropriate

address, as provided below, no later

than 5:00 p.m. on June 9, 1997.

ADDRESSES: Mail written comments (one

original and three copies) to the

following address: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: HSQ–238-P, P.O. Box 7518,

Baltimore, MD 21207–0519.

If you prefer, you may deliver your

written comments (one original and

three copies) to one of the following

addresses:

Room 309-G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW, Washington, DC 20201, or

Room C5–09–26, 7500 Security

Boulevard, Baltimore, MD 21244–

1850.

Comments may also be submitted

electronically to the following e-mail

address: hsq238phcfa.gov. E-mail

comments must include the full name

and address of the sender and must be

submitted to the referenced address in

order to be considered. All comments

must be incorporated into the e-mail

message because we may not be able to

access attachments. Electronically

submitted comments will be available

for public inspection at the

Independence Avenue address below.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

HSQ–238–P. Comments received timely

will be available for pubic inspection as

they are received, generally beginning

approximately 3 weeks after publication

of a document, in Room 309–G of the

Department’s offices at 200

Independence Avenue, SW,

Washington, D.C., on Monday through

Friday of each week from 8:30 a.m. to

5:00 p.m. (phone (202) 690–7890).

For comments that relate to

information collection requirements,

mail a copy of the comments to: Office

of Information and Regulatory Affairs,

Office of Management and Budget,

Room 10235, New Executive Office

Building, Washington, DC 20503, Attn:

Allison Herron Eydt, HCFA Desk

Officer.

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

37194, Pittsburgh, PA 15250–7954.