11004 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Proposed Rules

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 484

RIN 0938–AI00

Medicare and Medicaid Programs;

Revision of the Conditions of

Participation for Home Health

Agencies and Use of the Outcome and

Assessment Information Set (OASIS)

as Part of the Revised Conditions of

Participation for Home Health

Agencies

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Introduction to proposed rules.

SUMMARY: In this Part IV—of this issue

of the Federal Register, we are

publishing two notices of proposed

rulemaking relating to revised

conditions of participation that home

health agencies must meet to participate

in the Medicare and Medicaid programs.

This introduction explains the

background for the two proposed rules

and the interrelationship of the two

documents.

FOR FURTHER INFORMATION, CONTACT:

Susan Levy, (410) 786–9364 and Mary

Vienna, (410) 786–6940.

SUPPLEMENTARY INFORMATION: As part of

the President’s and Vice President’s

regulatory reform initiative, the Health

Care Financing Administration (HCFA)

is committed to changing current

regulations that focus largely on

requirements for measuring procedural

standards. One of HCFA’s key initiatives

in Reinventing Government (REGO) is to

revise many of its conditions of

participation (COP) to focus on

outcomes of care and to eliminate

unnecessary procedural requirements.

HCFA is working in partnership with

the rest of the health care community to

institute better, more common sense

ways of operating. Within the coming

year, HCFA plans to propose revisions

to the COP for home health agencies

(HHAs), hospitals, and end stage renal

disease (ESRD) facilities and also to

mount additional research in the area of

ESRD to provide the basis for future

changes.

A. Common Efforts

1. Reinventing Government (REGO)

Initiative

To meet our REGO commitment, we

are focusing on an approach for all sets

of COP that is:

• Transitional toward a patient

outcome based system.

• Intended to stimulate

improvements in processes, outcomes of

care, and patient satisfaction.

• Patient centered.

• Supported by patient outcomes

data.

• Interdisciplinary in the approach to

care delivery, reflecting the team

approach to health care delivery.

The COP generally adhere to these

basic requirements, varying in some

degree due to the unique environment

and patient case mix of the provider

type.

2. Transitional Framework

The transitional framework for each

set of COP—

• Begins shifting the oversight focus

toward patient health outcomes and

away from burdensome and costly

procedural requirements, restructures

the traditional COP along essential

conditions centered on patient care,

reflects an interdisciplinary team

approach to patient care.

• Prepares the foundation for

provider adoption and use of more

detailed patient outcome measures

developed through private sector

experience and research.

• Provides a flexible framework for

incorporating better measures as they

are developed and tested.

3. Structure

The basic structure of all of the COP

follows the Joint Commission on

Accreditation of Healthcare

Organizations’’ (JCAHOs) ‘‘Agenda for

Change.’’ This structure involves

reducing the number of conditions in

crosscutting categories; focusing on

comprehensive assessment and patient

outcomes; and deleting, where possible,

process requirements that are not

specifically mandated by the statute or

believed likely to produce outcomes

vital to the protection of patient safety.

Each set of COP has the same

essential four conditions that reflect the

cycle of patient centered care. The

essential four conditions are:

• Patient rights.

• Patient assessment.

• Care planning and coordination of

services.

• Quality assessment and

performance improvement.

It is important to note that each of the

sets of COP requirements are tailored to

specific statutory requirements, the

historical context of the provider type,

the unique form of care delivery, and

patient case mix.

4. Professional Input

For each set of COP, national

meetings of provider and practitioner

groups and beneficiary representatives,

and our partners in State survey

agencies were consulted about our

approach and provided comments. Each

proposed set of COP reflects extensive

consultation with these groups. We

recognize the importance of

collaboration and communication with

the industry and invite further public

comment on the proposed COP and

related rules.

B. Challenge for Home Health

The challenge for revising the home

health COP has been to—

• Emphasize a regulatory approach

that:

+ Moves toward a patient outcome

based system;

+ Focuses on quality assessment and

performance improvement;

+ Centers on the patient; and

+ Reflects the interdisciplinary team

approach to home health care delivery;

• Develop a standard core assessment

tool that will: 1) be useful as a

management tool for providers; and, 2)

eventually enable providers,

government agencies, and health care

consumers to compare patient

indicators and outcomes across more

than 9000 HHAs.

What follows in this issue of the

Federal Register are two discrete

documents:

l. Revised HHA COP. These COP

include the refinements discussed

above.

The fundamental principles guiding

the development of the revised HHA

COP are to:

• Stress quality improvements,

incorporating to the greatest extent

possible, outcome oriented, data

supported quality assessment and

performance improvement. The quality

assessment and performance

improvement program is of the HHA’s

own design and allows the HHA

flexibility to create its own tailored

program of continuous improvement.

HHAs could be increasingly flexible and

creative in their approach to patient care

and delivery of services as they use their

own information to assess and improve

patient services, outcomes, and

satisfaction. HCFA has developed the

OASIS core standard assessment data

set to support this proactive approach to

quality improvement.

• Facilitate flexibility in how an HHA

meets our performance requirements.

For example, HCFA is proposing to

adopt the REGO approach to personnel

qualifications by indicating, in cases

where personnel qualifications are not

statutorily required, the HCFA

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

would apply only in States without a

licensing requirement.

• Eliminate unnecessary

administrative requirements. Process

oriented requirements are included only

where we believe they remain highly

predictive of ensuring desired patient

outcomes and protect patient safety.

• Assure patients rights.

• Focus on continuous, integrated

care centered around patient

assessment, care planning, coordination

of service delivery, and quality

assessment and performance

improvement. The four ‘‘core

conditions’’ are Patient Rights, Patient

Assessment, Care Planning and

Coordination of Services, and Quality

Assessment and Performance

Improvement.

• Incorporate the program integrity

approaches.

2. The Proposed Implementation of

the Outcomes and Assessment

Information Set (OASIS).

This proposed rule would revise the

new conditions of participation for

HHAs by requiring an HHA to

incorporate the 79-item, core standard

assessment data set, referred to as the

OASIS, into its comprehensive patient

assessment, as well as use OASIS

information as part of its internal

quality assessment and performance

improvement program. The OASIS will

serve as the foundation for future

reliance on patient outcomes in

provider decision making, regulatory

oversight and consumer choice. This

proposed rule does not require the HHA

to collect and report OASIS to a national

data system.

This proposed rule is an integral part

of the Administration’s larger efforts to

achieve broad-based, measurable

improvement in the quality of care

furnished through Federal programs. It

is a fundamental component in the

transition to a quality assessment and

performance improvement approach

based on measurable patient outcomes

of care and satisfaction with the

Medicare home health benefit. In order

to reach the point where we can build

and use a national data set of measures

of outcomes and satisfaction, we must

begin with a requirement that all HHAs

use the same valid and reliable core

standard assessment data set. By

integrating a core standard assessment

data set into its own more

comprehensive assessment system, an

HHA can use such a valid and reliable

data set as the foundation for its quality

assessment and performance

improvement program.

We expect to receive positive and

constructive comments on both of these

documents. We have published these

documents as separate rules. They

reflect discreet steps in the transition

toward a regulatory system based on

patient outcomes. While linked in

important ways, they have different

impacts on the provider community. We

have published them in the same

Federal Register because together they

reflect a more complete picture of the

Department’s patient outcome based

strategy.

We have published the description of

the OASIS as a separate proposed rule

following the proposed HHA COP in

this Part of this issue of the Federal

Register. Please note that the

implementation of OASIS would change

only §§ 484.55 and 484.65 of the revised

HHA COP. We have included several

notes in the HHA COP to direct the

reader to the OASIS notice for more

comprehensive information.

(Catalog of Federal Domestic Assistance

Programs No 93.774, Medicare—

Supplementary Medical Insurance, and No.

93,778, Medical Assistance Program)

Dated: January 21, 1997.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: January 30, 1997.

Donna E. Shalala,

Secretary.

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

BILLING CODE 4120–01–P

42 CFR Part 484

[BPD–819–P]

RIN 0938–AG81

Medicare and Medicaid Programs;

Conditions of Participation for Home

Health Agencies

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule revises the

existing conditions of participation that

home health agencies must meet to

participate in the Medicare program.

The proposed requirements focus on the

actual care delivered to patients by

home health agencies and the results of

that care, reflect an interdisciplinary

view of patient care, allow home health

agencies greater flexibility in meeting

quality standards, and eliminate

unnecessary procedural requirements.

These changes are an integral part of the

Administration’s efforts to achieve

broad-based improvements in the

quality of care furnished through

Federal programs and in the

measurement of that care, while at the

same time reducing procedural burdens

on providers.

DATES: Comments will be considered if

we receive them at the appropriate

address, as provided below, no later

than 5 p.m. on June 9, 1997, except for

comments on information collection

requirements, which must be received

on or before May 9, 1997.

ADDRESSES: Mail written comments (one

original and three copies) to the

following address: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: BPD–819–P, P.O. Box 7519,

Baltimore, MD 21207–0519.

If you prefer, you may deliver your

written comments (one original and

three copies) to one of the following

addresses:

Room 309–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC 20201, or

Room C5–11–17, 7500 Security

Boulevard, Baltimore, MD 21244–

1850.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

BPD–819–P. Comments received timely

will be available for public inspection as

they are received, generally beginning

approximately 3 weeks after publication

of a document, in Room 309–G of the

Department’s offices at 200

Independence Avenue, SW.,

Washington, DC, on Monday through

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

5 p.m. (phone: (202) 690–7890).

For comments that relate to

information collection requirements,

mail a copy of comments to: Office of

Information and Regulatory Affairs,

Office of Management and Budget,

Room 10235, New Executive Office

Building Washington, DC 20503,

Attention Allison Herron Eydt, HCFA

Desk Officer.

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Superintendent of Documents, P.O. Box

371954, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

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