[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]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Health Care Financing Administration
_______________________________________________________________________
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:
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
[[Page 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 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]
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