[Federal Register Volume 62, Number 46 (Monday, March 10, 1997)]
[Proposed Rules]
[Pages 11004-11005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5314]



[[Page 11003]]

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Part IV





Department of Health and Human Services





_______________________________________________________________________



Health Care Financing Administration



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42 CFR Part 484



Medicare and Medicaid Programs; Revision of Conditions of Participation 
for Home Health Agencies and Use of Outcome Assessment Information Set 
(OASIS); Proposed Rules

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

[[Page 11004]]



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.

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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:
    <bullet> Transitional toward a patient outcome based system.
    <bullet> Intended to stimulate improvements in processes, outcomes 
of care, and patient satisfaction.
    <bullet> Patient centered.
    <bullet> Supported by patient outcomes data.
    <bullet> 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--
    <bullet> 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.
    <bullet> Prepares the foundation for provider adoption and use of 
more detailed patient outcome measures developed through private sector 
experience and research.
    <bullet> 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:
    <bullet> Patient rights.
    <bullet> Patient assessment.
    <bullet> Care planning and coordination of services.
    <bullet> 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--
    <bullet> 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;
    <bullet> 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:
    <bullet> 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.
    <bullet> 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

[[Page 11005]]

would apply only in States without a licensing requirement.
    <bullet> 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.
    <bullet> Assure patients rights.
    <bullet> 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.
    <bullet> 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 Secs. 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