[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

June 10, 2009

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

Proceedings By:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703)266-8402

CONTENTS

P R O C E E D I N G S

Agenda Item: Call to Order and Welcome

MR. REYNOLDS: Okay, good morning. Let us go ahead and get started and I
would like to call this meeting to order. This is it the first of two days of
meeting of the National Committee on Vital and Health Statistics. The National
Committee is the main pubic advisory committee to HHS on national health
information policy. I am Harry Reynolds and Chair of the committee. I work with
Blue Cross and Blue Shield in North Carolina. I want to welcome committee
members, HHS staff and others here in person and also welcome those listening
in on the Internet.

I would like to remind everyone to speak clearly and into the microphone and
as you are talking, if you are looking at anybody in particular and the
microphone is not right in front of you, yesterday we had some problems with
everybody else hearing it. So make sure that the microphone follows your mouth
as you are speaking. It is a real simple procedure.

Now I would like to have introductions around the table and then around the
room. For those on a national committee, I would ask if you have any conflicts
of interest related to any issues coming before us today, would you please so
publicly indicate during your introduction. I have no conflicts of interest.
Marjorie, we will go your way for that.

MS. GREENBERG: Good morning and welcome to NCHS. I am Marjorie Greenberg. I
work here at NCHS, EDC and I am executive secretary to the Committee.

DR. TANG: I am Paul Tang, Palo Alto Medical Foundation, member of the Camino
Complex

DR. SUAREZ: I am Walter Suarez with the HIPAA/HIT Notation on Research. I am
a member of the Committee and no conflict.

DR. CARR: Justine Carr, Caritas Christi Health Care, member of the Committee
and no conflicts

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and
Quality and on loan to the Office of the National Coordinator liaison to the
full Committee.

DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the
Committee, no conflicts

DR. MIDDLETON: Blackford Middleton, Partners HealthCare, member of the
Committee, no conflicts

DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente, member of the Committee,
no conflicts

MS. McCALL: Carol McCall, Humana, member of the Committee, no conflicts

MS. MILAM: Sallie Milam, West Virginia Health Information Network and West
Virginia Healthcare Authority, the only possible conflict is that we are an
NHIN contractor.

DR. SONDIK: Ed Sondik, Director of NCHS

MS. BUENNING: Denise Buenning, Centers for Medicare and Medicaid Services,
Office of E-Health Standards and Services and I am lead staff to the Standards
Subcommittee.

DR. O’GRADY: Jim Lepkowski, no I am Mike O’Grady, I am the liaison for the
Board for Scientific Counsel, no conflicts.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services,
liaison to the Committee

MR. LAND: Garland Land, National Association for Public Health Statistics
and Information Systems, member of the Committee, no conflicts

DR. GREEN: Larry Green, University of Colorado, member of the Committee, no
conflicts

DR. FRIEDMAN: Charles Friedman, Office of the National Coordinator for
Health Information Technology

DR. FRANCIS: Leslie Francis, University of Utah, philosophy and law, member
of the Committee and no conflicts

MR. HOUSTON: John Houston, University of Pittsburg Medical Center. I am a
member of the Committee and I have no conflicts.

MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, we also have an NHIN
contract, but I do not believe there are any conflicts.

MR. J. SCANLON: Good morning, everyone, Jim Scanlon, Academic Assistant
Secretary for Planning and Evaluation at HHS and I am Executive Staff Director
for the full Committee.

MR. CONNELLY: I am David Connelly from Capital Associates

MS. JONES: Katherine Jones, staff to the Committee.

MS. SCHEER: Maria Freedman Sheer, Scripps

DR. WATTENBERG: Sarah Wattenberg, SAMHSA

MS. KHAN: Hetty Kahn, National Center for Health Statistics, CDC

MS. JAMISON: Missy Jamison, National Center for Health Statistics, CDC

DR. BURKE: John Burke, College of American Pathologists

MR. WANG: Eric Wang, Social Security Administration

MS. JACKSON: Hi, Debbie Jackson, National Center for Health Statistics, CDC,
Committee staff

MR. REYNOLDS: Yesterday we had a good hearing on privacy and security so
that was an excellent effort. A couple of housekeeping things: first I would
like to welcome Chuck Friedman. Chuck is our liaison from the Office of
International Coordinator will be joining us on a regular basis, has to leave
this afternoon but not because of lack of interest, because of the fact that
things are moving quite quickly and if he has to be in one place or the other,
we would like him to keep it moving. So Chuck, welcome

DR. FRIEDMAN: Thank you very much.

MR. REYNOLDS: Glad to have you with us. The other thing that was interesting
was I was looking back through some comments I had made about when I took over
the Committee about this so these continue to ring true. This is a time of
change and transition for the National Committee, but also for the country as a
whole. I would like to thank each of you for your dedication, hard work and
leadership, again. Things are moving incredibly quickly in the country. We have
to continue to run alongside some of them, help on some as we will talk about
in a little bit, and others we are going to need to leave. So we are going to
have to play multiple positions as things start to come to fruition and I think
that is going to be very important for us and our Subcommittees to make sure
that we stand ready to do all three of those; depending upon the subject,
depending upon the timing and depending upon the issues is what we need to do.
So I ask the Committee to do that, especially during this time of significant
transition and incredibly rapid change. So that is exciting to be a part of
that.

First update on our agenda today is Jim Scanlon at the Department of Health.

Agenda Item: Department Update, including the American
Recovery and Reinvestment Act

MR. J. SCANLON: Thank you, Harry, and welcome everyone. Well, as Harry said,
a number of developments have occurred since we met, I think in February and of
course with number of Subcommittee meetings, another hearing since then and I
want to update the Committee today on the transition and personnel, budget and
the Recovery Act and then I will go into a little more detail about the
Recovery Act and then I will talk a little bit about the looking forward to
legislation and some new projects at HHS.

So let me start in terms of the transition that we are well past the
transition beginning by now. As you all know we now have a Secretary, Kathleen
Sebelius from Kansas and a Deputy Secretary at HHS. We have agency heads in
place for some of our biggest agencies: CDC; FDA; HRSA; and the Indian Health
Service. We have nominees for some of the other operating divisions and we have
nominees or intends to nominate, I guess, for most of the other staff of
offices within the department. In addition we have a senior crew officials
heading and directing the other agencies and staff offices where there is not a
political person yet. We have also established an HHS Office of Health Reform a
couple of months ago. That office will work with the White House Office of
Health Reform to coordinate HHS and the administration’s positions and work on
health reform.

In terms of budget, again we are always looking at three different years for
budget as you are all in your organizations. We are now in fiscal year 2009
with a full operating budget for the year. The fiscal year ends in September.
The President has sent the fiscal year 2010 budget to Congress. They have
already begun having hearings on those and we have also begun working on the
2011 budget. In terms of the 2009 and the 2010 budget, we are very fortunate on
the population statistic side. Increases were included for National Center for
Health Statistics. I think Ed will talk about this a little later and as well
in the President’s fiscal year 2010 proposal, a sizable increase was included
for National Center for Health Statistics as well. So in terms of statistics
agencies and most agencies, NCHS at least for the past two years is probably
getting a, well we hope anyway will get a good boost in terms of bringing it up
to the area where we thing the operating level should be.

In terms of the HHS budget our total, again this is the 2010, it is a very
large budget: 880 billion as you know, but only ten percent of that is
discretionary. The rest is Medicare, Medicaid, CAMA, FEM and other that are
called mandatory programs and there is less, I do not want to say there is no
control over there, but the budget is handled differently in terms of options,
flexibility and much of that is determined by Congress and annual
appropriations.

In addition to the budget itself, of course, we began talking last time
about the Recovery Act, the Stimulus Act and the Stimulus Act provides more or
less a one or two year, three year infusion of funds, anti recessionary kinds
of funds, anti cyclical kinds of funds that help the economy get back on track
and for HHS, it includes well we estimate to be about 167 billion dollars over
ten years and again making the mandatory discretionary distinction, that would
include about 144 billion for the mandatory side of the budget and much of that
is Medicaid. These were grants to assist states during the recessionary period
and it included basically the federal government increased our net for state
Medicaid and related programs.

We have also received 22 billion on the discretionary side for Recovery Act
activities and again, for the most part, these are one or two year funds. In
the case of the information technology, though the funding is actually I think
it is available to expend it, which is a very unusual and very almost every
agency likes to have that arrangement where you can hold the money. It does not
disappear at midnight on September 30th.

Now the main parts that I wanted to talk about under the Recovery Act in all
three of these are things that the Committee has worked on and provided
recommendations relating to and in support of. Two billion dollars of that
discretionary amend was for the HITECH and this is being coordinated by – and
Chuck will talk more about this later, they are up through the National
Coordinator, the Act provides $2 billion for establishing LNC, a variety of
activities creating standards and policy committees, standards, outlines a
process for standards at option, provides grant assistance for states for
health information exchange, grants for health IT workforce training and
national and regional technical assistance centers to help with the adopter and
implementation of interoperable health IT. A second part of that is the, as my
colleagues like to refer to it as the retail side, 19 million dollars or more
because again this the mandatory side of the budget, for incentives through
Medicare and Medicaid to providers and others who adopt electronic health
records and other technology and who meet some threshold criteria of actually
meaningful use. As you remember, the Committee held two days of hearings to try
to get some definition framework and operational sense of what does meaningful
use mean. That is what would qualify Medicare or Medicaid provider for
incentives that are quite sizable beginning in 2011 and then continue for a few
years and then phase out. So again, these are all activities that the Committee
has worked on. A lot of folks at HHS have worked on. In a sense the sale has
been made. Now is the time to deliver in the sense of being able to actually
adopt and find technology that actually makes a difference and get them to be
used.

In addition, there are provisions to strengthen privacy confidentiality and
HHS is working on regulations for those as well.

A second part of the Recovery Act deals with a prevention and wellness fund
that is about 1.1 billion dollars in HHS. Some of the money went to CDC for
vaccine activities and for efforts to prevent hospital acquired infections, but
the bulk of the money, probably 600 million dollars is held in a prevention and
wellness fund that the Office of the Secretary is working on and there is a
fair amount of flexibility in terms of what those dollars would be used for. So
there are work groups within HHS now putting together options for what would be
a meaningful investment in that area. To some extent I think this was meant to
be trying something new even if it is a little riskier, trying something
different. Do not just put the money into normal grants, in the states, or
communities or other places but you know try a long pass every now and then to
use a football analogy. This might be try to use some imagination and see what
happens. That is roughly a two-year program so and again, the details are being
worked out. A lot of discretion is left to the Secretary.

The third part of this is comparative effectiveness research. The Recovery
Act included a billion dollars for comparative effectiveness research. Again
there are three parts of this: about a third went to NIH; another third went to
ARC; and then the remaining 400 million again remains in the Office of the
Secretary as a pool. Again there are work groups thinking of what would be the
best way to invest these funds in terms of comparative effectiveness. In fact,
a federal coordinating council was established. It is meeting later today. It
has a series of listening sessions much like our own public meetings where we
try to hear what advice people have about how to spend the money, what the
priorities would be. The final one is being held today. Recommendations will
hopefully be made. Reports to Congress are required. An IOM study on priorities
is also due I think at the end of the month and then a spend plan to Congress
from HHS about how would we actually spend this money and what process would we
use.

So again, a number of very exciting activities underway. I think most people
view the health fee.

DR. HORNBROOK: Do you entertain questions? Sorry. Two questions, in the
federal coordinating counseling, is there an awareness or self awareness of the
seemingly strange environment that they are working in when any manager worth
his salt in the health care system needs costs in order to make a decision
among the comparatively effective options as having a simple ranking of
comparative effectiveness of the options does not tell you what to do because
some of them are much difference in cost. You cannot notice a solution until
you get the costs. There is a huge suspension of disbelief by leaving costs out
of this and it feels like we are through some sort of fairy tale. The other
aspect of the fairy tale is nobody seems to be talking about effectiveness.
What does that mean? Affect on the tumor? Affect on a strain of bacteria?
Affect on a cell, on a gene? Or, affect on our utility weighted preference
weighted way of life? Where does anybody have a discussion about how that
comparative effectiveness is supposed to be scaled? Is this going on down there
or are they totally leaving you out?

MR. J. SCANLON: Well, cost is a four letter word, as you know. That was not
included in the statute and there is great sensitivity on the top as there is
always is that cost effectiveness. Remember, this is funding for comparative
effectiveness research where cost is not there.

DR. HORNBROOK: No, I understand but I mean how do we go through society and
go through this blinder dance knowing that cost is something that we cannot
talk about.

MR. J. SCANLON: Well, I will not even speculate, but there is a fear that
cost effectiveness research will lead down the path of rationing and I think
that is the great fear of some of the folks who passed this bill is that many
folks in the industry now how this all plays out. Clearly we are circumscribed
in terms of the kind of research we can do. You raised questions that other
folks have raised as well. We will be focused on certain

MR. O’GRADY: Would you like someone outside of the government to –

MR. J. SCANLON: Yes, please.

MR. O’GRADY: Yes, because he is putting you on the spot here.

DR. HORNBROOK: Of course and I do not always say.

MR. J. SCANLON: But, you are not, you are not.

MR. O’GRADY: They know the costs involved here, but there are also this is
the group when they are dealing with this methodology and it is not clear to
the people who need to have a consensus here that this is ready for prime time
so are they ready to take the first step and think about comparing these
things. Clearly they know costs. Costs is used in the privacy sector. It is the
gorilla in the room, but it is also many of the people who you really need buy
in to make sure this work have not had the experience that other people have
with cost effectiveness and I do not think they are convinced yet. You take on
your first step, you do a proof of concept, you show how this develops and then
you get to your consensus, but there is no slam dunk here that this is the way
to go in national policy. It certainly is very popular among the research
community. I do it myself and I like it, but I also as I do that methodology, I
see the data I do not have. I see the variables I cannot pick up and you have
to convince the many players here that this really is a fair game. This is not
just a way to sort of stick it one player or another and so they all know that.
Nice guys like Jim cannot just say those sorts of things that he is still in
the government. When you retire you can say things. Okay.

DR. HORNBROOK: I am not going to take the bait.

MR. O’GRADY: This is the same process we saw with risk adjustment five or
six years ago. We need the method to work then we can talk about it afterwards.

MR. REYNOLDS: So another nice guy, Blackford has a question and then Bill
Scanlon and then Garland.

DR. MIDDLETON: Thank you, Mr. Chairman. I guess, Jim the basic question and
we had a little brief conversation about it at least this morning over
breakfast is where will the NCVHS relate to comparative effectiveness and the
new councils and bodies that are forming. I think it is sort of clear that
there are relevant issues pertaining to the quality of the data and the data
standards, data transmission, and their use with respect to privacy, security,
confidentiality that will be underpinning all of the comparative effectiveness
including ultimately an assessment of the costs and value. So can I ask can we
put this on the docket somewhere sometime that we have a comparative
effectiveness day at NCVHS?

MR. J. SCANLON: And in fact, I think that the again the focus now is just
sort of making sense of how, what would be the best investment of the 400
million and what mechanisms would be used, what priorities would be set. Again,
I think for the money that is in the Office of the Secretary pool, it was not
meant to just duplicate what NIA in fact if you crowd around NIH or ARC
research, it would really be a great lost opportunity so I think we are trying
find ways, very open process, but I think this as much as we all love control
randomized clinical trials and I love them as much as everyone does, it is not
the only path and I think that there are other methodologies and all of them
depend on having other data sources including large longitudinal link claims
data and distributed clinical information systems. I would actually like to see
down the road maybe where the Committee would think of having looking at some
focus on research and methods for comparative effectiveness research,
experimental and non-experimental, maybe a hearing, but I think that would
help. But the folks are not even at that stage yet in terms of just sorting out
the kinds of questions that they are easy to answer.

MR. REYNOLDS: Bill?

DR. W. SCANLON: I agree with Mike. This is honestly an evolutionary process
that we are going to be witnessing. Although I thought that the Congress
provided sort of more latitude; that there was a debate over the issue of
clinical versus cost effectiveness and the word clinical was in the Senate bill
and was not in the House bill when the conference came out, the word clinical
came out. It seems to provide more latitude in terms of what this research may
actually investigate. Though the issue of cost effectiveness is very different
than clinical effectiveness, in my mind at least, because while physiology may
not change as a result of the analysis, the cost may change. If you are
interested in maintaining your market and suddenly you are not the cost
effective option, you may think it is better to have your market at a lower
price than at our current price and so this is part of what we need to be
thinking about in terms of how we ever end up using these kinds of analysis.

MR. REYNOLDS: Garland?

DR. LAND: I was wondering the Committee sent a letter to the Acting
Secretary on March 1st recommending peer recommendations in terms of the
Recovery Act maze: one on e-vitals hit on population base surveys and I did not
hear any mention of what happened to that letter. Is it getting passed to one
of these committees that you talked about? We went to an Undersecretary I was
just wondering if it got stuck in an inbox someplace. How do we make sure that
–

MR. J. SCANLON: I realize it had Committee support. I think it is reflected
in an increase forensic test. I mean I think the whole idea was to increase the
funding for population data both the ’09 and 2010.

DR. LAND: Well that certainly helps support the base. It does not address
the issues in terms of electronic systems I think was what was intended here in
terms of the Recovery Act of one time funding toward electronic systems and so
forth. I wonder if that is still.

MR. J. SCANLON: Well, Chuck will talk about a little bit, but there are
because it is still somewhat pre-decisional what some of the dollars will be
used for but there are public health. There is some of that money will go to
public health and there were a number of projects proposed. I do not know that
vital statistics, the e-vitals whatever, I am forgetting what exactly what the
proposal was, but that was under consideration. I do not know what the decision
was.

MR. REYNOLDS: Okay, any other questions for Jim or Jim, did you have any
other comments? Okay, well thank you. Yes, Mark?

DR. HORNBROOK: Just to follow up then. For my own personal understanding,
the reason why cost is not allowed to be talked about is because people fear
that when you bring cost into the equation, effectiveness drops out and people
make all of their decisions based on cost without looking at effectiveness, so
it is a domino or a slippery slope argument that we are going to go to hell? Is
that the paranoid that is motivating the opposition to cost? Do you think?

MR. J. SCANLON: I will take that as an observation. Mark, is that it?

DR. HORNBROOK: Sorry, I am asking the wrong person.

MR. REYNOLDS: Comment so noted. Okay, Karen?

Karen Trudel from CMS is going to update us e-prescribing and the PHR pilot
test.

SPEAKER: Karen is not going to take the bait either.

Agenda Item: CMS Update – E Prescribing and PHR Pilot
Tests

MS. TRUDEL: Observation so noted. Actually I am going to talk about a little
bit about our work in the PHR area and I want to provide the Committee with an
update on activities related to the new HIPAA transaction code set standards
that became effective on March 17th, which was the 50-10 transaction set at
ICD-10 code set for diagnosis and procedures.

In a sense these two initiatives have been upstaged a bit by the Recovery
Act and the discussion around initiatives and all of the other supporting
activities like the regional extension centers, but 50-10, and ICD-10 remain a
significant workload for providers and plans and CMS is continuing to push
forward to try to assist the industry in making this transition. I remind you
that the 50-10 code sets, which replace the existing HIPAA transactions for
claims, eligibility, queries, remits, advices, et cetera, the administrative
suite of standards will become effective in 2012 and the ICD-10 diagnosis and
procedure codes will be required for use in those transactions effective
October of 2013, which seems like a lot of time but in points of fact, it is
not and those two processes need to happen in a step-wise manner.

CMS internally has established an ICD-10 steering committee, which is
comprised of representatives of all of our operating divisions. This is an
activity that will encompass all of the systems and processes within CMS
including our claims and payment process, our coverage edits, a lot of our
quality measurement activities, our program abuse, coordination of benefits,
Medicaid policy, appeals, all of these business lines are affected to one
degree or another. What we are doing is to finalize a CMS impact analysis which
is in its second generation now. We will be finishing at the end of the year
and will have developed not only an impact for each of the lines of businesses
at CMS but also a game plan for how to move forward on issues that cross
business lines including mapping from one code set to another.

We have been also working very hard to try to get the word out to people in
the industry about ICD-10 and 50-10 in providing educational information. In
the middle of May we did a national provider education conference call
detailing some of the ins and outs of the ICD-10 mapping and we had more than
5,000 people registered. Yesterday we did an educational call, a national call
one Medicare fee for services implementation of the 50-10 transaction standards
and again had more than 5,000 people participating. So we know that there is a
significant need for information out there and we are continuing to try to meet
that.

We are probably within a few weeks to a month of awarding a national
contract for program management, which we will use to manage our internal
processes to make sure that CMS and especially Medicare fee for service and
Medicaid wind up where they need to be, on time and available to test and we
are also at a about the same time we will be awarding a national contract for
outreach, which will allow us to really extend past our normal trading partners
and our normal mechanisms in terms of fee for service, reaching providers,
reaching plans and we will try to look for hard to reach providers, small
providers, software vendors, clearinghouses, and some of the organizations that
we traditionally do not have close communication relationships with. So those
are some of the things that we are doing with 50-10 and ICD-10.

With respect to PHRs, we are continuing to operate our two pilots and I know
there was a discussion in the privacy Subcommittee meeting yesterday about some
of those pilots; one in South Carolina and that is the single PHR that Medicare
fee for services beneficiaries can elect to use — it’s supply by Health Trio.
We have about 4,000 beneficiaries in an eight county area who are actually
using it. The general population that we think in that eight county area who
could potentially use that is 100,000 so 4,000 out of 100,000 is not a lot, but
it is a pilot and we are learning a lot from it. We also have pilot in Arizona
and Utah which is called PHR Choice because we give beneficiaries the option of
choosing one of four PHRs including Google Health and Health Trio and two
others and in all of these cases we do provide Medicare claims information to
the PHRs and in the case of South Carolina, Tricare beneficiaries who are also
Medicare beneficiaries can receive automatic inputs on their active medications
from Tricare.

We are also in the process of doing evaluations of these pilots, both of
which will come to an end at the end of this calendar year. There are two major
components to this. We are doing beneficiary surveys. We are doing also
analysis of the impact on selected quality measures and care utilization for
people using PHRs. So we want to know, did the beneficiary like them? But we
also want to know, did it actually have a quantifiable, measurable impact on
their health? I will not go into how we are doing that because I do not really
get the details, but we are also looking at satisfaction, we are looking at
which features they think were helpful. What ones they thought were not
helpful. What kinds of outreach they felt was compelling that caused them to
want to utilize a PHR.? What they think the impact of the use of the PHR was on
their health condition in general. Did it facilitate communication with their
provider and what factors caused them to either continue to use the PHR or to
stop using the PHR.

So essentially, we are going to be able to find out toward the end of this
year we think, a lot more information than we knew before about what Medicare
beneficiaries really think about PHRs, who they use them or do not use them. Is
this something that they find compelling and useful and what does it actually
mean in terms of their health care, which will lead us to a number of
additional questions and some additional policy deliberations after that.

I will take questions if you have any.

DR. CARR: Thanks, Karen for the update. You mentioned that you are already
learning a lot. Can you say a bit more about what you have learned so far?

MS. TRUDEL: I think what we are learning, I have the best sense in terms of
South Carolina, but there we are finding that one thing that works best in
terms of outreach is actual person to person. The contractor has been doing a
lot of health fairs and things like that. They actually take a computer with
them. They will sit down and show the person what the PHR does, help them get
them going. That seems to help a great deal. I think what we are learning most
about right now is what works and does not work in terms of outreach. I do on
not have a good sense yet of the outcomes and what I was especially interested
in learning and I do not have a good sense of that yet either is once the
people sign up, how many of them continue to use it on an ongoing basis as
opposed to I signed up, I checked it out, I did not like it or I tried it for a
little while and I stopped. That is really going to me the big factor.

MR. REYNOLDS: We have Leslie, Larry, Jim and Karen.

DR. FRANCIS: We did not hear yesterday how many people are participating in
the Utah Arizona, so that is just a quick question, but maybe a longer question
is that there is a real difference between the Utah Arizona pilot and the pilot
in South Carolina in that in the Utah Arizona one, it looks a whole lot more
like the market. You know, what is out there in the real kind of rough and
tumble world. It is not just one that is being offered seniors. It is different
and it is some of the very high profile vendors like Google and I wonder if you
could comment at all on what you are planning to try to figure out about the
differences between those two; whether you have any preliminary sense about
just even maybe reflected in people signing up and people using about the
difference between those two pilots and what you are planning to try to learn
about that.

MS. TRUDEL: That is going to be a little bit tricky because there is an
apples and oranges sense about this. While I agree with you it does look more
like the rough and tumble world, the main distinction between the fact there is
choice is that in South Carolina, our contractor actually did the extensive
outreach as part of the contract. In the PHR choice pilot, most of the outreach
is being done by the PHR vendors themselves. So we will have to factor in the
variations in how they approach that. We have about 800 signed up so far I
believe in Arizona and Utah and again that has only been operating since I
believe January or February and it also does reflect the fact that CMS is not,
at this point doing outreach ourselves. We had a kickoff event and our regions
are planning to do some outreach in the future, but at this point we are
relying on the vendors themselves to sign beneficiaries up. That is one issue
and the other that will be very interesting to see is the considerations across
the different products. What did people like more than in product A more than
in product B.

MR. REYNOLDS: Larry?

DR. GREEN: Thank you, Karen, very much. I want to build off of both Justine
and Leslie’s questions. They reveal what I presume is a shared interest in
basically the entire Committees. I think we are eager to learn from the PHR,
PCMH trials that are, how are we going to do that? How can this Committee
rather efficiently learn from these Medicare trials what we need to know to do
our job? These are very promising, very important events it seems to me and do
we have a strategy about how we are going do that?

MR. REYNOLDS: We will take up –

MS. TRUDEL: We have been working with Jim’s office and a number of other HHS
operating divisions to collaborate on the evaluations and we would be happy to
get a group together to come and actually do a formal briefing when they are
completed.

MR. REYNOLDS: Yes right. The other thing is we had an excellent John and
Leslie invited that group from both sets of pilots to the privacy and security
meeting yesterday and they gave an excellent discussion. Again, that particular
discussion was focused on privacy and security and I think added a lot to it
and the other thing to remember is these are claims-based PHRs so if we are
gong to take up the subject as a Committee, I think it would also be good to
probably include some that are not claims-based, that have more others so I
think maybe holistically as a team if we take it on. They are coming up with
real data and that is great, but the other thing you always hear when you take
the whole subject as we have all dealt with on our Subcommittees and so on,
then where is the clinical and so if we could add that to it, then I think we
would have a real good look at the whole thing.

DR. GREEN: I just want to express one view. I think this is really important
and there is a lot of time, effort and money going into these things and from
my perspective, this ties directly to the reason we exist and that we really
need to drain out of these things what we can so a systematic approach to doing
that would be welcome from my perspective.

MR. REYNOLDS: All right, so you are going to comment on that?

DR. J. SCANLON: I guess friendly amendment there as well, I think as Karen
said we, again when we do pilots, we like to learn from them and we do not like
to leave a pilot without learning something from them. So we have three of
them, I guess. The other one is the plan, one where the evaluation that is
plans, but I think we could share certainly. We are in the process of putting
together the evaluation design for the western states, but we can share that
the Committee and maybe once have a special session on the varieties and the
effectiveness of PHRs, we would be happy to do that.

MR. REYNOLDS: Okay, we have two follow ups and then we have Blackford, Carol
and Mike, so will get it done so Marjorie, do you want to follow up on this?

MS. GREENBERG: Yes, I was just going to say and follow up to what you said.
From what we heard yesterday, although they are claims-based, they have lab
data; they have got pharmacy data, so it is more than just the claim from the
clinician. Also, there was mention of like the CDA and so it was not quite
clear to me the extent to which it went beyond. Some of them potentially could
get information beyond what was just being obtained from the Medicare records.

MS. TRUDEL: Could I answer that, Harry?

MR. REYNOLDS: Yes

MS. TRUDEL: Just to clarify, we are providing, pre-loading claims data
because that is all we have. Until there are more providers using EHRs, that is
a main source of data and from my personal perspective, I think that claims
data will always have some kind of a use in PHRs as beneficiaries try to get
information to figure out how to manage their care from a financial
perspective. So, I think what we are seeing is we looked at PHRs at the various
candidates that we were going to use both in South Carolina and in the western
states and all of those products can bring in data from a number of different
sources including labs, including meds and in fact in the western states demo,
we are using the CDA as the way that we communicate the claims data to the four
PHRs, although we are populating only a very small part of it. We are also
trying to step along and show that you can build on this and we are using the
transmission mechanism that you could use for clinical data. We are just
pulling it from a claims source and sending forth what we have.

MS. GREENBERG: If I could just add one thing and I really commend everybody
who was not at the hearing yesterday because you know look at some of the
testimony and particularly you all remember E. Dave (?) who gave claims data a
bad name we thought, but his testimony is very thoughtful about the value to
him and to what he felt of a beneficiary or consumer patient getting that
claims data whether you find problems in it or not. I mean that is part of it.
So his testimony was much more nuanced than I think the newspaper articles, but
anyway.

MR. REYNOLDS: Paul, follow up comment then

DR. TANG: Yes, just to pick up on what Larry said, is there an opportunity
to get involved with the evaluation in terms of its design or is that too late?

DR. J. SCANLON: Well the only difficulty is the contracts part of this. Let
me think of a way we could do this, but I think it could be done. There should
be a way we can do this.

MR. REYNOLDS: Okay, Blackford?

DR. MIDDLETON: Actually it is on the same thread following Paul’s comment
that I think this is obviously going to be very critical in understanding not
only how patients interact with health care information technologies, but
eventually how patients and technology interact with their clinicians in health
care delivery systems and each other. In my observation actually based on some
work we have done and Paul participated in is that the value proposition may
actually vary a lot with the different architectural approaches. What I mean by
that is to what degree data standards are being abided by? In fact what are the
information exchange patterns? What are the communication patterns and what
not? I realize this may be beyond what is happening today, but I would hope we
could do with this evaluation and even then follow on evaluations is think not
only about the clinical impact and satisfaction, kind of our usual clinical
effectiveness kinds of things, but to actually add to the evaluation
informatics or architectural considerations to see what makes the most sense
and provides the most value. I think looking at IT in general, we do not know
what are those response curves. We do not have a good idea for how much PHR
actually causes a positive response like we do with drug studies. I think that
is the way we need to go ultimately.

MR. REYNOLDS: John has a comment on Blackford’s statement.

DR. J. SCANLON: Well, yes.

MR. REYNOLDS: If it is not then you do not get to talk because Paul has one
on Blackford’s and if it is not then you do not get to talk and Carol, you are
next and you will get your time.

MR. J. SCANLON: I just want to make one piece of insight. We heard from
somebody from the Pew yesterday about some of the work that they have done
generally and I think there will be some values and general overlap some of the
survey type of work that they are doing on these PHRs with what some of the
type of work that Pew does because they have sort of a, I do not want to say,
different perspective, but they add a different dimension to try to explain why
things are what they are and why people’s habits are what they are. I think it
was interesting to listen to her speak yesterday just because of the way they
sort of go about doing studies and how they infer information and it might be
helpful in trying to understand PHR adoption and use and things like that.

MR. REYNOLDS: Paul?

DR. TANG: The reason for picking up on what Blackford said and it relates to
my previous question is both the contracts and the evaluation were pre-Recovery
Act. With the Recovery Act in meaningful use, there may be other dimensions
that were considered initially and that might be a reason why you might amend a
contract for the evaluation before you get more of it.

MR. J. SCANLON: The contract is for, I cannot say too much about it, but it
basically will be a design evaluation and get some very baseline data so there
will be an opportunity as soon as that is public. Maybe we could even use the
Committee as a technical advisory at helm for some of that.

MR. REYNOLDS: Leslie, did you have comment based on yesterday?

DR. FRANCIS: Yes, what I wanted to say two things. First of all, everybody
on the Committee knows the Google and other products that were negotiated by
CMS with Google Health and others are not exactly the same thing you would get
if you signed up with Google. There are more protections in them. That is just
an information statement.

MR. REYNOLDS: Make sure you are speaking into the mike.

DR. FRANCIS: Just an information point, but also we are planning to produce
and you will hear more about this later in the full Committee agenda both some
informational materials from the testimony as well as some recommendations on a
pretty fast track for the full Committee to be discussing so those should be
available to CMS in timely fashion before you have to do your evaluation.

MR. REYNOLDS: Carol?

MS. McCALL: I would like to link some of this conversation back to actually
to Jim and it is going to end in money, but for a different reason. I think
everybody is very excited about the pilots that are going on and so Larry
expressed that very well, very enthusiastic to know what is going on. I think
that in addition to being explicit about what we are trying to learn from these
particular pilots and we do need to be explicit about what it is that we hope
to get out, I would like to see us do a lot more experiments and I mean a lot
more. We are entering a brand new field of information products that at their
absolute extreme begin and end in data and we just do not know what we do not
know yet. Everything from standards and the things we are comfortable with all
the way to the extremes of new forms of knowledge representation and semantics;
things that if we go out and ask this end consumer, they do not even know to
articulate, but they will know when they see it. And so I too am very
enthusiastic and I am enthusiastic not just for what you are learning, Karen,
but for all of the things that I am hoping, Jim, that are part of the funding
so that we are much more intentional and much more aggressive about the types
of discovery work that we do. Any money there for that?

MR. J. SCANLON: Some of that is evaluation and some of it is prospective in
the sense of looking at these new ways of displaying and presenting information
and looking at what the affect is. We have a number of mechanisms that HSS
test, that kind of test those. To be honest, they come from the old, the older
communications world and I think we have to extend it to some of the newer
social media, but from my office evaluation is our middle name and we generally
like to learn. If we do a pilot or we do a program, we generally like to at
least learn what they did and what worked and what did not work and why so we
can use it for the next time. For example, if a bill appeared on the hill that
Medicare has to do PHRs for everybody at least offer them, well if we did not
learn anything from these pilots and that may or may not be a good idea. It may
be a good idea now or later or not, but we would at least like to know what we
benefited from these pilots about what people. We are clearly seeing dynamics
that are not anticipated and maybe it is the demographics of the Medicare
population, you know, people might register and then use it once and then never
here again. It depends on whether there is a health issue or a health problem.
There are a lot of dynamics underway there that we are beginning to understand
them now that we are monitoring it closely. I agree completely. We should base
this on some sort of evidence.

MS. MCCALL: Just to add on a little bit, I am not at all surprised that you
are being surprised. I think my point is that we should both anticipate that
and invite it and see if there are ways that we can do a lot more in terms of
funding it, but also speed them up. There is an insight and a feedback loop
that I think if could learn to accelerate, a lot of this would come much more
quickly. So there could be a role there.

MR. REYNOLDS: Okay, Karen, follow-up and then we have Mike, Walter and Mark.

SPEAKER: You faked me out by putting me in.

MR. REYNOLDS: Mike.

DR. FITZMAURICE: Two things, one is that express some appreciation for what
the Chairman has invented that is a system of comments and here is a chain of
follow-ups. You can comment on the follow-up, but then we get to the main chain
of comments.

MR. REYNOLDS: Yes, but when we run out of time and somebody is left out, it
does not work so good. Parliamentary procedure.

DR. FITZMAURICE: Secondly, Karen you mentioned that CMS is doing an impact
analysis for each line of business for a 50-10 and ICD-10 and they are both
coming on line in 2012 and 2013. ARA and incentive payments come on line in
2011, maybe even October of 2010. I am wondering if the same analysis team is
also looking at the impact of meaningful use, although we do not know what it
is yet, but maybe quality measures. Certainly they have to make payments to
providers. Are they looking at the impact of that also on Medicare’s line of
business because that might even be more immediate and more, I will not say
threatening, but of greater concern at this point?

MS. TRUDEL: We have a completely different team and a completely different
executive board that is overseeing the Recovery Act, but it is doing it in the
same way; looking at all of the lines of business, all of the policy decisions
that need to be made before we can develop regulations and bring up our program
and at this point, we are looking at it from a policy perspective, but we are
also starting to look at the architecture aspects of it as well.

DR. FITZMAURICE: Thank you, Karen.

MR. REYNOLDS: Mike, it is all that in the same ecosystem regardless who is
looking at it. The same doctor’s office gets it. Walter?

DR. SUAREZ: Thank you, well I am going to go back to the PHR, this is very,
very exciting certainly to see all of this; experiments happening and I wanted
to link something that was mentioned earlier, Jim, and that is comparative
effectiveness research. I have been pushing at every meeting I have a chance
to, to expand the vision of comparative effectiveness to include not just
clinical outcomes, but include comparative effectiveness of health information
technology such as the PHRs and try to look at innovative research that can
lead us to see how different technologies and in the field of PHRs different
approaches can lead to different effectiveness and outcomes ultimately. So, I
wanted to bring that up and I really like the idea that Blackford mentioned
earlier about having a whole day about comparative effectiveness and include in
that day not just comparative effectiveness on clinical outcomes, but again
comparative effectiveness of health information technology, comparing different
health IT approaches. I mean the PHR is specifically exploring the possibility
of doing a research around different approaches and how they ultimately lead to
different outcomes. So that is one comment I wanted to make.

The other one, I think is very important. There is a population dependency
certainly on the experimenting done by Medicare. The Medicare population has a
unique demographic altruistic and I wanted to suggest the importance of looking
at similar experiments, similar experiences in another population and that is
Medicaid and see how, if there is a possibility to support the implementation
of personal health records in Medicaid programs and explore and understand
better the expectations and the experiences and the learning lessons that can
be extracted from having a Medicaid population experience electronic of
personal health records and I do not know if there is a possibility of that. I
know the Medicaid transformation grants that CMS has provided, has funded the
adoption of health IT of Medicaid agencies and they have been using it to
implement electronic health record claim base, electronic health records and
some other aspects but very few, if any, of the Medicaid agencies are exploring
personal health records. I think there is an opportunity to lead that so I do
not know that there is something that could be done about that.

MR. REYNOLDS: That is a good idea as we do our evaluation planning.

MR. J. SCANLON: I might just add on the comparative effectiveness research,
you will see on the HSS Recovery Act dot gov website a framework for
approaching and I think comparative effectiveness research is seen as a
continuum from the clinical to the community and it is not just head to head
clinical necessarily, but a definition is there to comment and then look at as
well as the framework and it is a very open process. It should be a somewhat
broader definition.

MR. REYNOLDS: Mark.

DR. HORNBROOK: I just do not want us to lose sight as we talk about PHRs
that there is an electronic health record up there that is much more
functional. On an anecdotal basis, I just had my eyes examine. I have glaucoma
risk in my family and so my ophthalmologist was able to pull up all of the eye
pressure readings over the course of time and technologies. They zigzag around,
but then all of a sudden they pop up and so now they are going to put me onto a
digital photography regimen to take a picture at the back of my eye. That also
becomes part of the electronic record. What I need is if I ever happen to leave
Kaiser, I want all those data to go to my next ophthalmologist. I do not want
to be locked into Kaiser because that is the only system that has electronic
data. They same goes for PSAs, glucose and hemoglobins, BMI, all of these
clinical measures are really where it is getting at the continuity of care. It
is not just utilization, although that is a good first step, but we have to
take the next giant leap to get real differences in effectiveness of our care.

DR. TANG: We are just down the street.

MR. REYNOLDS: Now that we have gotten personal on somebody else’s marketing,
we will move on to the next. Karen, would you? So the two things that we listed
you have not touched base on yet. Did you have anything to say on e-prescribing
or oh you did pilots. Do you want to say anything else on e-prescribing? I am
not requiring you to, I am just asking a question.

MS. TRUDEL: The reason that I decided to talk about 50-10 and ICD-10 was
that I thought that the work that is going on there was more prepared and
compelling and really and really there is not that much going on in
e-prescribing at this point.

MR. REYNOLDS: No, no that is great. I just want to make sure that you
realize that you have additional time. Okay, we have got Chuck and then Walter.

DR. FRIEDMAN: Just a quick comment because several of the folks who spoke in
the preceding discussion made reference to issues related to research on health
IT and to a future of perhaps higher functioning technology that the general
public thinks, I love what Carol said, the general public may not be able to
describe it, but they will know it when they see it. In that light I would like
to call attention to one aspect of the Hi-Tech Act that I do not think has been
mentioned yet today and this is the enterprise integration centers. They have a
somewhat interesting name. If you juxtapose it with the mission for them that
is described in HITECH, and we really cannot go beyond at this point of what
the statute says about them, but these enterprise integration centers are a
potentially important vocation for some of the work to be done that was
discussed by the committee in the past few minutes and I would just people who
are interested I suggest you go to those few nice paragraphs in the statute and
take a look at what they say.

DR. MIDDLETON: Chuck, I think this is extremely interesting to investigators
in the field obviously and is extraordinarily relevant to actually making also
the extension centers work well because we need more implementation science as
well as some of the other research that we have addressed. Can you provide any
more detail thought because everyone is kind of waiting with baited breath what
kind of announcements will be made, what kind of RFAs, RFPs and when will they
happen?

DR. FRIEDMAN: No I really cannot, Blackburn. Obviously I certainly can say a
large number of us are working very, very hard on it, but I do not want to say
anything that might be premature or misleading about dates. I just to be sure
everybody was aware of the enterprise integration centers as an element of
HITECH.

MR. REYNOLDS: Okay, Walter then Larry.

DR. SUAREZ: This is question for Karen. It is about the security guidance
and the efforts of your office regarding the recall react security regulations.
If you could talk a little bit about what the status of that is and what are
some of the next steps.

MS. TRUDEL: Actually, the Hi-Tech Act appropriately in my opinion very
closely links security and privacy and breach reporting and education and all
of the issues that relate to security and privacy are very closely intertwined.
So essentially to work that section of the Hi-Tech Act, the department has put
together a group of folks, for instance OCR, the Office of National
Coordinators, CMS who are all collaborating on different aspects of that
process.

MR. REYNOLDS: Larry?

DR. GREEN: Another question, Karen, totally new subject area here. Can you
alert us to whether or not the Medicare pilots or demonstrations are evaluating
anything to do with mental health? Or said differently, maybe to you too, Jim,
there may be questions, where in this discussion lies mental health?

MS. TRUDEL: I have to say that I do not know that we are evaluating it
specifically in terms of, I am assuming you mean usage and outcomes and whether
that as the principle diagnosis would affect the usage of a PHR? I am not sure.

DR. GREEN: Yes, my underlying, I should be explicit when I, my underlying
assumption is that this is inseparable from the care people. It is inseparable
from improving health care. It is inseparable from improving health and as I
read what I can get my hands on and listen to reports, it strikes me that there
is a relative neglect of the issues of mental health. Privacy and security
aspects of this, quickly often migrate towards stigma with impediments to
reporting and collection of relevant data. I am just wondering if these
demonstration projects are going to be a source of information about how
emotional behavioral problems are monitored, identified, aligned as co-morbid
conditions, that sort of stuff. If we are going to learn these things from the
more, should we be looking elsewhere?

MS. TRUDEL: I would venture a thought that we probably do not have a robust
enough sample size to learn an awful lot from either of these pilots. I do
know, and I believe this was discussed yesterday in the privacy hearing that
for the South Carolina pilot, we have actually tried to address some of the
concerns about release of that kind of information by using SNOMED to collect
what we have called informational sensitive topics and that when users of the
PHR make a determination whether they want someone else to have access to it;
whether it is caregiver or a healthcare provider or whatever, they can opt out
of having some of that sensitive information shared to that person. So, the
construct of the tool itself is trying to be sensitive to that, but I do not
know that we will actually learn anything specific about that group of
diagnosis.

MR. REYNOLDS: I also think that I would concur with Karen. There was an
awful lot of discussion about that in the hearing we had yesterday and that is
an environment where the committee should be able to weigh in quite heavily
with the testimony that we have been getting. So through the efforts of the
John and Leslie are leading, I think that came up not only in the panel from
the CMS group, but some of the other panels and that we had talked about that
significantly. So we should be able to not only deal with mental health, but
other sensitive situations that came up quite significantly in the discussion.
So, make sure you stay tuned with us on that and follow up to make sure that
that does occur.

Karen, I would also like to thank you as somebody on the ground that is
using 50-10 and ICD-10, I think CMS has done a magnificent job stepping up and
has I would say to all of you has learned quite significantly from the other
HIPAA implementations as to where they can play and how they can play and how
they can get out in front and really help the industries. So, I do see a
significant change in that and thank you to you, Tony and Denise and others so
thank you very much for that. That is much appreciated.

With that, we will get back together at 10:35 and see you then.

(Break)

Agenda Item: NCVHS Summary Following Public Meeting
on “Meaningful Use”

MR. REYNOLDS: Let’s go ahead and get started. The next item on the agenda is
our discussion of the kind of effort we put in on meaningful use.

First before we get started, I would like to say some kind of special thank
you’s to Margaret A., Marietta, Debbie, Karen, Denise, Jeannine, Cynthia, and
so on. If I left anybody out, I am sorry. That is maybe the fastest hearing put
together with the most oomph to it in the history of the United States. It was
put together well. We worked closely with Chuck at ONC. Outstanding job putting
that together through the process. Tony Trinkle and David Blumenthal, and so
on.

One thing – just a level set for some of the committee that maybe has
not been around a long time, this assignment was taken on by the Executive
Subcommittee and the reason it did not come back here before the documents went
through is there were no recommendations. All we did was basically have the
hearing, listen to the input in the hearing, and then we grouped it up into
some observations. We did not make any recommendations. No recommendations can
come out of this committee without it being through the committee and without
the Full Committee’s involvement.

I wanted you to understand that. We were asked to complete an assignment to
be an environment for a hearing, listen to the hearing, put a read out of the
hearing, and then we grouped that up into some observations and I will go
through some of those briefly. But I did want some of you that – well, I
had not seen it happen at that level before quite the way it did, so we were
all kind of making it up as we went. But that is exactly why the documents are
already complete. We did not send forward any recommendations to this
committee.

Now, if we are asked to do so as a next step, by ONC, whether we do or
don’t, that would come back through the Full Committee for full jurisdiction by
the Full Committee and would go forward in our consensus manner as usual. I
just wanted to make sure that you were aware of that.

So we went through all the structures and everything that we needed to, to
do that and that is why we took it in that way. I wanted you to be aware of
that so that nobody felt that we had gone outside process – we went
outside process, but we stayed within the right process to be out there, as you
look at it.

Mike.

DR. FITZMAURICE: John Lumpkin, in his daily blog, has announced that on June
16th, David Blumenthal will announce the “meaningful use criteria” –
the first draft of it. I was wondering if given this expertise by NCVHS, that
we would plan to make comments on that draft of meaningful use?

MR. REYNOLDS: A lot of time we do – when new things come out, we do as
a group, decide whether or not we would want to comment on it.

DR. FITZMAURICE: So we will just wait and see until we see what it looks
like?

MR. REYNOLDS: Jim.

MR. J. SCANLON: I believe what they are doing on the 16th, Mike, is the
Health IT Policy Committee will be – one of its workgroups will be
releasing what they think is the meaningful use. So it is basically a FACA
product, as I understand it.

DR. FITZMAURICE: So it will be the workgroup according to the FACA?

MR. J. SCANLON: It is the work of another advisory committee. Again, the
committee could react or not. It is not an HHS adoption of what they say.

DR. FITZMAURICE: So the question really is is there a policy that we don’t
comment on what another FACA says or we just wait and see what the importance
is and see if we have anything to contribute to it.

MR. J. SCANLON: My only point was it is not an HHS document, it is a FACA
document.

MR. REYNOLDS: But it is being put out there for public comment, I believe.

Chuck, help us through what the process is here so we know whether to jump
in or jump out.

DR. FRIEDMAN: This discussion is just a bit premature. The matters discussed
in the past three minutes are not completely settled. But there is a
subcommittee, as John Glaser and Jodi Daniel will describe at 11:30. There is a
subcommittee of the Policy FACA, dealing with this topic. There is a meeting of
the FACA on June 16th.

DR. FITZMAURICE: I am only reporting rumor that John Lumpkin had in his
daily blog, so it is public knowledge.

DR. FRIEDMAN: Right. So I am just stating the facts as I know them to be
fact. I think if John or Jodi are more comfortable saying anything beyond that,
they will.

MR. REYNOLDS: The other thing, let me say for the discussion between now and
noon, let me try and put a little box around it. Everybody knows that there are
two new FACA committees. Those FACA committees are playing in some cases in the
same space as us, in some case in other spaces – different spaces than us.
We are, myself, Jim, Marjorie, we will be continuing our communications with
Dr. Blumenthal. You can rest completely assured that when they know more about
exactly what they are going to do and what space they are in, we are continuing
and we set up an excellent relationship I think, through the Meaningful Use
that we just did, to continue to show what we do and how we do it. You will be
made aware of how this all plays together instantly upon it becoming clear.

I think the one thing that all of us do since we are so anxious to make a
difference, I think it is important right now while the structure of how a
difference might be made is under construction, which is exactly what is going
on right now, in this whole space with as fast as it is moving and with new
players on the block, that you just understand that we are saying to you
clearly, we understand that is an issue. We understand it is an elephant in
this room. We understand it is an elephant in a lot of discussions and we are
excited about elephants.

(Laughter)

We are absolutely – we are ready to ride the elephant, we are ready to
feed the elephant, we are ready to do whatever, but the main thing is we also
realize that we have things we can do ourselves. So for example, in the earlier
discussion on PHRs, we are the main FACA committee in the country that is right
now focusing on PHRs and everything related to it. Don’t stop. Don’t slow down.
Keep going.

On comparative effectiveness, since it is new and since it is in its infant
stages, if were to want to be thought leaders in that environment and think
about what ought to be thought about, perfect example. So let’s don’t paralyze
ourselves or our thinking or do we want to chastise somebody else that can’t
give us the answers to questions that may not even be on the table yet. It is
not a lecture, it is a request. I can tell you we have taken this very
seriously and we continue to take this seriously – the three of us sitting
here along with Dr. Blumenthal and we are in constant contact about that.

We will be sitting down soon. When soon is the right soon. So just please
understand that we have got to do that due process because the worst thing that
can happen right now is people fighting for turf that is not understood. The
worst thing that could happen right now is to slow down what needs to move
fast. We will follow, walk beside, and lead, as appropriate in this next period
of time and I ask you to continue to remind us what those should be. Those
shots that we have that are clear, go and go fast. I think that we showed that
we can go fast in helping also, and I think what we did in an excellent way
with the Meaningful Use. I just ask your indulgence in that.

Rather than asking Chuck, when he presents, asking him the same question,
and then John Glaser and then Jodi. I’ve said as comfortably as I can, we need
to get over that for right now and we need to make sure that we find what we
want to do, how we want to do it, and so on, and then we put it through the
right filters to make sure that we are not – because it is the same
department. It is the same effort. It is the same environment – let us
make it happen.

Chuck, you had your hand up.

DR. FRIEDMAN: Yes, Harry, thank you. I just wanted to add because the agenda
formally shows me doing the update at 11:30 solo. I wanted to be sure that
everyone was aware that at 11:30, John Glaser and Jodi Daniel will be dialing
in and we will be giving an informational update on the activities of the two
new advisory committees – very much in the spirit of what Harry just said,
primarily for the purpose of you all being fully informed of what – or as
informed as you can be in the time allowable, of what these committees are
doing. And of course, because they are federal advisory committees on the
HealthIT.hhs.gov website, there is a full set of materials describing the
committee’s activities. But Jodi and John will be coming on the phone and
giving you an informational update.

MR. REYNOLDS: The other thing we want to make sure we do is there needs to
be some courteousy in this clearly, we want make sure that even though our
recommendations go directly to the Secretary, we are working in the same space.
Let’s make sure we don’t deter ourselves in what we are able to do but
courteousy is a very important thing as you are working in this tight of a box
on this big of an issue.

Walter.

DR. SUAREZ: Just a quick question, the observations document – has it
been sent?

MR. REYNOLDS: Yes. It is already posted on the website. Actually, I commend
Dr. Blumenthal, as soon as he got it he posted it even before he in fact,
evaluated it. That is transparency at its best. Taking our document as we had
prepared it and putting it out there for public view before they had even spent
anytime scrutinizing it for anything. I take that as a compliment. That is as
good as it gets right there. When they take it and put it straight out there
and say – I think we have done a good thing there.

Let’s turn to, if you would, tab 8. I am sure not in any way going to read
this. I just want to kind of go through kind of the structure and have you
understand how we organized this. Obviously the first document in here is
actually the observations, which is a good place to start because it kind of
shows you how we grouped up what we heard.

The five bullets on page one, really kind of got into the overall – it
kind of gave us a general theme that we dealt with. We spent a lot of time
trying – and actually had a lot of consternation over if we had 17
observations, then we came up with themes – did we need to put those
themes under the observation. We had a lot of discussion about that. Hopefully
these themes are just really a good way of breaking down what we heard and not
necessarily do they apply in anyway one to one, or any other way, with the 17
observations, but were just some of the things that we heard.

We really broke the document from that point on, if you move onto the second
page and so on, common directions. I don’t know if you know it or not, but we
had a 150 testimonies. We had 40 personal right there in the room, that were
invited, we had 20 that came to the microphone in the open public mic, and we
had 90 written. I can comfortably tell you and it is important that this is
clearly stated in public record, we read them all, they all mattered the same.
If you went through the documents you can find where there are key premises
that were only in written, only on the microphones, or only in testimony. Then
we took the common threads across all of them.

Because what I think what is extremely important as we go forward, and each
of you in subcommittees or anything, if you ask for written testimony, you must
read it, you must include it, and you must consider it, otherwise we would be
making that testimony secondary to what else went on. It was a lot of stuff,
guys. It was a whole lot of stuff on a subject that is incredibly exciting. It
was very rich and I think it was helpful.

I also would like to say to those of you who were not at the original
hearing, Dr. Blumenthal, except for the last hour of the second day, remained
in the room the entire time, as did Tony Trinkle from CMS. This was something
that was played out clearly. We had up to 300 people in the room for the
hearing much of the time. It was an interesting event but I think we got a lot
of stuff and we did it well.

So the common directions were obviously easy to at least identify, maybe not
communicate. Then we had, if you move to page four, we had multiple options. As
you can imagine, with 150 testimonies, there was some difference of opinion as
to how some of the options can play out.

Then if you go to page five, we actually recognize some gaps. The reason
that we did it that way is obviously as the other two FACA committees move
forward and ONC takes a look at this, where there were gaps in testimony and
maybe gaps in what is going on out that, that would be an excellent opportunity
for them to focus and have somebody look at that further, whether it be them or
someone else, take a look at those things further if those thing were not in
fact, spelled out by the 150. It put us in that position to make sure that we
did that. That is kind of what we did.

Leslie, you have a comment.

DR. FRANCIS: I just wanted to describe what John and I did, for example,
about Privacy and Security. As chairs of the different subcommittees, we were
asked to pay particular attention to our areas of interest and expertise. We
actually went through and every time anybody mentioned privacy or security, we
did a little compendium and then we worked from that to see what was said or
what was simply not treated. That is the methodology that we used.

MR. REYNOLDS: Again, that was done pretty well across the whole group so all
the chairs were asked to look at the testimony in its entirety, as well as make
sure we did not – since they had an expertise, that we did not oversee
something. Then obviously, our summary.

That again, was after the big work, which if you turn to the back of that a
little further a long in that section, the whole document itself, which is a
substantially larger document that we went through. We tried to put it very
much in the categories – on page one, a vision of health care transformed.
The reason I am doing it this way is we have people on the internet, and maybe
people in the audience, that don’t hear this. I know you have your documents in
front of you and I know that you can follow pages, so I am not reading to you
as fifth graders. I am making sure to the entire that they at least understand
what we have put together and where it is.

After our introduction and purpose, really the vision of health and
healthcare transformed, we heard, and I would recommend to all of you that you
– if you don’t spend a lot of time on the document, I think it would be
important for you to really, really look at some of this vision stuff because
those people were selected mainly to kind of take a look at how all this moves
forward. So as we continue to be thought leaders and we continue to move
forward on what we are doing, that is a good section to keep an eye on. We are
not any way saying, right, wrong, or indifferent, we are saying these are some
interesting visions that were out there as we went through it.

Then this whole idea of meaningful use capacity. As was said earlier, I
think one thing to be mindful of as Karen was going through 5010, ICD-10, and
then you take this meaningful use capacity on top of that, there is an industry
out there that is going to, between now and 2015, have a lot of change going
on. We, and others, have to be careful not to just take one lane of that
highway and focus on it, we have got to deliver the whole highway system of all
these changes and all the lanes. I heard a comment the other day that right
now, with as much as is going on, there are orange cones in every lane. So you
are going to have to do some weaving to get through this whole thing over the
next period of time to get this done. We have all got to group up and make sure
that we help in every way that we can.

Then the path to meaningful use. I think one of the things we heard clearly,
and everybody else did, is this whole idea this is a journey. Some offices may
be starting from zero in their electronics, and others may be large medical
centers and there may be states that have health information exchanges already.
So there is a broad spectrum of who is going on as we deal with it.

The other thing I thought was a key one to point out there is the vendor
cycles, which is on page nine. The important thing is when you talk about new
functionality and you talk about the other things that are going on out there,
if they are delivered through vendor systems then their ability to adjust,
change, and react, as they mention in here in a 18-24 month cycle. So if you
start thinking about 2015 and you go back to 2009, you don’t have a lot of
cycles. You don’t have a lot of those two-year cycles left between now and the
end of the journey. So that is another key element as we think about this. Same
thing with providers and so on, as they deal with it. So we have a number of
sections on that.

Then the whole thing on certification and meaningful use. The product and
the strengths and weaknesses of some of the certification that is going now
– what does it mean? What does somebody have to adopt to be certified? So
if you get a certified system do you need to do the whole thing to actually do
meaningful use? Those are the kinds of filters that are going to be needed
– get into measuring meaningful use and so on.

That is kind of how we – that is the way the hearing was set up. That
is the way we heard what we heard and that is how we categorized it and tried
to turn it into a document, which I believe that ONC has already found
valuable, and then the observations take it to a next level as to put it into
other categories.

With that, I would like to open it for discussion by the committee or anyone
else that has any comments. If there is a question I will open it to all
members to answer by the Executive Subcommittee. I will not assume that it is
directed at me or anybody individually.

With that, Justine, please.

DR. CARR: Thanks. Thanks to everybody. I echo your thanks to everyone who
worked so efficiently and deliberately to make this work so seamlessly. It was
really a remarkable effort.

I want to put out the question of with this initiative going on, does this
shape what NCVHS – the directions that we take going forward based on this
work and this focus of activity within our subcommittees? Would this enter into
our plans for hearings or topics to address?

MR. REYNOLDS: I think a couple of things. I think it is one input to it. For
example, we talked this morning about comparative effectiveness day –
whether we want to go after comparative effectiveness PHRs. I think there is no
question – this is my opinion and I will open it to others – the
subject is in here, absolutely. There are a lot of subjects that are listed in
here. I think as soon as meaningful use comes out, any kind of a definition,
this was as we all know, the initial thing was kind of everybody say what you
think. Then the observations took it down and then whatever comes out, whether
it be June 16th or whatever, comes out as some kind of initial guidance.

I think us looking at where there might – we could either add thought
leadership by holding hearings. Whether we have already done work in some of
those areas that may be submitted to that. I think that is exactly what I would
want each of our co-chairs to be looking at.

Again, as we continue this relationship with ONC, those recommendations can
be taken forward so that coordinated with Jim, Dr. Blumenthal, that we take
what we have. On the other hand, as I said, some of these items we won’t need
to ask anybody’s permission to be working on. They are part of their charter.
They are part of what we do and they are part of how we do it. That is why I
would hope that all the efforts that are going on right now, including the
discussion earlier this morning where we highlighted a couple of things, would
energize people around the room to really – when your subcommittees
breakout, really think about how do we make the biggest difference right now.
Whether it is thought leadership. Whether it is kind of helping formulate
something that is going on or whether it is helping somebody else’s ideas. I
know that is what I am thinking about and I would hope that that is what every
committee thinks about. Period.

DR. CARR: I just want to second that because what I think worked well about
this is we did the things that we do well. I think as we look at this and
examine maybe the gaps or the things that were not said, these are areas that
we can continue to contribute without being redundant or duplicative.

MR. REYNOLDS: Absolutely. I think that was well said.

MR. HOUSTON: I think the challenge is is always trying to figure out where
input is meaningful, where it is welcomed, where somebody really is looking for
somebody to provide input. Again, I don’t like to meddle or make
recommendations in areas where I don’t think somebody is really wanting us to
involve ourselves. I think it is interesting in listening to Karen this morning
about some of the forming in order to address the new privacy rules within HHS
– the groups that are forming. At least from a privacy and security
perspective, maybe than rather than making assumptions or trying to read a
crystal ball that may not be reality, I guess I am looking for more guidance.
Tell me what do you want?

MR. REYNOLDS: Who is “you”?

MS. GREENBERG: Who is advising whom?

MR. HOUSTON: That is the question. By example, if Karen says they are
pulling together a group within I guess, HHS, correct Karen, to look at some of
the privacy stuff. Are there gaps? Are there areas where they say you know
something, we really could use input through our processes on a privacy and
security perspective from NCVHS. Right now we are taking testimony on PHRs and
it is obviously an area where the privacy rule requires recommendations over
the next four to six months. Are timing for getting something out of lines with
the timing in the – where do they want us to be use and where do they want
us to be of use and how do we accomplish that?

MR. REYNOLDS: Here is how I would recommend it. We have heard loudly from
Marjorie and Jim both, at time. We need to have a customer. Sometimes a subject
can be our customer. If there is a subject where we need to be out in front
– that can be our customer.

So, for example, – Jeff, I see your hand and I have got you on the list – if
you look at standards, and this may be what Jeff was going to say, but I will
use how we are doing this along the way. If you notice we took the standards
subcommittee to do this hearing. On the other hand, what Jeff and Judy are
doing is talking to CMS. Since there is another standards committee, and since
right now figuring out exactly how we all play is a question.

So if you took 5010 IC-10 as just an example – I am not recommending
that we do or don’t do this, but it is a great example, there is a lot of work
that needs to go on in this industry over the next three years on 5010 ICD-10
and I promise you none of the new committees have ????

Meet with the people who you tend to deal with. Think about the people that
would be your audiences. So that was a great fit for Jeff and Judy to start
talking to CMS – okay, fine, all this other is going on – 5010
ICD-10, e-prescribing, dah, dah, dah, some of these other things that are going
on, can we go there now, make a difference there now since that is a big change
coming, and let the rest of this fall out as it needs to. Oh, by the way, we
may find three standards areas we need to go into or we may actually have a
couple of things that ONC might want us to do. It doesn’t matter. We are
working with who are our customers. ONC is a customer. CMS is a customer. The
Department is a customer. I am deferring some of that to Jim and others to do
it. That is what I want you to do. That is kind of how to look at it.

So I think the PHR – since obviously since they are doing pilots, I
think it is great that we do that. Again, for example you referenced to one
lady that talked so much about how electronics are changing out there in the
general public. That is something that we can bring to the table that working
with Medicaid population would not necessarily come out. Walter mentioned
Medicaid.

We have got Larry, Bill, Jeff, and Carol – did I see your hand? Larry.

DR. GREEN: Harry, one of the – actually I will prioritize it differently.
The thing in the report that leaps out at me – what is the right word
– most confusing or most inviting or –

MR. REYNOLDS: We will go with “inviting”.

DR. GREEN: Is the word certification juxtapose to two words, meaningful use.
This is on page four, page five, in the summary, it is in the vision statement,
it comes out in pages 14, 15 and 16 again. I could use a little help with more
elaboration about – I am concerned that I may be just framing this up
completely wrong from those of you who were at the hearing. But there seems to
be a real tension here in the report about what certification accomplishes and
specifically, what is certified. Is it a finished product that is certified or
is it a set of standards that are certified? Is it the exchanged standards that
are certified? This strikes me as being pretty important and pretty problematic
–

MR. REYNOLDS: It is and I will make a comment and then I will open it to my
friends around the table who were there to make any comments. Some of them are
much better at this but I will give a general statement.

The first general statement is that back to the point of the openness. The
whole subject of certification was put on the table by CMS – by ONC and
CMS as part of the process. They were asking people to consider, evaluate, and
challenge, if necessary, the status quo of what certification is or isn’t? What
it means and doesn’t mean? Who does it and who doesn’t do it and what it looks
like? I commend them for that panel.

You are absolutely correct because now where certification in the past had a
certain meaning on certain things, a lot of that has changed. With that, I will
close my mouth.

Jeff, and Walter is into that kind of stuff closely, so I am picking
designated hitters here that know their subjects.

MR. BLAIR: I think the fact that you observed – you picked out that
there are tensions, inconsistencies, in terms of testimony we received about
certification. Well, then that means this report did its job because remember
these are observations. We did not try to reconcile them. We are at a stage,
and I think ONC is at a stage where a lot of those tensions – it is going
to be their role to reconcile those. This was as far as we could go and I think
that the report did its job by pointing out that – it communicated well in
that you picked up the fact that there were some inconsistencies –

DR. SUAREZ: Of all the things that have been done about health IT in the
last six, seven years, the one thing that has been the most of which we have
had experience, is certification because the certification commission was
created first. Even before any of the standards existed or the harmonized
standard that HITSP has done – any of the other pieces that the Office of
the National Coordinator established, CCHIT started. I think the question was
raised was after four or five years of experience, how much has this been
successful? How much as been useful in the meaningful use perspective? Are we
certifying the right things of the right tools? Are we using the right process
to certify those and measure them and evaluate whether they are being actually
used?

To me the bottom line of the message was we have a certification process
that is very detailed and specific, but then we have an implementation process
that doesn’t necessarily match what the certification is. In other words, and I
have been saying that several times, what is being certified might not be what
is being implemented and that is the bottom line – is it the certification
process measuring the right elements that need to be certified or does it need
to measure, not necessarily through certification but through other means, the
adoption and implementation of those elements that have been certified.

So I think that to me, was sort of the essence of the discussion.

MR. HOUSTON: Could I just add one point to Walter’s point, there was a real
interesting slide that was put up where they showed a certified product and
then it sort of had a scatter gun graph of what actual customers implemented as
part of a certified product. It was across – it was nothing to everything
and it was a really interesting slide because it really tells the story that
certification is not the end all be all – implementation of certification is
what has to be really emphasized.

MR. REYNOLDS: Bill.

DR. W. SCANLON: This goes back to Justine’s question about where we are
headed. Since I have been on the committee, and particularly involved with the
Population Subcommittee, the focus very much has been on the issue of the
adequacy of data to monitor population health since they have an impact on
population health. I think partly one of the themes has been the issue of
resources and sort of the adequacy of resources and therefore the adequacy of
data.

While that may continue to be a theme, I think there is another one that we,
as a defensive mechanism were developing, which is how do we get data and use
data most efficiently? From that we have had hearings about linkages. We have
had discussion of access of information. I feel like we are now at a turning
point with this Stimulus Act and sort of the investment in IT because up to
this point probably our thinking about health information technology has been
as a hypothetical tool, it might improve population sort of health data.

Now we are at the point where maybe it can be an effective tool to do it.
But it is not a given that that is going to happen. A major portion of whether
it is going to happen is going to depend upon how meaningful use ends up being
defined not June 16th, but over the course of the next five years or more.

I think it is very important, since we have probably on this committee sort
one of the few groups that has a focus on population health, that we think
about meaningful use definitions evolve, what is the impact going to be in
terms of how do we change the statistics on health at the population level for
the country.

MR. REYNOLDS: One thing good about you being a co-chair, you have that
opportunity.

Jeff, Carol and Walter.

MR. BLAIR: I just want to make a couple of comments about the FACA
committees and their roles. It wasn’t very long ago, it was less than 10 years
ago, when NCVHS was in an environment where there was no Office of the National
Coordination of Health Information Technology. The role that we played at that
time was a little bit different.

Then in 2004, by Executive Order, The Office of National Coordinator was
established with limited funding. Progress has been made and now the Office has
a great deal of funding and it has a new national coordinator, who has only
been in place for a few months. A few months, gosh, it is just barely over one
month – isn’t it?

The thinking that I had and I am going to echo a little bit what Harry was
saying, I put them in a different order. Leading, following, or getting out of
the way – each of those roles are appropriate at different times. There
will be times in the future when NCVHS will be looked for for leadership. There
are other times like with the meaningful use, where it was a short period of
time we were asked to help. We were asked to follow some of the lead that was
needed in a short period of time. There are other times when we need to get out
of the way and not be an impediment because a lot has to be done in a short
period of time.

I think that the role and capabilities of NCVHS – capabilities and
limitation of NCVHS are pretty well known. The Health Information Technology
Policy Committee and Standards Committee, to be honest with you, I think
reflected the fact that the nation needs to do some new things, and NCVHS
doesn’t have the time, the resources, to do it all. I don’t think it was a
criticism of what NCVHS has done because essentially it has kind of implemented
a lot of the things we have asked to be done. Be careful what you ask for and
what you recommend – you just may get it. In a lot of ways we have gotten
what we have asked for.

Now things have to be sorted out a little bit because when it was put in
place – I think Congress did a very good job in the way they defined the
roles of ONC with the additional funding and the roles of those two new
additional committees, but there are a few pieces there that don’t quite fit
yet in the fact that NCVHS still has responsibility HIPAA transactions,
e-prescribing, privacy, and for a number of other areas.

I feel as if, just as Harry has said, we need to give the new coordinator a
little bit of time to wind up figuring out what they must do under the law,
where they have deadlines, and what they can do and where NCVHS can help them.
We have been partners in the past. I think we will be partners in the future
and we need a little bit of time for our new partner to get their feet on the
ground a little bit. Those were my thoughts.

MR. REYNOLDS: Spoken well as the sage of the committee. Carol.

MS. MCCALL: Looking at the documents that you put together, I love first of
all, that you added a section on gaps – things that you did not hear. I
think right now, it is going to be particularly relevant. Obviously there are a
lot of things happening but there is this – the surgical field is small
and yet there is a lot going on. Right? Given how small it is and how much
there is it is amazing things are missed, but they are.

I think when I was reading through the letter to Madame Secretary, we talked
a little bit about the history. I thought the letter was very good. We talked
about framing. We talked about bringing together consensus. I would add gaps.
I, too, think that the idea of taking testimony, creating observations and
given our knowledge, identifying gaps could be a distinct need and role that we
could play right now. That is point number one.

Point number two. Where there are gaps I think there could be an opportunity
to highlight those and you go, man, this one needs to rise to the top of the
list because if you don’t address it now it is going to be a mess. That would
be something within there.

The other thing that could be needed was to identify connections between
where two big themes need to meet each other. For example, we have talked about
comparative effectiveness. We also talked about ICD 10. When I think about what
happens when we cross those two streams – oh, my god. We sit and we
complain about data and look, data happens. It is always going to be messy and
dirty and need taxonomies and semantics but data happens. And we think about
piling it high and using it for comparative effectiveness, but what happens
when how you interpret the future or how you run the future is not how you
describe the past. Those have some very specific and painful details in there
and I don’t know how to cross-walk that. We can barely get all our data
together, let along decide giant do-over. Let’s just wait until we build
mountains off our new vocabularies.

That is a connection between two very important themes, two things coming at
about a 1000 miles an hour and I don’t know if that would be ours or somebody
else’s – but it is a gap.

MR. REYNOLDS: Great. Walter.

DR. SUAREZ: I have two comments. First of all I want to echo everybody’s
acknowledgement of all the people that were involved in this hearing. I think I
have not seen anything quite that extensive and complex and comprehensive and
successful and well attended as this hearing.

I have two comments. The first one, in going with the theme that in some
cases we can lead and in some cases we can collaborate and in some cases we can
get out of the way. I think there is also this perspective that in some cases
we can get into the nitty-gritty, into the get dirty kind of detail of issues
and sort of dive down into the details of them.

In some cases we will need a committee like this one to stay and look at the
forest rather than be trapped in the trees. My sense is that both the policy
and standards committees that have been created are going to have a very
specific focus and attention to details. That is going to be part of their
responsibility. I think our committee has the opportunity to keep also looking
at sort of the larger issues that cut across not just health IT, but other
areas, particularly the things we deal with consistently; population health,
for example, is one of the fundamental pieces of our work or quality
measurement or quality assessment.

That is I think, one opportunity we have is the ability to try to stay high
level in some topics and issues and in other issues sort of take the lead and
responsibility to dive in to the details. That is one comment I wanted to make.

The second one is the progression of activities that related to some of the
key elements that are interplaying in this whole health IT arena and all
healthcare systems. I think in the late nineties, we were moving to
evidence-based medicine and started focusing a lot of attention on that and now
we are moving into comparative effectiveness. At some point I hope we will be
moving to optimization of processes because I think we might actually find in
the comparative effectiveness research that there are some things that are
better than others. But when you look at those that are better, one can think
of making it even better – optimizing those processes. I don’t know that
there is enough attention being put into that area of optimizing those
processes that are comparatively more effective than others.

I think the next edge in this process in my view, my sense, is really
looking at optimizing processes. That might be an opportunity that we would
have.

MR. REYNOLDS: Judy Warren just joined us. Judy, why don’t you introduce
yourself.

MS. WARREN: I am Judy Warren, University of Kansas School of Nursing and I
have no conflicts that I know of other than with airplane schedules.

MR. REYNOLDS: What I would like to do now is open it to the group for any
other comments on this before we – in five minutes we will have ONC
calling in.

Mark.

DR. HORNBROOK: I was not able to attend the meeting for Meaningful Use Panel
but you think about the word “meaningful use”. I was sitting in the
waiting room one day. This Hispanic lady walks in with a little boy with her
and wanders back and forth for a few times. Finally gets the courage to go up
to the receptionist and she talks in Spanish to the boy and the boy translates
to the receptionist the question. They are looking for a particular medical
office.

So the receptionist replies in English that this is a Kaiser office, you
need to go up to the third floor. I thought, oh, god, how in the world is this
receptionist going to explain to this woman who barely speaks any English, what
in the world the concept of a HMO and Kaiser is and why she can’t get her care
in this office because it is exactly the same as the one on the third floor, it
is just a different set of health care arrangements.

It raises the question of course, of whether EMRs are set up to be
culturally sensitive? I know there are a number of Kaiser Members who are not
English speakers. So when they go in looking at their charts, is it given to
them in Spanish? As far as I can tell, one flavor fits all.

Then another thing about meaningful use is – what is it half of the
personal bankruptcies in this country are medical bankruptcies. Most people
still need care. How in the world do you set up a medical record system to
facilitate somebody who has got $300,000 of debt hanging over – they can’t
afford any more medical care but they are still sick. What is the kind of
guidance that you give to both sides for that type of exchange? Do you ignore
the fact that they have the debt thing going on?

What about patients who live in abusive environments? Do you keep that
secret or does the provider get to know that this patient needs to be
protected? You don’t just walk into this examine knowing that this patient is
just like any other college educated sophomore who happens to have high command
of English and a high command of the bureaucratic organization.

There are a whole series of social aspects of meaningful use of medical
record systems that we have barely begun to scratch the surface.

MR. REYNOLDS: Better known in today’s world as a target rich environment
where we ought to be able to come up with some good things. Righ here, and then
Dr. Sondik and then Larry?

MR. O’GRADY: Outside of meaningful use, you’ve also talked about sort of the
notion of the role of an advisory panel, and how you fit, so I just want to say
a few things having been a policy maker who used this advisory panel and other
ones.

Just a few things to be kind of careful as you proceed. Really what the
Secretary is looking for what the department’s looking for out of one of these
kind of FACA panels is an outside expertise and a second opinion. There’s great
expertise within the Department there is no doubt about that, but it may not be
taken into account all the things you’re seeing on the outside. It is that
trying to get a second opinion that is the real value added to a Secretary or
to an assistant secretary.

So you want to be sure that you’re not obstructionist at the same time you
don’t want to be a rubber stamp either. You want to be sure that you bring that
extra to the table, but if the emperor has no clothes you do have a
professional responsibility to say something about it.

I would advise you in terms of surviving these somewhat difficult waters,
that the way often to do that is to be out in front. That you sort of are a
exploring those new things you’re afraid that folks inside, who are really busy
trying to implement, don’t have time to look at, and you can sort of explore
those. You have better feel for what’s out there, what’s going on in California
or Colorado or whatever, and that’s something where you can kind of raise and
do a value added. But it is really, I mean, the whole point of doing this if
you could rely on SES and GS15’s and the various agencies for everything, this
would be a waste of the taxpayers money candidly. So it is that idea of
thinking about what you bring to the table, what is unique, and it can be very
helpful. It’s very reassuring for a Secretary when both there internal advisors
and there external advisors both say of the four options on the table, option
two is probably the smartest way to go. That just allows them to sleep a little
better at night that there getting that they haven’t been caught up group
think?

So you don’t want to be obstructionist, you don’t want to be a pain, you
want to be helpful to this process, at the same time you don’t want to be
totally part of the rush.

MR. REYNOLDS: Thank you that was well said. Dr. Sondik.

DR. SONDIK: At the risk of repeating what Bill Scanlon said, I just want to
draw everybody’s attention to the summary paragraph, first summary paragraph on
page seven, that says that the focus must be on the ultimate vision for quality
outcomes, health status improvement, and control and cost. I think that’s
really crucial, because it was, as you pointed out, a tremendous amount of
testimony. To me this is the bottom line, and what we all hope is that the
technology would in fact do this. It would eventually lead to, maybe even more
immediately, but lead to improved outcomes.

I think it’s very important that we have in place the means of measuring
that in a very objective, Mike O’Grady third party, if you will, kind of way
that says this is what is being achieved and even more so this is what is not
being achieved. These are the gaps, these are not being filled, and so forth.

New York City has a project of personal health records, I guess, that’s
being put in place, and the defined focus of that is to improve health status.
I think that is something this committee can really bring to this discussion,
and I think it’s something that’s very easy to get lost in all of the technical
details of the difficulties of mounting something. But if it isn’t happening
then I think the decision makers really need to know that.

I think it’s a really hard question as to know as to how to judge that and
when to judge it. It would be very easy not to judge it and say well we’ll look
in a decade and we’ll see what things look like. I don’t think that’s really
good enough. I think we need to put in place a strategy for evaluating this,
and not just in terms of process but really in terms outcome.

MR. REYNOLDS: Okay we got Larry and then, Carol do you have a follow up on
that.

Ms. MCCALL: Yes I did, just to follow onto that, and I still use the
picture from vision for a health statistics enterprise for the 21st century,
and I think about how its like opening the aperture from disease and even
functional status and well-being, to communities and other broader contexts,
and I think you’re right. I think if we talk about it a lot, but the data and
the metrics necessary to do that, just to get started we talk about it, but
there’s important work to be done. So that would be an area where I think we
could make a material contribution to actually engage what are the sources of
data that are available or could be. What are the measures? Let’s move beyond
data and get to measures that we could begin to use, so that we can start
measuring. They won’t be perfect but they’re a start, and they’re important.
And it actually goes back to our roots as well.

MR. REYNOLDS: Larry last comment, and then we got some people calling in
that’s what I want to make sure that we-.

DR. FITZMAURICE: They just left the clinical quality worker group and are
calling in.

MR. REYNOLDS: Okay yes, that’s what I mean, I want to be courteous of them,
so Larry we’ll take your comment, and then-

DR. GREEN: I’ll be quick, Harry in the spirit of Mike’s comments, I would
just like to notice something since we last met. Since we last met I’ve had the
privilege of attending a lot of meetings, like all of you, like the

American Heart Association, just came from New Orleans for the American
Diabetes Association, the Association of Health Behavioral Scientists, American
Cancer Society, and then a number of residency programs that are revising their
training programs for physicians to accommodate the health information age. I
had noticed something in the last few months that sort of startled me. The
conversation where I am seems to have shifted from the acquisition of an EHR to
the acquisition of a module that can solve a problem that needs to be solved in
order to help people. And it’s gone very public very fast.

Yesterday in New Orleans I heard several illustrations where people just
stood at the microphone and blatantly said, if you think you’re ever going to
get an EHR to do that, at least in my lifetime, I think you’re crazy, here’s
what I think you ought to do.

So this relates back to this discussion about meaningful use-

MR. REYNOLDS: And your certification discussion.

DR. GREEN: And the certification discussion. I think it is possible that
events are over taking us. And that people that are going face to face with
patients – orthopedic offices, whatever, they are looking for ways to get
rid of clicks. They are looking for modularity and interoperability, hyper
exchangeability, being able to get the information to where the patient is. It
sort of builds off of what Mark was talking about, about how do you build a
culturally sensitive HER from the ground up? Is that really what we want or do
we just want the mechanisms and the flexibility and the adaptability – the
ability to adapt to what we have got to get done in our town, our place, and
our system.

Again, Mike, you prompted this in what you said. I think the folks on the
committee need to keep our eyes and ears where we are between committee
meetings. I just wish to report that because for me, this is like a bucket of
cold water. For what it is worth.

MR. REYNOLDS: That is good. And again, we will have more time to discuss all
this. Great discussion on what we have done so far.

Chuck, I want to turn it over to you. Are John and Jodi on the phone?

MS. DANIEL: Yes we are.

MR. REYNOLDS: Welcome. Glad to have you with us. So Chuck, if you will lead
us through this portion, please.

Agenda Item: Office of the National Coordinator for Health
Information Technology (ONC) Update and Current Activities

DR. FRIEDMAN: Thank you, Harry.

MR. REYNOLDS: John and Jodi, just to update you, we have discussed all the
interactions amongst the committees and so you should not be receiving any
questions about those situations. We look forward to your information and we
will take it for information. Thank you very much for being willing to join us.
You missed that conversation so I did want to update you.

DR. FRIEDMAN: Thanks, again, Harry. We have under the rubric of the ONC
Update, actually three parts to present to you this morning. John Glaser and
Jodi Daniel are on the phone to update you from an informational perspective,
as I mentioned before, on the recent activities of the two new policy
committees.

I will follow that up with a brief presentation and hopefully a illuminating
discussion around the regional extension centers – a draft report on which
was recently published in the Federal Register. Because I know that John and
Jodi’s time is limited, let us start with them.

John and Jodi, have you worked out which of you would go first? I believe,
Jodi, you are doing the policy committee and John you are doing the standards?

MS. DANIEL: That is correct.

DR. FRIEDMAN: Jodi, do you want to lead off?

MS. DANIEL: I would love to. Thank you so much. Thank you Harry and members
of the committee. We are just going to give very brief updates on the federal
advisory committees; the policy committee and the standards committee. I am
going to be talking about the policy committee, which met for the first time
last month and is scheduled again to meet June 16th from 10:00 a.m. to 2:00
p.m. eastern time.

The policy committee has a fairly broad charge. They are charged with
recommending a policy framework for the development and adoption of a
nationwide health information technology infrastructure that permits electronic
exchange of health information, as well as to recommend areas and priorities
for standards, implementation, specification and certification criteria. Which
will inform the standards committee as far as the priority from a policy
perspective that they should be looking at.

Then the statue also goes through and lists some very specific areas that
the policy committee should or may, consider these two broad objectives.

As I mentioned, the committee met for the first time last month. We have
representatives from a variety of different stakeholder groups and with a
variety of expertise representing providers, consumers, vendors, health plans,
et cetera. We have got quite a variety of folks. We have got experts in privacy
and security as well. Then David Blumenthal is chairing that committee, as
well, so I think that is very helpful in sort of helping to shape the work of
the policy committee in letting folks know sort of where we are working and
what kind of advice would be most helpful and what areas.

We will have a vice-chair named. I suspect that a vice-chair will be named
at the next committee meeting. The policy committee established three work
groups at its first meeting. One on meaningful use. That work group has been
talking about meaningful use and will be making their recommendation on June
16th to the Full Committee about meaningful use in 2011 and beyond.

The second work group is the certification adoption workgroup, which is
looking at the certification process in the short term. Making recommendations
to the Full Committee on what we should be thinking about for certification
process – the certified technology, as well as looking at some other
related issues like the health information extension center, work force
training, et cetera. So it is quite a broad charge for that group.

The third group is the health information exchange work group, which will be
looking at issues related to health information exchange from the perspective
of policy, governance, sustainability, et cetera. We have both the privacy and
security experts on that work group and we expect that some of those issues
will come up as well as some other relevant issues that we need to think about
for making sure that health information exchanges is available for those that
are documenting this technology to be meaningful users of that technology.

All of the committees will be presented on June 16th. We expect the most
thorough discussion from the meaningful use work group. I believe that the
other workgroup will be following in short order in the next month or so, with
some early recommendations to the Full Committee so that the input can be
helpful as we are trying to role out some of these big efforts.

The Full Committee will be meeting about once a month, in the future. The
dates to be set later, but the next one after June 16th will be July 16th
– so one month later. We expect more progress from some of the other work
groups at that time.

I will turn it over to John for an update on the standards committee.

DR. GLASER: Thanks Jodi, and thanks Harry, for the opportunity to spend a
little bit of time with you. As Jodi mentioned there is a standards committee
that is parallel or sister of the policy committee.

As Jodi mentioned, there is a series of work that the policy committee will
carry out, looking at a broader ray of topics, but some of those topics will
involve obviously changes that ought to be made to the way certification is
handled, perhaps because of new meaningful use criteria and other national
health priorities. Similarly, there may be recommendations and priorities
surrounding where we need standards and whether those are transaction standards
or standards for a particular piece of data that will have recommendations.

Those are to flow through to the standards committee, which has really the
broad charge of given the guidance and priority and recommendations of the
policy committee, what are the standards, implementation specifications, and
certification criteria, recently specific that they would recommend be put in
place by the underpinning of the foundation for a lot of the work the policy
committee has put forward.

The standards committee is chaired by John Perlin, from HCA and also John
Halancuff from Beth Israel Deaconess Medical Center. Just like the policy
committee, it has created three work groups – one of which centers on
clinical operations. So the standards and the certification criteria that sort
of surrounds the on-going activities and clinical care delivery mechanisms that
exist in a wide variety of provider settings.

The second committee is dealing with the – it is called the clinical
quality work group. This is to look at specific recommendations regarding
standards for quality measures and also performance measures that might be
coming out of meaningful use as a way this is actually occurring.

The third will deal with privacy and security. So specific standards or
certification criteria relevant to privacy and security.

The standards committee has had one meeting. It has another meeting on June
23rd. This week, I’m actually running parallel to the conversation we are
having now. We are introducing all three work groups to their charge and asking
them if they have core questions about what to do. They do have a very
immediate set of activities, and as Jodi mentioned, we will be hearing from the
meaningful use work group on the policy committee on Tuesday. They are going to
present some recommendations for a definition of meaningful use for 2011, 2013,
and 2015. As you may recall, it is sort of an evolving definition of meaningful
use.

We have to do a fair amount of work to take the recommendations and
obviously, with other input from the public to sort of guide HHS in an eventual
decision about meaningful use. But that eventual decision has to make its way
into regulation. And in order for us to deliver an interim final rule in
December, we essentially have to begin the rule writing apparatus in
mid-August. So there is a relatively short period of time to settle in on a
definition of meaningful use.

Specifically, the relevance of that to these three work groups is we have
done some work to take the meaningful use definition as they will be
recommended, and cross-walking those with the relevant CCHIT criteria and also
the relevant accepted standards that have gone through the HITSP process –
in a sort of three-way walk across the board.

In addition, there are some proposals coming out of the meaningful use work
group surrounding measures that can be used to determine whether meaningful use
has occurred. And by dent of the legislation, they are also required or
meaningful use is required to support some quality measures. So they have some
measures along those lines to.

We will take all of that and ask the various work groups that we have here
to comment on the work that ONT has done to mask from meaningful use definition
to CCHIT criteria to standards work that has been and to see whether our
homework has been done correctly because the criteria in the standards has to
be folded into the regulations. In order to receive your financial incentive
you not only have to engage in meaningful use, but you also have to be using a
certified system. So we need to determine or define what that means. And you
also have to be using a set of standards – and we have to define those.

The last thing is to review, and in some cases there may be holes – we
know there are holes, so there will be some questions of the degree to which we
can fill those holes. For example, some interim CCHIT criteria or where the
hole filling conversation will take longer than that, and perhaps it is not a
2011 meaningful use statement but rather a 2013.

Those three work groups have some very near term work to do which is to help
us frame the content that will be necessary to go into the regulation that
surrounds the specifics of meaningful use relevant criteria and also relevant
standards.

That is where we are both in their broad intent of formation of three work
groups, and an immediate charge that they have, along with a longer term charge
and set of responsibilities that have been outlined for interacting with the
policy committee.

So Chuck, we will stop and see if there are questions for either myself or
for Jodi.

MR. REYNOLDS: We will go ahead and take questions on the first two
presentations since they have a time constriction. Any questions from anybody?

You two are the greatest presenters we have ever had because I have never
seen this group not ask a question.

DR. GLASER: It is either that or we were incoherent. They are wondering what
in the world was that.

MR. REYNOLDS: I got their attention so now they are in. Mike and then Mark
and then Walter.

DR. FITZMAURICE: John and Jodi, this is Mike Fitzmaurice. Is there any
expiration date on the FACA committees or are they in existence to help provide
guidance for the foreseeable future?

MS. DANIEL: There is no expiration date. I think there is an expiration of
the charter but the statute provides that they do not expire. There is no
expiration date for them.

MR. REYNOLDS: Okay, Mark.

DR. HORNBROOK: In our use of the epic system at Kaiser Northwest, there are
4,000 data tables inside that system. It is possible for a systems programmer
on the health plan side to make a new table and leave the old table sitting
there, but never tell anybody that it has been obsoleted. So if somebody wants
to add a variable to a table, they create a new table. Is the certification
process going to deal at all with these kinds of delving inside of these
thousands and thousands of tables that make up these complex systems for making
sure there isn’t a bunch of systematic errors inside?

DR. GLASER: Under the current near term, I think the certification process
will largely look like it has in the past, where there is a performance testing
capability that you would want to see for e-prescribing or for any discharge
summary from the hospital to a receiving care provider.

It might be at this point to go into more of how that product is being
managed in situ, so to speak, and whether the particular implementing
organization uses it, et cetera. So there will be, as the data are exchanged,
there is a indication that that data reported or exchanged conforms to
standards that will occur but again will be focused on the inter-organizational
movement of data rather than things from the internal management of a set of
infrastructure and data tables. Focusing to be internal, and although it is a
big deal it is coming through meaningful use, their meaningful use is
describing a collection of internal actions on the part of providers, whether
they are managing a population of diabetics well or reporting to public health.

One of the things we have done under the certification work group that is
part of the policy committee, is asked them to look at the certification
process and how that will evolve or how do we improve on it, things we didn’t
do so well (phone connection interrupted).

DR. HORNBROOK: Hey John, you are going to have to get back up on Jodi’s desk
again – you are cutting in and out.

DR. GLASER: I think along with a response, I think certification will still
look like it does today, which is conformance testing of products rather than
management once installed. And that the reporting or exchange criteria will
look at the transaction standards and field level standards that are being
adopted or not adopted at the exchange. But again unlikely to go within the
walls of the organization and see whether you manage one table or multiple
tables or whether you keep thing internally consistent or not.

DR. HORNBROOK: There are three things that are very relevant to this
committee. One happens to be births and linking moms and babies, and that table
is essential inside the EMR system to make sure that moms and babies aren’t
disconnected or reversed. The other is deaths – linking death
certificates. So from a vital health statistics issue it seems like this
committee would be very interested in certifying that EMRs can talk to the
public health statistics systems.

MR. REYNOLDS: Carol, did you have a follow-up on that?

MS. MCCALL: I think it is actually something that could go on our potential
list. It is a gap. And it is a gap in the following way – when we talk
about certification, a lot of times it has been historically about software.
Functionality doesn’t do what I think it is going to do. And then you can talk
about certifying pipes, interoperability. But we are going to get to a place
where we are going to need to certify data itself, the content that actually
goes through. We are getting into a world of information products of the likes
that we really haven’t dealt with before.

So certifying the actual content itself, the data is not – you can pick
on birth and death, but for me I am only going to do each one of those once.
But there are data streams that move a lot faster and are a lot more dynamic.
So data itself becomes a living, breathing thing, metaphorically anyway. But
what is its birth date and how is it changing? So data gets smarter. Data
changes and will become aware. It is an architectural issue as well as a
certification issue. There are contexts to where architecture, as you can
imagine, someday data with an RFID tag to tell you where it has been, tell you
who is using it, how they used it, did they change it, was it okay, et cetera.
Those are fundamentally different. But it is a concept that I think we need to
break out and keep in mind.

DR. GLASER: I think that is a fair point. The current trajectory of both the
NS(?) committee and the policy committee is exactly as you say, it is
conformance tested, can the product do what it says it does or do what it
necessary to at least give you the ability to engage in meaningful use, and
does the data that is moved between organizations satisfy current standards and
criteria? It is silent on what is required to do good data management practices
or the evolution of data management practices as a managerial function within
the walls of the organization. It doesn’t touch that, and I think you would be
right in pointing out that that is an area that needs some attention and an
area that at least the current policy and standards committees are not
tackling.

MR. REYNOLDS: Okay, we have Walter, then Judy and then we need to move onto
Chuck’s presentation.

DR. SUAREZ: Thanks. This is Walter Suarez. Just a quick question about kind
of following up on the certification. One of the fundamental observations that
we highlighted is the issue of certification versus implementation, meaning a
lot of the current products are being certified through a certification
process, but yet in the implementation side there is kind of a lack of
activation or use of some of the features that are specific kind of certified
characteristics of an EHR that relate to the meaningful use of the ERH.

So in the concept of certification, how is the expectation being built
around the verification of the implementation of those criteria that is being
used to certify the product?

DR. GLASER: Good point, Walter, the certification criteria, patient process,
at least for the near term, is whether the product is or isn’t capable. But
that doesn’t mean is or is not well used or work flow adapted or all kinds of
stuff that would need to go on to really take advantage of what the product has
to offer.

The intention with the extension centers is that they provide the talent,
the horsepower, the experience that will help providers, hospitals or
physicians realize how best to apply the technology and really use the
features, and whether the training is good or not so good, or whether the
workflow, all that kind of stuff, has been done as well as you possibly can. It
will have a particular orientation to those kinds of workflow changes, training
use, et cetera, that are necessary to support meaningful use. There will still
be a need for folks to work with providers, to make sure they are doing all
that they can or want to do, frankly, in using the product and the fact that
the product is certified – and I thought we had plenty of interesting
testimony at the hearings you had a couple of weeks ago, testimony about the
fact that the CPOE-certified systems at the level of usage is really quite
diverse here. So certification will only carry so far. We’ll need the series of
extension centers that leverage existing IT and support organizations to help
people do all the right things to take full advantage of those systems.

MS. DANIEL: And I can jump in here, I think in order for the incentive
payments, again, it is really a two-part task, and this is sort of the way I
think of it, which is one, they have to be using certified EHRs. And then the
second is that they have to meaningful use. So the certification is not enough.
There is sort of a second test. Are they meaningfully using that technology? So
to your point, Walter, the certification, as John was saying, doesn’t get you
all the way there and it is not just buying the products, but then there is a
second hurdle to jump through to make sure an NCA is actually a meaningful user
before the incentive payments would be available.

MR. REYNOLDS: Judy, you have the last question.

DR. WARREN: Mine has been partially answered by Walter’s question. I just
wanted to clarify what I heard. Earlier I believe, John, you said that you
weren’t really looking internally to see what hospitals were doing with their
EHRs and then in part of your answer to Walter you said that that would be part
of the extension services. The reason I keep asking about that is some of the
work that I have done, as I can see different hospitals using the same vendor,
the same certified software, and one hospital has a class EHR and the other one
has numerous errors occurring because of the implementation and eventually they
turn it off or it becomes a hazard. So it is really looking at the talent and
skill of the people who are doing the implementation and are they clued into
that.

Can you clarify for me again – are we looking at that level or is that
the extension centers?

DR. GLASER: Sorry for the confusion. The Standards Committee will be looking
to make sure the product is certified and that the transactions either between
organizations or reporting measures follow standards that have been there. So
in a way it is silent on whether you use bubble gum or an advanced EHR to get
the HIE out the door, so to speak, and it doesn’t, per se — we know you have a
certified system but whether you implement it well or you don’t implement it
well, isn’t inherently the purview of the Standards Committee. Nonetheless we
know that if you are going to do meaningful use well and we help you do that,
we have to get in and help you, whoever you work with, processes, work flow and
training in a wide variety of things like that. So we have to provide
assistance to those organizations so that they are capable of taking advantage
of the certified product and know how to effectively use it —

I guess the per se we will not be looking at practices internally. One of
the possibilities will be either certifying or guiding data management
practices is not on the plate of the Standards Committee at this point –
it may not be. But on the other hand we want to make sure that the workflow
changes are as good as they can be and training and all that other stuff. I
don’t know whether that clarified or just further confused my comments to you.

DR. WARREN: I am getting clearer.

MR. REYNOLDS: Good. John and Jodi, thank you. I know you stepped out of
another meeting to join us. Thank you very much. We really appreciate what you
are doing and updating us.

So Chuck, I will turn it back over to you.

DR. FRIEDMAN: Thank you, Harry. I would like to focus for a few minutes on
the regional extension center’s program, which has already come up in this
discussion. What I have decided to do in lieu of showing you slides is to give
you the actual raw data for this discussion, which is a copy of the draft
report that was published on May 28th in the Federal Register. I hope everybody
has a copy of this to refer to.

I hope we can have a bit of a discussion, but I thought I would call your
attention to some of the features of this report. I will mention by way of
preface that the regional extension center’s program is one of four grants
programs that is mandated in the sense that the verb “shall” is used
in the statute in HITECH. One of these programs is the extension center’s
program. Another is grants to states to promote health information technology.
The extension center’s program is in Section 03012, the grants to states in
Section 3013. A third “shall” program is a program in Section 3016
relating to training of the health IT workforce, and then the fourth is the
enterprise integration centers which is actually charged to NIST, the National
Institute of Standards and Technology to implement.

So with focus on the regional extension centers I will call to your
attention the statement in the middle of the first page of the report, which
highlights the complex task facing doctors of health information technology,
including the need to assess needs, to select a vendor and negotiate with that
vendor, and to implement the workflow changes without which just about
everybody believes the EHR cannot make a positive difference in health care.

I will also point out that the extension center program actually has two
parts to it, a central national center, and a system of regional centers. I
have already mentioned that the program is mandated. I will also point out to
you, turning to the second page of the report, page 25,551 – you have to
love the Federal Register – that it is stipulated that the regional
centers will become, upon award, members of a national consortium, so they
won’t be silos. The anticipation here is that they will function in cooperation
with one another in a way that is facilitated by this central national center.

Further down the first column of the second page it is noted that four kinds
of customers of these regional extension centers will receive priority,
although over and above a requirement that the centers in some way serve all
providers. The four prioritized providers are public, not-for-profit, or
critical access hospitals, federally qualified health centers, entities in
rural and underserved areas, and individual and small group practices. I have
abbreviated these descriptions, but in your handout they are obviously in full
detail.

The centers must be affiliated – top of the third column of the second
page – with non-profit organizations or consortia thereof. That is an
important feature of them and then also on the second page of your handout,
25,551, in the third column, are listed a number of required criteria for the
centers, including a defined region of service, a catchment, that is defined,
if you will, defined levels and approaches for support of prioritized and other
providers. A plan to put what we call boots on the ground, a plan that brings
something analogous to agricultural extension agents, here referred to as
health IT extension agents to the practice sites where the health IT is going
to be deployed.

A capacity to facilitate cooperation among various elements of practice in
that area, a demonstrated ability to meet the needs of those prioritized sites,
and finally what I would call a capability to go broad as well as deep, to both
put boots on the ground to support health IT deployment and meeting the
challenges thereof, as well as providing deep specialized expertise in such
things as organizational development, legal issues, topics related to privacy
and security and evaluation and others.

There are tow preference criteria listed in this draft report. One would
give preference to regional centers which are organized as multi-stakeholder
collaborations.

MR. REYNOLDS: Where is that in the document?

DR. FRIEDMAN: I am on the bottom of the third column of the second page,
25,551. So this first preference criterion refers to those organizations that
incorporate multi-stakeholder collaborations that leverage local resources and
a range of stakeholder groups that might come together in these regional
extension centers are called out here – I would emphasize that in addition
to the whole document being a draft, the list here is a partial list and
specifically allows for other types of stakeholder groups to participate. And a
second preference would be a preference for applicants who can bring to bear
some kind of matching funds.

The way the statute is worded, it is worded to actually require matching
funds, but there is also a statement in the statute that allows, under certain
circumstances, these matching funds to be waived and we are actually proposing
in this draft document to waive the absolute requirement for matching funds. So
matching funds would move from a requirement under this draft to a priority
element.

Finally, to bring this overview to a close, initial awards for these
extension centers is anticipated as early as the first quarter of 2010.
Blackford, to your question early about timing, this is the one thing I can say
now and we are anticipating these will be two-year awards, and we are also
anticipating more than one application date for applicants to stand up. We
expect that there will be multiple, I wouldn’t say quite a rolling, where you
could apply at any time, but perhaps multiple discreet dates by which those
entities ready to apply will be able to submit applications.

So that is a brief overview and I am happy to entertain questions. By the
way, the notice is not only a draft notice and description but it is also a
request for comments, which are due on June 11th. I guess that is two days form
today and I would encourage in addition to any comments you might make here in
the meeting –

SPEAKER: That is tomorrow.

DR. FIREDMAN: It’s tomorrow. But I would encourage in addition to any
comments that you might make in the meeting hat you would also send those
comments in to us.

MR. REYNOLDS: We are starting off with Jeff.

MR. BLAIR: Since the priorities are to be able to serve rural underserved
populations, is there any reason why telehealth is not mentioned within either
the law or the draft for the extension centers?

DR. FRIEDMAN: Jeff, I will take that as a comment. I think what would be
most useful to get from the committee at this point would be your comments and
observations. I probably can’t go too much further in answering a question than
almost repeating what was written here.

MR. BLAIR: The other question that I have is it is clear from the timing of
the Health Information Technology Extension Program that you want to get this
going as much as possible before 2011, when the incentives will go into place
meaningful use of EHRs. Is there anything that you can share with us with
respect to the funding of HIE networks, which are probably also a prerequisite
before 2011?

DR. FRIEDMAN: No, we cannot share with you at this point, any date related
information relating to the other programs that will relate to Health
Information Exchange. The statute does call for a minimum of $300 million to be
of HITECH money to be put directly in service of sub national health
information exchange. So there will be a program. There will be a program in
place to do that.

I would also comment, perhaps stating the obvious in response to your
question, that the push to get the regional extension centers funded and stood
up(?) as quickly as possible, is in the interest of providing as much support
service to as many providers as possible to help them qualify as meaningful
users sometime in calendar 2011 so they can qualify for the payment incentives.
Time- wise, that is the whole plan here.

MR. BLAIR: My last comment is setting up these regional extension centers
probably will require quite a bit of structure and analysis during these next
couple of years. So I will do a shameless advertisement of there may be areas
as you move through this during the rest of this year, where the NCVHS might be
able to assist you. Keep us in mind.

DR. FRIEDMAN: I will make a shameless acceptance of that offer.

MR. REYNOLDS: Now that you both have recused yourself from this subject.

I have one clarifying thing and then I will go to Paul and the rest of the
people on the list. Is there a definition of matching funds? In other words,
there is a couple ways to look at it. Matching funds are new matching funds or
if capabilities are added to existing environments, the fact that money is
being spent in those environments already – is that matching?

DR. FRIEDMAN: I will take that as a comment also and a very valuable one for
us to think about.

MR. REYNOLDS: I think that is very important because the difference is if
you force people to build it all new that costs more than people being able to
add it to something and take some of that overhead and consider it matching.
That is just an input.

Paul.

DR. TANG: Just a point of clarification. You mentioned funds being released
the first quarter of 2010. Is that fiscal year or calendar year? I don’t know
if this is the same repeat of Jeff’s question – the same question about
the state grants for HIEs.

DR. FRIEDMAN: It is fiscal year.

MR. BLAIR: Which means it is October of this year –

DR. FRIEDMAN: As early as – and don’t take that as a firm date –
take that as our appreciation of the need to do this as quickly possible while
still doing it well.

MR. REYNOLDS: We have got Sally, Walter, Larry and Mark.

MS. MILAM: Following up on Jeff’s question about section 3013 grants to
states for health information exchange, which organization will actually issue
the grants? Will that be ONC or will it be a sister agency such as HRSA or AHRQ
or some other agency? Has that decision been made?

DR. FRIEDMAN: No the decision has not been made. I can say that the relevant
planning is going on but those decisions have not been made yet.

DR. SUAREZ: I have to say that this is one of the most exciting areas of
HITECH and one of the ones that will have potentially the most meaningful
utility of all the provisions. Having been a educator for so many years on
standards. I used to be called actually “father Walter” because I was
a HIPAA evangelist. And having gone through regional education activities on
HIPAA – my question is around the encouragement you might give to form a
statewide coalition to receive these funds.

In other words, if we fragment this too much to the level having so many
different competing interests – even within states, the ability to reach
out will be minimized and the effect will be minimized. I know there is an
average value of the one million to two million. What is the number of grants
– and probably you won’t be able to comment directly on the total, but
what is the range of the number of grants that you expect to provide and are
you actively encouraging states to form statewide coalitions that could
actually leverage better the funds across a state?

DR. FRIEDMAN: Well, first let me tell you what I can’t say. I can’t give you
an exact number that we intend to fund. I can say, and I think it is sort of
implicit here, that other than saying that a regional center must have a
defined regional catchment. We are silent on what a region would be. We really
are hoping that the nation in responding to this, will not only in the
organizational arrangements that it uses, but also in the way it approaches
regionality be creative and come up with the best possible solutions. This was
an area where, at least at the level of writing this draft, we did not want to
be prescriptive. We are hoping that the best solutions will come from the folks
– very much in keeping with the philosophy of the whole program. We very
much hope that the best solutions will come from the folks on the ground in
that region, whatever the region is, who knows that that region needs.

DR. TANG: Just a quick follow up. Could you say the size of the total
funding to be provided through this program? Is it $300 million or $200
million?

DR. FRIEDMAN: No, we have no number defined at this point. The $300 million,
just to be clear, the $300 million figure I mentioned was specifically called
out in HITECH as a figure tied to sub-national health information exchange that
is not directly related to the regional extension center program.

DR. GREEN: I want to echo Walter’s enthusiasm for this. This is actually a
game changer. It moves us out of theory and practice and it is very, very
exciting. But as I understand it the statue itself refers to the cooperative
extension agency. This is really grounded in agriculture. This is a 90 year
story or so or something like that.

The material in the Federal Register is close to silent on expecting what is
known to have been crucial to the agricultural extension agency. It was
credibility based on personal relationships that wee sustained over time. The
comment I would like to make officially as a member of the Committee, that
might be a crucial criteria in the evaluation of who can get this job done.
That might need to be part of the evaluation of the application proposals and
that sort of stuff.

Is this extension center capable of establishing and maintaining
relationships with the providers they are suppose to serve in a sustained way,
for years and years. Because we are not talking about a 90 day consult here or
a two-day consults, we are talking – if we are going to model it after the
agricultural extension agency – we are talking about boots on the ground
month, after month, after month, after month.

DR. FRIEDMAN: Thank you. Excellent comment.

MR. REYNOLDS: And if you added unbiased to that, that would probably really
make it complete.

DR. HORNBROOK: Have you done any solicitation of interest in this
procurement yet?

DR. FRIEDMAN: No.

DR. HORNBROOK: Second question is, do you have any idea who the respondents
might be? Are they going to be beltway bandits? Are they going to be QIOs? Are
they going to be universities or what?

DR. FRIEDMAN: I think, just going back to a response to Walter, we are
expecting – we are hoping for creative, regionally responsive and grounded
multi-stakeholder solutions. We list in the draft a number of the kinds of
organizations that might participate as part of a multi-stakeholder regional
approach, but the list – just to say it again – the list we have in
the draft is not meant to be exhaustive and we see the potential for other
types of organizations than those listed there to participate.

DR. HORNBROOK: There is no exclusivity? I can combine almost any set of
organizations and come in with a viable proposal?

DR. FRIEDMAN: I think the spirit, without knowing what they would be, it is
hard to evaluate.

DR. HORNBROOK: Suppose I wanted my CTSA to get the state of Oregon to get
organized. Is that something that is possible or is it illegal under the terms
of this program?

DR. FRIEDMAN: There would be no problem, for example, with the CTSA.

DR. HORNBROOK: Just one example of a regional organization that could have
interest in this informatics structure.

DR. FRIEDMAN: Absolutely.

MR. REYNOLDS: Paul.

DR. TANG: I am sure you have thought about this Chuck, but where will all
the people come from?

DR. FRIEDMAN: Well, there is another program to develop the workforce.
Suffice it to say that the thinking that is going into the development of that
which is ongoing, is characterized by the same sense of do it as quickly as
possible while still doing it well – that is going into the extension
centers program.

We hope to be able to say something more about that program fairly soon but
it is not ready to be released yet.

MR. REYNOLDS: Leslie, Carol, Marjorie, done.

DR. FRANCIS: Just a comment, what about the risk of the land nobody wanted?
The question of do you envision the possibility that underserved regions might
– or regions that are particularly difficult to serve – if groups
define their own catchment area, might get left out.

DR. FRIEDMAN: Yes, thank you. We are aware of and concerned about that
issue. We are giving a lot of thought to it. Thank you for bringing it again to
our attention.

MR. O’GRADY: Can I make just a real quick on that. When we did Part D, it
was real important – this day and age, just take a mid-course correction.
You could not get anybody to take the Dakotas that wanted to take the Twin
Cities, maybe the state of Minnesota. But that was sort of the government deal
is that you have to take the Dakotas if you want the good market in downtown
Minneapolis. You just kind of “note for the file”. You may find it in
the next round – you have to negotiate a little tougher.

DR. FRIEDMAN: Thanks to both of you. Those are excellent and important
comments.

MR. REYNOLDS: For the public record, the committee does like the Dakotas.

MS. MCCALL: I am trying to imagine – I know that you said that you
won’t be prescriptive – I find myself trying to imagine the different
operating models, the different business models even, and who might respond. A
couple of questions within that. Specific ones and then one I really want you
to answer.

Would private businesses for example, be able to kind of come in and put
something like that together? Have you talked about and thought about adjacent
issues and needs around – we will call it the re-emergence of MSOs –
right, when you start thinking about some of the contractual issues. Did you
ever talk about them changing and morphing over time to information management
structures – so it is not just about the pipes but stuff is going to come
out the back-end and it needs managed and we have talked about that before.
Again, I am trying to imagine different operating models – the kind of
things over time that you are actually looking to explore and would welcome in
terms of submission?

DR. FRIEDMAN: Those are excellent points. I really – I want to
emphasize a couple of things – this report is a draft description of the
program. The comments – and it is not a request for proposals or
applications. It exists for many reasons as a draft report; among them to
solicit comments such as the ones that you have offered. The intent of the
draft – and I think if it works out as the draft would imply – the intent
of the program is to stimulate creative approaches.

MS. MCCALL: Does it expect that all of – you did not opine on how much
money would be made available – the size of the total pool – but will
it allow or would it prohibit actual business models here?

DR. FRIEDMAN: You mean for profit participation?

MS. MCCALL: Right, otherwise – yes, so that it can become self-funding
and self-sustaining, otherwise it has got to live on the funding that is
provided, in which case I want to know how much is there because I want to know
how big this you anticipate being?

DR. FRIEDMAN: Oh, right, so your are making another point which I will take
as a comment and a valid one. What happens after the two-year award? How do
these organizations become self-sustaining?

MS. MCCALL: Either that or during that two-year period because the funds
available – I saw a boundary of about only as much as $10 million for the
two-year period per any center. Depending on how big the regions are that may
not be enough. I don’t know.

DR. FRIEDMAN: All fair points and important comments.

MS. MCCALL: It is a great idea. Having been in the business of trying to get
doctors to adopt electronic health records – this in the trench work is
where it all happens or does not. If it is not anticipated that this is going
to be big enough to scale enough, the difference between the beauty of the idea
and the reality of the practice is going to be pretty big.

MR. REYNOLDS: Marjorie, last question.

MS. GREENBERG: I think we are all really excited about this and really
appreciate the work that you have done so far and the work that you are going
to be doing in the future. One thing that comes to my mind and I have not had a
chance to read the whole thing, and kind of follows up on what Carol said,
being the folks with the boots on the ground in the trenches – carry this
analogy too much farther, but it seems to me that these groups – and I
have to agree with Paul, I am wondering where are all these qualified extension
agents going to come from – but leaving that aside. That they will have a
better idea of how to really get meaningful use of electronic health records
than anybody. They will actually be trying to make this happen on the ground
with real people. They won’t be here in Washington philosophizing like some of
the rest of us – myself included.

I am wondering, and I see there will be a national group, which is very
good, that will kind of work with them, but if you have any thoughts about what
their relationship will be with these advisory groups, with the FACA groups, on
everything from evolving definition of meaningful use to how do you measure
meaningful use to evaluation – all of these things.

It seems like they could be such an important element of that, having this
real life experience, but in order to effectively serve that role they might
need some capacity or functionality that is not just delivering services but
having that perspective as well – kind of the lessons learned and all of
that. They will report directly, I guess, to the national group or they will
each report to ONC. How do you see this working?

DR. FRIEDMAN: We are still working that out, but I think a key feature of
the program as we have envisioned it and as is described here, is that these
regional centers will function as a consortium and will have the capability of
learning from each other and sharing resources of various sorts amongst each
other to avoid reinventing the wheel in however many centers there are.

We have not figured out how exactly we are going to make this work, but it
would seem that the value of having an inter-cooperating set of centers as they
figure out how to do all of this very, very well, is incontrovertible.

MS. GREENBERG: And then have them feed in to the policy process.

MR. REYNOLDS: Chuck, thank you for the whole thing that you have done. I
think it shows the speed at which you are doing things. It shows that there is
a lot of thoughtfulness but there is a lot of openness, and there is not much
more that you can ask in a subject. We are glad to have you as our liaison and
we will continue to look forward to that relationship. Thank you.

DR. FRIEDMAN: Thank you, Harry. I want to add my thanks to the committee and
the staff for all of the great work you all are doing and particularly for the
work everyone did to prepare for and conduct the April hearings – which
have been invaluable to us.

MR. REYNOLDS: We will be reading the letter that we were going to do at
12:00 – we will be reading it right when we get back, during the 2:30
discussion portion. So we will move that. With that we are adjourned for lunch
until 1:30 p.m.

(Whereupon, a luncheon recess was taken at 12:30 p.m.)

A F T E R N O O N S E S S I O N

MR. REYNOLDS: Looks like we have a few stragglers back from lunch but we
will go ahead and get going so that we can honor time commitments. Our next
agenda item is Measure and reporting Functional Status and Dr. Lisa Iezzoni and
the thing I would like to let all of you be aware of is she was a two time
member of NCVHS so one of our own. The positives are she has been a member of
NCVHS and has had an outstanding career. She has had her challenges like
working with Justine. So moving right along, Dr. Iezzoni thank you so much for
coming and we look forward to your comments.

Agenda Item: Measuring and Reporting Functional
Status

DR. IEZZONI: Thank you. My title is a tiny bit more creative and
metaphorical than the title that was listed in the program: Are the Stars
Aligning for ICF in the United States? Anything intelligent that I say in the
next hour I can attribute to John Hough and Marjorie Greenberg.

The US health care system, I do not need to tell this crowd is awash in
codes. Coded data do everything for us–diagnoses and procedures, help us
figure out how to pay hospitals, how to pay Medicare advantage plans, how to
measure quality, how to monitor service use and how to also increasingly
monitor public health concerns.

Mostly what we are kind of talking about is this volume, the CPT volumes and
ICD, as all of you know, is now 30 years old and finally we’re about to in 2013
get moving into ICD-10. But even the diagnoses and procedures, even though they
tell us a lot about patients, they don’t tell us sometimes the most important
information about health and how people just get through the day, how they
participate in activities of daily life.

You’ve all heard about this volume. This is the International Classification
of Functioning Disability and Health and this is going to be the focus of
today’s conversation. The ICF was endorsed by the World Health Organization
back in 2001 and in that universal endorsement they endorsed it for research,
surveillance, reporting “as appropriate in member states”. I think
we’re a member state but the ICF has actually never gained traction in the
United States. When I was a Chair of the Population Subcommittee I tried to
find some physician groups who had even heard of the ICF. I don’t know if we
could now in 2009, but we really couldn’t back then. That is kind of the
grounding of my talk.

If you go onto nasa.gov and look for stars, this is a picture. I chose it
because it looks like the stars are kind of aligning so it kind of helped with
the metaphor that I’m trying to build here. Today my talk is really going to be
what are the key leverage points for saying that maybe we can finally get ICF
into the code sets.

I’m going to try to talk quickly as I possibly can about five different
forces that could be helping this alignment: social forces, demographic forces,
the consequences of health care reform, public health focus on determinants of
health, and then a growing recognition of the ICF in the United States,
finally. The NCVHS report that we put out in 2001 noted that the concept of
functional status applies to all persons regardless of age, physical or mental
condition, or other characteristic. The kind of slant that I’m going to take on
it in my talk this afternoon, as you could imagine that I might, is going to be
on a disability side but everybody, even people who don’t have to use
wheelchairs, have a functional status. It is just maybe different than mine is
so just kind of keep that in mind that that will be my bias in my conversation
with you this afternoon.

Societal forces. Franklin Delano Roosevelt, arguably the most famous person
of the 20th century but nobody was supposed to know this. It was
supposed to be a secret from the public. In fact, this is only one of two
remaining pictures of FDR sitting in his wheelchair. As a woman said to me a
number of years ago when I was interviewing people with disabilities for a book
project I was doing, disability is a lonely state. But here we have George
Herbert Walker Bush and what he said was the proudest moment of his
presidency–this is July 26, 1990, the signing of the American’s with
Disabilities Act. From that point onward, people with disabilities really were
often out front. I’m from Boston, this is the starting line of the elite
wheelers at the Boston Marathon. I am always proud to say that the wheelers
come in about 25 minutes earlier than the bipeds do but we won’t hold that
against you. Most of us are not elite wheelers but there are so many of us out
there now on the streets. The societal force that I wanted to emphasize is that
people with disabilities are no longer hidden behind closed doors as they were
in FDR’s time. They are out walking around. They are going to the store. They
are going to parks. They are going to schools. They are everywhere.

There are still barriers and of course, the New Yorker gives us kind of a
social view of some of this. This is the Grim Reaper in a scooter following an
old man in a scooter. Then this was the cover of the cartoon issue back in
2004. It is a kind of–I am just going to be biased here and say a grumpy
looking older lady about to foot her four-point cane on four banana peels. I
view this as a Rorschach test for how people respond to this one. The point
that I wanted to make here is that the ADA functions differently than other
civil rights law and I’m going to show you a couple of slides to make this
point because accommodations require that disability be known and noticed. That
is where the codes come in.

Here is my two slide version about how disability civil rights differs from
civil rights, for example, for racial minorities and for women. This is the
picture of the iconic figure of the civil rights movement, Rosa Parks, who
refused to give up her seat on a bus to a white man back in 1955. Rosa Parks
knew that she achieved civil rights when the color of her skin, the
stigmatizing attribute that made people think she should move to the back of
the bus, was no longer relevant to where she sat on the bus. She would get on
the bus, the color of her skin was irrelevant, she had achieved civil rights.
For somebody like me to even get onto the bus, my stigmatizing trait has to be
noticed, somebody has to react to it, the bus has to be made that will allow me
on board. So because of that we need to have information about my disability,
somebody noticing it, and somebody reacting to it.

Now, you would think that health care systems are completely accessible to
people with disabilities–who thinks that in this room? You are wrong. Somebody
raised their hand. They are wrong. We need codes and medical records to alert
physician staff and other nursing staff to patient’s needs because health care
settings are not accessible. They are, in many cases, kind of like the bus.
People can not literally get onto them.

Here is a three slide set that I am going to show you that is like the
Olympic games where somebody is kind of approaching the horse that people jump
over. What is that called? The horse thing. This is a woman with spina bifida.
The standard examining table in a doctor’s office is fixed height at 41 inches.
It was set at 41 inches because that is the height for a standing doctor to
find it convenient to examine a patient. There are, however, tables that do
automatically lower to wheelchair height. It is just that they cost a tiny bit
more, not a lot more, but a tiny bit more, people need to think about them. So
here is a series of pictures about how Janice, who is very proud of her
abilities–she has spina bifida, can get onto the fixed height exam table. She
approaches. She twists around. And then she is on the table. This is all well
and good but what you may not notice here is that she is 22 weeks pregnant. Are
you going to want her doing this later in her pregnancy? I don’t think so.
Wouldn’t it be nice if there was a code in a medical record and if the health
care facility happened to have one of these automatically adjustable examining
tables that were lowered to wheelchair height so whenever somebody like Janice
made the appointment to come in, that code would automatically tell the
practice staff that she should be put in the room with the automatically
adjustable examining table?

Demographic forces. Across the lifespan, Americans are living with growing
numbers of chronic conditions and disabilities. The epidemiology is pretty
clear that younger people have lower rates of disability than do older people.
40-54 million Americans, the younger folks maybe six percent, seven percent,
once we get to 75 years of age more than half of people will have at least some
form of disability.

There are pockets of people with disabilities. This is the cover of the New
Yorker magazine with a soldier sitting at the foot of some stairs. I have a
feeling that this came out at the time that the Walter Reed scandal came out a
year or so ago. Obviously there are pockets of young people coming back with
incredible disabilities that people are noticing, but most disability is in the
older age group and these are some data from the Census Bureau showing that
since the year 1900, we just have many, many more people 65 and older and,
incredibly, also 85 years of age and older. Even for older groups, the life
expectancy continues to rise even from 1950 on it continued to rise.

Disease and disability are distinct concepts, although they often coexist.
The causal links are pretty obvious. Disease frequently contributes to
disability. Osteoarthritis is the single most disabling condition among adults
in the United States. Obviously osteoarthritis impairs walking. Diabetes can
cause vision problems. Disability can cause new diseases. For example, a spinal
cord injury can cause urosepsis or contribute to a pressure ulcer. The MMWR, a
month ago, released information about rising disability that they then linked
back to chronic conditions with arthritis, again, being the number one
condition that was disabling, back problems number two. It was kind of cute the
word that they used, the said heart troubles was number three.

Aging-related impairments, many of us in this room kind of can relate to
this a little bit–vision, presbyopia, glaucoma, macular degeneration, hearing
presbycusis, which is aging related hearing loss, cognitive dysfunction with
Alzheimer’s, organic brain disease and functional impairments, again,
arthritis, back problems. These are diseases of aging that then contribute to
disability.

These slides show the percent of people aged 65 and older who report having
selected chronic conditions that are very associated with disability. The blue
bar shows men and the reddish bar shows women. As you can see, sometimes men
have more and sometimes women have more. Arthritis, again, is the most common.

Then we have to talk about the functional impairments that people have.
About 48 percent of men have some trouble hearing compared to 35 percent of
women. About 60 percent of men have some trouble seeing compared to 18 percent
of women. Then we have people over 65 who have various functional
problems–problems stooping, reaching overheard, writing, walking, lifting. So
disabilities are more prevalent in the older age group but that doesn’t mean
that these people want to go and not participate in the rest of daily life.
This woman who I interview when she was about 55 has had multiple sclerosis for
probably about 30 years said to me, “the baby boomers are coming, we’re
not going to warehouse them in nursing homes. These boomers are not going to go
quietly into the night”.

As the Future of Disability in America said, the Institute of Medicine
committee that reported in 2007, virtually everybody in the United States is
going to as some point in their life have a disability or live with somebody
who does or love somebody who does. Disability is not a minority issue. It
affects, today, everybody or will affect tomorrow the lives of most Americans.
The future of disability in America will depend on the country’s response to
this demographic shift.

Health care reform. There is a lot of heated rhetoric about health care
reform. I am using Obama’s kind of phrase from his campaign the fierce urgency
of now. As the President said, “Our families will never be secure, our
businesses will never be strong, and our government will never again be fully
solvent until we tackle the health care crisis.” Of course, I’m teasing
you a little bit because that president was Bill Clinton and this was a quote
from his state of the union address in February of 1993. I raise it just to
make the point that we really do not know what is going to happen with health
care reform. I mean, we kind of think that the stars are aligning there, too,
but we are not entirely sure. Although, Obama, in his now famous letter to
Kennedy and Baucus dated June 2nd–I think it was just a week
ago–this year we must do more than discuss, we must act. America’s future
depends on it. Of course, the 2.4 trillion dollars that our nation is spending
on health care does tend to focus the mind a little bit on this topic. As he
said, without a serious sustained effort to reduce the growth of health care
cost, affordable health care coverage will remain out of reach.

Now, I showed you the slides in my last kind of stars aligning segment about
the demography and you would think that part of the reason that health care
costs are going up so much is because of the aging of the population and the
increasing number of people with disabilities. In fact, the CBO, the
Congressional Budget Office, the nonpartisan group that looks at costing and
budget issues for congress, looked at several studies to try to figure out what
is driving differences in cost over time. From 1940 to 1990, the aging of the
population only contributed, according to all three studies–they were very
consistent in this–about two percent of the increase. If you look at the
bottom of this slide, the place where the money really is–I literally mean
money–is in technology-related changes. That includes not only imaging but
also pharmaceuticals and various different surgical techniques and so on
contributing maybe up to 65 percent of the increased growth.

Even in Medicare and Medicaid, you can see here that the thin wedge, which
is the dark blue, is the effective aging alone on the incredible increase that
is projected through 2082 in the costs of Medicare and Medicaid. Now, health
care reform might happen this time because basically what Obama has done is he
has taken Clinton’s playbook on how to do it as a reverse playbook. So he is
kind of taking what Clinton did and done the exact opposite. He basically told
Congress you figure this out. He gave Congress broad principles. He has tried
to involve all the stakeholders as much as possible. The broad
principles–there were eight of them, protect financial health of families,
make health insurance affordable, aim for universality — although, he’s a
little uneasy and squishy about the mandate thing but we will see how that
works itself out — make coverage portable, guaranteed choice, invest in
prevention and wellness care, improve patient safety and quality of health
care, and maintain long term financial sustainability.

Quality is where I want to focus now. People recognize this is the cover of
the seminal report of the Institute of Medicine in 2001, Crossing the Quality
Chasm. We know that we do not give as good quality of care in the United States
as we should be. The diagnostic and procedural data that we have to be able to
look at health care quality only goes so far. We really need to know more about
patients’ functional status, number one, to be able to look at the outcomes of
care. Ideally, we also would like to know more about patients’ preferences for
care but that might be asking too much from the coded data system.

In 2007, Medicare started again releasing the mortality report cards for
hospitals that they had started actually back in 1986 but had rescinded during
the Clinton era because of risk-adjustment problems that were happening back
then that actually haven’t gone away but we will get to that in a few minutes.
It is a program called Medicare Hospital Compare and I suspect that you have
probably heard about that at NCVHS. Have you heard about this at your committee
meetings? The risk adjustment for this–it is 30-day post-admission mortality
and the risk adjustment relies on going back twelve months previously in
Medicare claims looking for history of coronary angioplasty, coronary artery
bypass graft, heart failure, myocardial infarction, and then using secondary
diagnoses from the admission that is the index admission that they are looking
at from diabetes, metastatic cancer, other kinds of conditions that they viewed
as risk factors.

This is from my hospital, the Massachusetts General Hospital. This is the
Medicare Hospital Compare Report, just pulled off the web about a month ago,
for heart failure. What this slide shows is that the MGH had 348 people in
2006/2007 that qualified, according to Medicare, to be in this particular
population to look at. Our expected mortality rate was 9.3 percent and our
confidence intervals overlapped the national average of 11.1 percent. So the
Massachusetts General Hospital is just an average hospital in terms of its
quality of care for congestive heart failure patients, if you believe that the
Medicare Compare data tells you about quality of care.

The risk factors that they used were fine but, frankly, from a clinician’s
point of view, not the major risk factors that one would want to look at for
heart failure. There is something called the New York Heart Association
Functional Class that cardiologists are always assigning to their heart failure
patients because this basically tells you whether the extent to which the heart
failure limits the person’s ability to even get up and walk around a room. This
is a critical indicator of risk in heart failure. If you have the ICF codes
embedded in the discharge abstract, you could just pull right out of the ICF
codes to be able to convey that information. You need full information on
patient’s clinical risk to avoid penalizing hospitals with sicker patients.

Of course, one of the big problems with this is that the discharge
abstract–although, in Massachusetts that has changed in 2007. Our discharge
abstract now does include do not resuscitate status–that often the patients
who died, in fact, were hospice patients. There was a study that was published
by Holloway and Quill in JAMA in 2007 where they looked at the heart failure
deaths at a hospital in Buffalo, New York, that had been found to be one of the
35 worst hospitals in the United States. They found that 40 percent of the CHF
deaths, when they reviewed the medical record, were, in fact, do not
resuscitate or hospice cases and the mortality reports did not adjust for that.

Health information technology does not need to wait for Obama’s health care
reform to take place. I think HIT is lucky because it was kind of enshrined in
a way in the ARRA, the American Recovery and Reinvestment Act, that you were
talking about greatly this morning so I don’t need to review this for all of
you guys. The 20 million dollars to the National Institute on Standards and
Technology to work on technical standards is already there. You are already
talking about what makes a qualified electronic medical record but I am just
going to remind you what the words are that come directly from ARRA. Improves
health care quality, reduces medical errors, reduces health care disparities,
and advances delivery of patient-centered care, requires HIT to “reduce
health care costs resulting from inefficiency, medical errors, inappropriate
care, duplicative care, and incomplete information”, and provides
appropriate information to help guide medical decisions at the time and place
of care. If you read these words you know that ARRA requires information on
functional status. It just has to be there to be able to achieve these things
that the law says that it needs to achieve.

What are the electronic options? Can ICF be integrated within the standard
electronic framework? The really excellent 2005-2006 work of the Consolidated
Health Informatics Initiative, the CHI, Phase I Disability Work Group tell us
that yes. In fact, the ICF codes could be helped to be determined through the
LOINC process and the NCVHS report that came out in November of 2006 really
talks about this in a very specific way. In fact, what they said was that
endorsing ICF as a CHI standard for functioning and disability allows it to be
used in all these different and helpful ways such as inclusion in the Unified
Medical Language System, mapping between ICF and SNOMED, expanding the coded
disability content available for use, and making ICF available for use in
standardizing patients’ assessments.

Of course, we still have this vexing problem and Marjorie I remember we went
out to Baltimore one day when I was on NCVHS and we heard this exact same
thing–that there are these silos, right? That the nursing homes have the
minimum data set, the home health care system have the OASIS data set, that the
in-patient rehabilitation still use the IRF-PAI. We literally did go out to
Baltimore to try to hear about how at the time–I can’t remember what year it
was–they were trying to homogenize and figure out some way to make the kind of
coding and data collection for what is basically a continuum of looking at
functional status more cohesive but that still hasn’t happened and you still
have these silos of data collections that, again, could be helped by having an
ICF framework in place.

Public health. The Health People 2010 came out before the ICF was mandated
but an earlier version of the ICF, the ICIDH–it was a kind of crazy
acronym–had the same kind of environmental point of view. One of the chapters
in Health People 2010 quoted that as kind of talking about the contribution of
the environment to people’s health. In fact, I think Health People 2020 is
going to go farther than that.

This is the action model to achieve Health People 2020 that was proposed by
the Secretary’s Advisory Committee last October in their report. I’m going to,
actually, on the next slide give you the text of the outermost circle because
it is kind of hard to read those words when they go upside down. It basically
talks about what the determinants of health are. You start with kind of the
biology of the individual and then you go out to the social and family
environment and the living and working conditions but you also have to look at
the broad social, economic, cultural health and environmental conditions and
policies at the global, national, state, and local levels. The ICF can actually
help you do that. That is part of the framework of the ICF.

Healthy People 2010 also had chapter six, which talked about health care
disparities for people with disabilities. The Surgeon General picked up on this
in 2005 and on the 15th anniversary of the signing of the American’s
with Disabilities Act, July 26, 2005, issued a call to action noting that
people with disabilities experience disparities in the health care that they
receive compared to other people.

We, ourselves, have done some work on this. I will just show you one slide
of our results but we have a series of slides that I could show you. I will
just show you one. We looked at the use of breast conserving surgery for women
with early stage breast cancer. For the non-clinicians in the room, breast
conserving surgery is considered medically equivalent in terms of disease-free
survival as mastectomy as long as post-lumpectomy the woman gets radiation
therapy. We were able to show that for women with disabilities under age 65,
they were 20 percent less likely than other women to get breast conserving
surgery. Now, that might not be a disparity. There might be all sorts of
reasons why women with disabilities were 20 percent less likely to get breast
conserving surgery as other women but if they did get breast conserving
surgery, they needed to get the radiation therapy so they could have the same
disease-free survival as the women who had a mastectomy. What we found was that
they were 17 percent less likely to get radiation therapy and–no
surprise–women with disabilities were 45 percent more likely to die from their
breast cancer.

What data did we use for this? We used a very, very prominent data source,
the SEER data registry–that’s the Surveillance, Epidemiology, and End Results
cancer registries that are produced by the National Cancer Institute. They now
cover about 21 percent of the US population. Quite a few years ago they merged
these data with Medicare claims and there has been a lot of work on disparities
in cancer using the merged SEER/Medicare data but our group was the first to
actually look at the under 65’s. Every other paper that used SEER/Medicare data
there will be a single phrase in the methods sections: we eliminated the people
who are under age 65. There is never any rationale for that but that is what
they always do. We did not. We looked at the under 65.

The SEER registry, even though it has all this great detailed information on
the tumor type, it does not have any information on the functional status of
the patient. For oncologists, they look at functional status. They look at
Karnofsky scores. They look at whether the patient can get up from the bed to
know if they should give the patient aggressive chemo therapy or what types of
therapies that they should give them. What we had to use for our ability to
identify women with disabilities was we needed to use the fact that they were
on Medicare, which is equivalent to the fact that they have social security
disability insurance. The only way that we were able to identify disability was
through an administrative definition that the woman was on SSDI. Wouldn’t it be
an easy thing to have, in the SEER registry, a single code from the ICF or two
codes that would indicate what the patient’s functional status was.

Back in 1999, the Congress required the Agency for Health Care Research and
Quality, AHRQ, to start reporting national health care disparities reports.
They use all sorts of information that I think Ed Sondik’s group produces and
it is really terrific–the MEPS, the NHIS, and all sorts of other kind of
surveys. The report is to talk about the prevailing disparities in health care
as it relates to racial factors and socio-economic factors in priority
populations. The law defines priority populations in a very broad way. Women
are a priority population, children are a priority population, old people are a
priority population but so are people with disabilities.

If you go to the most recent disparities report, 2007, the content on
disabilities is vanishingly small. They talk about exercise counseling in obese
adults probably from NHIS merged with the Healthy People supplement. They talk
about inappropriate medication use by elderly people, delay in receiving care,
and then children with special health care needs, delays in care for illness
and injury, and poor communication with health providers reported by the
parents. That is probably from MEPS or from NHIS.

MS. GREENBERG: Actually a supplement to HIS.

DR. IEZZONI: Supplement to HIS, okay, yes. The basic point that I am making
is that a lot of the other content comes from claims and other data sources
that has diagnosis and procedure codes but the only place that you can get the
information on disability is from the National Health Interview Survey or some
of the other survey sources, which are great and terrific but it does mean that
it is limited in terms of looking at some of the disparities, especially in use
of services because things like NHIS do not code services the way that the
claims files would be able to allow you to do. So limited definitions of
disabilities and relatively few reported measures.

Growing recognition, finally, my final star that is aligning. Alright, I
have to talk about your reports. The first one is the report that I was
involved with back in 2001 where we said that the ICF is the only existing
classification system that could be used to code functional status across the
age span. Again, we just talked about the Consolidated Health Informatics
Standards Adoption Recommendations and ICF being CHI-endorsed standard for the
functioning and disability domain–both really excellent reports and a good
place to start recognizing ICF.

We also have the National Library of Medicine adding ICF in 2009 to its
Unified Medical Language System, which is a terrific thing, in a partnership
with the World Health Organization. What this now means is that UMLS users can
link ICF terms with other classifications, terminologies, and vocabularies.

There are other examples, the National Institute on Disability and
Rehabilitation Research, NIDRR, incorporating ICF into its Logic Model and
referencing in defining disability. Endorsements now by about a dozen
professional organizations. Then, again, as I noted already, Healthy People
2010 had the ICIDH as part of their conceptual framework in an earlier draft.

Right, finally, the 2007 report, The Future of Disability in America that
came out at the Institute of Medicine was also quite clear about this. I was on
this committee so I can speak a little bit to it. There really wasn’t an
alternative. When the committee was talking about what could we use to code and
classify functional status, the ICF was really, basically, the only kind of
reasonable thing that we could focus on. Recommendation 2.1, out of that IOM
committee, was that the National Center for Health Statistics, the Bureau of
the Census, the Bureau of Labor Statistics, and others should adopt an ICF
framework when you are thinking about functional status and disability in
designing your surveys. They also suggested promoting refinements and
improvements to the ICF and that the interagency committee on disability
research take charge of this. The directions that the IOM committee recommended
were, number one, clarifying the activity and participation concepts, number
two, incorporating quality of life, number three, delineating personal factors
more than they already are, four, extending the classification of functional
factors, which are already kind of extensive but they could be extended more,
number five, incorporate secondary health conditions, and, number six, add a
dynamic model reflecting movement of functional status across different state
of functioning.

Back again to ICF, are the stars, in fact, aligned to make this happen? This
is, again, off the nasa.gov website. This is the picture of a star being born.
There is a lot of hot air, a lot of gas, okay? It might be a little bit of a
mess but it is also beautiful, don’t you think? So I think that the rationale
and impetus are there, it is just really seizing the moment and who is going to
make that happen is really what we are waiting for. That is the end of my talk.
I hope the stars have aligned for ICF.

MR. REYNOLDS: Thank you. Question? Will?

DR. SCANLON: Thank you very much that was really very interesting and very
timely I think, too, because I think this is the part that is essential for
health reform if we are going to be thinking about it. We talk about wanting to
reform the delivery system and we have ideas like bundling, ideas like paper
performance, medical homes, et cetera. One of the things that we are really
missing is the ability to define what a patient needs. Your point about risk
adjustment is exactly on target. We have had faith that we are improving our
risk adjustments but we are not necessarily at the level of adequacy yet. Going
beyond diagnosis is a critical part. We have been stuck with diagnosis because
that is in the claims so I think one of the things we have to think about is
what will cause no harm in this process as we sort of move forward.

My question is because one of the things that has bothered me about sort of
all of the talk about delivery reform is the fact that as we think about
improving risk adjustment and we say we are going to look at more dimensions of
the patient and we are going to focus on the outcomes, we have people that are
not going to get better–permanent disabilities maybe sort of on a trajectory
to die. What I worry about is the issue of rating a situation where there is an
incentive to avoid those people. Right now there is some confidence in terms of
SNIF and home health care that–look at all the people who’s functional status
improved when we look at OASIS or we look at the MDS, okay? Some of that you
can say, well, that is because they had their joint replacement and that is the
expected outcome but there are other people that I think we don’t want to leave
behind in the process. How are we going to be able to get the data to tell us
that we don’t have to worry about them, we can protect them is kind of my
question?

DR. IEZZONI: Well, that is such a huge question and thank you for the
empathy that was conveyed in the way that you articulated that question. Let me
just say that when I started the project that I mentioned earlier where the
woman told me disability is such a lonely state I was interviewing people who
had mobility problems because of progressive chronic conditions. I asked a
gentleman once, tell me about your trouble walking. He said I don’t have any
trouble walking. I don’t walk. I use a wheelchair. We have to get away from the
notion that being able to walk is the be all, end all of disability or
somebody’s value. That is why I think it is really important to look at other
functions that people perform. The fact that they serve in their family as kind
of a caregiver. The fact that they are still able to go to work even if they
use a wheelchair. The fact that they participate in activities of daily living
and daily life. That is one of the things that ICF does. It looks at the
various other things that people do in life. Yes, it looks at whether they can
walk but it also looks at all sorts of other types of functions that other
people can do.

The thing that really frustrates me about the quality measures and it
frustrates everybody about most of the quality measures that P4P, pay for
performance is based on, is it is usually based on processes of care–what is
done to patients. There is very limited information about outcomes. That is
because the only outcome that we kind of reliably code is lived or died. We
have got to get away from that. The only way that I think we are going to get
better outcome information is if we start to get more information on
functioning and, you know, activity and participation in daily life. Trying to
make that case, it is who are the powers that be that are going to have to
enshrine that in the data sets that we routinely collect for the P4P type of
initiatives where the hospitals are already so burdened by the coding that they
are required to do.

DR. SCANLON: One potential bit of hope for you is I think it’s CMS actually
does have a common instrument now for post-acute care that they are either
testing or–

DR. IEZZONI: They have been working on that and, in fact, back in the time
when Marjorie and I went out to CMS, they had people working on it back them.
This has been something that has been–you know, that goes back maybe a dozen
years or so, Marjorie, is that possible? So I know that they are working on it.
They have–I think–RTI is working with them on it but it might be nice to
actually hear more detail about it.

DR. CARR: Thank you, Lisa. That was great, as always. My question was along
the lines of what you were starting to talk about. What are the on the ground
operationalizing challenges? For example, who provides that information that
then gets coded? Does it come from the person, from the physician, from someone
else in the practice and where does it appear so that it can be captured?

DR. IEZZONI: It is a really, really excellent question Justine. Back many,
many years ago when I was first starting my research career, we went and
reviewed medical records at 15 metropolitan Boston hospitals. We were
collecting information on severity of illness in a very medicalized way but we
were also collecting information on functional status. We could not find any
information on functional status in the physician notes. We simply could not
find it. The doctors were not noting it. My colleagues were not noting it. It
was in the nursing notes.

However, the first project that I ever did when I moved to the Beth
Israel–and it was Beth Israel back then, the BI back in 1990–we did a project
where we were looking at predicting mortality based on electronic information
that we were able to kind of download into relational database off of the BI
system. We were able to take the nursing functional pattern assessments off the
IBM mainframe, if you remember that, and then we were able to take the labs off
the other system. We couldn’t merge five percent of the cases, which is I guess
a pretty common thing that even if you have the same hospital, the same
patients, you can not merge five percent of the cases but we were trying to
predict mortality for people with pneumonia and congestive heart failure. Low
and behold the primary predictor–and we had all of this–your creatinines,
BUN’s–blood urea nitrogens–the most promising and strong predictor was
functional pattern assessment–whether the patient could feed or bathe
themselves. That was really what was driving–because as you can think of it
from a clinician’s point of view, that is the overall kind of functioning of
the patient. That kind of just summarizes all of the information right there.

One of the problems in collecting functional status information is that
there is some research on this, not a lot but some, that shows that
doctors–nurses might be a little bit better at it–but doctors are not always
as good as the need to be at measuring functional status for their patients.
Often times they only see their patients at the sickest possible moment and
they do not know what the patient is like when the patient goes home so they
tend to over assess how functionally impaired the patient is. One of the
questions is whether the patient can help document the medical record
themselves. I certainly think that there could be some value for doing that but
I think that although I kind of glossed over and was trying to make an advocacy
case for adding functional status to routine data collections, it is going to
be hard and it is going to require, also, physicians to–it will require
physicians, I think nurses can do it but it is going to require physicians to
change their mindset a little bit and recognize its importance will take some
effort.

DR. FRANCIS: I want to raise a set of devil’s advocate questions in a way
but I think they are actually very serious as well. I think there are enormous
advantages, particularly on the aggregate data front for having measures of
functional status in medical records but I think there are enormous risks as
well. One is the confusion of disease and disability because it puts disability
is a medical context and a lot of people make that confusion. Your breast
cancer data may be indicative of that, actually. I think there is a huge risk
on the individual patient treatment side of people getting less treatment.
There is the old DALY problem. I don’t want to get you started but it is an
issue.

I also want to think about the question–I don’t know how to bend my brain
around it–there are many people with disabilities who hide that disability. To
get on the bus you need to disclose that you are in a chair. You don’t need to
disclose that you have MS if you can locomote onto the bus. MS is a
particularly interesting example of a hidden disability. Yet, there might be
some functional status codes, for example, that somebody can conceal but that
would show up in a functional status code. I’m wondering if you have thought
about masking possibilities?

DR. IEZZONI: Absolutely, you know, I can talk on either side of these
issues, too, as you can well imagine that I probably could. I have MS, myself,
so I am often asked by people early in the disease should I tell my employer?
My answer to them is no. Try to keep it hidden as long as you possibly can
because there will be stigma and you will be discriminated against. I have
experienced it personally, myself. That is why I am not a practicing doctor,
for example. I graduated from medical school in 1984, six years before the ADA.
Enough said on that one.

I think that I also very much respect situations where patients ask for
certain information not to be documented in the medical record. You know the
BRACA, the breast cancer gene, is a perfect example of that. The genetics
people tell me that before Kennedy signed the bill that he signed I guess a
year ago about protecting genetic information that they would have a
conversation with their patient about not documenting information in the
medical record.

I am sensitive, very sensitive to what you say about physicians withholding
treatment for people with disabilities because of their prejudice about what
that patient’s life is like but it troubles me to not have information out
there because you expect somebody to discriminate based on it. I think it is
better to have it out there and then what you can do is actually try to monitor
discriminatory behavior on the part of physicians.

It is interesting, our Boston Globe yesterday had an editorial. It was the
second editorial in the Boston Globe about adding disability to the state’s
effort to look at disparities in health care. It was based on BRFSS data, a
state disability consortium has just issued a report using the Behavioral Risk
Factor Surveillance System information from Massachusetts and identifying
serious disparities in care for people with disabilities. The Boston Globe was
out there saying to the state that the state has just passed a law about
eliminating disparities for racial minorities but they didn’t include people
with disabilities in it so The Boston Globe, even though its writer’s union had
kind of voted against–well, never mind there–whether the Boston Globe will
continue to exist–but they had a great editorial about adding this to the
disparities report.

I had a conversation later in the day with an attorney at Great Boston Legal
Services who does a lot of work with people with disabilities and I said to him
look, Dan, where are we going to get the information? People are not going to
necessarily want to disclose their disability. It is a conundrum but I really
have a lot of trouble–as an information committee, here, thinking about not
putting information some place because people will use it to discriminate
against other people.

DR. TANG: I just want to thank you, Lisa, for very powerful testimony. I am
really struck by your comparison in terms of this is something to be known and
noticed, which really rings true. It points out poignantly why it should be
these systems and the system should act on it to help us do the right things.

I just want to offer some words of encouragement. I don’t know if you keep
up with what we have been doing but we did decide to focus in on the patient as
an important source of their information, which is where Justine was going and
that PHR’s might be a source of that. You might also know that Robert Johnson
has this PHR activity looking at observations of daily living and it sort of
gets to your point about what is It like outside the acute setting and what is
it like in real life? In order to track that and provide feedback not only to
yourself but to the professional-sided health care team.

You are probably aware that Meaningful Use also has or at least the Recovery
Act has disparities recommendation for reducing in it so it seems to me that
not only is this a moment of opportunity to work with this committee but also
with the relevant FACA’s in that world.

DR. IEZZONI: Yes. Thank you.

DR. SONDIK: I had a question related to ICF or the little red book as I call
it. There are five different dimensions in it. Could you say a word about using
that for coding because it is very complex? One of the efforts that actually
Jennifer Maddens has been working on here is a set of questions that could be
used internationally to give us a better handle on disabilities and be able to
do international comparisons because right now–I won’t say impossible, she is
the real expert–it is really difficult to do. But just the coding using the
ICF is a challenge so if you could speak to that.

DR. IEZZONI: I am not going to argue that the coding is a challenge but what
I will say is that there are some really interesting codes in there that get at
concepts that are nowhere else, that you can not replicate with ICD. I think
that there are some codes that might be better done with ICD, frankly, but
there are a lot that you really can not find anything like it in ICD. I think
looking at those dimensions where ICD really can not capture it–the
environmental factors I think is especially powerful and that is something that
you really can not get in ICD. The activity and participation, I am not sure
whether that has worked itself out. I know that that has been, historically, a
problem that not only US investigators and users have had a problem with but
also some of the international users have also had a problem with that.

MR. REYNOLDS: Doctor, thank you so much. I really appreciate the insight and
the information so thank you. Judy, if you would now go ahead and read the
recommendation letter to the group, please?

Agenda Item: Recommendation letter on NCPDP 10.6

DR. WARREN: First, let me ask, Jeff, do you want to make any comments about
why we are bringing this letter forward?

MR. BLAIR: No. I just want to make sure we request Denise and her help on
this.

DR. WARREN: We had some hearings I think it was back in November from NCPDP
and they were–if you remember our prescribing task on the MMA, we were
required to make recommendations used in e-prescribing. In the early versions
that we put forward and were later accepted by Medicare, one of the problems
with the codes is they didn’t really handle to need for long-term care
facilities, which handles e-prescribing in a slightly different fashion. One of
the wonderful things that happened during our initial set of hearings on
e-prescribing was that the industry actually came together and started working
to improve the set of standards and to come together to do a set of standards
that did the whole process of e-prescribing. In our last letter to the
Secretary, we had recommended that they adopt 10.5 of the SCRIPT Standard from
NCPDP and they had to have an exemption for long-term care with that standard.

Now NCPDP has come to us again saying we have corrected those problems, we
now have SCRIPT Standard 10.6 and you can life the exemption from long-term
care facilities and all of the problems that were in using these standards have
been alleviated. We heard from both the long-term care community as well as the
e-prescribing community and the standard setting bodies so it was a nicely done
piece.

This is the letter that we would like to send forward to the Secretary about
why we need to now adopt the next version of SCRIPT Standard 10.6. With that,
what I would like to do is kind of read each section and then if there are any
comments we can take them then. So we gave it a tag line for Paul.

NCPDP SCRIPT Standard Version 10.6 for use in Medicare Part D e-prescribing
in long-term care settings. Dear Secretary Sebelius, which by the way makes me
very happy coming from Kansas, I just had to recommend that, she is one of our
favorite people–

MR. REYNOLDS: Have you stopped reading or what are you doing?

DR. WARREN: No, I’m making comments now.

MR. REYNOLDS: Oh, thank you very much. Just making sure.

DR. WARREN: Now I will start reading again. You know you Boston guys get all
this stuff so us Kansas guys–

The National Committee on Vital and Health Statistics, NCVHS, is directed by
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) to develop recommendations for uniform standards to enable electronic
prescribing, called e-prescribing, in ambulatory care. This letter will
specifically address the current exemption for long-term care facilities from
use of adopted e-prescribing standards, the progress that has been made in
modifying the standards to make the workable in long-term care, and our
recommendations regarding adoption of e-prescribing standards for use in
long-term care.

Any comments on that?

DR. FRANCIS: It is a little bit long.

DR. WARREN: We tried everything. Denise did a Trojan job on trying to break
some of this stuff up and I think part of it are the titles of things–that
they make it long as well.

DR. SCANLON: This is coming from someone who has been involved with
long-term care and it is the issue of confusion over what long-term care is.
Long-term care facilities is a broad term. I had this discussion with Jeff
before, I think if we maybe put after long-term care facilities the first time
we used it, in parentheses, skilled nursing facilities or nursing facilities.
That gets to the things that are actually certified under Medicare and
Medicaid.

MS. BUENNING: Bill had mentioned this to me prior to the beginning of
today’s session. Under Part D, long-term care is defined specifically as
skilled nursing facilities. Other entities such as assisted living communities
are not called long-term care under Medicare Part D. We can either put in a
phrase here or I had actually penciled in something on the third paragraph of
the background section–the last line that says therefore, long-term care
facilities (defined under Medicare Part D as skilled nursing facilities) were
exempted from the requirement. The reason I put it there is because it talks
specifically about the exemption under Medicare Part D. So if you would like to
entertain that change, I can make that change and have everybody take a look at
it.

DR. WARREN: So that gets your–you don’t need to have it in that first
paragraph?

DR. SCANLON: No, just somewhere we need to warn people.

DR. WARREN: Anybody else on that first paragraph?

DR. FRANCIS: This is a wordsmithing. It will be my only one. I would just
say that this letter will specifically address three things, one, the current,
two, the progress, three, our recommendations because otherwise it is very hard
to follow.

DR. WARREN: Did you get that one, Denise, about address three things? I have
got it. It says this letter will specifically address three things–

MS. BUENNING: Three things or three issues? Do we want to say things?

DR. FRANCIS: This is beyond wordsmith as long as we put something–address
three issues and just put the number one in front of where it begins the
progress–

MR. HOUSTON: That’s not an issue, though. Progress is not an issue.

DR. FRANCIS: Okay, three areas.

MR. REYNOLDS: So tomorrow when it comes back up the appropriate word that
you would like to use. Continuing on.

DR. WARREN: Background, what I am going to do is read to the bottom of the
page and stop there so that we can address this. The MMA established a
voluntary prescription drug benefit program for Medicare Part D. Prescription
Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations offering
Medicare Advantage-Prescription Drug Plans know as MA-PD are required to
establish electronic prescription drug programs to provide for electronic
transmittal of certain information to the prescribing provider and dispensing
pharmacy and pharmacist.

Second paragraph. There is no requirement that prescribers or dispensers
implement e-prescribing. However, prescribers and dispensers who electronically
transmit prescription and certain other information for covered drugs
prescribed for Medicare Part D eligible beneficiaries, directly or through an
intermediary, would be required to comply with any applicable final standards
in effect for e-prescribing.

Next paragraph. The November 2005 regulation that adopted foundation
standards for e-prescribed contained three exemptions from the requirements to
use the standards. One was based on comments from the health care industry that
indicated that the proposed standards, while well-accepted in the ambulatory
setting, were not proven to sufficiently support the workflows and legal
responsibilities in the long-term setting. Therefore, long-term care facilities
were exempted from the requirements to use the NCPDP SCRIPT standard.

I think that is the paragraph that you want to add–

MS. BUENNING: Right. If I can direct your attention to the screen, I have
inserted the proposed language in the parentheses.

DR. WARREN: So it’s the next to the last line of the third paragraph so that
it reads therefore long-term care facilities (defined under Medicare Part D as
skilled nursing facilities) were exempted from the requirements to use NCPDP
SCRIPT standard.

So let’s take any other comments about those three paragraphs.

MR. REYNOLDS: Yes, I have a question. Is it still appropriate to say in the
first sentence of paragraph two that there is no requirement that prescribers
or dispensers implement e-prescribing? Isn’t there something out now that by
2011–If you don’t implement it by a certain time you are going to get–

MS. BUENNING: There are disincentives. Still it is voluntary.

MR. REYNOLDS: Thank you. I know. I guess as we continue through history at
some point when there are disincentives–this is a fact but some of the reasons
that we are doing some of these things is so that people won’t fall into those
disincentives. Is that not correct?

MS. BUENNING: I mean, we certainly encourage them and there are obviously
incentives to e-prescribe but it is still voluntary in that you can choose
whether to e-prescribe. Now you will, perhaps, experience a disincentive but
this is still–

MR. REYNOLDS: As we continue forward, I want to make sure that–I don’t want
to change it now.

MS. BUENNING: Under the MMA, e-prescribing is still voluntary.

DR. WARREN: It may be what would be better here is to turn that around.
Instead of saying that it is not required, make the statement that under MMA
e-prescribing is a voluntary process.

MR. REYNOLDS: We don’t need to change it. I am just making a point as we go
forward. We are going to have incentives, we are going to have disincentives,
we are going to have some other things going on–saying it is not a
requirement, somebody reading this that is not as close as we are–

MR. BLAIR: Could I make a friendly suggestion saying not a requirement but
the clarification Denise just gave us is that it is not a legal mandate. So
maybe if we changed it to legal mandate then that would be more specific. Does
that help, Harry, or not?

DR. WARREN: I think the issue is it is a voluntary practice with financial
incentives attached. Is that it?

MS. BUENNING: But not under MMA.

MS. MCCALL: Can I ask the importance of making the point at all? It is there
for a reason. What is it?

MR. REYNOLDS: That is where I am going.

MS. MCCALL: So the people that put this together, you guys put this in for a
reason. It was to communicate what?

DR. WARREN: I would like Denise to talk about that because that was
something that came out of her office to make the statement. Also, people that
testified had talked about it as well. Denise, do you want to?

MS. BUENNING: I guess we always put this language in to clarify that it is
voluntary for prescribers. Plans must support e-prescribing under MMA but in
terms of prescribers they still can choose whether to e-prescribe. If they do
e-prescribe, they must use the standards.

MS. TRUDEL: It is an important point to make in that we want to make sure
that people don’t read this as once we have removed the exemption, long-term
care facilities are required to e-prescribe. They still are not.

MS. MCCALL: Maybe just stating it that way and not withstanding our
recommendation it is important to remember that it remains voluntary and that
is what I would say.

DR. SCANLON: I think the reason for making some acknowledgement here is to
show that Medicare has thought about the importance of doing this. The
acknowledgement that I would make because this paragraph is really about the
MMA would be to put a footnote in at the end of that sentence saying–I think
it’s MIPPA, Medicare Improvement for Patients and Provider Act, which created
sort of an incentive and ultimately penalties for not e-prescribing. It’s
incentatory prescribing and you can just say it in a sentence. The notion is
that we move forward beyond MMA and not dwell on it.

MS. TRUDEL: That’s correct. The MIPPA incentives apply to practitioners
apply to practitioners not to long-term care facilities so I think there is a
little bit of a disconnect there.

DR. SCANLON: But a prescriber has to be a practitioner, right, because the
facility can’t prescribe. We are modifying the prescriber here, not the
facility. The facility is in charge of overseeing the dispensing but not the
prescriber.

MS. TRUDEL: Well, the use of e-prescribing in a long-term care facility is
going to be under the control of the facility not the physician. That is the
distinction. There is no disincentive to the facility for not e-prescribing. I
guess that is closing the loop.

DR. SUAREZ: One way to deal with this is maybe start the sentence with a
while there are incentives for adoption, there is no requirement that
prescribers or dispensers implement e-prescribing. It addresses the two points.
It clarifies that there are incentives for adoption but still there is no
requirement for implementation.

DR. SCANLON: There just aren’t incentives, though, for the dispensers. There
are no incentives for the dispenser. It is up to the physician. The physician
receives the reward or the penalty.

MR. REYNOLDS: Let us do this, can you guys take this–since the letter will
be finalized tomorrow–can you take this particular issue under advisement. I
think you have had more than enough input from a number of us. Please continue.

DR. CARR: I had a question on the November 2005 regulation. E-prescribing
changes workflow for everyone so I am not quite following why the change in
workflow was a non-starter for long-term care facilities.

DR. WARREN: It is the whole piece of who writes the prescription and how
they are managed because long-term care facility patients do not go visit their
doctor and get prescriptions. It is the facility that manages the renewal of
those prescriptions either through a nurse practitioner or they have a medical
director that comes in periodically and signs those. There are different ways
of managing prescriptions. It is not like in-patient care. It is not like
ambulatory care. It is different. Trying to track the thread of responsibility
for that prescription was what was missing before in the standard.

So, healthcare delivery in long-term care (LTC) settings is unique for
several reasons. Nurses are frequently the primary caregivers, with physicians
(who are often not at the site of the LTC) monitoring care. Specialized
long-term care pharmacies are located off-site with drugs being delivered to
the facility. Given these unique factors, the calendar year 2006 pilot project
tested the use of foundation standards within LTC facilities in a
“three-way prescribing communications” between the long-term care
facility, physician, and pharmacy. This pilot setting provided a special
opportunity for understanding e-prescribing’s impact and use of both foundation
and initial standards on a patient population, provider type, and prescription
delivery system that is quite different from ambulatory or acute care
facilities.

I’m going to read the next paragraph then I’m going to stop again.

In long-term care a prescription order typically remains an open order with
no end date or with an end date far in the future. A prescriber may need to
modify this order and notify the pharmacy. Changes might include dose, form,
strength, route, modifications of frequency, or a minor change related to the
order. Also, in the long-term care environment, there is a need to send a
refill request from a facility to a pharmacy. An example is when a medication
supply for a resident is running low (2-3 doses remaining), and a new supply is
needed from the pharmacy. The facility needs a way to notify the pharmacy that
a refill for the medication is needed. E-prescribing was evaluated within the
unique context of long-term care workflow from facility to pharmacy.

Any comments about those two paragraphs? Denise?

MS. BUENNING: I propose that I remove the letters CY. It doesn’t add
anything and people trip over it.

DR. CARR: This is explaining what I just asked about, is that what this is?

DR. WARREN: Yes.

DR. CARR: Is there a reason why we have to give this much detail because it
is a long letter.

DR. WARREN: When we put this out to the subcommittee there were quite a few
people who wanted to know what were the differences between 10.5 and 10.6 and
why we were asking for this update so we felt that it had to be spelled out
what the unique differences are because most people think ambulatory or
in-patient and not the unique needs of this setting.

MS. TRUDEL: In addition, it would prove to be helpful to HHS on the back end
as we develop a regulation and go through the briefing process with the
Department principles and OMB to be able to point to the letter and say here is
what the background is, here is what the industry told us. It would be helpful
for us.

DR. WARREN: Any other concerns about these two paragraphs? Okay, next
paragraph.

The long-term care pilot site grantee tested the NCPDP SCRIPT 8.1 standard
in the long-term care setting, and, upon demonstrating that the standard was
not feasible for use in the long-term care setting, used workarounds
(modifications) to test the standard as required to ensure complete
prescription data was transmitted and received appropriately. On completion of
the LTC pilot, the proposed modifications that were identified and tested by
the grantee were formally submitted to NCPDP to modify the standard by adding:
bullet one, identification for facility unit, room and bed, for medication
delivery; bullet two, census update transactions to notify the pharmacy about
census events such as a new resident, a change to a patient’s demographic
information or a patient discharge; bullet three, a new transaction type of
“Resupply Request”; bullet four, a change of prescription status flag
for discontinue or cancellations in the request segment; and, final bullet,
fields for needed no later than with a date and time.

These requests were fully incorporated in NCPDP SCRIPT 10.2, and approved by
the NCPDP Board of Trustees in July 2007, with industry feedback indicating
that NCPDP SCRIPT 10.2 meets the basic needs of the long-term care industry
relative to e-prescribing.

We are going to go on and talk more about the standards. Walter?

DR. SUAREZ: Just a minor suggestion. In those bullets it might be helpful to
put in quotes the few elements like in the last bullet “Needed No Later
Than”. In the first bullter “Facility Unit, Room and Bed”. The
second bullet, the “Census Update Transactions”. Fourth bullet the
“Change of Prescription Status”.

MR. HOUSTON: In the first sentence, second line–it’s upon demonstrating
that the standard was not feasible–I would simply say upon demonstrating that
version 8.1 of the standard was not feasible because what you basically said
afterward is that the standard was adapted to be feasible. Just add that.

DR. WARREN: Did you get that Denise?

MS. BUENNING: Got it.

DR. WARREN: We also had a request from members of the subcommittee to put in
the differences between NCPDP SCRIPT 10.5 and 10.6 so that is the next section
of our letter.

Since that time, NCPDP SCRIPT 10.5 was approved by the NCPDP Board of
Trustees in June 2008. This updated standard version built upon NCPDP SCRIPT
10.2, supporting an XML Implementation section and a Health Information
Technology Standards Panel (HITSP) recommendations for Medication Management
Use Cases; making changes to the PVD Segment (Pharmacy) prescription fill
status notification (making RxFill mandatory), and inserting new PVD Segment
fields and additional clarifying notes.

The NCPDP has further advanced its SCRIPT standard in other areas to achieve
Version 10.6, preserving all the previous NCPDP SCRIPT standards requirements
needed to support e-prescribing in long term care settings. The additional new
functionalities offered by NCPDP SCRIPT 10.6 are primarily related to the
Medication History functionality, which was adopted in the April 7, 2008
e-prescribing final rule–and then we have the number of the final rule. They
include: first bullet, prescriber order number added to Medication History
response; bullet two, source and fill number information added to Medication
History Response; bullet three, a “Sold Date” value added to the DRU
Segment Date/Time Period Qualifier. As an aside, DRU is not an abbreviation. It
is what the name of the segment is called. Bullet four is enhancements to the
DRU Segment enabling a physician to include prescribing-time drug utilization
review alerts and comments to the pharmacist when communicating a prescription.
This applies to retail, mail order, and long-term care pharmacy settings. The
final bullet is an Allergy Segment and Diagnosis Segment for use in the CENSUS
transaction that allow sharing of person’s full allergy and diagnosis profiles
with the pharmacy at time of admission and/or changes in their allergy or
diagnosis statement, to help pharmacists catch additional, potential drug-drug
interactions. These additions facilitate better record matching,
de-duplication, and rich information being presented to the prescriber at the
point of prescribing.

The long-term care industry has expressed its readiness to NCVHS to embrace
e-prescribing so that it can enjoy the potential workflow and patient care
benefits. I will stop there for any comments.

DR. CARR: What is de-duplication?

DR. WARREN: One of the things that we heard testimony on was there were many
duplicate orders written. Is this something that you heard, Denis, and that is
why you used the word de-duplication.

MS. BUENNING: I have heard it before, yes. It basically means elimination of
duplication.

DR. WARREN: If you want different wording we can do that.

DR. CARR: If everyone is familiar with the term–maybe it is just me, I
never heard of it.

MR. REYNOLDS: If the term is not easily translatable, let’s change
something.

DR. WARREN: Reduction in duplication.

MR. LAND: On the last dot point, shouldn’t that be allows and not allow?

DR. WARREN: Yes, thank you.

MR. REYNOLDS: Please continue.

DR. WARREN: Okay. Recommendation one: The NCVHS recommends that NCPDP SCRIPT
Version 10.6 be considered for voluntary adoption under the streamlined process
for backward compatibility standards. In June 2008, NCVHS recommended that
NCPDP SCRIPT Version 10.5 be considered for voluntary adoption under this same
process. However, given the availability of the updated NCPDP SCRIPT Version
10.6, this version would provide the expanded functionality needed in long-term
care settings to communicate information about prescription drugs and
prescription drug-related information. It would also allow for the voluntary
use of a more recent, backward compatible version of the NCPDP SCRIPT standard
in ambulatory settings. Denise?

MS. BUENNING: I see Walter already has his hand up. Walter has made a
recommendation regarding recommendation number one and he would like to see the
NCVHS recommends that NCPDP SCRIPT 10.6 be adopted by the Secretary for
voluntary adoption. I think it should be adopted by the Secretary for voluntary
use under the streamlined process for backward compatible standards.

DR. GREEN: The recommendations both get lost in all the words and we repeat
our rationale again in the recommendations. What would you think about
streamlining these to where the recommendations state the recommendations? If
we want the additional language just have an additional explanation or
something but the first sentence of recommendation one and approaching
recommendation two is really what the recommendation is, what follows is not a
recommendation at all in either case.

DR. WARREN: Anybody else agree with Larry’s suggestion?

DR. CARR: Yes. I agree because there is a lot to take in here so either put
it–I think it is actually in the background so I don’t think we need to repeat
it. I would just make it real clear what the two recommendations are.

MR. REYNOLDS: Yes, we have warmed them up.

MR. BLAIR: Can I make a suggestion with a friendly amendment? It is fine
with me as we decide to do that but let’s make that decision after we have read
both recommendations to see if that same practice would apply to both. Is that
okay?

DR. WARREN: Any other comments on recommendation one? Okay. Recommendation
two: The NCVHS recommends lifting the current exemption from the requirement to
use the NCPDP SCRIPT standard for non-prescribing provider in long-term care
settings. The exemption currently applies to prescribers when they are required
by law to issue a prescription for a patient to a non-prescribing provider
(such as a nursing facility) that in turn forwards it to a dispenser. While
long-term care facilities would be able to voluntarily use the NCPDP SCRIPT
10.6 standard even while the exemption is in place, we believe lifting the
exemption sends a clear message to the industry about the desirability of
e-prescribing in long-term care.

MR. REYNOLDS: Before we take up Jeff’s amendment, Karen, you are obviously a
key customer in this. Style-wise I agree with Larry, I want to know whether
removing some of that content is a detriment to this being able to be used by
the government when we are not in the room.

MS. TRUDEL: Well, I think if it is repetitive that is not a problem.

MR. REYNOLDS: Well said. I wanted to have you on record.

MS. BUENNING: The only question I would have is is that the only place that
we use backward compatible, Karen?

MS. TRUDEL: That is a critical point that needs to be in the letter. It is
backward compatible.

MR. REYNOLDS: Yes, and that is a cornerstone for everything we have been
doing on NCPDP is backward compatible. So regardless of how we streamline it,
those words must remain in that area.

DR. FRANCIS: An easy way to streamline it would be simply to delete the
second sentence and then say this version would and then bullet provide and
bullet allow for the voluntary use for. That way you haven’t looked like a
recommendation and you preserve all the functionality and you don’t have to
figure out where to put it back in somewhere else.

MS. BUENNING: If you look at the screen, I have made that change if you want
to take a look at it.

DR. FRANCIS: You want the provide and allow for. This version would and then
you bullet provide and then you bullet allow for because you have two different
concepts here.

MR. REYNOLDS: Let’s do this. I think Larry made a good point, Jeff played
off of it, Leslie added to it and so on. Why don’t we let that be what the
subcommittee does, come back with an abbreviated version tomorrow. Larry?

DR. GREEN: Sounds good. It also seems more logical to me to reverse the
recommendations in their order. At least to me, the first recommendation is to
lift the current exemption and then the second recommendation I to do
something.

DR. WARREN: Actually, you can’t lift the exemption until you say that you
have the standard. The only reason we can lift the exemption is because we have
recommended the standard. That’s why we put it in that order.

DR. GREEN: I take your point. Thank you.

MR. HOUSTON: I’m trying to understand and, again, this not being my area of
expertise, you are talking about all these different versions. I am assuming
that we are not going to come back every six months or a year to write a new
letter on a new version of NCPDP for whatever use and whatever setting it is. I
understand that what I think you are trying to say is you want to adopt 10.6
for use within long-term care settings, correct?

MR. REYNOLDS: I think we have a couple things going on. Two things. One is
you sit and read this letter if you are not as close to the game but this is
huge and let me tell you why it is. A lot of the complaint in the industry is
standards don’t happen fast enough. With this letter, which to some of you may
seem like we are trudging through some wording, immediately enhances a
standards process dramatically and allows it to be as current as possible.
Second, I know there are final rules and other things that are being dealt with
so as the industry moves and we can make the right things available for when
these things occur, that is a good thing to. Third, we are enhancing an
exciting segment of the industry and allowing them to move forward with
everyone else.

MR. HOUSTON: I think you may be missing my point.

MR. BLAIR: It’s more than long-term care.

DR. WARREN: Let me see if I understand. One of the problems was when we made
recommendations on MMA, we were asked to specify a version of the standard and
that went into the rule. Any update on the version of that standard has to go
through a formal process to be updated. We can’t just say the current.

MR. HOUSTON: My point is more basic, though, does NCVHS need–I understand
the basic premise of this letter and I think it is appropriate. You really are
endorsing a specific standard for use within long-term care facilities and I
think it is absolutely vital and viable that it gets–

MR. REYNOLDS: That’s one subject, yes.

MR. HOUSTON: I’m almost feeling like the letter is us having to in one sense
certify or recommend each version and do we want to get in the game–

MR. REYNOLDS: Yes, because somebody has to recommend it. The second thing is
we have taken it up because if we don’t do it in a public forum and we don’t
restate things like backward compatible and everything, you can be leaving a
significant portion of the industry out that is shooting towards something.

MR. HOUSTON: Okay, but what happens when version 10.7 comes out?

MR. REYNOLDS: Well, when 10.7 comes out, if it doesn’t meet the same
criteria and it doesn’t allow the industry to move forward and it starts
putting undue restrictions, we have the public hearing to help decide.

MR. HOUSTON: Is it NCVHS’ responsibility to review each one?

MR. REYNOLDS: Yes it is.

DR. WARREN: Yes, as specified in MMA. NCVHS has that responsibility.

MR. HOUSTON: Okay, because it sounds like this becomes almost an
administrative task for NCVHS–

DR. WARREN: Much in the way HIPAA is that we have specifications that we
have to do for HIPAA.

MR. REYNOLDS: But compared to the other standards process, it has turned it
into light years different. In other words, this is what you would always hope
standards might work like and you might be able to do the right things at the
right time as they occur and put some value on them.

MR. HOUSTON: I’m just reacting to the fact–

MR. REYNOLDS: No, no, good questions.

MR. HOUSTON: I think NCVHS obviously wants to involve itself in making these
seminal decisions about adoption of a technology and adaption of a technology
for different areas, such as what this is talking about. If NCVHS wants to stay
as a spot leader, my fear is this sounds like it could just become this task
that always has to be done by NCVHS and it sounds like in many cases it very
well might be something that doesn’t require my input. That’s just my thought.
I understand we have an obligation to do it.

DR. WARREN: You bring up a good point. We had a lot of dialogue within our
subcommittee about it, although, it is mandated in the law that we do this.
This last version we were able to bring in a panel to provide testimony for why
we needed to make this recommendation, do it during a full committee meeting,
one of our breakout sessions, put together the letter–I think it is the
fastest turnaround we’ve done so we’re getting better at that.

MR. HOUSTON: I understand our need. When there is a need and when there is a
value it sounds like it’s a great thing to do. My fear is you would get down in
version and subversions.

MR. REYNOLDS: Agreed, but I could argue back that we actually are acting as
spot leaders as compared to the rest of the normal standards process in doing
it so that we are able to literally stay up with the industry and able to allow
CMS and others to move as rapidly as they need to, especially on something that
is not on the street yet as far as everybody wants it to be on the street.

MS. BUENNING: Under recommendation number one I have made some revisions.

MR. REYNOLDS: Well, we will just bring it back tomorrow. I would rather
bring it back tomorrow. Mark, last comment and then we will get off this.

DR. HORNBROOK: Are you going to have any implication by size of SNF? And
rural versus urban? Are we, in essence, requiring all SNF’s regardless of where
they are sitting and how big they are to be electronically compliable?

DR. WARREN: Not required. This is all voluntary but the standard will now
have the fields to communicate the appropriate information that they need to do
e-prescribing.

MR. REYNOLDS: It’s allowing them, if they choose to do it, to have the means
to do it. Marjorie and then Karen.

MS. GREENBERG: I wanted to suggest because I think I heard a lot of
discussion about people getting kind of bogged down in the letter but on the
other hand there is a lot of useful information here to be in the letter and
that is fine. I would say, just in response to John, if we had to get into the
weeds like this with everything, of course, we couldn’t, but I think it’s
actually good for the Committee to have some things that it’s very specifically
responsible for and other things that it can be more big picture about. I don’t
think that the balance is out of whack. There’s something to be said for that
to increase the Committee’s utility and visibility. In any event, I was just
wondering if we might, I mean the “Re:” says what we’re talking about
but it doesn’t even say that we’re recommending something and then it kind of
refers to our recommendations in that first paragraph but we don’t get to these
recommendations to the bottom of the third page. I think the letter would pack
more of a punch if after the first paragraph, we actually stated, generally,
what we’re recommending and then you can provide all the background you want
and repeat the recommendations. They say tell them what you’re going to tell
them, tell it to them, and then tell them you told them or something. Put the
bottom line up front.

DR. WARREN: Let me just clarify, I mean, we followed the format of our
letters, which always puts the recommendation at the end.

MS. GREENBERG: Yes, but most aren’t this long.

DR. WARREN: Well, the original NCPDP letter was very long.

MR. REYNOLDS: The point is–with two recommendations a lot of times our
letters are long and we have series of recommendations and so you have to build
it up. Again, I’d like the subcommittee to take that under advisement. Karen,
your comment?

MS. TRUDEL: One of my comments was to Mark and to point out that we did hear
a lot of input from the long-term care industry and they were very favorable
about our moving forward with this because they thought that it paved the way
for them when they are at a point that they are interested in adopting EHR
e-prescribing technology and also that they felt that it sent a very clear
message to the vendors in that space that this is the way you do it.

MR. REYNOLDS: Yes. The exciting thing about the way that e-prescribing is
moving forward is the standards development organization comes in and they
unanimously agree and then the industry comes in and it unanimously agrees
also. So everything you would hope that you saw in a room, that you would want
in a process, literally occurs in the room. That’s why we’re able to move this
along and then with backward compatible as the keyword so that you’re not
leaving somebody out.

DR. HORNBROOK: So are we working towards a model, ideally, where the nurse
and a SNF can send the prescription refill request into the pharmacist, the
pharmacist contacts the doc electronically, the physician sends back an
electronic signature approving it, or even skipping the physician all together?
I mean, we’re not saying that the physician has to get involved for refills,
are we?

MS. TRUDEL: It’s as appropriate. Basically, we’ve taken the flow that is
occurring out there now and enabled that to occur electronically with a nurse,
a physician, and a pharmacy being in the loop as needed.

DR. HORNBROOK: Right now most of it is by phone, isn’t it?

MS. TRUDEL: Yes.

MR. REYNOLDS: Okay, so Judy and Jeff I think you have a letter to take into
the committee.

Agenda Item: Committee Direction Discussion and
Strategic Planning

So moving on to discussion, there are some breakouts, I noticed. Privacy
doesn’t have one because we just had one.

As you go into your breakouts,–and I want to hear anything from the
co-chairs–we had a lot of discussion this morning about who we are, what we
are, what we’re doing, what we can effect, so please don’t go into your
breakouts and just act like we always acted before. There are whatever subjects
on the table that we think should be the right subjects on the table. We have
some that carry over. Again, two came up this morning, the whole comparative
effectiveness and the PHR, which right now is only really being dealt with
significantly by the privacy group–whether or not those are subjects. If any
committee decides that they would like to take the subject, not just the
subcomittee portion of the subject on any of these, then it is a good time to
step up and do that. Again, you may have to have some other players in the room
help you do that but I think those are some of the things to consider.

Then, as we look at our meetings in September and our meetings in November,
if, as we have done a couple other times, if those need to be educational or
other kinds of things and if a subcommittee will pick that up and take that as
a to do, bring in the right people to educate the full committee and/or make
sure that the subject gets discussed, whether that’s PHR–I’m just using these
as two examples that came up this morning–or any of these other things. Again,
I think the most important thing is we’re trying to continue to drive this,
making sure that we keep the full committee educated on the right subjects so
that when the letters come in and the issues come to the table, we’re not
starting everybody from ground zero and they haven’t had a chance to ask their
questions along the journey, not all of a sudden when we have a letter of
recommendation that appears to have been done by a subcommittee and nobody
knows what is going on. I challenge you to take that. I also challenge you that
it couldn’t be a more exciting time for us and all of us that are trying to
make a difference. I really ask you to make a difference. Don’t just do what
maybe your subcommittee thought before, acted before, did before, or believed
before. How do we make a difference? Period. That’s what I’m really excited
about here. How do we make a difference because there is a lot to do in a lot
of ways.

Any comments from any of the subcommittee chairs or anybody else before we
break into our breakouts?

DR. FRANCIS: Could I take this opportunity, actually, as an invitation?
We’ve had three days of hearings on PHR’s and we have the need to have
recommendations be ready by, at the very latest, November to be out the door if
they are going to make a difference in the work of both HHS and the FTC with
respect to personal health records. We have a work plan over the summer to
develop a set of recommendations. They will be primarily on topics such as
transparency, the importance of people really understanding what they’re doing
when they set up a PHR with some attention to how you get that genuine
understanding, as well as not having bait and switch–not having the data be
put in for one purpose and then, unbeknownst to the person, being used for
another. We have a series of conference calls schedule over the course of the
summer and we will let everyone know when they are if you would like to join
in. We will also send around an informative summary that’s just going to be a
working document, not a public one as of yet, from the hearings that you are
all welcome to have a look at as background.

MS. GREENBERG: There will be minutes, also.

DR. FRANCIS: There will be minutes but I think a couple of us–Paul,
actually, came up to me this morning and John suggesting that the analytic
summary would be a good idea just as a working document. We’re going to send
that around to members of the committee. As we get the recommendations put
together, we will also make sure that those get circulated around so that we
have an opportunity for people because if this is going to make a difference,
it has to be signed, sealed, and in a pretty little bow by November. That gives
us two committee meetings at max. Just a heads up folks. It’s coming.

MS. BERNSTEIN: I thought that we also agreed that we would announce when the
phone calls are scheduled so that all the members of the committee who might
want to can participate in those.

DR. FRANCIS: We will send that around to everybody, I think. I don’t have
the list of dates, myself, right now. I don’t think we have it yet but we will
make sure that all of you have it when we have it. I think the first one will
be July 17th.

MR. HOUSTON: I know that Blackford has graciously offered to help. Mr. PHR
help–involve himself.

DR. MIDDLETON: I just love that stuff.

MR. HOUSTON: I know you do.

MR. HOUSTON: To expand upon what Leslie said, just very briefly, we had
three days of testimony and a lot of really great input. I think, unlike EHR’s,
PHR’s are going to evolve in many, many ways. While we heard a lot of people
talk about privacy and concerns over privacy in PHR’s, we also recognize that
we don’t want to stifle innovation and I think PHR’s are going to be an area of
great innovation over the next foreseeable future. As Leslie said, we think
that the way to bridge the gap between privacy and not stifling innovation is
really this concept of absolute transparency and trying to do it in a way that
engages consumers so that they really do understand and have the ability to
make choices when deciding to use PHR’s rather than imposing some type of
regulatory burdens on PHR’s that may cause them to fail in providing services
that people really want. There’s so many different forms of PHR’s, everything
from social networks to what we classically think of as a PHR, whether it be
claims based or tethered to an EHR. It’s a very complex subject area and we do
really do encourage people to involve themselves because I think that the more
we got involved, the more we recognized how incredibly complex and powerful
this is.

MR. REYNOLDS: I would add to that, every time you sit in one more of the
days of hearing, it changes your perspective. So please engage because this is
one that you are going to really need to take a look at. You’re going to really
need to have a sense of what you’re doing because it’s happening quickly and
some of the testifiers kind of gave us the same flavor, others have continued
to move it forward. It’s going to be an interesting challenge as things
continue this quickly so that’s very important to do.

Judy, you had your hand up? No? Okay. Anything from Quality or Populations?
You will be back tomorrow? Good. One last comment before we break into our
breakout groups is we have drafted a letter to Rob Kolodner for his service as
the National Coordinator and I don’t plan to read it. It’s well done by a lot
of people and it is heartfelt as to the difference that he made and especially
his relationship with us and how he was very open to work with us and very
inclusive with us and we were the same with him. I just wanted to mention that
and get an approval from the group to forward that from the Committee to Rob
even though he has moved on to other opportunities.

MR. BLAIR: May I make a motion?

MR. REYNOLDS: So moved, second? All in favor?

MR. REYNOLDS: Opposed? Okay, thank you. So we’re adjourned for today. Break
out sessions and then we’ll start promptly tomorrow morning at nine for the
full committee.

(Whereupon, at 4:40 p.m, the meeting was adjourned.)