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Withdrawal/Redaction Sheet
Clinton Library
DOCUMENT NO.
SUBJECT/TITLE
DATE
RESTRICTION
AND TYPE
001. talking points
Personal (Partial) (1 page)
ca. 1995
P6/b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Domestic Policy Council (Karen Guss)
OA/Box Number: 5931
FOLDER TITLE:
Epidemiology [2]
2012-0820-S
ms480
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RR. Document will be reviewed upon request.
AHCPR
Article Reprint
Agency for Health Care Policy and Research
Methodological Challenges and
Innovations in Patient Outcomes
Research
SERVICES.
INDIAN
USA
U.S. Department of Health and Human Services
HEALTH
Public Health Service
8
Agency for Health Care Policy and Research
MEDICAL CARE
Volume 32, Number 7, PP JS13-JS21, Supplement
© 1994, J.B. Lippincott Company
Methodological Challenges and
Innovations in Patient Outcomes Research
CLAIRE W. MAKLAN, PHD, MPH, RICHARD GREENE, MD, PHD,
AND MARY A. CUMMINGS, DRPH, RN
Between 1989 and 1992, the Agency for Health Care Policy and Research
(AHCPR) awarded funding to 14 special projects known as Patient Outcomes
Research Teams (PORTs). These large, complex projects form the centerpiece
of the first generation of research under the Medical Treatment Effectiveness
Program. In carrying out their individual 5-year research plans, and through
collaborative work of six Inter-PORT Work Groups, PORTs have contributed
to methodological advances related to their specific clinical focus and to out-
comes research in general. Each of the PORTs has followed a standard re-
search model, involving the application of: systematic literature review,
measurement of outcomes, analysis of cost and claims data, decision analy-
sis, and strategies for disseminating findings. This article reports what has
been learned by individual PORTs, and by AHCPR, regarding the usefulness
of each of these methodologies, both for the ongoing projects and for the next
generation of effectiveness research. Examples from individual PORTs and
work groups illustrate some of the methodological gains that have been
made in effectiveness research and provide a glimpse of the work that re-
mains to be done. Key words: patient outcomes research; medical effective-
ness research; effectiveness research methods.
This supplement addresses some of the
tient Outcomes Research Teams (PORTs),
major methodological challenges in patient
have been on the leading edge of methodo-
outcomes/medical effectiveness research as
logical developments for health services re-
carried out under the auspices of the Agency
search in general, and outcomes research in
for Health Care Policy and Research (AHCPR).
particular. In the case of PORTs, researchers
It presents an inside look at collaborative ac-
have been challenged to explore, adapt, and
tivities that have helped pioneers in outcomes
sometimes invent methods for dealing with
research grapple with the difficult issues that
new concepts and complex data.
they faced in common.
To address these challenges, while work-
Many AHCPR investigators, and especially
ing on their individual PORTs, repre-
those involved in the projects known as Pa-
sentatives of each PORT have participated
in six "Inter-PORT Work Groups." These
work groups are organized around research
From the Agency for Health Care Policy and Research,
activities in which all PORTs are engaged,
Center for Medical Effectiveness Research, Rockville,
namely: the measurement of outcomes,
Maryland.
analysis of the utilization and costs of health
Address correspondence to: Claire W. Maklan, PHD,
MPH, Agency for Health Care Policy and Research,
care, systematic literature review, decision
CMER, Suite 605, 2101 East Jefferson St., Rockville, MD
modeling, and dissemination of research
20852.
findings. The following six papers, by par-
JS13
MAKLAN ET AL.
MEDICAL CARE
ticipants in each work group, describe and
mately $48 million in fiscal year 1994. To
discuss PORTs' collaborative deliberations
date, these funds have supported over 150
on shared methodological problems and
research projects.
their individual solutions. The experience of
PORTs are AHCPR's largest extramural re-
PORTs is relevant to the next generation of
search investments. The "PORTfolio" consists
medical effectiveness research and to ongo-
of 14 five-year projects (10 grants and 4 con-
ing discussions about the need to tie health
tracts) with average annual budgets of one
care reform to a strong base of evidence re-
million dollars. PORTs are multi-discipli-
garding effective practice.
nary, multi-faceted, multi-method, and multi-
site. Each project focuses on a clinical condi-
Medical Treatment
tion or procedure(s) and tries to relate
Effectiveness Program
different patterns of clinical practice to differ-
ent patient outcomes. The research teams in-
Under the Medical Treatment Effective-
clude both academicians and practicing clini-
ness Program (MEDTEP), AHCPR carries
cians, with expertise in the clinical subject as
out a significant program of clinically ori-
well as other pertinent disciplines and meth-
ented extramural research. These studies
ods, usually including epidemiology, statistics,
break with both traditional health services
economics, decision modeling, and outcomes
research and with traditional clinical "effi-
assessment. PORTs are distinguished from
cacy" studies. As a result, they entail differ-
other MEDTEP projects in part by their size
ent types of data and methodological ap-
and scope and in part by the expectation that
proaches. MEDTEP research shifts the focus
each will carry out a series of activities that in-
of health services research from issues of or-
cludes: systematic literature review and formal
ganization and process to the outcomes of
analysis; analysis of variations in practice pat-
health care. Moreover, concern is with out-
terns and patient outcomes; and dissemina-
comes in the real world. MEDTEP research
tion of findings and evaluation of the effects.
is expected to address questions about what
clinical interventions work best for typical
Systematic Literature Review and Formal
patients, cared for by typical health care
Analysis
providers. Another major new feature is
MEDTEP's emphasis on outcomes that pa-
PORTs carry out comprehensive reviews
tients understand and care about. Thus, im-
of the literature on the clinical condition or
portant outcomes include quality of life,
procedure(s) under study. If possible, one or
functional capacity, symptom relief, and cost
more quantitative synthesis (or meta-analy-
(in contrast to physiological measures and
sis) is conducted. The literature review has
parameters that focus more on organs than
multiple uses, including refinement of re-
their owners). Questions of cost effective-
search hypotheses, testing hypotheses, in-
ness and appropriateness of treatment deci-
put to decision models, and assessing qual-
sions are other basic themes in this research.
ity of the evidence.
The substantive and methodological
contributions of MEDTEP research have
Analysis of Variations in Practice Patterns
begun to emerge. The recognized potential
and Patient Outcomes
for policy-relevant findings has been a
major factor in the substantially increased
PORT investigators conduct extensive
federal support. From fiscal year 1990, the
analyses of clinical, administrative, and
first full year of the program, the MEDTEP
patient-reported data. Secondary data, espe-
research budget has grown steadily from
cially claims data from Medicare and other
approximately $22 million to approxi-
payors, are used to address questions of
JS14
Vol. 32, No. 7, Supplement
CHALLENGES IN OUTCOMES RESEARCH
practice patterns, costs of care, and selected
established. Each work group consisted of
outcomes. Primary data (usually prospec-
a primary and alternate representative
tive) are collected to provide details of clini-
from each of the PORT projects and two
cal care and information about patient out-
members of AHCPR staff. Over their more
comes, including quality of life and physical
than 4-year history, the work groups have
and psychosocial functioning.
carried out their activities through peri-
odic conference calls and occasional face-
Dissemination of Findings and
to-face meetings.
Evaluation of the Effects
PORT and Inter-PORT work group expe-
rience is now considerable. Four of the 14
MEDTEP places major emphasis on the
PORTs are in their fifth (and final) year of
importance of effective dissemination of
work; seven more are in their fourth year. In
research findings. Each PORT is expected
this supplement, they share their experience
to disseminate its findings to providers,
with the broader community of researchers,
patients and the public in a systematic and
especially in terms of what has been learned
scientific manner. The effects of the dissemi-
about the adaptability and varied uses of
nation are then evaluated in terms of
"PORT methods" in effectiveness research
change in practice patterns and, if possible
and the contributions of PORTs to the de-
within the funding period, in terms of pa-
velopment of these methods.
tient outcomes.
In considering these issues, we take the
view of program administrators who can
Inter-PORT Work Groups
step back from the individual work groups
and from individual PORTs and attempt to
In fall 1989, soon after award of the first
draw general conclusions that reflect our
PORTs, AHCPR sponsored a meeting for in-
awareness of success and failure, competing
vestigators on the four new projects, i.e., the
objectives, hopes for the future, and the ad-
PORTs on acute myocardial infarction, cata-
vantage of hindsight. We will discuss some
ract, low back pain, and prostate disease.
of the accomplishments of individual work
Participants held in-depth discussions re-
groups and relate these to the continuing
garding the data and methods necessary to
evaluation and development of AHCPR's
carry out their research. They concluded that
medical effectiveness research program.
it would be beneficial for the investigators,
and helpful to AHCPR, for PORTs to main-
Outcomes Assessment: Coming to Terms
tain contact and exchange information
With the Terms of Effectiveness Research
across projects. To accomplish this, the
PORTs proposed establishment of inter-
At the heart of every PORT is the critical
PORT working groups. These committees
and difficult task of accurately identifying
would serve to augment the talent of the in-
and measuring the outcomes in terms of
dividual PORTs with additional expert re-
which treatment effectiveness is to be as-
sources and perspectives, to facilitate con-
sessed. All PORTs measure multiple out-
sultations to complement that expertise
comes, and they obtain these data from
when necessary, and to provide forums for
multiple sources, reflecting multiple per-
discussion of common issues.
spectives. In general terms, PORT outcomes
Initially, five work groups were formed: Lit-
typically include survival, morbidity, compli-
erature Review and Meta-Analysis, Use of
cations, physical functioning, and resource
Claims Data, Decision Modeling, Outcomes
use (cost, readmissions), as well as "softer"
Assessment, and Cost of Care. In October
outcomes such as overall health status,
1990, the Dissemination Work Group was
symptom relief, role functioning, and satis-
JS15
MAKLAN ET AL.
MEDICAL CARE
faction with care. Some outcomes data are
of clinical conditions, and permit longitu-
necessarily provided by physicians or payors
dinal follow-up of individuals makes these
and reflect their definition of the problem
data extraordinary. But, PORT experience
and their abstract experience of the patient's
has tempered early enthusiasm about the
condition. Other important outcomes are
ability of claims data to answer effective-
known only by patients, so pertinent infor-
ness questions.
mation must be obtained from them.
The problems and potential of administra-
The Outcomes Assessment Work Group
tive data, especially Medicare data, have
has focused its attention on these issues and
been the focus of the Cost of Care and
the influence of the clinical condition being
Claims Data Work Groups. Although their
studied on selection of measures, study de-
specific interests are different, the experi-
sign, data collection method, and data inter-
ence of both groups has been a similar mix
pretation, in particular. Underlying much of
of frustrations and accomplishments. A ma-
this group's activity is the early conclusion that
jor problem affecting all PORTs is that the
none of the existing measures of general
only outcomes addressed in Medicare data
health status or quality of life is clearly the
are survival, subsequent morbidity (espe-
"best" measure, i.e., no one measure is useful
cially in terms of subsequent admissions,
in all outcomes research. The most widely
diagnoses and procedures), and costs. An-
used and tested general measures, the Sick-
other general problem, the limited informa-
ness Impact Profile (SIP), the MOS Short-
tion about the patient's clinical condition,
Form General Health Survey (SF-36), and in-
either at the time of treatment or sub-
dices of activities of daily living, all have both
sequent to it, precludes accurate classifica-
strengths and weaknesses. This conclusion
tion of patients with the same diagnosis by
"freed" the PORTs to create new condition-
severity, procedure, or resource use. For ex-
specific measures and new versions of existing
ample, the Medicare coding rules for acute
measures for assessing outcomes in many
myocardial infarction (AMI) lump together
clinical entities. However, it also provides fur-
patients admitted as "rule out AMI," pa-
ther indication of the challenges that still lie
tients with small infarcts and normal car-
ahead, especially in view of proposals for a
diac function, and patients with massive
"health care report card."
AMIs who are in extremis. Because the pa-
tients may not be comparable, it is risky
Claims Data Analysis and Cost of Care:
to draw conclusions about observed vari-
Secondary Data Take Second Place
ations in the few outcomes that are cap-
tured.
All PORTs that deal with inpatient condi-
PORTs quickly identified other serious
tions affecting adults (11 of the 14 PORTs)
limitations of the Medicare data, including
have utilized Medicare claims data to de-
the fact that bilateral anatomical structures
scribe variations in practice and have tried
(e.g., eyes, hips, knees) are not coded as
to associate practice with outcomes. This
left or right, and that for many important ef-
approach is principally the result of opti-
fectiveness questions, untreated patients
mism about the usefulness and relatively
cannot be identified at all. For example, al-
low cost of secondary data in general, and
though all Medicare patients who under-
Medicare administrative data in particular,
went gallbladder surgery can easily be iden-
which is reflected in AHCPR's authorizing
tified for any given time period, there is no
legislation. The fact that the Medicare data-
way to identify comparable patients who
bases represent essentially the entire U.S.
had symptoms of gallbladder disease, but
population older than age 65, provide infor-
who were treated conservatively or who
mation about resource use for a vast array
were not treated at all. Similarly, Medicare
JS16
Vol. 32, No. 7, Supplement
CHALLENGES IN OUTCOMES RESEARCH
cost data only address Medicare-covered
technique is extraordinary, because it can
services, so there are no data, for example,
elicit outcomes information from a sample
on the use of outpatient drugs.
of Medicare beneficiaries representative of
PORTs have developed substantial exper-
whatever characteristics are reported in the
tise in building and linking complex patient-
Uniform Hospital Discharge Summary. The
specific administrative databases. Sharing of
fact that the PORT was able to obtain a 92%
experience and expertise within the Claims
response rate in their survey further argues
Data Analysis and Cost of Care Work Groups
for this use of Medicare claims data.²
has enabled PORTs to deal successfully with
many tricky problems in these data: codes that
Literature Review: You Can't Tell a Book (or
change over time, idiosyncratic coding con-
Journal) by Its Cover
ventions, missing data, linking problems, and
the logistics of managing enormous data sets.
PORT literature reviews brought several
PORTs have taken these data to their limits
surprises. First, in carrying out systematic re-
and, although those limits have been disap-
views of published (and, occasionally, unpub-
pointing in some cases, analyses of these data
lished) studies pertinent to their topics,
have also led to some very important findings.
PORTs found that studies often failed even
The Cataract PORT provides a good illus-
the simplest tests of quality with regard to de-
tration of innovation in the use of available
sign. The Prostate Disease PORT performed a
data. The PORT's analyses of Medicare data
structured literature review to determine the
suggested that the risk of retinal detachment,
clinical course of localized prostate cancer, the
while remaining low, is significantly in-
effectiveness of radical surgery and radiation
creased in cataract patients who sub-
therapy, and treatment complications. Al-
sequently undergo a procedure known as
though they could compare complications as-
Nd:YAG laser capsulotomy.¹ The lack of de-
sociated with different treatments, they were
tailed clinical information in the Medicare
not able to determine the effectiveness of
data precluded direct confirmation of this
treatment for localized prostate cancer be-
possibility, but these same data do afford a
cause of methodologic inadequacies in the re-
unique opportunity for examining some out-
viewed literature.³ Other PORTs that con-
comes of treatment. First, the vast number of
ducted formal assessments of the quality of
cases in the Medicare dataset enabled the
the literature also found it very disappointing.
PORT to identify individuals with this seri-
PORT documentation of inadequacies in pub-
ous, but very rare complication. This, in turn,
lished studies are accompanied by specific
made it possible to obtain medical records
recommendations regarding the design and re-
for these patients. With these detailed clinical
porting of research (that may contribute even-
records, it will be possible to test directly the
tually to overall improvement in the litera-
link between laser capsulotomy and elevated
ture).4,5
risk of retinal detachment.
Another surprise for some would-be
Another very important use of Medicare
meta-analysts was the result of different re-
claims data was developed by the Prostate
search traditions within various clinical ar-
Disease PORT when they created a repre-
eas. In the entire English language literature,
sentative sample of Medicare beneficiaries
there exists only one randomized controlled
with early or localized prostate cancer who
trial comparing radical prostatectomy to
had undergone radical prostatectomy. The
watchful waiting in localized prostate cancer
PORT surveyed this cohort 2- to 4-years
patients. The PORTs on Biliary Tract,* Total
post-surgery to ascertain the prevalence of
serious adverse effects of surgery such as in-
Personal communication with Jesse Berlin, Biliary
continence and impotence. The power of this
Tract Disease PORT.
JS17
MAKLAN ET AL.
MEDICAL CARE
Knee Replacement and Low Back Pain
numbers of clinical trials. After carrying out
found no relevant randomized clinical trials
both traditional and cumulative meta-
for certain common procedures.⁶ Thus, for
analyses, the investigators concluded that
some PORT conditions, statistical pooling of
cumulative meta-analysis of a set of small
data from published clinical trials to produce
therapeutic trials can produce statistically
new information could not be done, at least
significant evidence of efficacy in advance of
not in the conventional way. Although it is
definitive large scale trial results. 8
extremely important to define rigorously the
limited knowledge on treatment effective-
Decision Analysis: Healthy Decision Trees
ness in some fields, clinical literature con-
Provide More Light than Shade
sisting mostly of descriptive studies does
not support definitive conclusions about the
Each of the PORTs has developed (or is
effectiveness of treatment. The results of
developing) a decision model to help define
PORT systematic literature reviews chal-
the optimal path to the desired outcome,
lenge directly "the inevitable tendency to let
through a vast number of patient charac-
sleeping dogmas lie."7
teristics and treatment options, and modi-
As described in the paper by the Litera-
fied by probabilities, patient utilities, risks,
ture Review/Meta-Analysis Work Group,
and costs. These complex models, which
PORTs have been innovative in their use of
may incorporate data from literature re-
this relatively new research method. All
views, claims data analysis, chart abstrac-
PORTs have extended "formal" literature re-
tion, and surveys, are designed to predict
view approaches and criteria far beyond the
various outcomes and/or costs for patients
narrow range of traditional meta-analysis.
with the same disease or clinical problem,
Although the specific features that distin-
but who present with different charac-
guish the type of formal literature reviews
teristics and who undergo different man-
being carried out by PORTs are numerous
agement strategies. For example, the model
and subject to debate, several elements
developed by the Ischemic Heart Disease
stand out. Unlike the reviews that preface
PORT examines the treatment alternatives
most research reports (and grant applica-
following cardiac catheterization, including
tions), these reviews are distinguished by
medical management, percutaneous trans-
the fact that they are critical, systematic,
luminal coronary angioplasty (PTCA), and
usually quantitative and, at least theoreti-
coronary artery bypass graft (CABG) sur-
cally, reproducible. A full record of the meth-
gery; and predicts the outcomes of each.
ods and decision criteria, as well as the iden-
The decision model of the Prostate Disease
tity of the studies that were reviewed and
PORT focuses on the expected length of life
their place in the synthesis permits prospec-
for men older than 65 with early prostate
tive users of the review to assess the com-
cancer who have a radical prostatectomy.
prehensiveness of the search and the valid-
Projections based on this model can con-
ity of the conclusions.
tribute to patient decisions relative to sur-
Another innovative approach to literature
gery vs. watchful waiting.9 The decision
review advanced through PORT work fo-
analysis being done by the Cataract PORT
cuses on "cumulative" meta-analysis.
will help to define strategies for managing
Among PORTs, the literature review work
cataract patients that optimize the tradeoff
of the Acute Myocardial Infarction PORT
between effectiveness and cost. This model
was distinguished by the existence of large
will project the impact of anticipated
t Personal communication with Chris Callahan, Total
$ Personal communication with John B. Wong, Is-
Knee Replacement PORT.
chemic Heart Disease PORT.
JS18
Vol. 32, No. 7, Supplement
CHALLENGES IN OUTCOMES RESEARCH
changes in the demographic distribution of
The Low Back Pain PORT has designed a
the U.S. population on the cost-effectiveness
program of continuing medical education
of cataract care over the next 30 years.
and "study groups" focused on informing
The newness of applying decision model-
primary care physicians, surgeons, and hos-
ing and analysis to effectiveness research
pital administrators about variations in rates
prompted the Decision Modeling Work
of surgery for low back pain. For patients,
Group to develop a guide for selecting an ap-
the PORT has developed an educational
propriate model based on characteristics
brochure and, in collaboration with investi-
(e.g., acute VS. chronic, linear vs. nonlinear
gators at Dartmouth Medical School, Mas-
course of disease, anticipated outcomes, etc.)
sachusetts General Hospital, and the Foun-
of the clinical problem being studied and for
dation for Informed Medical Decision
assessing critical elements within the model.
Making, an interactive video disk to provide
Using each other's work as subjects of cri-
information pertinent to treatment options.
tique, PORT investigators compared and
The effects of these diss emination strategies
contrasted the benefits, strengths, limita-
on practice patterns are being tested in a
tions, and liabilities of alternative modeling
randomized community-based study in
strategies, including Markov models, deci-
which five communities receive the inter-
sion trees, and simulations. The framework
vention and five serve as controls.
that they developed, and present in their pa-
Another avenue of PORT information dis-
per, will assist reviewers in judging the ade-
semination is through involvement in the
quacy of decision models and will aid other
development of AHCPR-sponsored clinical
investigators in selecting an appropriate
practice guidelines. The PORTs on Prostate
strategy for building new models.
Disease, Low Back Pain, and Cataract have
all made important contributions to AHCPR
Dissemination: Lost Findings
guideline work in their respective clinical
Lead Nowhere
areas.
11,12
Exceeding the usual research expectation
Conclusions
of preparing results for the academic
community, PORTs are also actively dis-
In applying similar methods to distinct
seminating their findings to community
research questions, each PORT has faced a
practitioners, patients, policymakers, and
unique set of challenges, and, in the end,
the public at large. Moreover, as described in
each will have a different story to tell. A full
the paper by the Dissemination Work Group,
evaluation of the PORT approach must
PORTs are using a variety of creative ap-
await completion of the projects. Although
proaches to accomplish effective dissemina-
the work has gone along smoothly, there
tion and assimilation, i.e., not merely to dis-
have been some surprises and some disap-
tribute materials.
pointments. PORTs have dealt with these
The Prostate Disease PORT has pioneered
creatively, assisted in part by the Inter-PORT
the use of interactive video disk technology
Work Groups. Moreover, we all stand to
to inform patients of the risks and benefits
benefit from PORT and work group feed-
of surgery and alternative treatments. Early
back: the clinical literature can improve,
results of the PORT's evaluation of this
changes can be made in administrative data,
method of disseminating information indi-
and government programs can evolve to re-
cate that patients with benign prostatic hy-
flect experience and emerging needs.
pertrophy, who have seen the video, tend to
The now ample evidence of the worth of
choose watchful waiting or conservative
the PORT approach can be illustrated by
medical treatment over surgery. 10
accomplishments of the Prostate Disease
JS19
MAKLAN ET AL.
MEDICAL CARE
PORT. The work that has been completed to
consensus in the United States that a ran-
date illustrates how the individual compo-
domized trial is needed to compare radical
nents of the PORT model fit together to
surgery to watchful waiting for men with lo-
build complementary evidence and how this
calized cancer. Although the PORT meth-
multi-method approach can have enlarged
ods, by themselves, do not resolve the effec-
impact. In its examination of localized pros-
tiveness question, they have uncovered an
tate cancer treatment, the PORT has com-
epidemic of radical surgical intervention
pleted a comprehensive and critical review
that is not supported by scientific evidence
of the clinical literature; an analysis of Medi-
of effectiveness.
care data to reveal patterns of treatment in
The strengths and limitations of the PORT
elderly males in the United States; a 2- to
model have been analyzed by AHCPR in
4-year post-operative survey of a repre-
conjunction with PORT investigators, work
sentative sample of men who were treated
group members, and outside methodolo-
with radical prostatectomy; and a decision
gists. The methodological lessons, in par-
model that weighs risks and benefits of radi-
ticular our fuller understanding of the spe-
cal prostatectomy as a function of patient
cific possibilities and problems inherent in
age. Each of these approaches has led to im-
individual PORT methods and the total
portant findings, as follows:
PORT model, are reflected in our plans for
the next generation of medical effectiveness
The scientific literature provides no
research. A new set of grants, the "PORT-IIs"
hard evidence that radical prostatectomy
that will be funded starting in mid 1994, will
is an effective treatment for localized
prostate cancer.³
continue the PORT tradition by tackling im-
portant clinical questions and breaking new
(In spite of this lack of evidence for
methodological ground. 14:15 They will incor-
clinical effectiveness), Medicare data
show that the rate at which U.S. men older
porate what has worked best in the original
than 65 underwent radical surgery for
PORTs into new research strategies that are
prostate cancer increased more than 500%
tailored to determining effective and inef-
between 1984 and 1990. There was a
fective therapies for a new set of common
greater than 20-fold variation in radical
clinical conditions. PORT-IIs will make ad-
prostatectomy by state. 13
ditional methodological advances by apply-
PORT data from a national survey of
ing a broad set of research tools to measur-
men who underwent radical prostatec-
tomy reveal a much higher rate of serious
ing the effectiveness of different clinical
complications 2- to 4-years post-surgery
strategies. The challenge for PORT II and for
(e.g., 63% incontinence and 89% impo-
the effectiveness research field is to design
tence) than has been published in surgical
research approaches that have both a high
case series.²
degree of internal validity and generalizabil-
The PORT decision model shows
ity. We have learned from the first 14 PORTs
that, for men older than 70, even the
that there is no simple formula for answer-
most optimistic claims of benefit of
radical prostatectomy treatment would
ing medical effectiveness questions and that
not result in significant enhancement in
research methods must be tailored to each
survival. Yet, half the prostatectomies
specific problem.
performed on Medicare patients are on
As we eagerly await the final products of
men age 70 and older.⁹
our original PORTs and look forward to
PORT-IIs, we will continue to evaluate and
Collectively, these powerful results have
refine the strategies for effectiveness re-
shaken complacent views about the effec-
search when warranted. Through this con-
tiveness and appropriateness of radical sur-
tinuous, critical approach, we will build
gery for prostate cancer. They have led to a
both the quantity and quality of evidence
JS20
Vol. 32, No. 7, Supplement
CHALLENGES IN OUTCOMES RESEARCH
on the effectiveness, appropriateness, and
6. Turner JA, Ersek M, Herron L, et al. Patient out-
cost effectiveness of clinical interventions
comes after lumbar spinal fusion: A comprehensive lit-
and, simultaneously, we will strengthen the
erature synthesis. JAMA 1992; 268:907.
methods and measures for additional
7. Grimes DA. Technology follies: The uncritical ac-
ceptance of medical innovation. JAMA 1993;269:3030.
research.
8. Lau J. Antman EM, Jimenez-Silva J. et al. Cumula-
tive meta-analysis of therapeutic trials for myocardial in-
Acknowledgments
farction. N Engl J Med 1992;327:248.
9. Fleming C, Wasson JH, Albertsen J, et al. A decision
The authors thank Ira E. Raskin, PHD, and Risa J.
Lavizzo-Mourey, MD, for their helpful comments.
analysis of alternative treatment strategies for clinically
localized prostate cancer, prostate patient outcomes re-
search team. JAMA 1993;269:2650.
References
10. Kasper JF, Mulley AG, Wennberg JE. Developing
shared decision-making programs to improve the quality
1. Javitt JC, Vitale S, McBean AM, et al. National out-
of health care, QRB 1992;18:183.
comes of inpatient cataract extraction. 1. Retinal detach-
11. Clinical Practice Guideline, No. 4., Cataract in
ment following inpatient surgery. Arch Ophthalmol
1991;98:896.
Adults: Management of Functional Impairment, AHCPR
Pub. No. 93-0542, Feb. 1993.
2. Fowler FJ Jr., Barry MJ, Lu-Yao G, et al. Patient-
reported complications and follow-up treatment after
12. Clinical Practice Guideline, No. 8, Benign Pro-
radical prostatectomy, the national Medicare experience:
static Hyperplasia: Diagnosis and Treatment, Pub. No.
1988-1990. Urology 1993;42:622.
94-0582, Feb. 1994.
3. Wasson JH, Cushman CC, Bruskewitz RC, et al. A
13. Lu-Yao GL, McLerran D, Wasson J. et al. An
structured literature review of treatment for localized
assessment of radical prostatectomy: Time trends,
prostate cancer. Arch Family Med 1993;2:487.
geographic variation, and outcomes. JAMA
1993;269:2633.
4. Carson CA, Fine MJ, Smith MA, et al. Quality
of published reports on the prognosis of community
14. Agency for Health Care Policy and Research,
acquired pneumonia. J Gen Intern Med 1993;9:13.
Medical Treatment Effectiveness Research: PORT-II.
5. Powe NR, Tielsch JM, Schein OD, et al. Rigor of re-
Grant Announcement, August 1993.
search methods in studies of the effectiveness and safety
15. Agency for Health Care Policy and Research,
of cataract extraction with intraocular lens implantation.
Medical Treatment Effectiveness Research: PORT-II.
Arch Ophthalmol 1994;112:228.
Grant Announcement, May 1994.
JS21
U.S. Department of
Health and Human Services
Public Health Service
Agency for Health Care Policy and Research
Executive Office Center, Suite 501
2101 East Jefferson Street
Rockville, MD 20852
Official Business
Penalty for Private Use $300
AHCPR
AHCPR Pub. No. 94-0113
September 1994
AHCPR
grant announcement
Agency for Health Care Policy and Research
August 1994
Executive Office Center, Suite 501, 2101 East Jefferson Street, Rockville, MD 20852. (301) 594-1360
Medical Treatment Effectiveness
Research - Summary
national activity for setting priority areas. AHCPR
Ongoing Announcement
urges applicants to submit grant applications with
relevance to the specific objectives of this initiative.
Agency for Health Care Policy and Research
Potential applicants may obtain a copy of "Healthy
People 2000" (full report: stock No. 017-001-00474-0
PA: PA-94-074
or summary report: stock No. 017-001-00473-1) from
PT: 34; K.W. 0730021, 0408006
the Superintendent of Documents, P.O. Box 371954,
Pittsburgh, PA 15205-7954; or by contacting the
Purpose
Government Printing Office order desk at telephone:
(202) 783-3238.
The Agency for Health Care Policy and Research
(AHCPR) has ongoing interest in research under the
Eligibility Requirements
Medical Treatment Effectiveness Program (MEDTEP).
Applications may be submitted by domestic and
This grant announcement outlines the common themes
foreign nonprofit organizations, public and private,
inherent in all MEDTEP projects and identifies major
including universities. clinics; units of State and local
ongoing areas of research. MEDTEP research
governments, nonprofit firms, and nonprofit
encompasses three main areas of emphasis:
foundations. Applications from minority and women
(1) determining what clinical interventions are most
investigators are encouraged. Foreign applicants are
effective, cost effective, and appropriate:
advised to contact the AHCPR Grants Management
(2) methods and data to advance effectiveness
Officer regarding limitations and special requirements
research; and (3) dissemination and evaluation of the
(see "Inquiries").
impact of research findings on clinical practice and
outcomes. This announcement serves as a general
Mechanisms of Support
reference for other publications and contacts regarding
The research project grant (R01) mechanism is the
current MEDTEP research interests and award
principal mechanism of support for MEDTEP research.
mechanisms.
The small grant (R03) mechanism is available for
Healthy People 2000
projects that do not exceed 2 years and $50,000 in total
direct costs for the entire project period. Responsibility
The Public Health Service (PHS) is committed to
for planning, direction, and execution of the proposed
achieving the health promotion and disease prevention
project is solely that of the applicant.
objectives of "Healthy People 2000," a PHS-led
In addition, AHCPR may issue requests for
Note: This grant announcement amplifies a program
applications (RFAs) and program announcement (PAs)
announcement that appeared in the "NIH Guide for Grants and
that announce new MEDTEP program interests and/or
Contracts." Vol 23, No. 22, on June 10. 1994. It supersedes the
"Medical Treatment Effectiveness Research" announcement
the availability of other mechanisms of support for
published in the "Federal Register" of August 14, 1990 (FR 55.
MEDTEP research. For further information, contact
33170-33172).
SERVICES.
HUMAN
USA
U:S. Department of Health
and Human Services
Public Health Service
the Center for Medical Effectiveness Research
Multidisciplinary: MEDTEP research requires
(CMER), the Center for Research Dissemination and
theoretical and practical understanding of a wide range
Liaison (CRDL), and/or the Center for General Health
of clinical and nonclinical variables that determine the
Services Extramural Research (CGHSER). Please
structure, processes, and outcomes of health care.
refer to the "Inquires" section for contact information
Studies typically involve a team of researchers who
(i.e., names, addresses, and telephone numbers).
bring the knowledge and methodological expertise of
both the clinical and social sciences, plus
Research Objectives
understanding of the perspectives of patients,
MEDTEP Research Themes
providers, and policymakers.
Medical effectiveness research is a major component
Types of Studies
of the health services research agenda of AHCPR.
MEDTEP research encompasses three main areas of
MEDTEP grew out of awareness of significant
emphasis: (1) determining what clinical interventions
unexplained variations in clinical (medical, nursing,
are most effective, cost effective, and appropriate;
and allied health) practice and the inadequacy of
(2) methods and data to advance effectiveness
scientific evidence to support many practices and
research; and (3) dissemination and evaluation of the
procedures. MEDTEP projects assess the relative
impact of research findings on clinical practice and
effectiveness, cost effectiveness, and appropriateness
outcomes.
of available strategies for the prevention. diagnosis,
treatment, and management of illness, in terms of
1. Clinical Studies
patient outcomes. While MEDTEP research projects
All MEDTEP clinical studies address the basic
vary in focus, size, scope, methods, and complexity, all
MEDTEP themes described above to obtain evidence
are expected to be:
for. or against. the effectiveness, cost effectiveness,
Generalizable: "Effectiveness" research is
and/or appropriateness of available interventions.
concerned with the outcomes that can be expected in
Most focus on a particular disease or clinical condition
typical patients, receiving care in typical clinical
and assess the outcomes associated with different
situations, not with outcomes that can only be achieved
interventions that are available for its prevention.
in selected patients and in controlled clinical situations.
diagnosis, treatment, and/or management. Some
MEDTEP clinical studies focus on an established
Thus. a critical feature of all MEDTEP projects is that
the questions have broad applicability and the research
technology or procedure. Of interest are conditions or
design supports wide generalization of the findings.
procedures that are common and costly, either in the
Pragmatic: MEDTEP projects address questions
general population or in a major subpopulation. Major
categories of MEDTEP clinical studies are described
that have high clinical and policy significance and are
below:
designed with attention to the eventual implementation
Patient Outcomes Research Teams (PORTs) and
of findings. They obtain empirical evidence or
PORT-IIs. Between 1989 and 1992, AHCPR awarded
strengthen the science base in ways that can directly
14 special MEDTEP projects known as Patient
contribute to improved patient outcomes and
Outcomes Research Teams (PORTs). PORTs are
decisionmaking processes (including clinical practice
distinguished from other MEDTEP clinical studies by
guidelines). and to a more equitable and cost-effective
their broad scope, multimethod approach to patient
health care system. The usefulness of MEDTEP
outcomes questions, and by the standard 5-year model
research stems, in part, from MEDTEP's requirement
they follow. AHCPR does not anticipate award of
that the clinical problems and practices addressed are
additional projects that use the PORT model.
common and costly, and from attention to the realities
In July 1993, AHCPR issued an RFA initiating a new
of clinical practice.
generation of MEDTEP research. called "PORT-II,"
Patient-centered: MEDTEP research evaluates
with the first of these grants awarded in summer, 1994.
health care in terms of outcomes that emphasize the
An ongoing PA, "Medical Treatment Effectiveness
patient's experience and perspectives. In addition to
Research - PORT-II," was published in the NIH
survival, morbidity, and complications, MEDTEP
Guide for Grants and Contracts, Volume 23, Number
studies consider patient-reported symptom relief,
18. on May 13, 1994. PORT-IIs continue the PORT
functional capacity, quality of life, satisfaction with
tradition by addressing important clinical questions and
care, and economic burden. Demographic, social and
breaking new methodological ground. They are
cultural characteristics, as well as personal preferences
distinguished from the original PORTs by their
are important independent variables.
individualized research strategies and from other
10
MEDTEP clinical projects by the expected direct
effectiveness and cost effectiveness of care for
impact of the empirical evidence they obtain on clinical
conditions that are often undifferentiated, as they
practice, patient outcomes, and health care policy.
present in unselected or nonreferred populations, in
PORT-IIs are not feasible or desirable in all clinical
primary care settings, and the role of primary care
areas. There must be sufficient existing information to
physicians in enhancing the effectiveness and cost
permit the formulation of effectiveness questions and
effectiveness of care. For information, contact
design of a research strategy tailored to the clinical
CGHSER, Division of Primary Care, Dr. Carolyn
problem and the population at risk, so that convincing
Clancy, Director, telephone: (301) 594-1357, ext. 137.
evidence of optimal patient care can be realistically
expected within the project period. PORT-IIs focus on
2. Methodological Studies
the establishment of direct linkages between practice
Effectiveness research frequently requires new kinds
and outcomes and on research methods that facilitate
of data and analysis, and new applications of existing
direct comparisons of two or more distinct clinical
tools. MEDTEP supports projects that aim to
strategies, e.g., medical vs. surgical treatment. For
strengthen or define the limits of existing data and
information on MEDTEP clinical studies, including
develop or test measurement and data collection
PORT-IIs, contact CMER.
instruments, and analytic methods useful for outcomes
Other MEDTEP Clinical Studies. The majority of
research. For example, MEDTEP projects may
MEDTEP clinical studies are designed to build the
develop new outcomes measures, methods for linking
science base in areas where a PORT-II is not currently
or enhancing existing databases, methods to assess
feasible or desirable. This includes research designed
patient preferences, or methods for cross-cultural or
to document patterns of practice, describe the natural
international comparisons of patient outcomes.
history of diseases, synthesize the evidence for various
Methodological work may be the main focus of a
clinical strategies, or answer relatively discrete
project or may be embedded in a larger project. For
effectiveness questions. Major ongoing program areas
information on these studies, contact CMER or
focus on pharmaceutical therapy, minority health, and
CGHSER.
primary care.
3. Dissemination and Evaluation Studies
AHCPR's program of studies on pharmaceutical
therapy, established in 1992. focuses on the
Some MEDTEP projects focus on approaches or
effectiveness and cost effectiveness of available
technologies for achieving optimal dissemination and
pharmaceutical interventions. especially the
integration of new knowledge into practice. This
relationships among drug therapy. other pharmaceutical
includes research. demonstrations. and evaluations that
services, and patient outcomes. Studies address
examine issues of diffusion. awareness, acceptance,
preventive. acute. or chronic treatment in inpatient,
and adoption of research findings and clinical practice
ambulatory. or long-term care settings. For further
guidelines by health care providers and consumers.
guidance, contact program staff in CMER (see
For example, projects may examine the role of opinion
"Inquiries").
leaders and practitioner study groups in influencing
In 1991. AHCPR established a research program
practice, or various approaches to enhancing patient
focused on the effectiveness of current clinical practice
participation in health care decisions.
for health conditions of special significance among
MEDTEP also supports studies to develop and
racial and ethnic minorities. This program is
evaluate clinical practice guidelines, information
highlighted by the 11 MEDTEP Research Centers on
systems, and clinical evaluation tools designed to help
Minority Populations. which train minority
practitioners and consumers make better health care
investigators to develop and conduct effectiveness
decisions. Contact CRDL regarding dissemination
research. Although additional MEDTEP Minority
studies. Contact CGHSER regarding evaluation
Centers are not anticipated, AHCPR has continuing
studies.
interest in studies of the effectiveness of care related to
Research Methods
special problems in minority populations. For
information, contact Dr. Miriam Kelly, CMER,
MEDTEP studies draw on a wide range of research
telephone: (301) 594-1485; or the Associate
methods, especially those used in the clinical,
Administrator for Minority Health, Dr. Morgan
evaluative, and social sciences. The research design
Jackson, telephone: (301) 594-6665.
may he experimental, quasi-experimental,
AHCPR's program of primary care research includes,
observational. or a combination of designs. Any
but is not limited 10, effectiveness research topics.
appropriate type(s) of statistical analysis, modeling, or
MEDTEP primary care studies focus on the
synthesis may be proposed. Types and sources of data
3
may include: new, established, or adapted surveys of
"Inquiries." AHCPR program staff also may provide
patients or providers; clinical data obtained
additional relevant information concerning this policy.
prospectively, or from clinical registries, practice-based
networks, or other health care providers; administrative
Application Procedures
data maintained by providers, insurers, or institutions;
Applications are to be submitted on the grant
and published research findings. Laboratory-based
application form PHS 398 (rev. 9/91). They will be
studies are not appropriate.
accepted at the standard application deadlines indicated
Applications must be explicit and detailed in
in the application kit. (Until further notice, these dates
describing data, methods, and tools for data collection
are: February 1, June 1, and October 1.) State and
and analysis. The research plan must be justified in
local governments may use form PHS 5161 and follow
terms of potential for answering the research questions
accompanying requirements for copy submission.
under study.
Application kits are available at most institutional
Applicants who propose to use Medicare or Medicaid
offices of sponsored research or from the Office of
data must specify the required data files and explore
Grants Information, Division of Research Grants, NIH,
the availability and cost of obtaining these data with
Westwood Building, Room 449, Bethesda, MD 20892,
the Health Care Financing Administration (HCFA).
telephone: (301) 594-7248. For AHCPR, applications
The estimated cost must be presented, along with
may also be obtained from:
documentation from HCFA, as part of the grant
application. This cost should not be included in the
Global Exchange, Inc.
total budget request for the project. For more
7910 Woodmont Avenue, Suite 400
information about data budgets, contact AHCPR's
Bethesda, MD 20814-3015
Grants Management Officer (see "Inquiries").
Telephone: (301) 656-3100
Fax: (301) 652-5264
Study Populations
Inclusion of Women and Minorities in
To receive a copy of an announcement referred to
above, please contact Global Exchange. Or. if you
Research Involving Human Subjects
have a fax machine with a telephone handset, you may
It is the policy of AHCPR that women and members
use the AHCPR InstantFAX system. Dial (301) 594-
of minority groups must be included in all AHCPR-
2800 and use the key pad on your receiver when
supported health services research projects involving
responding to prompts from this system. The
human subjects, unless a clear and compelling rationale
requested announcement will be faxed at the end of the
and justification are provided that inclusion is
ordering process.
inappropriate with respect to the health of the subjects
The completed. signed. original application and five
or the purpose of the research.
legible copies must be sent or delivered to:
A new National Institutes of Health (NIH) policy
resulting from the NIH Revitalization Act of 1993
Division of Research Grants
(Section 492B of Public Law 103-43) supersedes and
National Institutes of Health
strengthens NIH's previous policies (concerning the
Westwood Building. Room 240
inclusion of women and minorities in study
Bethesda, MD 20892
populations), which were in effect since 1990 and
The Division of Research Grants (DRG) will not
which AHCPR had adopted. The new NIH policy
accept any application in response to this
contains some provisions that are substantially
announcement that is essentially the same as one
different from the 1990 policies. AHCPR plans to
currently pending initial review, unless the applicant
publish guidelines specific to AHCPR. In the interim,
withdraws the pending application. The DRG will not
AHCPR will follow the NIH guidelines. as applicable.
All investigators proposing research involving human
accept any application that is essentially the same as
subjects should read the "NIH Guidelines for Inclusion
one already reviewed. This does not preclude the
of Women and Minorities as Subjects in Clinical
submission of substantial revisions of applications
Research," published in the Federal Register on March
already reviewed, but such applications must include
9, 1994 (FR 59, 11146-11151) and reprinted in the NIH
an introduction addressing the previous critique.
Guide for Grants and Contracts, Volume 23. Number
*Note: This mailing address is the central mailing address for
11. on March 18, 1994.
NIH. Applicants who use express mail or a courier service are
Investigators also may obtain copies of the NIH
advised 10 follow the carrier's requirements for showing a street
address. The address for the Westbard Building is: 5333 Westbard
policy from AHCPR program staff listed under
Avenue, Bethesda, MD 20816.
4
Review Procedures
Direct inquiries regarding primary care,
Upon receipt, applications will be reviewed for
methodological studies, and evaluation studies to:
completeness by the referral office, DRG. Incomplete
Norman W. Weissman, Ph.D.
applications will be returned to applicants without
further consideration.
Director, Center for General Health Services
General review criteria for all grant applications are:
Extramural Research (CGHSER)
significance and originality from a scientific and
Agency for Health Care Policy and Research
technical viewpoint; adequacy of the method(s);
Executive Office Center, Suite 502
availability of data or adequacy of plan to collect
2101 East Jefferson Street
required data; qualifications and experience of the
Rockville, MD 20852
principal investigator and proposed staff; adequacy of
Telephone: (301) 594-1349, ext. 106
the plan for organizing and managing the project;
reasonableness of the proposed budget; and adequacy
Direct inquiries regarding dissemination studies to:
of the facilities and resources available to the applicant.
Phyllis M. Zucker
An appropriate peer review group will evaluate
Director, Center for Research Dissemination
applications for scientific/technical merit in accordance
and Liaison (CRDL)
with the general criteria stated above, and any special
Agency for Health Care Policy and Research
review criteria applicable to an individual mechanism
Executive Office Center, Suite 501
or as listed in specific announcements.
2101 East Jefferson Street
Applications requesting total direct costs in excess of
Rockville, MD 20852
$250,000 will be reviewed by AHCPR's National
Advisory Council for Health Care Policy, Research,
Telephone: (301) 594-1360
and Evaluation. The Council also may review
Direct inquiries regarding fiscal matters. including
applications requesting total direct costs in excess of
budget justification for HCFA data. to:
$50,000.
Special Review Criteria
Ralph L. Sloat
Grants Management Officer
Applicants are advised to refer to individual
announcements and to contact the staff offices listed in
Agency for Health Care Policy and Research
Executive Office Center, Suite 601
the next column regarding special review criteria.
2101 East Jefferson Street
Award Criteria
Rockville. MD 20852
In making funding decisions, AHCPR will consider:
Telephone: (301) 594-1447
quality of the proposed project as determined by peer
review, program balance, and availability of funds.
Authority and Regulations
Inquiries
This program is described in the Catalog of Federal
As indicated above, several AHCPR offices are
Domestic Assistance, Nos. 93.180 and 93.226. Awards
involved in MEDTEP extramural research. Those
are made under authorization of the Public Health
considering applying in response to this announcement
Service Act, Title IX 142 U.S.C. 299-299c-6 and
are strongly encouraged to discuss their project with
Section 1142 of the Social Security Act (42 U.S.C.
appropriate AHCPR program administrators. AHCPR
1320b-12). Awards are administered under the PHS
welcomes the opportunity to clarify any issues or
Grants Policy Statement: and Regulations 42 CFR Part
questions from potential applicants.
67, Subpart A; and 45 CFR Part 74 (45 CFR Part 92
For MEDTEP clinical studies, including PORT-IIs,
for State and local governments). This program is not
pharmaceutical outcomes, and other MEDTEP clinical
subject to the intergovernmental review requirements
studies; and related methodological studies. contact:
of Executive Order 12372.
Richard J. Greene, M.D., Ph.D.
Director, Center for Medical Effectiveness
The Public Health Service (PHS) strongly
Research (CMER)
encourages all grant recipients to provide a
Agency for Health Care Policy and Research
smoke-free workplace and promote the nonuse
Executive Office Center, Suite 605
of all tobacco products. This is consistent with
2101 East Jefferson Street
the PHS mission to protect and advance the
Rockville, MD 20852
physical and mental health of the American
Telephone: (301) 594-1485
people.
5
U.S. Department of
Health and Human Services
Public Health Service
Agency for Health Care Policy and Research
Executive Office Center, Suite 501
2101 East Jefferson Street
Rockville, MD 20852
Official Business
Penalty for Private Use $300
AHCPR
AHCPR Pub. No. 94-0089
August 1994
Withdrawal/Redaction Marker
Clinton Library
DOCUMENT NO.
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DATE
RESTRICTION
AND TYPE
001. talking points Personal (Partial) (1 page)
ca. 1995
P6/b(6)
COLLECTION:
Clinton Presidential Records
First Lady's Office
Domestic Policy Council (Karen Guss)
OA/Box Number: 5931
FOLDER TITLE:
Epidemiology [2]
2012-0820-S
ms480
RESTRICTION CODES
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PI National Security Classified Information |(a)(1) of the PRA]
b(1) National security classified information [(b)(1) of the FOIA|
P2 Relating to the appointment to Federal office |(a)(2) of the PRA]
b(2) Release would disclose internal personnel rules and practices of
P3 Release would violate a Federal statute [(a)(3) of the PRA]
an agency ((b)(2) of the FOIA]
P4 Release would disclose trade secrets or confidential commercial or
b(3) Release would violate a Federal statute |(b)(3) of the FOIA]
financial information [(a)(4) of the PRA|
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P5 Release would disclose confidential advice between the President
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and his advisors, or between such advisors (a)(5) of the PRA
b(6) Release would constitute a clearly unwarranted invasion of
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personal privacy [(b)(6) of the FOIA]
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b(7) Release would disclose information compiled for law enforcement
purposes [(b)(7) of the FOIA]
C. Closed in accordance with restrictions contained in donor's deed
b(8) Release would disclose information concerning the regulation of
of gift.
financial institutions [(b)(8) of the FOIA]
PRM. Personal record misfile defined in accordance with 44 U.S.C.
b(9) Release would disclose geological or geophysical information
2201(3).
concerning wells [(b)(9) of the FOIA]
RR. Document will be reviewed upon request.
Talking Points for American Academy of
[001]
Otolaryngology - Head and Neck Surgery
Thank you. It is a pleasure 10 be here leon Penetta asked me to let you
know how sorry he is that he couldn't join you.
P6/b(6)
P6/b(6)
can tell you that
there are few people in this world who appreciate your work more than I do
THE CLINTON ADMINISTRATION CONTINUES TO FIGHT FOR REAL
HEALTH CARE REFORM.
As you know, last year the Clinton Administration fought hard for health care
reform. While we could not reach agreement on legislation, there can be little
disagreement that the problems remain. Nearly 40 million Americans have no health
insurance and millions more are just one pink slip or illness away from losing it.
Eighty-four percent of the uninsured in 1993 were in working families. and more
that 55 percent lived in families headed by full-time workers. And while health care
costs have begun to slow down, they are continuing to rise at three times the rate of
inflation.
As the President said in his State of the Union address and in his December letter to
the Congressional Leadership, we remain firmly committed to guaranteeing health
security to all Americans and to containing health care costs for families, businesses
and Federal, state and local governments.
The President believes that we should take a step-by-step approach. This year, we
can take the first steps. The Congress can and should:
Reform the insurance market -- so that people don't lose their insurance
when they lose their job or change jobs or a family member falls ill, and so
that small businesses can afford to buy insurance for their workers.
Make coverage affordable for and available to children.
Help workers who lose their jobs keep their health insurance.
Level the playing field for the self-employed by giving them the same tax
treatment as other businesses.
Help families provide long-term care for a sick parent or a disabled child.
1
Because their constituents are demanding action. some Republicans have begun to
respond to the President's challenge by coming forward with proposals and bills.
We look forward to working with them to take the first steps this year.
Eut as we continue to work toward health reform. we must continually rémember
that we have the highest quality of care. the most talented and dedicated health
professionals. and the most advanced research institutions in the world. All health
reform proposals must be measured by their ability both to fix what is wrong and to
preserve what is right about our health care system.
THE CLINTON ADMINISTRATION IS FIGHTING BACK TO PROTECT
DOCTORS AND PATIENTS FROM SEVERE CUTS IN MEDICARE AND
MEDICAID.
cuttay
Unfortunately, for too many Republicans in Congress, "health reform" has turned
into the code word for slashing Medicare and Medicaid to pay for tax cuts for the
number
wealthy Republicans in the House and the Senate have talked about cutting both
of
Medicare and Medicaid by hundreds of billions of dollars:
appears
to
slated
Republicans have signaled their intention to out Medicare
about $300
for
billion between now and 2002.
appomath
Republicans have suggested cutting Federal Medicaid
at least
berry
$180 to $190 billion between now and 2002.
tageted
spending cuts
fir
It's not hard to figure out what that means for the doctors and hospitals who treat
patients receiving benefits under these programs, and for the patients themselves.
It means significant cuts in payments to hospitals. physicians and other
providers.
additional
the
It means shifting a staggering financial burdens to elderly and disabled
Medicare beneficiaries. Or to small businesses and families who will pay
higher premiums and fees if these programs are slashed without overall
reform.
cut
In many states.
foreing them
diap
It means dropping coverage or shrinking. benefits for mothers and children on
Medicaid. Or it means asking States to pick up the tab to preserve the
Medicaid program, and in doing so, forcing them to raise taxes or slash
set
spending for services like education and public safety.
As you have all said, spending cannot be ratcheted down without affecting
access to and quality of care for mothers and children, and for the elderly and
disabled.
2
The President presented a responsible budget to Congress -- a budget that made
tough choices to get our rising deficit under control. but a budget that protected
hard-working Americans and investments in our children. Now it is Congress' turn
to act. To detail where they will get the cuts they need to pay for their tax cuts for--
the wealthy. To step forward with their plan for deficit reduction.
The President has consistently said that we cannot get a hold of the deficit without
passing meaningful health reform. Over the next five years alone, almost 40 percent
of the growth in total Federal spending will come from rising costs in Federal health
care programs. We must contain costs in these programs. But we must do it as we
reform our health care system as a whole -- not by arbitrarily cutting programs that
serve the most vulnerable Americans.
That is not to say that these programs cannot and should not be improved.
The Clinton Administration is committed to continuing to give States
flexibility to reduce costs while maintaining coverage in their Medicaid
programs.
And we are committed to continuing to reduce regulatory burdens, streamline
administration, and improve cost effectiveness in the Medicare program while
increasing choices for beneficiaries and ensuring that quality of care is
protected.
These are the kind of changes that the Clinton Administration is doing now.
And these are the kind of changes that we look forward to working with
Congress on in the coming months.
To note at the end:
Unfortunately, I am on my way to another event so I will not be able to take
questions.
3
Additional Notes for Speech
1.
Anti-Smoking
As you know, more than 400,000 smokers die each year from smoking-related
illnesses. Tobacco use kills more people each year in the United States than AIDS, car
accidents, alcohol, homicides, illegal drugs, suicides and fires combined. And the real
tragedy is that these deaths are preventable.
The Clinton Administration is committed to the nation's campaign against smoking
and tobacco use. The Administration has a number of initiatives -- across a wide range of
departments -- aimed at increasing awareness about the harmful effects of tobacco use and
second-hand smoke and at preventing smoking.
To take just a few examples. The Centers for Disease Control and the National
Cancer Institute provide funds to States for education and prevention programs. The
Environmental Protection Agency and HHS have united to voice support for the
scientific evidence on the dangers of second-hand smoke. Armed with this evidence,
the Public Health Service is working -- with health professionals -- to increase
public awareness about the impact of second-hand smoke in the home on children's
health. The Department of Labor is working against occupational exposure. The
Department of Defense has banned smoking indoors in military installations. And,
as I am sure you know, the Food and Drug Administration has undertaken a review
to determine whether nicotine should be regulated as a drug.
Perhaps most tragic is the epidemic of youth addiction to nicotine. A casual
decision at a young age to use tobacco products can lead to addiction and serious
disease. The Department of Education is spearheading efforts to educate children,
particularly adolescents, about the dangers of tobacco use -- in order to prevent kids
from smoking, hopefully before they start. In addition, our Goals 2000 legislation
requires all schools to be smoke-free -- which will provide cleaner learning
environments for all of our children.
Your concern and leadership on tobacco issues has been extremely important and I
urge you to continue those efforts.
2.
Regulatory Reform
I thought that all you should say about regulatory reform is what I included on the
second page under the part about improving the Medicare and Medicaid programs.
You could add that this is part of the Administration's overall regulatory review
initiative to reduce the burdens of government and make it more responsive to its
customers -- in this case the doctors and patients who must manage the maze of
Medicare and Medicaid -- while ensuring health and safety.
I am reluctant to include the specifics, because Elaine has been clear that this will be
unveiled in a coordinated way. As you know, we are considering proposals to: (1)
eliminate the physician attestation form; (2) change CLIA significantly; and (3)
move to performance standards in reviewing and certifying hospitals, home health
agencies and ESRD facilities (but not-nursing homes).
3.
Medical Liability Reform
We have not changed our policy from last year on medical liability reform, but, as
you know, we have not yet discussed our position going forward. This group was
not satisfied with the "modest" reforms in the Health Security Act (especially
because we did not include caps on damages). I would not raise this issue in
light of the debate this week on the Republicans' Common Sense Legal Reform Act
and our strong public position against it.
4.
Antitrust Relief
Physicians want clear antitrust exemptions so that they can better compete in a
marketplace increasingly dominated by managed care organizations and other
insurance companies. As with medical malpractice, we have not changed our
position, but we have not yet developed a policy for the coming months. The
Justice Department has shortened review times and released nine antitrust policy
statements to guide physicians and hospitals (i.e., describing joint ventures that will
not violate antitrust laws). The physician and hospital groups see these policy
statements as a good first step but believe that we have not gone far enough. Last
year. a number of Republicans supported stronger antitrust relief (best known was
the Hatch-Archer bill which delineated safe harbors for certain activity and provided
for streamlined antitrust review).
03/29/95 11:19
202 219 6064
DOL OSHA A/S
0
001
U.S. Department of Labor
Assistant Secretary for
Occupational Salerv and Meann
01/07/ E
Washington. D.C. 20210
THIRED STATES SEPARTMENT
FACSIMILE TRANSMISSION
DATE:
MARCh 29, 1995
TO:
Karen Goss
FAX NUMBER: 456-7431
TELEPHONE NUMBER:
NUMBER OF PAGES. INCLUDING COVER SHEET:
4
FROM:
Nelson Reyneri
TELEPHONE NUMBER: 2022196027
FAX NUMBER:- 202 219 6064
SPECIAL INSTRUCTIONS:
03/29/95
11:19
202 219 6064
DOL OSHA A/S
002
Susan Harwood
Adam Finkel
(202) 219-7075
Talking Points for Carol Rasco
Society for Healthcare Epidemiology of America
OSHA Regulations
SHEA was an active participant in the development of the Bloodborne
Pathogens Standard, published in 1991, and they have been involved
in OSHA's ongoing activities related to occupational exposure to
tuberculosis. We should acknowledge their participation and active
involvement.
Occupational Exposure to TB
The regulatory activities of primary concern to this group are
those that relate to occupational exposure to tuberculosis. At
present, OSHA has two parallel activities:
Ongoing enforcement activity Beginning in October of 1993, OSHA
began nationwide enforcement activities to respond to the hazard of
occupationally-acquired tuberculosis. This ongoing activity is
based on OSHA's General Duty clause as well as other existing OSHA
regulations. Guidance for many of the protective measures to be
taken is found in the CDC guidelines for control of tuberculosis.
Development of a TB standard OSHA is currently developing a
proposed standard for occupational exposure to tuberculosis. OSHA
recognizes the significance of CDC's TB guidelines and anticipates
that they will serve as one of the primary bases for the proposed
standard. We anticipate that the proposed standard will be
published in Octobere of this year if there is no regulatory
moratorium.
Red Flag for TB
The type of respirator required is far and away the most
controversial issue related to this hazard. Both CDC and OSHA say
that respirators are necessary under certain circumstances when the
employee has contact with a person who has active TB. For example,
if an infectious TB patient is in a hospital isolation room,
employees entering the room must wear a respirator.
03/29/95
11:19
202 219 6064
DOL OSHA A/S
003
Question: Why does OSHA require expensive, uncomfortable HEPA
respirators when there is no scientific evidence that they are
necessary and that lighter, less expensive respirators work just as
well?
Answer: At present, the minimum respirator that meets the
recommendations of the CDC TB guidelines is a high-efficiency
particulate air (HEPA) respirator. This is currently the only
respirator which is certified to filter out airborne particles in
the size range of those which contain the tuberculosis organism.
When the National Institute for Occupational Safety and Health
(NIOSH) completes the revision of its respirator certification
procedures, additional respirators may become available.
Question: When will the revised NIOSH certification regulations be
published and go into effect?
Answer: (HHS will have to supply the answer.)
Occupational Hepatitis B
The following is information about a hazard that has been addressed
by OSHA's standard for Bloodborne Pathogens. Since it is based on
data from the CDC, it is important that we get agreement from HHS
before this information is used by Carol Rasco in her speech. As
soon as we have gotten agreement from HHS, we will let you know.
In 1986, there were approximately 12,500 hepatitis B infections in
high risk healthcare workers (those with frequent blood exposure)
This dropped to 8, 8,700 in 1987, when CDC published its
recommendations for the prevention of HIV transmission in the
health care setting which included rigorous adherence to
precautions designed to prevent exposure to blood. In 1987 and, to
a greater extent, in 1988, OSHA began responding to complaints
concerning occupational exposure to these hasards. In December of
1991, OSHA published the Loodborne Pathogens standard that went
into effect the following year. By 1993, the number of hepatitis
B infections in this group had dropped to 1, 450.
This approximately 90% decrease in occupationally related
hepatitis B infections over a seven year period is the result of
the combined efforts of all those involved, including the exposed
healthcare workers, the committees and individuals responsible for
implementing precautions in the workplace, as well as CDC and OSHA.
will
In 1993, the most recent year that statistics were available, the
Center for Infectious Diseases at CDC reported that the number of
cases of hepatitis B in occupationally exposed workers had been
reduced to 727. The primary factor enabling the reduction of
occupationally related hepatitis B was in promulgation of OSHA's
Bloodborne Pathogens Standard. Clearly, individuals such as the
03/29/95
11:20
202 219 6064
DOL OSHA A/S
004
members of SHEA have made a significant contribution to this
reduction through your implementation of and commitment to programs
designed to reduce exposures and to intervene when accidental
exposures take place. This is a result we can all be proud of.
Note: There will be individuals at this meeting who feel that
OSHA's regulation had no impact, wasted money and they will get up
and say so. The information above is taken directly from the
revision from Health People 2000 and the individuals at CDC
involved with this information are in agreement with the
information.
TEL:
Mar 24 95 10:17 No.001 P.01
TRALTH PUBLIC PUBLIC SERVICE 'S'n
1798
DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. PUBLIC HEALTH SERVICE
Agency for Health Care Policy and Research
Office of Program Development
Program Planning, Research Development, and Evaluation Branch
Executive Office Center
2101 East Jefferson Street, Suite 603
Rockville, Maryland 20852
(301) 594-1455
TO:
FAX number:
202 456-7431
Name:
Karen Guss
Organization:
Old Executive Office Building
Telephone:
202 456-7431
FROM:
Name:
Irma E. Arispe, Ph.D.
Evaluation Officer
FAX Number:
(301) 594-2157
Number of pages including this page:
5
MESSAGE:
March 24, 1995
TEL:
Mar 24 95
10:17 No. 001 P.02
RUMAN
SERVICES
UNA
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MIALIN
2
Agency for Health Care Policy
and Research
Rockville MD 20852
NOTE TO: Karen Guss, Assistant 10 the First Lady
From:
Irma Arispe, Evaluation Officer, Agency for Health Care Policy and Research
Date:
March 24, 1995
This note responds to your request for information to assist in the preparation of a speech for
the Society for Healthcarc Epidemiology of America, Inc. (SHEA). If you have any
questions about this information, please contact mc or Jill Bemstein at 301 594-1455.
The Agency for Health Care Policy and Research (AHCPR), is an agency of the Public
Health Service. Its primary mission is quality measurement and improvement. AHCPR
works to improve quality of care by
analyzing variations in current medical practice and examining the
effectiveness of alternative treatments (through outcomes research, technology
assessments, and the development of clinical practice guidelines) and
developing mcasures of quality (clinical quality indicators for providers as well
as quality measures for consumers and health care purchasers).
Claire Maklan has provided you with information on outcomes research. The remainder of
this note provides information on AHCPR's quality measurement and improvement activities.
Defining Clinical Quality.
Clinical performance measures (also sometimes called clinical quality indicators) allow you to
answer questions such as
-
Was effective care provided to each patient?
-
Was it provided safely and in an appropriate time frame for each patient?
-
Was the outcome as good as could be expected given the patient's condition
and personal characteristics and the current state of medical science?
-
Was care delivered, outcomes achieved, and pertinent information
communicated in a manner that mccts patient's needs and expectations?
Understanding and Choosing Clinical
Quality Indicators
AHCPR, working with the Center for Quality of Care Research and Education at the
Harvard University School of Public Health and the Center for Health Policy Studies of
Columbia, Maryland, has recently issued a report, "Understanding and Choosing Clinical
Performance Measures for Quality Improvement: Development of a Typology." I enclosed a
TEL:
Mar 24 95
10:18 No 001 P.03
copy of the report with the packet of information prepared for you by Claire Maklan. The
first chapter of the report provides a nice overview.
The purpose of this project is to collect and analyze clinical performance measures currently
used by public and private organizations. The federal government, and AHCPR in
particular, has funded the development of many of the indicators and measurement tools used
by public and private organizations to assess the quality of medical care. In addition, many
private organizations have developed quality indicators. However, until now, there has been
no single source of information on clinical quality measures, nor have there been any
generally accepted criteria for evaluating the validity or usefulness of various measures. The
"Measurement Typology Project" fills this gap.
This is a two step project:
1.
to collect clinical performance measures currently in use and create a
classification system for describing and evaluating the incasures, and
2.
10 expand and validate the system to create a more comprehensive source of
information on quality measures.
The first step, which is completed, tells us what measures exist and are in use and provides
ways to assess the validity and usefulness of quality measures. The project has identified
over 1200 clinical performance measures used by
government organizations (such as HCFA, the Department of Veterans Affairs,
and AHCPR),
-
accrediting organizations (such as the Joint Commission on Accreditation of
Healthcare Organizations and the National Committee on Quality Assurance),
and
private organizations such as the Bay Area Business Group on Health and
United Health Care).
The project develops a standard method for describing the measures, and this will
facilitate a uniform system of quality measures. (See incoming letter from the Society
for Healthcare Epidemiology). This report is available from the AHCPR Clcaringhouse at
1-800-358-9295. AHCPR will also make this report available through NTIS (the National
Technical Information Service).
The next step, which will begin next month, will expand, validate, and refine this
classification scheme. AHCPR will be working in partnership with organization like the
Joint Commission on Accreditation of Healthcare Organizations (mentioned in the SHEA
2
TEL:
Mar 24 95
10:18 No 001 P.04
letter) to identify and promote valid quality incasures that permit systematic comparison of
health care organizations.
Developing New Quality Indicators.
AHCPR is also sponsoring projects to develop clinical quality indicators. An important part
of our research involves translating clinical practice guidelines into guideline-based incasures
of quality. AHCPR has contracted with the American Medical Review Rescarch Center
(AMRRC) to develop quality and utilization review criteria and performance measures based
on three AHCPR-supported clinical practice guidelines (for urinary incontinence, acute
postoperative pain, and benign prostatic hyperplasia or BPH).
These measures have been tested in random samples of medical records of Medicare patients
and have successfully targeted quality improvement opportunities. For example, the acute
pain guideline recommends
the development of a preoperative pain management plan in collaboration with
the patient so that the patient will understand the surgical procedure, the type
of pain he or she is likely to experience, and the methods available for
relieving pain and
the use of a scaled pain assessment tool to regularly cvaluate the patient's pain
symptoms.
The project found that typically these recommendations were not followed, yet hospital
length of stay was significantly lower among patients whose care complied with these two
guideline recommendations. By examining clinical performance using these guideline based
measures, health care providers can identify ways to improve care.
AHCPR is also working with Rand to develop clinical quality indicators based on the
guidclines for cataract in adults and prediction and prevention of pressure ulcers.
Quality Indicators for Consumer Choice.
AHCPR's work has also shown that patients can provide information on the quality of care
they receive. AHCPR has sponsored a number of consumer quality initiatives including
a model survey to assess consumer attitudes about the accessibility, quality
and effectiveness of health care they receive. Health Plans, employers,
consumer advocacy groups, alliances, government agencies, and others will be
able to use this survey to provide valid and comparable information from
consumers about their health plans and providers.
3
TEL:
Mar 24 95
10:19 No 001 P.05
a patient based tool to assess clinical quality, called "Patient Reports on
System Performance" or PROSPER. This project collects objective
information from patients on time to receive services ( access to care),
communication between providers (coordination of care), and follow up after
tests and treatment (continuity of care).
These projects, which create rates of consumer satisfaction, consumer access, and clinical
performance will also facilitate clinical qualtiy improvement.
4
Booom
I
Contacts
Bob Irwin CDC
CDC
6908598
Nelson Reynev, OSHA 219 6064
AHCPR
Irma Asperi Arispe 301 594 5941455
NIOSH Sharon Morse, KathySybes
respirators Jill Hargas, HHS 6906133
I
Q & A
Q:
You mentioned the Administration's response to the risk of occupational exposure to
tuberculosis. Physicians and other health care professionals are extremely worried
about the spread of tuberculosis in hospitals. To protect themselves, they are supposed
to wear TB respirators. However, the respirators that are approved for use in hospitals
today are unsatisfactory. HEPA respirators, or "pappers" are so cumbersome and
expensive that few people actually use them. The other type of approved respirator
has been shown to leak in laboratory tests.
The National Institute for Occupational Safety and Health has drafted regulations that
will update the process by which TB respirators are tested. Under the proposed
process, a new generation of respirators would be approved. These respirators will be
extremely effective and less expensive than today's respirators. The health care
industry, respirator manufacturers, and labor unions and other affected constituencies
support the new regulations. Yet, due to the current anti-regulation climate, the
Department of Health and Human Services and the Office of Management and
Budget have failed to sign off on the new regulations so that they can go into effect.
In the meantime, thousands of health care professionals are at risk of infection. What
is being done to address this problem?
A:
I fully understand your concerns about the TB respirator regulations. I can assure you
that the Administration is working hard to get the new regulations finalized and ready
to go.
Q:
The Centers for Disease Control and Prevention are the world's leading authority on
using epidemiology to improve public health. So why is CDC not involved the study
of health care quality indicators, a very important aspect of epidemiology?
A:
Of course, CDC is very interested in health care quality management as part of its
mission to control and prevent disease. For example, as you know, the National
Center for Infectious Disease can play an important role in controlling the spread of
infections in hospitals and other health care settings. CDC is also working with other
agencies within the Public Health Service to develop a uniform set of performance
indicators to be used in assessing the quality of health care in programs currently
funded through block grants.
However, healthcare quality management has aspects that go beyond control and
prevention, so the agencies of the Department of Health and Human Services believe
that spreading its healthcare quality management efforts around works best. Under the
current system, AHCPR focuses on medical effectiveness and health services research.
The Health Resources and Services Administration (HRSA), which is concerned with
maternal and child health programs, rural and migrant health, and the care of persons
with AIDS, focuses on the implementation of quality measures in health care settings
8
where these services are delivered. HRSA is also involved in the development of the
health professions, and it concerns itself with integrating quality management into
health education. The Substance Abuse and Mental Health Services Administration
works on implementing quality measures related to the prevention and treatment of
addictive and mental disorders. The Health Care Financing Administration applies
quality indicators in its quality oversight and quality improvement efforts in the
Medicaid and Medicare programs. And of course, all of these agencies are in
communication with one another through Public Health Service workgroups.
Q:
I have heard that there have been many problems with the immunization program. Is
this true, and if so, what is being done to fix the problems?
A:
Most of the President's Childhood Immunization Initiative have progressed quite
smoothly. As I mentioned before, we've helped states extend clinic hours and made it
easier to keep parents and providers on the appropriate vaccination schedule.
The Vaccines for Children program has been attacked by some on Capitol Hill and by
some vaccine manufacturers. But we are working out issues in the program including
those related to the complaints of vaccine manufacturers that they must sell too much
vaccine at a discounted price. At the same time, evidence of the program's
effectiveness is becoming available -- a recent study revealed that the Vaccines for
Children program in New York has allowed the state to provide more vaccinations to
children in the primary care setting where they first receive care. And more and more
public and private health care providers are getting involved. By January 1995,
20,000 private provider sites and 8,000 public provider sites were already enrolled.
And 36 states have reported that they have centralized distribution systems in place to
ship vaccines to public and private providers, with the remaining participating states
and the District of Columbia distributing vaccines to a portion of enrolled providers.
We remain committed to this program, and we invite you all to get involved. So I
want to remind you that National Infant Immunization Week -- a week of community
outreach highlighting the role we can all play in protecting our children from disease -
- is coming up at the end of April.
9
The White House
withing
mm
<<<<<<<<0
<<<<<<<<
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name <<<<<<<01 ####
DOMESTIC POLICY
FACSIMILE TRANSMISSION COVER SHEET
TO:
Dr. Yamauchi
FAX NUMBER:
501 320 3418
TELEPHONE NUMBER:
FROM:
Karen GUSS
TELEPHONE NUMBER: 202 2/4 456-5603
PAGES (INCLUDING COVER):
COMMENTS:
Carol asked me to let you know
how flattered we are that you are
interested in having this speech!
Karen
Talking Points for Society for Healthcare Epidemiology of America, Inc.
Thank you for that kind introduction. It is truly a pleasure to be here and to visit with you
all and with my dear friend Dr. Yamauchi. As I'm sure you all agree, Dr. Yamauchi is a
credit to the medical profession and to this association. His tireless efforts in the areas of
children's health and AIDS, the depth and breadth of his knowledge on a variety of topics, his
dedicated public service, and his good humor have all been an inspiration to me at one time
or another. Dr. Yamauchi and I spent a great deal of time working together -- and battling
the state legislature together -- when we both worked for Bill Clinton in the Governor's
office in Arkansas, and I can tell you, it would be wonderful to have him as an on-the-scene
ally in Washington today. So thank you all for having me here.
I want to touch on about four different areas today that I think will be of interest to you. I
am going to talk about health care reform, quality management research within the Clinton
Administration, our efforts to fight the on-the-job infection of health care workers and the
President's Childhood Immunization Initiative.
THE CLINTON ADMINISTRATION CONTINUES TO FIGHT FOR REAL HEALTH
CARE REFORM.
As you know, last year the Clinton Administration fought hard for health care reform.
While we could not reach agreement on legislation, there can be little disagreement
that the problems remain. Nearly 40 million Americans have no health insurance and
millions more are just one pink slip or illness away from losing it. Eighty-four
percent of the uninsured in 1993 were in working families, and more that 55 percent
lived in families headed by full-time workers. And while health care costs have
begun to slow down, they are continuing to rise at three times the rate of inflation.
As the President said in his State of the Union address and in his December letter to
the Congressional Leadership, we remain firmly committed to guaranteeing health
security to all Americans and to containing health care costs for families, businesses
and Federal, state and local governments.
The President believes that we should take a step-by-step approach. This year, we
can take the first steps. The Congress can and should:
Reform the insurance market -- so that people don't lose their insurance when
they lose their job or change jobs or a family member falls ill, and so that
small businesses can afford to buy insurance for their workers.
Make coverage affordable for and available to children.
Help workers who lose their jobs keep their health insurance.
Level the playing field for the self-employed by giving them the same tax
treatment as other businesses.
Help families provide long-term care for a sick parent or a disabled child.
Because their constituents are demanding action, some Republicans have begun to
respond to the President's challenge by coming forward with proposals and bills. We
look forward to working with them to take the first steps this year.
But as we continue to work toward health reform, we must continually remember that
we have the highest quality of care, the most talented and dedicated health
professionals, and the most advanced research institutions in the world. All health
reform proposals must be measured by their ability both to fix what is wrong and to
preserve what is right about our health care system.
THE CLINTON ADMINISTRATION IS FIGHTING BACK TO PROTECT DOCTORS
AND PATIENTS FROM SEVERE CUTS IN MEDICARE AND MEDICAID.
Unfortunately, for too many Republicans in Congress, "health reform" has turned into
the code word for cutting Medicare and Medicaid to pay for tax cuts for the wealthy.
A number of Republicans in the House and the Senate have talked about cutting both
Medicare and Medicaid by hundreds of billions of dollars.
It now appears that Medicare will be slated to be cut by about $300 billion
between now and 2002.
It also appears that Medicaid is being targeted for at least $180 to $190 billion
in spending cuts between now and 2002.
It's not hard to figure out what that means for the doctors and hospitals who treat
patients receiving benefits under these programs, and for the patients themselves.
It means significant cuts in payments to hospitals, physicians and other
providers.
It means shifting additional financial burdens to the elderly and disabled. Or to
small businesses and families who will pay higher premiums and fees if these
programs are cut without overall reform.
In many states, it means being forced to drop coverage or shrink benefits for
mothers and children on Medicaid. Or it means asking States to pick up the
tab to preserve the Medicaid program, and in doing so, forcing them to raise
taxes or cut spending for services like education and public safety.
2
The President presented a responsible budget to Congress -- a budget that made tough
choices to get our rising deficit under control, but a budget that protected hard-
working Americans and investments in our children. Now it is Congress' turn to act.
To detail where they will get the cuts they need to pay for their tax cuts for the
wealthy. To step forward with their plan for deficit reduction.
The President has consistently said that we cannot get a hold of the deficit without
passing meaningful health reform. Over the next five years alone, almost 40 percent
of the growth in total Federal spending will come from rising costs in Federal health
care programs. We must contain costs in these programs. But we must do it as we
reform our health care system as a whole -- not by arbitrarily cutting programs that
serve the most vulnerable Americans.
That is not to say that these programs cannot and should not be improved.
The Clinton Administration is committed to continuing to give States flexibility
to reduce costs while maintaining coverage in their Medicaid programs.
And we are committed to continuing to reduce regulatory burdens, streamline
administration, and improve cost effectiveness in the Medicare program while
increasing choices for beneficiaries and ensuring that quality of care is
protected.
These are the kind of changes that the Clinton Administration is doing now.
And these are the kind of changes that we look forward to working with
Congress on in the coming months.
THE CLINTON ADMINISTRATION'S EFFORTS TO IMPROVE THE HEALTH
CARE SYSTEM ARE CONTINUING WITHIN THE HEALTH CARE AGENCIES.
THIS WORK INCLUDES EFFORTS TO MAINTAIN AND IMPROVE THE QUALITY
OF HEALTH CARE.
Developing Quality Measures
As you know, the Agency for Health Care Policy and Research (AHCPR), an agency
of the Public Health Service, works to improve the quality of care by developing
measures of quality both for health care professionals and for consumers.
More than 1200 clinical performance measures are now in use. However, as you
know, there has been no single source of information on clinical quality measures.
Nor has there been a generally accepted criteria for evaluating the validity or
usefulness of the various measures. An important project now underway to fill this
gap is AHCPR's "Measurement Typology Project."
3
Working together with the Harvard School of Public Health and the Center for
Health Policy Studies of Columbia, Maryland, AHCPR has collected the
clinical performance measures being used by public and private organizations
and has developed a standard method for describing them.
Next, AHCPR will work with organizations like the Joint Commission on
Accreditation of Healthcare Organizations to identify and promote the most
valid of the quality measures they have found. This will facilitate the systemic
and uniform comparison of health care organizations -- a vital task in today's
changing health care industry.
AHCPR is also developing new quality indicators based on adherence to clinical
practice guidelines. Because practice guidelines are derived from scientific evidence
of what really works for patients, these new quality indicators should prove to be
extremely useful.
In addition, AHCPR is working to help consumers make choices about health plans
and providers by surveying consumers directly about the accessibility, quality, and
effectiveness of the care they receive. Health plans, employers, consumer advocates,
purchasing alliances and other consumers will be able to turn to this survey for
information that will help them make their own informed decisions. By encouraging
knowledgeable choices based on quality, these surveys will encourage clinical quality
improvement.
Evaluating the Effectiveness of Clinical Practices
Besides developing measures of quality, the Clinton Administration is working to
improve quality of care by examining the effectiveness of different clinical practices
that are now being used. AHCPR's Medical Treatment Effectiveness Program --
MEDTEP -- is looking at the effectiveness of differing treatments for a wide range of
conditions including cancer, heart and kidney disease, cataracts, childbirth, and
schizophrenia.
MEDTEP research is part of the shift in focus from issues of organization and
process requirements to outcomes measures in health care. MEDTEP's concern
is with outcomes in the real world -- what works best for typical patients
cared for by real health care professionals.
A major feature of MEDTEP research is its emphasis on outcomes that patients
understand and care about. These outcomes include quality of life, functional
capacity, symptom relief and cost. Other basic themes in this research include
cost effectiveness and appropriateness of treatment decisions.
4
Learning what works from MEDTEP and other medical effectiveness research
will continue to be important as we work to maintain and improve health care
quality in the face of enormous health care cost pressures.
THE ADMINISTRATION IS WORKING TO PROTECT THE HEALTH AND
SAFETY OF HEALTH CARE PROVIDERS
SHEA has actively participated in the Administration's efforts to fight the occupational
hazards you and your colleagues face. We appreciate your assistance and expertise in
this area and we hope that you will continue to be involved.
Alongside health care professionals, we have fought occupational hepatitis B -- and
between 1987 and 1993, the number of cases contracted by health care workers
exposed on the job fell 77%. Today, we are working to contain the threat of on-the-
job exposure to tuberculosis.
The Occupational Safety and Health Administration (OSHA) has undertaken
nationwide enforcement activities aimed at ensuring that employers are taking
proper measures to protect their employees.
Currently, OSHA is working to develop a standard for occupational exposure to
tuberculosis. One of the primary bases for this standard will be the
tuberculosis guidelines issued by the Centers for Disease Control and
Prevention (CDC). We hope to publish OSHA's proposed standard in October.
We are also continuing the process of finalizing for publication regulations that
will change the method for testing TB respirators. As you know, under the
new regulations, a new generation of better TB respirators are likely to become
available.
THE PRESIDENT'S CHILDHOOD IMMUNIZATION INITIATIVE IS DESIGNED TO
STRENGTHEN EFFORTS TO IMMUNIZE CHILDREN AND TO REDUCE OR
ELIMINATE VACCINE-PREVENTABLE DISEASES
Another Clinton Administration health care initiative that I know many of you are
interested in is the Childhood Immunization Initiative. The Initiative's goal is to
immunize at least 90 percent of the two-year-olds in this country with the initial and
most critical doses by 1996 and at least 90 percent of all two-year-olds with the full
series of vaccines by 2000.
The Childhood Immunization Initiative will:
5
Improve the quality and quantity of vaccination services:
In 1993, the Federal government sent $129 million to states and local health
departments to improve existing services. Each local area uses its own
discretion to allocate these funds to meet local needs -- whether that means
extending clinic hours or automating records.
Reduce vaccine costs for parents:
The Vaccines for Children program will reach more children with free vaccine
than ever before, including many at their own doctor's offices. Sixty percent of
our Nation's children will benefit, including the uninsured, those on Medicaid,
Native American children, and children served by federally qualified health
centers.
Increase participation, education, and partnerships in communities:
The Administration's plan sends outreach coordinators around the country to
increase awareness of the importance of vaccinating children and to encourage
health care providers to use every opportunity to vaccinate children in their
care. Community and business groups, religious and service organizations,
schools, and the media are joining community-based networks to increase
infant vaccination efforts. For example, Gerber Products Company put an
immunization message on the back of baby cereal boxes, Kiwanis International
created a national public awareness campaign, including public service
announcements, billboards, and posters, and McDonalds featured an
immunization message in its tray liners.
Better monitor diseases and vaccinations:
We are creating a better system to monitor vaccine-preventable diseases so that
we can spot problems early and prevent cases from escalating into epidemics.
The Centers for Disease Control and Prevention are working to pinpoint the
populations that are not receiving the benefits of infant vaccination.
Improve vaccines and how they are used:
We developed a single childhood immunization schedule by working with the
Advisory Committee on Immunization Practices, the American Academy of
Pediatrics, and the American Academy of Family Physicians. This single
schedule simplifies what parents and providers must know to ensure proper
immunization.
6
We are increasing applied research into new vaccines in an effort to reduce the
number of shots children must receive and to ensure safe and effective
vaccines. Finally, although available vaccines are very safe and effective, CDC
is working with states and some providers to improve systems that detect those
problems that do occur after a vaccination.
7
Simmons/Gelfand
TEL 901-726-8249
Apr 05.95 10:57 No. 005 P.02
ary: Event file
SHEA
XC: Keein & Guss
The Society for Healthcare Epidemiology of America, Inc.
April 5, 1995
President
(1/93 12/95)
Bryan P. Simmons. M.D.
FYI
Memphis, Tennessee
(901) 726-8823
(901) 726-8249 FAX
Carol H. Rasco
President-Elect
11/09 12/95)
Assistant to the President for Domestic Policy
William J. Martone, MD.
The White House
Allanta Georgia
(404) 639 6400
1600 Pennsylvania Ave.
(404) 639-6458 TAX
Washington, DC 20500
Vice-I'resident
(1NS 12/95)
Robert A. Weinstcin, M.D.
Dear Ms. Rasco,
Chicago. Illinois
(312) 633-3237
On behalf of SHEA, I want to thank you for your
(312) 633-5187 FAX
wonderful prescntation. J believe that you and
Past Preddent
President Clinton have an excellent healthcare
(1/25 12/95)
Person A. Chana. M.D.
strategy, especially the emphasis on children. Your
Hackensack. New Jersey
talk was the highlight of SHEA'S Annual Meeting. I
(201) 996-2013
(201) 487-0885 FAX
will contact Terri Yamauchi shortly about the
Secretary
invitation to the White House to discuss a couple of
11/93 12/95)
items that are important to many involved in
Date N. Genting. M.D.
Chicago. Illinois
healthcare. 1 am eager to accept your invitation as
(312)640-2193
soon as I can arrange a conference call with the SHEA
(312) 640-2252 FAX
Board, probably in the next 1-2 weeks.
Treasurer
11/92 12/95)
Blies Abrutys, M.D.
Thanks again!
Philadclphia, Pennsylvania
(215) 823-5800
(215) 823-5168 FAX
Sincerely,
Academic Councilors
(1AM -12/95)
Bagan Summers
Leigh n. Donowits. M.I.
Charlotterille, Virginia
(804) 92s 5896
Bryan Simmons, M.D.
(804) 924-5284 FAX
President, SHEA
(1/95 12000
John W. Froggen, III. M.D.
/ps
Acheville. North Carolina
(704) 299-2515
(704) 299.2502 FAX
CC: Terri Yamauchi, M.D.
Practice Councilors
(1/94 12/05)
Timothy W. Lane, M.D.
Greensboro, North Carolium
(VIO) 574-8062
(910) 574-8026 FAX
11/95 12/96)
Deleard S. Wong. M.D.
Richmond Virginia
(801) 230-1365
(004) 230 6856 FAX
EXECUTIVE OFFICE
Presutive Director
Coloy Lyons
A73 Kings Highway
Wondbury, NJ 08096-3172
(609) 845 1636
(609) 853-0411 FAX
EXECUTIVE OFFICE OF THE PRESIDENT
13-Apr-1995 03:52pm
TO:
Karen R. Guss
FROM:
Carol H. Rasco
Economic and Domestic Policy
SUBJECT: see attached
Anything you see in this based on your conversations with Tappan
and others perhaps that raises red flags in your head?
EXECUTIVE OFFICE OF THE PRESIDENT
13-Apr-1995 03:39pm
TO:
Carol H. Rasco
FROM:
Sally Katzen
Office of Mgmt and Budget, OIRA
SUBJECT: HHS/NIOSH Final Rule on Respirators
attached is an e-mail report from my staff on the briefing from HHS. Its
generally positive. HHS will likely send the revised rule over by the end of
next week and we should be able to conclude review in several weeks (it alway
S
takes longer when we have to coordinate with other agencies). Let me know if
you
need more. Sally
EXECUTIVE OFFICE OF THE PRESIDENT
10-Apr-1995 06:02pm
TO:
Sally Katzen
FROM:
Daniel J. Chenok
Office of Mgmt and Budget, OIRA
CC:
James B. MacRae Jr.
CC:
John F. Morrall, III
CC:
Shannah Koss
CC:
Gary D. Rowe
SUBJECT: HHS/CDC/NIOSH Briefing on Respirator final rule
Linda Rosenstock, NIOSH Director, Claudia Cooley and their staff
briefed Shannah and I today on their forthcoming respirator final
rule. HHS expects to submit the rule within a week, and is asking
for rapid action thereafter.
In general, HHS has made reasonable changes from those proposed in
the NPRM. They have loosened requirements on manufacturers in a
number of areas, and will do more in this regard as a result of
today's discussion. They made a convincing case that this rule
will be welcomed by most of the affected parties, including
workers using respirators, respirator manufacturers who currently
live under a 1930s standard, and industrial users. They did
indicate that some small firms may be disadvantaged, and will
provide us with more data on employment effects in these firms.
They argue that the rule is a cost saver, though total costs will
depend on how OSHA applies the standard in various industrial
settings; NIOSH has not prepared an economic analysis that
demonstrates cost effects. Also, they have not included risk
analysis language in the rule. They argue, and may be justified
in doing so, that the dose-response data for respirators is not
sufficiently developed to use in full-blown risk assessment. They
will add language to the rule that bolsters their risk arguments
and provides a more convincing case for not conducting the full
assessment.
They have coordinated the rule with OSHA, and we will follow up to
ensure that OSHA is comfortable since OSHA will apply the NIOSH
standard.
The advance draft included some disclosure requirements for which
clearance would be covered under the new PRA; HHS is considering
whether to issue those as a separate paperwork requirement to
speed publication of the rule.
Last, HHS could publish two versions of the rule: a short version
with only the new regulatory language, or a longer version with
the whole rule. They say the Federal Register did not allow them
to publish the short form for the NPRM, which would have
incorporated by reference the existing language. Thought you
would want to know this vis-a-vis you conversations with the
Register.
004
02/12/95
16:19
K9ras.qxd
Vol. 16 No. 9
INFECTION CONTROL AND HOSPITAL- BRIDEMIOLOGY
Special Report
Special Update on Healthcare Reform From The
White House
Keynote Address, SHEA Annual Meeting, April 1906
Carol H. Rasco
INTRODUCTION
don't lose their insurance when they lose their job or
VI want to touch on four different areas today that
change jobs or a family member falls ill, and so that
I think will be of interest to you. I am going to talk
small businesses can afford (1) buy insurance for their
bullets)
about healthcare reform, quality management
workers.
research within the Clinton Administration, our
Make coverage affordable to: and available to,
efforts to tight the on-thejob infection of healthcare
children
pay for
tsmall
workers, and the President's Childhood
Help workers who lose their jobs to keep their
Immunization Initintive.
health insurance.
Level the playing field for the self-employed by
TIJE CLINTON ADMINISTRATION
giving them the same lax treatment as other busi-
CONTINUES TO FIGHT FOR REAL
nesses.
HEALTHCARE REFORM
Help families provide long term care for a sick
As you know, last year the Clinton
parent or a disabled child.
Administration fought hard for healthcare reform.
Because their constituents are demanding
While we could not reach agreement on legislation,
action, some Republicans have begun to respond to
there can be little disagreement that the problems
the President's challenge by coming forward with
remain. Nearly 40 million Americans have no health
proposals and bills. Wc look forward to working with
insurance, and millions more are just one pink slip or
them to take the first steps this year But we con-
illness away from losing their insurance. Eighty-four
tinue to work toward health reform, WC must contin-
percent of the uninsured in 1993 were in working
ually remember that we have the highest quality of
familics, and more than 55% lived in families headed
care. the most talented and dedicated health profes-
by full-time workers. And while healthcare costs have
sionals, and the most advanced research institutions
begun to slow down. they are continuing in rise at
in the world. All health reform proposals must bc
three times the ratc of inflation.
measured by their ability both to fix what is wrong,
As the President said in his State of the Union
and to preserve what is right about our healthcare
Address and in his December letter to the
system.
Congressional Leadership, we remain firmly commit-
ted to guaranteeing health security 10 all Americans
THE CLINTON ADMINISTRATION IS
and to containing healthcare costs for families, bust-
FIGHTING BACK TO PROTECT DOC-
nesses, and federal, state, and local governments.
TORS AND PATIENTS FROM SEVERE
The President believes that we should take a
CUTS IN MEDICARE AND MEDICAID
step-by-etep approach. This year, we can take the first
Unfortunately. for too many Republicans in
steps.
The
Congress can and should:
Congress, "health reform" has turned into the code
Reform the insurance market. so that people
word for cutting Medicare and Medicaid to pay for
From The White House, Washington, DC.
Address reprints to Carol H. Rasco, Assistant to the President for Domestic Policy, The While House, Washington, DC.
95-SK-107. Rasco CH. Special update on healthcare reform from the White House: heynote address, SHEA Annual Meeting, April
1995. Infect Costrol Hosp Epidemial 1995;
Roman
02/12/95
16:20
005
2
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
September 1995
to
tax cuts for the wealthy. Anumber of Republicans in
months.
of billions--
THE CLINTON ADMINISTRATION'S
of-dollars.
EFFORTS TO IMPROVE THE HEALTH-
It appears that Medicare will bc slated-to-bc-
CARE SYSTEM ARE CONTINUING
$270
cut by about billion between now and 2002. -It
WITHIN THE HEALTHCARE AGEN-
also.appears-that-Mcdicaid is being targeted for at
CIES. THIS WORK INCLUDES
least S180 billion to-S190-billion in spending cuts
EFFORTS TO MAINTAIN AND
between now and 2002. It's not hard to figure out
IMPROVE THE QUALITY OF HBALTH
what that mcans for the doctors and hospitals who
CARE
existing
quality
measur
2
treat patients receiving benefits under these pro-
grams and for the patients themselves.
Developing Quality Measures
your
and
It means significant cuts in payments to hospi-
As you know, the Agency for Health Care
tals. physicians, and other providers.
Policy and Research (AHCPR) agency of the Public
It means shifting additional financial burdens
Health Service. works to Improve the quality of care
to the elderly and disabled or to small businesses
by developing incasures of quality both for health-
new
and families who will pay higher premiums and lees
care professionals and for consumers.
science-
if these programs are cut without overall reform.
More than 1,200 clinical performance measures
based
In many states, it means being forced to drop
are now in use. However, 11:1 you know, there has
coverage or shrink benefits for mothers and chil-
been no single source of information on clinical
dren on Medicaid. Or it mcans asking states to pick
quality measures, nor have there been generally
up the tab to preserve the Medicaid program, and in
accepted criteria for evaluating the validity or use-
doing so, forcing them to raise taxes or cut spending
fulness of the various measures. An important Dro-
for services like education and public safety.
jeet now underway to fill this gap is AHCPR's
The-Presldent-prescnled"aresponsiblerbudget
"Measurement Typology Project."
to-Congress=a'budgctthatmade-tough-choicesto
Working together with the Harvard School of
get.our-rising-deficit-under-conrol-but-a-budget
Public Health and the Center for Health Policy
fhat-protectel-hardworking-Amcricans and Invest-
Studies of Columbia, Maryland. AHCPR has collect-
our children.
ed)the clinical performance measures beingused by
act.to.detail-where-they-wilgel-the-cuts-they-ncedas
public and private organizations and has developed
E-equently
to-pay-for-thcir-tax-cuts-for-le-wallyand-t-sterp0 standard method for describing them.
such
centrali:
forward with their plan-for-deficit-reduction.
of
Ncxt, AHCPR will work with organizations like
informati
The President consistently has said that we can-
the Joint Commission on Accreditation
of
on
not gct ahold of the deficit without passing mean-
Healdicare Organizations, to identify and promote
the
ingful health reform. Over the next 5 years alone,
thc-moet-valid-of-the quality measures they have
National
almost 40% of the growth in total federal spending
found. This will facilitate the systemic and uniform
Committee
will come from rising costs in federal healthcare
comparison of healthcare organizations-a vital task
programs. We must contain costs in these pro-
in today's changing healthcare industry.
regularres on Quality
grams. But we must do it as we reform our health-
AHCPR also is developing new quality indica-
United Health
care system as a wholc-not by arbitrarily cutting
tore based on adherence-to clinical practice guide-
care smottle
programs that serve the most vulnerable Americans,
lines. Because practice guidelines are derived from
Health care
(which-is-not-to.say-thatthese-programs canot-and--
scientific evidence as to what really works for
-should-not-be*improved):-
Finiancing
patients, these new quality indicators should prove
Advinistration
The Clinton Administration is committed to
to be extremely useful.
continuing to give states flexibility to reduce costs
In addition, AHCPR is working w help con-
while maintaining coverage in their Medicaid pro-
sumers make choices about health plans and
granis. And, WC are committed LU reduce regulatory
providers by-qurveving-consumers-directy-about
to help
burdens, streamline administration, and improve
the accessibility, quality, and effectiveness of the
costeffectiveness in the Medicare program while
care they receive. Health plans, employers, con-
increasing choices for beneficiaries and ensuring
sumer advocates, purchasing alliances. and other
allect
that quality of care is protected. These are the kind
consumers will bc able tosturn- to this survey-ford
of changes that the Clinton Administration is doing
information that will help them make their own
now, and these are the kind of changes that we look
informed decisions. By encouraging knowledgeable
forward to working with Congress on in the coming
choices based on quality, these Luse surveys will encour
developing consumer
survy hatcanasses survey
02/12/95
16:21
006
Specialritieport
Vol 16 No.9
INFECTION Correct AND Hoornas TRIDEMOLOGY
3
age clinical quality improvement.
Discase Control and Prevention (CDC). We hope to
Health
publish OSHA's proposed standard in October.
Evaluating
the
liffectiveness
We also are continuing the process of finalizing
Practice
for publication regulations that will change the
Besides developing measures of quality. the
method for testing TB respirators. As you know,
Clinton Administration is working to improve quali-
under the new regulations, a new generation of better
ty of care by examining the effectiveness of different
TB respirators likely will become available.
clinical practices that are now being used. AHCPR's
Medical
Treatment
Effectiveness
THE PRESIDENT'S CHILDHOOD
Program-MEDTEP-looks at the effectiveness of
IMMUNIZATION INITIATIVE IS
differing treatments for a wide range of conditions
DESIGNED TO STRENGTHEN EFFORTS
including cancer, heart and kidney disease,
TO IMMUNIZE CIILDREN AND TO
cataracts, childbirth. and schizophrenia.
REDUCE OR ELIMINATE
MEDTEP research is part of the shift in focus
VACCINE-PREVENTABLE DISEASES
from issues of organization and process require-
Another Clinton Administration healthcare ini-
ments to outcomes measures in health care.
trative that I know many of you are interested in is the
MEDTEP's concern is with outcomes in the real
Childhood Immunization Initiative. The initiative's
world-what works best for typical patients cared
goal in to immunize at least 90% of the woycarlolds
2
IT
for by real healthcare professionals.
in this country. with the initial and most critical doses
A major feature of MEMEP research is its
by 1996, and at least 90% of all olds with the
emphasis on outcomes that patients understand and
full series of vaccines by 2000. The Childhood
the
care about. These outcomes include quality of life,
Immunization Initiative will:
year
functional capacity, symptom relief, and cost. Other
Improve the quality and quantity of vaccination
basic themes in this research Include cost Effective-
services.
ness and appropriateness of treatment decisions.
In 1993, the Federal government sent $129 mil- "
Learning what works from MEDTEP and other
lion to state and local health departments to improve
medical effectiveness research will continue to be
existing services. Each local area uses its own discre-
important as we work to maintain and improve
tion to allocate these funds to meet local
healthcare quality in the face of enormous health-
needs-whether that means extending clinic hours
care cost pressures.
(define,
or automating records.
Reduce vaccine costs for parents.
THE ADMINISTRATION IS WORKING
The Vaccines for Children program will reach
TO PROTECT THE HEALTH AND
more children with free vaccine than ever before,
SAFETY OF HEALTHCARE PROVIDERS
including many at their own doctors' offices. Sixty
SHEA has participated actively in the
percent of our nation's children will benefit, including
Administration's efforts to fight the occupational
the uninsured, those on Medicaid, Native American
hazards you and your colleagues face. We appreci-
children, and children served by federally qualified
atc your assistance and expertise in Unis area, and
health centers.
we hope that you will continue to be involved.
Increase participation, cducation, and partner
Alongside healthcare professionals. we have
ships in communities.
fought occupational hepatitis B-and between 1987
The Administration's plan sends outreach coor-
and 1993. the number of cases contracted on the job
dinators around the country to increase awareness of
by healthcare workers fell 77%. Today, WC are work-
the importance of vaccinating children and to encour-
ing to contain the threat. of occupational exposure to
age healthcare providers to use every opportunity to
tuberculosis.
vaccinate children in their care. Community and busi-
The Occupational Safety and Health
ness groups. religious and service organizations.
Administration (OSHA) has undertaken nationwide
achoola, and the media are joining community-based
enforcement activities aimed at ensuring that
networks to increase infant vaccination efforts. For
employers are taking proper measures W protect
example, Gerber Products Company DUE an immu-
their employees.
nization message on the back of baby cercal boxes;
Currently, OSHA is working to develop a stan-
Kiwanis International created a national public aware-
dard for occupational exposure to tubcrculosis. One
ness campaign, including public service) announce-
of
of the primary bases for this standard will be the
ments, billboards, and posters; and McDonald's fea-
tuberculosis guidelimes issued by the Centers for
tured an Immunization mcssage in its tray liners.
16:21
007
4
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
September 1995
Better monitor discasca and vaccinations.
already
We are creating я better system to monitor vac-
uppheneted
cine-preventable diseases SU that we can spot prob
word
lems early and prevent cases from escalating into ept
demics. The Centers for Disease Control and
Prevention is working to pinpoint the populations
that are not receiving the benefits of inlant vaccina-
Put in
please more whole word down m This part up.
columns
Improve vaccincs and how they are used.
We developed a single childhood immunization
schedule by working with the Advisory Committee
on Immunization Practices, the American Academy
of Pediatrics, and the American Academy of Family
Physicians. This single schedule simplifics what par-
cnts and providers must know to ensure proper
immunization.
We are increasing applied research into new vac
cines in an effort to reduce the number of shots chil-
dren must receive and to ensure sale and effective
vaccines. Finally, although available vaccines are
very safe and effective, CDC is working with states
and some providers 10 improve systems that detect
those probleme that do occur after я vaccination.
- 002
02/12/95 16:18
AUTHOR'S PROOF
IMPORTANT
Please review the enclosed proof carefully for any
typographical errors. If proofs of photos and figures are
included, review for correct orientation and compare
with legends. Also check authors' names and affiliations
and proofread tables carefully.
Approval of the attached must be indicated by your
signature below. Return one set of these galleys with
your corrections no later than
7-20
or
phone your corrections in to the number indicated
below. Keep the second copy for your files.
If your corrections are not received by mail or phone by
the above date, your article will be printed as attached.
The Publisher and Editor are not responsible for cor-
rections not made because of the author's failure to
meet this deadline.
RETURN PROOFS TO:
Susan Cantrell
INFECTION CONTROL AND HOSPITAL
EPIDEMIOLOGY Editorial Offices
Vanderbilt University
School of Medicine
A-1131 Medical Center North
Nashville, Tennessee 37232-2637
615-343-1095
Fax 615-343-1582
Author's Signature
Date
AHCPR/CMER
TEL : 301-227-8211
Jul 1995 11:03 No 002 P.01
AGENCY FOR HEALTH CARE POLICY AND RESEARCH
Center for Medical Effectiveness Research
2101 East Jefferson Street - Suite 605
Rockville, Maryland 20852
Phone: (301) 594-1485
Fax: (301) 594-3211
Date/Time: 7/19 10:55 AM
To:
Karen guse
Fax: (202) 456-9439
7028
Phone:
From: Claire W. Maklan, Ph.D., M.P.H.
Message:
as requested Please see "attached."
Number of Pages (Excluding Cover Sheet): 3
AHCPR/CMER
TEL 301-227-8211
Jul 19 95
11:03 No 002 P.02
July 19, 1995
NOTE TO KAREN GUSS. from Claire Maklan and Irma Arispe, AHCPR
re: Requested comments on galleys
AHCPR's emphasis on the need for good evidence of effectiveness as a
scientific basis for valid and reliable measures of quality suggests the need to
reverse the order of the two sections about AHCPR work. This could be
done with only a few wording changes that should fit within the current
space limits. Suggested modifications follow, with insertions and changes in
bold:
Under the existing heading, THE CLINTON ADMINISTRATION'S
EFFORTS TO IMPROVE. P. 2, start with:
Evaluating the Effectiveness and Quality of Health Care (delete: Clinical
Practice)
DELETE: "Besides developing measures of quality,"
The Clinton Administration is working to improve the quality of
health care by examining the effectiveness and relative effectiveness of
different clinical practices that are now being used. Responsibility for this
rests with the Agency for Health Care Policy and Research (AHCPR),
an agency of the Public Health Service, through its Medical Treatment
Effectiveness Program (MEDTEP). MEDTEP looks at the effectiveness of
different treatments for a wide range of common conditions and
procedures, including cancer, heart and kidney disease, cataract, childbirth,
schizophrenia, and hysterectomy.
MEDTEP research reflects a shift in focus from issues of
organization and process to evaluation in terms of patient outcomes.
MEDTEP's concern is with and appropriateness of treatment decisions.
Learning what works from MEDTEP and other medical
effectiveness research will continue to be important as we work to define,
maintain, and improve healthcare quality in the face of enormous health
care cost pressures.
AHCPR/CMER
TEL 301-227-8211
Jul 19 95 11:04 No. 002 P.03
NOTE TO CLAIRE MAKLAN
FROM:
Irma Arispe
DATE:
July 19, 1995
RE:
Comments on White House article for Infection Control
and Hospital Epidemiology.
Thank you for the opportunity to review this section of the
article. Here are a few comments. All comments pertain to the
section called "Developing Quality Measures", in which there is
discussion of the typology project.
1. Page 2, First paragraph.
Suggested Change: In addition to examining the medical
effectiveness of various clinical practices, AHCPR works to
improve the quality of health care by coordinating existing
measures of clinical quality and by developing new science based
measures of quality for both health care professionals and
consumers.
Rationale: This change assumes that the medical effectiveness
section will precede the section on quality measures.
2. Page 2, Second paragraph under this section.
Suggested Change: Change first sentence to, "There are literally
hundreds of clinical performance measures now in use."
Rationale: We identified over 1200 but we know there are hundreds
(if not thousands) out there.
3. Page 2, Third paragraph
Suggested Change: "Working together with AHCPR has collected a
sample of clinical performance measures most frequently used by
public and private organizations
Optional Additional Change: After this sentence you may want to
add the following, "The project has identified more than 1200
such measures."
Rationale: The project focused on the most frequently used
measures, but we know that many other measures exist. AHCPR is
currently augmenting this inventory.
4.
Page 2, Fourth paragraph, first sentence
Suggested Change: Next AHCPR is working with organizations such
as the Joint Commission on Accreditation of Health Care
Organizations, the National Committee on Quality Assurance,
private health care organizations such as United Health Care, and
2
AHCPR/CMER
TEL : 301-227-8211
Jul 19 95 11:05 No. 002 P.04
government organizations such as the Health Care Financing
Administration and the Department of Veterans Affairs to identify
and centralize information on clinical performance measures.
This will facilitate the systematic and uniform comparison
Rationale: The project seeks to coordinate federal and private
efforts at clinical quality measurement (to avoid duplication and
to encourage public private partnership). By mentioning only the
Joint Commission, one might misconstrue the paragraph as being a
government and regulatory effort to impose certain types of
measures. I suggest not using the word "promote" because the
project does not impose a certain type of measure. It is a tool
to provide information that will inform or assist in the
selection of measures.
5. Page 2, Fifth paragraph, first sentence.
Suggested Change: Delete the word adherence. Change sentence
to: "AHCPR is also developing new quality indicators based on
clinical practice guidelines
Additional Suggested Change: After the second sentence, add:
"The typology will include these new guideline based quality
measures as they become available and this will health care
providers, purchasers, and consumers in seeking better
information on quality."
Rationale: The word "adherence" connotes a very regulatory
meaning to providers. The last sentence is intended to convey
that the value of this government sponsored project is to
coordinate information and develop tools that will assist in
making this information available to health care providers,
purchasers, and ultimately consumers.
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The Official Journal of The Society for thoure Epidemiology of America
INFECTION CONTROL AND
HOSPITAL EPIDEMIOLOGY
FAX COVER SHEET
Date:
8-22-95
To:
Carol Rasco
Karen 6055
Fax No:
(202) 456-2878
From:
Sussa Cashell
Number of Pages Following This Page: 4
Comments: Per our previous fox (7.25.95) these are second
page proofes. These profa are due back in our office
at 2 pm (our time) tomorrow. As we mentioned, This is NOT
a time -/o make change Normally we do Not send 2nd perofs
to authors. Since your changes were so extensive, we are
If you do not receive the entire fax or have other transmission
problems, please call (615) 343-1095.
Michael D. Decker. MD. MPH
Editor
sending These proofe for you to make
Editorial Offices
sure that the changes called in by
Vanderbilt University
School of Medicine
Karen guss are on the proofs. Thank
A-1131 Medical Center North
Nashuille. TN 37232-2537
you for your kind attention to this important
matter.
Telephone (615) 343-1095
FAX (615) 343-1882
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526
INFECTION CONTROL AND HOSPITAL EPIDEMOLOGY
September 1995
Special Report
Special Update on Healthcare Reform
From The White House
Keynote Address, SHEA Annual Meeting, April 1995
Carol H. Rasco
INTRODUCTION
Reform the insurance market, so that people
Today, I want to touch on four different areas
don't lose their Insurance when they lose their jobs or
that I think will be of interest to you. I am going to
change jobs or a family member falls ill, and so that
talk about healthcare reform, quality management
small businesses can afford to buy insurance for their
research within the Clinton Administration, our
workers.
efforts to fight on-the-job infection of healthcare
Help workers who lose their jobs to pay for
workers, and the President's Childhood
their health insurance.
Immunization Initiative.
Level the playing field for the self-employed by
giving them the same tax treatment as other busi-
THE CLINTON ADMINISTRATION
nesses.
CONTINUES TO FIGHT FOR REAL
Help families provide long-term care for a sick
HEALTHCARE REFORM
parent or a disabled child.
As you know, last year the Clinton
As we continue to work toward healthcare
Administration fought hard for healthcare reform.
reform, we must continually remember that we
While we could not reach agreement on legislation,
have the highest quality of care, the most talented
there can be little disagreement that the problems
and dedicated health professionals, and the most
remain. Nearly 40 million Americans have no health
advanced research institutions in the world. All
insurance, and millions more are just one pink slip or
healthcare reform proposals must be measured by
illness away from losing their insurance. Eighty-four
their ability both to fix what is wrong and to pre-
percent of the uninsured in 1993 were in working
serve what is right about our healthcare system.
families, and more than 55% lived in families headed
by full-time workers. While healthcare costs have
PROTECTING MEDICARE AND
begun to slow down, they are continuing to rise at
MEDICAID
three times the rate of inflation.
The Clinton Administration is fighting back to
As the President said In his State of the Union
protect doctors and patients from severe cuts in
Address and in his December letter to the
Medicare and Medicaid. Unfortunately, for too
Congressional Leadership, we remain firmly com-
many Republicans In Congress, "health reform" has
mitted to guaranteeing health security to all
turned into the code word for cutting Medicare and
Americans and to containing healthcare costs for
Medicaid to pay for tax cuts for the wealthy.
families, businesses, and federal, state, and local gov-
Medicare will be cut by approximately $270 bil-
ernments.
lion between now and 2002. Medicaid is being tar-
The President believes that we should take a
geted for $182 billion in spending cuts between now
step-by-step approach. This year, we can take the first
and 2002. It's not hard to figure out what that means
steps. Congress can and should:
for the doctors and hospitals who treat patients
From The White House, Washington, DC.
requests
Address reprints to Carol H. Rasco, Assistant to the President for Domestic Policy, The White House, Washington, DC.
95-SR-107. Rasco CH. Special update on healthcare reform from the White House: Asynote address, SHEA Annual Meeting, April
1995 Infect Control Hosp Epidemial 1995;16:526-529.
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Vol. 16 No.9
SPECIAL REPORT
527
receiving benefits under these programs and for
quality measures, nor have there been generally
the patients themselves.
accepted criteria for evaluating the validity or use-
It means significant cuts in payments to hospi-
fulness of the various measures. An important pro-
tals, physicians, and other providers.
Ject now underway to fill this gap is AHCPR's
It means shifting additional financial burdens
"Measurement Typology Project."
to the elderly and disabled or to small businesses
Working together with the Harvard School of
and families who will pay higher premiums and fees
Public Health and the Center for Health Policy
if these programs are cut without overall reform.
Studies of Columbia, Maryland, AHCPR has collect-
In many states, It means being forced to drop
ed a sample of the clinical performance measures
coverage or shrink benefits for mothers and chil-
most frequently used by public and private organi-
dren on Medicaid. Or It means asking states to pick
zations and has developed a standard method for
up the tab to preserve the Medicaid program, and in
describing them.
doing so, forcing them to raise taxes or cut spending
Next, AHCPR will work with organizations
for services like education and public safety.
such as the Joint Commission on Accreditation of
The President consistently has said that we can-
Healthcare Organizations, the National Committee
not get ahold of the deficit without passing mean-
on Quality Assurance, United Healthcare, and the
ingful health reform. Over the next 5 years alone,
Healthcare Financing Administration to identify and
almost 40% of the growth in total federal spending
centralize information on the quality measures they
will come from rising costs in federal healthcare
have found. This will facilitate the systemic and uni-
programs. We must contain costs in these pro-
form comparison of healthcare organizations-a
grams. But we must do It as we reform our health-
vital task in today's changing healthcare industry.
care system as a whole-not by arbitrarily cutting
AHCPR also is developing new quality indica-
programs that serve the most vulnerable
tors based on clinical practice guidelines. Because
Americans.
practice guidelines are derived from scientific evi-
The Clinton Administration is committed to
dence as to what really works for patients, these
continuing to give states flexibility to reduce costs
new quality indicators should prove to be extremely
while maintaining coverage in their Medicaid pro-
useful.
grams. And, we are committed to reduce regulatory
In addition, AHCPR is working to help con-
burdens, streamline administration, and improve
sumers make choices about health plans and
cost-effectiveness in the Medicare program while
providers by developing a consumer survey that can
increasing choices for beneficiaries and ensuring
assess the accessibility, quality, and effectiveness of
that quality of care is protected. These are the kind
the care they receive. Health plans, employers, con-
of changes that the Clinton Administration is doing
sumer advocates, purchasing alliances, and other
now, and these are the kind of changes that we look
consumers will be able to use this survey to collect
forward to working with Congress on in the coming
information that will help them make their own
months.
informed decisions. By encouraging knowledgeable
choices based on quality, these surveys will encour-
QUALITY
age clinical quality Improvement.
The Clinton Administration's efforts to improve
the healthcare system are continuing within the
Evaluating the Effectiveness
healthcare agencies. This work includes efforts to
of Health Care
maintain and improve the quality of health care.
Besides developing measures of quality, the
Clinton Administration is working to Improve quali-
Developing Quality Measures
ty of care by examining the effectiveness of different
As you know, the Agency for Health Care
clinical practices that are now being used. AHCPR's
Policy and Research (AHCPR), an agency of the
Medical Treatment Effectiveness Pro-
close
#
Public Health Service, works to improve the
qual-
gram-MEDTEP-looks at the effectiveness of dif-
up
lose
up
ity of care by coordinating existing quality measures
fering treatments for a wide range of conditions
#
and by developing new science-based measures of
including cancer, heart and kidney disease,
quality both for healthcare professionals and for
cataracts, childbirth, and schizophrenia.
consumers.
MEDTEP research is part of the shift In focus
More than 1,200 clinical performance measures
from issues of organization and process require-
are now In use. However, as you know, there has
ments to outcomes measures in health care.
been no single source of Information on clinical
MEDTEP's concern is with outcomes in the real
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528
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
September 1995
world-what works best for typical patients cared
The Initiative's goal is to immunize at least 90% of the
for by real healthcare professionals.
2-year-olds in this country, with the initial and most
A major feature of MEDTEP research is its
critical doses by 1996, and at least 90% of all 2-year
emphasis on outcomes that patients understand
olds with the full serles of vaccines by the year 2000.
and care about. These outcomes Include quality of
The Childhood Immunization Initiative will:
life, functional capacity, symptom relief, and cost.
Improve the quality and quantity of vaccination
Other basic themes in this research include cost-
services.
more
effectiveness and appropriateness of treatment
*In 1993, the federal government sent $129 mil-
italicized
decisions.
lion to state and local health departments to improve
lined to
Learning what works from MEDTEP and other
existing services. Each local area uses its own discre-
medical effectiveness research will continue to be
tion to allocate these funds to mect local
be first
important as we work to define, maintain, and
needs-whether that means extending clinic hours
Sentence
improve healthcare quality in the face of enormous
or automating records.
following
healthcare cost pressures.
Reduce vaccine costs for parents.
bullet.
The Vaccines for Children program will reach
HEALTH AND SAFETY
more children with free vaccine than ever before,
The Administration is working to protect the
including many at their own doctors' offices. Sixty
health and safety of healthcare providers. SHEA has
percent of our nation's children will benefit, including
participated actively in the Administration's efforts
the uninsured, those on Medicaid, Native American
to fight the occupational hazards you and your col-
children, and children served by federally qualified
leagues face. We appreciate your assistance and
health centers.
expertise in this area, and we hope that you will con-
Increase participation, education, and partner-
tinue to be involved.
ships in communities.
Alongside healthcare professionals, we have
The Administration's plan sends outreach
fought occupational hepatitis B-and between 1987
coordinators around the country to increase aware-
and 1993, the number of cases contracted on the job
ness of the importance of vaccinating children and to
by healthcare workers fell 77%. Today, we are work-
encourage healthcare providers to use every oppor-
ing to contain the threat of occupational exposure to
tunity to vaccinate children in their care. Community
tuberculosis.
and business groupe, religious and service organiza-
The Occupational Safety and Health
tions, schools, and the media are joining community-
Administration (OSHA) has undertaken nationwide
based networks to increase infant vaccination efforts.
enforcement activities aimed at ensuring that
For example, Gerber Products Company put an
employers are taking proper measures to protect
immunization message on the back of baby cercal
their employees.
boxes; Kiwanis International created a national pub-
Currently, OSHA is working to develop a stan-
lic awareness campaign, including public service
dard for occupational exposure to tuberculosis. One
announcements, billboards, and posters; and
of the primary bases for this standard will be the
McDonald's featured an Immunization message it
on
tuberculosis guidelines issued by the Centers for
its tray liners.
Disease Control and Prevention (CDC). We hope to
Better monitor diseases and vaccinations.
publish OSHA's proposed standard in October.
We are creating a better system to monitor vad
stacked
We also are continuing the process of finalizing
cine-preventable diseases so that we can spot prob
for publication regulations that will change the
lems early and prevent cases from escalating into epti
hyphens
method for testing TB respirators. As you know,
demics. The Centers for Disease Control and
under the new regulations, a new generation of better
Prevention is working to pinpoint the populations
TB respirators likely will become available.
that are not receiving the benefits of infant vaccina-
tion.
CHILDHOOD IMMUNIZATION
(Improve vaccines and how they are used.
INITIATIVE
We developed a single childhood immunization
Another Clinton Administration healthcare ini-
schedule by working with the Advisory Committee
tiative that I know many of you are interested in is the
on Immunization Practices, the American Academy
Childhood Immunization Initiative. The President's
of Pediatrice, and the American Academy of Family
childhood immunization initiative is designed to
Physicians. This single schedule simplifies what par-
strengthen efforts to immunize children and to
ents and providers must know to ensure proper
reduce or eliminate vaccine-preventable diseases.
immunization.
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We are increasing applied research into new
able vaccines are very safe and effective, CDC is
vaccines in an effort to reduce the number of
working with states and some providers to
shote children must receive and to ensure safe
improve systems that detect those problems that
and effective vaccines. Finally, although avail-
do occur after a vaccination.