Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 484

[BPD-819-P]

RIN 0938-AG81

Medicare and Medicaid Programs; Conditions of Participation for

Home Health Agencies

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule revises the existing conditions of

participation that home health agencies must meet to participate in the

Medicare program. The proposed requirements focus on the actual care

delivered to patients by home health agencies and the results of that

care, reflect an interdisciplinary view of patient care, allow home

health agencies greater flexibility in meeting quality standards, and

eliminate unnecessary procedural requirements. These changes are an

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

improvements in the quality of care furnished through Federal programs

and in the measurement of that care, while at the same time reducing

procedural burdens on providers.

DATES: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on June 9,

1997, except for comments on information collection requirements, which

must be received on or before May 9, 1997.

ADDRESSES: Mail written comments (one original and three copies) to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: BPD-819-P, P.O. Box 7519,

Baltimore, MD 21207-0519.

If you prefer, you may deliver your written comments (one original

and three copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201, or

Room C5-11-17, 7500 Security Boulevard, Baltimore, MD 21244-1850.

tration, 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

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As an alternative, you can view and photocopy the Federal Register

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ate. 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.

As an alternative, you can view and photocopy the Federal Register

document at most libraries designated as Federal Depository Libraries

and at many other public and academic libraries throughout the country

that receive the Federal Register.

FOR FURTHER INFORMATION CONTACT: Susan Levy, (410) 786-9364 and Mary

Vienna, (410) 786-6940.

SUPPLEMENTARY INFORMATION:

I. Introduction

As the single largest payer for health care services in the United

States, the Federal Government has a critical responsibility for the

quality of care delivered under its programs. Historically, the Health

Care Financing Administration (HCFA) has adopted a quality assurance

approach that has been directed toward identifying health care

providers that furnish poor quality care or fail to meet minimum

Federal standards. These problems would either be corrected or would

lead to the exclusion of the provider from participation in the

Medicare or Medicaid programs. However, we have found that this

problem-focused approach has inherent limits. Trying to ensure quality

through the enforcement of prescriptive health and safety standards,

rather than trying to improve quality of care for all patients, has

resulted in HCFA expending much of its resources on dealing with

chronic problems with marginal providers, rather than on stimulating

broad-based improvements in quality of care.

We believe that a different approach toward achieving quality

health care for Federal beneficiaries is needed both to take advantage

of the continuing advances in the health care delivery field and to

keep up with growing demands for services. This approach necessitates

revising our requirements to focus on the expected patient-centered

outcomes of Medicare services

ments in quality of care.

We believe that a different approach toward achieving quality

health care for Federal beneficiaries is needed both to take advantage

of the continuing advances in the health care delivery field and to

keep up with growing demands for services. This approach necessitates

revising our requirements to focus on the expected patient-centered

outcomes of Medicare services. Thus, for home health services, we have

developed a core set of requirements encompassing patient rights,

comprehensive assessment, and patient care planning and coordination.

Tieing these requirements together is a fourth core requirement--

quality assessment and performance improvement--that rests on the

assumption that a provider's own quality management system is the key

to improved performance. Our objective is to achieve a balanced

approach combining HCFA's responsibility to ensure that essential

health and quality standards are achieved and maintained with a

provider's responsibility to monitor and improve its own performance.

To achieve this objective, we are now developing revised

requirements for several major health care provider types, including

the new HHA requirements set forth in this proposed rule as well as

revised requirements for hospitals, hospices, and end-stage renal

disease facilities. In addition, elsewhere in today's issue of the

Federal Register, we are publishing a proposed rule (Use of the OASIS

As Part of the Conditions of Participation for Home Health Agencies)

that describes the core standard assessment data set that we are

proposing to require HHAs to incorporate into the comprehensive

assessment process. This proposed rule is discussed below in section

II.D of this preamble

, 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

d 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

n.

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

as, 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

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

4021 of the Omnibus Budget Reconciliation Act of 1987 (OBRA

``87, Public Law 100-203), which added section 1891 of the Act. Most

recently, we made minor revisions to the HHA COPs on December 20, 1994

(59 FR 65482). However, many of the current COPs have remain unchanged

since their inception.

Our decision to propose major changes to the existing conditions is

based on several considerations. First, as discussed above, the

revision of the HHA requirements is part of a larger effort by HCFA to

bring about improvements in the quality of care furnished to Federal

beneficiaries through a new approach to our quality of care

responsibilities. Moreover, nowhere is the need for change more acute

than in home health services. During the 1980's and early 1990's, major

changes have taken place in the home health benefit, the provider

industry, home health care practices, and the characteristics of home

health care users that have combined to make home health services the

most rapidly growing segment of Medicare expenditures.

In response to challenges associated with the expanding use of home

health services, HCFA in 1994 began the Medicare Home Health Initiative

(Initiative) to identify opportunities for improvement in the Medicare

home health benefit. The Initiative is an agency-wide effort that

routinely solicits input and feedback on a wide variety of issues from

HCFA's partners in the home health care community. Representatives from

HCFA, consumer groups, the home health care industry, professional

associations, regional home health intermediaries, and States

(including State Medicaid agencies) have convened in a series of

collaborative meetings during 1994 and 1995. Among the Initiative's

primary recommendations is that HCFA develop HHA COPs that include a

core standard assessment data set and patient-centered, outcome-

oriented performance expectations that will stimulate continuous

quality improvement in home health care

ermediaries, and States

(including State Medicaid agencies) have convened in a series of

collaborative meetings during 1994 and 1995. Among the Initiative's

primary recommendations is that HCFA develop HHA COPs that include a

core standard assessment data set and patient-centered, outcome-

oriented performance expectations that will stimulate continuous

quality improvement in home health care.

The existing HHA COPs do not provide patient-centered, outcome-

oriented standards, nor do they provide for the operation of a quality

assessment and performance improvement program. Historically, we set

requirements for participation in the Medicare program by establishing

requirements that address the structures and processes of health care.

These requirements are largely the result of professional consensus,

since there are no data supporting the link between structure and

process requirements and positive patient outcomes. The combination of

process-oriented requirements with an enforcement approach that focuses

on identifying providers that do not have the required structures and

procedures in place will not be adequate to meet the growing challenges

associated with the changing home health care environment. Thus, we

have concluded that significant revisions to the HHA conditions of

participation are essential.

C. Transforming the HHA Conditions of Participation

As we began to develop new proposed COPs for HHAs, we solicited the

advice and suggestions of the home health industry, professional

associations and practitioner communities, as well as consumer

advocates and State and other governmental agencies with an interest or

responsibility in HHA regulation and oversight

rticipation 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

icipate 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

he 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

Coordination of Services COP would incorporate the interdisciplinary

team approach to providing home health services. The fourth proposed

core COP, Quality Assessment and Performance Improvement, would then

charge each HHA with responsibility for carrying out a performance

improvement program of its own design to effect continuing improvement

in the quality of care furnished to its customers.

In the revised COPs, we are proposing to include process-oriented

requirements only where we believe they remain highly predictive of

ensuring desired outcomes and the prevention of harmful outcomes (for

example, home health aide competency and supervision and timeliness of

patient assessment). Far more frequently, however, we have eliminated

process details from the existing requirements and instead included the

related area of concern as a component that must be evaluated by the

HHA as part of the HHA's overall quality assessment and performance

improvement responsibilities. For example, we removed the process

requirements under existing Sec. 484.12(c) that an HHA and its staff

must comply with accepted professional standards and principles. We

transformed the approach by incorporating current clinical practice

guidelines and professional standards applicable to home care as a

factor to be considered in the HHA's overall quality assessment and

performance improvement program. The practical effect of this approach

would be to stimulate the HHA to find its own performance problems, fix

them, and continuously strive to improve patient outcomes and

satisfaction, as well as efficiency and economy

actice

guidelines and professional standards applicable to home care as a

factor to be considered in the HHA's overall quality assessment and

performance improvement program. The practical effect of this approach

would be to stimulate the HHA to find its own performance problems, fix

them, and continuously strive to improve patient outcomes and

satisfaction, as well as efficiency and economy.

We believe that the proposed COPs based on these principles reflect

a fundamental change in HCFA's regulatory approach, a change that to a

large extent establishes a shared commitment between HCFA and Medicare

providers to achieve improvements in the quality of care furnished to

HHA patients. The proposed COPs invest HHAs with internal

responsibility for improving their performance, rather than relying on

an externally-based approach in which prescriptive Federal requirements

are enforced through the punitive aspects of the survey process. This

change would enable HCFA and the States to use our resources

principally in joining with HHAs in partnerships for improvement. This

change in our regulations to a patient-centered, outcome-oriented

approach will also likely fundamentally change our approach to the

survey process. For example, since the proposed regulation sets a

performance expectation that an HHA constantly improve, it may be

possible to alter significantly, or possibly eliminate altogether, the

current Functional Assessment Instrument (FAI) that surveyors use to

assess the outcomes of care through home visits and some record review.

In an expanded review of the agency's approach to quality assessment

and performance improvement, we may approach this task differently,

with greater flexibility than the current FAI affords. We anticipate

fewer compliance surveys and the reduced need to threaten or take

adverse actions that could jeopardize a HHA's reputation, viability as

a going concern, and participation in the Medicare and Medicaid

programs

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

mple, for many years, in nursing homes surveyors have been trained

to interview residents and family members, seeking information that

contributes to their assessment of how the nursing home's performance

is experienced by the residents and their families. Before the use of

outcome oriented surveys, surveyors focused on record reviews and

observing care processes and organizational structures.

These proposed regulations contain two critical improvements that

support and extend our focus on patient-centered, outcome-oriented

surveys. First, the proposed regulations are designed to enable

surveyors to focus explicitly on assessing outcomes of care, because

the regulations would specify that each individual receiving the care,

his or her assessed needs demonstrate is necessary (rather than

focusing simply on the services and processes that must be in place).

Second, the addition of a strong quality assessment and performance

improvement requirement not only stimulates the provider to

continuously monitor its performance and find opportunities for

improvement, it also affords the surveyor the ability to assess how

effectively the provider has been pursuing a continuous quality

improvement agenda. All of the changes are directed toward improving

outcomes of care.

We have already begun the process of identifying the tasks

necessary to train surveyors and their supervisors and managers

effectively in this refined, expanded approach. In addition, HCFA is

implementing a new State survey agency quality improvement program that

is designed to help State survey agencies increase their focus on

improvement strategies in the survey and certification process

.

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

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

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

'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

484.55 Condition of Participation: Comprehensive Assessment of

Patients

484.60 Condition of Participation: Care Planning and Coordination

of Services

484.65 Condition of Participation: Quality Assessment and

Performance Improvement

484.70 Condition of Participation: Skilled Professional Services

484.75 Condition of Participation: Home Health Aide Services

Subpart C--Organizational Environment

484.100 Condition of Participation: Compliance with Federal, State,

and Local Laws

484.105 Condition of Participation: Organization and Administration

of Services

484.110 Condition of Participation: Clinical Records

484.115 Personnel Qualifications for Skilled Professionals

B. Proposed Subpart A, General Provisions

Like the existing COPs, the revised conditions would begin with a

brief section (proposed Sec. 484.1) that would specify the statutory

authority for the ensuing regulations. The only change proposed in this

section would be the elimination of the reference to the statutory

authority for an HHA's institutional planning responsibilities

(existing Sec. 484.1(a)(2)). This change reflects our proposal to

eliminate from the HHA COPs a restatement of the statutory requirements

at section 1861(z) of the Act concerning institutional planning. See

section III.D of this proposed rule for a further discussion of this

issue.

Under proposed Sec. 484.2, we would set forth definitions for terms

used in the HHA COPs that we believe need clarification. We are

proposing to eliminate existing definitions for several terms for which

we believe meaning is self-evident, such as ``HHA,'' ``nonprofit

agency,'' or ``bylaws,'' as well as for terms that would not be

included in the revised COPs. We are proposing to delete the current

definitions for ``subdivision'' and ``subunit'' because the terms draw

distinctions for participation and payment for which there are no

differences

xisting definitions for several terms for which

we believe meaning is self-evident, such as ``HHA,'' ``nonprofit

agency,'' or ``bylaws,'' as well as for terms that would not be

included in the revised COPs. We are proposing to delete the current

definitions for ``subdivision'' and ``subunit'' because the terms draw

distinctions for participation and payment for which there are no

differences. We are proposing to delete the current definitions for

``clinical note,'' and ``progress note,'' and ``summary report''

because the terms are commonly accepted as documentation requirements

reflecting good medical practice to assess the individual's reaction or

response to services furnished. We believe that the focus should be on

documentation of the actual care provided to the individual via the

interdisciplinary team within the comprehensive assessment, plan of

care, and clinical record rather than the term used to describe the

entry. We are deleting the definition for supervision from this section

and incorporating the concept under the proposed skilled professional

services COP. We are soliciting comments on the feasibility of a

consolidated definition section in the Code of Federal Regulations

(CFR) for definitions that are applied consistently throughout the

Medicare program.

The definitions that would be included under proposed Sec. 484.2

are as follows:

Branch means a location or site from which a home health agency

provides services within a portion of the total geographic area served

by the parent agency. The branch office is part of the home health

agency and is located sufficiently close to share administration,

supervision, and services in a manner that renders it unnecessary for

the branch independently to meet the conditions of participation as a

home health agency.

Parent HHA means the agency that develops and maintains

administrative control of branches

ea served

by the parent agency. The branch office is part of the home health

agency and is located sufficiently close to share administration,

supervision, and services in a manner that renders it unnecessary for

the branch independently to meet the conditions of participation as a

home health agency.

Parent HHA means the agency that develops and maintains

administrative control of branches.

Quality indicator means a specific, valid, and reliable measure of

access, care outcomes, or satisfaction, or a measure of a process of

care that has been empirically shown to be predictive of access, care

outcomes, or satisfaction.

With the exception of ``quality indicator,'' all of these terms are

defined in the same way as in existing Sec. 484.2. We are adding a

definition for the term ``quality indicator'' because, as discussed

above, the use of quality indicators is central to an HHA's successful

implementation of a quality assessment and performance improvement

program.

We note that we would not retain the provisions of existing

Sec. 484.4, Personnel qualifications, under proposed subpart A, General

Provisions. As discussed in detail in section III.D of this preamble,

we are proposing major modifications to the prescriptive personnel

qualification requirements now in place. Remaining requirements would

be set forth under proposed Sec. 484.115.

C. Proposed Subpart B, Patient Care

1. Patient Rights (Proposed Sec. 484.50)

Section 1891(a)(1) of the Act establishes as a Medicare COP that an

HHA must protect and promote the rights of each individual under its

care. These rights encompass being informed in advance regarding the

care to be provided and having an opportunity to participate in care

planning; voicing grievances; confidentiality of records; respect for

property; being informed about specific coverage and noncoverage of

services; and availability of information in writing and through a home

health services hotline

h individual under its

care. These rights encompass being informed in advance regarding the

care to be provided and having an opportunity to participate in care

planning; voicing grievances; confidentiality of records; respect for

property; being informed about specific coverage and noncoverage of

services; and availability of information in writing and through a home

health services hotline. These statutory provisions are incorporated in

existing regulations at Sec. 484.10.

We would retain these statutory provisions in the proposed

regulations and redesignate existing Sec. 484.10 as proposed

Sec. 484.50, the first core COP, and also the first COP in proposed

Subpart B, Patient Care. We are proposing one substantive change to the

patient rights provisions. Specifically, we would expand the standard

under existing paragraph (c)(l) relating to informing the patient in

advance regarding care and treatment to be provided by the home health

agency. We propose to specify that the patient must also be informed

about ``expected outcomes'' of treatment and ``barriers'' to treatment.

We believe that these revisions represent an additional safeguard of

patient health and safety. Open communication between HHA staff and the

patient and access of the patient to treatment information are vital

tools for enhancing the patient's participation in his or her

coordinated care planning. In addition, there are many environmental

factors (for example, lack of nutrition and lack of family and

emotional support) that are barriers that could impact the

effectiveness of treatment decisions.

2. The Cycle of Care: Assessment, Planning, and Delivery

The patient care assessment, planning, and treatment process that

is embodied in the next three COPs can be seen as a cycle. Through the

use of a comprehensive assessment, accurate and timely patient

information is made available for use in the patient treatment process.

The treatment process is the actual interdisciplinary care furnished to

the patient

re: Assessment, Planning, and Delivery

The patient care assessment, planning, and treatment process that

is embodied in the next three COPs can be seen as a cycle. Through the

use of a comprehensive assessment, accurate and timely patient

information is made available for use in the patient treatment process.

The treatment process is the actual interdisciplinary care furnished to

the patient. The patient treatment process results in an effect on the

patient's condition, whether it is positive, negative, or neutral. An

HHA's assessment of the effect of treatment then enters into subsequent

treatment decisions, and the cycle of comprehensive assessment

continues. Through this cycle, accurate patient information yielded

from each comprehensive assessment will result in more effective and

appropriate treatment decisions, thus generating a positive effect on

treatment decisions and yielding desired outcomes.

a. Comprehensive Assessment of Patients (Proposed Sec. 484.55)

Introduction The proposed Comprehensive Assessment of Patients COP

reflects the patient-centered, interdisciplinary approach of the

proposed COPs and underscores our view that systematic patient

assessment is essential to improving quality of care and patient

outcomes.

Patient assessment contributes to quality of care improvements in

three closely linked stages. First, the information generated from an

interdisciplinary, comprehensive assessment of each patient is a vital

tool for developing a patient's care plan and making individual

treatment decisions. An HHA would then track the patient's progress

towards achieving the desired care outcome and make appropriate changes

to the patient's plan of care and treatment. As an HHA carries out this

process on a repeated basis, the second contribution of patient

assessment becomes clear. That is, the HHA is able to evaluate the

results of its treatment decisions on an aggregate basis

tment 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

undation for a long-term strategy in which HCFA would use assessment

information from many HHAs to define and measure care outcomes for home

health care users. As discussed above, these quality indicators could

then be built into a national data system for use by HHAs to improve

the quality of care they provide and by HCFA to monitor patient

outcomes.

Proposed Patient Assessment Requirements

The primary requirement under the proposed COP would be that each

patient receive from the HHA a patient-specific, comprehensive

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

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

discharge planning needs. For Medicare patients, identifying the need

for home care would include the assessment an individual's homebound

status. An individual's homebound status is a critical eligibility

requirement. This requirement would promote program integrity because

it is the first regulatory requirement that directly evaluates

homebound status.

Under our proposal, each HHA would have the responsibility and the

flexibility to determine the content and process of its own patient

assessment, within the broad requirement that it identifies the

patient's care and discharge planning needs. The intent of requiring

patient-specific comprehensive assessments is to avoid the use of

``canned'' patient assessments that do not reflect the individual needs

of each patient. The comprehensive assessment must fully reflect each

individual patient situation.

We are also proposing to require that the assessment must

incorporate the use of a core standard assessment data set that is

established by HCFA as a regulatory requirement under the comprehensive

assessment condition elsewhere in this issue of the Federal Register

reflect the individual needs

of each patient. The comprehensive assessment must fully reflect each

individual patient situation.

We are also proposing to require that the assessment must

incorporate the use of a core standard assessment data set that is

established by HCFA as a regulatory requirement under the comprehensive

assessment condition elsewhere in this issue of the Federal Register.

The data set includes only information necessary to measure outcomes of

care for quality indicators; thus, our intent is not to develop a

complete patient assessment but rather to identify standardized data

elements that fit within the HHA's overall comprehensive assessment

responsibilities. That is, the incorporation of the core standard

assessment data set will complement the HHA's current approach to

comprehensive assessment.

The existing COPs contain several requirements that address the

need for patient assessment, including most notably a long and detailed

list of items under existing Sec. 484.18(a) that are required to be

covered in a plan of care, such as pertinent diagnoses, mental status,

and functional limitations. In place of this requirement, we would

emphasize the importance of the comprehensive assessment by

establishing patient assessment as a separate COP, specifying the

desired outcome of the assessment (that is, the identification of a

patient's care needs), and then allowing HHAs the flexibility to

determine how best to achieve this outcome. We believe that this

approach is consistent with current accepted practices in HHAs and that

most HHAs

he 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.

The first standard under the proposed comprehensive assessment COP

concerns drug regimen review (proposed Sec. 484.55(a)). Under this

standard, we would retain the existing requirement of a drug regimen

review from Sec. 484.18(c), but would clarify the requirements by

eliminating the identification of ``adverse actions'' and

``contraindicated medications'' and substituting the more concise

requirements of review for drug interactions, duplicative drug therapy

and noncompliance with drug therapy. This modification narrows the

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

the assessment toward data predictive of a significant patient outcome.

The second proposed standard sets forth the requirements for the

initial assessment visit. Specifically, at proposed Sec. 484.55(b), we

propose that a registered nurse must perform an initial assessment

visit based on physician's orders to determine the immediate care and

support needs of the patient either within 48 hours of referral or

within 48 hours after the patient's return home, or within 48 hours of

the physician-ordered start of care date, if that is later. If

rehabilitation therapy services are the only services ordered by the

physician, the initial assessment would be made by the appropriate

rehabilitation skilled professional. We welcome comments on the

appropriateness of using competent individuals other than a registered

nurse or appropriate therapist to perform initial patient assessments

ician-ordered start of care date, if that is later. If

rehabilitation therapy services are the only services ordered by the

physician, the initial assessment would be made by the appropriate

rehabilitation skilled professional. We welcome comments on the

appropriateness of using competent individuals other than a registered

nurse or appropriate therapist to perform initial patient assessments.

We also invite comments on the feasibility of permitting the delegation

of nursing responsibilities within the scope of State nurse practice

acts to competent individuals.

The third standard (proposed Sec. 484.55(c)) would specify the

timeframe in which the HHA must complete the comprehensive assessment.

We propose that the HHA must complete the comprehensive assessment in a

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

later than 5 working days after the start of care.

The fourth standard (proposed Sec. 484.55(d)) concerns updates of

the comprehensive assessment. We would provide that the comprehensive

assessment must discuss the patient's progress toward clinical outcomes

and be updated and revised as frequently as the patient requires, but

no less frequently than every 62 days from the start of care date,

which is when the patient's plan of care is revised for physician

review and when the patient is discharged.

These proposed standards essentially would replace the requirements

concerning the duties of the registered nurse under the existing

skilled nursing services COP (Sec. 484.30(a)). Currently, a registered

nurse must regularly reevaluate the patient's nursing needs, initiate

the plan of care and necessary revisions, prepare clinical and progress

notes, coordinate services, and inform the physician and other

personnel of changes in the patient's condition and needs. The existing

requirement emphasizes the patient information process

nursing services COP (Sec. 484.30(a)). Currently, a registered

nurse must regularly reevaluate the patient's nursing needs, initiate

the plan of care and necessary revisions, prepare clinical and progress

notes, coordinate services, and inform the physician and other

personnel of changes in the patient's condition and needs. The existing

requirement emphasizes the patient information process. In contrast,

the proposed comprehensive assessment COP would focus on ensuring that

all critical information concerning a patient is routinely incorporated

through timely assessments that identify a patient's initial and

changing needs.

Under proposed Sec. 484.55 (b) and (c), we are proposing specific

timeframes for the initial assessment, completion of the assessment,

and interim updates to the patient assessment. We believe that these

requirements, though process-oriented, are predictive of good patient

care and safety, as well as necessary to prevent harm to the patient.

Our rationale for these timeframes is that by definition, a new patient

being referred to a home health agency for initiation of services is at

a point of immediate and serious need, especially as patients are

returned home from hospital care sooner than ever before. Likewise, as

the complexity of the care needs of patients increases, so does the

need for comprehensive assessment of the patient, and the importance of

implementing an effective care plan promptly becomes paramount.

We believe that these requirements pose little or no burden for the

well-managed home health agency since they would in all likelihood be

performed in the absence of regulations. However, the proposed

timeframes serve as a strong performance expectation for HHAs that may

not have adequate resources (financial and human resources) by setting

the outside acceptable time for these activities to occur

lieve that these requirements pose little or no burden for the

well-managed home health agency since they would in all likelihood be

performed in the absence of regulations. However, the proposed

timeframes serve as a strong performance expectation for HHAs that may

not have adequate resources (financial and human resources) by setting

the outside acceptable time for these activities to occur. If too many

patient referrals occur together, some patients might be neglected or

harmed by the HHA's inability to see the patient quickly or to conduct

and complete the needed comprehensive assessment so effective service

delivery can begin. Thus, if an HHA recognizes that its workload is

such that it is not capable of beginning work with a patient virtually

immediately upon referral, the patient should not be accepted for care.

Under proposed Sec. 484.55(d), we are proposing that the

comprehensive assessment be updated as frequently as the patients

condition requires but not less frequently than every 62 days, for

several reasons:

(1) Especially in the early stages of care, patient needs,

progress, and circumstances can change greatly, and changes in the

status of the patient can and should prompt changes in approaches to

care, so reassessment as needed helps to inform the revision of the

care plan and service delivery;

(2) When HCFA and the home health community are prepared to begin

collecting and utilizing quality indicator data (which will come from

the core standard assessment data set), it will be necessary for the

HHA to report the data on a regular basis. The developers of the core

standard assessment data set have found the roughly 2-month timeframe

to be an effective interval for data points for comparison purposes,

which also coincides well with the recertification timeframe in item

(3) below; and

cator data (which will come from

the core standard assessment data set), it will be necessary for the

HHA to report the data on a regular basis. The developers of the core

standard assessment data set have found the roughly 2-month timeframe

to be an effective interval for data points for comparison purposes,

which also coincides well with the recertification timeframe in item

(3) below; and

(3) An HHA is required to have the patient recertified for

continued care every 62 days, which serves as a logical point for

updating an assessment if no updates have already been completed.

We welcome comments on whether the specific proposed timeframes in

the regulation text are reasonable and consistent with current medical

practice, and whether the timeframes should be used as benchmarks to

reflect patient health and safety concerns involving the timeliness of

the assessment components.

3. Care Planning and Coordination of Services (Proposed Section 484.60)

Currently, the condition of participation concerning the plan of

care is set forth at Sec. 484.18. We propose to revise the contents of

this section, and place them in a new condition, ``Care planning and

coordination of services'' (proposed Sec. 484.60). This condition would

contain four standards that reflect the interdisciplinary approach to

home health care delivery. The standards are discussed in detail below.

This proposed COP would first state the fundamental requirement

that the patient's plan of care must specify the care and services

necessary to meet the patient's specific needs as identified by the

physician and in the comprehensive assessment, and the measurable

clinical outcomes that the HHA expects will occur as a result of

implementing the plan of care. Again, a clinical outcome can be defined

as a change in an individual's health between two or more points in

time. We would retain the existing requirement that patients are

accepted for treatment on the basis of a

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

reasonable expectation that the patient's medical, nursing, and social

needs can be met adequately by the agency in the patient's place of

residence.

In accordance with our goal of eliminating prescriptive

requirements that do not directly relate to patient care, we have

simplified the plan of care standard at existing Sec. 484.18(a). The

first standard under this condition, ``Plan of Care,'' set forth at

proposed Sec. 484.60(a), would require that all home health services

must follow a written plan of care established and periodically

reviewed by a doctor of medicine, osteopathy, or podiatric medicine in

accordance with Sec. 409.42. We would specify that all patient care

orders must be included in the plan of care. We believe that our

proposal would decrease the burden on HHAs and would allow agency staff

to develop care plans that best suit the needs of the patients they

serve.

Under the second proposed standard, ``Review and revision of the

plan of care'', we would add to the language at existing

Sec. 484.18(b). The current requirement that the physician and the HHA

review the plan of care as frequently as the patient's condition

requires but not less than once every 62 days would be retained, with

the additional clarification that this period begins with the date of

start of care. We would continue to require that the HHA promptly alert

the physician to any changes in the patient's condition that suggest a

need to alter the plan of care. We would also extend the current

requirement to specify that the HHA must promptly alert the physician

if measurable outcomes are not being achieved

the additional clarification that this period begins with the date of

start of care. We would continue to require that the HHA promptly alert

the physician to any changes in the patient's condition that suggest a

need to alter the plan of care. We would also extend the current

requirement to specify that the HHA must promptly alert the physician

if measurable outcomes are not being achieved. If measurable outcomes

are not being achieved, the HHA must review, assess, and document the

patient's responses to his or her current medical and environmental

situation (including barriers to care), and implement a physician's

revised plan of care as often as necessary to meet the patient's needs.

At a minimum, revised plans of care should be established and

implemented when a patient experiences significant changes in his or

her medical condition or functional capacity. An example of an

environmental situation that would be considered a barrier to care

would be a patient who was not receiving proper nutrition. In such a

case, the agency staff would document the situation and revise the plan

of care accordingly. We believe that these requirements would reflect

our outcome-oriented approach to patient care in that they would

require the HHA to focus on the patient's responses to treatment

decisions. Additionally, these requirements would not impose a burden

on HHAs since agencies are already required to complete a plan of care

for each patient. These requirements would be set forth at proposed

Sec. 484.60(b)(1). We are soliciting comments on the need for frequent

regular physician reviews of plans of care for patients who are only

receiving personal care services.

Under Sec. 484.60(b)(2), we propose to require that a revised plan

of care must include current information from the patient's

comprehensive assessment and information concerning the patient's

progress toward outcomes specified in the plan of care

oliciting comments on the need for frequent

regular physician reviews of plans of care for patients who are only

receiving personal care services.

Under Sec. 484.60(b)(2), we propose to require that a revised plan

of care must include current information from the patient's

comprehensive assessment and information concerning the patient's

progress toward outcomes specified in the plan of care. We are

soliciting comments on the utility of adding an additional requirement

that would require the original plan of care that initiates care to be

reviewed and revised in a timely manner consistent with the patient's

immediate needs, but no later than 5 to 10 working days after the

completion of the comprehensive assessment. This would ensure that the

plan of care would be revised to reflect the incorporation of the

completed comprehensive assessment, which must be completed in a timely

manner consistent with the patient's immediate needs, but no later than

5 working days after the start of care. This additional requirement

would ensure the link between the completed comprehensive assessment

and a revised plan of care.

In the third standard, ``Conformance with physician orders'', we

would retain language at existing Sec. 484.18(c). In December 1994, we

revised this standard to require that oral orders be put in writing and

signed and dated with the date of receipt by the registered nurse or

qualified therapist responsible for furnishing or supervising the

ordered services (59 FR 65482). We also provided that oral orders are

only accepted by personnel authorized to do so by applicable State and

Federal laws and regulations as well as by the HHA's internal policies.

We would include these standards in the Care planning and coordination

of services condition under proposed Sec. 484.60(c).

We propose to add a new standard, Coordination of care, at

Sec. 484.60(d). This standard would incorporate provisions at existing

Sec

ccepted by personnel authorized to do so by applicable State and

Federal laws and regulations as well as by the HHA's internal policies.

We would include these standards in the Care planning and coordination

of services condition under proposed Sec. 484.60(c).

We propose to add a new standard, Coordination of care, at

Sec. 484.60(d). This standard would incorporate provisions at existing

Sec. 484.14(g) (Organization, services, and administration, Standard:

Coordination of patient services), which requires that all personnel

furnishing services maintain liaison to ensure that their efforts are

coordinated effectively and support the plan of care, and that the HHA

must document such liaison. Our proposed standard would go beyond this

requirement by linking the level of the coordination of services,

caregivers and the patient to identifiable care need and barriers to

care and by requiring HHAs to adjust the degree of coordination to meet

the needs of the patient. Specifically, we would require the HHA to

maintain a system of communication and integration of services, whether

provided directly or under arrangement, that ensures the identification

of patient needs and barriers to care, the ongoing liaison between all

disciplines providing care, and the contact of the physician for

relevant medical issues. Additionally, we would require the HHA to

identify the level of coordination necessary to deliver care to the

patient and involve the patient and the caregiver in the coordination

of care.

We believe that this standard is appropriate for a number of

reasons. Since a home care patient may encounter many services

delivered at different times by a variety of individuals with different

skills, efficient communication and integration among members of the

home health team is essential in responding to patient needs in a

timely and effective manner. Further, effective coordination of

services is necessary to avoid duplicative or conflicting services

ns. Since a home care patient may encounter many services

delivered at different times by a variety of individuals with different

skills, efficient communication and integration among members of the

home health team is essential in responding to patient needs in a

timely and effective manner. Further, effective coordination of

services is necessary to avoid duplicative or conflicting services.

Finally, we recognize that an interdisciplinary approach to the

delivery of home health services reflects actual practice for most home

health agencies, and we believe that, when possible, our regulations

should coincide with current industry practice.

4. Quality Assessment and Performance Improvement (Proposed Section

484.65)

We are proposing to eliminate two conditions of participation,

existing Sec. 484.52, Evaluation of the agency's program, and existing

Sec. 484.16, Group of professional personnel, and replace them with a

single, new quality assessment and performance improvement condition of

participation. Existing regulations for HHAs do not provide for the

operation of a quality assessment and performance improvement program

whereby the HHA examines its methods and practices of providing care,

identifies opportunities to improve its performance, and then takes

actions that result in better outcomes of care and satisfaction for the

HHA's patients. In light of our intention to raise the performance

expectations for HHAs seeking entrance into the Medicare program as

well as those currently participating, HCFA is proposing that each HHA

develop, implement, and maintain an effective, data-driven quality

assessment and performance improvement program. We believe this

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

requirement would stimulate an HHA to continuously monitor and improve

its own performance and to be responsive to the needs, desires, and

satisfaction of its patients. This proposed new requirement epitomizes

the approach of these new COPs in that it provides a constant

expectation for improved performance, in contrast to the current

approach that only sets a floor of structural and procedural

requirements that are intended to be surrogate measures for ensuring

quality. This condition is intended to set up a self-sustaining system

for improvement, under which an HHA monitors its performance to a point

that surveyor findings would confirm an HHA's own assessment of where

performance improvements are needed.

We have not prescribed the structures and methods for implementing

this requirement, and have focused the condition of participation on

the expected results of the program, that is, quality indicators and

other outcome-oriented measures. This provides flexibility to the HHA,

as it is free to develop a creative program that meets the HHA's needs

and reflects the scope of its services.

Currently, the first COP that addresses quality of care (existing

Sec. 484.52, Evaluation of the agency's performance), provides for the

evaluation of the agency's total program at least once a year. The

agency must have written policies requiring the evaluation, the

evaluation must include a review of the HHA's policies and

administrative practices, and the results of the evaluation must be

separately recorded and maintained as administrative records

ting

Sec. 484.52, Evaluation of the agency's performance), provides for the

evaluation of the agency's total program at least once a year. The

agency must have written policies requiring the evaluation, the

evaluation must include a review of the HHA's policies and

administrative practices, and the results of the evaluation must be

separately recorded and maintained as administrative records. The

agency must also review a sample of open and closed clinical records at

least on a quarterly basis. The second condition of participation that

addresses quality of care (existing Sec. 484.16, Group of professional

personnel), requires a group of professional personnel, which includes

at least one physician and one registered nurse, to establish and

annually review the agency's policies governing the scope of services

offered, admission and discharge policies, medical supervision of plans

of care, clinical records, personnel qualifications and program

evaluation. This group is required to meet frequently to advise the

agency on professional issues, to participate in the evaluation of the

agency's program and assist in liaison functions. Minutes of the

group's meetings must be documented. These requirements focus on the

meetings and documentation of the agency's evaluation of their quality

of care and do not account for the outcome of these activities.

Instead of continuing to prescribe the structures and processes by

which an HHA evaluates its services, we have identified the outcomes

expected of an agency that assesses its performance and improves the

services that it provides to beneficiaries and set forth under proposed

Sec. 484.65 the required major components of an effective quality

assessment and performance improvement program. Our expectation is that

the HHA will successfully operate a continuous quality assessment and

performance improvement program on behalf of its beneficiaries. We

believe this is a reasonable expectation, for which the HHA can and

should be held accountable

set forth under proposed

Sec. 484.65 the required major components of an effective quality

assessment and performance improvement program. Our expectation is that

the HHA will successfully operate a continuous quality assessment and

performance improvement program on behalf of its beneficiaries. We

believe this is a reasonable expectation, for which the HHA can and

should be held accountable.

Previously, the only motivation for quality improvement for some

HHAs was the adverse effect of having been found by surveyors to be out

of compliance with one or more conditions of participation and

threatened with termination from the Medicare program. With an

effective quality assessment and performance improvement program, the

HHA can identify and reinforce the activities that it is doing well and

seek out and respond to opportunities for improvement on a continuous

basis. The desired outcome of this proposed requirement is that the HHA

itself, rather than the survey process, will be the driving force for

continuous improvements, enabling HCFA to focus its resources on

supporting that effort and on HHAs that fail to meet the requirements,

even after efforts have been made to improve performance.

The proposed condition requires the HHA to develop, implement, and

evaluate an effective, data-driven quality assessment and performance

improvement program. The program must reflect the complexity of HHA's

organization and services (including those provided directly or under

arrangement). The HHA must take actions that result in improvements in

the HHA's performance across the spectrum of care.

The first standard at proposed Sec. 484.65(a) requires that an

HHA's quality assessment and performance improvement program must

include, but not be limited to, the use of objective measures to

demonstrate improved performance with regard to:

se provided directly or under

arrangement). The HHA must take actions that result in improvements in

the HHA's performance across the spectrum of care.

The first standard at proposed Sec. 484.65(a) requires that an

HHA's quality assessment and performance improvement program must

include, but not be limited to, the use of objective measures to

demonstrate improved performance with regard to:

(1) Quality indicator data (derived from patient assessments) to

determine if individual and aggregate measurable outcomes are achieved

compared to a specified previous time period. The terms ``quality

indicators,'' ``performance measures,'' and ``outcome measures'' are

often used interchangeably, though technically, they vary somewhat in

meaning. Regardless, they all refer to attributes of care and

satisfaction that can be used to gauge quality of care in specific

aspects of care. For example, the degree and rate of improvement in a

functional area (such as the ability to walk after a hip replacement)

can be shown to be a quality indicator. The method of defining and

measuring that improvement is the ``performance measure'' or ``outcome

measure.'' These measures assign a specific value to the care dimension

being measured. The appropriateness of the combination of services

reflected on the plan of care, the effectiveness of the communication

among the interdisciplinary team, or the competency of the mix of

professionals used on the team to implement the services could all be

possible indicators of the outcome-oriented performance expectations

that should stimulate ongoing quality improvement in home health care

delivery.

Some measures, though, are of processes of care that are predictive

of outcomes of care. These process measures quantify one or more

dimensions of the manner in which care is actually provided or

administered (or negatively, is not provided or administered)

icators 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.

gram, 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

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.

d 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

gram. Under our proposal, an HHA would

develop and implement specific measures on an ongoing basis to

determine from patients and their families whether they are satisfied

with services provided and outcomes achieved and the extent to which

the HHA respected their rights. We expect that an HHA would use this

information to search for opportunities to improve services and patient

satisfaction. We do not intend to prescribe to specific tools for

measuring patient and family's views, but we do intend to ask the HHA

during a survey to demonstrate its patient rights and satisfaction

measurement system and how it is used as part of the overall internal

quality assessment and performance improvement program.

(5) Effectiveness and safety of services (including complex high

technology services, if provided), including competency of clinical

staff, promptness of services, and whether patients are achieving

treatment goals and measurable outcomes. For patients to experience the

needed and desired outcomes that the Medicare home health benefit is

intended to achieve, staff must be able to demonstrate the skills and

competencies necessary to enable patients to achieve needed and desired

outcomes. The HHA is expected to include data-based, criterion-

referenced performance measures of staff skills, to utilize that data

to ensure that staff maintain skills, and to provide training as new

techniques and technologies are introduced and as new staff arrive. We

intend that the HHA would be able to demonstrate that it has a system

of appropriate complexity for keeping track of the skills and

competencies of the staff and that effectively identifies and addresses

training needs. These ``data'' should be an integral part of the HHA's

internal quality assessment and performance improvement program,

providing continuous feedback on staff performance

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

lems with the accuracy

of medication administration, it is not enough for the HHA to consider

this area as a candidate for an improvement program that may or may not

be chosen from a list of potential projects. Rather, since the accuracy

of medication administration is critical to the health and safety of

patients, the HHA must intervene with a correction and improvement

approach immediately.

When we use the word ``measure,'' we mean that the HHA must use

objective means of tracking performance that enable both the HHA and

the survey agency to identify the differences in performance between

two, points in time. For example, a measure that states an HHA is

``doing better'' as a result of an improvement approach would be

unacceptable. There must be identifiable units of measure that any

reasonably knowledgeable person would be able to distinguish as

evidence of change. Not all objective measures must have been shown to

be valid and reliable (that is, subjected to scientific development),

to be useable in improvement approaches, but they must at least

identify a start point and end point stated in objective terms that

actually relate directly to the objectives and expected/desired

outcomes of the improvement program.

Under the second standard at Sec. 484.65(b), we are proposing that

the HHA must take actions that result in performance improvements and

must track performance to assure that improvements are sustained over

time. This requirement links the quality assessment and performance

improvement program to a pattern of actions over time. The focus is on

the pattern of behavior recognized by the HHA and how the HHA used its

own experience to continuously strive for improvements.

The third standard under the Quality Assessment and Performance

Improvement Program at proposed Sec

rovements are sustained over

time. This requirement links the quality assessment and performance

improvement program to a pattern of actions over time. The focus is on

the pattern of behavior recognized by the HHA and how the HHA used its

own experience to continuously strive for improvements.

The third standard under the Quality Assessment and Performance

Improvement Program at proposed Sec. 484.65(c) states that the HHA must

set priorities for performance improvement, considering prevalence and

severity of identified problems, and giving priority to improvement

activities that affect clinical outcomes. However, any identified

problems that directly or potentially threaten the health and safety of

patients must be corrected immediately. Prioritizing areas of

improvement is essential for the HHA to gain a strategic view of its

operating environment and to ensure the consistent quality of care

provided over time. Overall, an HHA would be expected to give priority

to improvement activities that most affect clinical outcomes.

Conditions that may threaten the health and safety of patients must be

immediately and

directly addressed when they are identified.

The fourth standard under the Quality Assessment and Performance

Improvement COP, at proposed Sec. 484.65(d), would require the HHA to

participate in periodic, external quality improvement reporting

requirements as may be specified by HCFA. An example of participation

in an external quality improvement activity would be the future

requirement for the HHA to report quality indicator data (as discussed

elsewhere in today's issue of the Federal Register). Participation in

the survey process is another example. A different example might be

that the Secretary, reviewing the quality indicator data (or other

information), decides to embark on a national project to improve the

management of multiple medications from multiple doctors of HHA

patients

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

f participation * * * and the enforcement

of such conditions * * * are adequate to protect the health and safety

of individuals under the care of a home health agency and to promote

the effective and efficient use of public moneys.'' Congress mandated

broad authority to allow the Secretary to keep up with the myriad of

changes in quality health care delivery that reflect the state of the

art. The use of outcome measures is a significant feature of

accreditation for organizations such as the Joint Commission on

Accreditation of Healthcare Organizations' (JCAHO) Agenda for Change

and Community Health Accreditation Program's (CHAP) Benchmarks for

Excellence in Home Care.

The use of quality indicators and outcome measures as part of

external quality improvement reporting requirements stems, in part,

from the statutory requirement that surveys of HHAs employ quality

indicator data. Specifically, section 1891(c)(2)(C)(i)(II) of the Act

states, ``A standard survey conducted under this paragraph with respect

to an HHA shall include (to the extent practicable), for a case-mix

stratified sample of individuals furnished items or services by the

agency * * * a survey of the quality of care and services furnished by

the agency as measured by indicators of medical, nursing, and

rehabilitative care.''

Looking beyond the actual service delivered toward the outcome

resulting from that service allows the HHA the opportunity to

incorporate that information to change patterns of behavior or policies

and continually improve future performance. Although reaching the

desired outcome is beneficial, the revised approach focuses on

continuous change in an HHA's behavior over time. The regulatory

approach to outcome measures is not predicated on punishing those who

do not reach desired outcomes, but on examining how the HHA used its

own experience to change behavior and ultimately improve performance

over time.

Finally, this condition includes a standard about infection control

at proposed Sec. 484.75(e)

ach focuses on

continuous change in an HHA's behavior over time. The regulatory

approach to outcome measures is not predicated on punishing those who

do not reach desired outcomes, but on examining how the HHA used its

own experience to change behavior and ultimately improve performance

over time.

Finally, this condition includes a standard about infection control

at proposed Sec. 484.75(e). We expect the HHA to maintain an effective

infection control program as part of its overall quality assessment and

performance improvement program. We recognize that an HHA cannot be

directly responsible for the maintenance of an infection free home

environment, especially since the HHA cannot be physically present in

the home at all times. However, it can be responsible for (1) ensuring

that all staff know and use current best practices themselves to ensure

they are not the source of the spread of infection in the course of

providing home health services, and (2) on educating families and other

caregivers on best practices for the control of the spread of

infections within the home during the course of the family/caregivers''

interactions with the patients. One example of the use of ``current

best practices'' is the universal precaution of the use of gloves when

handling blood or blood products. HCFA is not proposing any specific

approaches to meeting this requirement, but would expect to see clear

evidence that the HHA aggressively seeks to minimize the spread of

infection through the use of infection control techniques by its staff

and through the efforts made to help families and caregivers to

minimize the spread of infection.

5. Skilled Professional Services (Proposed Section 484.70)

Existing regulations at Secs. 484.16, 484.30, 484.32, and 484.36

specify standards that identify detailed tasks that must be performed

by agency staff in the provision of skilled nursing services, therapy

services, and medical social services respectively.

We propose to delete Secs

and caregivers to

minimize the spread of infection.

5. Skilled Professional Services (Proposed Section 484.70)

Existing regulations at Secs. 484.16, 484.30, 484.32, and 484.36

specify standards that identify detailed tasks that must be performed

by agency staff in the provision of skilled nursing services, therapy

services, and medical social services respectively.

We propose to delete Secs. 484.16, 484.30, 484.32, and 484.36 and

replace them with a more simplified new condition on skilled

professional services. Instead of specifically identifying tasks, we

are broadly describing the expectations of the skilled professionals

who participate in the interdisciplinary team approach to home health

care delivery.

We would specify that skilled professionals who provide services to

HHA patients directly or under arrangement must participate in all

aspects of care, including an ongoing interdisciplinary evaluation and

development of the plan of care, and be actively involved in the HHA's

quality assessment and performance improvement plan. We are reducing

the concentration on process requirements and shifting the focus to

outcomes. The expected outcome is the coordinated, comprehensive,

interdisciplinary delivery of appropriate and effective skilled

professional services delivered and supervised by health care

professionals who practice under State licensure requirements and the

HHA's policies and procedures. Skilled professional services for

purposes of this section include: skilled nursing care, physical

therapy, speech language pathology, occupational therapy (as defined in

Sec. 409.44) and medical social services and home health aide services

(as defined in Sec. 409.45).

At proposed Sec. 484.70(a), we provide that skilled professional

services are authorized, delivered, and supervised (that is, given

authoritative procedural guidance) only by health care professionals

who meet the appropriate qualifications specified under Sec

cupational therapy (as defined in

Sec. 409.44) and medical social services and home health aide services

(as defined in Sec. 409.45).

At proposed Sec. 484.70(a), we provide that skilled professional

services are authorized, delivered, and supervised (that is, given

authoritative procedural guidance) only by health care professionals

who meet the appropriate qualifications specified under Sec. 484.115

and who practice under the HHA's policies and procedures. We believe

that this approach to supervision provides clarity to the current

definition.

We are proposing to require that an HHA ensure that a majority of

at least 50 percent of the total skilled professional services are

routinely provided directly by the HHA. We are

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

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

control over quality of care. This performance

safeguard seeks to ensure continuity and quality of care through the

restriction of the significant use of contracted care in home care.

A major home health care association has supported the

establishment of limits on Medicare certified HHAs' use of contracted

care as a way to establish performance expectations for the quality of

care provided. The proposed direct services requirement is an attempt

to address our concerns with the growth in ``shell'' operations and

provider accountability. It is important to note that HHAs currently

report employment data on their cost reports. We welcome comments on

the percentage approach to the proposed direct services standard to

control the excessive use of the contracting of services. We welcome

comments on this shift in our approach and on any concerns HHAs may

have regarding their ability, both operationally and financially, to

undertake this new approach.

6. Home Health Aide Services (Proposed Section 484.75)

Section 1891(a) of the Act requires the Secretary to establish

minimum standards for home health aide training and competency

evaluation programs. Section 1861(m)(4) of the Act requires Medicare

covered home health aide services to be furnished by an individual who

has successfully completed a training and/or competency evaluation

program that meets the requirements established by the Secretary.

Currently, the condition of participation concerning home health

aide services is set forth at Sec. 484.36, (Condition of Participation:

Home health aide services). For the most part, we would retain the

existing requirements although in some cases we have made

organizational or editorial changes in the interest of brevity or

clarity. In addition, we are soliciting comments on some possible

alternatives for future revisions. Under our reorganization scheme,

this condition would be located at proposed Sec. 484.75.

Standard: Home Health Aide Qualifications

or the most part, we would retain the

existing requirements although in some cases we have made

organizational or editorial changes in the interest of brevity or

clarity. In addition, we are soliciting comments on some possible

alternatives for future revisions. Under our reorganization scheme,

this condition would be located at proposed Sec. 484.75.

Standard: Home Health Aide Qualifications

Currently, provisions concerning the qualifications for home health

aides are set forth at Sec. 484.4, Personnel Qualifications. As

discussed in detail below, we are proposing substantial revisions to

the personnel qualifications section. In light of our proposed

revisions and our reorganization of part 484, we believe that the

qualifications for home health aides would be more appropriately

located in this section. Thus, at proposed Sec. 484.75(a) we would

provide that a qualified home health aide is an individual who has

successfully completed a State-established or other training program

that meets the requirements of proposed Sec. 484.75(b) and a competency

evaluation program or State licensure program that meets the

requirements of proposed Sec. 484.75(c), or a competency evaluation

program or State licensure program that meets the requirements of

proposed Sec. 484.75(c), or has completed a nurse aide training and/or

competency evaluation program approved by the State as meeting the

requirements of existing Secs. 483.151 through 483.154 and is currently

listed in good standing on the State nurse aide registry. We are

soliciting comments on our proposed change to the home health aide

personnel qualification, which would include the interchangeable

paraprofessional training and/or competency standards for home health

aides and nurse aide requirements at requirements at existing

Secs. 483.151 through 483.154 (part of the Long-Term Care Facilities

Requirements for Participation). The home health aide workforce is

ridden with high turnover rates

hange to the home health aide

personnel qualification, which would include the interchangeable

paraprofessional training and/or competency standards for home health

aides and nurse aide requirements at requirements at existing

Secs. 483.151 through 483.154 (part of the Long-Term Care Facilities

Requirements for Participation). The home health aide workforce is

ridden with high turnover rates. We believe that the proposed changes

to the home health aide personnel qualifications yield flexibility to

HHAs in their ability to retain equally competent paraprofessionals

from a wider pool of employment prospects.

Under proposed Sec. 484.75(a)(2), we would retain (with

clarification) the current personnel qualification requirements

governing home health aide employment status during a continuous period

of 24 consecutive months. An individual is not considered to have

completed a training and competency evaluation program or a competency

evaluation program if, since the individual's most recent completion of

this program(s), there has been a continuous period of 24 consecutive

months during none of which the individual furnished services described

in Sec. 409.40 of this chapter for compensation. If an individual has

not furnished services described in Sec. 409.40 for compensation during

a continuous period of 24 consecutive months, then the individual must

complete another training and competency evaluation program or

competency evaluation program as described in paragraph (a)(1) of this

section.

Standard: Home Health Aide Training

We propose to retain the same requirements for content and duration

of training as those under the current requirements at

Sec. 484.36(a)(1). However, we propose more concise language.

hs, then the individual must

complete another training and competency evaluation program or

competency evaluation program as described in paragraph (a)(1) of this

section.

Standard: Home Health Aide Training

We propose to retain the same requirements for content and duration

of training as those under the current requirements at

Sec. 484.36(a)(1). However, we propose more concise language.

Specifically, at proposed Sec. 484.75(b)(1), we would provide that the

home health aide training must include classroom and supervised

practical training that totals at least 75 hours. A minimum of 16 hours

of classroom training must precede a minimum of 16 hours of supervised

practical training.

Proposed Sec. 484.75(b)(1)(i) would clarify provisions regarding

communication skills currently located at Sec. 484.36(a)(1)(i)

(Standard: Home health aide training-(1) Content and duration of

training). We would provide that communication skills include the

ability to read, write, and make brief and accurate oral and written

presentations to patients, caregivers, and other HHA staff. We propose

to retain current requirements under Sec. 484.36(a)(1) (ii) through

(xii) at proposed Sec. 484.75(b)(1) (ii) through (xii) (Standard:

Content and duration of training). We propose to retain current

Sec. 484.36(a)(1)(xiii) with clarification at proposed

Sec. 484.75(b)(1)(xiii). We propose to modify the current language,

``Any other task that the HHA may choose to have the home health aide

perform'' by adding the following: ``The HHA is responsible for

training the home health aide, as needed, for skills not covered in the

basic checklist.''

At proposed Sec. 484.75(b)(2) and (3), we would essentially retain

the provisions governing conduct of training by organizations and

qualifications of instructors under existing Secs. 484.36(a)(2) (i) and

oose to have the home health aide

perform'' by adding the following: ``The HHA is responsible for

training the home health aide, as needed, for skills not covered in the

basic checklist.''

At proposed Sec. 484.75(b)(2) and (3), we would essentially retain

the provisions governing conduct of training by organizations and

qualifications of instructors under existing Secs. 484.36(a)(2) (i) and

(ii).

At proposed Sec. 484.75(b)(4), we would essentially retain the

documentation of training requirement under existing Sec. 484.36(a)(3)

to include State approved nurse aide training and competency evaluation

as reflected in the definition of the personnel qualifications for home

health aides.

We propose to separate existing Sec. 484.36(b)(Standard: Competency

evaluation and inservice training) into two separate standards,

Competency Evaluation and Inservice Training. These standards would be

set forth at proposed Sec. 484.75(c) and (d) respectively.

Standard: Competency Evaluation

In order to simplify this standard, at proposed Sec. 484.75(c) we

would combine the current requirements for an HHA's responsibility for

the applicability of the competency evaluation requirements under

existing Sec. 484.36(b)(1) and the limitations on the applicability of

the competency evaluation requirements for personal care attendants

under a State Medicaid Personal Care benefit under existing

Sec. 484.36(e)(2). An individual may furnish home health services on

behalf of an HHA only after that individual has successfully completed

a competency evaluation program as described in this section. We

propose that the HHA must ensure that all individuals who furnish home

health aide services to patients meet the competency evaluation

requirements of this section. The only exception would be for personnel

care aides who exclusively provide personal care services to Medicaid

patients under a State Personal Care benefit.

We propose to combine the requirements for competency evaluation

under existing Sec

the HHA must ensure that all individuals who furnish home

health aide services to patients meet the competency evaluation

requirements of this section. The only exception would be for personnel

care aides who exclusively provide personal care services to Medicaid

patients under a State Personal Care benefit.

We propose to combine the requirements for competency evaluation

under existing Sec. 484.36(b)(2) with the subject area requirements

under existing Sec. 484.36(b)(3)(iii). We propose the competency

evaluation must address each of the subjects listed in

Sec. 484.36(a)(1) (ii) through (xiii). Subject areas Sec. 484.36(a)(1)

(iii), (ix), (x), and (xi) must be evaluated by observing the aide's

performance with a patient. The remaining subject areas may be

evaluated through written examination, oral examination or after

observation of the home health aide with a patient. These provisions

would be set forth at proposed Sec. 484.75(c)(2).

At proposed Sec. 484.75(c)(3) we would to retain the current

requirements for the conduct of competency evaluations by organizations

under Sec. 484.36(b)(3)(i). A competency evaluation program may be

offered by any organization except as specified in existing

Sec. 484.36(a)(2)(i).

At proposed Sec. 484.75(c)(4) we would retain the current

requirement at Sec. 484.36(b)(3)(ii) that the competency evaluation

must be performed by a registered nurse. However, we recognize the

interdisciplinary approach to home health care and propose the

requirement that the registered nurse should perform the competency

evaluation in consultation with other skilled professionals, as

appropriate. At proposed Sec. 484.75(c)(5), we would retain the current

requirements for competency determinations under Sec. 484.36(b)(4).

At proposed Sec. 484.75(c)(6), we propose to retain the current

requirements for documentation of competency evaluation currently

located at Sec. 484.36(b)(5). We propose to delete the effective date

requirements under existing Sec

lled professionals, as

appropriate. At proposed Sec. 484.75(c)(5), we would retain the current

requirements for competency determinations under Sec. 484.36(b)(4).

At proposed Sec. 484.75(c)(6), we propose to retain the current

requirements for documentation of competency evaluation currently

located at Sec. 484.36(b)(5). We propose to delete the effective date

requirements under existing Sec. 484.36(b)(6) because they refer to a

timeframe in 1990 and are no longer necessary.

Standard: Inservice Training

At proposed Sec. 484.75(d) we would retain the requirements for the

amount of in-service training located at existing Secs. 484.36(b)(2)

(ii) and (iii). We propose to clarify the 12-month period to address

calendar year and anniversary date issues. We would combine the current

requirements to propose that the home health aide must receive at least

12 hours of inservice training in a 12-month period. During the first

12 months of employment, hours may be prorated based on the date of

hire. The in-service training may occur while the aide is furnishing

care to a patient.

At proposed Sec. 484.75(d)(2) we would revise the current

requirements for the conduct of inservice training by organizations

under Sec. 484.36(b)(3)(i). We would provide that an inservice training

program may be offered by any organization except as specified in

Sec. 484.75(b)(2).

We propose to revise the current requirement for instructors of

inservice training under Sec. 484.36(b)(3)(ii). The current requirement

states that inservice training generally must be supervised by a

registered nurse with specific experience requirements. Thus, at

proposed Sec. 484.75(d)(3), we would provide that the inservice

training must be supervised by a registered nurse

484.75(b)(2).

We propose to revise the current requirement for instructors of

inservice training under Sec. 484.36(b)(3)(ii). The current requirement

states that inservice training generally must be supervised by a

registered nurse with specific experience requirements. Thus, at

proposed Sec. 484.75(d)(3), we would provide that the inservice

training must be supervised by a registered nurse. The revised language

does not include the current experience requirements because we believe

it is appropriate to give the HHA flexibility to utilize qualified

professionals to instruct and evaluate aides in an appropriate manner

in order to meet the outcome which is ensuring that the individuals who

furnish home health aide services on its behalf meet the competency

evaluation requirements of this section.

Standard: Home Health Aide Assignments

At proposed Sec. 484.75(e), we would retain the revisions to

existing Sec. 484.36(c), Standard: Assignments and duties of the home

health aide, published in December 1994 (59 FR 65482), with one

additional requirement. Specifically, at proposed Sec. 484.75(e)(3), we

propose to restore the requirement that home health aides must report

changes in the patient's medical, nursing, rehabilitative, and social

needs to the registered nurse or other appropriate skilled professional

and complete appropriate records in compliance with the HHA policies

and procedures. This requirement was inadvertently removed in the

December 1994 final rule. Home health aides may observe changes in

patient needs that are crucial to future treatment decisions and should

be reported to the appropriate professional in order to implement

effective and appropriate changes in care.

Standard: Supervision

At proposed Sec. 484.75(f), we would retain the home health aide

supervision

requirement was inadvertently removed in the

December 1994 final rule. Home health aides may observe changes in

patient needs that are crucial to future treatment decisions and should

be reported to the appropriate professional in order to implement

effective and appropriate changes in care.

Standard: Supervision

At proposed Sec. 484.75(f), we would retain the home health aide

supervision

requirements under existing Secs. 484.36(d) (1), (2), (3), and (4).

We have concerns about whether quality supervision can be done

without the requirement of an aide's presence performing a direct

patient service. We have discussed several alternatives, including a

requirement that the registered nurse or appropriate skilled

professional must make an onsite visit to the patient's home while the

home health aide is providing patient care no less frequently than

every 30 days. We welcome comments on changing the current indirect

supervision requirement and will address the issue in the final rule.

We are also soliciting comments on the idea of focusing aide

supervision on individual aides rather than each patient. The purpose

of the supervisory visit is to determine if services are being

provided, to assess relationships with the patient, competency with

tasks, and evaluation of the employee's contribution to the

organization's goals to provide high quality care.

Generally, assessing patient needs, developing a plan of care, care

coordination, and other skilled visits are performed at a frequency

that generally exceeds a biweekly aide supervision schedule. These

visits traditionally encompass supervision functions by the nature of

being home and ascertaining whether the patient's needs are being met.

Therefore, the current supervisory requirements may not add the quality

measure of care and may duplicate functions that are inherently

provided by the interdisciplinary team

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.

only ensure that the aide is competent to perform the

necessary skills (see competency evaluation), but also evaluate the

aide's ability to perform such functions on a continual basis.

Supervision must be provided by the appropriate professional to ensure

the health and safety of the patient, especially when specialized tasks

and delegated functions have been added to the competency subjects.

(2) The frequency of routine supervision is established by the

HHA's policies which promote high quality patient care through the

employment evaluation processes. These evaluation tools should begin at

the time of employment and are evaluated thereafter on a regular

employment basis, allowing for variations to accommodate time in

service with the hiring HHA and the employees' recorded evaluation

ratings with that HHA. Employment status should be calculated by the

most appropriate method for the organization to ensure regular

evaluations. HHAs who arrange for aide services through a non-Medicare

certified HHA must ensure equivalent supervision requirements in the

arrangement contract with the primary HHA responsible for compliance

with these requirements.

(3) The evaluation process includes, but is not limited to,

measuring the aide's continual ability to perform routine tasks,

specialized tasks, reporting problems to the HHA with care plan tasks,

recognizing and reporting barriers to the anticipated outcomes, and

patient satisfaction issues.

in the

arrangement contract with the primary HHA responsible for compliance

with these requirements.

(3) The evaluation process includes, but is not limited to,

measuring the aide's continual ability to perform routine tasks,

specialized tasks, reporting problems to the HHA with care plan tasks,

recognizing and reporting barriers to the anticipated outcomes, and

patient satisfaction issues.

(4) Nonroutine supervision is also essential to monitor the need

for paraprofessional care plan revisions. For example, HHAs could

perform spot home visits (direct or indirect observation), telephone

interviews, and other mechanisms to ensure protection of the health and

safety of the patient and respect for patient's privacy and property.

Nonroutine supervisory techniques provide a forum for open and frequent

communication to obtain essential and timely feedback. Feedback can

also be obtained from other care providers (formal and informal),

significant family, and others deemed necessary to properly evaluate

the paraprofessional.

(5) In accordance with HHA policies, the aide should also provide

feedback on his or her employment environment and the evaluation

processes.

Additionally, we welcome comments on the efficacy of using

competent individuals other than a registered nurse to perform

training, competency evaluation, and assignment or supervision

functions for home health aides.

Standard: Medicaid Personal Care Aide Services--Medicaid Personal Care

Benefit

At proposed Sec. 484.75(g) we would retain the current requirements

under Sec. 484.36(e) (1) and (2). A Medicare certified HHA that

provides personal care aide services to Medicaid patients under a State

Medicaid Personal Care Benefit must determine and ensure the competency

of individuals who perform those Medicaid approved services.

Alternatives for Future Revisions

Personal Care

Benefit

At proposed Sec. 484.75(g) we would retain the current requirements

under Sec. 484.36(e) (1) and (2). A Medicare certified HHA that

provides personal care aide services to Medicaid patients under a State

Medicaid Personal Care Benefit must determine and ensure the competency

of individuals who perform those Medicaid approved services.

Alternatives for Future Revisions

Home care patients are a vulnerable and confined population. It is

necessary to ensure the provision of safe quality care to patients in

their homes. We are proposing one specific measure in this proposed

rule--a criminal background check of home health aides as a condition

of employment (Sec. 484.75(h)). In addition, we are considering the

utility of several other process measures that could be included in

this regulation that are predictive of the desired outcome of

delivering safe quality care in the patient's home. One possibility

would be to adopt the language that is currently used in the Conditions

of Participation for Intermediate Care Facilities for the Mentally

Retarded (ICF/MR) at Sec. 483.420, modified to reflect the HHA

environment and population served. The ICF/MR provisions governing

client protections at Secs. 483.420(d)(1)(iii), (2), (3), and (4)

state:

The facility must prohibit the employment of individuals

with a conviction or prior employment history of child or client abuse,

neglect or mistreatment.

The facility must ensure that all allegations of

mistreatment, neglect or abuse, as well as injuries of unknown source,

are reported immediately to the administrator or to other officials in

accordance with State law through established procedures.

The facility must have evidence that all alleged

violations are thoroughly investigated and must prevent further

potential abuse while the investigation is in progress

re 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.

We are soliciting comments on the costs and benefits of requiring

criminal background checks for home health aides and the possible

adoption of the additional patient safeguards modified to reflect the

HHA environment.

D. Proposed Subpart C--Organizational Environment

1. Compliance with Federal, State, and Local Laws (Proposed Section

484.100)

Currently, provisions concerning compliance with Federal, State,

and local laws are located at Sec. 484.12, Condition of Participation:

Compliance with Federal, State, and local laws, disclosure of ownership

information and accepted professional standards and principles. We

would retain most of the provisions contained in this condition with

minor changes, which are discussed in detail below. Under our proposed

reorganization scheme, discussed above, this condition would be set

forth at Sec. 484.100.

Under the first standard, compliance with Federal, State, and local

laws and regulations, at proposed Sec. 484.100(a), we would revise the

language at existing Sec. 484.12(a)

n most of the provisions contained in this condition with

minor changes, which are discussed in detail below. Under our proposed

reorganization scheme, discussed above, this condition would be set

forth at Sec. 484.100.

Under the first standard, compliance with Federal, State, and local

laws and regulations, at proposed Sec. 484.100(a), we would revise the

language at existing Sec. 484.12(a). That is, we would require that the

HHA and its staff must operate and furnish services in compliance with

all Federal, State, and local laws and regulations applicable to home

health agencies. If a State has established licensing requirements for

HHAs, all HHAs must be approved by the State licensing authority as

meeting those requirements whether or not they are required to be

licensed by the State. The Secretary may find an HHA to be out of

compliance with these conditions of participation if the HHA is found

out of compliance with any Federal, State, or local law or regulation

by the appropriate enforcement agency for that law or regulation and

the Secretary determines that the law or regulation affects the HHA's

ability to deliver home health services safely and effectively. When a

facility is actually found out of compliance and is cited by that

agency for a violation, HCFA will exercise discretion in determining

whether that violation should be cited as a violation under these

conditions. Clearly it is not in the interest of patients or providers

to decertify facilities or to require corrective action plans for

certain reasons (for example, a facility's failure to pay its local

property taxes on time or building a fence 3 feet over the property

line). We would not cite an agency whose problem was remedied (for

example, the facility paid its taxes)

tion under these

conditions. Clearly it is not in the interest of patients or providers

to decertify facilities or to require corrective action plans for

certain reasons (for example, a facility's failure to pay its local

property taxes on time or building a fence 3 feet over the property

line). We would not cite an agency whose problem was remedied (for

example, the facility paid its taxes). However, HCFA intends to cite

agencies when their violations of Federal, State, or local laws or

regulations affect the health and safety of patients, the ability of

HHAs to deliver quality services, the rights and well-being of

patients, and/or the management of the agency and its ability to

recruit qualified staff. We welcome comments on this interpretation.

Similarly, in the second standard, Disclosure of ownership and

management information, we propose to retain the requirements at

existing Sec. 484.12(b). We would continue to require that the HHA

comply with the requirements of Secs. 420.200 through 420.206 regarding

disclosure of ownership and control information. Additionally, the

second standard would continue to require that the HHA also disclose

the following information to the State survey agency at the time of the

HHA's initial request for certification, for each survey, and at the

time of any change in ownership or management:

The name and address of all persons with an ownership or

control interest in the HHA as defined in Secs. 420.201, 420.202, and

420.206.

The name and address of each person who is an officer, a

director, an agent, or a managing employee of the HHA as defined in

Secs. 420.201, 420.202, and 420.206.

The name and address of the corporation, association, or

other company that is responsible for the management of the HHA, and

the name and address of the chief executive officer and the chairperson

of the board of directors of that corporation, association, or other

company responsible for the management of the HHA.

Existing Sec

of the HHA as defined in

Secs. 420.201, 420.202, and 420.206.

The name and address of the corporation, association, or

other company that is responsible for the management of the HHA, and

the name and address of the chief executive officer and the chairperson

of the board of directors of that corporation, association, or other

company responsible for the management of the HHA.

Existing Sec. 484.12(c) provides that an HHA must comply with

accepted professional standards and principles. To reflect an emphasis

on the importance of continuity of care and our focus on quality,

regardless of the site of service, we propose to move the current

provisions at Sec. 484.12(c) and incorporate the performance

expectation of the provisions into the quality assessment and

performance improvement program. HCFA has long used the term ``in

accordance with accepted standards of practice'' in its various

provider and supplier requirements both to set a performance

expectation and to serve as an enforcement tool should grossly

divergent practices be identified in the survey process.

We believe that requiring an HHA to participate in a strong,

quality assessment and performance improvement program would stimulate

an aggressive effort to identify and use the best practices available

for all care providers in the HHA. As discussed above, for the HHA to

be successful in its quality assessment and performance improvement

program, it will be obliged to seek out best practices continuously.

HCFA's survey effort can then be devoted to assessing how the HHA has

sought out and adopted best practices in the field as part of the

surveyor's evaluation of the quality assessment and performance

improvement requirements, rather than HCFA prescriptively defining

``accepted professional standards''.

At proposed Sec. 484.100(c), we would provide that the HHA and its

branches must be licensed in accordance with State licensure laws, if

applicable, prior to providing Medicare reimbursed services

s in the field as part of the

surveyor's evaluation of the quality assessment and performance

improvement requirements, rather than HCFA prescriptively defining

``accepted professional standards''.

At proposed Sec. 484.100(c), we would provide that the HHA and its

branches must be licensed in accordance with State licensure laws, if

applicable, prior to providing Medicare reimbursed services. This

provision seeks to ensure that HHA patients receive the same level of

quality care from the appropriate personnel at all sites of service.

The requirement that HHAs comply with State licensure laws before

providing services to Medicare beneficiaries would apply to the HHA as

an entity as well as its staff furnishing services to HHA patients

directly or under arrangements.

Finally, we propose to move the current requirements at

Sec. 484.14(j), Organization, services and administration, Standard:

Laboratory services, to proposed Sec. 484.100(d). We believe that the

laboratory services standard is a Federal requirement that is better

suited under the revised condition of participation governing

compliance with Federal, State, and local laws.

2. Organization and Administration of Services (Proposed Section

484.105)

The proposed COP on organization and administration of services

would revise existing regulations at Sec. 484.14 (Condition of

participation: organization, services and administration) and replace

the existing regulations at Sec. 484.38 (Condition of participation:

Qualifying to furnish outpatient physical therapy or speech-language

pathology services). The proposed new condition simplifies the

structure of the current requirements and provides flexibility to the

HHA by replacing the current focus on organizational structures with

new performance expectations for the administration of an HHA as an

organizational entity

4.38 (Condition of participation:

Qualifying to furnish outpatient physical therapy or speech-language

pathology services). The proposed new condition simplifies the

structure of the current requirements and provides flexibility to the

HHA by replacing the current focus on organizational structures with

new performance expectations for the administration of an HHA as an

organizational entity. With the wide diffusion of home health

organization and management structures, it is imperative to ensure

accountability within HHAs by setting performance expectations for the

clear, unambiguous, and accountable operation of all

services. The overall goal of the proposed condition is clear,

accountable organization, management, and administration of an HHA's

resources to attain and maintain the highest practicable functional

capacity for each patient in terms of medical, nursing, and

rehabilitative needs as indicated on the plan of care.

One of the most critical responsibilities for the governing body of

the HHA to meet is stated explicitly at the beginning of proposed

Sec. 484.105: The HHA is expected to ``attain and maintain the highest

practicable functional capacity for each patient * * *'' This language

derives from section 1891(c)(2)(C)(i)(I) of the Act, which directs the

Secretary to devise a survey process that includes home visits to a

case-mix sample of patients ``for the purpose of evaluating * * * the

extent to which the quality and scope of items and services furnished

by the agency attained and maintained the highest practicable

functional capacity of [E]ach such individual * * * '' Thus, the

expectation for performance of the HHA, as stated throughout these

proposed rules, especially in the comprehensive assessment, care

planning and coordination, and quality assessment and performance

improvement COPs, is to achieve outcomes of care that are commensurate

with a patient's condition and expectations for returning to improved

functional status as much as possible

* * '' Thus, the

expectation for performance of the HHA, as stated throughout these

proposed rules, especially in the comprehensive assessment, care

planning and coordination, and quality assessment and performance

improvement COPs, is to achieve outcomes of care that are commensurate

with a patient's condition and expectations for returning to improved

functional status as much as possible. The placement of this

requirement in the COP that includes the governing body is intended to

express clearly our intention that the responsibility for achieving the

best outcomes possible for the patients served lies with the

administration of the HHA, including its governing body and

administrator.

This requirement lends support to the importance of the HHA using

current best practices within a strong quality assessment and

performance improvement program. It promotes the HHA's seeking out and

using comparative data where available and using its own data compared

to previous points in time to demonstrate internal improvements in

outcomes over time.

We recognize that there is no single test of this requirement; each

patient is unique and the expectations for outcomes vary in every case.

Yet, we will expect surveyors to determine that the HHA, overall, has

aggressively pursued this statutory expectation for outcomes for

patients and either achieves it, or demonstrates its efforts to achieve

it when desired outcomes are not successfully achieved.

In the proposed organization and administration of services

condition, we revise the current standard on governing body

(Sec. 484.14(b)), retain, with only minor changes, the current standard

on services furnished (Sec. 484.14(a)), retain, with only minor

editorial changes, the requirements with respect to services under

arrangements that are now stated in Sec. 484.14(h), delete the current

standards on administrator (484.14(c)), delete the current standards on

supervising physician or registered nurse (Sec

y

(Sec. 484.14(b)), retain, with only minor changes, the current standard

on services furnished (Sec. 484.14(a)), retain, with only minor

editorial changes, the requirements with respect to services under

arrangements that are now stated in Sec. 484.14(h), delete the current

standards on administrator (484.14(c)), delete the current standards on

supervising physician or registered nurse (Sec. 484.14(d)), delete the

current standards on personnel policies (Sec. 484.14(e)), delete the

current standards on institutional planing (Sec. 484.14(i)), relocate

the existing condition, qualifying to furnish outpatient physical

therapy or speech-language (Sec. 484.38) under this condition, and

relocate the current standard on laboratory services (Sec. 484.14(j))

under the compliance with Federal, State and local laws COP.

In developing the proposed governing body standard, we emphasize

the responsibility of the HHA governing body (or designated persons so

functioning) for the management and provision of all home health

services, fiscal operations, quality assessment, performance

improvement, and the appointment of the administrator. We have retained

the necessary administrative features that promote and protect patient

health and safety from the current standard on governing body at

Sec. 484.14(b) while providing flexibility in the actual approach to

the performance expectation of the provision of quality care to all

patients. Thus, in the proposed governing body standard, the actual

approach to the administration of the HHA as an organization is left to

the discretion of the governing body of each HHA. The proposed

governing body standard reflects our goal of promoting the effective

management and administration of the HHA as an organizational entity

without dictating prescriptive requirements for how an HHA must meet

that goal

oposed governing body standard, the actual

approach to the administration of the HHA as an organization is left to

the discretion of the governing body of each HHA. The proposed

governing body standard reflects our goal of promoting the effective

management and administration of the HHA as an organizational entity

without dictating prescriptive requirements for how an HHA must meet

that goal.

In the proposed governing body standard, the HHA's governing body

(or designated persons so functioning) must assume the full legal

authority and responsibility to ensure the performance expectation of

the sound fiscal operation of the HHA, appoint a qualified

administrator who is responsible for the day-to-day operation of the

program, and may appoint designated persons to carry out those

functions. We believe the proposed standard on governing body

encompasses the performance expectation of an HHA administrator and of

organizational fiscal operations, and, therefore, propose to delete the

current prescriptive standards on the administrator at Sec. 484.14(c)

and on institutional planning at Sec. 484.14(i). We propose to replace

the current process-ridden institutional planning standard at

Sec. 484.14(i) with the performance expectation of the HHA governing

body's responsibility for the fiscal operation of the HHA.

We propose to remove the current statutorily based institutional

planning requirements from the HHA conditions of participation. Because

the HHA conditions of participation are primarily intended to reflect

patient health and safety standards, we feel the COPs are an

inappropriate location for the institutional planning provisions found

under section 1861(z) of the Act. The proposed standard requires the

governing body to assume full legal authority and responsibility for

fiscal operations and appointment of an administrator who is

responsible for the day-to-day operation of the program without

specifying the means to achieve the goal

eel 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

e, 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

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

rtification.

In the proposed rule, we have retained the current definitions, and

we are also incorporating the previous definition material into the

organization and administration of services COP in order to clarify

that this is a management responsibility of the organization. The

standard states that a parent home health agency provides direct

support and administrative control of branches. The branch office is

located sufficiently close to effectively share administration,

supervision, and services in a manner that renders it unnecessary for

the branch to separately meet the COPs as an HHA. We have added

``teeth'' to the current definition of the parent and branch by making

it a standard level requirement. This will enable surveyors to cite a

deficiency when the performance by an HHA's branch does not ensure that

the branch is meeting the HHA requirements applicable to its operation.

Since the parent/branch reference in the current rule is only a

definition, surveyors cannot presently cite a deficiency.

We are proposing at Sec. 484.105(e) to revise the current services

furnished requirement at existing Sec. 484.14(a). Specifically, we

would retain the current requirement that part-time or intermittent

skilled nursing services and at least one other therapeutic service

(physical therapy, speech-language pathology, or occupational therapy;

medical social services; or home health aide services) are made

available on a visiting basis in a place of residence used as a

patient's home. We would revise the second part of the standard to

state that an HHA must provide at least one of the qualifying services

directly, but may provide the second qualifying service and additional

services under arrangements with another agency or organization.

Medicare makes a distinction between services provided directly as

opposed to under arrangement. As discussed above, the most common way

services are provided directly is through the use of employees

an HHA must provide at least one of the qualifying services

directly, but may provide the second qualifying service and additional

services under arrangements with another agency or organization.

Medicare makes a distinction between services provided directly as

opposed to under arrangement. As discussed above, the most common way

services are provided directly is through the use of employees. The

common law definition of ``employee'' fundamentally relates to whether

a person is under control by the entity or individual providing the

services, so by and large producing a W-2 form would constitute

providing the services directly. We are exploring a straightforward way

to define the provision of direct services as opposed to services

provided under arrangement.

3. Clinical Records (Proposed section 484.110)

We are proposing a new COP, clinical records, that embodies several

of the requirements in existing Sec. 484.48, Condition of

participation: Clinical records. In this condition we would retain only

those process requirements that are essential to protect of patient

health and safety.

The primary requirement under the proposed clinical records

condition of participation is that a clinical record containing

pertinent past and current findings is maintained for every patient who

is accepted by the HHA for home health services. We propose to add the

requirement that the information contained in the clinical record must

be accurate, made available to the physician and appropriate HHA staff

and may be maintained electronically. The accuracy of the clinical

record must exhibit consistency between the diagnosed condition and the

actual experience of the patient. Accuracy can be reflected in the

appropriate link between patient assessment information and the

services and treatments ordered and furnished in the plan of care

, made available to the physician and appropriate HHA staff

and may be maintained electronically. The accuracy of the clinical

record must exhibit consistency between the diagnosed condition and the

actual experience of the patient. Accuracy can be reflected in the

appropriate link between patient assessment information and the

services and treatments ordered and furnished in the plan of care. In

light of the decentralized nature of HHAs, that is, patient care is not

furnished in a single location, we believe that members of the

interdisciplinary team must have access to patient information in order

to provide quality services. Many HHAs maintain electronic records and

we recognize this technological change in the home health environment.

The first standard of the condition, contents of the record, would

include several elements that we currently require HHAs to include in

the clinical record. We would retain the requirement that the record

include clinical/progress notes, a discharge summary, and the plan of

care. To give HHAs flexibility in maintaining clinical records, we

would no longer specify that the record must include appropriate

identifying information, name of physician, drug, dietary, treatment

and activity orders, and copies of summary reports sent to the

attending physician. Finally, we would add requirements to this

standard that reflect our outcome oriented approach to patient care.

Specifically at proposed Sec. 484.110(a), we would require that the

clinical record include: (1) The patient's current comprehensive

assessment, clinical/progress notes, and plan of care; (2) responses to

medications, treatments, and services; (3) a description of measurable

outcomes that have been achieved; and (4) a discharge summary that is

available to physicians upon request. We believe that these

requirements would give HHAs flexibility in maintaining clinical

records as well as ensure that the records contain information

necessary to provide high quality patient care

; (2) responses to

medications, treatments, and services; (3) a description of measurable

outcomes that have been achieved; and (4) a discharge summary that is

available to physicians upon request. We believe that these

requirements would give HHAs flexibility in maintaining clinical

records as well as ensure that the records contain information

necessary to provide high quality patient care.

We propose to add a new standard at proposed Sec. 484.110(b) to

provide for authentication of clinical records. We would require that

all entries be clear, complete, and appropriately authenticated.

Authentication must include signatures or a computer secure entry by a

unique identifier of a primary author who has reviewed and approved the

entry. The move to computerized records has resulted in transcription

of doctor's orders and electronic signatures. This standard is

currently in the COPs for hospitals, and addresses technological

changes in information management.

Under proposed Sec. 484.110(c) we would retain the current

requirement under Sec. 484.48(a) (Standard: Retention of records). That

is, we would continue to require that clinical records be retained for

5 years after the month the cost report to which the records apply is

filed with the intermediary, unless State law stipulates a longer

period of time. HHA policies provide for retention of records even if

the HHA discontinues operations. If the patient is transferred to

another health facility, a copy of the record or an abstract is sent

with the patient.

We also propose to incorporate into this condition the first

requirement under existing Sec. 484.48(b) (Standard: Protection of

records). At proposed Sec. 484.110(d) we would provide that patient

information and the record are safeguarded against loss or

ntinues operations. If the patient is transferred to

another health facility, a copy of the record or an abstract is sent

with the patient.

We also propose to incorporate into this condition the first

requirement under existing Sec. 484.48(b) (Standard: Protection of

records). At proposed Sec. 484.110(d) we would provide that patient

information and the record are safeguarded against loss or

unauthorized use. We believe the other requirements under existing

Sec. 484.48(b) concerning the release of clinical record information

are best incorporated into the new standard at proposed Sec. 484.50

(Patient Rights: Confidentiality of clinical records).

4. Personnel Qualifications (Proposed section 484.115)

Currently, provisions concerning the qualifications of HHA

personnel are located at Sec. 484.4. This section now includes very

specific credentialing requirements and provides that any staff

required to meet the conditions of participation must meet our

qualifications. In keeping with our goal of eliminating process

requirements that are not predictive of good outcomes for patients or

necessary to prevent harmful outcomes for patients, we are proposing

significant revisions to the personnel qualifications COP.

Specifically, we would provide that in cases where personnel

requirements are not statutory, or do not relate to a specific payment

provision we would apply State certification or State licensure

requirements. Under our proposal, the personnel qualifications would

fall into three basic categories, personnel for which there is a

statutory set of qualifications, personnel for which we have specified

requirements since all States do not have licensure or certification

requirements, and personnel for which all States have licensure or

certification requirements. Under our proposed reorganization of part

484, the personnel qualifications would be located at proposed

Sec. 484.115. We discuss the personnel qualifications in detail below

of qualifications, personnel for which we have specified

requirements since all States do not have licensure or certification

requirements, and personnel for which all States have licensure or

certification requirements. Under our proposed reorganization of part

484, the personnel qualifications would be located at proposed

Sec. 484.115. We discuss the personnel qualifications in detail below.

The first category of personnel qualifications are those in which

we would defer to State law. At proposed Sec. 484.115(a), we would

specify that skilled professionals who provide services directly by or

under arrangements with the HHA must be legally authorized (licensed or

if applicable, certified or registered) to practice by the State in

which he or she performs, and must act only within the scope of his or

her State license or State certification.

The second category would consist of personnel for which there is a

statutory set of qualifications. Section 1861(r) of the Act essentially

defines a physician as a doctor of medicine, osteopathy, or podiatry

legally authorized to practice medicine and/or surgery by the State in

which such function or action is performed. We would refer to this

definition at proposed Sec. 484.115(b). The Act also contains a

definition of a speech language pathologist. Specifically, section

1861(ll)(3)(A) defines a qualified speech language pathologist as an

individual with a master's or doctoral degree in speech-language

pathology who is licensed as a speech-language pathologist by the State

in which the individual furnishes such services, or in the case of an

individual who furnishes services in a State which does not license

speech-language pathologists, has successfully completed 350 clock

hours of supervised clinical practicum (or is in the process of

accumulating such supervised clinical experience), performed not less

than 9 months of supervised full-time speech-language pathology

services after obtaining a master's or doctoral degree in speech-

language pat

urnishes services in a State which does not license

speech-language pathologists, has successfully completed 350 clock

hours of supervised clinical practicum (or is in the process of

accumulating such supervised clinical experience), performed not less

than 9 months of supervised full-time speech-language pathology

services after obtaining a master's or doctoral degree in speech-

language pathology or a related field, and successfully completed a

national examination in speech-language pathology approved by the

Secretary. The Act also defines the qualifications for home health

aides at section 1891(a). We believe that the description of

qualifications for home health aides would be more appropriately

locat

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