[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

[[Page 23252]]

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