[This Transcript is Unedited]



June 17, 2004

Hubert H. Humphrey Building
Room 800/Eisenberg Room
200 Independence Avenue, SW
Washington, DC

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, VA 22030
(703) 352-0091


P R O C E E D I N G S (10:10 am)

Agenda Item: Call to Order

DR. LUMPKIN: Good morning. We’re going to get started. We’re going to start
off with introductions. I want to just call the attention to the members of the
committee that the revised letter are at your place. And we hope, because
Richard needs to leave a little bit early, so if we have an opportunity, we’ll
get to those, even if it is just right before we break for lunch.

So, having said that, of course we don’t have a lot of time for lunch
anyway, but we’ll try to find a time to cover those. If you do have any problem
with the letters, if you see an issue, please let Richard know between now and
then, so we can get a gauge on how long it will take us. But basically, what we
asked for has been done to the letters.

My name is John Lumpkin. I’m Senior Vice President at Robert Johnson
Foundation and chair of the committee.

MR. SCANLON: Jim Scanlon. I’m the head of the Science and Data Policy
Office in ASPE, HHS, and I’m the executive staff director for the committee.

DR. HARDING: Richard Harding, University of South Carolina School of
Medicine, and a member of the committee.

DR. ROBBINS: Aldona Robbins, and I’m the liaison from the Board of
Scientific Counselors for the NCHS.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality, liaison to the National Committee and staff to the Subcommittee on
Standards and Security.

MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member
of the committee.

MS. BEREK: Judy Berek, Centers for Medicare and Medicaid Services, liaison
to the committee.

MS. HANDRICH: Peggy Handrich, Wisconsin Department of Health and Family
Services, member of the committee.

DR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, Health Care IT,
member of the committee.

MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, and
member of the committee.

DR. HUNTER: Ed Hunter. I’m sitting in for Ed Sondik, who is director of
NCHS, and I’m an associate director at NCHS.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina,
member of the committee.

DR. LENGERICH: Gene Lengerich, Penn State University, member of the

DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, Bloomberg School
of Public Health, member of the committee.

DR. COHN: Simon Cohn, Kaiser Permanente, and member of the committee.

MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
liaison to the committee.

DR. WARREN: Judith Warren, University of Kansas School of Nursing, member
of the committee.

DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the

[Additional introductions were made.]


Our first presenter for this morning’s session, Ed Thompson, was in the air
— actually tried to be here. His flight was canceled. Of course, that has
never happened to any of us. And he may be on the phone.

DR. THOMPSON: Yes, John, I’m on the phone. Can you all hear me?

DR. LUMPKIN: Oh, I’m sorry, Ed, I didn’t see you.

Agenda Item: CDC Futures Initiative – Dr. Ed
Thompson, CDC

DR. THOMPSON: Okay, our connection must be pretty good then. If you are
ready for me to present, I’ll go to it.

DR. LUMPKIN: Please, go ahead. Thank you.

DR. THOMPSON: I’m reminded in this of an experience I had once when I was a
state health commissioner years ago in Mississippi. I was making a talk. It was
a Lion’s Club. It was about diabetes. It was a big issue at the time and still
is. And I had all of my material on slides, old 35 mm slides, the kind of the
carousel. The entire talk was on the slides.

I had brought my own projector and my own screen, and I went to the
restaurant at which the Lion’s Club met. I got there just before the
presentation. I walked into the fairly crowded room, and the first person I met
came up, and I said where should I set up my screen so that it will work the
best? He said, well, it doesn’t really make much difference, most of us are

And what I didn’t know was this was a special Lion’s Club for blind, and
almost all of them were so visually impaired that they would not be able to see
my slides. So, I had to vividly describe those slides. I learned a lesson about
that. I’ll try to do the same thing today, because you are not going to see the
slides that I would have shown you, but it’s not really important, because it’s
really about concepts anyhow.

John asked me to talk to you this morning about CDC’s Futures Initiative,
and what that has resulted in. So, what we began doing almost a year and a half
ago, Dr. Gerberding charged us with looking at where CDC — not where we are,
but where we need to be 5, 10, 15 years down the road in order to have the
leadership in public health that we should be exerting.

We know that things are changing in our health care delivery system, in the
other factors that influence health around the country, and in public health
itself. And some of the major events of the last three years in particular that
have involved public health have driven home the point that there is a new
normal in public health practice that we’ve got to respond in the way CDC does
its business.

And so, we began to look at what that new arrangement needed to be. We
began to get input from literally hundreds of people around the country. And we
got input through discussion groups, from talking with CDC stakeholder

Some of you may have been interviewed individually by some of our
consultants with partner groups and organizations, non-governmental
organizations in and out of the health related fields, individual people
through focus groups, CDC’s own staff, the Department of Health and Human
Services other components, other policymakers in Washington, members of
Congress and of the administration.

We got feedback from a variety of sources, and from that, we have
synthesized first of all, six strategic imperatives for CDC in the coming
decade. And they are first of all, health impact. CDC is going to become a more
goal driven organization. And our goal is ultimately to have positive health
impact, to improve people’s health, to protect people’s health. And if we can’t
demonstrate that what we are doing is actually making people healthier, or
allowing people to remain healthy, then we are doing the right things. We are
not doing our job.

The second of these, the second imperative is customer focus. The customer,
in this case we concluded is ultimately the American public, just as the
customer of each state health department is the citizens of that state, and of
each city health department, the citizens of that city. CDC, likewise, owes its
ultimate responsibility to the public.

Now, we share that customer based with a lot of other folks, because are
trying to provide health protection services along side our partners in the
state and local health departments and a variety of others. But that’s the
ultimate customer, and CDC will be more outwardly focused rather than inwardly
focused as we try to turn toward those customers.

The third strategic imperative is public health research. We learned that
CDC needed to be more involved in promoting public health research, the kind of
applied research that translates the strict bench research into actual applied
public health interventions, evaluating those interventions, seeing if they
work, finding new interventions.

And particularly, we will turn more to emphasizing extramural peer-reviewed
research funded through CDC. Now, it is important to understand here that our
vision of increased extramural peer reviewed research is not a vision of zero
sum game, where that extramural research comes at the expense of CDC’s very
important intramural research. We will continue to have a strong intramural
research program. We would anticipate resources increasing that would allow us
to be able to increase our extramural research as well.

The fourth strategic imperative was leadership in the nation’s health
system. And in particular, in building the nation’s public health
infrastructure. Here, we are looking initially to work with governmental public
health infrastructure, but to broaden that to include the non-government
organizations, the academic institutions and others that are also part of our
nation’s health system. And CDC will try to exercise its proper role in
leadership, along side the leadership roles of others in the nation’s health
system, with a particular focus on building the public health infrastructure.

The next strategic imperative, the fifth one is an increased focus on
global health. We have learned, and I think very dramatically in the last
couple of years, how globalized health protection has become, and how important
international cooperation and international activity is to protect our health,
and the health of the rest of the globe from an increasingly globalized disease
transmission pattern. And because of that, we will increase our already highly
active presence in the area of global health.

And then finally, the sixth strategic imperative was to increase the
effectiveness and accountability of CDC’s own business practices. The business
practices within CDC, and our business practices in doing business with the
outside world. Remember that 75-80 percent of the resources CDC receives go out
the door to state health departments, to academic institutions, and a variety
of others. And increasing the efficiency with which we pass those resources
out, the ease of use of our resources to those to whom we pass them, and the
accountability for those resources is an important strategic imperative. Those
are our six strategic imperatives.

We also derived from the futures input process, two overarching strategic
goals. The first of these is a preparedness goal. And that goal is broad. All
people and communities will be protected from infectious, environmental, and
terrorist threats. This is a broad goal aimed at these issues from which people
cannot protect themselves, for which they have to turn to governmental agencies
for protection, and both naturally occurring infectious disease outbreaks, and
bioterrorism outbreaks are an important component of this. But also,
environmental threats.

Any state that has never experienced a chlorine car derailment in an urban
area, simply hasn’t lived. When you have an environmental disaster of that
nature, public health response becomes critical. And terrorist threats of
various sorts of course remain an issue for us.

The second overarching strategic goal is one in health promotion and
prevention of injury, disease, and disability. And that goal is that all people
will achieve their optimal life span with the best possible quality of health
in every stage of life. Here we will address many of the chronic diseases, the
injuries, the endemic infectious diseases, the myriad things that are part of
ongoing health protect and health promotion.

And we will approach this from a life stage perspective, looking at the
different health concerns for infants, for children, for adolescents, for
adults, and for older adults. Those are our two overarching strategic goals.

And then finally, we have a new organizational structure, which we will get
the organizational design chart to you before you have left. I will work
through our CDC Washington office to have copies of that made, so that you will
actually be able to see what I’m about to describe for you.

But before I move to the organizational structure of CDC, are there any
questions that you would like to ask about our strategic imperatives, or about
our overarching goals, John?

DR. STEINWACHS: This is Don Steinwachs.

One question was as you think about your extramural research agenda, as you
said, that’s really searching for additional funding to undertake public health
research, have you thought through what the relationships are as you see in
that research agenda between CDC, NIH, and AHRQ? And how you will orchestrate
what I assume are in many ways complementary and sometimes overlapping areas of

DR. THOMPSON: Yes, we have. And it is altogether fitting and proper that
there be some overlap among that research. It’s impossible for there not to be.
That’s actually a good thing, rather than a bad thing. Overlap is one thing,
unnecessary duplication is quite another.

The basic distinction here is that the type of research in which CDC is and
needs to be more engaged is the more applied end of the research spectrum,
particularly in the area of research into how to translate the research that
NIH and others have done into public health practice that results in health

And the major distinction is between very, very basic research on one end
of the spectrum, which clearly falls into the purview of NIH. And very, very
applied on the other end, which clearly falls into the purview of CDC. And in
between, there is lots of overlap with both NIH and with AHRQ and others.

The way we are approaching this is internally, and I’ll talk about this in
the organizational structure. We are creating an Office of Public Health
Research within the Office of the Director at CDC to coordinate all of CDC’s
activities, and to coordinate them with others involved in research.

We have already, in addition to that, particularly with NIH, we have
exchanged liaisons, and CDC now has a liaison at NIH, and the reverse is also
true, to coordinate our research agendas together. So, we are very serious
about trying to have a coordinated research agenda within the Department of
Health and Human Services. And we are accomplishing that by the two means I
just described to you.

Any other questions about this?

DR. LUMPKIN: Seeing none, let’s go on to the organizational structure.

DR. THOMPSON: Okay, this is where you’ve got to use your imagination and
listen to my vivid description. I’ll paint a picture in color in fact.

What we have done in terms of reorganization is not particularly radical,
although we can considered all sorts of ways of organizing ourselves from a
structural standpoint. We wound up with a structure not greatly different from
what you are used to at CDC. We have retained all of the centers and
institutes, and have aggregated some of them together into what we call
coordinating centers.

One of these is the Coordinating Center for Infectious Disease, as a good
example. It will include the National Center for Infectious Disease, the
National Center for HIV, STD, and TB Control, and the National Immunization
Program. They will all continue to have their separate identities, but they
will also be working together in this coordinating center to realized the
synergies between and among those programs, and where there are shared
economies of scale, capitalize on those.

The next coordinating center is the coordinating center for health
promotion. And into that we are aggregating the existing National Center for
Chronic Disease Prevention and Health Promotion, the National Center for Birth
Defects and Developmental Disabilities, and we will create a new activity, not
yet a center, around genomics.

The third coordinating center is the Coordinating Center for Environment,
Injury, and Occupational Health. And in that we will include the National
Center for Environmental Health, ATSDR, the Agency for Toxic Substances and
Disease Registry, the National Injury Prevention and Control Center, and the
National Institute for Occupational Safety and Health. There is an enormous
relationship among these centers now, and we are aggregating them together into
a coordinating center to maximize those relationships.

We will have a fourth coordinating center, which is new, and which will
include some newly created centers. That is the Coordinating Center for Health
Information and Services. Now, this is the exciting new part of CDC. And in
that, we will include the existing National Center for Health Statistics,
because it’s a logical place for. We will create a new National Center for
Public Health Informatics.

And perhaps the newest and most novel idea, we will create a National
Center for Health Marketing in which we will approach the health protection
goals that I described earlier, particularly the maximum life span and the
maximum health status, and minimum disability within that life span that we
talked about earlier as one of our overarching goals.

That will be focused in the National Center for Health Marketing, as we
approach how to market health and public health to the American public. That is
the Coordinating Center for Health Information and Services.

And then we have two offices on a par with the coordinating centers, the
new Office of Global Health. We have had an Office of Global Health on a small
scale within the Office of the Director. It is now broken out as its own
identity. And the Office for Terrorism Preparedness and Emergency Response,
once again an existing activity, moving from the Office of the Director, into
its own separate and distinct status.

So, four coordinating centers, and two offices make up the organizational
units of CDC other than the Office of the Director. Within the Office of the
Director we have kept some existing positions. We have created some new ones.
The item of most interest is the creation of the new Office of Workforce and
Career Development. This is an innovation.

It is a new office within the Office of the Director, and it will be
responsible for training and career development of CDC’s own workforce, but
much more important, for providing training support to the external public
health workforce in state and local health departments in particular.

We already have a tradition of providing laboratory training, epidemiology
training for people who will work in the external public health workforce. And
we will increase our capability, and coordinate our ability to provide that
external training as well.

When we have talked to our partners in local and state health departments
about what we can do to help improve the public health infrastructure, one of
our strategic imperatives, one of the things that always comes back is the
value of the training that CDC has provided, and could provide even more of.
And so, this new Office of Workforce and Career Development has been created to
focus our efforts on that particular need.

The other significant change is the creation of the Executive Board at CDC.
The director of each of the coordinating centers, and the two offices that I
just described, in addition to the chief science officer, the chief public
health improvement officer, the chief of the Office of Workforce and Career
Development, the chief of the Office of strategy and Innovation, and the chief
operating officer will make up the executive board, which Dr. Gerberding will
use as a decision-making body at CDC to consider policy, make recommendations
to her for decisions, and to discuss and debate issues of policy at CDC. And
this Executive Board will be CDC’s decision-making group, subject always to the
final decision of the director.

So, that’s the new description of our organizational structure. The
important thing about it is that we realize that that organizational structure
is not going to achieve our goals for us, and it’s not going to address our
strategic imperatives for us. It is simply an arrangement through which, if we
utilize that structure right, and if we interact properly within it, we’ll
achieve those goals. But no structure in and of itself is going to achieve our
health goals for us. It is simply part of the process through which we focus on
those goals.

We hope this new structure will be easier for external partners to use. We
hope it is relatively transparent to them, but its ultimate focus is to make
CDC more accessible to people outside, and to make the flow of information into
and out of CDC more efficient.

Can I answer any questions about our new organizational structure for you?

DR. STEINWACHS: When you look at the Coordinating Center for Health
Information and Services, it would be useful to me to hear a little bit about
how you see the three entities within it working together and complementing
each other, the National Center for Health Statistics, which is already well
established, and what I gather would be the new National Center for Public
Health Informatics, and the new National Center for Health Marketing.

DR. THOMPSON: There is a little problem with the speaker phone breaking up,
but I think I got all of your question there.

The National Center for Health Statistics will be probably one of the least
affected of CDC’s centers by its new organizational home, because obviously, it
will continue to function in much the same way that it has always functioned.
The advantage though of having it grouped together in a coordinating center,
particularly with the National Center for Public Health Informatics I think
should be relatively self-evident.

As we improve our informatics techniques, we would, we hope, be able to
better link and integrate the vital statistics and other health statistics that
are collected and processed by the National Center for Health Statistics, with
many of CDC’s other databases, particularly our disease surveillance databases,
our activities in public health surveillance and other areas that right now
don’t interact even optimally with each other, let alone with the wealth of
information that comes from the activities of the National Center for Health

So, we hope we can wind up ultimately with a public health information
network that will integrate all of our health information in a much more
effective manner. And that is one of the reasons for grouping it together with
public health informatics.

I think particularly this group of people, you on the committee, are
acutely aware of the increasing importance of public health informatics as a
discipline. And because of that, the creation of the center I think reflects
that increasing importance of public health informatics.

The health marketing center is not so much focused on the collection of
information, as it is going to be on the dissemination of that information, the
use of that information to assist people in achieving their maximum health
status. It’s going to be concerned much more with the out-flow of information,
and integrating it together with the in-flow of that information is the reason
that it’s located in the Coordinating Center for Health Information and

Did that address your question, at least in part?

DR. STEINWACHS: Can I do a little, short follow-up just to make sure I’m
clear. One of the things that I guess isn’t immediately apparent is why the
National Center for Health Marketing isn’t part of the health promotion
activity, since you are saying, and I would agree that it is functionally
different than the other two centers there.

And then I guess if you could also comment on would you be awaiting
appropriations for these two new centers to come into being? Or is this a
reallocation of funding? And are there directors appointed or pending?

DR. THOMPSON: First of all, there is a distinction, and it’s a difficult
one for us to describe adequately, but there is a distinction between some of
the health promotion activities and the Coordinating Center for Health
Promotion, and the concept of health marketing, which is broader than just
health promotion. So, they don’t have the same mission, although they share
some elements of the mission.

The second question about resources, no, we will not necessarily have to
have new appropriations to create the new centers. And we will create the new
centers effective really the beginning of the next fiscal year, which is
October 1 for CDC. We are in the process of creating them now. They are being

We will rearrange our existing budget to accomplish this. We have
sufficient flexibility in our appropriation now to allow us to rearrange and
reaggregate these centers without new appropriations, or even changes in our
appropriation language.

The directors of these centers either acting or permanent, have been named.
And they are now putting their centers together, or creating their coordinating
centers. I’ll run through that if it’s of benefit to you.

The Coordinating Center for Health Information and Services, the newest
group, and the most sort of innovative group we’ve got will be headed by Dr.
Jim Marks, whom many of you have known for years from his service as director
of the National Center for Chronic Disease Promotion. And Jim will also serve
as acting director of the National Center for Health Marketing.

The National Center for Public Health Informatics, we have not finally
named that director completely. John Lonkz(?) is functioning very heavily in
the leadership role there right now. The National Center for Health Statistics,
of course will continue to be headed by Ed Sondik; that does not change.

The Coordinating Center for Infectious Diseases, which includes the
National Center for Infectious Disease, the National Center for HIV, STD, and
TB Prevention, and the National Immunization Program will be headed by Dr.
Mitch Cohen, who comes from within the National Center for Infectious Disease.

The Coordinating Center for Health Promotion, which includes the Chronic
Disease, and Developmental Defects and Birth Defects Centers, and the new
genomics activity is being headed on an acting basis by Donna Stroud(?). And
the Coordinating Center for Environment, Injury, and Occupational Health is
being headed by Dr. Henry Faulk(?), who will continue, at least for the time
being, as the Director of the National Center for Environmental Health, and the
Agency for Toxic Substances and Disease Registry.

Many of you know that we have recently administratively consolidated the
National Center for Environmental Health and ATSDR, and Henry is heading that
consolidated group. He will also be the director of that coordinating center.

The Office of Global Health will be headed by Dr. Steve Blout(?), who heads
that office now in the Office of the Director. The Office for Terrorism
Preparedness and Emergency Response will be headed by Charles Schabel(?),
talking over the responsibility from Joe Henderson, who is moving to New York
state to take on new responsibilities for CDC.

The other offices in the Office of the Director, the chief operating
officer is Bill Jemson(?). He is already in that role. The Office of Strategy
and Innovation will be headed by Kathy Cahill, who is doing a very similar role
right now.

The Office of the Chief of Science is currently headed by Dixie Synder, and
he will continue in an acting basis as chief science officer. The Office of the
Chief of Public Health Improvement is my office, and I will head that office,
continuing to have much the same responsibility I have had heretofore. And the
Office of Workforce and Career Development will be headed by Dr. Steve
Facker(?), whom many of you know from his long service in the Epidemiology
Program Office.

So, those are the personalities that will be involved in the new centers.
And our effective date for full implementation of the organizational structure,
at least the changing of the budgets from one spreadsheet to another is the end
of this fiscal year, September 30, the beginning of the new one, October 1.

DR. LUMPKIN: Ed, speaking of EPO and PHPPO, I don’t see them on the chart.
What happened to them?

DR. THOMPSON: We did disassemble the Public Health Practice Program Office
or PHPPO, and the Epidemiology Program Office or EPO. And we have put the
various parts of them in the places where they seemed to make the best sense
within the organizational structure.

Much of the Epidemiology Program Office, as many of you know, was devoted
to various forms of training, the Epidemic Intelligence Service, and other
programs to train people in various levels in epidemiology. That goes to the
Office of Workforce and Career Development, because it so logically fits there.

A few of the activities of the Epidemiology Program Office will be located
in the new marketing center, but most of them will be in the new Office of
Workforce and Career Development. A small part of the Epidemiology Program
Office is likely to go into the National Center for Public Health Informatics.

The Public Health Practice Program Office functions have been scattered
through several locations. Many of those program office functions will go to
the new Center for Health Marketing, because there we will have another
activity called sector management, which will be programs aimed at the various
sectors, such as the public health system, the health care delivery system, the
business community, the education community, and other federal agencies as a

And many of the activities within PHPPO that were directed at some of those
sectors between the public health systems sector will go to the National Center
for Health Information Services in the National Center for Health Marketing.

Some of the functions of the Public Health Practice Program Office go to
the Office of Workforce and Career and Development, and some of them come to
the Office of the Chief of Public Health Improvement. And we will actually have
some program activity going on in that office as well.

So, those are the places into which we have moved the various parts of the
PHPPO and EPO that are the only parts of CDC that actually cease to exist in
the new organizational structure.

DR. FITZMAURICE: This is Michael Fitzmaurice.

Part of maybe our nature or my nature is some wordsmithing. I’m looking at
the National Center for Health Marketing, compared with the National Center for
Public Health Informatics, and the National Center for Health Statistics. I see
quite a bit of science in NCHS and the Public Health Informatics, and I see at
least the name connotes more business in the health marketing.

Just a suggestion, you might want to consider something like a National
Center for Public Health Information Dissemination or National Center for
Health Dissemination to make it more scientific.

DR. THOMPSON: That term “health marketing” is one we struggled
with, and continue to struggle with. And not just the names of the centers,
because this is a transitional organizational structure. The names of some of
these centers may change. Indeed, some of the names on this chart have changed
within the last week, and also, some of the relationships between different
parts of this.

Some units that have been placed in one location, we may find as we
implement this, work better in a different location, and may get moved. And
some of the titles here are almost certain to change. So, we are looking at the
way we are describing these things through their names. And if there are better
ways, you may well see different names on different parts of this as this
evolves. So, that’s a point well taken, and one that has been frequently
raised, by the way.

DR. LUMPKIN: Other questions?

I think one question that as we look at this organizational structure, we
note that the National Center for Health Statistics, which we have had a
special relationship with, seems to be in some ways more buried in this
organizational structure than it has been in the past in that they no longer
have a direct relationship with the secretary.

I was wondering if you might comment on how you see that operating
functionally in regards to an important organization within the federal
government, which has implications not only for CDC, but also other federal
agencies within HHS.

DR. THOMPSON: First of all, this organizational structure is not strictly
hierarchical. There is a certain hierarchical character to it. That is correct
that the director of the National Center for Health Statistics will not report
directly to the director of CDC, but instead will report to the director of the
Coordinating Center for Health Information and Services, who in turn reports
directly to the director of CDC.

But that is not the only relationship, and there will continue to be
interaction between the director of that center, and the director of CDC, and
certainly with the secretary. So, we don’t mean to imply a rigid hierarchy
within this organization at all. One of the intentions of our new structure is
that it will be much more collaborative than CDC has been in the past, both
within CDC, and with the rest of HHS.

DR. LUMPKIN: Well, I think that looks like the end of the questions.

DR. THOMPSON: Do you all have a copy of that organizational chart now? If
not, we’ll get you one.

DR. LUMPKIN: We do. It’s in our book that we have for the meeting.

DR. THOMPSON: Okay, very good. If you don’t have any further questions,
once again, I wish had been able to be there in person, but I thank you for the
opportunity to do this by phone. We hope this has given some clarity to what
CDC is doing. We hope more than anything else, that you won’t notice the
difference, except in terms of improvement.

So, thank you all a lot.

DR. LUMPKIN: Thank you, Ed.

Okay, let’s go to our letter. Richard.

DR. HARDING: At your table you have two letters, law enforcement letter and
the school letter drafts that we brought up yesterday. The subcommittee
recovered from the narcissistic injury of you all not feeling that our letter
was just perfect yesterday, but we quickly regathered ourselves and came back
with changes that we think actually made it a better letter, and we appreciate
the input actually.

The first one I would like to go over is the school letter. It’s on the
back page in italics, the new rendition of the bullet. The bullet was changed
to say, “HHS should make special efforts to focus its outreach and
educational activities in a timely manner on schools, physicians, and state
health departments to clear up any confusion regarding the permissible
disclosures of health information in the context of dealing with the health
needs of students in the school setting.”

With that change, then we can have discussion, or move the letter and
discuss it, however you prefer.

DR. LUMPKIN: We have a motion by Richard to adopt the letter. Is there a
second? Seconded by Harry. Is there further discussion?

All those in favor say aye. Opposed, nay. Any abstentions?

[Whereupon, the letter was unanimously approved as presented.]

Thank you, that was a nice revision.

DR. HARDING: The law enforcement letter is next. On the first page in
italics is worked two paragraphs. And this was to clarify what diversion is.
And we put in two examples of what diversion happens to mean. We took out some
of the things that didn’t apply, for instance chemicals. What that is, is
diversion of chemicals that go into making heroin, or the chemicals that go
into making methamphetamine. That can be diverted also. And there are laws that
have been written in 1988 or so that covered those internationally.

But I’ll read the new paragraph and sentence that we replaced.
“Witness from the DEA’s Office of Diversion Control testified that his
office is responsible for preventing the diversion of controlled
pharmaceuticals, including narcotics, depressants, and stimulants (manufactured
for legitimate medical use). Diversion cases include for example, physicians
who sell prescriptions to drug dealers or abusers, and pharmacists who falsify
records and subsequently sell the drugs. Under federal law, all businesses that
manufacture or distribute controlled substance, all health professionals
entitled to dispense, administer or prescribe them, and all pharmacies entitled
to fill prescriptions must register with the DEA. Registrants must comply with
a series of regulatory requirements relating to drug security records,
accountability, and adherence to standards.”

The next sentence we changed just a little bit. It would say, “The
DEA’s witness indicated that he believed that the HIPAA Privacy Rule has had
the effect of limiting the provision of information to DEA diversion
investigators by professionals subject to controlled substance laws.” So,
it’s just trying to clarify that word that people were appropriately
questioning about diversion. And I would move that.

DR. LUMPKIN: The letter is being moved. Is there a second? Seconded by
Judy. And just so we don’t get diverted, Marjorie?

MS. GREENBERG: I think this is quite a good explanation, but I still wonder
if there is something missing here at the end of the first sentence, just from
what I heard in the discussion yesterday. Maybe it’s redundant, but the
diversion of controlled pharmaceuticals to inappropriate sources, or something
like that. I think people seemed to think diversion to whom?

It’s a term of art apparently, diversion, but certainly you are diverting
to somebody. So, I think that still would benefit from diversions to
inappropriate sources, or something like that. Then you have some examples,
like physicians diverting prescriptions to drug dealers, or pharmacists selling
to drug dealers.

DR. HARDING: To illicit channels?

MR. HOUSTON: I think the example clarified who they are going to.

DR. LUMPKIN: How about diversion for nefarious purposes?

DR. HARDING: How about non-medical or something like that?

MR. SCANLON: Diversion itself in this term of art is an illegal activity.
But I think in the substance abuse world — Don, you probably know better —
illicit is the term, illicit substance abuse in terms of the receiver and user.

DR. LUMPKIN: The Witness from DEA’s Office of Diversion Control testified
that the office is responsible for preventing the diversion of controlled
pharmaceticals for illicit purposes.

MR. FANNING: Well, as long as we are drafting it out loud here, but then
the parenthesis doesn’t fall in the right place.

MS. GREENBERG: We could say after the parenthesis, for illicit purposes.


MR. HOUSTON: Maybe we can take the parenthesis information and make a
separate sentence. Simply say these substances include.

DR. LUMPKIN: So, the witness for the DEA’s Office of Division Control
testified that the office is responsible for preventing the diversion of
controlled pharamceuticals for illicit purposes. These pharmaceuticals include
narcotics, depressants, stimulants manufactured for legitimate medical use.

MR. HOUSTON: Then the next sentence is another include in it. So, do we
need to choose a different word?

DR. LUMPKIN: For example, diversion case could be.

DR. ROBBINS: I would just say examples of controlled pharmaceuticals are,
and then you can use your include in the next sentence.

DR. LUMPKIN: Okay, include examples of controlled pharmaceuticals are.

MS. GREENBERG: Did you determine whether this does include like reporting
doctor shopping or that type of thing?

DR. HARDING: It does not.

DR. LUMPKIN: We have an amended motion before us.

DR. FITZMAURICE: I think with the changes that the committee suggested,
that this is excellent. It’s an outstanding letter, and the drafters have every
reason to feel narcissistic after we pass it.

DR. HARDING: Thank you. I’m relieved.

DR. LUMPKIN: Well, at some time I will tell you my extremely long joke
about illicit purposes.

Okay, all those in favor signify by aye. Opposed say nay. Any abstentions?

[Whereupon, the letter was unanimously approved as amended.]

Thank you.

Agenda Item: Reports from Subcommittees and Workgropus –
NHII Workgroup – Dr. Lumpkin

DR. LUMPKIN: While Ed is setting up we can do a quick report back from the
NHII Workgroup.

The NHII Workgroup spent most its time discussing the upcoming conference
on July 21-23, and the role of the workgroup. The conference, which I think all
of you are invited to, and many of you are planning on attending — how many
are planning to attend the upcoming conference in full or in part? Okay.

The agenda is somewhat in flux, because our next speaker will be presenting
some opening comments and remarks, there will be various discussions after
that. But the key focus for us as a committee will be the third day on the
23rd, which will be a report back from the various breakout sessions.

That report back will be to the NHII Workgroup. The workgroup will hear the
report back from the sessions. There will be a closing discussion, and then
lunch. After lunch, the workgroup will then get together and sort of try to
digest, synthesize, and develop next steps for moving forward with our plans.

We spent a lot of time discussing how that should take place. We decided we
didn’t have quite enough information to move that forward. We will be
attempting to have a conference call sometime in the early part of July, when
the plans are a little bit clearer, to finally formalize that session. It may
have some impacts, depending upon timeframes and agendas for the efforts of the
department to move forward the health informatics agenda.

So, that’s kind of where the workgroup is. And are there any questions or
comments? Great.

Thank you for coming.

Agenda Item: National Healthcare Disparities Report –
Dr. Edward Kelley, AHRQ

DR. KELLEY: My pleasure. I’m glad I got here early. It’s one of the most
efficient NCVHS meetings I’ve ever been personally to — being ahead of
schedule, I mean.

I did want to start off by thanking John, thank you and the committee for
inviting the Agency for Healthcare Research and Quality and the National
Healthcare Disparities Report team to come down and present to give you an
update on the disparities report. The two reports obviously are quite closely
linked, but we’ll concentration on the disparities report today.

The committee provided extensive support for AHRQ and the team and the
whole department — this is the department’s report through the secretary to
the Congress — during the development process, with some very detailed
comments and really invaluable input, as well as providing us a forum through
the Quality Workgroup to hold a hearing in summer of 2001, on the measures and
the measure set and the proposed structure of the reports in Chicago.

And we had the AHA, the AMA, JCAHCO, the Midwest Business Group on Health
among others come and testify to us about directions for the report. And given
the kind of relatively blank check in the figurative sense of the word, not
literal, that we were given by Congress to do these reports, the guidance was
really invaluable.

So, I wanted to give you two overarching messages that I have for the
presentation. We had going into this, probably one single main criterion for
success, and that was actually completing this report, the National Healthcare
Disparities Report. And it sounds like a low bar, but disparities report is in
terms of number of measures and number of dimensions of quality assessed, the
most extensive examination of health care disparities done ever in the US or
any major industrialized nation. I have done quite a bit of work with OECD and
other countries, as many folks in this room have.

And given also that this was being done by the department, but the federal
government, with all that goes with it in terms of the consensus building that
goes along with it, it was quite an undertaking.

That said, the second message that I have is that I think AHRQ, the
department, and the secretary all feel that kind of product-wise, the first
time you tackle something this complex, you are not going to get it all right,
and I don’t think any of us has any illusions that we did get it all right.

Blessedly for some people perhaps but not me, these are annual reports. And
we have the opportunity to improve on it this year, and improve on it next
year, and in subsequent years. And we are right now in the process of
strategically planning out an agenda over a longer term. So, we are not
scrambling to get the next report together.

But with that in mind, I wanted to just summarize briefly what happened
with the 2003 report and the findings, as well as present some kind of broad
strokes plans for 2004. And feel free to interrupt me, but barring sort of
anyone raising their hands, I’ll just go through and then we can take
concentrated questions at the end.

The reports, as I was mentioning, were mandated by Congress in AHRQ’s
reauthorization legislation. The disparities report language was significantly
more detailed than the quality report, which basically asked AHRQ to produce
annual a report on the quality of health care provided to the American people.

The disparities report, the main purpose of it was to track, “the
prevailing disparities in health care delivery as it relates to racial factors,
and socioeconomic factors in priority populations. And it listed out
specifically what those priority populations were, and that we were supposed to
look at those priority populations along racial and ethnic lines, and
socioeconomic lines.

So, broadly speaking, expanding upon that, the goals of the first report
were to provide an assessment of disparities baseline, identify gaps where
performance between the actual and ideal existed, and promote awareness about

There was some work also at the state level in more derivative products,
not specifically in the report, to provide tools for self-assessment and
national benchmarks, and again, to promote awareness. But the quality report
does track national and state data.

The disparities report, because of the number of just things it was
supposed to report on in terms of crossing all those racial and ethnic
categories, and all those socioeconomic categories with different priority
populations, concentrates at the national level. There is also, as many of you
know, limited state data available on this, but we did get into some state work
with NHDR.

In terms of how the two reports are related, and AHRQ really looked at the
disparities report as an opportunity to examine disparities through a quality
lens, which is not brand new, but it’s also not necessarily the prevailing way
that disparities have been looked at in the literature.

Where the NHQR, the National Healthcare Quality Report is a snapshot of
quality of health care in America, the DR looks at disparities, and looks at it
not just at quality, but also takes the basic framework of the quality report
— I didn’t want to get into too much on frameworks and conceptual frameworks,
but I didn’t mean to downplay the importance of them.

The Institute of Medicine provided the National Healthcare Quality Report
with a framework that was very much derivative of Crossing the Quality
, that looked at patients’ health care needs in terms of staying
healthy, getting better, living with disability, and end-of-life care, and
looked at different dimensions of quality, specifically effectiveness, safety,
timeliness, and patient-centeredness.

And the dimension of equity, which as many of you know is featured quite
prominently in Crossing the Quality Chasm was specifically what the
disparities report was supposed to look at. So, it looked at those dimensions
of quality, i.e., those same measures that the quality report looked at, and
examined them along equity lines, as well as added a relatively large portion
of measures, approximately 100 measures on access-related issues.

The topics that are here, once we had the framework from the Institute of
Medicine, and I should pause. The disparities report really built on the
quality report work for a lot of reasons — schedule, and also just
conceptually it was attractive. The quality report work with the Institute of
Medicine progressed first.

The Institute of Medicine’s disparities report workgroup, the
“Envisioning the National Health Care Disparities Report” began
later, and finished as we were sort of in the process of developing the report.
But because we had gotten such good guidance on the quality report and were
building off of it, we felt relatively safe, although it was a relief when
Shelly Greenfield and the rest of the group gave us a framework that matched up
with what we had organized the report around. This, in kind of bullet format,
summarizes the different pieces of the framework and how we looked at them.

Now, in terms of clinical conditions, many of you are also familiar with
the Institute of Medicine’s priority areas for national action. AHRQ does a lot
of work with the Institute of Medicine. And that document laid out a set of
areas that were originally envisioned as organizing clinical condition or
condition areas for the National Healthcare Quality Report and Disparities

Timing-wise, it was finished just too late for us to be able to deliver the
2003 reports to Congress. But we then lined up, in the absence of having that
document, with Healthy People 2010 clinical conditions. And those are mostly
listed under effectiveness. And the quality report and disparities report look
at both of those areas. I won’t go through them as they are on the slides and

I will mention that the NCVHS hearing that we did hold in July 2001, was
helpful in terms of getting input on both reports. And we did have two rounds
of public comments, one for the NHQR measures, and one for the NHDR measures in
terms of what we were going to be talking about.

Just before I get into some of our key findings, the release schedule for
the reports, which has been for good reasons, kind of the subject of some
confusion, in July through late November, we were in the clearance process. A
number of you are familiar with this. But basically, it goes through the entire
department in terms of review.

Now, we had two interagency work groups, one for the quality report and one
for the disparities report. There was some overlap in membership, particularly
with our colleagues at National Center for Health Statistics in terms of
membership, but they were both involved in giving input on the two reports.

The official clearance started in July, went until late November, just
hashing out a lot of issues. And again, we felt like we chalked this up to the
first time you’re doing this, it’s going to be difficult. And no matter how
much audience research we did, which was not insignificant, it’s just very
difficult until you actually have the document itself, to get really solid
feedback on things. And in a lot of cases people said, oh, that’s what you
meant. No, I don’t think that’s going to work.

And so, we had to go back to the drawing board and kind of rework things.
Also, a lot of time we spent, given the nature of the effort that I mentioned,
developing consensus on the measures and the measure set, and getting the data
sources right. And I’ll get to some of the data issues with the disparities
report in a moment.

But because of that, we spent, and AHRQ chalks this up to our own
development process involved, relatively less time on vetting and planning the
writing and the layout of the report itself. And I think that came through when
we got to the review process. But that’s what review processes are for. The
document that we came out with in December, Carolyn and the rest of the agency,
as well as the interagency work groups felt like it was much improved upon.

In January, there was a lot of review of the report, both within the
department and outside of the department by a lot of experts. And we got a lot
of feedback specifically on the disparities report in terms of the tone and the
final layout of the text of the report.

In discussing this within the department, the secretary requested that AHRQ
re-release the original version of the report, not from the sense that the
report that we finally came out with had data errors. We were standing behind
all of the data. But in order to quiet any sort of questions.

We now have up on our Website, the July version of the reports that was
originally sent into clearance, and that is the last version that is available
up on our Website. And that was re-released in February 2004. There is not a
small amount of minor or less minor rather, that we have worked on for that.

But I’ll just leave that release there, and say that since that was only a
couple of months ago, and we’ve got the 2004 reports due, we had already
started moving on the planning for the 2004 reports. So, we are looking forward
to building off of what came out of that process for the 2004 and beyond

So, now what I will talk about here in terms of the findings are based on
sort of what we originally, with the knowledge that I have of corrections, good
data corrections and all that colleagues gave us in the July 2004 reports.
Basically, frequently, for those of you who have kids or don’t have kids, when
you have the portion of the NPR or some other news story that is coming on that
says this next section contains shocking information. You think about turning
it off for your children.

This next section contains nothing shocking for anyone in this room,
because all of you know this stuff already. And I think that we may have been a
little bit of what’s behind some of the criticism of the report. But when you
are relying on tried and true measures, and that was what we relied on, were
measures that had wide, broad, national consensus, not cutting edge research in
terms of health care quality or disparities, but a broad consensus of national
measures, and there are about 250 in the disparities report and about 150 or so
in the quality report.

Anyway, you end up with conclusions that reinforce what a lot of us already
know. It’s unfortunate that the whole nation doesn’t know this, but that’s the
mission of the report.

Disparities in quality of health care are pervasive. Disparities in access
contribute to disparities in quality of care. Management of chronic diseases,
which is by far the vast majority of the clinical areas that are measured by
the report, present unique challenges and opportunities for preventive care
frequently missed. Finally, there is more to learn, and greater improvement is

I thought I would just touch briefly on each one of these with an
illustration. It doesn’t do justice to the 250 measures that we have here, but
I’ll just take a moment to say that the way that the information was presented,
the report itself was really actually a small part of — by that I mean the
report text — was actually really a small part of the whole effort in the
disparities report.

The biggest effort, and actually what we feel like is probably the ongoing
legacy, at least of this first report, is the consensus that went into the
measures. That these are important things to measure in quality of care. These
are important things to track in terms of subpopulations, in terms of
disparities of care. And secondly, all the data that was amassed.

Now, the disparities report has something that the quality report does not
have in addition to the text, where things are summarized, that are relatively
high level. It has summary tables in each section. There is a quality chapter,
an access chapter, and a priority populations chapter.

And the priority populations chapter takes what is discussed in the
previous two chapters and cuts it along specific priority populations as kind
of pull outs for people who are concerned with those specific populations.

In each of those chapters it ends with a summary table that goes through
measure by measure, and summarizes the findings of racial and ethnic groups
compared to the reference group, which in that case is white, and socioeconomic
groups compared to the reference group, which is the richest group. We used the
percentage of the federal poverty level.

And it uses Consumer Reports-type symbols to summarize where things in any
given area for different populations. And you are able to look down columns for
different racial and ethnic groups or across four different measures.

And then there are the detailed tables, which are the upwards of 400-500
detailed tables in the tables appendix, that go through each measure, and there
is one table on racial or ethnic breakdowns and one table on socioeconomic

That sort of long digression was just intended to emphasize the fact that
again, the report itself, and you will see this when we talk about our plans
for next year, is one piece, and it’s actually relatively a small piece of the
entire picture on the NHDR.

This particular slide illustrates some of the differences between racial or
ethnic groups in terms of post-operative complications of care. This comes from
the Health Care Costs and Utilization Project, which is a partnership that AHRQ
runs with state partners on submitting administrative data.

It is one, if not the largest administrative databases in the country, and
has a census of administrative data not in every single state, but we are
approaching that. I’ll come to the 16 state database issue, because this was an
example of where we had to really work to get good racial or ethnic information
from something that is actually quite a rich database.

But you can see — and this is something that is illustrated in the rest of
these slides — but a 50 percent difference between whites and blacks in terms
of post-operative septicemia.

Disparities in access contribute to disparities in quality of care. Many
racial and ethnic minorities and individuals of lower SES are less likely to
have a usual source of care. Hispanics and people of lower SES are like to
report unmet health care needs. And higher rates of avoidable admissions by
blacks and lower SES persons may be explained in part by lower receipt of
routine care by these populations.

And I will touch on some of the difficulties the report has just because of
its mandate and how it was set up in terms of looking at going beyond what’s
the picture, to what caused this picture.

Opportunities for preventive care are frequently missed. This shows some
patterns for influenza and pneumonococcus vaccinations for Medicare
beneficiaries, and the data source being a CMS QIO program. It also illustrates
the wide variety of data sources that we had, from surveillance data to surveys
to chart review to administrative data.

Similar patterns were seen in childhood vaccinations and screening for
cardiac risk factors, just as an illustration of preventive care opportunities
that might be missed. And we tried to summarize some of this in a recent fact
sheet that we did in part for the secretary’s summit on prevention. Again, I
can provide that to anyone who is interested in that particular summary.

Management of chronic diseases presents challenges. Now, this in some ways
illustrates the issue that I was talking about earlier on avoidable
hospitalizations. This slide presents rates of hospitalizations related to
diabetes, one for short-term complications, and the other for lower extremity
amputations. And again, there is a several fold difference between whites and
blacks in particular, but even for lower extremity amputations, there are
differences between whites and Hispanics.

There is more to learn. Of course, we wouldn’t be the Agency for Healthcare
Research and Quality if we didn’t end with we just don’t know it all yet. But
that’s of course, doubly true — it’s true for the quality report — it’s
doubly true for the disparities report. And in large part, that’s because of
the limited data. And NCVHS has been at the forefront of examining this
question, so I won’t go into it.

But in particular, there are some groups where there is just limited data
in terms of the national databases that provide breakouts along these lines.
And I have listed some of them up there.

In addition, there was a lot of work we had to do even with data sets that
provided relatively rich data. For instance the HCUP database that I mentioned,
you would think this would be the perfect spot for this type of information.
You have millions and millions of potential observations to look at. But in
fact, race data is not reliably coded.

People know this. It’s not reliably coded, or at least differentially coded
across the country by different states and just according to how things are
coded, and what the administrative data regulations for hospitals. We worked on
constructing a separate database of 16 states, and this was after considerable
analysis of race and ethnicity fields within the database to 16 states that met
certain statistical criteria for reliability on coding.

And that required quite a bit of resources, and quite a bit of work. We had
other databases that just only support, just because of numbers issues, small
or limited analysis along race/ethnicity, and in many cases no income
information, QIO data, SEER information, that kind of thing.

And then obviously, we have some data sources that just have no race or
ethnicity data. For instance, although I should pause and say that we are
working on a number of those. For instance, the quality report tracked home
health care quality. It was right about the same time that CMS was working on
its home health care quality initiative, and we worked with them actually on a
technical expert panel looking at potential measures for CMS for its public
reporting, and potential measures for the NHQR and NHDR.

We came up with a set of measures, went forward with both initiatives, but
we were not able in terms of OASIS, to get that — and for those of you who
don’t know the OASIS data set, the power is the home health compare and the
home health pro-quality initiative program — to get that race data for last
year. We do hope to have it in this year’s. It sort of just arrived. Anyway,
it’s quite late in the process, but we’re willing to take it, that’s for sure.

There is also relatively limited understanding, and this was something that
again — was a slight difference between the quality and disparities report —
a limited understanding about best practices for disparities reduction. We
worked hard in the reports on not just presenting the picture, and these are
all of the gaps. But also trying to identify, and each section had a section on
this, what can be done.

Each section ended with what we don’t know, which for those of you who have
read Health Care Canada, that’s something that is sort of borrowed from them.
And there are sections in that quality report with that, and as well as what
can be done. And there, we tried to highlight best practices in improving
quality in a given area that the chapter talked about, as well as improving
disparities within a given chapter.

And we just had a really difficult time. For those of you who know, best
practices reporting is often done in the gray literature by and large. There
are initiatives out there, nationally recognized programs that provide awards
or stamps of imprimatur on best practices. It’s difficult to find some quality
best practices that had data behind them, so you weren’t just reporting
practices, but these were actually something that people might want to look at
a little bit deeper. But in disparities it’s really a blank area.

The report also provides limited knowledge across the whole measure set for
why disparities exist. And in large part, the mandate of the reports was to
present a national snapshot. Although we did get quite a bit of feedback that
this was an area lacking when we were in departmental review, there just was
not the time or the resources, and not the mandate frankly, to look at the
causation behind some of these disparities. But it is something that we are
looking into in terms of trying to do some focused analyses.

The report does offer some illustrative suggestions, which are highlighted
in the executive summary that is up on the Website. Poorer communication is
cited frequently by many racial or ethnic groups. Asians and Hispanics and
lower SES individuals frequently cite difficulty in accessing health care
information, including prescription drug information.

Finally, greater improvement is possible. Again, in the quality report we
talked about some specific gaps, and then tried to highlight a broad range of
departmental initiatives in quality. We tried to do the same in disparities.
And in fact, the department had just finished putting together a compendium of
departmental actions that the department is working on in terms of disparities.
And that is available through the department or through AHRQ. But we did
emphasize the need for greater improvement in this particular finding.

Blacks and Hispanics do worse that whites on half the quality measures.
Hispanics and Asians do worse than whites on two-thirds of the access measures.
And poor people do worse on two-thirds of quality and access measures. And
actually, it’s not surprise, but poor people as defined by the report, do not
do better than the comparison group on any one of the 250 measures across the
entire report.

And this highlights one thing that we are also trying to work on for future
reports, better ways of summarizing across the data without losing the richness
of the 250 measures, and making assumptions that are not valid. We are working
on that for the second report.

I might want to just pause real briefly here, because the next couple of
slides that I wanted to end with focus on a little bit of AHRQ’s reorientation
towards a more implementation mindset, and how the reports plan to work on
that. If you have questions that focus on that, that’s great, but what are you
going to do with it, the next portion is coming up, so maybe you can hold it.
But I might want to pause, just because people might have questions on the 2003

If not, I’m happy to keep going.

DR. LUMPKIN: Keep going.

DR. KELLEY: John is willing to give me the benefit of the doubt that the
answer lies in the next five slides. It’s only a couple of slides, so it really
just highlights that AHRQ has been working hard at agency-wide reorganization,
small R, I guess. We have a new mission statement that focuses on improvement
in the quality and health care for all Americans.

And that is a shift from our work that traditionally has focused a little
bit more on research to support improvement, or aiding other agencies in
improvement. And the reports have shifted in their focus as well. My own
background is in quality improvement, and when we presented up on Capitol Hill
to give a briefing to Congress on the release of the reports, we had one
congress person’s staffer who has been very helpful to us over the years say —

Caroline was presenting, and said, “Caroline, this looks like a really
big report. And it looks like it took a lot of work, and there is a lot of text
in there. And thanks for that summary of the findings, but can you tell me what
is the bottom line? I’m someone who advises a policymaker on what to do in
terms of the direction for health care in America. Tell me what the bottom line
is on this.”

That was a lesson that we took. The mandate of the reports is not to spell
out a blueprint for the American health care system. That would not be
appropriate for AHRQ or any one agency to try and give to the department. But
it is supposed to provide information that can help folks this individual, and
like those of you in the room to work on initiatives to actually improve the
care of the American people.

In terms of that, there are then three activities. One, people have to know
about the report. They at least have to know about the report. Once they know
about it, they need to understand it. Once they understand it, they need to
actually be convinced to do something with it. Without going into a lot of
information, that will harken back for some of you, including me, to graduate
school days. We tried to organize our work around diffusion of innovation
theory. Of getting people going from knowing about something, to actually doing

And some of these tools that I will highlight here show a little bit more
of the knowing about things. We have a new Website qualitytools.ahrq.gov, that
features the two reports quite prominently on the front page. This is the front
page. And it’s hard to read probably on your handouts as well, but AHRQ has
worked over the past year and a half on compiling quality tools. And this was
through a nomination process.

For those of you who are familiar with our National Quality Measures
Clearinghouse, it’s just about the same thing, but for quality tools. And they
had to meet certain criteria, and be evaluated for inclusion. And you can sort
the tools according to a different search criteria. If you typed in diabetes,
you would get the diabetes-related ones. You can also look according to
different stakeholder groups — providers, policymakers, patients and
consumers, and payers and purchasers.

We have been working on again, some of the getting to know, to actually
doing something about type of activities through our user’s liaison program,
through some Webcasts,as well as through peer reviewed literature. We worked
with our colleagues at CDC on an article on prevention and health care quality
in America in their online journal, Preventing Chronic Disease, as well as a
medical care supplement that is coming out this fall.

And we are beginning some of the work on data tools. So, for folks who say,
well, that’s great that the report summarizes these important gaps. What I
would like to do is benchmark my state versus other states. For instance, we
are working on a Web-based tool that will allow people to cut information
across the data tables.

And this is not so powerful when you only have — I shouldn’t say one
year’s worth of data. In some cases we have multiple years, but that’s a
relatively limited number of measures. Only 57 measures in the first report
have multiple years worth of data. Obviously, the second report has many more.
Some measures have changed, so not every single one. But that will become more
important as we go forward, and we hope to build an online database that people
can search, not too dissimilar from our MEPSNet information.

And we have begun to talk about using the National Quality Measures
Clearinghouse as a jumping off point for a quality improvement clearinghouse in
terms of information that would be categorized similar to what I just mentioned
on qualitytools.ahrq.gov.

Finally, some of the key changes that this mindset of making the reports
relevant for people brings up, for the 2004 report we’re moving to a chartbook
format. The text-based format that we had was a good first shot. But again, the
audience feedback that we got, and we did an evaluation. For those of you who
work in evaluation, all of us wish that both the federal government and other
programs would actually look at what they did, and not just assume they know
what the problem was. And obviously, we had some problems.

We thought we knew all of them, but actually, we didn’t know all of them.
We got a few extra ones thrown in there in this evaluation that we had done,
both at the process of doing the reports, and the end product. And some of the
feedback that came back from that evaluation was a move to a chartbook format
that would focus on a smaller number “highlight” measures.

Now, both of these, the measure set and these proposed highlight measures
are right now out for public comment through June 28th. The comments come back
directly to me. It was a Federal Register notice that was published on May

We have the addition of trends over time in the 2004 reports, where there
was a lot of discussion about now 60 percent on measure X. Is that good? Is it
bad? Is it going in the right direction? We were finally able to answer that
last question, and two years worth of data in many cases for these measures,
does not a trend make, but at least it gives you something to talk about in
terms of your direction.

There is an addition of more sub-national analysis at the state level,
particularly for the NHQR, looking at sub-national variation. So, the charts
emphasize trends in the NHDR, and emphasize trends in racial or ethnic
subgroups and socioeconomic subgroups. And then at the NHQR emphasizes trends
at the national level and sub-national variation.

And these are some of the e-mails and the Website that you can contact for
additional information.

Thank you very much.

DR. LUMPKIN: Questions?

DR. STEUERLE: I’m just curious, as you go into the stage when you go into
further analyses, I’m wondering how much consideration you are able to give to
distinguishing among factors that may or may not be amendable to change?

And again, it’s one thing to note the disparities. It’s another thing to
think about what are the alternatives to deal with these disparities, even
though you are not going to make proposals. Let me give you one example by way
of anecdote. And I only have it by anecdote. I don’t even know whether it’s
exactly true.

I have heard that among high school students differences in inoculation
rates, and differences in access to health care had less to do often with
whether they had insurance, than whether they just happened to have some
clinics nearby. That in a lot of cases they had the insurance, they just never
got around to making use of it. I don’t know whether that’s true or not, but I
have heard that.

Certainly, if your data were done in a way that found disparities at a
given age level, and you had in the data, whether or not the person had
insurance, you had in the data whether or not the person had access to
something like a clinic nearby the school or something, and ran a regression on
it, you might be able to tell us something about whether one or the other was
indicative of something that might help deal with that issue.

It’s only one example. I’m sure you could think of 100 others. I’m just
curious how far you are able to move into those types of directions, or plan to
move in those directions as you go into the future?

DR. KELLEY: I think that’s a great question, and one that actually came up
quite a bit in the departmental review. The original attempt at looking at this
data, the temptation is to say, well, here are all these differences that
exist. And first off, you would have the kind of issues of looking at enough
comparisons, you are going to find something that’s different just by sort of
the laws of chance if you look at enough of them.

But then secondly, the issues of when you do find a difference, what does
that actually mean? And the reports are very limited, the disparities report in
particular, because it looks at so many different comparisons, we are just very
limited in our ability to tease out some of that information.

We have talked at AHRQ about in terms of the kind of implementation of the
reports, is that the next step should be exploring some of those differences. I
think the conclusion is, and something we have chatted about some in the
interagency work group, that that type of exploration should be undertaken in
derivative products, not necessarily in the report proper.

That the report itself, especially given the move that we got through the
whole clearance and public comment process that it should be more readable, and
a boiled down version, would remain as a high level snapshot.

We have begun work on a series of products that are tentatively called
right now knowledge packs, that look at issues across the measure set, and
across the reports that are not necessarily even chapters in the reports right
now. And by and large, that would be the exact type of thing that would be
looked at, sort of the impact of insurance status across a wide set of

And we do have some resources, somewhat limited, but for looking at a
priority set of factors that would be related to that across the measure set.
Again, we are somewhat limited in terms of the types of data that are in
national data sets in the sense that not every data set has educational status
or allows you to cut for instance children by kind of different age groups in
terms of having enough power, that is, to do that, to look at children under 5,
5-12, 12-18, that kind of thing.

But I think that we haven’t quite outlined exactly the best way to come up
with these priority factors for more in-depth analysis. And I think it’s
something we are going to explore in the coming year. But we would love to get

First of all, we also have our national advisory council, a subcommittee of
which provides us input in the reports, which we would probably like to vet it
with as well. Maybe it would be useful to do a public notice on topics that
would of further input, that AHRQ would put some significant resources on
looking at.

Since as you moved on that continuum of kind of knowing about something,
but doing something, it takes more resources. And if you are just providing a
snapshot, and you do that broadly at a very superficial level, getting more
in-depth requires more resources.

The one other thing that I will mention though is that along those lines,
we have talked about I don’t know that AHRQ always saw itself as generalists
necessarily, but these reports are definitely generalist documents. I mean they
are very broad, and they are very high level.

We are hoping to, in the 2005 report, in moving to a focused topic, not
dissimilar from the way Health US and some other publications release their
information. Which would be that we would still have all of the detailed
tables. We would keep these kind of highlight monitoring measures. There are
about 20 in each report. But the test itself would focus on a particular topic
that would be cross-cutting such as insurance status, or such as access to
primary care, or something like that.

And again, that would be something that we would have to vet quite
extensively as to what those priority topics should be. And we would map those
out for about four or five years as part of the strategic plan we have been
talking about.

MR. SCANLON: Thanks very much, Ed. It’s a very good presentation. And I
think you are looking forward for what occurred with the first report in terms
of how you would design the next. I was going to suggest the Health US model as

But there are two other things to follow-up on Gene’s question. Will there
be an opportunity even in the chartbook to look at say socioeconomic factors as
— well, a two way table, basically, disparities by race, and then accounting
for socioeconomic disparities as well. So, it would be a two way table. It
wouldn’t just be race/ethnicity. Again, you may not have the data.

And secondly, this almost suggests that this iterative process of
developing the report actually suggests the research and analytic agenda in
terms of new data, new data development, grants, analytic kinds of things as
well, so that you do begin ultimately to fill in the causation and the other
factors that account for the amount of differences in disparities. Would you do
even in the chartbook format for this year, say SES by race? Or is that just
not available very much?

DR. KELLEY: The way that the charts are right now, and right now we are
sort of in this pre-clearance time. We are hoping roughly mid-July, which you
all saw the timeframe for when we finish the last report. So, we have this very
overlapping process. But right now we are in the process of vetting very
preliminary drafts within the interagency work group on this.

But the way that they are laid out right now, the charts primarily, for
instance on the disparities report, look at racial or ethnic groups, and the
change that has happened over time, and then SES groups over time. But the
detailed tables do provide, and it would be something that would be a
possibility, especially if we wanted to do this for a limited set of ones we
thought were most relevant, the detailed tables do provide kind row variables
of SES status, with race or ethnic groups. And the same thing for the SES
columns, you have the race and ethnic groups. So, it does break it up that way.

DR. STEINWACHS: To come back to I guess the thesis that many times people
see health care as fundamentally a local issue when you say how do you fix it,
Gene’s point. Is there a capacity to sort of answer the questions of how much
variation, sort of the small area variation issue, taking sort of Jack
Weinberg’s idea maybe into the quality or disparities arena. How big are the
small area variations on some of these measures, so people understand?

And I guess out of that too is to what extent can some of these measures
actually in local areas, drill down that far? And I know you mentioned moving
toward utilities that would allow states on some of the measures, to be able to
pull out. But is there also the possibility of major metropolitan areas and
other things to pull out at a more local level.

DR. KELLEY: Right, that’s an excellent point. A lot of the hearings on the
disparities report, there was quite a bit of testimony offered by folks on the
appropriate level for analysis, and should it just remain at the national
level, and a number of people speaking quite passionately that it should not.

For both the quality and disparities reports, the emphasis has been on the
national and state level, as I mentioned. And a number of the data sources do
offer us the ability to look at the kind of zip and smaller area variation. We
are actually looking quite extensively specifically for the quality report on
the amount of variation.

It’s been a fascinating discussion that we have in the interagency group
about we were looking at criteria for change. And you just have such different
sets of data, that you have to come up with some sort of criteria where HCUP
database, which has millions and millions of records, you could see
statistically significant change over time that is actually clinically,
probably very unimportant — not unimportant, but not very important I guess,
and very small.

So, we were talking about what really constitutes improvement in this area?
What constitutes change? And we did look across the entire — we looked at the
state level, to look at average change, and then change across all of the
measures and the spread between those. And so, this year’s report does
concentrate quite a bit on that change.

Most of it is at the state level, but we have started work on — again, I
think this is a perfect example of where the reports will do sort of the best
they can in this limited fashion, and AHRQ is working on derivative products
that could go into more depth on some of these things.

We have completed almost work on a resource guide and workbook for state
leaders, the first topic. We envision this as a series, the first topic of
which is diabetes, where we have good state information, and good information
from data sources that support zip code level analyses, looking at screening
for diabetes, as well as we would hope in the future, preventable

And the workbook kind of serves a lot of purposes. A lot of us sort of
believe that it’s a proven quality. Everyone would want to do that. Why
wouldn’t you want to spend money? But actually, not everyone thinks that. I’m
here to actually tell you that. But the front portion of the portion of the
book walks a state leader and those who support them on the importance of
improving quality in this particular topic area, and the impact it could
potentially have.

And then it goes through ways of comparing your state and different regions
within your state to the nation, to other states, and then within your state.
And then the workbook actually walks people through using some of the detailed
tables in the NHQR. And that’s a start.

Again, I think it’s mostly focused on the state level, and I think we need
to do a better job of looking at smaller areas. We have looked at a potential
companion product for employers that again would be — employers aren’t
necessarily interested in what is going on in the entire state, and frequently
their employees come from a tri-state region, and so they wouldn’t be
interested in smaller area analysis. And so, it’s a challenge, given the data
sources, but we are working on it.

DR. STEINWACHS: Just to throw out one little idea. The Robert Wood Johnson
Foundation has been investing for a while in the Center for Studying Health
System Change, which does develop data on a few geographic areas, plus a
sample. It would be a great, interesting sort of private-public thing here if
on those areas where there exists really good data from providers,
institutions, and other things in the community, if you want to look at some of
these indicators and say are there some best practices out there?

Because I think part of what you are pointing to is we have no way to
communicate best practices probably at the community level, because a lot of
that literature doesn’t exist in a research sense. But yet, there probably are
variations in these communities where some are doing better than others, and
you need that kind of information to go with your indicators.

DR. KELLEY: That’s a great point.

DR. LUMPKIN: We only have time for one more question, and Kevin was in


As health care folks, when we look at health disparities, and it’s just
natural to be thinking in terms of health care responses, access, and quality,
but I think as we all know, to actually eliminate health disparities, it will
take a much broader set of tools and solutions. A significant number of them
will be outside access and quality. These are necessary, but not sufficient

And we talked about the socioeconomic forces. But educational attainment in
particular seems to have a very robust relationship with health disparities,
and strikes me as an attractive lever to be pulling. And I think to the extent
that the report indicates that there is a broader set of tools and
interventions that must be applied outside of health care disciplines to
eliminate health disparities, then the report will have done a great service.

And I think to underscore the nature of the interdisciplinary attack that
is required, and the coordination of multiple federal agencies in eliminating
health disparities — I’m talking about the Department of Education and others
— and to develop the necessary data sets that cut across these disciplines to
get at causality, but then also to show improvement. And I think that would be
an important objective.

DR. KELLEY: That’s a great point, Kevin. I’m really glad you brought that
up, because I don’t think the report is doing a good job of talking about that.
It really focuses on not even — the mandate was to look at health care, and we
have gotten pushed in a lot of areas that say how are you different from
Healthy People 2010?

DR. VIGILANTE: Actually, I noticed that your purpose was not to improve
health, but your purpose was to improve health care. And ultimately of course,
one is just a means to the end.

DR. KELLEY: Right, exactly. I think that’s a great point. I plan on
bringing all of this back to the interagency work group, and we can work on
some of that language.

DR. LUMPKIN: Great. Thank you very much for coming in.

I’m just going to make one editorial comment, and then hopefully our next
speaker will be here. If you go back about six slides to your opportunities for
prevention, if you notice the differential between the white and the African
American rate, which is roughly 6 or 7 percent. But if you notice the adherence
to the guideline, which ought to be 100 percent, the rate of disparities is
really nothing compared to the fact that there is a huge quality issue.

And reducing the gap doesn’t even get us anywhere close to where the
quality care should be. So, keep up the good work, and thank you for coming.

DR. KELLEY: Thanks, John.

We talked about change, and in some areas we are seeing improvement in the
measure sets. This is leaking the 2004 report, but it doesn’t get you anywhere
if in a lot of cases the gap stays the same, if between groups the disparities
still exist. And John brings up the flip side that, which is you can be
shrinking the gaps, but overall no one is doing very well.

DR. LUMPKIN: David, welcome. Congratulations.

As you all know, on May 6, the secretary announced the response to the
president’s executive order in relationship to the identification of a
coordinator for health information technology. And as we learned last night in
the National Health Information Infrastructure Workgroup, that there is also
now created an Office of the National Coordinator for Health Information
Technology, of which none of us can pronounce the acronym, so I’m not going to
ask you to either.

Agenda Item: National Health Information Technology
(NHIT) – David Brailer, MD, PhD, NHIT Coordinator, DHHS

DR. BRAILER: Thank you. Thanks for having me. I will make only a few brief
comments, keeping my comments in proportion to my tenure here. When you have me
back in a few years they will be voluminous.

First, I just want to start, having watched NCVHS from the outside, just
thank you for your leadership. Clearly, this issue that I now am immersed in is
happening in large part, because of the leadership that this group has
expressed. And I know from prior reports that your work has led nearly directly
to the formation of this office, and to the work that we are about to
undertake. So, I guess I will say thank you, I think.

I’ll just quickly review the executive order and the context for how it is
that this came to be. John has already said, and you heard last night, and I’ll
try not to repeat that on April 27, Pres. Bush issued an executive order
following on his state of the union speech on this topic and other comments,
that called for a nationwide interoperable health information infrastructure
with EHR use for most Americans; something clearly that you have been calling
for, for a while, and helping figure out what the steps are to get there.

As part of that, this role of the national coordinator was created, and as
you know, on May 6 I was named in this role. We have several key functions, and
we are trying to get our arms around these right now. The first is to develop
and maintain a strategic plan. And that plan is really talking about how it is
that we use the assets of the federal government, and how we work with the
private sector, and to be as linear as possible in achieving the goal that has
been laid out.

The order also asks that I serve as the secretary’s principal advisor on
health information technology. This is a secretary who has a longstanding
commitment to this topic, who has a very broad and encompassing vision for
this. And I think so far my role as advisor has been playing catch up to him,
but I very much have been playing the role of steering some of the vision the
secretary has towards this plan.

We are charged with directing HHS health information technology programs.
And to that end, our primary task to date has been to catalogue the programs. I
think for the first time, we are getting a comprehensive view of all of the
different components of health information technology, not only in the
department, but in the other agencies that have some relationship to this plan.

We are charged with coordinating between executive branch agencies that are
related to health information technology. And specifically enumerated were two
things. One, to avoid duplication of effort, and secondly, to maintain a focus
among agencies on areas for which they “have experience and

And clearly, part of that is simply defining what it is that the term
“coordinate” means. There are many different forms of active to
passive coordination. And we are right now exploring what those range of
options are, and having dialogues with the agencies and the covered departments
in a way that we could determine what the best role we could provide from their
perspective, what the best role we could provide from other people’s
perspective, and how it is that the coordination role actually supplement,
enhances, and advances the work that the departments are doing, not replace,
slow down, or redirect.

Also, we are charged with coordinating outreach and consultation by
executive agencies, including commissions, et cetera, with public and private
organizations, consumers, payers, providers, administrators. I think that is a
clear charge to us to work closely with NCVHS, to work with other advisory
bodies such as the to be formed commission on systemic interoperability, and
others that may come to the fore in the future to make sure that what we do is
transparent, is supported, and results in a wide number of organizations and
participants supporting this goal.

Finally, we are to provide comment and advice on health information
technology and budgets at the request of OMB throughout the federal government.
And we in fact are already underway with that process within HHS. So, that
there is a very clear mechanism by which the coordination mechanisms, the
discussions, the findings of our work translate into spending and investments
that are made for the future.

The executive order also called on the agencies to do some particular
functions. It called on the Department of Health and Human Services to develop
a plan, and report on that plan for how it will use incentives and other
mechanisms to accelerate adoption of health information technology and health
information exchange.

It called on the Office of Personnel Management to explore how the federal
employees’ health plan and the purchasing power that it uses there can align
with private purchasers for the goal also of advancing adoption. And it also
called on the Department of Defense and the Department of Veterans Affairs to
explore how they could support technology transfer of their inventions or other
discoveries or work into the private sector, with a particular focus on
supporting rural and underserved areas, where we know there is a technology
adoption deficit.

Right now, we cover or are in discussions with nearly every agency in HHS.
Clearly, CMS, which has numerous internal and external activities going on
related to health information technology; the National Institutes of Health;
CDC; FDA; the Indian Health Service; AHRQ, SAMHSA; HRSA. I think the list is
quite complete given the importance of health information technology, and the
longstanding priorities for that here.

I have also mentioned DoD, the Veterans Affairs Department, and the Office
of Personnel Management. There are other federal agencies as well that have
information technology programs as an artifact of their missions, and we are
exploring what those are, and what they do, and how those pieces may fit

Our timing is aimed at a progress report on our strategic plan being
released on July 21; that is July 21, 2004, which is a month from now. We’ve
been on the job 30 days. I emphasize it is a progress report. I certainly don’t
think we will have the answers. I certainly hope we will have the questions,
and be able to at least have directionality, and have a sense of what the
principles are.

I think the goal is quite clear here. The assets are becoming clear, what
tools we have and don’t have. But I think the thing that is at least the
short-term focus for us is what are the rules of the road? How do we go about
doing this? What are the principles that we will follow to achieve the goal?
And from that, many tactical actions and specific programmatic objectives will
be identified.

In particular, the strategic plan has a few enumerated functions. It is to
identify public and private collaboration towards advancing the goal;
identifying technical, scientific, and economic barriers, and solutions for
addressing these; identifying the economic benefits and costs for health
information technology and health information exchange; and exploring privacy
and security issues, particularly aimed at deficit technologies such as
authorization, authentication, encryption, things that may actually be rate
limiting in the exploration of this topic.

That’s what we are doing. We are focusing on how to bring that forward. It
will be released at the July 21st day of the NHII conference. That day has been
designated as the Secretary’s Second Health Information Technology Summit,
following on the first, which was May 6. And it will be a discussion about what
has been learned, and where we are.

And it will then feed into the discussions that have been planned at the
NHII conference, which will be more action-oriented towards how do we go
forward, which will then flow into the July 23rd NCVHS-NHII Subcommittee
hearings on that topic.

I do look forward to working with NCVHS. Beyond the charge that we have, I
think what are doing is something that we should all be proud of, and has a
very important role in the future. At the minimum, we want to explore how to
coordinate the input at the meeting, and in the months beyond with your
processes, to make sure that they serve the needs of all the different sectors
that are involved in this, which is quite broad.

And secondly, perhaps following up on your 2001 report, in looking at where
lessons have been applied, and where lessons need to be updated to be
consistent with the changes that have swept this topic in the past several

I’m optimistic. I’m here because I’m optimistic about this. I know we have
a lot of work to do, and in the process of putting together a team of people,
relationships with agencies and departments, and a set of operating principles
that will add to this discussion, and try to make some real results that will
be lasting.

Thank you very much, and I look forward to answering your questions.

DR. LUMPKIN: Thank you.

Questions? Michael.

DR. FITZMAURICE: Dr. Brailer, in the executive order I see number five,
that you are not to assume or rely upon additional federal resources, or
spending to accomplish the adoption of interoperable health information
technology. Do you look upon that as a limiting factor in what you can
recommend for interoperability? Or could it involve a reprioritization of
things in the federal budget?

DR. BRAILER: Well, I certainly hope that when we’re done with what we are
doing, Mike, that we are not spending more on things that are covering health
information technology than we are now. Every industry and most health care
organizations that have invested in health information technology do so to
improve quality of service, customer service, and to be more efficient. So, I
hope that we are producing net savings to the industry as a result of this.

I think there are clearly cash flow issues about how do you make those
investments to reap the benefits, and over what time table there is. But I
think we shouldn’t do this without expecting to get those returns back.

I also think that investments that need to be made have to be shared across
various sectors of both public and private, depending on where the benefits
might group. And that concept of sharing the investment I think is essential to
being able to deal with this.

So, I guess in that sense I don’t see it as being limiting. I think we are
not prepared, even if that line item was not there, in order to simply say here
is how much it will take, and here is what we will do with the money, and here
is how it is going to directly and specifically lead to the results that we
want. And I think that is part of the goal that we have in near-term.

MR. HOUSTON: Just to ask one sort of clarifying question. You indicated
that you obviously want to try to balance the value versus the cost
appropriately across public and private. Also, I guess one of the key issues I
see is that it seems like the benefit may accrue to the insurers rather than
the providers in a lot of cases. Is that also what you are implying that also?

DR. BRAILER: Implying yes. I’ll state it specifically. I think that there
is a misalignment of national benefit and investment. And that has been known.
That’s been talked about by many parties. I see it at three tiers, at the
enterprise level, at the risk holder level, and then at the societal level.

At the enterprise level, because of how it is that health care is financed
in the United States, things that information technology does, i.e., improve
efficiency or reduce errors, results in probably negative changes to the
financial environment of most organizations. There are market factors that
could change that. There are just operating strategies that could change that.
But if we look at the broad main market, I think there have been very few
people that have disputed that.

On first principles, it seems that risk holders, i.e., plans other health
care financing entities, perhaps self-insured purchasers would accrue these
benefits. But again, I think there are factors in the market, the fragmentation
of plan coverage across populations, the turnover of patients across various
plans that could actually disperse those benefits in a way that they are not

And then thirdly at the societal level, there is a very macro equation of
how health care efficiency improvement changes the productivity, the
competitiveness of industries, the standard of living that translates into
productivity growth over the long-term. That has probably been the least
explored, but probably in a way the most important.

So, it’s those three factors that we are going to be looking at, and trying
to summarize where there is evidence, where there is not. Making sure that
research studies that are coming forward are addressing those, so we will have
the evidence, if we don’t have it today. And trying to develop a rational or
objective framework for how to think about the economics of this.

That is not to belittle the quality and the safety and the very human
dimension of this. But I think most elements of society are there, and it’s
this question of economics that are rate limiting in terms of how we go

DR. LUMPKIN: Let me pose perhaps what may be a somewhat more difficult
question to follow-up on a comment that you made. Our committee is charged
really to be the health information policy advisor to the secretary. And we are
charged as such by Congress.

During the HIPAA process our committee worked very closely with staff from
the agency to bring the comments of the outside world, those who are really
deeply affected by any potential HIPAA regulation. It was the place where that
discussion occurred, and recommendations, as required by the law, came forward
from our committee to the department.

Based upon our recommendations on patient medical record information, the
department changed its strategy through the consolidated health informatics
process to move from a mandated, to a leadership role in the area of data
standards. And we worked very closely as an advisory committee to help vet the
consolidated health informatics initiatives of various domains, and the
recommendations related to those domains.

I give that kind of long lead in to probe a little bit more on the issue of
working with this group. To what extent do you see, and do you see we can help
you in move forward what obviously we believe is a very important agenda and a
very important role; a role that obviously we have advocated for, for some
years? And how do you see us helping you move your agenda forward?

DR. BRAILER: If that was a hard question, I think I missed the subtle of
it, so thank you.

Well, first and foremost, this is a topic which now has moved from the
short list of long lists to the short list of short lists. And I think we all
know that. And those people like you, and people in the audience and myself,
who have believed in this topic for a long time, now have to go from being the
cheerleaders, to being very thoughtful and I think quite careful to make sure
that we deliver on the promises and the expectations that have been made. And
to that end, I think we need all the help we can get.

There are two factors. First, and this is partly my philosophy, but I think
to the extent that I am aware after 30 days on the job, the philosophy of this
administration, this is not something the government will do to or for the
private sector. Which means that most of the operational things that need to be
done are not contained in the walls of these beautiful buildings in Washington,
which means we need input and discussion and consensus from private

As we move from the phase we have been in, to a phase that is more action
oriented, there are going to be economic stakes for various organizations, and
I think we need to be careful to keep the policies and actions that we take
balanced. That they are acceptable. That they are fair.

And I think this body is a perfect body for being able to maintain, to
advance that dialogue, and that public purpose for this, particularly as we
think about how do we build some of the market institutions, some of the agents
and entities in the market that are needed to deliver this. For example, how
will interoperability be built, not on paper, but in reality? That requires I
think, a very careful tuning.

So, I see this body, and I don’t want to presume what an independent body
would want to do certainly, but I would hope that you would take a leadership
role in that, and help us think this through, help make us smarter about that.
Help make sure that as actions are taken, that there has been very careful

Secondly, I think there are pieces that go beyond what we do. For example,
we talked about economics. I think a very important step is to summarize and
evaluate what the economic truths are here. There have been many pieces of it,
but they haven’t been pulled together.

There are things, if you read the charge, that we have to do where there
are simply deficit technologies and infrastructure. That if we today, were to
invest substantially and heavily in this, I fear that we still have a high
point of care failure rate in terms of physicians trying to do this. We lack
some of the institutions that are necessary to look out for the interests of
consumers and physicians as they do this, et cetera.

And I think this is a separate role about how do you view the strategic
plan, and how do we gain reality and substance that hangs from the principles.
I see our plan being a living, breathing document. It’s not, at least as I
would view it, not going to sit on a shelf. It’s going to be continually
updated as events in the industry update. And I think this is a perfect

But I guess I would want to end this way, John, knowing you for a long
time, what did you have in mind?

DR. LUMPKIN: I will explicit what was implicit in my question. And that is
that as a committee, when we were charged by Congress to give advice on
e-prescribing, it became clear to us that there was interest by the secretary
to move that agenda, and move it very quickly. And so, what we have now finally
started to call Simon LeGreed, has set a committee agenda and schedule that is
accelerated and really quite aggressive going into the summer. And members of
the Standards and Security Committee are spending quite a bit of in August and
so forth, time when most of think about vacations, trying to get those
recommendations ready.

So, I think as you move forward, what would be useful for us is not only
thinking about where you are going with your strategic plan, but also the role
of the committee, but also the timeframes. And to the extent that we can get in
synch, we are willing to modify our schedules and agendas to move those items
forward to help you with process of vetting to help meet those timeframes,
within reason.

But I do remember getting up at the May 6th meeting and understanding that
I think the answer to the question when the secretary says can you do it four
months is yes.

DR. BRAILER: I’ve learned the answer yes. And just to respond to that, we
have a very binary world as we are trying to meet this delivery deadline, and
form an office, and develop relationships. We have divided the world into the
world between now and July 21st, and everything else. And clearly, there will
be many more subtle textures to the everything else.

But we are using the strategic planning process with the various agencies
to actually identify what some very macro timelines look like after that. We
are using to, if you would, essentially dialogue about what our role is with
respect to those agencies. What’s on the table and off the table, again,
setting very large boundaries.

So, this process I think between now and then will be very chaotic and very
noisy. We are barely able to execute as an office, but we have a very gungho
and excited group of people, and we are focused on the task. Nothing will
happen between now and then, except for preparing that and whatever process of
vetting and clearance, which will start in early July, I think will involve
whatever parties are supposed to be involved with that, and it’s not clear to
me yet who does that.

But I don’t imagine that the next day after, on July 26th, which would be
the Monday following your hearings, that other things would be done in the
absence of considering what we learned at that meeting, and where we go from

So, I think the most tangible way is for us to have whatever dialogues are
legitimate between now and the 21st, and then to plan to have other discussions
soon thereafter, so that what is learned from all of this, can be fed into a
process, and to make that part of the official record, also then to decide
where we go from there.

DR. STEUERLE: One thing that is in synch, and perhaps it’s already being
done is I noticed that your report, which you are now expected on July 21st, on
options to provide incentives in HHS programs is going to apparently come out,
or at least going to go to the secretary the same day we are going to be
meeting on the incentive issues at our NHII meeting.

So, I’m hopeful that whether you can formally let us know what those
options are, or informally, that we have some list of those that we actually
can put forward at that incentives meeting, and say here are some options. If
you don’t want to label them as your own, here are some options being
considered. And use us as a vehicle for getting some reaction right away,
rather than waiting a month or a year later.

Now, perhaps it’s already being planned, I don’t know, but it seems to me
to be an obvious area of coordination right up front.

DR. BRAILER: I think that’s a good idea. The plan currently is that there
will be a single master report including all the different agencies. Now, this
is walking the walk. If we are going to behave in an integrated way, we should
start by authoring an integrated report. And given the timeframes, that may be
all we can do on the 21st is to report on how we are moving towards that. The
full strategic plan I’m sure will be released sometime thereafter.

But the key parts of the incentives should be, at least the boundaries
should be put out in that timeframe. So, I will plead ignorance about what we
are allowed to do and not do between now and then, but we’ll find out. And
whatever we can guide input then, I think the sooner the better. We are trying
to take advantage of the interest in this topic while it’s here.

DR. STEUERLE: Let me be more direct. I am hopeful that in this incentives
subgroup or whatever we’re calling it, that we literally at times put forward
specific examples, what would happen if we did X, Y, and Z? Even if they are
off the wall, we could get a public reaction to whether these are directions
that might be moved. What happens if HHS does pay an extra $1 for a Medicare
prescription that meets certain minimal standards of reporting? Is that a good
incentive or not? I don’t know.

I’m hoping rather that speaking very generically about these things, we
actually have options that we put forward. So, to the extent that you get ideas
like this, whether they are good or bad, but at least that are worth vetting
somehow, use this vehicle to vet them.

DR. BRAILER: I appreciate the clarification. There have been a variety a
mechanisms that have identified specific incentive modalities. But I’m not
aware of a public vetting of those, so that the list can be shortened or can be
evaluated with respect to both the efficiency and the equity, the benefits it
creates or the disadvantages. So, that could be very useful.

I would find that very helpful, because to me, we have to take the economic
discussion up several notches to how does this fit within our context of
investment in other things that we have. How does this match the private
sector’s needs for investment, et cetera?

DR. LUMPKIN: Other questions?

DR. HARDING: Just listening to you, and trying to put myself in your shoes,
and I have to say that I am very impressed with the process that you are going
through, the time requirements that you have. But I’m also impressed with some
of the choices that you have made for people that you have surrounded yourself
with. Some of them have worked with committee in the past. I’m thinking of
Kathleen Fyffe and others. You’ve got some good people, and congratulations
that you chose them. I think they will serve you well, as they have us, and be
very helpful.

The point my introduction there was to ask about where you feel the issue
of privacy and security will start coming into the picture? This always seems
to be somewhat of a morass to get into that. It’s a difficult topic. And I just
wondered if you had any thought about that particular part of the whole

DR. BRAILER: Sure. Well, first, the topic is a morass, because society
chooses it to be that way, and I don’t think we will ever untangle it.
Necessarily, there is a conflict between the things that we could do to protect
all forms of privacy and confidentiality, and the things that we want to do to
deliver care to a human, to advance public health, to protect against other
forms of risk in our environment.

And so, this is one where at least as I view it, the only answer starts
with the following words, a carefully balanced trade off among these. And I see
HIPAA and its wanderings through various iterations of moving towards the
reality that it has, has found that careful balance. And so, I see that being
at least a model or a benchmark of how to address this, at least in terms of
federal policy in the rule of law.

But it goes beyond that. There are technology issues. How does that get
expressed? I do think we have lacking technology, or in a basic science sense
we have some technologies, but they are not affordable or usable in a way that
can allow us to perform the security and privacy operations that we would want
to do. And one of the things that we are looking at is how do we advance those
technologies so they become more cost effective, or more simply usable?

There are also, if you would, business framework questions about how do we
operationalize the rule of law when we talk about institutionalizing health
information exchange as a formal mechanism in the industry that is explicit, as
opposed to being implicit today with the paper movement?

So, I see ourselves advancing this without unraveling that carefully
orchestrated balance. And in doing that, we may find new areas where there are
deficits, or where we can’t go beyond a certain framework. As an officer of the
federal government I have sworn to uphold the law, and that law is one we will
uphold, but I don’t know where the boundaries of it are.

So, in my opinion privacy is first and foremost, because in the end the
trust that the Americans have in how we protect information will set the upper
limit of their acceptance of technologies that can be used to improve care. And
we, therefore, have to think about both of those.

I appreciate the question.


MR. BLAIR: Thank you for managing to get us on your schedule. I really
appreciate the opportunity to make a few comments and questions. One of them is
that you pointed out that there are a lot of different initiatives, and we did
a rough and dirty drafting of all of the different initiatives, whether they
are from the federal government, the private sector, from the standards
organizations, and there are a lot of folks that feel as if they are on the
path to being part of the National Health Information Infrastructure.

Yet, as you discuss what the National Health Information Infrastructure is
with each of them, not all of their concepts of what the NHII is, is exactly
the same.

When the NCVHS pulled together our recommendations for the NHII, we really
were at the level of a vision. We didn’t go beyond the level of a vision. It
probably wasn’t appropriate for us to do that. But as of now, the vision that
the NCVHS set forth is ambiguous, and many people feel as if what they are
doing can be accommodated by that.

The concern that I have is that as we develop the strategic plan, it is
clear that we do have to engage a lot of these groups that will be part of
that. And you have already indicated that you are doing that. And that will be
very helpful, and we will be able to put forth what we can do realistically
within the next year or two or three, because it’s an extension of what is
being done today, and it’s addressing near-term needs.

The concern that I have is that in addition to that, a lot of hard work
needs to be done getting a better definition or models of what we want the NHII
to be 7-10 years from now, because in this next year or two, we are already
going to wind up looking for demonstration projects.

And if we are going to wind up choosing which of the initiatives would be
getting federal money for demonstration projects, and if we don’t have a better
idea of whether or not the initiatives are going to converge to that better
definition of an NHII for 7-10 years from now, I’m very concerned that we may
wind up funding initiatives that are not on the convergence paths.

And I did that as plural paths, because I don’t think that there is one
path. I think there are many different initiative today that don’t necessarily
connect, but that’s okay. But they need to connect 7-10 years from now. And all
they all offer different values, and they contribute in different ways.

So, maybe the thing that I would ask and encourage is that at the same time
that we are working forward on defining what can be done and what needs to be
done for the next 2-3 years, we also put a priority on what I think of as a set
of models to help us define the NHII for 7-10 years from now, so that we know
that there is a multiple paths of convergence as to where we need to go.

DR. BRAILER: Thanks, Jeff. I appreciate both the insightful comments, and
the question, which as you usual from you, cuts to the very heart of the key
issue. And this is one that I have worried about a lot.

I’ll take it one level higher, which is I read into your question what is
the federal role? And this really became very clear to me earlier this week
when I spent time with Anthony Nolan, who was the architect and designer of the
British National Health Service’s NHII.

And after listening to him talk and describe what they did, I said to
myself, oh, isn’t it easier to solve the problem of fragmentation in an
unfragmented delivery system? And woe to those who try to solve fragmentation
when we are starting with fragmentation, because this gets to the issue of
whether or not there is such a thing as a top-down model. Or to the extent that
the top will set boundaries and rules that will allow various organic or
bottom-up processes to flow.

My complexity theorist friends point out constantly that there is only a
certain amount of domain control that the top can exercise in an independent
set of unaligned systems, yet the very archetype of what we are creating is the
opposite of that. And so it really sets a conundrum.

And I am struck by a few things. First, we spent a large amount of time
discussing both as individuals and as a society, what the macro models of
health information exchange are. And I have started at a different point. I
want to use a slightly different lens to help keep me focused, which is I’m
starting at a micro level, which is what happens when a physician sees a
patient, or a patient engages in care.

Because you know what’s interesting to me is that is so similar and
constant even across nations, let alone across the various settings. And in a
way, it becomes a touchpoint for us to think about a different way with this,
which is how much variation around the macro factors, the technology factors,
the business policies, the rules of law, the behavior of the actors in a market
do we even care about? And where are the boundaries that we don’t want to

And I say this because I view this at this point, and this is one month
into it, and I will reserve the right to come back and contradict myself at any
point, including five minutes from now, that this is almost definitionally a
somewhat organic process. We don’t know what we don’t know about this yet. And
we want to be, I think somewhat experimental without being harmful.

And what I mean very particularly is that if you look at the diversity of
health care markets, if you look at the diversity of financial forms, the types
of relationships among doctors with each other, doctors with hospitals, doctors
with plans, any of those with patients, they are almost necessarily going to be
a variety of different macro models that organize the business authority or the
technical organization of health information exchange.

And to some degree, my thinking today is that we want to betroth that
within some degree of variation, and not espouse the concept of there will be
the NHII, but there will be a set of ranges or boundaries around that that
could exist in different ways.

Separate and apart from that is well, what is the common denominator that
we have to minimally pull together to support these, to take away something
which could be problematic for all? For example, these technology barriers like
how do we handle some security issues? I don’t think regional or state-based
exchanges have the wherewithal to do research and development, and bring to
market, but perhaps as a nation we do.

And so find that least common denominator in part of a federal role, either
through the federal government or through the private sector is to provide
that, so that these enablers are in place. And in the end, I think we want to
think about ourselves as what actions does the federal government take? Because
the federal government is a major purchaser and deliverer of care, and a
financier of care, which are within the bounds of law and reason that the
federal government should take.

Secondly, what are the actions that the private sector could take which are
within the bounds of law, which are within their proprietary or public
interest? And the really complicated part is not both of those, it’s the
middle, which is what are the public/private actions where we need to cooperate
together? Where we can’t rely on private commerce to deliver the things that we
need. Or the federal government doesn’t have the reach or touch, or the ability
to manifest that.

And that is I think, in the essence of your question, because those are
very complicated. They are relatively new in this arena of health information
technology. We’re actually exploring where they have been used in other parts
of the government. And I’m hoping that we can learn lessons from there and
bring back.

So, this is a topic where my answer can only be this is a line of thinking,
as opposed to an answer, and I appreciate your bringing it up.

DR. LUMPKIN: David, I think we have run out of time. We really appreciate
that one of your early acts as the CHIT, the coordinator, is coming to visit
with us.

DR. BRAILER: Thank you for having me.

DR. LUMPKIN: We’re looking forward to a long and fruitful partnership. We
are here to serve and to help move the agenda forward in the best way that we
can. And we appreciate the fact that someone of your skill, experience, and
personality, and sense of humor has come to work with us on this topic. And
once again, congratulations, and thank you for coming.

DR. BRAILER: Thank you, and thank each of you again.

DR. LUMPKIN: At this time we are going to take a short break for lunch. We
come back at one o’clock. Dr. McClellan will be here, the CMS administrator. He
is going to be on a very short time schedule, so we all need to be back here
exactly by one o’clock.

[Whereupon, the meeting was recessed for lunch at 12:35 pm, to reconvene at
1:00 pm.]

O N (1:13 pm)

DR. LUMPKIN: Well, good afternoon. We will start the afternoon session with
the good fortunate of having Dr. McClellan here, who is the Administrator for
the Centers for Medicare and Medicaid Services. Many of us were thrilled to see
Mark move over from FDA. FDA’s loss, but particularly someone who has had a
longstanding interest in the areas and issues that we are concerned about in
health informatics.

As soon as he got over there, Congress came around with some small change
to the process called the Medicaid Modernization Act, which certainly has
caused him to have a certain amount of his agenda focused on that. So, we are
really thrilled that you could spend some minutes with us, and share your
insight of where you see it going.

Just so you know, some of our work as we were charged by MMA to be involved
e-prescribing. And Simon Cohn, who chairs up the subcommittee, and Jeff Blair,
who has the lead on that, has now gotten a nickname of Simon LeGreed for the
number of hearings that have been scheduled between now in the fall in order to
give recommendations to the department to fit your accelerated timeframe. So,
we continue that partnership, and certainly look forward to hearing your

Thank you for coming.

Agenda Item: Medicare Modernization Reform Act and
CMS Quality Initiatives Review – Dr. Mark McClellan, CMS

DR. MC CLELLAN: John, thank you very much, and thanks to all of you for the
tremendous work that you do not only on behalf of the country, but with the
Medicare and Medicaid programs in particular.

I haven’t been at the agency that long, but I know how important you are
for our work on measuring how we are doing in terms of quality of care and
health of the beneficiaries that we treat, and of all Americans, because we
have such an important role to play in the health care of this country, of
improving the quality of care that our beneficiaries and that all Americans
receive. Your leadership there had really helped us tremendously.

And as John just mentioned, I think we are going to be taking this kind of
collaboration/interaction to a new level as a result of the Medicare
Modernization Act, which includes a very important direct role for NCVHS in
bringing along e-prescribing as quickly as possible, which as I’m sure you know
is a top priority for all of us in the department, the president, as well as
the secretary, David Brailer, who I think you heard from this morning, and me
at CMS. I want to talk about that a little bit more in a few minutes.

So, I hope that this discussion will be just a reinforcement of all the
great work that is going on, our representation in NCVHS, and your strong
commitment to issues like disparity, addressing disparities, and improving
quality, and improving the health of our population.

Obviously, one of the main things on my mind right now is the
implementation of the Medicare Modernization Act. I want to just briefly
highlight a few aspects of this legislation. People appropriately are focusing
a lot on our implementation of the drug benefit effectively, and on our moving
from just talking about helping seniors with their drug costs to actually doing
something about it.

And we’ve got a drug card program in place right now that has over 3
million people, I think close to 3.4 million people enrolled out of a projected
enrollment that people thought we would get to by the end of the program of
about 7 million. So, there are a lot of people signing up.

Already many people already getting savings on their drugs, not only
through discounts that are made possible by getting seniors banded together and
giving them an unprecedented amount of information on the actual prices that
they are paying for their medicines, so they can really comparison shop,
something that hasn’t happened for prescription drugs, especially at
neighborhood pharmacies.

But also some additional help for low income beneficiaries, a $600 credit
this year and next year, some wrap around very large discounts from eight major
drug manufacturers now. Pfizer just expanded their program to include basically
any willing card that wants to pass on the very prices to the beneficiaries.

So, for low income beneficiaries who have been struggling with drug costs
on the one hand, costs of other basic necessities on the other, this is
literally thousands of dollars of help right now that we want to get out there,
and start having impact on the health of these needy Medicare beneficiaries.
Millions who are below the income limits for qualifying for this program, and
who are getting very little help with their drug costs now, can get literally
thousands of dollars in assistance.

So, the drug card, the drug benefit have gotten a lot of the attention, but
I want to spend a couple of minutes before just having an open discussion,
talking about several other provisions that are very important in the
legislation as well, and I think particularly important for our interactions
with NCVHS.

We are at a time in medicine now that I think is unique. And coming from
the FDA, I feel like I’ve got a little bit of a special perspective on it.
There are more new products in development than ever before. New sciences like
genomics, proteomics, nanotechnology, which you read about a lot in the papers,
yet actually have had very little impact to date on the care that patients
receive. Those technologies, those ideas haven’t been turned into safe and
effective approved treatments yet, but they are getting closer.

So, we’ve got the potential for better health, more individualized, better
understood management of diseases, and prevention of diseases in patients than
ever before. But if we are going to find ways to bring all of this increasingly
complex, increasingly personalized medicine to bear at a cost that we all can
afford, we’ve got to change the way that we do things.

And electronic prescribing is an important part of that, as are other
elements of this legislation that I think relate very closely to things that
NCVHS works on. I’ll start out by talking about electronic prescribing, because
as John mentioned, you all are absolutely critical in the implementation of

The law, as you know, contemplates the role of NCVHS in developing
standards, and hopefully helping us implement pilot programs that would lead to
widespread adoption of e-prescribing, and adoption of the e-prescribing
standards in 2008 and 2009. As you may have heard from David, and as I hear
repeatedly from the president and the secretary, we want to do it much faster
than that. We think we can.

From the many meetings that you all are holding, it’s clear that there are
some good ideas out there on how we can implement e-prescribing effectively.
Some common sense steps as making it easier for doctors and other health
professionals to use. There are e-prescribing programs in place now in Medicaid
programs and the in the private sector that are working, that are acceptable to
providers, and that actually lead to higher quality care and lower costs.

So, we need to figure out how we can get that adopted more widely. We are
going to have regulations out on our proposed — proposed regulations for the
drug benefits soon. Electronic prescribing will figure prominently in that, and
how we can accelerate the pace. So, anything we can do to work with you to
identify standards where there is consensus. And not wait for the statutory
deadline, but get them in place beforehand.

Identify pilot programs that can work. And then implement our regulations
in a way that supports those kinds of electronic prescribing activities well
before 2008, I think is a great way for us to improve quality and reduce the
cost of this benefit, while giving people access to the medicines that they
need. Giving them better information at the time that they are choosing their
prescriptions, so they can get better, higher quality care without errors, and
meeting their drug needs at the lowest possible cost.

So, we will continue to put a lot of effort into our work with NCVHS on
standards development. And again, I hope you all will work closely with us on
the other components of this program, like identifying pilot programs that
work, like building in these approaches to our proposed and final regulations
this year, so that we can get to a substantial amount of e-prescribing as soon
as 2006.

I want to mention another area where I think NCVHS can be very helpful, and
that is in our movement towards providing better information on quality, and
using information on quality to influence our payments, and hopefully to
provide stronger incentives to get to improvements in population health.

One program that I would like to highlight here quickly is in the area of
Section 721 of the law, which was the Chronic Care Improvement Program. Some of
you may be familiar with this. I think a lot of you are familiar with some of
the other programs in quality reporting that CMS is doing now.

We’re, as a result of the law, going to be paying more to hospitals
starting next year if they report on 10 validated quality of care measures. And
we’re going to expanding that significantly next year to include additional
quality measures, to include patient satisfaction measures too — validated
patient satisfaction measures.

But beyond that, the 721 program is another example of how we are moving by
actual payments to quality improvement. The way that this pilot program is
going to work — it’s a pilot program and not a demonstration, which we intend
to take fully national in a fee-for-service Medicare program — is that we now
have a request for proposals out to entities that want to assist beneficiaries
in the fee-for-service program who have costly chronic illnesses, in particular
heart failure, complex diabetes, and chronic obstructive pulmonary disease, to
assist them in getting better care at a lower cost, and achieving better
outcomes at a lower cost.

What we envision these entities doing is adopting some proven steps in
disease and care management. These are programs focused on the whole patient,
not just the one illness that the patient might have. Steps like educating
patients about their illness, and about the contributions of their medicines to

There is a lot of evidence that when patients understand — patients with
diabetes or other conditions understand how their disease works, the basics of
how it works, and what the medicines do, what the tests and compliance steps
that they need to take mean, we can get better compliance.

The programs also I think will help patients monitor for complications
sooner and more quickly, so they can not only stay out of the hospital, but
hopefully stay out of the doctor’s office as well.

Now, in our current fee-for-service program, our payments aren’t very well
designed to encourage those kinds of steps, even though they are proven, even
though they work to lower costs and improve patient outcomes. We pay more for
more admissions to the hospital, more visits to the doctor, with more
complications. That’s going to change.

These entities who bid in this program, and get selected to participate in
this program will only be paid if they do several things at the same time. One
is reduce overall costs, and we’re aiming for a 5 percent reduction in total
Medicare costs for the patients who are in these demonstration programs.

A second requirement is improvements in clinical outcomes. So, improvements
for example for diabetes patients in their glucose controls, maybe as reflected
in a hemoglobin A1c levels and the like, similar kinds of good, basic,
validated quality and outcome measures for the other conditions.

And third, improvements in patient and provider satisfaction. From the
patient standpoint, did they find the program helpful? From the provider
standpoint, did it help the patient follow the plan of care that the provider
had developed? It’s not something that is going to happen in isolation for the
providers in order to succeed. These programs have to work effectively with
what the doctors and the health professionals think is best for that individual

And we are going to be evaluating this in a very large scale randomized
trial, basically. We’re going to have up to 300,000 patients enrolled in this
pilot program. We’re going to augment the data that we routinely collect in
Medicare, and should be using more than we are, and will be using more than we
are to help assess quality and cost, what we’re getting for our spending. We’re
going to augment that with some of the additional simple clinical measures.

And we think we can get this whole study done for 300,000 patients on a
population-basis in 10 regions of the country for the single digit millions or
so, not a tremendous amount of cost when it comes to doing large scale clinical

I think this kind of model is important in itself for several reasons. This
is an area where we are spending a lot of money, and not getting as good
outcomes as I would like to see. It’s also an area where we can really
implement on a fairly large scale, our payment for improving performance system
in the fee-for-service Medicare program.

And third, it’s a way for us to start moving to better use of the data that
we collect now, and augmentation of that data so we can really see what’s
working and what’s not, and where the opportunities for improvement are in the
care that we are providing, and the quality of the outcomes that we receive,
and the cost of that care.

So, this kind of model, I think you will see us trying to apply in other
settings as well. Now, obviously, the fee-for-service Medicare isn’t
everything. We’ve got an expanded Medicare Advantage Program too as part of the
new Medicare law. And in those cases as well, we’re going to be expanding our
quality measures, and helping patients to choose providers based on the quality
of care, and then plans based on the quality of care that they provide.

These are all areas where I think we can use the input and assistance from
the NCVHS on validated measures of health outcomes, on tracking the outcomes of
our populations, and seeing what kind of interventions like these are actually
helping in improving the quality of care and reducing the costs of care.

It’s really kind of a new, more prevention-focused and performance-focused
approach to many aspects of the Medicare program whose time has come. And I
think that by working together we can make the most out of these new
approaches, which are made possible by the Medicare law, to get more for our
money, and to get more for our patients, better quality and better outcomes for
a lower cost.

So that when all these new treatments continue to come along, we will have
a system that better supports, an environment that better supports using them
effectively, where they actually can improve patient care.

So, there are lots of new opportunities under the new Medicare law. It’s a
very challenging one. These are going to be hard to implement effectively, in a
way that doesn’t disrupt existing care, but that’s definitely our goal, to add
this on to the current programs, and do it in a way that providers and patients
can find effective, and can support easily.

And that’s why we need help. And I think the work that you all are doing in
areas like e-prescribing is tremendous. And I hope we can continue to work
closely as well on these other areas of measuring quality and assessing the
performance of our health care system through assessing its most important
impact, and that is its impact on the health outcomes of our beneficiaries.

So, I want to conclude just by thanking you for all the work that we’re
already doing together, and by challenging you to work with us on a new set of
initiatives made possible by the new Medicare modernization act.

DR. LUMPKIN: Well, thank you very much for that quick run down. I also
wanted to thank you for assigning Judith Berek to work with us. She has served
well in helping to coordinate the staffing that has come from CMS. So, thank
you very much on that regard.


DR. LENGERICH: We heard earlier this morning about the health care
disparities report, and I was wondering if your pilot programs would
particularly target or use that as part of the criteria as how they get
selected, whether it be race, ethnicity, socioeconomic position, geographic
location, rural, urban, if there would be a variety?

DR. MC CLELLAN: Absolutely, those are considerations. I should have
clarified that these chronic care improvement programs are required to be
population-based. So, what we intend to do is for the programs that are
selected to participate, there are going to be up to 10 around the country, as
they get a geographic region that they basically bid on. And we look at the
overall outcomes for the population of patients with these conditions in that

So, we are not focusing in on a select group of beneficiaries that that
program wants to target in this area. They can’t just pick and choose. They
need to focus, and they only get paid if they improve overall health outcomes
and help reduce overall costs. And we will definitely be including urban-rural
type patients in this program.

We will definitely be paying attention to impacts in some of the more
vulnerable populations, patients with multiple chronic illnesses, lower income
patients, patients with cognitive impairments who often have these conditions,
and of course patients from minority populations.

DR. VIGILANTE: Is there a vision for — of course we are all focused very
sharply on adoption of electronic health records by physicians, and sort of
realigning those incentives so the market creates an environment in which
adoption will proceed more quickly. Is there a vision for CMS in playing a role
in sort of equalizing those incentives or aligning those incentives, either on
a programmatic basis or even on a pilot or demonstration basis?

DR. MC CLELLAN: Yes, there is. I think the big picture, long-term I think
the kinds of steps that I described towards moving towards payment for
performance is going to get there, because these information systems do lead to
better outcomes at a lower cost. And if we have payments that reflect that
goal, I think IT systems and other changes in care, that get better outcomes at
a lower cost will be better supported by our programs.

In the shorter run, also in the Medicare Modernization Act there is a new
demonstration program set up for exactly these kinds of incentives,
particularly focusing on physician offices. So, Section 649, a so-called
demonstration is going to apply financial incentives to demonstration set of
physician practices in four states where we will be paying, we will have
financial incentives for adopting health IT.

I think it’s also important again, not just to focus on IT for its own
sake, but for its connection to improved outcomes. So, we are looking at ways
of incorporating both of those kinds of financial incentives. Incentives for
adopting IT capabilities that meet certain performance standards, as well as
using those systems to actually improve the care of patients that the
physicians are treating.

But that’s a demonstration program that is in process right now that we are
working on extensively through our QIOs, and in close collaboration with the
David Brailer and the new health IT coordinator office. And we’ll hopefully
have results very soon.

As you know, there’s a lot of interest in how quickly these kinds of ideas
can be applied more nationally, and not just on a demonstration basis. And one
of David’s top priorities is to try to answer that question. So, we are working
very closely with him on it.

From the hospital standpoint, I think as we keep moving towards the
development and use of a broader set of validated quality measures, and get
people focused on those for choosing their care, that basically is going to
help drive IT adoption as well. You can’t achieve I think good best level
performance on standards of care for heart attack, for pneumonia, for
preventing infections unless you are supported by a viable and effective IT
system too. But we’ll be doing what we can as well to improve the financial
incentives in hospitals.

DR. VIGILANTE: I often thought it would be interesting to select out the
upper decile of say Weinberg’s highest spending HSAs to make that kind of
dimension, to see what could be produced.

DR. MC CLELLAN: We have been talking to Jack and some of his colleagues
about that kind of idea. There is a lot known about variations across areas,
thanks in part to Dr. Weinberg’s work and many people who followed after him.
What I think is a little bit harder is how you move areas from very high costs
and no better outcomes to lower costs and better outcomes.

What are the specific steps? It’s not the variation is there, but what
exactly can we do? What are proven steps that we can take to address it? And we
have been having a lot of discussions with Dr. Weinberg, with other academic
experts about that. I think it would be a good topic for more public discussion
soon as well, and I think it would fit in with the same kinds of themes we have
just been discussing.

DR. COHN: Mark, first of all, thanks for joining us.

I have been responsible for a lot of the e-prescribing, along with Jeff —

DR. MC CLELLAN: And thank you.

DR. COHN: I actually wanted to first of all, just acknowledge two of your
staff who have really been critical in terms of moving us forward, both Karen
Trudel and Maria Friedman. And we would not be making I think the rapid
progress we are without them.

DR. MC CLELLAN: You’re absolutely right.

DR. COHN: Now, you had mentioned I think the desire to obviously both
accelerate the standards, but also accelerate the implementations. And I’m just
curious about if you have thoughts about really how we can get e-prescribing
out and implemented more quickly. Obviously, standards are a piece, but it’s
really this issue of pilots which in legislation don’t occur until 2006.

DR. MC CLELLAN: Well, they can occur sooner. It doesn’t say we can’t do it
sooner. Give us the standards. And in all seriousness, there are a number of
what you could call pilot programs out there now that are influencing care. I
have had an opportunity to hear a lot about what the Florida Medicaid Program
is doing for example.

And the heavy prescribing Medicaid doctors in Florida now have palm devices
that can not only connect up with a patient’s medication records, but also with
the state’s formularies, can handle off-formulary appeals automatically. And
that has already in the state, helped them improve care by addressing
polypharmacy issues, and better coordinating medication use.

It has helped them reduce fraud in the program. There is some diversion in
many Medicaid programs of medicines from their intended us to others uses. It’s
helped them reduce costs and enforce the law that way.

These program actually work, and there are other private sector systems, GM
is working on some in Michigan, that are around now. And I would like to do
what we can quickly to catalogue these pilots, look at what their main features
are, and see if there are some that could be good models for broader use of
e-prescribing in the Medicare program.

Remember that we do have an opportunity to push in this direction through
the implementation of the drug benefit. We are going to address the issue of
e-prescribing in our proposed regulation for the drug benefit that will be
coming out very soon. And we’ll be looking forward to comments at that point. I
hope all of you will weigh in heavily on how we can design the drug benefit to
support effective e-prescribing sooner, to hopefully provide incentives for
earlier adoption.

So, that seems like a major way to try to get e-prescribing done sooner,
but we do need those standards, and we do need models of what actually works.

DR. STEINWACHS: Simon is doing the tough work around here. Some of the rest
of us are trying to pick on other pieces, and I wanted to get your reaction and
thoughts. In order to do pay-for-performance, the pilot you are talking about
in chronic disease management, there needs to be a flow of all the quality of
care data coming through. And certainly under HIPAA and HIPAA transactions
right now there is not something that sort of looks like a quality transaction
that would carry that data and maybe append it.

I was wondering if you had some thoughts about using the transaction
system, or for the claims system to move that information that is necessary for
looking at quality routinely, or whether there are other strategies that ought
to be thought about and explored?

DR. MC CLELLAN: Good question. I actually would appreciate the views from
this committee on that, either now or subsequently. But I think the claims
system can be helpful in addressing quality issues. Cost is certainly one
dimension of quality if care is not being delivered efficiently and affects
unnecessary utilization.

Claims data can also be helpful for monitoring various types of
complications, admissions to hospital with eventually preventable diabetes
complications. AHRQ has done a lot of good work in recent years on getting
those measures developed and used at the state level, and maybe we can
contribute to that too.

I don’t think it’s the whole answer, because there are just other aspects
of quality that we don’t capture in our claims data. And that’s why in this
Chronic Care Improvement Program we are doing some targeted additional data
collection through a contractor. And we are trying to find the most efficient
ways to add in critical, validated, clinical information that can augment what
we can do through claims data alone.

The other challenge in all this process is exactly what was said with
HIPAA, is that we are going to be compliant with all of the necessary and all
the essential privacy and confidentiality standards in hailing this kind of
information. And that means this is not just a simple thing that we can jump
into. We have to set up data systems that can be used for quality assessment,
quality improvement purposes, but in a way that doesn’t compromise patient
confidentiality or the sensitivity of some of the underlying information.

I think there are ways to do that. We’re working on them now, but it is
another part of the challenge here. But I think the answer to your question I
think is definitely, but along the way we need to recognize the limitations of
the claims data. And we need to make sure we are handling it in a way that
fully respects patient confidentiality and the security of the data.

DR. STEINWACHS: Just a small piece I guess. One of the thoughts had been
for instance that you might have a way to transmit laboratory results through a
claims system, which we can’t now. We trying to look at some of those ways to
modestly expand administrative data so that that would be one vehicle,
recognizing that’s not the end all.

DR. MC CLELLAN: That’s right. It is a way of sort of getting back to the
goal of developing better evidence on what works, to do that at a much lower
cost. Right now, when a major clinical trial is done, it’s basically a one off
approach. You have to kind of start from scratch of setting up a system to
abstract data from charts, or call around the labs or what have you, and it can
be very costly.

One good example that I would like to talk about is the ALHAT(?) study,
which was tremendously useful for learning about the effectiveness of different
approaches to managing hypertension. However, it took a lot of years. It cost
over $125 million. And at that clip, we can’t afford to develop very much new

On the other hand, if there are lower cost ways for us to build on our
existing systems, and capture data that might be useful for other purposes, and
can also create an infrastructure for doing these kinds of large scale
effectiveness studies, I think there is a lot more potential.

And we’re going to try that out with this Chronic Care Improvement Program.
We have also started a new partnership with the National Cancer Institute. They
have developed a very impressive cancer bioinformatics grid. Soon it will
encompass all of their cancer clinical trial network. They have focused in the
past on studies of treatments that are still in development, prior to FDA

But the same system, especially if we can integrate it with some of the
data that we have from claims, can be useful for doing postmarket studies of
approved treatments, where we might want to know more about how they work, and
minorities populations in the elderly with co-morbid conditions, where they
haven’t been tested as extensively. If we can find ways to do all that at a
lower cost, it would be really helpful.

And just yesterday we announced a new cover decision for PET and
Alzheimer’s disease, positron emission tomography, which has some considerable
promise, but where the evidence is not very compelling yet for many types — at
least the experts we talked to, and we talked to a lot of experts — it’s not
very compelling in general yet as appropriate treatment for early stage
cognitive impairment and possible Alzheimer’s disease. There are some narrow
indications where the evidence was more compelling.

So, what we want to do to try and fill in that gap is we’re going to work
with the National Institute on Aging, Alzheimer’s Association, and other groups
to get a large clinical trial done of the effectiveness of this technology for
potentially broader use in diagnosis and management of early Alzheimer’s

We’re going to pay the clinical cost of that trial. We are going to try to
contribute to the data collection at a lower cost. We’ve got to partner with
other organizations to actually conduct the research. But it’s another example
of ways where I think we can develop better evidence at a lower cost than
people have thought possible in the past. But more steps like that I think are
really essential, and now is the time to do it.

MR. HUNGATE: I want to applaud the approach. And I want to thank you for
having Trent Haywood participate with the Quality Workgroup.

DR. MC CLELLAN: He’s great.

MR. HUNGATE: He’s great. We’re going to use his knowledge a lot in moving

You mentioned in your comments outcomes a lot of time. This committee knows
how much I like that word. I won’t belabor it. But I wonder what your
confidence is in the level of the validity of measures of outcome?

DR. MC CLELLAN: It varies. I think there are some outcome measures that are
much better validated than others. I think for a lot of them there are still
question marks. That’s why a lot of the quality measures that we’re focusing on
now are process-oriented, where you discharge on beta blockers after AIM if you
had a proper work up for your heart failure, things like that.

But outcomes are what we really care about. And a lot of my own research
before coming into government was focused on exactly this question, how can we
reach valid conclusions from data on outcomes, and either randomized studies,
or in observational data collection on our patient population.

It’s a tough problem, but I think we are making a lot of technical
progress. And I think there are outcome measures that have been validated, so
they are acceptable to the health experts, and can be used as part of this
overall process of quality measurement, and then potentially in

I think I’m going to have to leave after one more question.

DR. STEUERLE: I’d like to invite you to use this committee to get
information you might have a little more trouble gathering if came up directly
from CMS. I’m particularly thinking about the incentives, which I care a lot
about. If you announced some proposed regulation, or even some trial study that
might have some negative impact on some providers, it might make some headlines
in ways that it wouldn’t if our — for instance we have this meeting coming up
on NHII.

We’re going to have a meeting on incentives. And I’ve been struggling, like
a lot of people, with the different incentives. Maybe there are different
incentive payments you could make to states or providers. Maybe it’s nothing
more than you would pay 50 cents more to a doctor’s office that kept electronic
records, even without standards. That might be enough of an improvement just
for your own compliance efforts.

But you may not to announce that, or some might even be a decrease in
payments for those who don’t have electronic records. But I would like very
much to be able to put these types of examples before a public audience. So, as
opposed to my speaking off the top of my head, we could actually put it before
a very informed public.

DR. MC CLELLAN: Have some structured public discussion.

DR. STEUERLE: That’s right. And I just hope that you will think about ways
to use our committee to help you. And even some ones that you might not think
are good ideas, are high risk, but they have high potential, if you could think
about ways of using us.

DR. MC CLELLAN: I will do that. We will definitely take you up on that. I’m
certainly looking for all the help we can get, especially in areas of sensitive
decisions like the payment rate. So, NCVHS’s help on this will be appreciated.

But again, in all seriousness, I think you all are doing terrific work. Our
staff have worked with you. They are all great on our end, but the
collaboration is helping us do our job much more effectively at a critical time
for the agency, at a time when we are facing some unprecedented challenges, but
some really wonderful opportunities to improve care in this country. And I’ll
look forward to continuing a close collaboration.

Thank you very much.

Agenda Item: Reports from Subcommittees and
Workgroups – Executive Subcommittee – Dr. Lumpkin

DR. LUMPKIN: Okay, we’re actually a little bit ahead of schedule. Let’s
move on to the reports from subcommittees and workgroups. We’ll start off with
the Executive Subcommittee.

I don’t think we have anything to report other than we do have a retreat
scheduled on August 6 in Princeton, New Jersey, a venue that we are returning
to since last year, the garden spot of the garden state.

As usual at these retreats we’ll be discussing some of the functions and
working of the committee, and planning for the oncoming year, and trying to
coordinate the various activities.

We talked about the NHII Workgroup, so standards and security.

Agenda Item: Reports from Subcommittees and
Workgroups – Subcommittee on Standards and Security – Dr. Cohn

DR. COHN: I think you have probably pretty much heard about what we are
doing. We have meetings coming up, a three day session on e-prescribing, July
28-30; and then again August 17-19. We are hoping that we will have some early
recommendations to share with the full committee in September, and hopefully
with additional information coming up after that.

MR. BLAIR: We’re also praying a lot.

DR. COHN: I just want to thank the subcommittee members for hanging in

DR. LUMPKIN: I was wondering if perhaps you or Jeff might just a couple of
minutes. This is going to be our last opportunity before September, if you
might just sort of put the members of the committee in the frame of mind, for
which if you bring something in September, we might actually be able to make a

DR. COHN: Jeff, do you want to lead off on that one?

MR. BLAIR: Sure.

DR. LUMPKIN: What is this e-prescribing stuff? Isn’t it just NCPDP? Didn’t
we do that part already?

MR. BLAIR: I think that this is what John is alluding to, and if I’m off
the mark, then guide me a little more in terms of the information to share. Our
subcommittee has never produced recommendations on a schedule that is this
fast. And let me give you a little bit of the thinking that Simon and I and the
rest of the subcommittee members and the staff have, at least at this moment.
Because we are having to respond to realities as we engage them.

We have had an outstanding start, and we have had testimony that has been
extremely informative. And we already feel as if we have a pretty good idea of
the primary messages, identifiers, and terminologies that are used today in
e-prescribing. And of course our CMS staff is with us, and that information is
shared with them.

And in addition to that, we also have had a wonderful document that has
been prepared by our consultant Margaret Amaytulakin(?), that has mapped the
areas of standardization that the law has guided us to look at with the
different standards options, with the limitations of those standards, the
places where we have gaps, and the recommendations the testifiers have given us
so far.

In July we expect to hear from the remaining stakeholders that the law asks
us to listen to and consider. And then in a very short window of time, we are
going to compile all of the standards in use, the gaps, the limitations, and
those recommendations, and send them to the standard development organizations
and the terminology developers and the identifier developers and wind up saying
how quickly can you address these gaps?

How quickly can you move us forward? Can you do some of these in 6 months,
some of them in 12 months, some of them in 18 months? Give us a feeling for
what improvements we could make. And then we hope to take that guidance, and
maybe prioritize those. And this is going to be August 17, 18, and 19.

And then turn it around very, very quickly in a document to the full
committee whereby we would say if CMS feels that they want to begin
demonstration projects immediately, here are the standards that are available.
If they feel that there is some where we could offer some significant
improvements to the standards and terminologies that are out there, which
translate to better patient care or cost effectiveness, then some of these are
6 months away, others are 12, others might be 18.

And, John, did I cover what you were looking for?

DR. COHN: Let me actually also comment. As Jeff has commented, we are
obviously running on a very tight timeframe right now. But I think as we have
looked at the industry, obviously e-prescribing has tremendous amounts of
value. But currently, the way it’s being implemented is significantly different
from one environment to another.

And if we are ever to move into this world of interoperability, I think we
all need to come up with some agreements about a standards-based approach,
which I think has really been the hallmark of the committee now for a number of
years in terms of trying to do things so that we are not just doing it in one
location, but as all those locations begin to coalesce and converge,
prescriptions really will be able to move from one place to another seamlessly.

Now, I think what we are seeing right now is that there are message format
standards for many of the uses that we need, though there are still some
variations in how they are used. But in those standards many times what is
happening is that the actual content in many cases is non-standard, is free
text, is whatever in terms of communication.

And whereas that’s sort of okay, it’s not terrible, it however, prevents
really any motions towards things that improve patient safety in any
significant way in relationship to drug interactions, drug allergy
interactions, dosage checking, all of these things that I think that we are
looking in the future as having e-prescribing assist with improving patient
safety that we are going to be needing.

So, I think we are taking particular pains. Recognize that those are a lot
of the gaps that currently exist, to try to see if we can get those filled in,
or at least highlighted, so that as the implementations go forward, the current
implementations will be able to migrate to those standards, new implementations
will just be able to implement them.

And I think that’s our overall view. It’s why we are trying to take the
time, as well as identifying the gaps, as opposed to just what’s there.

MR. REYNOLDS: I think the other thing that is a little different about what
we are having to face is when you think of HIPAA, and you go back to Dr.
Brailer’s comment, HIPAA was institutions dealing with each. And although this
has some similar things, the only way that e-prescribing is going to work is if
each individual prescriber at the doctor level is able to do it, wants to do
it, and sees some benefit in doing it. And then somebody comes forward with
some incentive for them to do it.

So, this is different than maybe HIPAA. HIPAA didn’t really have to go all
the way down to ground zero. It could stay a little bit at the institutional
level. This has to be taken all the way to ground zero, as well as the large
standards organizations and the large payers and the large networks and
everybody else. It’s got to go down there too.

So, we’ve got to make sure that after we — just like his comment — after
we looked at it with everybody in mind, we have to go look from the bottom-up,
not putting the doctors on the bottom, but from the base level. The doctors are
ground zero, as well as the patients. And so, we’ve got to make sure that
whatever we build, however we structure it, we’ve got to go back and validate
it from the ground-up, otherwise it is not going to deliver, and that’s not
going to play.

DR. LUMPKIN: I think that given the short timeframes, if I could request
from the subcommittee and of the full committee so that we are all prepared to
take the actions that we need to take in September, that for instance you have
discussed the standards. If sometime before we meet there is some short
preparatory document that you could prepare to send us before the final
recommendations come, because I think that that will make it easier for members
of the committee who have not lived and breathed standards for the last few

DR. COHN: Well, John, I think I would almost frame it as — we obviously
have documents, most of them unfortunately are unintelligible. I think my view
is that, and I think what you are asking for is I think needs to be in the body
of the letter that we come forward with in September. Something that actually
is clear enough and concise enough and understandable enough that it sort of
explains what it is, as opposed to just a set of well, why don’t you use this
standard for this data element, and that standard for that element, and all of

Because in reality, it’s going to be able to communicate to Mark McClellan
and to others in the community in a way that is sort of obvious. And they look
at this and they say, well, of course this all comes together and this makes
sense. And so, maybe I’m seeing it in a different way, and maybe the committee
needs to see earlier drafts of that sort of a piece.

DR. LUMPKIN: I think you are saying it. The unfortunate thing is that if
you look at the work of the subcommittee over the last few years, and you go
back to the documents — and I have taught classes at the school of public
health — our documents have been wonderful primers on issues related to
electronic data interchange and others.

I’m not sure that the subcommittee has the time to do that. But certainly,
to the extent that in the body of the letter, that exactly what you described
is done, and it can get to the full committee in time for them to plow through
it, it would be extremely useful.

Okay, thank you. Thank you for the foreshadowing.

Subcommittee on Privacy and Confidentiality, anything to add? I think we
have completed the work.

Agenda Item: Reports from Subcommittees and Workgroups
– Subcommittee on Privacy and Confidentiality – Mr. Houston

MR. HOUSTON: I think we got done with the letters. I guess we went through
a very, very minor — one word we added or changed.

DR. LUMPKIN: I thought we already approved those letters.

MR. FANNING: We approved it, but we thought that we should give the
chairman a look at the very last version. We’ll do that as the meeting comes to
an end. I don’t think there is any other substantive thing to be addressed.

DR. LUMPKIN: Do you have a hearing come up?

MR. HOUSTON: We have a hearing in July, yes.

MR. FANNING: The 14th and 15th, and we are to hear testimony about
disclosure to the press, about use of information in marketing, use of
information in fund-raising. And we are also going to have a briefing on the
security rule.

DR. LUMPKIN: To what extent are you looking at those other issues, the
off-shore and other kinds of issues? I think that obviously, the committee’s
plate sounds quite full with the current work, but something there are some
things on the horizon which will enable you to have a full agenda for the next
few years.

MR. FANNING: Yes, and I think the committee would welcome suggestions about
things that especially need to be addressed.

MR. HOUSTON: The last year or so I think we have really tried to focus on
HIPAA privacy rule issues. And I don’t think we really have been looking
outside of that box. And I think that what we talked about was that with some
of the new legislation like regarding off-shore movement of DHI, that we really
do need to maybe start to look at that issue, as well as maybe some other
issues that are even more tangential to HIPAA, but within that realm and

So, I think we are going to try in the fall. We have to talk to Mark,
because Mark really wasn’t privy to those conversations, but I would suspect
this fall we would probably try to delve into those.

DR. LUMPKIN: And one of the things I think, if I can encourage you to
perhaps — if we could send a letter, not one of our official committee
letters, but to a few of the EMS-related organizations, just to sort of query
as to whether or not that problem has been fixed in relationship to privacy,
and the functioning that we had heard about had been fixed with the new
guidance. But I just picked up some rumors that that may not be as fixed as we
thought. And I can give you the names of the organizations. There are four or
five, and we should be able to reach out.

Okay, thank you very much.

Subcommittee on Populations.

MR. HOUSTON: I forgot to say one thing. Simon and I were also speaking
about privacy and security, maybe doing some testimony in September. We had
talked about maybe doing some joint testimony, and we needed to talk to Mark
about the dates.

But there was a thought of maybe pulling together a hearing to speak
specifically to our hear testimony from medical device manufacturers, as well
as maybe query some of the organizations further as to whether there are any
looming security-related issues. So, that looks like the September timeframe.

DR. COHN: But the privacy subcommittee is leading that effort.

Agenda Item: Reports from Subcommittees and
Workgroups – Subcommittee on Populations – Mr. Localio

MR. LOCALIO: This is Russell Localio. I’m sitting in on behalf of Vickie
Mays, who had to go back to the West Coast last night.

Now, we have edited quite heavily the document that we went through here
yesterday morning to do a number of things. Let me just give you a very brief
overview. We changed the title. Everybody should have received a copy of this.
We have some extras. We have changed the title to, “Commentary and

We have updated it to give it a place and a continuum of efforts by NCVHS
and other organizations in measuring race, ethnicity, socioeconomic factors in
health disparities. And we have also put in many more references to update it,
such as the recent activity of the Robert Wood Johnson Foundation, for obvious
reasons. That report is on the Web, thank goodness.

Now, I don’t know how to proceed. Yesterday, Vickie read the draft and
elicited suggestions. I can do the same thing today, but I know time is short.
So, how do you want to proceed?

DR. LUMPKIN: I think we need to read the draft.

MR. LOCALIO: Fine, I will then proceed.

DR. LUMPKIN: And if I can suggest, if people have any issues or concerns,
just sort of raise your hand at the time, and then I will stop you at the end
of the paragraph if I see a hand go up. If not, plow ahead.

MR. LOCALIO: All right, so I will proceed.

“Recommendation on the Nation’s Data for Measuring and Eliminating
Race, Ethnicity, and Socioeconomic Health Disparities: A Report by the National
Committee on Vital and Health Statistics Subcommittee on Populations.

Abstract. The federal efforts to eliminate health disparities, and improve
the health of all Americans depend on the ability to target those at high risk
and with great need. In the most recent of days through a number of important
landmark reports the nation’s attention has been focused on the range of
disparities in health status and health care of racial and minority populations
and their need for better data. The National Committee on Vital and Health
Statistics in its advisory role to the secretary on health statistics has a
long history in proposing initiatives to assist the Department its efforts to
eliminate health disparities. The Department of Health and Human Services also
has a long history of the development and implementation of several important
and successful initiative to achieve the healthier US citizens.

However, there is a new sense of urgency in light of the recent release of
the Institute of Medicine’s report on the collection of data on race and
ethnicity, and the Department’s report on health care disparities for guidance,
coordination, monitoring, funding, research, and partnership at the private
health sector to achieve the goal of healthier citizens in the specific
populations of racial and ethnic minority populations.

The reports highlight some of the overwhelming disparities in their health
status, health care, and health information needs of particular groups of
particular racial and ethnic minorities. This requires information on the
diverse array of population groups that comprise the United States. Drawing on
hearing testimony, previous recommendations, and other sources, this report
from the National Committee on Vital and Health Statistics examines the
limitations of health data on racial and ethnic groups as currently collected
and used.

Some challenges stem from the Office of Management and Budget’s 1997
guidance on race/ethnicity classification. On the basis of this analysis, the
report recommends a set of actions to remedy problems and fill information
gaps. The committee makes these recommendations to assist the Department in
achieving its mission of eliminating health disparities through an enhancement
of the collection, use, and dissemination of health and health care data on
racial and ethnic populations.”

Obviously, we’ve got a couple of typos here that crept in between eleven
o’clock and now.

DR. LUMPKIN: I’m just going to suggest that there are a couple of words
that are obviously awkward. If the group is acceptable, those kind of things I
will ask the committee just to clean, and I will review for whether or not they
are of content significance. In which case if they are changing the word and,
the, and those kind of things, we can move forward.


MS. GREENBERG: Yes, and I think obviously you had to write this on the
quick here, and I think it does need some editing. And Susan Canard, and the
extent to which she was involved with this, she can probably clean it up. And I
don’t think we should get into editing here on the spot. I do think there is a
problem with the new title, because you could almost read it as for measuring
and eliminating race, and we don’t want to do that.

MR. LOCALIO: The suggestion earlier was measuring and eliminating —

MS. GREENBERG: Health disparities based on race, ethnicity, and
socioeconomic —

MR. LOCALIO: Right, that was the recommendation a little while ago. So, we
will move health disparities up to after eliminating.

MS. GREENBERG: I think you need to.

DR. LUMPKIN: That works. Okay, just let me read that. Recommendations on
the Nation’s Data — Recommendations for Improving —

MS. GREENBERG: You have to have data in there though. That’s part of the
problem actually in the whole thing. You kind of mix up the data issues, which
are this committee’s, and the strategies to eliminate disparities, which really
go sort of beyond the focus of this committee, I think. Hopefully, the data
will help.

DR. LUMPKIN: Recommendations on National Data for Measuring —

MS. GREENBERG: It’s not just the national data though.

DR. LUMPKIN: It includes private, state.

MS. GREENBERG: How about recommendations on data for measuring?

DR. LUMPKIN: Recommendations on data for measuring and eliminating health
disparities based on race, ethnicity, and socioeconomic.

MR. LOCALIO: Why couldn’t you say recommendations on data for measuring and
eliminating race, ethnicity, and socioeconomic health disparities in the United

MS. GREENBERG: I would rather have health disparities right after

DR. LUMPKIN: How about data-related recommendations —

MS. GREENBERG: It’s really data for measure. See, the recommendations are
on the data needed to measure and eliminate health disparities.

DR. LUMPKIN: Okay, we’re going to drop the title for right now, because we
could spend a fair bit of time doing this. If we are comfortable with the
subject matter that is beyond the title, and the title is the only problem, we
can fix it. But if there are other problems that come up, we may have to send
this back.

MR. LOCALIO: I understand.

MR. BLAIR: How about if I make a motion that we accept the letter pending
the review of the chair for appropriate editing? How’s that?

DR. LUMPKIN: But we have to go through it, because there are changes.

MR. LOCALIO: There are substantive issues that I think we have to agree on.
But I think we can proceed and cover those issues, and we can amend the title
to be grammatically correct, as well as appropriately descriptive.

MR. HUNGATE: There is an element of uncertainty raised by the label
abstract on the first part of this document. And then it refers to this report,
which we haven’t seen. Now, if it just referred to these pages, then the
abstract could be called an introduction instead. And the report becomes simply
what we have.

MR. LOCALIO: The discussion yesterday was that the abstract was to go with
the forthcoming report to be due in September. We then changed the title after
the abstract to commentary and recommendations, because this is a commentary on
which the recommendations are based. So, this is not a report, although the
abstract was intended to be an abstract of the report, which you are correct,
you have not seen.

DR. LUMPKIN: But I think we can, by changing the word “abstract”
to introduction, this paragraph works.


DR. LUMPKIN: Anything else on the introduction? Okay.

MR. LOCALIO: “Commentary and recommendations. Measuring and
eliminating health disparities. Compelling evidence exists that differences in
health status, access to care, and the provision of physical and mental health
services are significantly related to race, ethnicity, and socioeconomic
position. Despite advances in medicine, and increased emphasis on disease
prevention and health promotion in the United States, the country’s racial and
ethnic minority populations generally have higher rates of illness and disease,
and poorer quality of care than Whites. For example, life expectancy for Whites
in the United States in 2000 was 77 years, while for Blacks it was six years
less at 71 years.”

I’m not going to read the footnotes. Is that acceptable?


MS. GREENBERG: Actually, the footnote is new.

MR. LOCALIO: Then I will read the footnote. “Socioeconomic status has
traditionally been measured by education and income, however, more recent
research has suggested that a broader view encompassing additional
characteristics such as current wealth and historical contextual variables such
as socioeconomic conditions during childhood are important for health outcomes.
This more expanded view is referred to as socioeconomic position, SEP.
Measuring SEP is a challenge, as there is no consistent agreement about which
factors should be included in SEP, or what time period during childhood is most
important. Some of the factors may vary depending the specific outcomes of
interest, or the populations being studied. IOM reports — and the reference is
going to be included.”

So, that refers to two references there, the IOM reports and the study by

DR. LUMPKIN: And those will be then included in the document. Anything else
on that paragraph?


MR. LOCALIO: “The national goal of eliminating health disparities
among racial and ethnic group has come increasingly to the fore in recent
years, along with growing recognition that the nation’s health must be improved
population group by population group, with greatest attention to those at great
risk. The Institute of Medicine (IOM) has made a strong statement about
disparities in its landmark report, “Unequal Treatment,” and the
National Research Council Panel on DHHS Collection of Race and Ethnicity Data
furthers public attention to these issues with its new report.

The issues and goals are at the heart of Health People 2010, reinforced by
the recent National Care Disparities Report by the Agency for Healthcare
Research and Quality (AHRQ), and addressed in multiple other reports, and by
the Robert Wood Johnson Foundation report.” Reference number six.

“In addition, as far as the five steps to effectively reduce a
community’s cancer burden, the National Cancer Institute and the Centers for
Disease Control and Prevention recommend reviewing data to identify populations
at greatest risk, and the extent of health disparities between

We have attempted here to update with the most recent references, including
those delivered today and yesterday. Those discussed yesterday and today at the
main committee meeting.

DR. LUMPKIN: I’m actually just a little bit uncomfortable with my
organization being singled out, and I think maybe and others instead of the
Robert Wood Johnson Foundation. The Kaiser Foundation has done other work.
There are others.

MR. LOCALIO: And by others, such as the Robert Wood Johnson Foundation, so
we can keep the reference?

DR. LUMPKIN: Yes, I think you can keep the reference, and you just say
addressing multiple other IOM reports and by others.

MR. LOCALIO: Fine, thank you. We’ll keep the footnote six. We’ll proceed?


MR. LOCALIO: “To achieve these goals, the Department of Health and
Human Services (HHS), must be able to target interventions and monitor progress
for those at high risk and great need. The targeting and monitoring in turn
depend on having estimates of the health status and knowledge of the health
needs of the many population groups and subgroups the comprise the US. For each
racial and ethnic group and subgroup, data are needed not only on health
factors, including health status, health care, health care expenditures, access
to care, and experiences in the health care system, but also on contextual
factors such as socioeconomic position, and the conditions in which people
live. Sources of these data include national population-based survey, the major
focus of this report, as well as state data, targeted surveys, and
administrative data.”

DR. LUMPKIN: Comments? Okay.

MR. LOCALIO: “The problem is that the very groups at particular risk
for ill health and poor health care are those about whom health statistics and
contextual data are most deficient. National population-based surveys are
essential sources of estimates on the health of the United States population.
They are used for general Black/White comparisons, and to a lesser degree
comparisons among Blacks, Latinos, and Whites. However, such surveys, at least
as currently designed, are not an effective source of information about the
health of American Indians, Alaska Natives, and Asian and other Pacific
Islanders, or other population groups that are concentrated in a specific
geographic area. It is significant that Healthy People 2010, which has an
overarching goal of eliminating health disparities, lacks baseline data to
quantify specific improvement for some subpopulations in many areas.”

Comments? Marjorie, you are very worried looking.

DR. LUMPKIN: It’s just an editorial comment that this has to do with the —

MS. GREENBERG: The Asian and Other Pacific Islanders is no longer the OMB
terminology, is it?

MR. SCANLON: Asian is a separate category.

MS. GREENBERG: Then there is Hawaiian and other Pacific Islanders.

DR. LUMPKIN: Right, but that’s editorial.

MR. LOCALIO: Thank you. Proceed?

DR. LUMPKIN: Proceed.

MR. LOCALIO: “A Changing Landscape. Gaps and deficiencies such as
these are not easily remedied. And those trying to collect and use data on
American racial and ethnic groups face a host of challenges. For example, the
US is an increasingly multiracial society. The number of subgroups is daunting,
and racial and ethnic self-reported identity is affected by who is collecting
the data, the purpose for which the data are being collected, and other
characteristics of the respondents can change over time. Moreover, the
confidentiality of personal information can be compromised when group size is
small, thus limiting data use, as well as raising privacy concerns among those
supplying the data, and some institutions cite concerns about legality or
acceptability to clients as a reason for not collecting data on client’s race
and ethnicity. In addition, race is a social construct that is not well defined
or understood.”

Comments? Proceed?

DR. LUMPKIN: Proceed.

MR. LOCALIO: “In 1977, the Office of Management and Budget (OMB)
required a common language in federal collection and use of data on race and
ethnicity with statistical policy directive 15. In October 1997, taking effect
in January 2003, OMB issued a new method for accommodating changing population
make up and identities, and providing categories for data on additional
population subgroups. Specifically, the new guidance provides five categories
for data on race: American Indian or Alaska Native; Asian; Black/African
American; Native Hawaiian or Other Pacific Islander; and White. It also
provides two categories for data on ethnicity, Hispanic or Latino, and not
Hispanic or Latino. In addition, for the first time significantly, the revision
offers respondents the option of selecting more than one racial designation.
While the new OMB classification opens the way to greater detail in racial and
ethnic data, it also has created complex challenges in data collection,
tabulation, and analysis for those charged with monitoring and improving
population health. These are discussed below.”


MR. HOUSTON: In the abstract there is a discussion about OMB, challenges
stemming from the OMB racial and ethnic classifications. I’m just wondering if
that is even warranted being in the abstract, because it doesn’t seem like this
is an overarching part of this document. I’m just wondering whether it’s going
to raise somebody’s ire because of the fact that OMB is singled out in the
beginning, in the abstract.

MS. GREENBERG: It was actually a major focus of the hearings, I know, and
the report. And the recommendations —

MR. HOUSTON: It didn’t seem like OMB was much of a focus when I read
through. And now when it is rewritten, I don’t know.

DR. CARR: The way it’s written in the abstract, it sounds like OMB is part
of the problem. They are actually part of the solution

MR. HOUSTON: That’s my point exactly.

MS. GREENBERG: Yes, I think it kind of leaves that hanging.

MR. HOUSTON: So, in other words, you are comfortable for the body of the
text, but you want some edits in the abstract to make that consistent with the
body of the text in terms of the characterization — to make sure that this
does not connote that OMB is a problem.

DR. LUMPKIN: Couldn’t we say that some challenges stem from the
implementation of the OMB.

MR. LOCALIO: We are talking about the introduction, right?

DR. LUMPKIN: In the introduction.

MR. LOCALIO: But people are satisfied with the text in the body?

DR. LUMPKIN: Yes, but we’ve got an edit that I think will solve the problem
in the introduction. Good connection. Anything else on this paragraph? Go.

MR. LOCALIO: “NCVHS contributions. The National Committee on Vital and
Health Statistics (NCVHS), established in 1949, advises the Secretary of Health
and Human Services and Congress on the health information and data issues
underlying federal policy. NCVHS has completed many important initiatives to
improve population health data, including a number of activities on behalf of
racial and ethnic minorities. The NCVHS Subcommittee on Populations focuses on
health data concerning the US population generally, as well as data about
specific vulnerable groups within the population that are disadvantaged by
virtue of their special health needs, economic status, race and ethnicity,
disability, age, or area of residence. The present report summarizes recent
work by the Subcommittee on Race and Ethnicity Data.”


“While the new OMB classification and the changes in question it has
engendered are one important focus of concern, the Subcommittee finds it useful
to look at classification-related issues in the context of the broader topic of
the information needed to monitor and eliminate population-level health
disparities. This report recommends and underscores the urgency for a range of
actions by the federal government to create the conditions for the collection
and use of reliable and complete data on racial and ethnic minorities. It draws
upon past NCVHS recommendations, the testimony at a 2002 hearing convened by
the Subcommittee, and the National Research Council report. It also builds on
data quality improvement efforts already underway at NCHS, NIH, and the
Department’s Data Council, and elsewhere. The ultimate goal is insuring that
the Department can play a key role in helping to eliminate health disparities
within the population.”


MR. SCANLON: A friendly amendment — can continue to play its role.

MR. LOCALIO: Thank you.

DR. LUMPKIN: Okay, go on.

MR. LOCALIO: “Specific data issue. The sources noted above highlight a
number of data issues that must be resolves. As seen in the recommendations
below, in many cases their resolution must begin with accelerated research,
federal guidance, and the coordination both within the Department and within
the private sector. Some issues pertain to data collection, and others to
tabulation analysis and interpretation. Sample design is one of the first
challenges, partly because of the difficulty of collecting and reporting
numbers from small racial and ethnic groups sufficient for analysis, but
without violating confidentiality protections. Other data collection issues
include the need for adequate subgroup data, as well as questions about primary
race, given the options offered by the revised classification system. There
also is a need for survey in languages other than English and Spanish.”


“The greatest impact of the new OMB guidance is on data usage. In
particular, allowing persons to report more than one race presents a host of
challenges. These and other changes impose a new burden on states a time of
reduced or flat budgets, forcing them to retool their data systems and bridge
old and new statistics. Data collectors and users alike are calling for federal
guidance on multiple questions including how to present multi-race data, what
Census denominators to use to calculate rates, and how and when to collect data
on subgroups. To permit trend analyses greater guidance is needed in
methodology to bridge or compare data collected under the new standards with
data collected under the old ones. Small analytic sizes are another


“Any additional category of data issues concerns the type of
information besides race and ethnicity that are needed to understand, monitor,
and eliminate health disparities. The most important topics cited in which
additional information is needed are socioeconomic position, geographic
location, age, primary language, other factors that contribute to health
status, and health care expenditures.”


DR. STEUERLE: I think there are a lot of categories of information that
could be more relevant to dealing with this issue than some of the ones
mentioned here. Kevin mentioned education. Expenditures isn’t the only item.
For instance, Minnesota spends a lot less person than does Florida, but it’s
probably because they are in more of an HMO-type system.

And it may be that expenditures isn’t relevant at all. It’s not just
relevant for quality of care. It could actually be relevant for disparities of
care, I don’t know. I think that there are a lot of additional items here that
— health behaviors is another one. Are there disparities in how much people
follow prescriptions that they asked to take? I just think there are a lot of
items that should be added to that list.

MR. LOCALIO: Just as a response, education is clearly subsumed under
socioeconomic position.

DR. VIGILANTE: It gets buried in there. And educational attainment is such
an important opportunity for intervention in part from other sorts of things
that go into socioeconomic status.

DR. STEUERLE: And I presume you mean education in health matter, it’s not
just number of grades achieved.

DR. VIGILANTE: No, I mean grades achieved, the attainment. Did you graduate
from middle school, high school as an independent variable apart from income.

DR. STEUERLE: So, it’s educational and health issues.

DR. LUMPKIN: Because both of you weren’t here yesterday, we actually had a
fairly detailed discussion about the difference between socioeconomic status,
which is a term that has been used a lot previously, and now socioeconomic
position, which is a much broader term that incorporates issues, and I think we
just had the footnote, but goes into educational attainment. Because in some
instances what your family’s income is, what your income was prior to the time
period may be more significant than your income.

MR. LOCALIO: So, we do at least want to include health behaviors? And do we
want to say the most important topics cited on which information is needed are
such factors as?

MS. GREENBERG: My concern about adding health behaviors is although I
understand what you are saying, I’m not denying the importance of them, I don’t
really think that was — Dale, maybe you can help me here or Audrey — but I
don’t believe that was referred in testimony. It was not a focus at all.

MR. HITCHCOCK: [Remarks off mike.]

DR. LUMPKIN: How about if we strike the word “important” and just
say the topics cited on which additional information included.

MR. LOCALIO: Okay. Proceeding, “Cross-cutting policy and capacity
issues. Much of the testimony received by the Subcommittee about data on race
and ethnicity suggested that these data collection and use challenges are not
insoluble. Rather, they require a centralized approach to solving them. The
Department has, for many years, expanded and improved the collection of data on
race, ethnicity, and socioeconomic position. Major contributions include basic
techniques for bridging across classification and for measuring the extent of
disparities. However, work in this area needs to be expanded and accelerated,
and at times conducted in partnership with other departments such as the Bureau
of Census, Labor, Education, and the Office of Management and Budget. In
particular, enhancing data on health care would benefit from partnerships with
the private sector in the collection of data on racial and ethnic populations.
This calls for a higher federal investment in research, guidance, and
coordination with appropriate levels of funding. Important infrastructure
capacity issues were also identified, including the need for training and
diversification of the survey and research workforces, as well as the need to
provide researchers, policymakers, and the American public in general with
timely data on the health and health care of racial and ethnic



MR. LOCALIO: “Overarching recommendations. Based on its finding, the
Subcommittee recommends the following actions to improve and augment the
current data available for measuring, tracking, and ultimately eliminating
health disparities for racial and ethnic minority populations.”

DR. LUMPKIN: I think we probably just need to eliminate sub, because this
is a report of the committee.

MR. LOCALIO: Thank you.

“1. — and I will stop at the end of each one of these, because these
are recommendations.

DR. LUMPKIN: And just to speed up the process, you don’t need to read the
fact that it maps out to the IOM report.

MR. LOCALIO: Thank you.

“1. DHHS should promote, extend, and intensify its current leadership
role with other departments, OMB, and the Census Bureau, and private and
academic organizations to promote and undertake methodological research
associated with race, ethnicity, and socioeconomic position, measurements and
surveys, research and Census data in order to improve the health and health
care data collected on racial and ethnic minority populations and


MR. SCANLON: You have two promotes there. You might just say HHS should
extend and intensify its current leadership role, instead of saying promote,

MR. LOCALIO: Thank you. Other comments?

DR. LUMPKIN: Go for it.

MR. LOCALIO: “2. DHHS should accelerate implementation of the multiple
strategy approach to data developing in racial and ethnic minority populations
and subpopulations consistent with recommendations that appear in title,
improving the use collection and use of racial and ethnic data in HHS.”
That just the title. I need not go through that. “In addition to
dedicating appropriate financial and staffing resources.”

MR. SCANLON: DHHS should accelerate implementation of its multiple strategy

MR. HITCHCOCK: I would see there are very little other ways of accelerating
implementation of these strategy approaches without dedicating appropriate
financial and staffing resources. I’m wondering if we should end with line 205
with a period. And then just start 206 with, “This will require dedicating
appropriate financial and staffing resources.”

MR. LOCALIO: “3. DHHS is urged to develop consistent strategies and
mechanisms for the broad dissemination of data on racial and ethnic minorities
including data on socioeconomic position that result from Departmental data
collection efforts, and targeted to specific racial and ethnic minority


“Specific strategies. The following areas represent strategies aimed
at increasing the quality and quantity of data on racial and ethnic populations
and subgroups, and should be regarded as top priorities by the Secretary of
Health and Human Services.

1. Improve coordination of racial and ethnic group data collection and use
through partnership development among entities responsible for data collection
and issuance of consistent data requirements.”


DR. VIGILANTE: Partnership with entities rather than — it’s a little
awkward there.

DR. CARR: Does the committee want to say that this is the top priority, or
do we want to say as high priority? Are we saying this is top above other

MR. LOCALIO: Why don’t we change top to high. Is that acceptable to
everyone, top on 217 becomes high?

“2. In consultation with the Office of Management and Budget provide
guidance of the following critical technical and methodological areas:

(a) methodology for bridging old and new data;

(b) analysis and interpretation of primary and multiple race

MR. SCANLON: The OMB standard does not refer to primary race. That is
something we are making up, but we’ll just leave it alone.


DR. LUMPKIN: Right. That’s not unintentional.

MR. SCANLON: I know.

MS. GREENBERG: Do you want to take that out?


MR. SCANLON: Leave it in.

DR. LUMPKIN: It’s just holding up the process by making a comment.

MR. SCANLON: That’s right.

MR. LOCALIO: “3. Strengthen the capacities of the health statistics
enterprise through improvements in access to departmental data on racial and
ethnic minority subpopulations, and in the dissemination” — we need your
help here on — “of research findings on racial and ethnic groups.”
We need your help in dissemination to whom?

DR. LUMPKIN: I think dissemination is just fine.

MR. LOCALIO: Finally, “4. Provide guidance on critical technical and
methodological issues including:

(a) improvements to the quality of race and ethnicity data in vital
statistics records;

(b) oversampling in national surveys were feasible;

(c) targeted studies for data development on subpopulations when
oversampling is not feasible about across affected populations;

(d) methodology to improve the quantity, quality, and participation rates
in racial and ethnic subgroup data collection;

(e) use of Census denominators for rate calculations;

(f) mechanisms to augment existing samples to target specific race or
ethnic groups nationally or in sub-national areas with adequate privacy

(g) the cultural validity of data collection tools.”

And that’s the end of the documents. Comments?

DR. VIGILANTE: You are using caps in your As and Bs on this side, and on
this side they are all lower cases.

MR. LOCALIO: Thank you.

DR. STEUERLE: If it’s appropriate, I wouldn’t mind adding at the end — it
may not have come up, so it may not be appropriate, but one of crucial issues
in a lot of these data collection efforts is the matching of data sources such
as the matching of different surveys, particularly the matching of survey and
administrative data.

Which does raise all sorts of issues about whether you can do this across
departments, but that’s often how you gather the information you need. The
survey is often not enough.

DR. LUMPKIN: So, the working would be matching across surveys and agencies?

DR. STEUERLE: Linkage of survey and administrative data.

MR. LOCALIO: Could we use both linkage and matching? Because linkage is a
term of art. This is (h).

DR. LUMPKIN: This one really says the Department should provide guidance on
critical, technical, and methodological issue, including linking and matching
across —

DR. STEUERLE: Different survey and administrative data sources.

MR. LOCALIO: Why don’t we just say across surveys and data sources? Can we
say that?

DR. STEUERLE: Administrative data —

MR. LOCALIO: Surveys and administrative data sources. So, it will read,
linkage and matching across surveys and administrative data sources. Is that


MR. LOCALIO: How do you want to proceed on this in terms of —

DR. LUMPKIN: Russ has made the motion that we would adopt this report with
the following conditions: (1) that the chair will review any editorial changes
for whether they are substantive or just purely wording; and (2) is that the
title of the document will be prepared by the subcommittee, and will be shared
with the full committee, and barring any objective, attached to the document.


MS. GREENBERG: And by chair, you mean yourself?

DR. LUMPKIN: That would be me, yes.

MR. LOCALIO: Yes, and the title is important. It’s something we probably
should have addressed yesterday in that it was not too changed from yesterday,
but thank you.

DR. LUMPKIN: It’s been moved and seconded. All those in favor say aye. Any
opposed say nay. Abstentions?

[Whereupon, the report was approved as amended.]


DR. FITZMAURICE: Does this mean that this is the report, or that there will
be a separate report coming later on?

DR. LUMPKIN: The answer is yes, this is both the report, and there will be
another report coming along.

Agenda Item: Reports from Subcommittees and Workgroups
– Workgroup on Quality – Mr. Hungate

MR. HUNGATE: Okay, the Quality Workgroup. We have a hearing scheduled next
Thursday and Friday to develop the business for data and information collection
and/or change. We welcome both Harry Reynolds and Simon Cohn to join that

The expected result from this discussion is a summarized business case for
presentation at the second hearing, which is now scheduled for September 14th,
where standards developing organizations and information implementer, AHIMA,
vendors, providers will be involved to assess the viability of the business
case for transferring some of the candidate recommendations to full
recommendations from the earlier quality report.

That’s I think as quick a summary as I can give. Any augmentation?

Beyond that, we need to think about the Quality Workgroup’s functioning
after completing this part of the agenda. And I think we will continue to talk
about that over time. And I think the hearings themselves will help bring some
focus to that.

DR. LUMPKIN: And for those of you who haven’t seen the agenda for the
hearings, it looks like it’s going to be quite an interesting hearing. And
particularly when you think about the comments we heard from Mark McClellan
about some interest in getting better access to quality data, it sort of
ratchets up our attention to this issue.

MS. GREENBERG: I just want to recognize Debbie Jackson, who served as
acting lead staff during the period in which we were looking for a replacement
for Eduardo, and did most of the work on putting together the agenda, with
other staff to the subcommittee, and now recognize Anna Poker from AHRQ, who
has recently joined AHRQ and our efforts in serving as the new lead staff.

DR. LUMPKIN: Any questions for the quality subcommittee? Thank you.

There will also be an opportunity at the Executive Subcommittee retreat to
have some discussion about future directions and interaction between Quality
and other workgroups and subcommittees.

MR. HUNGATE: I think there is some follow-up that is incumbent on me from
the last report, which talks about the resolution of the other candidate
recommendations. And I will initiate that with the other appropriate groups, to
get that discussion going.


Marjorie, upcoming meetings.

Agenda Item: Future Agendas for NCVHS Meetings – Dr.

MS. GREENBERG: Well, our next meeting is actually September 1-2, our next
full committee meeting. So, our having an executive retreat, as John said, on
August 6, certainly we’ll have issues from the NHII conference, and we have to
decide exactly how we are using part of the meeting for that. That is really
too late for us to be planning the agenda for the September meeting.

So, I think we had said we would need a conference call. But just a little
guidance here would be welcome. We have actually accomplished a number of our
goals with this meeting. We heard about the CDC Futures Initiative. We heard
about the CNSTAT report, and also heard from the CMS administrator. And we
thank all of you who were helpful, particularly Judy, in making that happen, as
well as hearing from Dr. Brailer. So, I think everyone who put together this
agenda, and I really take almost no responsibility for it, should get a round
of kudos, because I think they did a great job.

But in any event, we never run out of topics, obviously. There was
discussion about having a session either at this meeting, and then we deferred
it until September, about the kind of whole process of standards development. I
think the Subcommittee on Standards thought that that might be helpful, and who
the actors are. And I know this has come up in the Quality Workgroup.

Some greater kind of understanding and discussion about how standards get
developed, and the voluntary standards process. They have so much on their
plate with e-prescribing, and now these recommendations for September, I don’t
know whether that’s something they are still going to try to do or not.

DR. LUMPKIN: Well, we can explore that. Members of our committee are not
the only ones who can walk us through that process.

MS. GREENBERG: Well, that’s true. And to the extent that they are going to
do it, August 6 isn’t too late. My concern is if we are going to get outside
speakers or panels set up, we really need to know that very soon so we can
start contacting these people. They are gone in the summer often, on and off.
People are not available in the summer. And we certainly don’t want to start
contacting them in August. So, I guess that’s something we can follow-up with
Simon on.

We have had requests for presentations in the international arena about
international statistics issues, genomics, GIS. Gene has suggested a panel on
GIS, which is cross-cutting really. It deals with populations and privacy and
security and standards, and pretty much cross-cuts the whole committee.

The NIH Roadmap for Research was suggested. Those are the top ones.

We said we would like to have a joint meeting with the Board of Scientific
Counselors in June in 2005, but I don’t think we have to talk about that now.
And then we did talk about yesterday in Populations about whether it would be
useful to actually have a panel discussion on this whole issue of socioeconomic
position, and sort of the theory and methodology in that, and how it relates to
socioeconomic status and goes beyond it, important factors.

We didn’t do this on position, but we certainly did this on socioeconomic
status several years ago when there was an effort to get educational status
into the Uniform Data Set. So, it might be timely to update our knowledge and
thinking on that.

DR. LUMPKIN: Well, given that I think that just judging from nodding heads,
that one of the areas that we’ll try to see if we can do is a review of the
standard development process for the committee in September. I think the second
one that I saw was the NIH Roadmap. So, if we can try do to those as our two.
We have e-prescribing that will be on our plate. That will be fairly
significant, and we’ll have the Populations fuller report. I think that will
probably take us, with the department update.

My guess is that we will also want a presentation, an update on the CHIT
strategy and the framework and strategy very likely will be ready, and I think
we’ll want an update and a presentation, which will be my guess will be more
mature than will be the presentation in July.

MS. GREENBERG: So, those are your priorities?

DR. LUMPKIN: Is that agreeable?

MS. GREENBERG: I think we may need to have a conference call of the
Executive Committee anyway to talk about the agenda for the retreat.

DR. LUMPKIN: Okay. Anything else?

MS. GREENBERG: Maybe we could talk about GIS in November.

DR. LUMPKIN: I think we should really map out how we cover that subject.

MS. GREENBERG: All right, but I’d like to do this while Gene is still a

DR. LUMPKIN: Okay, at this time we are over a half an hour early.

[Whereupon, the meeting was adjourned at 3:00 pm.]