Dr. Straube: If I could ask people to take their seats, please, we'll
try to go ahead and get started. Good morning. I want to welcome
everybody here in the room, and the folks on the telephone line, and
thank you for participating in this listening session this morning
regarding next steps in effective health care research and evidence
development at the Department of Health and Human Services. These
activities are very important to every health agency in HHS and to the
entire American health care system. My name is Dr. Barry Straube. I am
the Acting Chief Medical Officer and the Acting Director of the Office
of Clinical Standards and Quality of the Centers for Medicare and
Medicaid Services. And I would like to welcome you this morning, and I'm
very pleased to have been asked to moderate the session this morning.
I'm joined here this morning by Dr. John Agwunobi, who is HHS's new
Assistant Secretary for Health, and Dr. Carolyn Clancy, who is the
Director of the Agency for Health Care Research and Quality, also within
HHS where the new Effective Health Care Program is currently housed. I
wanted to add that the secretary of HHS, Mike Leavitt, and my boss Mark
McClellan are extremely interested in the proceedings here this morning,
but they were unable to be here. I particularly send Mark McClellan's
regrets. I was in touch with him around midnight last night and he was
still concerned that he really wanted to be here but wasn't able to do
so. So I send his greetings to all of you for sure. In addition to those
of us here in the room--we have at least 50 people I would say here in
the room. We're joined by over 250 people on the telephone lines who
will be participating with the session this morning from around the
country. This is the second listening session that we've had, to obtain
input on priority areas for the effective health care activities that
were authorized under section 1013 of the Medicare Modernization Act
that came out at the end of 2003. The purpose of this meeting is to
provide an open door forum, if you will, for public input in order to
help the Department of Health and Human Services as we review the
priority conditions that should be included in our next round of
effective health care research and synthesis. The first listening
session took place in May of 2004. And it was part of the open process
that resulted in the Secretary\'s selection of ten priority conditions
for the first phase of the comparative effectiveness review process. The
first ten conditions were focused on the Medicare program in particular,
and that first list of conditions was published publicly in November of
2004. The Effective Health Care Program was then established at AHRQ and
the reviews have subsequently been launched. For those of you who are
following things closely, the first Comparative Effectiveness Review
under this program was issued last month and is published on the AHRQ
Web site. Nine more reviews are currently being developed. And a new set
of topics for the next set of reviews is currently being proposed on the
Web site which is
[www.effectivehealthcare.AHRQ.gov](http://www.effectivehealthcare.AHRQ.gov/).
That next set of reviews will also be based on the initial list of ten
priority conditions. Our purpose here this morning is to look beyond
these initial reviews and to consider what addition or other changes may
be needed in the list of priority conditions for future years. In
particular, we want to review whether there are conditions of special
importance, not only to the Medicare program, which we focused on in the
first ten conditions, but the Medicaid and the State Children's Health
Insurance Programs which are also covered under this program. This is
the beginning of a process of reviewing the priority conditions. We
don't have any preconceived ideas about what should be and should not be
identified as priorities, and how many should be included. But we
welcome the ideas of everybody in the room here and on the telephone in
guiding us in picking additional priorities. We also welcome your
comments on the program as it's developed so far and any other ideas you
may have on the future of the program. Let me remind everyone that with
this program you can participate very actively by going to the Web site
that I mentioned previously, signing up at the Web site. You can get
regular communications from the program on what's happening. In
addition, you also have the opportunity on the Web site to make comments
and give suggestions at whatever time point you want. It doesn't have to
be restricted to open door sessions such as the one today. The
Department of Health and Human Services wants this to be a very
transparent and open process, and I think the Web site and these open
sessions are a part of that. And the Web site, again, is
[www.effectivehealthcare.AHRQ.gov](http://www.effectivehealthcare.AHRQ.gov/).
Now before we begin our public comments this morning, I'd like to invite
my colleagues at the table here to say a few introductory words, and
I'll be making some also from Dr. McClellan. And I'll begin with Dr.
Agwunobi on my left here. As the new assistant secretary of health for
the Department, Dr. Agwunobi assists Dr. Leavitt in managing the
agencies of the U.S. public health service as well as formulating and
carrying out public health policy. So I'd like you to welcome and
introduce Dr. Agwunobi.

Dr. Agwunobi: My name is John Agwunobi. And as my colleague just
indicated, I serve as the Assistant Secretary for Health in the
Department. I recognize that there's work to be done today, and that
this is truly a work session. To some degree, I'm but the garnish, and
so I'm going to keep my comments nice and short so we can move on to the
real purpose for which you're here. It's pretty clear, and Carolyn and I
have had these conversations over the years, that as our Secretary has
built transforming health care into his 500 day plan, his 5,000 day
plan, as he has clearly stated across the agency that he wants to leave
the department when he's done having impacted the health care of our
nation in a positive way. That it\'s incumbent upon all of us who work
within the department and all of you, the community, the larger
community, its incumbent that we holler the word quality wherever we can
and whenever we can. It's important that those plans to transform our
health care system, our health system in the larger sense, always have
the goal of improving quality. I'm very grateful to be here, although I
must admit I\'m not an expert in the field. I am a practicing, or have
been in the past, a practicing pediatrician. I have been on that front
line. And I recognize and understand that sometimes in the fog of the
clinical war, it's easy for us to reach out to tradition and to common
practice and to the quickest source of information that we can find. The
truth of the matter is we are a health system that has---suffers from
both too much and too little information. Too much in that there is so
much research, there's so much progress. We live in an era where there
is so much going on in both research and clinical medicine. So little
because it's hard to access. Sometimes it's hard to find the answers to
critical questions. There are gaps in research. It's hard to tell where
they are. And this process of trying to find a way to compare therapies,
compare interventions, rank opportunities, offers us an ability to
better organize all of that information, an opportunity to make for a
much better quality of health care delivery. Steven Wolfe wrote an
article---he's with the Virginia Commonwealth University---in the
Washington Post Outlook section, that hallowed journal of science, last
Sunday. And in it I think he stressed the point that we definitely as a
larger community need to push for greater efforts to help our health
care system deliver the best quality care to America's patients. As we
watch the sunrise on this dawning of genomics and the pushing into new
frontiers for clinical science, it becomes even more important that we
understand how these new opportunities rank relative to each other. Now
that I think about it, many of the old tried, true, and tested therapies
and interventions have never really been compared in a real scientific
way against each other in different settings for different individuals
and for different populations. And that's the challenge that we face.
Mark McClellan often says that high quality of care is absolutely
essential to any strong plan to transform the health care system. But he
also goes on to say as he is known that we can't afford to do it any
other way. It really is about money as well. That it's not just about
clinical outcomes, but a truly transformed health care system holds
quality first, but it\'s efficient. It's productive. We have to work
together. And I recognize that we haven't always made these kinds of
comparisons, these kinds of decisions out in the open. I blame Carolyn
for the culture of transparency, the culture of openness that she's
pushing, in trying to do this task. She wants your opinion. She
recognizes that there may not be consensus as we begin the discussion on
a particular subject. But she wants that lack of consensus to be
apparent. I urge you not to just listen. I think we're the ones that are
supposed to be listening in this particular forum. Participate. Don't
throw anything at us, however. The right place to start, you know, we
have to find a way to figure out where do you begin? It's a long
journey. The vast number of opportunities in terms of comparing
therapies, in terms of the ability to look at the difference and the
relative value of interventions. There are so many opportunities today,
and as science progresses, there will be so many tomorrow. So we have to
figure out a way, a strategy, to be able to select where we're going to
begin. What are the priorities? Now once again, I've sat next to
Carolyn, Dr. Clancy, on many different panels and settings, and I've
always felt a little inadequate beside her because of her intense
intelligence, and her understanding of research and the broader issues
that are involved in nurturing a research community. I'm told, however,
that she's not the smartest in her team. That there are many just like
her on her team. And it's true that we could turn this task over to them
and they\'d come up with a solid product, a strategy, a plan, and they'd
be done in maybe all of three days. But it wouldn't include you, and it
wouldn't include your perspectives, and it wouldn't include your points
of view. So I applaud this method of getting it done. This open approach
to trying to develop a strategy. The work is already underway, and
you've already participated. I would urge you to stay the course, stick
with us, and see it through to the end. And if there are others on the
outside that you think need to be a part of this, invite them to these
forums. Invite them into the debates. It is a listening session. So I
would urge you to also listen to what others are saying. You can learn
as much as we can from listening to a colleague from across the room. I
think as we look at this program we're seeing an important part of the
future of health care. This concept of not just knowing what's a quality
drug, what's a quality intervention, what's a quality piece of equipment
I guess would also be included, but also comparing one quality product,
one quality drug, one quality therapy to another to try to figure out
which works best in a given setting, which works best on a given
population for a given disease or intervention need. That's the way of
the future. I think the other piece in that test is getting to those
answers by including everyone. It's also relatively new. Over the past
two decades we've learned about the wide variation in medical practice,
and we've learned that there all too often is very little rationale for
the things that we do, or at least for the variation in the ways that we
apply those interventions. I was reading an article recently that talked
about the fact that we all too often over-research long after we've
proven a point, long after it's well established that an intervention is
effective, or not. We keep flogging that horse to see if it will move
any faster. I'm hoping that this process and others will be a way for us
to rationalize and to, not reign in, but at least put a semblance of
structure on that process. And you can only get there by involving
everyone. There's no way you could do this in some regulatory office in
the back room of a large stone mausoleum-type building on Independence.
You really have to come out and have a discussion. I'm happy to see a
systematic movement towards effective health care taking root in our
public health service agencies for which I have now been given the
unique honor of being a part of. I've actually only been on the job for
a few days. I congratulate AHRQ, and I congratulate Carolyn, for their
work and for their accomplishments in this young new program. I look
forward to the comments that we'll hear today. I'll be leaving a little
early, but we'll leave someone behind so they can brief me later on what
exactly was said. But focus on AHRQ, and on CMS, and on your colleagues.
I think the reverberations of the conversations, they may not be loud
noises that you hear, but I think the waves will travel far. I do know,
and I'll end on this, that the Secretary himself plans on using the
priority lists. For example, he asks every once in a while what are the
five most important diseases afflicting our community today? And every
once in a while he updates that. His 500 day plan contemplates those
kinds of discussions. And I'm hoping that we talk not only about what
are the priority conditions, how should we select interventions to be
measured and ranked against each other, to be compared in a relative way
against each other. I know for a fact that our secretary is going to be
looking to AHRQ for input as he tries to formulate his strategies and
his priorities for the future. And that you will influence him in these
conversations, so let it out as I know you have. Thank you very much.

Dr. Straube: Thanks very much, Dr. Agwunobi. I'd like to put into
context what CMS is doing and how the Effective Health Care Program fits
in with what we're doing and try to put this in a national context too
to show how important we believe this program is. I'm going to talk
through---I have some slides here for people in the room on Power Point,
and I'll try to talk through these for folks on the phone lines. First
of all, again, Mark McClellan sends his regrets. He really did want to
be here this morning, but much of what I will be saying here comes from
the leadership of Mark and the direction that he's put CMS in. I think
first and foremost, Mark has expanded the image, and the perception, and
the vision of what CMS is meant to do above and beyond our just serving
as a payer organization, as a beneficiary rights protector, and as a
quality improvement type organization. And what I'm referring to
specifically is the concept of CMS as a public health agency. And this I
don't mean going out and doing flu clinics and providing preventive care
services, which are all important activities. This is a much broader
grander view. It's using the agency's influence and the fact that we
spend \$600 billion a year on health care services to our beneficiaries
in our various programs to leverage and transform the entire health care
system. So we're going to be focused on working with other folks to not
affect just the Medicare and Medicaid programs, but the entire U.S.
health care system. The focus in this vision is not just for high
quality, although I've listed that here as the first priority. I think
we also focused on value, on efficiency, on cost effectiveness. And as
Dr. Agwunobi mentioned to you, these are all issues that Mark has been
very passionate about and has instilled in the rest of us in the agency.
And tied in with this is the need, in order to achieve those goals, to
assist patients and providers in receiving evidence-based
technologically advanced care while reducing avoidable complications and
unnecessary costs. I think that phrase really captures all of the points
that Mark has stressed to us inside CMS, and that directly relate back
to the Effective Health Care Program we're here to talk about this
morning. Just to put in international context, this is just showing the
growing number of Medicare beneficiaries over the years. And you can see
projected to year 2030. There is somewhat of an asymptotic rise here in
the number of beneficiaries. The other points I'm about to make are
especially relevant to us in our Medicare population, but it's also
relevant to the Medicaid, SCHIP, and the commercial health care sector,
as well as the uninsured in this country. This shows---the slide that
I'm projecting right now shows what we spend in the United States as a
percentage of gross domestic product compared to other industrialized
nations in the world. And as we all know, I think, in this room and on
the phone, the United States spends more as a percentage of GDP than
other industrialized nations. This is juxtaposed to the fact that---I'm
now projecting a slide which shows the results of a seminal study that
Beth McGlynn and folks at the Rand Corporation did, published in the New
England Journal about two and one-half years ago now where they judged
patients coming in to a doctor's office, whether they received the type
of care the national consensus guidelines would suggest they should
receive. And Dr. McGlynn's study showed that about just barely over half
of patients coming to a doctor's office on average received recommended
care. The slide also projects here variation with respect to individual
disease states. The best that was listed in the study was cancer care
where 76 percent of women received recommended care. But I would flip
that and say 24 percent, even in the best condition, did not receive the
type of care that they would be expected to receive under guidelines.
And when you go to some other disease states such as hip replacements,
pneumonia care, et cetera, as you can see on this slide, the care
received was clearly way out of conformance with recommended guidelines.
This slide shows---what I'm projecting now for the folks on the line is
again, Jack Linberg's, one of his typical geographic variations across
the United States. This projects differences of the amount of money
spent for hospital care for Medicare beneficiaries across the country.
Now for those folks in the room, the dark red colors reflect high levels
of spending, on average about \$3,500 per beneficiary per year. The
whiter colors reflect lower spending, an average about \$1,500 per
beneficiary per year. And for the folks on the phone, there's great
variation. There are concentrations of very high spending, not
surprisingly in some urban areas like Los Angeles, New York, Chicago,
the Bay Area in California, et cetera. But surprisingly there are many
rural areas where the expenditures for hospital care are very high also.
But the main message from this slide is that there is gross variation in
the dollars being spent for health care across the United States. Now if
you keep in mind this slide for those of you in the room, and for those
folks on the phone, I'm now showing a slide which reflects the quality
of care based on CMS hospital quality metrics received across the United
States. And on this slide it's in black and white. The dark areas are in
fact the lowest quartile of performers, that is, the worst amount of
care. The white areas are the highest quartiles. And if you remember
back to the prior slide and for the folks on the phone, there seems to
be some relationship between high expenditures and poor care outcomes
conversely to the areas that are the lowest spenders that have the
highest quality of care outcomes. So again, gross variation in
expenditures across the country, gross variation in quality outcomes,
and perhaps some inverse relationship between the amount of money spent
and the quality of care that we receive in the end. CMS developed---this
past summer we published a CMS quality road map. And our vision is to
have the right care for every person every time. We have six aims which
align with the Institute of Medicine\'s six aims of safety,
effectiveness, efficient care, patient-centered care, timely care, and
equitable care. And we have five strategies that we intend to roll out,
our quality agenda in 2006 and beyond. I've listed them here on the
slide. The first, which is germane to this session, is to work through
partnerships to achieve specific quality goals. And again, we have to
have broad open consensus efforts with multiple stakeholders at the
table in order to achieve our quality goals across the United States.
And this forum is an example of that. We also believe very strongly in
publishing quality measures and information as a basis for supporting
more effective quality improvement efforts. Again, germane to this
session because of the effective health care studies that Carolyn and
her team are developing, and the need to publish those, and get them out
to providers and beneficiaries. The third strategy is the need for us to
reform our payment system. Again, we're not going to be talking about
that today. But clearly the evidence that comes out of these reviews can
be used in a variety of ways in so called pay-for-performance
initiatives and can be tied in in other ways to the reforms that we're
going to be making and that Congress will make in our payment system in
which we pay health care providers. The fourth strategy is we need to
assist practitioners in making care more effective and less costly,
particularly through the development of health information technology.
And I think that health information technology is going to be very, very
important to disseminate the results of the effectiveness reviews that
are being done by AHRQ. As an example, the Web site already is a very
effective tool in trying to include many, many folks and assist
practitioners in providing better care. And then last but not least,
we're focused on a fifth strategy which is trying to bring effective new
treatments, but also effective assessments of those treatments to
patients and providers in a more rapid manner, to develop better
evidence so that doctors and patients can work together to use medical
technologies in treatments in a more effective manner, and to improve
the quality of the care while avoiding unnecessary costs and
complications, as I mentioned earlier. Again, I'm going to let Carolyn
in her remarks talk more about MMA section 1013 so I'll skip over that.
But, we did in conjunction with AHRQ and some other stakeholders select
ten conditions that affect Medicare beneficiaries in particular, and
people will be commenting about those and others this morning. I've
listed them here: ischemic heart disease, cancer, chronic obstructive
pulmonary disease, stroke, arthritis and non-traumatic joint disorders,
diabetes mellitus, dementia, pneumonia, peptic ulcer disease, and
depression and other mood disorders. Clearly conditions that affect the
Medicare population. Our partnership with AHRQ, we have been represented
on the review committee that has looked at proposals for the DEcIDE
research centers that I suspect Carolyn will talk about and people will
comment on today. We've also been supporting the registry project which
is addressing topics of registry creation, registry operations, and the
evaluation of the design and operations of registries. And as I said,
Carolyn will likely review other aspects of the Effective Health Care
Program. Why do we need---why do we at CMS believe we need comparative
effectiveness reviews? Well, several points to be made. First, they
provide a sound foundation of evidence about which treatments work best.
And we believe that this is essential to help doctors and patients
achieve the best quality health care. We need to have such information
available in useful and understandable formats. And I think again, the
first report that's been put out and the presentation on the Web site,
et cetera, is evidence of where we need to be heading. We think that
AHRQ's issuance of the first review and subsequent reviews are simply a
milestone in achieving our goals at CMS, but likewise everybody in the
health care system achieving their goals. And we feel that because of
these reviews, that Medicare beneficiaries and their doctors and other
clinicians clearly have better information now about costs and benefits
of treatment for now one condition, but soon to be many, many other
conditions in which multiple treatment options are available. We think
that better evidence is a centerpiece of the prescription drug program
which we've just launched, and other reforms which are being implemented
by CMS right now to try to bring the Medicare program up to date. So
this Effective Health Care Program is essential to help us achieve that.
We need to do more to learn about and measure the effectiveness of
alternative treatments for common health problems. And this is the first
step in that regard. We also need to do more to help patients and
doctors get unbiased practical useful information on benefits, risks,
and costs. I've listed on this slide, and for the people on the line I
don't want to go into great detail, but we have a number of other
initiatives at CMS dealing with evidence collection, evidence
development, and evidence implementation. And they include the use in
our national coverage decision process including our most recent
coverage under evidence development process which we have just
implemented over the past year. We clearly are using evidence
development to help us in developing quality measures and benchmarks
both for quality improvement efforts as well as pay-for-performance
programs which are becoming more and more known to the American public.
We clearly use evidence in selection of new medical technologies and
innovations within the Medicare and Medicaid programs. We've been
listing medical evidence information for our beneficiary and provider
use and consumer use on our Web sites, the Medicare Compare ones in
particular. We use them in medical guidelines, clinical guidelines,
dissemination is a key part of our quality improvement programs. We use
them in the prescription drug program we just launched. We use them in
the Medicare Advantage Program. We use them in our health information
technology strategies and e-prescribing that are currently being
provided. And the list goes on and on and on. So in summary I think
again that the use of better evidence in clinical care and health policy
decision making will improve the quality of care, will improve health
outcomes, and well-being of patients. It will achieve better value for
health care dollars spent, and it will promote better health care
partnerships between patients, and doctors, nurses, and other
clinicians. And we at CMS certainly look forward to today's sessions
with the identification of new topics for effectiveness reviews. That's
the CMS perspective. And I now take great pleasure in introducing Dr.
Carolyn Clancy who is the Director of the Agency for Health Care
Research and Quality. Carolyn is a leader in health care in the United
States. She's certainly a colleague that I respect and look to for
counsel many times, and certainly helps us at CMS in innumerable ways in
improving our quality agenda. Dr. Clancy.

Dr. Clancy: Thank you, Barry, and good morning. I think you can see how
much we enjoy collaborating with CMS on a regular basis, and why I was
so excited. One of my best Christmas gifts was learning that Dr.
Agwunobi had been confirmed about a week before the holidays. So I want
to welcome all of you here in the room and on the phone to the second
listening session for the effective health care program. I'm really
pleased at the turnout. This is not a great weather day, but including
everyone here, I've been looking forward to this, to a way to continue
our work as the Secretary identifies the next round of priorities.
What's new about this new authority in the Medicare Modernization Act
are a couple of things. It's all about informed choices. Today Americans
have many, many situations where there are two or more options for them
to choose from. And the information that is going to be produced from
this program is actually going to help them make better choices about
what's right for them as individuals. This program does not make
recommendations or prescriptions. It's not about guidelines. It's about
presenting people with the facts in a way that they can understand. It's
also very much about ongoing engagement with all of you. So I think John
Agwunobi emphasized that very, very clearly. So again, it's part of the
reason I'm thrilled that you're here today. So let me wish all of you a
happy new year and tell you that the timing for today's session couldn't
be better. It's a new year, and it's just a few weeks after the release
of our first comparative effectiveness review on GERD, or gastro
esophageal reflux disease, for those of you who occasionally leave the
world of acronyms. I want to say---express my thanks and gratitude for
all the work our stakeholders have done both in preparing this report
and helping us to spread the word about the findings which shows that
certain drugs can be as effective as surgery in the treatment of GERD
which affects more than 10 million Americans. And I'm really very, very
pleased by the response from CMS to this report as well as from a broad
array of stakeholders across the health care industry. By comparing
treatment alternatives for GERD, examining their effectiveness, and
reporting the findings in a way that is immediately useful to patients,
providers, and payers, we believe that the program has already begun to
demonstrate its value right out of the gate and there's a whole lot more
to come. In the coming months we're going to be releasing a series of
reports of comparative effectiveness reviews on high priority topics
that include breast cancer diagnostics, heart disease, stroke, and
depression. So let me tell you right now a few areas that we would love
to hear from you. Before I do that, I'm going to just walk you through
one of the three components of the program. The priority setting is a
very, very clear part of it, and as Dr. Agwunobi mentioned, there was a
very nice article also from that journal, the Washington Post, recently
making the case that we would be much better off as a country if all of
our investments in very large trials and very large clinical studies
were preceded by systematic reviews. And that's exactly how this program
is set up. We start with systematic reviews, establish priorities, start
with systematic reviews. Those reviews will identify what we know, and
will also identify very important research gaps at which point we will
then be turning in two directions. One is to a new research network
called DEcIDE that Barry mentioned very briefly which takes advantage of
the fact that many health care organizations have already begun making
big investments in electronic health care data at the patient level. So
we're going to take advantage of that. Sometimes that network will help
us fill gaps, other times we're going to have to turn to partners in the
public and private sectors to address the research gaps that are most
important to address. But any time we do establish those partnerships to
launch very significant studies, we'll do it with the confidence that we
know that we've already done the systematic review to know that we're
not flogging a dead horse as Dr. Agwunobi said a few minutes ago. The
third part is the English to English translation part. No researcher on
the planet thinks that they're not putting things incredibly clearly.
And they are. Often for the researchers it is very, very difficult to
communicate scientific information in a way that everyone can understand
and use and understand what it means for them. To that end in
recognizing how challenging it is we've established a new center out at
the University of Oregon which will help us get better and smarter at
this. In your book you'll see the summary of the first review as well as
the patient page. That's only the beginning. We're also going to be
looking for partnerships to be able to get this information into
personal health records, into a variety of venues so people can use it
when they need the information. This center was named in honor of our
prior director, Dr. John Eisenberg. So we're hoping that we get better
over time in terms of making this information actionable and
understandable to a broad array of audiences. Now for systematic
reviews, choosing the topic area is very, very important, again why I'm
glad that you're all here today. Secondly, though, is actually getting
the questions right. Right now on our website there are some key
questions that we're putting out for public comment. And some specific
areas I just wanted to mention to you. One is the comparative benefits
and harms of drugs for Alzheimer's disease. Another is the comparative
long term benefits and harms of ACE inhibitors versus angiotensin
receptor blockers, or ARBs, for treating hypertension. Another is
comparative effectiveness of review of coronary artery stents versus
bypass surgery. And the list will go on and grow over time. So please
know that in addition to giving us feedback about priorities, in
addition to the opportunity to weigh in on the draft reports, we also
want your input so that we make sure we get the questions as correct as
possible. So my expectations today are great for several reasons. One,
all of you are here and on the phone. Secondly, after the first session
I think all of us left terribly energized. This program will be
successful to the extent that we can continue to engage all of you
throughout the process. And so far, I think we're doing very, very well.
We very much appreciate your commitment and combined wisdom, and your
collaboration is going to help us ensure the long term success of this
program. And we think we're off to a good start. The second reason I'm
confident about the success of this program is the equality of the
process we're using. Dr. Agwunobi emphasized the notion of transparency,
and every step of this process will be transparent, from establishing
priorities to the opportunity to comment on questions, to the
opportunity to comment on draft reviews. I should note that we actually
solicit reviews as well. But any citizen can actually go to our Web
site. For those of you in the room, that page is in your book,
effectivehealthcare.AHRQ.gov. For those of you on the phone, I think you
just heard us say it again, and we'll remind you before the session is
over. So as we gear up for the next set of priorities, we're very much
looking to all of you to give us the best kind of input possible.
Finding ways to deliver effective health care to all Americans is a task
that\'s worthy of all of our efforts and enthusiasm. And I don't think I
need to tell all of you that it's a big job. As George Carlin, the
humorist, is fond of saying, some people think of the glass as half
full, and some people think of it as half empty, and some people see the
glass as just plain too big. The glass, if you will, the health care
system in front of us is pretty big. But there is no doubt that our
commitment to turning evidence into action is much greater. With each
topic that we select, with each comparative effectiveness report that we
release, with each informed choice made by patients, providers, and
payers we serve we're making a difference. Thank you again for joining
us today. And now we get to listen. Thanks.

Dr. Straube: We're ready to start the formal part of the listening
session. And the format for this, again we have a large number of people
here in the room present, but we also have a very large number of people
on the telephone lines. So we're going to alternate. We'll begin here in
the room in D.C., but we'll periodically go to the telephone lines and
ask people there. I'd like to ask folks to first of all try to keep your
comments to three minutes or less. I know that's hard sometimes, but we
want to try to get as many comments as we can. And for those people in
the room here, we do need you to use the handheld microphones. This is
being recorded this morning, so that other people in the room can hear
you and people on the telephone line can hear you. If you would all
identify yourself by name and the organization you're with, that would
be very helpful also. So I think we'll start here in the room. Who would
like to make a comment or statement?

Mr. Burkholder: My name is Randy Burkholder. I'm with the Pharmaceutical
Research and Manufacturers of America and the policy department there. I
first want to just thank all of the speakers who have already made
comments, Dr. Straube, and Dr. Clancy, and Dr. Agwunobi, for the high
quality of your thoughtful comments. And I wanted to just start by
underscoring the fundamental importance of the shared commitment to the
goal that Dr. Agwunobi articulated when he opened, which is the shared
commitment to improving quality in health care and to transforming
health care by starting with improved quality as the basis for getting
better value and as the basis for reducing the cost of disease. I also
want to make a point that I think we still see something of a persistent
disconnect between that goal and the research agenda that has been
undertaken thus far under section 1013. In regards to Dr. Wolf's piece
in the Post on Sunday and as well as the work of John Weinberg, I think
they both make the fundamental point about the importance of health
system's challenges and addressing basic health system challenges if we
truly are going to transform quality in this country. And the
fundamental point we would make is to orient section 1013 towards
engaging in those health system level issues to truly make a difference
in improving quality. I'll try to hit on just a few other points. We
certainly appreciate the opportunity to provide comments. And we do
believe well-designed health outcomes research from the public and
private sectors such as that described in section 1013 can help us make
the fundamental quality improvements we need, can empower physician and
patient decisionmaking. We recognize and appreciate the important
progress that HHS has made in implementing this section of MMA over the
past couple of years, most recently and notably through the rollout of
the Effective Health Care Program a few months ago. At the same time, as
I indicated, we do remain concerned that key elements of this provision
have not been implemented, and we believe some further steps could be
taken to improve the transparency and openness of the process. I would
also point out in regards to the orientation of the program that
Congress, in passing its funding bill this year, affirmed both the
direction AHRQ has taken in beginning with the disease-based approach to
research under section 1013. It also underscored the importance of
conducting research in additional areas such as the organization,
delivery, and management of health care items and services, research
which directly addresses points made by those such as Steven Wolf, but
research that we feel has not yet been addressed by AHRQ, yet is
mandated in the statute. So we believe that is an important area to
consider going forward under the program. Finally, two other quick
points. One, just since enactment of MMA there has been a considerable
additional research that's affirmed the importance of this broader
quality-centered research agenda mandated by Congress. Just two quick
examples, an August 2005 study in the Annals of Internal Medicine found
a strong link between improved quality of care and better survival among
vulnerable older patients. Quality indicators in this study looked
across the continuum of care, at processes of care, patient follow up,
prevention, diagnosis, and treatment. Another recent study published in
Medical Care found that increased compliance to prescription drug
regimens improves clinical outcomes and can reduce medical costs.
Finally, a lecture that I know Dr. Clancy you're familiar with, Don
Berwick's, John Eisenberg lecture in April 2005 called on health
services researchers to adopt broader health systems approaches to
research in order to address the fundamental health system challenges we
face. We do appreciate AHRQ's support for research that looks at this
broader scope of inquiry. For example, the special emphasis notices
recently published by the agency looks like it's an example of that. We
appreciate that perspective. We think it's important to build that
perspective into implementation of section 1013 as well as directed by
Congress and stated in the statute. Regarding process---and if I'm
running over my time, just cut me off please. But we appreciate the
steps AHRQ has taken as well to establish broad and ongoing process of
consultation such as through these meetings, other steps as well, such
as the implementation of an electronic docket for review of input you've
received also has been valuable. We recommend a couple of additional
steps to improve the openness and transparency of the program. First,
AHRQ should, through an open public process, develop clear objective
criteria for selecting research priority topics, and when it proposes
research topics can then provide the rationale based on those criteria.
Finally, we would recommend a consistent approach to soliciting comment
on draft reports when they are released. We trust that will be the
approach going forward, but note that in release of the first couple of
reports, one has been released as final and one has been released as
draft for public comment. We would hope that going forward all of those
would be released as draft with opportunity for public comment. So we
appreciate the opportunity to provide and thank you. We appreciate the
opportunity to provide input today and we look forward to continuing
working with you to support a well designed research agenda under
section 1013. Thank you.

Dr. Straube: Thanks very much for your comments. I want to commend for
commenters going forward, the specific suggestions are very, very
helpful. So I thank you for your specific comments on how we might
improve things. Another question here in the room or on the phone?

Operator: Yes, we do have a question from Tricia Leddy. Please state
your organization.

Ms. Leddy: The Rhode Island Medicaid Program.

Dr. Straube: Tricia, go ahead. You're on the line.

Ms. Leddy: Hi. I just wanted to comment on, from the perspective of
Medicaid and running a Medicaid and SCHIP program for families. I looked
at the ten priority conditions that were set, I guess it was last year.
And most of those conditions focus on conditions prevalent in older
people. What we struggle with in running Medicaid and SCHIP programs
particularly for families are conditions that aren't necessarily listed
on that list. And I wanted to suggest that maybe some of the conditions
in the future be focused on some of the areas where States struggle to
know whether to cover a treatment or not. And specifically, I would
suggest that for children and for adults, that behavioral health for
people who are on our program, not just because they have a behavioral
health condition, but that behavioral health is a very big issue. We
have to decide all the time about what type of treatment is best. And
because in some areas such as in Rhode Island there's a shortage of
psychiatrists and particularly child psychiatrists. Primary care
physicians really struggle with these kinds of issues. The specific
conditions I would say get the most questions are depression, which I
noted is on your list already, but also other mental health conditions
such as bipolar disorder and schizophrenia in adults. Those three
conditions result in a lot of hospitalizations. They're the number one
cause of hospitalization as a group for our disabled adult population is
mental health conditions in Medicaid. And for children, conditions such
as conduct disorder, and ADHD, and ADD, where there is a lot of
treatment, drug treatment. There are often not available enough child
psychiatrists to be able to on an ongoing basis monitor that treatment.
And primary care physicians are put in the role of having to make
decisions about what's the appropriate treatment for mental health
conditions in children. And those are just a couple. Another related
thing that we really do struggle with as far as treatment is concerned,
and this is not necessarily drug treatment but other kinds of treatment,
is autism. Autism spectrum disorders are a big issue in Medicaid and
SCHIP, and there are treatments that we are covering and asked to cover
such as very intensive home based therapy. They're expensive treatments.
We want to make sure we're covering the most effective treatments, and
yet there is not a lot of research out there about the effectiveness of
the treatments. There are a few different kinds. They have different
names. There's little research with few subjects about these treatments,
and we want to make sure that those treatments that we are funding are
effective for the children that have autism. So it would be great to
have guidance on that. Another thing that is more and more prevalent in
our society is obesity. And thus Medicaid and SCHIP often gets questions
and requests to cover procedures such as surgical procedures or drugs to
treat obesity. Guidance on that such as when to cover a treatment
for---a surgical treatment for obesity would be useful to us. I would
say another issue that results in enrollment and cost for both Medicaid
and SCHIP is infertility treatment. There are 12 states including Rhode
Island that have a mandate in our state health insurance laws to cover
infertility treatment. Now infertility treatment is not covered on
Medicaid and SCHIP. But what we're finding from the very useful data
that CDC puts out in their PRAMS data set that infertility treatment is
associated with a higher rate of babies born with special health care
needs resulting in neonatal intensive care admissions and other ongoing
health problems. We find that a lot of these infants do end up, even if
the mothers were not on Medicaid or SCHIP during pregnancy, that because
of their special health care needs or because of the working or
employment condition of the family changes, that these babies do end up
on Medicaid and SCHIP. And some of the age ranges of the women who are
having babies conceiving using infertility drugs and other treatment are
from young to old, and from 20 into 40. And I wonder if there are some
kind of guidelines that could be developed for when is it appropriate to
use infertility drugs given that---is it only after a year, such as our
state law in Rhode Island says, of not being able to conceive, or given
that there would be---at least in Rhode Island--a twice as likelihood of
having a baby go to the NICU after infertility treatment.

Operator: Okay, Ms. Leddy. We'd like to remind you of the three minute
limit.

Dr. Straube: Tricia, again, I think you made some very helpful
suggestions there. We're going to have to move on to the next question
asker. Thank you for your comments. We appreciate them very much. We'll
go here in the room and we have a question up front.

Mr. Milzman: Good morning. My name is Dave Milzman and I'm a practicing
emergency physician here in the District for almost 20 years. I'm
representing today the American College of Emergency Physicians. Myself
and almost 30,000 other physicians certainly appreciate this opportunity
to address you. As you know, we are on the front line 24-7, providing
not only care for all urgencies and emergencies, but as our self-dubbed
health care safety net. We feel that we are a very active participant in
all of the diseases under 1013 that you have elucidated. We see all
forms of those diseases from acute exacerbations of COPD, asthma. We see
the failures of arthritis treatments. We see acute problems with
ischemic disease, as well as a high rate of recidivism with many of
these diseases when both pharmacologic and surgical treatments fail.
Based on this, we would like to let you all know that the American
College of Emergency Physicians very much shares your research agenda.
And based on that, that we want to let you all know that we feel that
there's a serious need for the acute care perspective that we offer more
than anyone in terms of significant numbers in the assessment of any
device, drug, or other technology. That based on rates of repeat
visitors, for instance, depression, we see a lot of those patients on a
recurring basis that might not be picked up if you're basing it just on
office care numbers. And in addition to the national ambulatory care
registries, still these are retrospective, but any prospective
evaluation we feel should involve our perspective. And I'll easily stay
my three minutes. Based on the Institute of Medicine report there
continues to be a need to support the foundation for emergency medicine
research at AHRQ. And we also strongly urge AHRQ and HHS to give a
significant consideration of your priority conditions in their acute
care phase in the emergency department when assessing what drugs are
actually available to the general public. There are many drugs that just
aren't available within the emergency department setting or the
ambulatory setting that many Americans either cannot afford or cannot
get access to based on their payer plans. And in the end while we fully
support the guidelines for your patient registries which we do
appreciate, we know better than anyone that these registries, without
including more of the acute care perspective in them, would be mistaken.
And lastly, we just ask that you give priority to the continued support
of emergency medicine in this and in all future evaluations, and that
the American public is very well aware of our availability on the 24-7
basis. And we do appreciate the continued support. Thank you.

Dr. Straube: Dr. Milzman, thank you for your comments. Operator, before
we take the next questioner on the line and then we'll come back here,
have we made it clear to everyone on the telephone line how they get
into the question queue?

Operator: That is correct. If you'd like to ask a question press \*1 at
this time and please limit your remarks to a maximum of three minutes.

Dr. Straube: Okay. And do we have someone on the line then, Operator?

Operator: Yes, our next question comes from Doris Lotz. Please state
your organization.

Dr. Lotz: My name is Dr. Doris Lotz. I am the Medicaid Medical Director
for the State of New Hampshire. And what I would like to say is that
there is so much opportunity in Medicaid and so few internal resources
that we rely very much on Federal agencies like yourselves to do this
kind of research and to make it publicly available so that we can build
policy off of it. That being said, there's no specific topic that I
would like to draw your attention to. What I'd rather do is talk about
specific contents for each topic that you may take on in your research
agenda. Specifically, in reinforcing some statements that were made
earlier, we need cost effectiveness information. It's very helpful
certainly to talk about what exists out there with respect to comparing
clinical treatment one to another. But without the cost effectiveness
information, it's incomplete. In addition, I'd like to ask that part of
your research agenda be to look at more head to head comparisons for
which those little industry interests or research funds to do. We need
the kind of information that takes new drugs, new technologies, new
pieces of equipment, and compares that to what is currently out there
that is certainly less exciting but perhaps more cost conscious. And
that research is not being sponsored by anyone else. So I find often
times that the best treatment is a value judgment and we need
information on cost effectiveness and information on how emerging
technologies, emerging new medical interventions compare to existing
ones to really set an appropriate policy agenda, especially for public
payers like Medicaid.

Dr. Clancy: Thank you very much. I can tell that enthusiasm is really
starting to pick up here in the room, and I'm sensing on the phone as
well. Since we will be here until 11:30, if you don't get a chance to
put your two cents or two hundred dollars, however you want to think
about it, to state your comments today, we very, very much welcome
comments which you can submit through the Web site. And you can submit
them any time. For those folks who have spoken up quite passionately and
articulately about Medicaid and SCHIP, I just wanted to clarify one
point. You're quite right that the first round of priorities was focused
on the Medicare population. This was the decision of then-Secretary of
Health and Human Services Tommy Thompson. We are quite explicitly
looking to broaden that mandate for here. So your comments will be
heard. I can assure you of that.

Dr. Straube: Thank you. Next question is here in the room.

Ms. Montalvo: Good morning. This is Isis Montalvo from the American
Nurses Association. Thank you for the opportunity to comment on the
Effective Health Care Program at AHRQ's listening session. The American
Nurses Association considers the registered nurse component a critical
component in any health care program. As you proceed in establishing
priorities and reviewing your Effective Health Care Program, we ask that
you consider including language that evaluates the entire health care
process. The nurse is in a pivotal role in assessing, planning,
implementing, and evaluating interventions. For example, teaching weight
management and intake and output measurements for the congestive heart
failure patients. Teaching patients and families to change injection
sites when administering insulin. Evaluating a patient\'s response to
therapy and how compliant the patient is in following their treatment.
As you proceed in selecting a new condition or selecting a comparative
review from existing conditions, the Effective Health Care Program would
benefit from inclusion of all related nursing interventions and
identification and evaluation of those nursing outcomes. Thank you.

Dr. Straube: Thank you very much. We're going to the phone line now.
Next question.

Operator: We have a question from Sue Tolleson-Rinehart. Please state
your organization.

Ms. Rinehart: Good morning. I'm calling from the UNC CERTs at the
University of North Carolina at Chapel Hill. The UNC CERTs is the
nation's only center for education and research on therapeutics devoted
to pediatric therapeutics use. We have a global concern. Children are
not small adults, as we all know, and the history of concern for the
protection of children as human subjects, combined with an absence of
obvious economic incentive has in the past significantly reduced the
number of drugs actually labeled for pediatric indications. If you put
these two things together you see an urgent need for more and more
pediatric therapeutics effectiveness research of all kinds for all
conditions affecting children. Recent legislation has improved this
situation somewhat. But even now by the FDA's count, 50 to 75 percent of
drugs used to treat the pediatric population are not labeled for
pediatric use. We need more comparative effectiveness research and
pediatric therapeutic use across the board. Now to three more specific
questions related to SCHIP. North Carolina like many other states,
created a separate SCHIP program. Now, like other states again, it is
moving at least some of its SCHIP age groups into Medicaid in an effort
to reduce costs and increase enrollment. This change and general
questions of delivery of high quality care to SCHIP-eligible children
suggests several areas of research, not restricted to diseases or
conditions, but for questions of therapeutic use generally. North
Carolina is presently experimenting with a voluntary academic detailing
program to reduce Medicaid drug costs with the ultimate goal of moving
toward an effective formulary. We urge more systematic research on the
comparative effectiveness and cost effectiveness of drugs both common
and more exotic used to treat children and the effectiveness of the use
of formularies to improve quality and efficiency, and perhaps to
standardize pediatric treatment. Our State's Medicaid primary care
managed care structure which is now beginning to include SCHIP-eligible
children under the age of six is experimenting with the use of standing
orders for prescriptions to transfer prescriptions to appropriate
in-network medications so long as there's no clinical reason not to do
so to reduce cost and improve effectiveness. We urge more research on
strategies such as the use of standing orders to evaluate comparative
effectiveness and to improve quality and efficiency. And finally, in
North Carolina, specialists, pediatricians, and others, will be
reimbursed 30 percent less in the Medicaid fee schedule than under the
SCHIP schedule as it had been constituted. As SCHIP-eligible children
under the age of six are moved into an expanded Medicaid program, will
this change reduce the incentive for specialists to see children in
these public programs? The literature does suggest that such reductions
in incentives can reduce access to care. So we urge more research on
such questions of access to pediatric specialty care for children
relying on public programs as a part of the larger consideration of
effective care. And the UNC CERTs thanks HHS and AHRQ for this
opportunity to participate this morning in the discussion on ways to
make care of our nation's children more effective. Thank you.

Dr. Straube: Sue, thank you very much. Great comments. We now have a
question here in the room.

Ms. Lee: Good morning. My name is Teresa Lee, and I'm here on behalf of
AdvaMed, the Advanced Medical Technology Association. AdvaMed is a trade
association that represents the medical device industry, and our members
include more than 1,300 medical technology manufacturers of all sizes.
We appreciate that HHS has held this forum today. We at AdvaMed have
been closely following AHRQ's efforts to implement section 1013 of the
MMA. And we've seen a good deal of activity on this Effective Health
Care Program from priority setting, to comparative effectiveness
reviews, to evidence generation, to communications of research findings,
all in a remarkably short time frame. We've noted the sheer volume of
activity that has taken place in a remarkably short period of time.
Overall we support comparative effectiveness research when it is done
appropriately because it can provide valuable information for patients
and physicians. However, we believe that comparative effectiveness
research is not generally appropriate for the use in the context it
covers decisionmaking because the treatment that is more effective on
average may not necessarily be best for a particular patient. We believe
that it is critical to protect the physician\'s ability to make
independent medical judgments for individual patients. For medical
devices in particular, comparative effectiveness research poses distinct
challenges. For example, medical device technologies pose a difficult
moving target for technology assessors due to the iterative and
continuous nature of device innovation. Medical devices have quite short
life cycles compared to drugs, and their effectiveness is dependent on
user training and physician experience. In studying medical devices,
assessment findings can quickly become dated as the technology matures
and physicians gain user experience and training. Consequently, a
snapshot of comparative effectiveness of a particular device at a
specific point in time may potentially understate the effectiveness of
an innovation. Today I have some very brief comments concerning the work
that is currently underway. First, the priorities you've established
through listening sessions and public comments are ambitious. We tend to
think that if they are to be expanded, you might also address areas
where there is underuse of proven interventions that would improve the
effectiveness and efficiency of the Medicare and Medicaid programs which
is the statutory mandate, statutory goals section 1013. We note that
evidence-based practice requires practitioners to not only avoid the
overuse of ineffective care, but also the underuse of effective care. In
addition, we note that section 1013 requires research on improving the
efficiency and effectiveness of Medicare and Medicaid through the
examination of ways items and services are organized, managed, and
delivered under these programs. And to date, AHRQ has not yet addressed
these priorities. In addition, we've noted that AHRQ has undertaken a
number of specific research endeavors and we commend the extensive
outreach efforts via the Effective Health Care Program Web site.
However, in comparative effectiveness reviews and with respect to
evidence generation, we note that the initial set of specific research
topics were not vetted publicly. And while we believe this was due to
AHRQ's desire to move quickly to implement section 1013, we think that
the law\'s requirement for broad and ongoing consultation with
stakeholders is equally important. Our concern is that these specific
initiatives need to be discussed as fully as the broad research
priority. For the research efforts already underway, where those topics
were not openly vetted, we believe those efforts should be made to
extend---efforts should be made to extend the comment period on studies
as they are prepared. We also think that the times allotted for public
comment on draft studies seem to be a little bit short, and that this
may potentially impact the quality of the public comment. We also want
to commend AHRQ for its efforts for communicating clearly and fairly the
findings of its comparative effectiveness reviews to date. We understand
the importance that the agency is placing on this matter, and the
results to date are commendable. We have some concern, however, with how
the evidence generation efforts AHRQ is undertaking as part of the
Effective Health Care Program will be handled. Our concerns do not
relate to the research on the methods that are underway, but rather to
the collection of observational data on particular interventions. The
rationale for selecting and prioritizing the current efforts is unclear,
and we think that this should be made available to stakeholders. We also
think that this data, due to its observational nature, needs to be
weighed carefully and should not simply be posted. We at AdvaMed
appreciate this opportunity to comment on this important program. Thank
you.

Dr. Straube: Teresa, thank you very much. Some very good comments. I'll
take the opportunity to put a plug in again for
effectivehealthcare.AHRQ.gov, the Web site, because I do think again
some of what you mentioned can be partially dealt with if people in
between times go to that Web site and make comments on any topic. But I
think your comments are well taken. We're going to go here in the room.

Ms. Shearer: Thank you. My name is Gail Shearer, and I'm from Consumer's
Union. I'm the director of health policy analysis at Consumer's Union,
and the director of our effort to translate evidence based medicine on
behalf of consumers which is called Consumer Reports Best Buy Drugs. I'd
like to start by commending you on your strong start in implementing
section 1013 of the MMA. As you know, the initial funding was a small
down payment in light of the scope of the task ahead, and we commend you
for making the most of this early funding. I'll briefly address some
findings from work that we have done that demonstrate why the work that
you are doing is so important for both the health and the pocketbook of
the nation's consumers and taxpayers. Our project at Best Buy Drugs
launched in December of 2004. We launched with three categories. We're
now up to ten categories where we look at the comparative effectiveness
and the comparative cost effectiveness of drugs in ten very common
categories: high cholesterol, high blood pressure, arthritis pain, acid
reflux disease, depression, menopause, allergies for example. Our task
is to translate complex systematic reviews of the clinical evidence of
effectiveness for consumers and their doctors so that they can put the
findings to work for them in the selection of drugs. We've also
translated our short reports into Spanish. We've prepared print
materials, two-page and twelve-page booklets, in our effort to get the
word out to consumers. During the month of December, we had about
150,000 visits to our site, and about 65,000 downloads from our sites,
and about 65,000 downloads of our reports. So as you can see, we're
getting some traction, but we're still at the beginning. And we realize
that we need to focus on the challenge, as you will when your reports
are completed, as how to get this important money saving and health
improving information into the hands of consumers. And we look forward
to working with you on that challenge. I wanted to talk a little bit
about two lessons, two key things that we've learned. First is that we
can have a major health impact. This kind of information can have a
major health impact. Just looking at one of the categories which turns
out is the category that is most often downloaded. It's the most
interest of consumers, and that is cholesterol reducing drugs or
statins. In our analysis, we found that if a person needs a modest
reduction in their cholesterol, they had a variety of drug choices that
were equally effective in meeting their cholesterol-reducing goal. One
of them, generic Lovastatin was available at a cost of about \$1 a day.
Many people who need modest reduction in their cholesterol are actually
spending about \$5 a day. Well, in this nation we have tens of millions
of people who cannot afford their statins, and if we can get this word
out about equal effectiveness of drugs and help people have access to
drugs at an affordable amount of money, I think that we can have a
dramatic effect on health care in this country. A second major lesson
and it has to do with the potential to save taxpayers and consumers
billions of dollars. Today we are releasing an update of our statin
report. We've updated the clinical effectiveness information and the
drugs that are available, and the price information for the
cholesterol-reducing category. But we're also releasing an analysis of
developments in the market place, the sales of various statins and the
price over time. But what we've done today is we've done an estimate of
what's at stake as we turn to a new Medicare benefit. What's at stake
for taxpayers and consumers when the generic of Zocor, simvastatin
becomes available in June of 2006? Our findings were very dramatic. A
lot of money is at stake. We estimate that if people switch from the
high priced brand drugs to generic Zocor, simvastatin when it is
available, that nationwide in the year 2007 the potential savings are on
the order of \$8 billion a year. Now as we all know, not everybody is
going to switch for one reason or another, but it's important to
understand the scope of money that is at stake. And this is just for one
widely used drug category. Access to information that educates the
public that the lower cost drug is as effective as the higher cost drug
is essential to achieving these savings. Turning to some comments on
your research priorities. In May of 2004, your first listening session,
we urged you to select as priorities, therapeutic categories that have a
broad impact on consumers, in particular categories that include
expensive drugs that are used by a large number of people. We commend
your initial selection of priority areas including arthritis, cancer,
diabetes, asthma, and peptic ulcer disease. We note that we have
selected many of these categories as well, and the key factors in our
choice of categories was both the high incidence of these diseases and
the existence of drug effectiveness review projects, systematic review
of the clinical evidence. And of course, our main source of information,
clinical effectiveness, is the OHSU-based drug effectiveness review
project. We believe that your first report provides valuable information
to patients with GERD. One key task, of course, is to ensure that this
valuable information gets put to use by practitioners and gets into the
hands of patients. And we plan to incorporate your findings in our next
update of drugs in this category. As you shape your priorities for the
next year to expand to conditions of Medicaid and SCHIP, we urge you to
once again focus on conditions that affect a lot of people and where
there are real differences in treatment options. Some of the studies
already underway will be valuable for these populations, but we also
would suggest that you consider studies in the area of ADHD, asthma,
obesity, and AIDS. We think they could be very valuable for these
populations. Again, one of the considerations for you should be whether
there is a credible database of information about treatment alternatives
such as DERP or the UK-based National Institute of Clinical Health and
Effectiveness, or the Cochran Collaboration. We appreciate the
opportunity to provide comments, and we look forward to advancing our
shared goal of providing the public with credible information about the
comparative effectiveness of alternative medical treatment. Evidence
based consumer friendly information is needed in the marketplace to help
consumers and taxpayers get better value for their health care dollar.
Thank you.

Dr. Straube: Gail, thanks very much. We have another question here in
the room.

Mr. Shaw: Good morning. I'm John Shaw, and I'm a health systems
engineer, and I'm with Next Wave in Albany, New York. And I wanted to
suggest two priorities, one a methodology priority and the second a
topic priority. And it's related to several of the other comments. The
first thing is the Institute of Medicine wrote an order in one of their
recent reports. The order is for partnering with health systems
engineers. And health systems engineers are focused on addressing the
issues in that 45 percent that we're not doing yet. And the clinical
area that I wanted to focus on is also a problem and issue in the
Medicaid population and that's pediatric asthma. I'm also a parent of
asthmatic children. I spent six years on the board of directors of the
American Lung Association in New York, and I'm currently the board
president for the Healthy Schools Network where asthma is one of the
major health issues for children in schools. And let me try to tie those
two together and see how it might help. Dr. Clancy mentioned that
getting the question right is a big part of the process. That's what the
system engineers are taught to do. So we're going to collect everything
like you say and see what's out there currently, but then we go a little
step further. We're sometimes accused of over specifying what it is
we're looking at. So we take the traditional description that we get
from the literature, and then we try to get inside it. And getting
inside it, we go talk to the patient, we talk to and perhaps follow
around the sharp end care givers. Those that are actually providing care
to the people who are receiving the care. And that gives us a better
perspective on issues that may be missed otherwise. And if we're talking
about getting care to the consumers, that's a big part of it. We're also
taught to look beyond the normal definition of the problem, to look at
the environmental construct, to look at things that may have a big
impact on the problem that are beyond the direct definition of the
solution. And lastly, we're taught to look at materiality, to constantly
throughout the process make sure we're focused on important parts. So
let me apply that to pediatric asthma. If we look at Eddy, Eddy is a
first grader who depends on Medicaid or SCHIP for controlling his
asthma. The traditional view of asthma is the chronic disease that
requires close monitoring to keep it under control. Eddy can't do it
himself. He requires caregivers to do it, which is typically his
parents. So we're focused on making sure they know how to do it. But
Eddy, right now as we speak, is in the school yard, in the school,
looking at his friends kicking up the dust, looking at the school buses
idling over here, looking at the construction over there, and
environmental factors are a big part of triggering or exacerbating
asthma. If we look at the medical solutions, including an AHRQ report
released just a few months ago, looking at suggestions for improvement,
from my perspective I looked at it. There was no recognition of school
environment or caregivers. Applying materiality to that, here are half
of the caregivers that are monitoring my child's condition and the
environment where they are spending a third of their time is missing. So
that's part of what incorporating systems engineering can do. If anyone
is interested in going into that further, a mile down E Street, the
Healthy Schools Network is meeting with its national coalition members,
talking about how to integrate health care, education, and the
environment and looking at the total picture from the perspective of my
child. Thank you.

Dr. Straube: Thank you. Interesting perspective. I think we're going to
go to the phone lines for one or more questions.

Operator: Okay. Our next question comes from Kathleen Weaver. Please
state your organization.

Dr. Weaver: This is Dr. Kathleen Weaver from Oregon Health Policy and
Research. Oregon Health Policy and Research, I'm the director for the
health resource commission there, has been working with Oregon Health
Sciences University Evidence Based Practice Center for the past four
years. And we've done 16 comparative drug studies, and have 6 new ones
that are underway. We've had a tremendous experience in working with
this drug evaluation review project, or DERP as it was mentioned by Gail
Shearer from Consumer Union. And they're now working with the DERP. The
DERP is a combination of 15 different Medicaid States and COTA, which is
the Center for Evaluation of Technology from Canada, which allows
different Medicaid States to pool their resources to buy these
particular reports. We found that having the ability to be in on
developing the key questions is so important because if you don't ask
the right questions, you don't get the right answers. And also, the
ability to comment on draft reports. What I think you're going to find
is, from AHRQ's standpoint is, that when your reports when finalized are
going to be utilized a lot more because people have access to be
participating early on. The health resource commission is now expanding
and going on to look at things outside of drug comparison things. And
one of the ones that was mentioned already we applied if you would go in
this direction is the treatment of obesity, the surgical versus
non-surgical treatment. In that case, it leased a preliminary check of
the type of systematic reviews. There's almost an excessive amount of
literature so we'll help to sort through this. One of the other areas
we're looking at is in the area of chemical dependency. And I would hope
that perhaps maybe this could be added to the list of things that you
look at. Specifically, methamphetamine use which is on the West Coast a
huge problem. In this case, preliminary look shows that there's
not---there's minimal literature or systematic reviews. So perhaps doing
this one would then point towards gaps in the research where things need
to be done. Also, I would like to commend the new areas that are key
questions that were just recently posted. We particularly are excited
about the comparison with ACE versus ARBs because although we compare
drugs within a class, we've not compared different classes. So this
would be helpful for us. Also, we've not taken on combination drugs such
as the lipid-lowering, where you're going to look at a combination of
drugs. And we welcome your looking at stents versus CABG and the
effectiveness of Alzheimer's drugs. People probably know in Britain
these are usually not considered effective at this point. So anyway, we
think it's a great process, and we look forward to working with you.
Thank you.

Dr. Straube: Thanks very much for your comments. We'll go back to the
room here.

Ms. Weber: Good morning. My name is Jennifer Weber, and I'm the Manager
of National Nutrition Policy for the American Dietetic Association. I'm
also a registered dietician and a public health specialist. The American
Dietetic Association represents 65,000 food and nutrition professionals
and is guided by philosophy based on sound science and evidence based
practice. We've already cited the Washington Post as a scientific
resource today so I'm going to point you all to the New York Times. For
those of you who read the New York Times on Monday, you saw a compelling
story about the impact of diabetes on individuals and communities. It's
a crime. Little did I know that today's New York Times would be an
exclamation point on my comments. Diabetes is a disease where food and
activity habits can be both preventive and treatment. For those with
diabetes, research documents the value of nutrition services and the
management of the disease. Persons who receive medical nutrition
therapy, or MNT, services are likely to require fewer hospitalizations
and medications, and have reduced incidence of complications. Not only
is the person's quality of life enhanced, but additional costs from
complications are cost to taxpayers. Diabetes is a research priority for
the effective health care program, but AHRQ has yet to identify the
priority and evaluate the behavioral aspects of diabetes prevention and
treatment under section 1013. Furthermore, it has not been looked at the
role of nutrition and activity lifestyle modification when drugs are
taken. Without including these lifestyle modifications, the comparative
effectiveness of different medical interventions cannot be fully
assessed. We know that diet and activity are safe, work, and cost
effective, but most people don't know how to implement, or do not have
the resources needed to help implement lifestyle changes. And
apparently, according to today's New York Times, no financial incentive.
Look at the photos and read the New York Times articles. It is evident
that drug intervention alone is doomed to fail. It is access to
preventive care and disease management that matters. We believe that
MNT, a proven cost effective intervention for diabetes, is an
underutilized service which may significantly improve the prevention and
treatment of diabetes. The underutilization of MNT can be attributed in
part to the fact that the service is not well known or understood, and
that it's not universally covered outside the Medicare program. AHRQ can
help consumers, health care providers, and others make informed choices
among treatment options, including MNT, by including lifestyle
modification in the Effective Health Care Program. Making lifestyle
modification in diabetes a research priority under section 1013 would go
a long way towards shaping policy that supports a healthier nation.

Dr. Straube: Thank you for those comments. Appreciate that. We'll take
another question here in the room.

Dr. Anderson: Good morning and thank you for taking my comments. My name
is Dr. Carol Anderson and I'm a legislative fellow with the American
Dental Education Association. And we're pleased to offer comments on
your priorities for research under the AHRQ Effective Health Care
Program. As you know, dental services are a small part of the Federal
Medicaid and SCHIP budget, but these services are a continually target
for cuts. Cuts that have an immediate and devastating effect on our most
vulnerable citizens, and have long lasting consequences. The challenge
to provide dental services to the underserved will only be exacerbated
as the health care programs face further budgetary restrictions.
Recognizing the challenges faced by dental professionals in providing
care to Medicaid and SCHIP beneficiaries, ADEA strongly encourages AHRQ
to consider the following dental health services research areas as
priorities and strongly urges you to incorporate dental considerations
into current and planned projects. Number one, an evaluation and
comparison of state based dental Medicaid innovations that have sought
to increase dentist participation and increase utilization of services
by mirroring such programs within the commercial dental benefit sector.
Two states have reformed their Medicaid program by contracting with a
single vendor to administer the dental program the same way they
administer the private insurance program. At least four other states
have established unique programs to address barriers that dentists and
communities have identified within the program, namely inadequate
reimbursement, administrative complexities, high appointment failure
rates, and lack of oral health literacy in the patient population. Many
other states have attempted program reform with little to no success.
And this is believed to be a result of focusing a limited programmatic
reform as opposed to a comprehensive reform approach. Number two,
studies on the effect of incentives such as state tax credit, loan
repayment, and scholarships increasing dentist participation in Medicaid
and SCHIP. Several Federal and State programs have used the strategy to
improve the distribution of dentists within states and communities, and
increase services. Such an evaluation would assist in determining
whether these incentives are cost effective and do improve recruitment
and retention of dental providers within public programs. Number three,
an examination of whether a correlation exists between graduation
indebtedness of dentists and their participation in Medicaid and SCHIP.
Dentists are small business owners and practices differ from medical
practices with much higher overhead costs. Past reports by Health and
Human Services\' Office of the Inspector General and the U.S. General
Accounting Office have indicated that there are limitations---that one
limitation to dentist participation in public programs is inadequate
reimbursement. And we need further research to determine how to develop
a balance between the two. ADEA appreciates AHRQ's consideration of our
comments. Thank you very much.

Dr. Straube: Thank you for those comments. I think we'll go to the phone
line for the next question, please.

Operator: Our next question comes from Lawrence Brown. Please state your
organization.

Dr. Brown: Hi. This is Dr. Lawrence Brown. I'm an assistant professor at
the University of Tennessee Health Science Center in Memphis. And one of
the things that I'd like to put forward as a focus area and it's been
alluded to a couple of times and that is the fact that medication alone,
although it's very beneficial, it's the appropriate use of medications
that really needs to be primary focus. And within the final role of
CMS's final role, they mentioned that they felt that MTM programs, the
medication therapy management programs, would become a real cornerstone
of the Medicare program because again, getting seniors medications
without making sure they have programs that get them to use them
appropriately, especially those with multiple chronic conditions and
multiple medications, a lot of seniors are having tough times managing
their medications. And now that they have access to them, I really think
the medication therapy management programs will be very important.
Having said that, in terms of specific areas of research, it will be
really important to know which models of medication therapy management
programs really have the best quality and best outcomes. For instance,
many of the PDPs, and MAPDs have in-house medication therapy management
programs where they may have pharmacists in-house to provide the
services through a call center based, or maybe nurses providing the
services through a call center based program. You also have pharmacists
and other qualified health professionals who are providing medication
therapy management in the community setting, or I guess in a face to
face visit. So there should be some comparison between those two models
to see which one actually provides the best quality care, the best
benefit to the patient, and fits in well within the health care system.
Or, if there's even a modified version of the combination of the two
where you have the call center taking care of minor issues with referral
to pharmacists or other health care providers in the community setting
for more intensive or advanced care. So again, I would just hope that
you would look to trying to answer that question as to which model is
most important because it seems like it is a program that will be slow
to take off because of people's lack of understanding, but will become
an integral part of the health care system. And it would be good to get
some early answers to the questions about which model is most effective
both from a cost standpoint and outcome standpoint. Thank you very much
for taking my comment.

Dr. Straube: Dr. Brown, thank you. Very good comments. We're going to
next back to the room here in DC

Mr. Sperling: Thank you, I'm Andrew Sperling representing the National
Alliance on Mental Illness. NAMI is the largest national organization
representing people with severe mental illness and their families. NAMI
shares the goals of section 1013 and AHRQ in improving quality and
getting better value for America's health care dollar. We commend AHRQ
for undertaking both reviews on depression, particularly the one on
off-level use of atypical anti-psychotic medications as commonly done as
many use as mood stabilizers in the treatment of bipolar disorder. And
it's very important this review be undertaken, and we commend you for
that. In the field of psychiatric medicine and severe mental illness we
are making progress on clinical research, on treatment in real world
settings. This is critically important. NIMH has three major studies,
some of which have been released in their first stages, some of which
are moving forward. There's the CATIE study on schizophrenia. The
Star\*D study on treatment resistant depression. It was just released
last week, the first stage last week, and the Step-BD study on treatment
of bipolar disorder. What's important about those is it's no
longer---it's not just comparative advocacy, it's also treatment in real
world settings, and it undertakes the really complex nature of these
disorders. And we encourage AHRQ and CMS to recognize the complexity of
the treatment of illnesses such as schizophrenia and bipolar disorder
and major depression. They're episodic illnesses. They don't follow a
pre-determined course. They often are accompanied by many, many
co-morbidities including substance abuse, diabetes, other types of
complicated co-morbidities. And there's an enormous challenge of ongoing
treatment adherence. When the very symptoms of an illness like
schizophrenia is the better someone gets, the more under control their
symptoms get, the less likely they are to adhere over time. And it's an
enormous challenge. And we need more research on that. And finally, most
importantly, the treatment needs to be individualized. This is something
we believe you need to recognize. And along those lines, Dr. Clancy
noted earlier that this undertaking is not about implementation of
uniform treatment guidelines for any particular disorder, and we commend
AHRQ for that. We think that's the route you want to go. But
unfortunately, we're increasingly seeing comparative effectiveness
research being labeled as "evidence based practice," and then being used
as pay arch (phonetic) because we state Medicaid programs as a
justification for a restrictive policy such as prior authorization, step
therapy, and in many cases outright removal of therapeutic options from
preferred drug lists. We believe that this is not what comparative
effectiveness studies need to be used for. We're already seeing this in
association with the first stage of the CATIE trial where you have some
of the newer atypical anti-psychotic medication compared against only
one of the older agents. And we see payers already using just the first
stage of this, we believe, in an inappropriate way to restrict access to
the newer more effective medication to treat schizophrenia. So we
strongly support what AHRQ is doing, and we support section 1013, but we
just want to make sure the comparative effectiveness trials are not
essentially unjustifiable used as the basis for restrictive policies
both in Medicare and SCHIP and Medicaid. Thank you.

Dr. Straube: Thank you very much. We're going to go in the room again
for the next question.

Dr. Wright: Donna Henry Wright. I'm president of Wright Associates
Health Care Public Affairs, but I speak today as a liver transparent
recipient. There is now currently available an FDA approved test called
the amino assay for immune system function that is not in widespread
use. However, this test has the ability to give physicians making
clinical decisions on prescribing and withdrawal of treatment in organ
transplantation, in cancer, in AIDS, and other immunomediated diseases.
And I would encourage CMS and other Federal agencies to find mechanisms
so that this test can be put into widespread use as it has implications
to affect not only the quality of treatment, but also the cost and
effectiveness of treatment by reducing patient risk for, in the short
term, for rejection of organs, as well as in the long term
cardiovascular incidence and stage renal disease incidence and cancer.
So I would just encourage more exploration in this area and
dissemination so it can be used more widely.

Dr. Straube: Thank you very much. We're going to go to the next question
on the phone line.

Operator: Our next question comes from Judy Kramer. Please state your
organization.

Dr. Kramer: I'm Dr. Judith Kramer. I'm the principal investigator for
the Duke Center for Education and Research on Therapeutics. The CERT
centers are an AHRQ-funded program whose goal is to conduct research and
provide education that advances the optimal use of drugs, medical
devices, and biologic products. So by nature, my comments are going to
be focused on therapeutics. I'm speaking not just for myself, but for
the seven national CERTs principal investigators who have gotten
together and synthesized their ideas into the topics I'm going to list
for you today. I'm listing general topics for study rather than specific
diseases or conditions. The first involves the safety and efficacy of
off-label use of drugs and devices. And Sue Tolleson-Rinehart from the
University of North Carolina CERT has already mentioned the tremendous
need in this regard for study of off-label use in children where many of
the things we use are off-label. But there are many other areas and
examples where this is important. And we would recommend, for instance,
the convening of an expert meeting in major therapeutic areas to
identify the highest impact off-label use areas for study, and continued
study of patterns abuse of off label use through large data sets. The
second area is one that AHRQ, as Carolyn Clancy has mentioned, very
involved in already, and that is the area of comparative effectiveness.
We applaud AHRQ's efforts to commission evidence reports as the starting
place here and to use DEcIDE network to convene meetings and conduct
research in this area. One concern that all of the CERTs PIs have are
methodological issues in this regard when conducting comparative
effectiveness studies with observational data sets, and even direct
randomized trials when you're dealing with non-inferiority hypotheses.
Fortunately, ARHQ has already commissioned some supplemental funding for
the CERTs to explore some of these methodological issues and is already
working on this. But it's a big area to focus on. In addition on
comparative effectiveness, we think it's important to prioritize
head-to-head comparisons that really are needed, things that actually
need to be sorted out through direct randomized clinical trials. For
instance, pulling together expert meetings by medical condition or
patient population to focus upon, to identify these lists. In addition,
we believe that it would be wise to explore the use of group randomized
trials, kind of practical clinical trials, where you have commonly-used
products that could be studied in this type of setting where you
randomized practices to alternative choices within health plans. The
third area that we would recommend focus on is that of drug-drug
interactions. There's been an estimate that the average Medicare patient
takes 17 different drugs per year. You can imagine with this that there
are significant problems with adverse reactions. There is definitely the
need for more pharmacologic and pharmacoepidemiologic studies on this
area of drug interactions. It's particularly a problem with many of the
older drugs that are used and are generic now because there frequently
is less information available in the pharmacokinetics of some of these
older agents. And there's added complexity when you consider the
combination of alternative medications in combination with prescription
drugs. The fourth area we'd like to focus on and it is covered with some
of the other topic areas, but I'd like to focus on, is that of medical
devices. Because of the different regulatory requirements for devices,
often there is less known about the benefits, risks, and clinical
outcomes, especially long term clinical outcomes with medical devices.
And we think that this is an area where we do need more complete
knowledge on comparative effectiveness and off-label use as well as
benefits and risks of many of these devices. The fifth area is one that
is noted in the Medicare Modernization Act and that is computerized
provider order entry. The MMA mandates that specifications for CPOE be
issued by 2008 and full implementation within a year after that.
However, there's really been little research to date on creating
standards for CPOE, and there are early reports indicating entirely new
types of errors from CPOE from coding malfunctions to provider entry
errors. Now we're not saying that this is not an appropriate concept. We
are very supportive of the added safeties that can be provided by CPOE,
but we need more generalizable knowledge about CPOE because we feel that
it is lagging behind the implementation of systems. So we think this is
a very important area for continued research and exploration. The sixth
area that we'd like to highlight is that of the need to look at factors
that influence prescribing. That gets into areas of both under
prescribing of effective therapies that some other people have mentioned
as well as overuse. And we think that there should be research into
testing novel methods to improve appropriate prescribing of therapeutic
agents. And then the last area, but not least, and silent area
frequently not mentioned, and that is laboratory monitoring of drug
therapy. There's significant variability in the frequency of laboratory
monitoring, both drug concentrations and renal and hepatic function
affects of therapeutics. And yet the effects on clinical outcomes of
these variable intensity monitoring schemes are really unknown. And this
is an important area to explore because we may be spending a lot of
money on things that aren't particularly effective in terms of outcomes,
or we may be missing monitoring things that could really improve patient
safety and outcomes. But we really don't have a lot of data on this at
this point. So I went fast through this so I could cover all of the
items in three minutes, and we'll be submitting written comments as
well. I appreciate the opportunity to speak.

Dr. Straube: Thanks very much for your comments. Appreciate that. We're
now going to switch back here to the room for the next comment.

Ms. Galbreath: Yes. My name is Laura Galbreath with the National Mental
Health Association. On behalf of the association, I want to thank the
agency for this opportunity to offer testimony on effective health care
programs. This new initiative has potential to have a significant impact
on Medicare, Medicaid, and other health care programs. Further, AHRQ
faces significant challenges in organizing and communicating the vast
amounts of research that exists on the different medical conditions. We
have several comments and questions that we'd like to present on public
comment, methodology, and structure of the key questions. Regarding
public comment process, we are pleased that AHRQ is holding public
comment periods for both the development of the key questions and of the
draft reviews. We strongly recommend extending the comment period for
the draft reviews to 30 to 45 days to allow for adequate time for
constructive comments from the public. We'd also like to request more
information on how the public comments will be used, and incorporated
into the final reviews. We're still a little unclear about the public
comments and whether they'll be put into the public record, and how AHRQ
will respond to some of the questions that are raised through the public
comment process. And then we also further recommend that AHRQ explicitly
requests public comments on some of the missing studies, the alternative
methodological approaches and revisions to the text of the reviews.
Regarding methodology, as AHRQ considers how to evaluate the
effectiveness of different medical treatments, we strongly recommend
that the agency consider a broader approach in selecting different
studies for inclusion in the systematic reviews as others have said.
NMHA recognizes that randomized controlled studies are generally
considered the gold standard for these reviews. However, we're concerned
that such a strong emphasis on them may be misplaced for systematic
reviews that will be used for public policy. While efficacy studies are
important, the effectiveness health care program should also look at
ways that measure the effectiveness of treatments, studies in not just
symptom reduction, but also changes in functioning such as reduction in
emergency room visits, psychosocial changes, reduction in homelessness,
returning to work, and the ability to communicate. To capture these
effective measures, the AHRQ may need to change its criteria for
inclusion when identifying studies for systematic reviews. For example,
AHRQ should plan to increase the use of observational studies to better
capture the effectiveness information. Regarding the key questions, as
AHRQ looks for better strategies to measure the safety and effectiveness
of different medication treatments, we first and foremost recommend a
revision of the key questions asked at the outset of the reviews. NMHA
has three core recommendations. We recommend that AHRQ include at least
one question to ask about the changes in outcomes for people receiving
different treatments. The search strings should include such measures as
increases and decreases in hospital visits, emergency room visits,
ability to return to work, school, daily activities. We also recommend
that AHRQ include at least one question to focus specifically on adverse
events, including consumer reports of side effects, physician reports of
side effects, in addition to specific adverse events such as emergency
room visits or encounters with the criminal justice system. Last
regarding key questions, we also recommend that AHRQ include at least
one question that focuses specifically on reviewing racial, ethnic, and
gender differences in responding to medication treatments. We were very
concerned that the draft review of off-label use of atypical
anti-psychotics did not include any questions to look at this key
measure. And given studies that have shown differences in the metabolism
rates of different medications, we think it is critically important to
include this question. So, again, we thank you for this opportunity to
provide comment, and look for future opportunities to partnership.

Dr. Straube: Thanks very much. Very good comments again. We're going to
the phone lines for the next question, please.

Operator: And our next question comes from Kathleen Lohr. Your line is
open.

Ms. Lohr: Thank you. I am from RTI International and the Evidence Based
Practice Center that we share with the University of North Carolina. And
my one question really and suggestion for topic is to understand the
extent to which AHRQ, in either the EPC work or DEcIDE Work, or CERTs
work will be examining issues relating to genetics and genomics to try
to understand what do we know now about those fields and their
applications in clinical practice, what sorts of tests are available for
what kinds of purposes, and what applications may be available for
individualized or personal prescribing. Thank you very much.

Dr. Straube: We'll go here in the room for the next question, please.

Mr. Wojcik: Hi, Steve Wojcik, National Business Group on Health
representing about 250 of America's largest employers. I'm going to be
very brief because we're going to submit our written comments
electronically. And most of the recommendations for future priorities
for comparative effectiveness research that we have, have already been
mentioned by a number of groups. We're pleased to see that the list of
future priorities that Dr. Clancy mentioned includes the comparative
effectiveness of stents versus surgery. Related to that, we also
recommend and other people have mentioned the comparative effectiveness
of statins for lowering cholesterol. That's also very important.
Alternative hypertension medications for lowering and managing blood
pressure. And then the other area of research that we would recommend
and other groups have mentioned is obesity, which as we all know affects
all three of the programs as well as the private sector in America as a
whole, increasingly the world as well. The effectiveness of various
bariatric surgeries including gastric bypass, banding, biliopancreatic
diversion, I hope I got that right, I'm not a clinician. And then also
the relative effectiveness of various weight loss medications, and then
the effectiveness of medically supervised weight loss. Those would be
our recommendations in the area of obesity. Thank you very much.

Dr. Straube: Thanks, Steve, for your comments. We're going to go here in
the room for your next---I keep saying question. Your comments, so I
apologize for saying questions repeatedly.

Ms. Bough: thank you, my name is Marcie Bough. I'm with the American
Pharmacists Association, and we're just pleased to be able to comment on
research issues with Medicare drug benefit and medication therapy
management services that are more addressed within the DEcIDE program,
but I just want to make you aware that MTM is a major priority of the
association right now in looking at the appropriate use of the
medications with the Medicare population and in just patients in
general, whether they're Medicare or not, is very important. And it will
be a good focus as MTM becomes more robust as we move along through the
implementation of the benefit. But we'd also like to point out that with
looking at the Medicare claims database information, there will be a lot
of information coming in through the Part D claims data, but it's also
important to loop that in with the entire health care cost through Part
A and Part B to look at the overall health cost for the benefit, but
then the implications it has for the other parts. So wanting to just
make you aware of that. Another point would be to look at the Medicaid
population which is kind of a unique set of individuals coming into this
claims database now. Coming from a state perspective in what's going to
happen with the information from the states as they move into the
Medicare database, and how are any issues with moving them into this new
drug benefit going to have implications on their safety of medication
use, compliance, issues with this transition to Medicare and how that
might affect the outcome of the medication, and the appropriate use of
the medication along with access. Thank you again, and we look forward
to working with you in the future.

Dr. Straube: Thanks for your comments. And we will now go to the phone
line for the next comment.

Operator: Joanne Lynn, your line is open. Please state your
organization.

Ms. Lynn: I'm with RAND, and I represent only the interest of living
long enough to be very sick and be a burden on everybody. I notice in
the list of things that are already committed to in this set of
projects, a real growth of some relatively small but exciting
possibilities of working on continuity and methods rather than just on
particular diseases, diagnoses, the typical way we split things up. And
I just wanted to give voice to really encouraging us to take on
seriously the problems of cross site continuity, continuity throughout
serious illness, the degree to which we can free ourselves of diagnosis
and setting limitations, especially in those last few years of life when
most people have multiple illnesses. A parallel issue is that I think we
really need to expand our scope to tackling the problems of caregivers
and how to make sense of their important role in the care system. We
face an enormous crisis in numbers of unpaid family care givers going
down at just a time we're going to need a substantial increase. And we
have almost no data on that. So effective health care is going to turn
very heavily upon the unpaid services of women who regularly impoverish
themselves and ruin their own retirement by dint of their work. We've
done very little to ease that work or even to catalog it. So I would
encourage that. In methods issues, I think we need to develop the
methods to tackle the very intriguing small area variations work that
doesn't lend itself very well to randomized control trials. Sometimes
the RCTs are, while conceivable, are just too expensive to ever get to.
And it seems that we really need to figure out how we can learn from
system reform in regions from demonstration, to quality improvement in
ways that are good enough to go forward rather than tying our hands and
saying we just can't learn about this because we can't run the proper
study. So we really need to see some methods work and one methods issue
that is especially close to my heart is figuring out how to account for
the variation in longevity as you get into the last few years into life
you can make almost any measure look better if people die more quickly,
with the exception, of course, of living longer. But we have very little
way of understanding that interplay and we're going to need it as more
and more of the health care gets allocated to the piece of time we're
spending living with serious illness. So that's something I would
encourage you to keep nurturing despite the fact that at the present
time they are only a small part of the portfolio.

Dr. Straube: Joanne, thanks very much for those comments. We're going to
go for the next comment in the room.

Ms. Friedman: Good morning. I'm Susan Friedman with the American
Osteopathic Association, and I've already heard this morning three times
obesity referenced as a topic for Medicaid and SCHIP. And I would like
to echo that and say that our council on scientific affairs has looked
at the material and they strongly recommend adding obesity as primary
and secondary disorder. Thank you.

Dr. Straube: Thank you. Back to the phone again.

Operator: We have a question from Gerald Boyd. Please state your
organization.

Mr. Boyd: I'm medical director of Employers Coalition in Rockford,
Illinois. My concern is I listen to all of this. You're getting plenty
of suggestions of what should be studied from a variety of sources, and
all of those are very good. My concern as a practicing physician as well
as the director of employers\' coalition is the point at which these
guidelines become deliverable, specifically at the point of the
interface of the patient and the physician. As we go along developing
these, we need some kind of rapid delivery to that point. Ideally this
would be an automatic import to a Web-based system, perhaps eventually
in a docket system that is being developed. But until that time, we need
to get this information once it's pulled together from all these sources
and get it in the hands of the physician because it may take years to
really get these guidelines to an effective application. One way may be
to have some kind of alert, some kind of delivery system announcing to
physicians that this is available. Many things that happened in the past
have floundered in the mass sea of information, and it isn't easily
available to the physician. Currently we do have a lot of sources for
evidence based medicine, but we must go to various sources, Web sites,
programs, et cetera to get those. I'm trying to go to bring to focus on
a rapid transit from the evaluation to the point of delivery of the
guidelines.

Dr. Straube: Thank you. Some very good points. We appreciate those
comments. We'll now continue on the phone with the next comment.

Operator: Lisa Simpson, your line is open. Please state your
organization.

Ms. Simpson: Good morning. This is Lisa Simpson from the National
Initiative for Children's Health Care Quality. I'm sorry I can't be
there in person. I'm going to focus my remarks on priority setting for
children in the Effective Health Care Program who are insured under
Medicaid and SCHIP, and make four points. One that when you engage in
priority setting obviously criteria that are developed should take into
account at least two things for children. First is the unique
characteristics of children's health and their health care which has
been described as the four D\'s: the differential epidemiology of
children, their dependency on adults for their care and others, their
rapid developmental change, and the differential systems that they are
served by, which is obvious in their reliance on Medicaid and SCHIP. And
I know full well that our colleagues at AHRQ are very familiar with
these criteria. The second point I want to make is that the priority
setting should really take into account the needs of multiple
stakeholders and today's process is part of that, and including
families, providers, purchasers, and clearly State organizations. The
second point is that the research program should include studies of the
effectiveness of both discrete clinical intervention and organizational
and system intervention, particularly since we have chosen a health care
system with 50 states and 35 different SCHIP programs. So the positive
side of that is we have lots of opportunity to learn from this
experience if we choose to do so. The third point is given the
significant variability and quality of care and outcomes for children,
we've got to invest in research to understand which strategies are
effective in improving care. And these studies should include broad and
diverse populations and settings. It should focus on spread and
sustainability going beyond single site studies to demonstrate
improvement, to sustaining change in a positive direction. And also,
they should include a cost effective component. States are very
interested in understanding how to spend their money efficiently to
improve care. And given these comments, I would just mention three areas
which have, I'm sure been mentioned already, will likely warrant
attention regardless of whichever priority setting process is adapted,
and those are obesity, behavioral health for children, and the care of
injured children. We must not forget that children, while luckily they
do not die very often, after they survive their first year of life, they
do die from injury and trauma. And there's much that we can learn about
how to improve the effectiveness and quality of care for injured
children in this country. Thank you for the time.

Dr. Straube: Thank you for your comments. Next comment will be here in
the room.

Ms. Matthew: Good morning. My name is Sarah Matthew, and I want to thank
you for the opportunity to present comments from the American
Association of Colleges of Pharmacy. U.S. colleges and schools of
pharmacy are actively engaged in a broad array of Department of Health
and Human Services-supported research and programs. section 1013 of the
MMA seems to speak directly to the role that colleges and schools of
pharmacy can and do play in improving health outcomes and determining
the appropriateness of pharmaceutical services. AHRQ has made very
positive steps in both CERT and DEcIDE program to strengthen linkages
with U.S. colleges and schools of pharmacy inside and outside of
academic health centers to fulfill the missions and goals of these
important programs. Regarding the list of priority conditions, AACP
would bring to your attention that all ten of the conditions recommended
for consideration by the Secretary depend on drug therapies for patient
management. This requires a greater attention to the best use of these
medications so Federal programs are operated to achieve the Institute of
Medicine's aim for health care delivery. AACP does not recommend any
particular prioritization of the list of priority conditions. What we
would recommend is that HHS, across the totality of its programs, look
for opportunities to bring academic pharmacy closer to the side of the
practicing physician in an effort to improve medication use. Especially
in the ambulatory and physician practice settings, these opportunities
should be considered in the context of the Medicare prescription drug
benefits, Medicare pay for performance demonstrations, telemedicine
projects, or support to state Medicaid programs for the development of
academic detailing programs. Regarding the methods to answer questions
of safety and effectiveness as quickly and efficiently as possible,
colleges and schools of pharmacy are actively engaged in the synthesis
and generation of knowledge regarding medication use that is being
readily translated to state Medicaid programs, Medicare quality
improvement organizations, and private sector health plans. It might
prove useful to inventory the research in program relationships
currently ongoing at our nations\' colleges and schools of pharmacy.
This would provide HHS with a quick response as to whether some of the
questions you have, have already been answered by the academic
community. To move our health care delivery toward a more
patient-centered process, HHS should require research questions to be
addressed through interprofessional teams. This approach, supported by
both the Institute of Medicine and the National Institutes of Health,
would readily take advantage of the special knowledge-based extant in
specific health professions. Toward this end HHS should strengthen
support for interprofessional health education programs. Health
profession students, through their experience on residency training,
could readily be catalysts for translating research finding in practice
on a real time basis. The AACP appreciates this chance to comment on the
important work of HHS to improve the effectiveness of health
intervention. We look forward to continuing to work with AHRQ and other
agencies to more closely link academic pharmacy with Federal programs
for the benefit of the public's health.

Dr. Straube: Thank you very much for those comments. We'll take the next
comment from the room here. I'm not seeing any hands. Do we have anybody
on the phone lines?

Operator: I'm showing no comments at this time.

Dr. Straube: Okay. One last chance here in the room. It's been a long
morning. I'm impressed. First of all, I want to thank everyone for one,
attending and coming, and participating in this session. Personally my
reaction is when I come to meetings like this I learn something at every
session. And I've learned some things, Carolyn, that won't apply just to
the Effective Health Care Program but will apply to some of the work
we're doing at CMS. So I want to thank people for some great ideas and
insights into a lot of areas that we don't think about every day. I was
jotting down, I thought it might be helpful, some general areas here
that at least I heard. I know Carolyn and her staff are going to be
going through all the comments and analyzing the other ones that they
get on the Web site. But what I heard today were a number of themes or
topics. One had to do with the area of transparency. People were talking
about how valuable the public comment aspect was, such as it is, but
we're looking for even more ability to improve and increase the public
comment period, the amount of public comment being made, public
participation more in the issue and question formulation, certainly more
participation in the draft review process, not only by increasing the
time frame but allowing more input there. So I think that's one general
topic that is going to certainly be heard. I've also heard something
that we've started to talk about internally at CMS certainly, but very
loud and clear that people were interested in cost effectiveness
information. That was repeatedly mentioned by a good number of the
commenters. I think the third area people were---there's a whole area of
issues in health systems reform and how health systems and health
organizations affect the actual effectiveness of these various
modalities that AHRQ is focused on. And it's perhaps a variable that we
don't think about regardless of how individual services or devices or
whatnot are effective depending on what system they are in, or depending
on whether we can tweak the systems and make them more effective. There
was a whole series of special needs areas, if you will, or special
factors. I appreciated the nurses, the dieticians, medical nutrition
therapy, health systems engineers, the dental aspects here, medication
treatment management, medication therapy management, the comments made
about the last years of life, and people with chronic illness in that
time frame. And there were several others. I probably missed some, but I
think there were some very, very good suggestions and awareness brought
to us about these special areas. A fifth area, clearly a number of
commenters were talking about access to care. And that being---I guess
it gets back to Carolyn's comment about asking the right questions. If
you can't get care, if you can't get access to care, the questions don't
even matter. So clearly access to care. And I think as a corollary to
that---that has been a topic very near and dear to my heart that we need
to address more. Continuity of care was mentioned also across different
sectors and across different settings of care and how we coordinate
that. You can have the best performing medication, but if you don't
educate the patient and then assure they're receiving that across care
settings, it's not going to work. Clearly there were a whole bunch of
specific areas, disease specific mostly, ADHD, behavioral health issues.
Very important, I think, on behavioral health, the emphasis we heard
today---asthma. Certainly obesity was another one that was very highly
commented on. AIDS, diabetes, and many, many other conditions including
the dental health that I mentioned earlier. And then last, but not
least, in a not all-inclusive summary here, I think that there were one
or two comments made. Something probably we have---we didn't comment as
much about today, and that has to do with communicating the results of
this whole process. How do we make it known to providers, to patients,
and to all people who need to get the information that comes out of
these reviews. So that's my quick and dirty summary. I'm going to, in
addition to thanking you all again for all the good comments, turn it
over to Carolyn for some last words.

Dr. Clancy: Well, my first word would be wow. This is officially the end
of the beginning. The comment period on priorities extends until March
15th. So for those of you who didn't have an opportunity to speak your
piece today, or had additional thoughts triggered by the discussion
today, or know of others who would like to contribute, you can do that
through the Web site and we'd be delighted to hear from you. I think
Mark Twain once commented on, if you were going to speak for a short
period of time that takes a whole lot more work than for speaking for a
long period of time. I know that the brief brilliant contributions we
heard today reflect an enormous amount of work. So I want to thank all
of the people who spoke both here in the room and on the phone for the
amount of work they put into their presentations before coming. You can
listen to this session for the next two weeks by dialing this number,
866-386-1299. After that, there will be a written transcript and all
entries in the spirit of transparency will be posted on the Web. Again,
this period is going to extend until March 15th. As with the last time
we did this, I'm leaving feeling very energized and my head is spinning
with all kinds of ideas. So let me just echo Barry's thanks and wish you
all safe travels wherever you're going. And we very much hope to keep
hearing from you. Thanks again.

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