[Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
[Notices]
[Pages 23251-23253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-232-N]
Medicare Program: Initiative Involving Facilities That Furnish
Hemodialysis Treatments
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice announces our planned initiative to demonstrate
the feasibility of collecting, collating, and analyzing data about the
treatment of hemodialysis patients. The collected data will be
distributed to participating facilities in a timely manner so that it
may be used for quality improvement. This effort is intended to lead to
the development of a quality assessment system for hemodialysis
facilities that will permit facilities to track, on a routine basis,
facility specific health and clinical outcome measures. The system is
intended ultimately to permit facilities to use this information to
design and implement specific interventions to improve care at these
facilities and to test the ability of regulatory agencies to use this
information to recognize best performers and to focus their survey
resources. If feasible, facility performance indicators results can
disseminated to patients and facilities in the future. This initiative
will have several phases. The first phase is described in this notice.
FOR FURTHER INFORMATION CONTACT: Judith J. Kari, (410) 786-6829 or
Jacquelyn A. Polder, (206) 615-2317.
SUPPLEMENTARY INFORMATION:
I. Overview
In July 1995, the President and Vice President of the United States
announced the Administration's ``Reinventing Health Care Regulations''
initiative. This initiative is part of a larger strategy to reduce
regulatory burden on the American public. HCFA also is committed to
reducing regulatory burden while meeting our responsibility for
ensuring quality health care services for Medicare beneficiaries.
We have several initiatives underway involving facility conditions
of coverage or participation that are directed toward improving
outcomes of care and satisfaction for patients, while at the same time
reducing the burden on providers, and increasing flexibility and
expectations for continuous improvement. This notice concerns one phase
of an initiative involving facilities that furnish hemodialysis
treatments to patients with end stage renal disease (ESRD). We believe
that by establishing information exchange systems between ESRD
facilities and HCFA we can collect identified clinical indicators of
care; analyze the data collected; and use it to design interventions to
improve care. Moreover, by using electronic systems effectively such
information can be collected and used in a timely fashion.
If we determine that this is a good monitoring system, ultimately
it could decrease regulatory burden. In the future, routine surveys of
these facilities might be conducted with less frequency than they are
now, or in ways that allow us to assess facility compliance without
being onsite. Surveys would still be conducted in response to
complaints about the quality of care or if the data indicate a
potential serious problem. This notice announces our initiative to test
such an infrastructure in a limited area.
The project will test a new mechanism that will permit hemodialysis
facilities to provide patient specific clinical information to us on a
regular basis for the purpose of evaluating the quality of care being
provided to patients with ESRD. They will evaluate care by comparing
clinical information within their own facility over time as well as
comparing their clinical data against national and network data. The
primary goal of this project is to improve the quality of care to
Medicare beneficiaries with ESRD by tracking specific clinical
indicators. A secondary goal is to collaborate with hemodialysis
providers in the designing of a measurement system that will assist
facilities in their efforts to improve care, and ultimately reduce the
regulatory burden on these facilities. In the future, HCFA will explore
the possibilities of awarding a certificate of achievement to
facilities that document sustained achievement in the outcome
indicators over a period of time.
II. Background
In 1993, as part of our effort to ensure quality care for Medicare
ESRD beneficiaries, we began a descriptive epidemiological evaluation
project called the End Stage Renal Disease Core Indicators Project. The
core indicators project was designed to assist us and health
professionals who provide care to dialysis patients by regularly
collecting and analyzing certain clinical data about ESRD hemodialysis
patients that are indicators of the quality of care being provided. The
``core'' indicators initially selected for evaluation included adequacy
of dialysis (as measured by pre- and post-dialysis blood urea nitrogen
levels to calculate an urea reduction ratio), anemia (as measured by
hematocrit levels), blood pressure control, and nutritional status (as
measured by serum albumin levels). They were developed by a workgroup
with representation from facilities and the professional community,
including the National Kidney Foundation, Forum of ESRD Networks,
American Nephrology Nurses Association, National Renal Administrators
Association, and Renal Physicians
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Association. Data on these core indicators have been collected on a
national random sample (3 percent) of patients with ESRD who were
dialyzed during the last calendar quarters of 1993, 1994, and 1995. The
preliminary analysis of data collected and analysis for patients
dialyzed during the last quarter of 1995 indicates a measurable
national improvement in the adequacy of dialysis and reduction of
anemia.
The 3 percent random national sample consists of approximately
7,000 patients of the over 228,000 end stage renal disease patients in
the United States. With approximately 2,747 hemodialysis facilities in
the United States, the average number of patients per facility included
in the core indicators project is between 2 and 4.
The core indicators project has been very useful because it
provides timely information about the quality of care being provided to
patients throughout the national system. Perhaps the most important
message from the first 3 years of the Core Indicators Project is that
there is a significant opportunity to improve ESRD care throughout the
country. The Core Indicators Project has enhanced the expertise of HCFA
and the ESRD provider community in using clinical indicators to improve
quality of hemodialysis care.
While the study is a statistically valid measure of national
performance and network level performance, it was not designed to
measure care provided at the facility level. An essential next step is
to develop the capacity to measure care at the facility level in order
to assist us and ESRD providers to design and implement quality
improvement interventions to address each facility's opportunities to
improve care.
III. Hemodialysis Facilities of Achievement Project
A. Scope of Initiative
The ultimate goal of the Hemodialysis Facilities of Achievement
project is to foster continuous quality improvement efforts in ESRD
facilities. This will be accomplished through an electronic data
collection system that can provide the information needed to design
interventions to improve care at such facilities.
We currently use periodic on-site surveys to measure whether
facilities approved to participate in Medicare meet the quality
standards contained in Federal law and regulations. The surveys are
carried out by State survey agency personnel operating under Federal
guidelines; however, because of budget limitations these surveys are
conducted infrequently. Moreover, the standards do not emphasize
outcome measures that can be used for continuous quality improvement.
On a separate track, these standards, called conditions for coverage,
are also under revision. It is anticipated that information learned
from this project will be useful in determining how outcome measures
can best be used under revised conditions for coverage.
The project we are announcing in this notice focuses on quality of
care through establishing a systematic collection of clinical data on
all of the patients within a limited number of participating volunteer
facilities. It builds on the knowledge and experience that we have
gained through the Core Indicators Project.
It will feature: A system to collect uniform clinical information
on each patient; a method to transmit these data to us; and a technique
to analyze these data that facilities will use to improve quality of
care. We will assist participating facilities to:
Establish baseline measures of identified clinical
indicators,
Use national and regional data from the Core Indicators
Project to set facility specific quality improvement goals, and
Provide a mechanism by which facilities can periodically
measure and monitor their progress over time.
This project will permit ESRD networks and us to help facilities
implement and evaluate intervention strategies responsive to the needs
of specific facilities, types of patients, or geographic areas.
It is our belief that an outcome-oriented approach to quality can
reduce the cost and improve the quality of the ESRD program and
ultimately reduce regulatory burden. This project will take advantage
of electronic communication technology through a system to track
identified quality indicators.
B. Selection of Participants
Our regional offices have the primary responsibility for oversight
of quality of care provided to Medicare beneficiaries. In the case of
ESRD facilities, the regional office works with the State survey
agencies and with ESRD networks to carry out this oversight
responsibility. The Seattle regional office will coordinate this
project; the Seattle office was responsible for the Core Indicators
Project and thus has both experienced staff and data support capacity.
The Seattle regional office staff will be responsible for the
operation of the project from initial assessment of capacity of
facilities through evaluation. Based on their evaluation of the
computer capacity and capabilities of facilities in selected geographic
areas they will: select participating sites; establish a mechanism for
electronic communication; develop software for the project; train
participating facilities in the use of equipment and data; collect and
analyze data on all patients in participating facilities on a regular
basis; profile and share these data with facilities and networks;
participate in planning quality improvement initiatives at the facility
and network level; and determine which facilities are to be recognized
for their successful participation in the project.
To begin the project, we will contact all hemodialysis facilities
in a defined geographic area to elicit interest in participation and to
assess the computer capacity and capability of the facility. Unless the
response overwhelms available resources, we intend to include any
facility in the geographic area that wants to participate and has the
computer capability to participate.
C. Establishing Communication and Information Sharing
Software and electronic access will be developed and field tested
by the Seattle regional office. The software used will be similar to
data input forms that are used in the Core Data Indicators project and
we anticipate that facilities will submit similar information. Once
these mechanisms are secure, regional office staff will begin the
training phase of the project. The regional office will provide
assistance to assure that all project participants understand how to
use the equipment and software programs that will be at the center of
this project. When each facility is trained and ready, it will be asked
to transmit to the Seattle regional office identified clinical
information similar to data collected as part of the Core Indicators
Project. Throughout the duration of the project, the facilities will
periodically submit clinical data to us and will work with us on
evaluation of the data.
D. Clinical Indicators
The clinical indicators that will be collected for the first phase
of the project will be similar to that of the Core Indicators Project
which were determined in consultation with renal care organizations and
patient groups. We have a data base with several years of data from the
Core Indicators Project, so we expect that the historical data base
will have an influence on suggestions for data collection.
E. Recognizing Facilities That Successfully Participate in the Project
The long term objective of this project is to assist hemodialysis
facilities in
[[Page 23253]]
developing the capacity and ability to engage in continuous quality
improvement. This will contribute to improved care for patients and
reduced regulatory burden for providers. This is not a simple endeavor
nor one that will be put in place quickly. It will be important to
recognize achievement by the facilities as they progress towards the
long term objective.
We place a high level of emphasis on helping providers develop and
maintain programs of quality improvement. In the case of hemodialysis
facilities we are demonstrating this commitment to work in
collaboration with providers to achieve that goal.
It is important to note that this is just the first phase of the
project. The real test of success will be when facilities have gained
the experience to have ongoing systems in place to assess the quality
of care they are providing to patients by evaluating quality indicators
of outcomes of care. With measurement systems in place, hemodialysis
facilities will be able to provide important information to patients
and to us about the quality of care being provided.
F. Evaluation of the Project
Information about project results will be packaged in brochures and
newsletters so that ESRD patients and non-participating ESRD facilities
will be aware of the results. We will continuously evaluate this
project as it progresses and perform a separate analysis upon
completion. We believe that all of the participants in this project
will learn a great deal, and we will remain open to the need to make
accommodations to unique situations that may arise. We are convinced
that this project has enormous potential to improve patient care,
lessen regulatory burden, and use scarce resources more wisely. The
definitive measure of success of this project will be that systems for
collecting patient specific clinical data are in place, that
transmission of data to us is done at regular intervals, and that
hemodialysis facilities are skilled in using the data to design
interventions to continuously improve care to their patients.
IV. Collection of Information Requirements
This notice contains information collection requirements, which are
currently exempt from the Paperwork Reduction Act of 1995, as outlined
in 5 CFR 1320.3(h)(5). The project described in this notice is an
extension of the National Core Indicators Project, which has been
reviewed and approved by the National Institutes of Health (NIH)
Clinical Exemption Review Committee; NIH Case # CE95-02-02, February
1995. As a condition of this approval, PHS/HCFA will submit a copy of
this up-dated data collection protocol, which will gather customary
medical information from patient records, captured during the course of
a medical examination, to the United States Renal Data System (NIH)
before the study is initiated.
Both the Core Indicators Project and the extension pilot project
described in this notice support a current REGO II effort to improve
the quality of care provided to Medicare beneficiaries. The Core
Indicators Project systematically, annually, collects clinical
information associated with the quality of care provided to a sample of
End Stage Renal Disease (ESRD) patients. This notice describes a pilot
extension of that project which expands the effort by collecting
information from patient records more frequently and communicating the
information more efficiently to HCFA in an electronic fashion for HCFA/
PHS evaluation.
It is envisioned that core information regarding outcomes of care
on all ESRD Medicare beneficiaries will eventually be shared with HCFA
electronically on a regular basis, to provide HCFA/PHS the data to
initiate and monitor quality improvement efforts. If this pilot is
successful, and HCFA decides to implement the REGO II project based on
the currently approved Core Indicators Project, HCFA will seek full OMB
approval for the data collection requirements that fall under the
purview of the Paperwork Reduction Act.
In accordance with the provisions of Executive Order 12866, this
notice was reviewed by the Office of Management and Budget.
Authority: Sec. 1881 of the Social Security Act (42 U.S.C.
1395rr).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: June 14, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: August 1, 1996.
Donna E. Shalala,
Secretary.
Note: This document was received in the Office of the Federal
Register on April 24, 1997.
[FR Doc. 97-11025 Filed 4-28-97; 8:45 am]
BILLING CODE 4120-01-P
