[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

November 13, 2012

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

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
caset@caset.net

CONTENTS

P R O C E E D I N G S

Agenda Item: Call to Order, Welcome, Review of Agenda

DR. GREEN: Welcome back. It is nice to see everyone. I understand that
several people had interesting evenings trying to get here. I appreciate the
proof of durability of NCVHS committee members, yet in another way. It is
really nice to see all of you. I am sure we have some folks calling in on the
phone, but we will do as we usually do here in a moment. We will run the tables
and introduce ourselves. We have some new committee members. We are pretty
excited about that. In case you have forgotten, we are fully populated. We
actually have a full house on the committee. It is a very wonderful thing. We
are very appreciative of that.

Our agenda is a little bit different. I want to start with the end for the
committee members. We are going to add one thing that we have not typically
done before to this meeting toward the end of the meeting. The last item I am
going to ask each of you to reflect on the meeting and stake out any territory
you want to, file any complaints, make any suggestions, surface any issues, say
no comment, whatever you want to do you can do. We will do a little wrap up. I
just want to give you heads up that I am hoping to hear from every single one
of you at the end of the meeting. We have the meeting designed to try to get
most of our work done expeditiously. It is not an overly intense agenda. We
have an important action item.

With that brief overview of the agenda, could we start with Marjorie and go
around the table? Everyone introduce yourselves, and remember to declare any
conflicts of interest.

MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National
Center for Health Statistics, CDC and executive secretary to the committee.
Welcome to NCHS on this rainy morning. It is good to see all of you.

MR. SOONTHORNSIMA: Good morning. Ob Soonthornsima, member of the full
committee and co-chair of Subcommittee on Standards with Blue Cross Blue Shield
Louisiana. No conflicts.

DR. FRANCIS: I am Leslie Francis. I am in law and philosophy at the
University of Utah. I am a member of the full committee and co-chair of Privacy
Confidentiality and Security and I do not have any conflicts.

MS. KLOSS: Linda Kloss, member of the full committee, co-chair of the
Privacy, Security, and Confidentiality Subcommittee, a health information
management consultant and no conflicts.

DR. SCANLON: Bill Scanlon, member of the committee, National Health Policy
Forum, no conflicts.

MS. BENNING: Denise Benning, acting deputy director, Office of E-Health
Standards and Services, CMS.

DR. CORNELIUS: Lee Cornelius. Llewellyn Cornelius for the record, University
of Maryland, School of Social Work, new member to the full committee and new
member to the Population Health Subcommittee.

DR. CHANDERRAJ: Raj Chanderraj, practicing physician, member of the full
committee, no conflicts.

DR. MAYS: Vickie Mays, University of California Los Angeles, member of the
full committee, member of the populations committee and privacy, security, and
confidentiality and no conflicts.

DR. COHEN: Bruce Cohen, Massachusetts Department of Public Health, member of
the full committee, co-chair of the Populations Committee and member of the
Quality Subcommittee, no conflicts.

MS. MILAM: Sallie Milam, West Virginia Health Care Authority, member of the
full committee, no conflicts, co-chair of Populations, member of Privacy,
Security, and Confidentiality.

DR. CARR: Justine Carr, Steward Health Care, chair of the Working Group on
Data Access and Use.

MR. SCANLON: Good morning, everyone. Jim Scanlon, Deputy Assistant Secretary
for planning and evaluation at HHS and executive staff director of the full
committee.

DR. GREEN: Larry Green, University of Colorado. Not a member of any
subcommittees anymore. Chair of the committee and no conflicts. I really want
to welcome our new member list. Let’s go to the phone. Who do we have on the
phone?

DR. WARREN: This is Judy Warren, member of the full committee and this is my
last meeting. Sorry I could not be there with everybody. No conflicts.

DR. GREEN: Judy, where are you?

DR. WARREN: I am in Kansas City, Kansas.

DR. GREEN: Welcome.

DR. PAZINSKI: This is Seth Pazinski with the Office of the National
Coordinator sitting in for Judy Murphy.

MS. MARCHESINI: This is Kathryn Marchesini, Office of the National
Coordinator, as well. I am here for Joy Pritts.

DR. GREEN: Thank you. Anyone else?

MS. MCANDREW: This is Sue McAndrew from the Office for Civil Rights.

DR. GREEN: Anyone else? Welcome to all of you on the phone. Marjorie.

MS. GREENBERG: This might be an opportunity to explain what is happening
with this transition. Jim can correct me if I get anything wrong. There are
several Judy’s. I just wanted to make clear who is on first with the membership
and then we certainly will introduce the audience. I did not mean to neglect
our audience who includes many staff and long-time colleagues.

It is a little confusing right now because we are in an in-between period
and Judy Warren, I apologize, I knew you were not going to be here in person. I
did not contact you about this so I am sorry to be telling you this on the
phone. I know that you are in and out over the next two days, in any event,
because you have other commitments.

We have had four new members appointed, as you know. I think Jim can give
you their names. Only one of them is here right now, Lee. I must say, Lee. I
think you actually — this was a first. The first time that a new member has
ever introduced himself or herself for the first time and designated his or her
subcommittee. That is a standard that we want to set. There has been a little
bit recruiting going on obviously. Actually, Lee — I can call you, Lee, right?
Lee is being local and having previously been the chair of the NCHS Board of
Scientific Counselors has even attended some meetings of the Population Health.
He had a head start.

Because the four new members have accepted their appointments, they have
signed the piece of paper and said they accept, they officially now have
replaced the members who were going off the committee. Two of them as you know,
Mark Hornbrook and Blackford Middleton, already had stepped down. The other two
are Justine, who is here in her capacity as chair of the Working Group, and
you, Judy.

Now, it puts us in a funny situation because only Lee who was already on the
board has completed his paperwork. There was not time for anybody else to, but
his was current already. The other three are not voting members. I do not want
to contradict you, chair, at your first full meeting to say that we are not at
full speed, but our full attendance or even membership, but in a way we aren’t
because those three new members who have not yet had a chance to do their
paperwork. It is not their fault. They are just receiving it. They could not
vote. And yet they have already replaced the people whom they were supposed to
replace. They could not replace them of course, they have attempted to fill
those positions of those who are vacating. That is the situation.

The voting members are at this point — I do not think I heard any voting
members on the phone, but we are forever in your debt, Judy, and you know you
will be hearing from us from time to time. But the voting members, I believe,
are those around the table right now, though I am expecting we will have a few
more. Let me see. (counts) Ten right now. So we do have a quorum. But I expect
we will have a few more members as well. That is the situation with who is a
voting member. But don’t hang up, Judy. We still welcome your input.

This all just came to my attention I would have to say, last Thursday I
think when even after 30 years with this committee, I did not realize that even
when new members had not completed their paperwork and so were not eligible to
vote, they still replaced the people whose terms they were filling.

DR. GREEN: Thank you, Judy. Let’s introduce our —

MR. LAZARUS: Steve Lazarus, Boundary Information Group representing CAQH
CORE.

MR. ALFANO: Bill Alfano, Blue Cross and Blue Shield Association.

MS. JACKSON: Welcome. Debbie Jackson, National Center for Health Statistics
committee staff, CDC.

MR. RODE: Dan Rode with AHIMA.

MS. JOHN-PAUL: Tamara John-Paul, CDC, NCHS.

MS. KHAN: Hetty Khan, CDC, NCHS, staff to the Subcommittee on Privacy.

MS. JONES: Katherine Jones, CDC, National Center for Health Statistics and
staff to the committee.

MS. TUREK: Kelly Turek, America’s Health Insurance Plans.

MS. KANAAN: Susan Kanaan, writer for the committee.

MS. QUEEN: Susan Queen, ASPE, staff to the committee.

MS. COOPER: Nicole Cooper, staff to the committee.

MS. SQUIRES: Mary Squires, staff to the committee.

DR. GREEN: Okay, Jim. Let’s do our updates.

Agenda Item: Updates from the Department

MR. SCANLON: Thank you. Obviously, a number of things have happened. First
of all, let me start with number one thanking our retiring members for their
wonderful service and the Secretary will have letters of appreciation and
certificates. Basically, Judy Warren, as Larry said, Mark Hornbrook and
Blackford Middleton. We have asked Justine to stay on as the chair of the
Working Group on Data Access. That will be her role as well.

Let me mention that we now have four new members all of whom have received
invitations from the Secretary, all of whom have accepted, but some of them are
still working other financial statements and other things as well.

Again, I should not fail to mention that the Secretary has reappointed
Sallie and Walter for another four-year term. In a moment of weakness, they
both agreed and we took advantage. The Secretary also asked Larry if he would
be the chair of the Committee and Larry graciously accepted.

Let me mention the four new members now. Lee is already here. Lee is local.
He is at the University of Maryland in health services research, a demographer.
He has worked at AHRQ. As he said, he chaired the NCHS Board of Scientific
Counselors. Lee will be a real asset to the committee in statistics. He knows a
lot of our issues and programs.

Lynn Blewett. I think many of you know Lynn. Dr. Lynn Blewett is from the
University of Minnesota. She is a professor there, but she also is the director
the State Health Access Data Center, SHADAC, which does a lot of work with the
states and with the federal government on state policy information, health
insurance estimates, health reform and so on at the state level. We are very
happy to have Lynn join the group as well. She can help us in that area.

We have Alexandra Goss who is an expert and very well positioned in the area
of standards. She was actually chair of X12 for a while. She is now at the
Governor’s Pennsylvania Office, where she works on the administration’s
E-Health collaborates and she is also working on health reform, health
information exchange, and insurance exchange in Pennsylvania. It will be good
to have here as well.

And then the fourth is Dr. Bill Stead. I think many of you know Bill. A very
eminent informatics professor, clinical informatics. Really one of the pioneers
in informatics. He, again, was invited and the secretary asked him to serve and
he has accepted as well, but he could not be here today. At least nominally,
with those four plus the current members we will have the full complement of 18
when everyone is cleared for their financial statements as well.

MS. GREENBERG: That is a good segue for me, here. We have someone with an
iPhone. As is our tradition, we would like to recognize our retiring chair. We
knew she would miss her gavel. This is presented to Justine M. Carr, MD for
outstanding service and guidance to the National Committee on Vital and Health
Statistics in advancing national health information policies, providing crucial
insights about standards and quality measurement and facilitating cohesion and
effective operations throughout the committee.

(Applause)

MR. SCANLON: I should do this now. The Secretary has written a nice letter
of appreciation to Justine. I will read it here and a nice certificate of
appreciation, which we wanted to have mounted on a mahogany plaque. Let me read
the citation. Dear Dr. Carr, it gives me great pleasure to award you this
certificate of appreciation for your seven years of services to the Department
of Health and Human Services as a member of the National Committee on Vital and
Health Statistics.

This committee is one of the oldest and most prestigious advisory groups
serving the department. Its recommendations have helped shape health
statistics, health data standards, health information policy, and public health
for the nation. Your knowledge, expertise, and experience have contributed
greatly to the excellent work of this committee.

We wish to commend you particularly for the time, effort, leadership, and
counsel you provided as chairman, co-chairman, member of the full committee,
co-chair and member of the Subcommittee on Quality, member of the Subcommittee
on Population Health, member of the Executive Committee, and member of the
Subcommittee on Standards. Just about every subcommittee. She says only the
very best are asked to serve and we are proud to have had the opportunity to
associate with you in this endeavor.

Should the occasion arise, we would like to feel free to call upon you for
further assistance, which we have already done. Congratulations Justine.

(Applause)

PARTICIPANT: Dr. Carr, do you have anything you want to say?

DR. CARR: It always has been and continues to be an honor and a privilege. I
have learned so much from the committee and from my colleagues that I treasure
the time I spend here almost all of it. Thank you all for your wisdom.

DR. GREEN: You may recall at our last meeting Justine made a list of
suggestions. I have those. I got them typed up and I have defaced the
University of Colorado property. I just nailed them right up over the top of my
computer in my office. I call them Carr’s plan for NCVHS. Thank you very much,
Justine.

Jim, let me interrupt just for a second. We have had other members come in.
Would you mind introducing yourself and declaring any conflicts?

DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee,
no conflicts.

DR. SUAREZ: Walter Suarez, Kaiser Permanente, member of the committee and no
conflicts.

DR. GREEN: Thank you.

MR. SCANLON: Let me continue. I remember about eight years ago we were
looking for members. Karen Trudell and Denise and the folks at CMS said we know
a good person who knows a lot about coding and data and her name is Dr. Justine
Carr. You cover a lot of other things besides those.

Let me update everyone then. Obviously, with the election results the
expectation at HHS is general continuity in our policies and program
initiatives. Obviously, there may be some tweaks. With the vagaries of policy
and politics, anything can happen, but basically, the initiatives we have
started including the Affordable Care Act and so on should see considerable
continuity. That means much of the policy and programmatic initiatives that we
talked about previously and I will mention them briefly should continue in some
fashion and probably some additional areas will be included as well.

And, again, these include HHS strategic plan, which we have talked about
before. We have strategic plans that are being implemented in tobacco control,
HIV, health care associated infections, addressing health disparities, which is
a major initiative at HHS. We have the National Quality Strategy and the
National Prevention Strategy as well, which we are implementing. An initiative
in global health, an initiative in early childhood health and development on
the human services side. We have an Alzheimer’s plan and a number of
disability-related initiatives as well.

And, again, as I said previously, whenever we start an initiative in HHS, we
try to assure that the team or the work group or the agency has data experts on
the team so that we actually can structure these initiatives in a way where we
can see where we are heading and what progress we are making as well as an
evaluation specialist.

Now turning quickly to health reform, the data side, you will remember that
we in compliance with the act we — secretary adopted several data collection
standards that were required by ACA. The data standards for sex, race,
ethnicity, language, and disability. We adopted those, I think, probably eight
months ago. They are now being implemented in all of our major surveys. We
should be at the point soon where we have a common core of commonly defined
social and demographic information.

When we completed that, the secretary asked — first we were asked to look
at SES. Was there potential for standardization in SES? We asked the committee
to give us a state of the art there and the committee gave us a very nice set
of really analysis of what the landscape looked like. We will be looking at
where we would like to go there. But it actually looks like OMB has caught the
fever as well. And now OMB is looking at with the working group what other
standards in terms of income and other areas we might want to standardize
across. Again, we will be looking at those.

But the other thing we started was to look at what data collection standards
we might want to consider for administrative data in HHS. This would be a core
set of data where we could we would try to include in all of our administrative
data systems. And, again, the idea here is to try to ask the questions in the
same way, agree on a minimum core. You can ask as much more as you would like,
but we would like to have these. And then we can relate the population data and
the administrative data, and the program data to each other and to national
data particularly when we start looking at state and sub-state data.

And then I mentioned previously that we were asked to look at particularly
in the context of health reform. Could we develop questions and measures on
vulnerable populations? Those included the disabled population, rural
populations and the LGBT population. We are completing with NCHS a field test
to look at how sexual orientation questions could be added to the Health
Interview Survey. It is our expectation if the tests work out that we would
include questions on sexual orientation in the January Health Interview Survey.
We continue to look at how we could actually measure transgender status, which
is much more complicated, but we are looking at that as well.

I mentioned previously and we will be going through another cycle now to
track changes in health system reform. We developed a web page at HHS called
Health System Measurement Project. We have here five to ten consensus measures
in each of ten areas. I will describe a few. But these were the areas that the
domains and essence that people thought we should look to see if the objectives
of health reform are progressing. For example, we have five to ten measures in
access to care. We would be happy to discuss and brief the committee because we
are going to go through another cycle of both the data updates and are there
other domains that we should be measuring and I think we would like the
committee’s advice. Insurance coverage, obviously. Is insurance coverage
improving, getting worse, and the sources of insurance coverage? Quality of
care, obviously. Vulnerable populations. Primarily race ethnicity and disabled.
Workforce, which is a big issue in terms of health systems change.

There was also interest in innovation. Can we think of measures of
innovation to see whether the delivery and the financing and some of the other
initiatives as part of health reform would have a positive or deleterious
effect on innovation? We have some measures there that involve FDA approvals
and so on. Population health, obviously. Prevention including preventive
measures and health information technology dealing largely with adoption.

Again, we will probably in a few months be updating most of the measures
with data and we will be thinking about should there be other domains and I
will try to get the committee’s advice there as well.

We have developed a guide to HHS surveys and major data systems. It is on
the ASPE and the data council website. We will be expanding that to include
almost all of our major data collections.

I mentioned our data strategy. This was the leadership of HHS asked our data
council to look at — to basically take a look at our portfolio of all of our
major data systems from several perspectives. One was to see are there — what
are the major data gaps that we were missing and I will mention those in a
minute. Secondly, to look at are we benefitting from the latest in technology,
for example, web-based data collection and other more technology advanced data
collection system. To what extent are we utilizing those. And third, we have
talked many times here in the committee. To what extent can we assure an
alignment framework and strategy so that the administrative data, the
electronic health record data, the surveys, the research, and public health
data can all align towards some common goals and supporting public health and
other factors?

As a result, we actually have a couple pilot projects underway at HHS to use
web panels, for example, the Health Interview Survey. It is not testing the
feasibility of a web panel under the Health Interview Survey. We are in our
second phase of that effort. The MEPS survey we will be looking at both the web
panel as well as — this will be a subpart of the MEPS sample. A quick
turnaround telephone survey where we could have it set up and then query the
group for fairly quick turnaround responses to how things are going.

We are looking at some more non-traditional data sources. Some of these are
commercial. Some of these are social media and so on just to see what the
capability is. We are looking at a couple of projects, which I will mention
here where we are trying to look at are there newer ways or better ways or has
the technology advanced in providing special population estimates. These are
harder to reach populations as well as small area estimates. I will mention
more on that in a minute.

In the area of alignment, what we have decided to do was move to the stage
of pilot studies. I will mention several studies. But basically, we are trying
to take the concept of alignment and actually trying to do it on a proof of
concept or a pilot basis. I will mention a couple of those studies as well.

You are all aware of the CMS initiative on data and information. It moves
along and progresses and gets larger almost month by month, and of course the
health data initiative. Really, this is the data liberation initiative, which
you are all advising us on as well. We are really trying to find ways where we
can get our data out to not just healthdata.gov, which is the main portal where
everyone goes, but really to get it out more generally. We are really learning
in the access-working group on some other ways to make the data available —
more or less of the statistical software that some of the others do. We will
talk about that as well.

Let me mention several new projects that we started. I think we probably
would like to get the committee involved in some of these. Later this week we
have a meeting on micro-simulation modeling for health policy. Here we are just
trying to get the benefit of the past and current experience to see if there
are principles and guidance basically for the consumers of — not so much for
the methodologists, but for the consumers of health and simulation models. When
do you need one? What are the other ways of estimating effects? What should you
watch out for? What should you look for? How should you interpret the models?
What should you look for and so on? We have the meeting Friday and then we will
see. We think the group will give us some ideas about it and then we will take
them back to what we might do research on.

Later on we have — we cannot have workshops anymore so we will have a
meeting. Thank you GSA. We cannot have workshops, conferences anymore. We will
have a study on small area data. Clearly, we will ask the committee members to
be a part of this. We are really looking at what does the state of the art look
like in making states and sub-states, metropolitan area estimates of health
policy and public health data. What is the state of the art now? What are the
opportunities? We know some of the methods. We have used some of the methods
obviously, but are there additional ways we should be thinking of for a
research program at HHS.

We are also looking at what kinds of data are needed to operate the state
health insurance exchanges. We have a study we are just completing with SHADAC
and with Robert Wood Johnson. They looked at about ten states to see what were
the considerations. What functionality do these exchanges have to have? What is
the data that would be needed to support them? It is really at the very
practical level of what do you need to do to make this determination or that
determination. We have a draft report, which I very much like to present to the
committee for some reaction.

We are also looking at how can public health benefit more from advancements
in health IT. In many ways, public health has always been on the outside
looking in. We thought that HIPAA Administrative Simplification and the claims
and so on would help and it does. The focus of a lot of EHR work now is on the
clinical setting obviously. It has to start there. There are certainly
meaningful use requirements that get public health into the picture in terms of
reporting and registries and so on. Again, we have a group looking at are there
additional ways that EHRs and health IT could benefit public health decide.

We have another project. This is kind of an interesting one. What is the
feasibility of conducting research on small and hard to reach populations
through EHRs? When the number of the group is fairly small, when the population
is spread, when the population is small and a sample survey is just not going
to be the way to approach a group, there are other ways to do this through
targeted studies. But the idea here is are there ways from what will ultimately
be. We hope a network of EHRs that can combine for secondary uses. Are there
ways of pulling that together for research on small populations? We have a
feasibility study we are planning based on an existing network to see if we can
pull this together.

With NCHS, we are looking at secondary uses of EHR data. This would be to
what extent can EHRs feed the information to our provider and our health care
surveys. Instead of the National Ambulatory Medical Care Survey, the Emergency
Department Survey, and so on, we will be looking at working with NCHS. To what
extent can we use? This is a very practical kind of study. This is looking at,
for example, specific brands of EHRs being able to provide the data that we
need for the surveys. We have the standard report of what the survey needs. It
could be a summary of an encounter. It could be information about the practice
or so on. And then it is looking back into the EHRs for the ability to pull
them. And, again, for a survey, a research project you do not necessarily need
a large probability sample. But for a survey, you actually do. Otherwise, you
sort of defeat the main assumption of statistical inference.

Two more things. We are working with NCHS on a web-based part of the
National Health Interview Survey. It gets very interesting. The NHIS already
has information on what the household has in terms of internet access, computer
access, other devices or so on. How would they be able to participate? We are
trying to see how representative that is and how would you supplement that. We
probably will be testing. We have already set up a short questionnaire that we
would be testing in that as well.

Finally, as I mentioned working with the MEPS, we will be testing a quick
response telephone survey. We are always, as you know same things happen in
your work. Everyone wants the information faster, better, and cheaper. We used
to be able to say we can do two of those, but not all three. Now we have to do
all three. Besides, we should be looking at quicker response measures anyway.
As the health system changes, public health and population changes, I think we
wanted to have methods of being able to get a quicker look at least on an
estimate basis for some of these measures. Let me stop there and see if there
are any questions.

DR. GREEN: Actually what I would like to do, mindful of the time if you do
not mind, jot down the question you want to ask. We are going to do such a good
job on the action letter that we are going to have time left in the morning.
Will you still be here, James? We will come back. I am mindful of the time. We
are fortunate to have Denise and others here. Let’s hear these other reports
before we do this. Denise, thank you for coming.

Agenda Item: CMS

MS. BUENNING: Good morning, everybody. I kind of feel like I am at the kids’
table over here. Welcome to our existing members, and to our new members as
well. It is great to have you here on this rainy morning. I just very quickly
wanted to update everybody on a couple of initiatives. As Jim has explained,
the department has the big picture in mind and is working on a number of
different areas. And of course, CMS is supporting that with some more specific
work on a wide variety of areas. And one of them of course is the EHR incentive
program.

As of the end of September, CMS is reporting that over 307,000 providers had
active registrations in both Medicare and the Medicaid EHR incentive programs.
Forty-eight states and Puerto Rico also are still maintaining open registration
for the Medicaid part of that program. The agency has paid out over $7.7
billion in payments. We obviously are looking to grow that as we go on as we
work through the program and answer everybody’s questions and provide more
outreach in education on how to participate in the incentive program.

With regards to privacy, as Jim had mentioned, the vast amount and array of
data that CMS has just from the Medicare program alone is causing us to, again,
take a more focused look at who is using the data, who has access to it, for
what purposes, et cetera. As, I think, we are all pretty much aware, there are
safeguards in place such as data use agreements and tracking.

But there is something new that we are working on right now and quite
frankly, it is one of our focuses. That is the privacy efforts in the area of
preparing to bring the exchanges on board in 2014. This means having to have
agreements in place to ensure the secure exchange of information between and
among Medicare programs, state and Medicare programs, other insurers and other
federal agencies such as the Veterans Health Administration and DoD TRICARE.

Each of these agreements will have some common elements among them. But of
course, as each entity may have specific security and/or other requirements,
our challenge is going to be executing these agreements in having them in place
well in advance of the 2014 date. That is what we are actively working on at
this moment.

With regard to Administrative Simplification, as I think you are all aware,
at the beginning of September the secretary issued both ICD-10 and HPID and NPI
regulations, final regs. Basically, as I think everybody knows, ICD-10 has been
delayed until October of 2014. That is to give us time to do full end-to-end
testing. I will get to that in a second.

But with regard to the health plan identifier, we do have an enumeration
system up. It is in test phase right now. Basically, what that means is that a
health plan can go onto that system and go through the steps to obtain a health
plan identifier. They will not be able to get it now for another couple of
months. And the reason is that we are learning from our NPI experience.

We want to make sure that the health plans feel fully comfortable with how
they are enumerating, answering their enumerating questions, and making sure
that when they actually do get an HPID that they do not have to backtrack and
make changes or alterations at the get go. We have had a number of national
calls to walk the health plans through it. We have had thousands and thousands
of participants. We feel very good about the level of interest in the HPID and
in the plans getting a more robust understanding of the enumeration options
available to them and how they are going to enumerate. Lots of training and
education taking place on that end.

With regard to ICD-10, of course we do have the delay. We are focusing more,
not so much on awareness, as you know, when we had the 2013 date, we were
focused very much on getting everybody to be aware of that data. I think that
the time for awareness is probably over. I think everybody is pretty much on
board with the 2014 date.

What we are doing now is we are focusing on tools, practical tools that we
can help especially small providers and small community hospitals to become
compliant with ICD-10 in 2014. We are approaching this from two different
points, one of which is a pilot that will develop a protocol, a testing
platform for end-to-end testing. We have a contractor on board who is going to
be reaching out to provider groups, the industry to get input and feedback. We
know that there are lots of end-to-end testing work groups that the industry is
undertaking.

We are hoping to gather a lot of that intelligence and come up with a
platform that we can then push out to the industry. We are hoping to have our
internal CMS systems and business practices ready to go in October of 2013 and
then spend the remainder of that year until 2014, again, conducting end-to-end
testing. We are hoping that the industry will follow suit on that.

The other pilot that we have going is one that is going to develop a
protocol for the pre-testing of standards to be adopted under HIPAA. One of the
things that we heard loud and clear from our version 5010 industry
implementation was that the standards have to be ready out of the gate. We
cannot get into testing or production and then find that there are issues or
problems that we have to resolve. It is very costly. And of course, it just
ends up being a delay issue.

We are using a version 6020 platform for this. I know that this is a
standard that X12 is not taking forward at least as indicated. They are not
taking forward to the NCVHS for consideration for adoption. But it is the
latest version of the X12 standards that we have available to us. We are going
to be using the 6020 and develop a protocol so that any standard going forward
will be pretested according to this protocol to make sure that it works before
we bring it up for adoption. That is something that we are undertaking as well.

Certification. I know that this is the next Affordable Care Act piece of
work that we have to take forward. We are working on a proposed rule. It is in
draft form right now. It is going through review processes. Again, with the
emphasis on trying to make attestation for the health plans as easy and simple
as possible. We are seriously looking at using an existing system. Perhaps the
health plan enumeration system, so that they can go in through that same system
and a test. We do not want to recreate the wheel or have them go to another
system if at all possible. We are trying to find synergies with existing
processes, again, to make that easy as possible.

On September 12, just again to remind everybody, Secretary Sebelius named
CAQH CORE as the authoring entity for the remaining operating rules for all the
transactions. Again, a reminder that operating rules for eligibility and claims
status kick in in January. I know CAQH CORE has been doing a lot of outreach
and education to the industry on those operating rules and are looking at
forming work groups and getting the work for the remaining operating rules
underway very quickly.

And finally, since we have a lot of covered entities out there that could
potentially be impacted by hurricane or super storm Sandy or whatever it is, we
are going to be exercising some enforcement discretion with regard to any
complaints that we receive about HIPAA covered entities not being able to
conduct HIPAA transactions correctly or having transmission problems. We will
address those on a case-by-case basis. So far, we have not received any
complaints. If we do receive complaints for entities that are located in any of
the states that have either declared federal disaster areas or had the governor
make a declaration of a disaster area then we will work with those entities to
provide them with some relief so that they are not penalized for not conducting
the HIPAA transaction correctly. We are working again with the department. We
are helping to coordinate with them because I know that the department has a
number of different initiatives on board with regard to various reliefs for
storm victims.

That is pretty much all I have right now. Thank you.

DR. GREEN: What have you been doing lately? Questions for Denise?

DR. CHANDERRAJ: You said ICD-10 -– most people are onboard with ICD-10.
But I hear a lot of talk in the community that this is not going to be. Some of
the major physician organizations are opposed to implementing that. Nobody is
taking this seriously in the physician community and nobody is gearing up to
get this going.

MS. BUENNING: I think my intention was not to say that everybody is onboard
with ICD-10, but I think that everybody was aware of the date. There are
certainly lots of industry segments that are still doubtful or have questions
about the viability of ICD-10 and whether this is going to go forward or not.
We are working really closely with a lot of the provider groups. Of course, the
American Medical Association even though they had come out in favor of ICD-11
is willing to meet with us to find out what we are doing for the small
providers. Our staff is actually meeting individually with providers across the
country, small providers to find out how they are approaching it and to share
those best practices and the small steps. A lot of the information out there of
course applies to very large provider groups. In most cases that does not apply
to the two or three physician practice out in Beloit, Kansas. We are really
looking to see what can we do practically to help to get these physicians
onboard with ICD-10. You will be seeing a lot more outreach and education with
that particular tact coming forward within the next couple of months.

MR. SOONTHORNSIMA: Good morning, Denise. Two questions. You mentioned
earlier about the health insurance exchange in terms of data agreement. Is that
correct? What are the expectations of the qualified health plans to do any sort
of data agreement?

MS. BUENNING: I am sorry. I heard after health —

MR. SOONTHORNSIMA: Qualified health plans that are going to have their
insurance products on the exchanges. Are they supposed to go through the
certification or the data agreement process?

MS. BUENNING: They are working on that right now to see what process is
going to be established for that. I can get back to you if there are any
updates.

MR. SOONTHORNSIMA: You mentioned January 14. I think we are supposed to have
everything ready by October 2013 to begin. Just making sure that we have the
date.

MS. BUENNING: That is correct.

MR. SOONTHORNSIMA: And a follow-up question. Could you tell us a little bit
more about this end-to-end testing pilot and how can the industry get a little
bit more involved —

MS. BUENNING: Our contractor is actually going to be reaching out to
industry and asking for participants. I know that in some instances, we are
looking for individual physicians to participate and we will be asking for
other entities as well to participate in this pilot. I think that right now the
contractor is gathering all of the Intel so to speak to see who is out there,
who is well along, who might be a potential candidate. I think we are limited
in the number of slots that we can make available in terms of the pilot. In
fact, we just had a meeting last week with the contractor and they have quite
an extensive list of different types of industry segments to contact. If anyone
has a particular interest in participating in a pilot, if they would get names
and contact information to me, I would be happy to pass it along to the
contractor. It may very well be that those entities are already on the list,
but we just want to make sure that everybody has an opportunity.

DR. COHEN: Denise, I am still very concerned about state Medicaid agencies.
Are you developing specific plans to target them?

DR. GREEN: Let’s do Bruce and then Walter. Seth, if you are on the phone, we
will come to you for your report.

DR. COHEN: Denise, I am still very concerned about state Medicaid agencies.
Are you developing specific plans to target them and if so, what are they?

MS. BUENNING: In what particular areas, Bruce?

DR. COHEN: ICD-10.

MS. BUENNING: Of course. Our CMCS group has been very much working very
closely with the state and Medicaid agencies. Some of the challenges for a
number of the agencies are that they are in the process of MMIS conversions.
They are asking for some relief and saying we are not going to be converting
until X date. We do not want to go and spend a lot of the money to make a
conversion to our existing system given that we are already making this massive
conversion here. We are trying to find some middle ground here with them. We
certainly sympathize that we do not want to spend money if they do not have to.
But on the other hand, we do have a law on the books. It says that you are
required to use the ICD-10 codes as of October 2014. We are looking at, again,
what I refer to as operational compliance. What is a base level of compliance
that we can reach to get the transactions through. Maybe we relax some of the
other outlying types of things if we can. We are still exploring that with our
ICD-10 steering committees to see what is feasible and what is not.

We are certainly amenable to trying to make this transition as easy as we
can because we have seen in the past. If we draw the line in the sand and the
industry is not ready, it is not going to work. All it does is create delays,
enforcement discretion policies, that sort of thing. We have another year. We
have an extra year.

What we really found out from version 5010 was the problem was really
testing. People did not test or they did not test adequately enough. We are
hoping that by trying to push everybody to get some level of readiness early on
that we can do this end-to-end testing and have it work and prep it for October
2014 transition. That is what we are actively working towards.

DR. COHEN: I would suggest including Medicaid agencies in end-to-end
testing.

MS. BUENNING: Absolutely. Medicaid agencies will be included as they can as
they are willing to participate.

DR. SUAREZ: Continuing on the ICD-10, I raised in the last meeting an
important concern or not concern actually. I see it as an opportunity. The
meaningful use requirements for Meaningful Use Stage 2 and the standards
adopted on the meaningful use adopted ICD-10 as an alternate standard for
codifying diseases, conditions, and procedures. The other standards adopted was
SNOMED.

But in practicality, the application of the standard is on generating
messages, a summary of record messages to send another provider for referral
purposes or generating a summary of patient history or a summary of record for
the patient. And in both instances, the most common and pretty much the most
practical vocabulary standard used is not SNOMED. It is actually ICD-10 in this
case it would be. In reality and in practicality, the expectation is that
because of Meaningful Use Stage 2 the EHR systems are number one going to have
to be ready for ICD-10 by October of next year to begin Meaningful Use Stage 2
and to begin using it in generating those messages.

You probably have some reactions and comments to that. The point I wanted to
make is there is a need to create a very strong message out there and clarify
this like I said opportunity to really begin to adopt and use ICD-10 within the
EHRs because that is going to be a requirement. There is a lot what I fear
confusion out there in the industry about what is this effect. Some people do
not even know about. In fact, some people probably among us do not realize that
there is this text in the Meaningful Use Stage 2 that requires the ICD-10 to be
adopted as an alternative standard mind you, but in reality and in practicality
the standard is going to be incorporated and used in the messages that are
going to be exchanged from one provider to another or from the provider to the
patient to create a summary for the patient to have and read.

Any comments. And, again, my hope is that there can be some strong messages
out there to clarify this opportunity.

DR. TANG: Can I piggyback on that? It is related. This is something that
NCVHS had made a comment on. Stage 1 was ICD-9 or SNOMED. Stage 2 is actually
SNOMED for diagnosis. In fact, this committee tried to seize on that
opportunity of if we are going to delay, could we move towards the clinical
terminology SNOMED. And, yes, for classification system use ICD-10 for the
classification for the epidemiologic research, et cetera. I think this was
still a moment. I am trying to piggyback to get CMS’ reaction to that whether
there is an opportunity to move towards clinical terminology for diagnoses and
still have the back end using, for example, the NLM supplied tools to map to
ICD-10. I would be interested in CMS’ position.

DR. BUENNING: I think that the incorporation of the ICD-10 alternative into
Meaningful Use Stage 2 started to send a signal to the vendor community that
whatever products they have out there are going to have to be compliant with
all the standards that are out there by the time 2014 hits.

This is something that when we first started ICD-10 we had a vendor
conference in Washington a number of years ago and all major vendors, small
vendors got into the room and of course assured us that they were going to be
able to meet all these deadlines. We know how that goes. We do not have any
direct influence or authority over the vendor community. People often say do
you have a list of approved vendors or whom do you recommend. Of course, we do
not do that. We have a different type of approach to it. For example, the
Office of the National Coordinator in doing their certification, they have some
more direct influence over what vendors should or should not put in.

With regard to ICD-10, that was I think a first step to signal to the
industry, to the vendor groups to say you better make sure that you have this
incorporated. I think that this represents a little bit of a different perhaps
strategic bent on the part of at least CMS and our group and the realization
that we have been talking about ICD-10 for so long as a stovepipe initiative. I
think that with the emergence of electronic health records and data and quality
measures I think that we are seeing — again, I think this group had asked for
a roadmap of how all these initiatives influence and converge. We are working
on that. I know that we were going to have a listening session scheduled this
past fall. Just because of everybody’s schedule and events that were
conflicting, we could not get it together. We are hoping to have that perhaps
at the beginning or at least the first quarter of next year.

But that is too, again, take a look at what is really driving this. It seems
to us that electronic health records are really becoming the driver because
everyone is focusing on that. Their use is becoming more prevalent and perhaps
our strategy quite frankly should not be as ICD-10 over here or the quality
measures over here, but converging it and focusing on electronic health record
in terms of getting providers and others to adopt ICD-10. That was the first
mini-step towards that. I think you will see as we go forward with these
initiative, we will start talking more about how they all converge and how they
should be working together because the end game is and I think we talked about
this at some previous meetings is the end game is having systems and having
business processes out there that are integrated, seamless, real time, robust
data, and secure. I think that if we look at that end game over here, we will
see that we are taking these little initiatives or milestones in the interim to
try to reach that point.

DR. GREEN: Maybe this is a good chance to hear from the ONC and see what is
going on there. Seth Pazinski, are you there?

Agenda Item: ONC

MR. PAZINSKI: Yes, I am here. Thanks for the opportunity to present on
behalf of ONC — the division director for planning and operations in ONC’s
Office of Policy and Planning. One of the things I am responsible for is the
Federal Health IT Strategic Plan, which this past week we reached the one-year
milestone of implementations. I will put some of my updates and contact of the
Federal Health IT Strategic Plan.

Five things I just wanted to talk about today. I wanted to talk about the
standards of certification criteria aligned to the stages 1 and 2 of meaningful
use and give an update on the stage 3 discussion of the HIT policy committee.

Also, I wanted to make folks aware of our FACA work group nomination
application website. Also, talk about the transition of the Nationwide Health
Information Network Exchange to eHealth Exchange, which is a public/private
initiative and give an update on the ONC eHealth consumer program.

As far as stage 1 meaningful use and the standards of certification criteria
— the update on all the progress as far as the payments and registration
associated with the EHR incentive program and just talk about the updates on
the certification side. Our Certified Health IT Product List or CHPL as we call
it, which is an authoritative and comprehensive listing of the complete EHR and
EHR modules that have been certified under ONC certification programs.

As of last week, there are over 1600 unique certified EHR products, which
include both ambulatory and new patient products. And 900 EHR vendors are
developing those products in the market place. The full listing is available on
healthit.gov.

The additional context for that is that meaningful use is a part of our
Federal Health IT Strategic Plan, which really is the centerpiece of the
federal government strategy on health IT. We made a tremendous amount of
progress over the past two years in implementing these programs.

For stage 2 meaningful use and the standards of certification criteria
associated with that, the temporary — certification program — with the
effective date of the 2014 addition EHR certification criteria. And ONC today
from 9 to 4:30 is holding a public workshop on the ONC HIT certification
program and that 2014 edition test method is a virtual workshop will cover the
2014 test procedures, test tools, test data, ONC timeline and the CHPL.

The test procedures — finalized and improved by the national coordinator
will be used for testing and certifying EHR technology under ONC’s HIT
certification program. Those test procedures are being developed in
collaboration with NHIT and will be used by testing laboratories of
certification bodies to evaluate the performance and functionality of complete
EHRs or EHR modules against the standards, implementation specs, and
certification criteria that the secretary adopted for 2014.

CMS also posted the clinical quality measures electronic specifications for
the 2014 standards and capabilities. In 2014, eligible professionals and
hospitals as well as — hospitals will report using these respective new 2014
criteria for stages 1 and 2 under the Medicare and Medicaid EHR incentive
programs.

For stage 3 meaningful use, at the November 7 meeting of the HIT policy
committee — walk through of a request for comment for stage 3. That request
for comment will be published this week for a public comment period ending in
early January. Stage 3 as framed by the policy committee talked about a
transition from setting specific focus to a collaborative patient family
centric approach.

For the FACA workgroup membership, the two federal advisory committee of
ONC, the HIT policy committee, the HIT standards committee, we have a variety
of workgroups that work and bring things to the committee that is up for
discussion. In an effort to continue to find new expertise, new individuals who
want to participate in that process, in early October ONC launched an
application website. Anyone interested in contributing his or her expertise for
health IT can submit their application to that site.

We plan to use that database as we establish new workgroups or as workgroups
experience turnover that is the first place we are going to go to look for
potential candidates for those workgroups. Anyone interested in applying for
those can register at healthit.gov.

Another announcement that ONC made in October was the transition of the
Nationwide Health Information Network to eHealth Exchange. eHealth Exchange is
a public/private partnership. It is composed of both federal agencies and
private partners that have implemented the Nationwide Health Information
Network standards and services as well as executed a Data Use and Reciprocal
Support Agreement or DURSA as we call it, which is a legal agreement that
securely exchange electronic health information.

The Exchange Coordinating Committee, which oversees eHealth Exchange,
designated Healtheway, which is a nonprofit organization to assume the
operational support of eHealth Exchange starting in October of 2012. And
Healtheway will support the eHealth Exchange in conformance and
interoperability testing on boarding new participants into the exchange, the
maintenance of the legal agreements as well as the operating policies,
procedures, and registry and digital certificates.

The Consumer eHealth Program, which was launched around the same time that
ONC published the Federal Health IT Strategic Plan. This is coming up recently
in November on its one-year anniversary. The ONC pledge program, which is a key
component of that, provides a forum for diverse organizations that can network,
learn, and support each other in driving towards enabling patients and
providers through health information technology. That program over the past
year has grown to more than 400 organizational members.

The members of this pledge program are in two different categories. One is
data holders, which are health care providers and ensure to pledge to make it
easier for patients to get electronic access to their health data as well as
non-data holders, which are software developers or — advocacy organizations
who pledge to educate the individuals that follow them about the value of
getting their health data and using it — empower patients.

ONC and the Department of Veterans Affairs invited designers to re-design
the patient health records, an initiative called the Health Design Challenge.
The purpose of this challenge is to improve the design of the personal health
record so it is more usable and meaningful for patients and their families. It
is an opportunity to take the plain text blue button files and then enrich it
with digitals and a better lay out so it is easier to use for patients and
their families.

One of the requirements is that it is done through open source and submitted
under their creative common license. This will allow the community user adapt
the design that come out of this challenge once the winners are announced. The
prize for first place associated with that is $15,000. In the upcoming dates
are that submissions are due at the end of this month on November 30 with the
winners being announced on December 12.

As mentioned a couple of times, the healthit.gov, which is a newer site for
ONC. Our previous site healthit.hhs.gov closed at the end of October and that
content has been migrated over to healthit.gov. The purpose of that site is
intended to be the primary source of health IT related information of the
federal government. It has information for both providers and consumers as well
as policymakers and ONC will be working to build up that content and bringing
in content to direct towards other federal IT programs in the coming months.

That is it as far as my updates. Thanks again for the opportunity to present
and I welcome any questions.

DR. GREEN: I think we have time for a couple of clarifying questions from
the committee. Seth, this is an amazing moment. The committee does not have any
of their cards up. I think the Office of Civil Rights has a report for us now.
I think Kathryn Marchesini is going to do that. Kathryn, are you on the phone?

Agenda Item: Office of the Chief Privacy
Officer

MS. MARCHESINI: Yes, I am. I am actually with the Office of the Chief
Privacy Officer within ONC — on privacy and security activities. I think Sue
McAndrew is on the phone for the Office of Civil Rights. I am happy to speak
more into the privacy and security activities going on with ONC if the group is
interested.

MS. MCANDREW: This is Sue McAndrew. I am on the phone.

MS. MARCHESINI: Thanks for giving me the opportunity to provide ONC’s
privacy and security policy update on some areas you may be interested in since
Joy Pritts provided the group an update in June. Some of the areas and
activities I will highlight are centered around the privacy and security
workgroups of the Health IT Policy Committee and the Health IT Standards
Committee, which are ONC’s FACAs meaningful use and Affordable Care Act and
ONC-funded privacy and security project.

You may be aware in July the HIT Policy Committee Privacy and Security team
and the HIT Standards Committee Privacy and Security workgroup held a hearing
focused on trusted identity of providers in cyberspace where they used a
National Strategy for Trusted Identities in Cyberspace as referred to as NSTIC
as a framework. Objectives of the hearing, which the group seemed to have
accomplished, included raising general awareness of NSTIC within the groups,
facilitating a comprehensive understanding of the real world implications of
issuing physician credentials that can be accepted by multiple relying parties.
They also illustrated the application of NSTIC in health care through selected
use case and had discussions around that. I will talk a little bit about the
group’s provider authentication recommendations that resulted from the outputs
later on when I touch on meaningful use.

But just so you are aware, later this month on November 29th the same
workgroups will host a virtual hearing on trusted identities of patients in
cyberspace from 12 to 4 p.m. Eastern time. There are currently three panels for
discussion and they will be looking at why identity proofing and authentication
of patients are important and what are the key issues. They are also looking at
what methods of identity proofing and authentications are in use now. And the
last panel will look at identity proofing and authentication solutions that are
on the horizons that potentially could be leveraged.

In addition to some of these FACA activities, I will touch briefly on the
area of meaningful use as an incentive for protesting health information. Seth
touched on the rule as a whole. As you are probably aware, earlier this fall
both ONC and CMS promulgated the stage 2 final rule. Just to briefly touch on
some of the privacy and security requirements included in the stage 2 of ONC’s
standards and certification criteria focused on end user encryption of the
device, the audit functionality of the EHR as well as providing the capability
to amend patient records.

In turning to the CMS EHR incentive rule for stage 2, there is a requirement
to conduct a review of security risk analysis in accordance with the
requirements under the HIPAA Security Rule. This includes addressing the
encryption, the security of data at rest in accordance with the HIPAA Security
Rule. It also requires participants to implement security updates as necessary
and correct identified security deficiencies as part of the provider’s risk
management process.

As you may be aware, stage 2 also provides for requirements around patient
engagement. In order to meet requirements and meaningful use stage 2, health
care providers must provide patients with the capability to electronically
view, download, and transmit relevant information from the provider’s
electronic health records and also for physicians and other clinicians
participating in the incentive program patient engagement for stage 2 also
include a requirement for bidirectional secure email with patients.

In looking ahead at stage 3, as Seth mentioned, last week the HIT Policy
Committee was discussed and finalized in a request for comment for stage 3,
which should be published in the Federal Register, as Seth mentioned, this
week. Just to highlight the Privacy and Security Tiger Team included questions
for comments. I will just briefly speak through those. The questions are
looking for feedback on the logical next steps to build on the security
requirement that is included in stage 1. For example, they are looking at
considering whether or not to require attestation for implementing the HIPAA
Security Rule provision regarding workforce outreach and training.

As I mentioned, there are some provider authentication recommendations that
came from the July hearing. Some of those are speaking to the recommendation
that ONC should move toward requiring multi-factor authentication for provider
users to remotely access protected health information so some of the questions.
Look at how can ONC test this recommendation and certification criteria as well
as should ONC permit the certification of an EHR as a standalone and/or an EHR
along with a third-party authentication service provider.

The ONC also touches on the questions around audit technology. For example,
is it appropriate to require attestation that audit logs are created and
maintained for a specific period of time? There are others that are in there.
If you are interested, it should be coming out soon.

Just so you are aware, in addition to the HIT Policy Committee questions ONC
chose to add some other questions for comments. Some of them include looking at
consent management, which I am sure this group is interested. This includes how
EHRs and HIEs manage information that requires patient consent to disclose at
populations receiving care covered by these laws are not excluded from Health
Information Exchange.

Some others that are focused on how MU can help improve the capacity of EHR
infrastructure to a record consent, manage consent, to communicate the
limitations on uses and restrictions, and lastly, looking at whether or not
there are existing standards such as those that were identified by the data
segmentation for privacy initiatives that are mature enough to help facilitate
the exchange of this type of consent information in today’s EHRs and HIEs.

Just to touch on to enable stage 2 of meaningful use and state-level payment
reforms, ONC through the Health IT Trailblazer State Collaborative, is working
with the National Academies for State Health Policy and CMS to support states
as they develop a state-level quality measurement reporting and feedback
infrastructure that combines data from multiple sources.

As part of this collaborative, ONC is providing technical assistance
including privacy and security expertise to help states ensure privacy and
security protections are in place. Currently, there are eight states involved.
They move forward with handling claims and clinical information with respect to
performance reporting.

I know I do not have much time left so I will briefly mention some of the
activities going on with ONC-funded privacy and security projects of the past
six months. In September in partnership with the VA, our Data Segmentation for
Privacy initiative performed a demonstration of the standards to allow
sensitive health information to be shared responsibly and to comply with
confidentiality laws and regulations among providers using electronic health
records.

Also in September, we released a Security Training Module. It is referred to
as CyberSecure: Your Medical Practice. It uses a game format that requires
users to respond to privacy and security challenges often faced in a typical
small medical practice.

Last month our CONSENT Project launched its month long live pilot at four
provider facilities in Western New York. This included two primary care and two
specialty care sites in urban, suburban, and rural areas.

And also in October in coordination with HHS Office for Civil Rights, we
kicked off our Notice of Privacy Practices project. We are looking at making
them more readable and usable for patients to compare notices and practices.

I guess lastly and focusing on some patient efforts, we recently fielded the
initial Privacy and Security Consumer Attitudes Survey. And we are currently
analyzing those results. As part of our health activities, we completed focus
group research into consumers’ attitudes and preferences regarding the use of
mobile technology to communicate with their providers. We are also currently
analyzing the results and compiling a report.

That is a snapshot of some of the privacy and security policy activities
going on with ONC. Pardon if I went over time and I welcome any questions.

DR. GREEN: Before we go to questions, is there anyone else on the phone who
would like to comment? I just cannot see any hands up. Folks here in the room?

DR. TANG: Probably this is for Jim. You talked about the alignment between
meaningful use and public health. I have to say that the policy committee is
very sympathetic and supportive of trying to get there. What happened is the
public health sector was left out of meaningful use in terms of additional
funding. The question I guess is are there ways that the public health
departments can get funding to do the work on their side to receive and
transmit information from and to EHRs. In stage 1, there was a testing
requirement with the functionality in EHRs. That turned out to be a hard thing
for people to do. And in stage 2, there is ongoing transmission. We tackled
immunizations, syndromic surveillance, and lab test results. Good stuff.

We were hoping in stage 3 to even get bidirectional transmission so we can
keep real time updates from public health to and from public health. Is there
anything that this committee can do in terms of providing recommendations or
what other ways can public health departments get funding to be able to
accommodate that?

DR. SCANLON: That is a good question, Paul. In the study we have underway,
that was I think, where does the public health community get funding to do all
this. It is a question. We have actually learned a lot of things. It is not
only money, but it is participating and it is working with the clinical public
health linkage. Then there were pure public health functions that will not
necessarily rely on that. But funding issues are very complicated.

What I can do I think is we are probably nearing the stage where we will get
some findings and recommendations from our public health. We actually pulled
together an expert panel of public health folks and EHR folks, talked to a lot
of people, interviewed a lot of people, and looked at programs. We are trying
to see where the opportunities exist. The funding is just very difficult
because CDC would be the — obviously they are not eligible for the incentive
payments. CDC was trying to get in the context of health reform some funding or
for health IT that would be available to states. But in this climate of the
fiscal situation, it might be difficult.

I think the meaningful use actually is a nice step. It has the public health
community already in there registered and folks thinking about it. They were
talking about broader things than that.

What I may do is if I could arrange a briefing for the full committee or one
of the subcommittees on what we have been finding in this study where we have
had the public health. This is the national, the state, the local,
community-level public health community and sort of where they are and where
they think there are gaps and where they would like to see things go.

We actually did another study on public health financing generally. Where
does public health get its funding? It is really a miniscule part of the
national health expenditure when you look at it and yet it is a fairly large
impact. You notice it when something happens, not when it is working. Your
successes are silent. What we are finding there too is all the complications of
state funding even when the money is available. We have actually got a series
of public health studies that are at least coming to fruition so maybe the best
thing.

I could probably share when we have that draft with the full committee or
better yet maybe have either with the population subcommittee or the full
committee.

DR. GREEN: I think there are a lot of heads nodding around the room. That
sounds like a good idea.

DR. TANG: I have one more if that is okay.

DR. GREEN: We will go Paul. Then we will go to Walter, then to Leslie, and
then to Bruce and that determines when you get to take a break. Is Sue McAndrew
on the phone wanting to give a report?

MS. MCANDREW: I am here.

DR. GREEN: We will do that next. My apologies. Go right ahead, Sue.

Agenda Item: Office of Civil Rights

MS. MCANDREW: Given the time, I will try to be extremely brief in terms of
bringing you up to date of where the Office for Civil Rights has been active
and will be active moving forward into 2013. Clearly, we are looking forward to
the launch our big initiative, which is the issuance of the final HITECH tech
regulations. This brings into — to make final most of the remaining pieces of
the HITECH statutes the most important thing I think in terms of new impacts
would be the ability to hold business associates liable for their use and
disclosure of health information as well as full compliance with the security
requirements for electronic health information.

This also will bring into play the genetic information nondiscrimination
protections to keep genetic information from being used by health plans for
underwriting purposes.

This regulation has been at OMB for most of this year and we are hopeful
that we will be getting a date from them soon as to when this can issue final.
But we are looking forward to lots of activities in 2013 in terms of rolling
out and providing compliance tools for our covered entity community as well as
increasing outreach to individuals.

There are a couple of other rule-making efforts. Just to touch on briefly,
we have been working with CMS in order to final the regulations, the NPRM that
was to provide test results from CLIA labs directly to individuals using the
HIPAA Right to Access. This regulation is moving along. We are hopeful perhaps
early next year of having this CLIA regulation issued in final form so that the
test results can begin to flow directly to individuals from labs.

There are a couple of other regulations, most prominently, the accounting
for disclosures expansion that was under the HITECH Act. You may recall we had
an NPRM that garnered significant negative comments that we have been trying to
retool that. We are looking forward to some of the efforts through meaningful
use and the expansion of audit laws and the improvement of communications with
individuals to help figure out where technology is so that we can craft a more
responsive way of approaching the expansion of accounting for disclosures and
the electronic environment. That is a work in progress. We will be working on
that in the early part of 2013.

I would say the unique role that OCR plays and has played is in the
enforcement arena for privacy protections. We have made that a focus and a very
high priority. The director, Leon Rodriguez, is extremely committed to having
an effective enforcement program and one that has a high profile.

We have increased the pace of our resolution agreements and imposition of
CMPs. Although most of them do go to settlements before they reach a CMP state.
In 2010, we have entered into four major resolutions and have corrected through
that process close to $5 million. There were a lot of firsts. We had our first
resolution agreement with small providers. That community is on notice that we
intend to have enforcement actions even if you are a small provider. The amount
of the penalty was scaled in recognition of the size of that provider.

We had our first state agency. We have begun to feed in the breach
notification incident into our enforcement activities. Many of the actions that
we took in 2012 really were based more on a reported breach than on our
complaints. Nonetheless, we continue to be quite active and complaints were
averaging about 775 complaints per month. Those do continue to get attention.
We have to date resolved with corrective acts and close to 18,000 complaints.

Breach notification. We have large breaches posted on our website. We are up
over 500 of those large breaches at this point. Clearly, theft is the major
problem. And electronic information does constitute the majority of the cases
that are reported. It is important to notice that about a quarter, something
less than a quarter of the cases do involve paper records so they are not
immune to breaches. Attention still needs to be paid if the information is on
paper. I think in 2012 breaches have affected close to 2 million individual
records.

One of the things that we were piloting in the enforcement area during 2011
and 2012 is the audit program. I think we have received really good feedback
from that. Overall, we have conducted through a contractor 115 audits through
this pilot. We were able to create a pool from our covered entity university
categorized them into four areas based on size and complexity and sampled out
of each of those four tiers. We developed a protocol for the audit process,
which is comprehensive. We have posted that on our website so it is available
for covered entities to use as a guide in their own compliance programs as well
as we put them on notice about what to expect from the audits if they should
get audited. I will say that no one else is going to get audited in 2012. We
have completed all of the audits there.

The funding for the pilot does run out at the end of the year. We will be
going forward within an evaluation contract into 2013 and we will be working
with that contractor to determine how best to scale the audit program to make
it a permanent part of OCR’s enforcement efforts. I think it really has just in
what we know to date without the official evaluation. It certainly has had a
great impact in the industry. I think we are getting some very good information
from it.

We are active in trying to produce good compliance tools both looking
forward to the issuance of the rule making for the HITECH provisions. We are
also close to publishing guidance on de-identification. We have been working
closely with ONC as Kathryn mentioned in a number of areas including access and
making individuals involved, getting better access to their information. I
think that is going to then move us forward with ONC back into the area of
personal health records. We have gotten type initiatives.

On the security side, we have been doing a lot with ONC to look at how to
best secure and use mobile devices. I think that there will be lots of
compliance material that will be put up jointly in the near future on that.

And a couple of notes in terms of consumers. We have been experimenting with
YouTube videos. We have eight consumer-oriented YouTube videos. There is one in
Spanish. We have not unfortunately gone viral yet with our YouTube, but we are
ever hopeful. I think we have our basic which is your health information your
rights has received close to 12,000 hits, but there are other videos up there
on the right of access and the security rule, which has been gaining in
popularity for some reason. There are also videos on the privacy and security
of electronic health records. The notice of privacy practice is friends and
family and then a Spanish video a version of health information your rights.

One final other experiment that we have done in the area about reaching
compliance is that we have partnered with WebMD on their education platform of
Medscape to put up two components that deal with culture of compliance. One of
the videos that has been up and we put up at the end of June, early July and we
have had over 8000 learners come to that video. It is a video of our director,
Leon Rodriguez, and Joy Pritts talking about the cultural compliance and
increasing awareness. We are really happy with the results that we are getting
from that collaboration with WebMD.

I will stop there. I really am sorry I was not able to get up there in
person.

DR. GREEN: I am sorry that I mistakenly went past you there. Thank you very
much. What we will do is we will do these questions. Let’s do them as
succinctly as you can. We will go back to Paul’s second one and then to Walter
and then to Leslie and then to Bruce and then we will readjust the schedule.

DR. TANG: I will try to make this brief. I do not know quite who to ask. Is
HHS using SNOMED at all in any of its programs? I understand the use of ICD-10.
Is SNOMED being used at all for clinical terminology?

DR. GREEN: Anyone on the phone know the answer?

MS. GREENBERG: You mean in actually any of its own programs.

DR. TANG: Or heading in that direction. I am trying to find the alignment
and synergy between the use of that and EHRs that we would like to connect to
public health and the public health program.

DR. GREEN: Anyone on the phone know the answer to Paul’s question about is
anyone using SNOMED?

MR. SCANLON: We will find out. Remember that HHS is actually to the NLM, has
actually made SNOMED available for uses in the US. We might actually have some
applications. They may. We could find out. That would be an interesting
question.

DR. SUAREZ: Mine was just a quick comment following on Jim’s point about
public health funding. The last couple of weeks I have participated in at least
three different meetings that have highlighted this as an issue. One
organization that I think is going to be important to bring in is JPHIT, the
Joint Public Health Informatics Taskforce, which is formed by the seven or
eight largest public health associations: NAPHSIS, NACCHO, ASTHO, et cetera.

They are going to be looking at the meaningful use stage 3 recommendations
and commenting on it. I think that is going to be one — I think there is a
strong concern about the lack of funding to support public health engagement.

The second one was just — AMIA just had a public health informatics
symposium. That was another major area of discussion. The readiness and the
concern about the possible increase or risk of increasing the digital divide
between clinical care and public health.

And then the third one was just last week the Public Health Data Standards
Consortium had its annual meeting. It also highlighted this concern about
funding. I think the essence of this is really probably they need to do a call
for action almost, kind of immobilizing the public health sector to raise
awareness of the concern about the lack of funding and the need to expand the
funding support to increase the capability of the public health information
system to do these exchanges.

DR. FRANCIS: This is for Kathryn. I was happy to hear that the request for
comments on stage 3 meaningful use, which are going to be posted soon will be
looking at data segmentation and consent management. As you know, this
committee has had a long-standing interest in those issues. I do not know
whether we want to do anything with respect to comments, but it strikes me that
the timetable probably will make it very difficult for us to do that because
from what I understood you to be saying the request for comments will go out
soon with a January timeframe. We will not have a committee meeting until
February. Will there be any opportunity within that timeframe? I do not know
because I do not know what you are going to be asking for comments about, but
we might well want to think about that.

DR. TANG: You are talking about the stage 3 RFC?

DR. FRANCIS: Yes.

DR. TANG: It is going out hopefully this week. There was a little bit of
hedging in terms of the due date, but it would not be past January.

DR. FRANCIS: Maybe that is the best that can be done. It might be nice to
have some way to reach out to other committees that might be interested that
have that timeframe issue.

MS. GREENBERG: Several years ago, there was a similar situation. I think it
was related to the HIPAA privacy rule. Again, comments were due I believe like
in January. And the committee did put together comments and held one or
possibly two open teleconferences, one to discuss them, and then a second one
to vote on them. It is possible. It requires getting organized now I would say.

DR. COHEN: A couple quick observations for Jim. I am really happy that ASPE
is going to continue some work on developing some of these standards. I thought
our SES project was really successful. Hopefully ASPE will get this committee
involved. In particular, you mentioned insurance coverage. There are lots of
different ways to collect basic insurance information. Some surveys are fully
devoted to it, but I think we are going to need more and more consensus about
how to in a very streamlined fashion collect insurance information. I think
this committee might be able to contribute.

That would be a wonderful opportunity to reach a sense of convergence around
a variety of issues. Also, patient-centered medical home as we move forward
developing consensus measures both in administrative and survey data for that
concept as well.

A couple other points. The populations committee hopefully will be
discussing more and moving into a space around providing smaller estimates to
communities because this has been mentioned many times. I think we would like
to get involved.

Finally, you mentioned the use of internet technology for surveys. I know
the BRFSS did experiments in the past. And in fact in Massachusetts we actually
successfully fielded did a pilot on internet health surveys. There is good
information out and I think this is a real opportunity to liberate data and use
different formations to collect the information we need. I really encourage
continuing those discussions.

DR. GREEN: Vickie has put her card up. She gets the last word.

DR. MAYS: I am very excited to hear the things you talked about particularly
in terms of the small populations, cluster methodology. There are a couple of
other things that I would like to put on the table. In terms of the small
populations, one of the things that came up when we had hearings on this a long
time ago is the differences that exist in terms of privacy, confidentiality,
and security.

What happens is that when different groups collect this data, they each have
a different standard. Then what happens is that we have difficulty being able
to link or merge those data sets. If we could in terms of looking at these
populations look at the rules that really get into the ability to be able to
use that data, we might find that we can use it, but right now it was very
inconsistent how it was defined depending upon not just the agency, but even
down to who the holders of those were. I think that might help to have greater
usage.

The other thing is we really need and this used to be something and Marjorie
will probably remember this. This used to be something that NCHS was great
about doing and that is this issue of training and development and statistics.
The problem is we can collect data, but we actually need more training and
methods developed for small populations. To the extent that those funds or
training or something can be taken up since NCHS does not do it anymore within
HHS that will also help us to get better methodology around methods and use of
small population data.

My last one really has to do with also this notion of as we are moving
forward in terms of thinking about SES, I think Bruce really said I think that
there is things that the committee would be very interested in kind of what HHS
is doing and have some synergy with that.

DR. GREEN: You have just witnessed us trying to drink about 3000 gallons out
of the fire hydrant in about a 1000-gallon time envelope. I appreciate
everyone’s attention on the phone. I particularly want to thank Denise for
being here. There is something very special about being able to see you as you
present. I thank the committee for your attention.

Here is what we will do. We are going to take a ten-minute break. We are
going to re-commence with the data stewardship letter at 10 after 11, and aim
to still have lunch. Come right back. Thank you.

(Break)

DR. GREEN: It actually takes a minute to exhale after all of that. I hope
you have done that. We have the opportunity to review what is our main action
item for this meeting, the Data Stewardship in Community Health Data report.
Linda and Leslie are going to present this. It returns to the agenda after a
substantial amount of additional work. There has been a lot of review and a lot
of opportunity to see this in advance, a lot of iterations. I want to avoid
jinxing this. I have a feeling that this additional opportunity has not been
squandered and that many of you have influenced the content of this letter and
it seems to me that it has a high probability of being in excellent shape. We
will see. Linda, are you starting?

Agenda Item: Data Stewardship in Community Health
Data, Report

MS. KLOSS: Yes. I am going to just start by framing where this letter has
come from for Lee’s benefit and for others who have not been through the
discussion over the course of the last two meetings now. We are presenting a
letter on behalf of the Privacy, Confidentiality, and Security Subcommittee and
the members of that subcommittee are listed. As Larry mentioned, we have all
had opportunity to have input.

I will note that the version of the letter that you have now has not fully
incorporated a number of comments from Vickie, but we would envision doing so
in our final editorial review that could be taken up by the subcommittee.

There is precedent for this committee certainly, addressing health data
stewardship. I will just remind everyone of the diagram we have used for some
time that was published in the 2009 NCVHS primer that we certainly used as a
backbone for consideration of the issues brought forward in this letter.

But the trigger specifically for the letter, came from the report published
just a year ago at this meeting, The community as a learning system; using
local data to improve local health. That report called out a number of issues
regarding the need for proactive building of trust through educating community
members and leaders about data use and benefits, involving them in decisions
about their data use, and more trust building among the organizations and
agencies that are data sources, and discussion on the need for governance.

One of the quotes from that report called for further efforts and leadership
to define a privacy and security framework to guide the innovative uses of
local data emerging in communities across the country hence this letter that
really is where this came from.

What we have done since last November 11, was held a hearing April 17 and
18. As we looked at defining what that hearing was about, we tackled issues of
not only privacy that is not an individual issue only. It is societal and
family. We also learned a lot about considerations of chain of trust,
discussions about participatory governance, spectrum of consent. These were
issues that are not easily nailed down in the traditional way that we think
about HIPAA privacy. We are pushing the boundaries.

One of the quotes that we found really resonated was trust is our most
important resource as we are using data to improve health and communities. And
trustworthy practices require attention to relationships and accountability. We
took these concepts in mind in framing.

The work that was done was not only to hold the hearing, but also based on
really your input and the subcommittee’s input to step back and look at
existing frameworks. That work was done going back to fair information
practices and other frameworks, identifying where those frameworks had elements
that applied in this new and emerging setting and where there might be gaps or
areas where they are simply not addressed or not addressed again in this new
emerging context.

We presented a draft of the letter in September at the September 12 meeting
and we had robust discussion. The way this group works as a deliberate body is
we had great deliberation. We went back and really did actually — we did a
draft between day one and day two in September and then we did a subsequent
draft. That is what we bring you today.

We consider as a subcommittee that it is complete with a notation that
Vickie had some additional suggestions that she passed along. With that, Maya
is going to bring the letter up and we are open for deliberation.

DR. FRANCIS: I also just wanted to add that we owe Maya big time for some of
this work.

DR. GREEN: This is the first time we have owed Maya big time.

DR. FRANCIS: Just to make sure everybody understands. It was circulated
before the executive committee discussion. There was a round of comments. This
is post the September meeting. There was a round of comments. Actually, it was
circulated to the Privacy Subcommittee first. We got around to comments. Then
to the Executive Subcommittee. We got around to comments and we made revisions,
and then we got some final comments.

DR. GREEN: Let’s stay on track. Our purpose here is not to edit this word by
word. We have it up there so that we can all look simultaneously at the same
spot. You can write down a word that is dear to you that you want to see.
Replace another word in the letter and give it to our committee chairs and Maya
and they will figure that out in the meeting here. The floor is open.

DR. COHEN: Great job. I am not going to do wordsmithing. I promise I won’t,
but there is just a concept that I would like to make sure that is in the
purpose specification section. At the end of your list — it is page 7, the top
paragraph. I can give you some language offline. But when you stewards also
need guidance about the types and data uses, that might be considered
significantly different from the original purpose. And your such as, is a
wonderful example. And I would like to add an example because one of the ways
that data are increasingly used in communities is by the linkage of existing
public health surveillance data systems like linking birth data to death data
or HIV surveillance data for case follow up and mortality. I think it is
important to explicitly add another such as that reads something like and one
public health surveillance data from different sources or links. I think it is
important to explicitly call that out. I will give you language later.

DR. FRANCIS: I do not see any problem with that. Our only point there just
for everyone is that there needs to be thought about whether repurposing
requires reexamination not that any particular one does.

DR. COHEN: I totally agree.

DR. MAYS: Page 4 to number 4. Since my edits did not show, but I am now just
going to — go the one that says data stewards must involve.

MS. KLOSS: Is this the paragraph that begins the committee offers?

DR. MAYS: Committee health data stewards must consider whether and how it is
appropriate to involve community members. Let me get the one you sent.

DR. GREEN: We will help you find it.

DR. MAYS: Let me just say what the concept is and then they can find it. It
is the difference between talking about community members participating in
something and community members being representative of the community
participating. That is just the only distinction there. You need them to be a
part of something and be accountable to somebody else. It is a little change,
but it is a really important change as opposed to people is just at the table
for themselves.

DR. GREEN: This is actually a clarification or an addition to make that
distinction.

DR. MAYS: It is just a clarification.

DR. GREEN: Linda, do you have a sense of where that is?

MS. KLOSS: Yes.

DR. FRANCIS: I think that is important to clarify, but I do not think it
changes the idea because the idea is that depending on the community and the
use it issue which model is appropriate is something that is going to need to
be thought about.

DR. CARR: I just wanted to, again, say what a greatly written letter this
is. With regard to the recommendations, I just wanted to see what we actually
envision these would look like if the secretary accepted the recommendations,
with regard to support the development of models for stewardship, support the
development, support the compilation and support and promote better training.
Is that financial support? What is the support that we are looking for?

MS. KLOSS: The use of support replaced action verbs that were a little more
action oriented in earlier. I think we were trying not to be prescriptive of
what nature that support would take. It might be support through research or
demonstrations or guidance materials and we were leaving it open and we were
not saying fund or right or develop guidance materials.

DR. SCANLON: I actually had the same reaction as Justine that the verbs — I
understood sort of where we were coming from in terms of trying to be less
prescriptive. I think that maybe the way to do that would be to be more
concrete though, would be to ask the Secretary to consider – the consider
being the operative word, and then give a set of potential vehicles that would
allow her to advance, support, et cetera. And just what you said. Research,
guidance, et cetera consider and then a set of options would be the things that
would be the recommendation.

DR. TANG: I think it is a well-done letter and I would second Justine’s verb
to be stronger. I think last time what we summarized was the best thing that
could be done is to develop models that can be used by these individual
communities. As strong as we can word that verb, the better.

DR. GREEN: Is considered supporting stronger?

DR. TANG: Maybe you do consider development. There is enough interest out
there. They just need some help. It is almost like these standard things. And
developing models of stewardship would be a big help for all the people at the
same time.

DR. FRANCIS: In terms of thinking about support, we meant to cover
everything from encouraging efforts within the department. There is always a
possibility that there could be request to advisory committees to think more
about these kinds of issues. There could be pilot projects, demonstration
projects, encouraging efforts in the private sector, helping to get state
health departments together.

There are all kinds of support possibilities. What we wanted to do was to —
the one thing that worries me about — first of all, I think consider is weaker
and secondly I think it suggests that it is for the secretary to consider. The
idea of encouragement or maybe encourage, would be a better word than support.
The idea that I have there is that it is an effort that goes beyond the
Department. We see this letter as speaking to a broader.

DR. TANG: I have a word: facilitate because that is not all Secretary, but
it is a catalytic kind of an action.

DR. GREEN: Bill.

DR. SCANLON: I think the issue here is that there is not sort of a means
that we are recommending. We are recommending an objective. I am certainly
happy with Paul saying that we want the Secretary to move strongly toward that
objective. I think that what makes it more concrete is if you study some of the
things that Leslie and Linda have just said in terms of what the options are
that the secretary might use to achieve the objective and leave the choice of
the options to her. I think we are not ready to be that prescriptive. When we
were moving away, we were moving away from being prescriptive. That is fine.
But give a hint as to what we think the secretary might take in the way of
actions.

DR. FRANCIS: We can certainly do that.

DR. CORNELIUS: The only comment that I have been kind of dwelling on deals
with item number four at the end of the recommendations. What happens when I
read — you have one, two, three, and four in there suggested recommendations.
But four sounds a value to because there is a word in there that says promotes
better training materials.

I thought of a phrase of just saying additional because saying better to me
sounds like we are making a judgment about good or bad material that is out
there in the public. I do not know what the deliberations were, but just trying
to be careful about the impact of the statement.

MS. KLOSS: Our intent was not judgment. That is a good suggestion.

DR. CORNELIUS: Just strike the word better and put in additional. I am just
changing the language of the statement itself. It takes out the evaluative
word. Better assumes that we are making an evaluative judgment about other
material that is out there.

DR. MAYS: In the same section, I guess what I was concerned about is there
is no timeframe in addition to specifics. And there is a slow way to do it,
which is telling NIH to do research on it, and we will see it 10 to 15 years
later or there is something else. It was kind of like before in number two. It
said monitor the use. I changed to examine and analyze. I guess I am trying to
figure out how to put more of a timeframe that has an urgency to it. The only
other way I could think about that was is there something that HHS is doing
that doing this would enhance that work such as either Healthy People 2020 or
something. I think it needs some kind of time to it.

DR. GREEN: Well, we do not have as a bullet the recommendation that opens
the recommendation section. NCVHS believes this is the right time to advance
the stewardship framework.

MS. KLOSS: Because of all of the other data initiatives. We were tying it to
the other department role.

DR. GREEN: How might you suggest we respond to Vickie’s point?

DR. COHEN: Do we ever ask the Secretary to report back to us to let us know
what progress has been made in implementing the recommendations?

MR. SCANLON: You work for her so it is a little funny to say what my boss —
but you can say that the committee would appreciate an update from HHS on
these.

DR. FRANCIS: Another way to put that which we might — when Linda and I were
talking about the discussion that I think is going to take place this afternoon
about what each subcommittee is going to be thinking about on the overall
initiative, part of what we are going to be thinking about is which of these
issues here are ones that everybody thinks it would be best to have us start on
because those are some of our next steps actually as a subcommittee. One thing
we might ask for is if she has any input about where this committee might be
most helpful to her on those initiatives. Maybe we should just ask for that.
That is not like reporting back, but it would certainly start an engagement we
hope in conversation.

MS. GREENBERG: I was just going to mention that in addition to sending this
to the secretary we always copy the HHS Data Council. We have someone here who
is quite involved in setting up the agenda for the HHS Data Council. One
possibility, we have certainly done this in the past, would be to present after
this letter is sent to the secretary, et cetera to have the co-chairs or one or
more or the chair present this at the data council and get feedback and input
from the agencies who would be involved. The secretary obviously is not going
to do this herself. That is certainly an approach.

MR. SOONTHORNSIMA: Can I cover another section?

DR. GREEN: Are we still in recommendations?

DR. CARR: One more comment. Do we have the idea that we may, in fact, be the
appropriate body to do some of the work that we are recommending? If indeed
that is what we are going to talk about today, I think the letter might be
strengthened by saying what our next step is going to be.

MS. BERNSTEIN: We do say at the end that we are ready to study and implement
these ourselves. It is a general statement.

DR. CARR: Yes, we always say that, but I think if we said NCVHS is planning
to hold a hearing, not a workshop, on whatever. If we were going to do
something, this would be the time to identify it.

DR. GREEN: Justine, what would you think about using our themes? We have
these three themes. We could say that the committee is organizing its work
around those three themes. Can we insert that?

DR. CARR: I would just keep it on point. If there is something that we know
we are going to do and we want to do, rather than asking the Secretary to do
everything, we could say the committee is going to take the next step on this
and do that. Other areas of interest are whatever. We do not have to be
flowery. We do not have to — our themes. But if we are going to do something,
let’s say we are going to do. Let’s decide if we are and then let’s say that we
are.

MS. KLOSS: I think we could be more direct in that sentence that we stand
ready to help. Be a little more direct there that we are committed to this
agenda and certainly to the need that has been identified in the work of the
committee. But we were not ready yet to specifically say what the next step
would be.

DR. CARR: If we could decide over the course of today because this letter
especially is exactly in the space that NCVHS does. The Secretary might read it
and say, why doesn’t NCVHS do this. If we are going to do something, let’s say
it in advance.

DR. GREEN: Okay.

MR. SOONTHORNSIMA: When everybody is done with this, I would love to go
another section if that is okay.

DR. GREEN: Let’s go to another section.

MR. SOONTHORNSIMA: Section 5, please. Accountability. I thought the
committee did a fantastic job taking in the feedback we gave last time. I loved
the examples. The only thing that I might suggest is really up to the committee
to consider this. In that first paragraph right there, I am not sure that there
is anything that talks about the responsibility of the steward to anticipate
any potential risks or possibility of misuse. To me that is part of the
accountability is risk mitigation, risk management. But the examples are great.
These are consequences of not doing a good job.

DR. FRANCIS: We will add that in.

DR. GREEN: The key idea is anticipate.

MR. SOONTHORNSIMA: Yes, anticipate of potential or possible risks and
mitigation measures, tactics, whatever for misuse of data. Something broad like
that, but enough action with a framework.

MS. BERNSTEIN: Do you have a particular suggestion about where you might put
that or just somewhere in that first paragraph? I do not know if you were
playing with it on your own.

MR. SOONTHORNSIMA: At the end of the paragraph perhaps, that first paragraph
right there because you have mechanism for redress.

DR. FRANCIS: Maybe right before the mechanism for redress.

MS. MILAM: Just as an alternate consideration, when you look at the role of
the data steward and the data steward has a different role to play throughout
these different principles. Another place to consider putting it is in four
with security because doing periodic security assessment is a component of that
principle.

PARTICIPANT: Where is that?

MS. MILAM: On four on page eight.

DR. GREEN: Maya, do you have a recommendation about which place to put it
in? Four or five?

MS. BERNSTEIN: I think Sally is right. I tend to think of anticipating risk
and doing mitigation is a security matter.

MR. SOONTHORNSIMA: The only reason I would put it there is because the
examples are terrific. This is more like unanticipated use.

MS. KLOSS: Perhaps if you are all right, we will read it through and decide
where it best fits, but it is an important concept. I think security tends to
have perhaps a narrower perspective then what you are bringing to this.

DR. GREEN: Let me divide this now for a minute, everything up to the
recommendations.

DR. CARR: I promise this will be my last comment. When we think about the
food chain of there is a person one day either today or a century ago or two
centuries ago that created a study that exists. Someone takes it and repurposes
it and anticipates the impact on the community. I think that the value that
this letter brings is to recognize the use of data because there are going to
be data that are disruptive that communities did not think they had high
schizophrenia or they did not think that.

I just want to be clear that we are not standing in the way of truth, but
that we are managing the message so that the impact of that message has a
receptor arm that can now do something about it.

My one thought on this letter is that we are maybe over stating the role of
researchers far early in the stream and that most, not all as I know you
pointed out, of the data use that we heard about in the communities is either
the taking of that and applying it to it or the juxtaposing it and linking of
it. I think that is where the real emphasis needs to be when we are talking
about community data. I just feel that we dilute the message when we go so
heavily into when you are constructing a research study, and developing a
consent and having people assign. At that time, you do not know who is going to
take the data and use it. You really cannot anticipate these unanticipated
consequences.

If you are a researcher, you have to be a good researcher and follow the
rules. If you are a data re-user, you have to think about if I have a difficult
message, how do I present it with an action statement that does not damage the
community, but uplifts a community?

DR. GREEN: Where?

MS. BERNSTEIN: I am a little confused by that because of the way I think of
it as you are initiating a research project or some kind of an initiative at
both of those times. You have a role if you are the creator of data in the
first instance and you have a role if you are the re-user of data and you are
starting a new project. Depending on where your data comes from whether you are
the creator of the data in the first instance or whether you are taking data
that has already been created previously, I think what this letter says is that
you have certain responsibilities and obligations to the population.

The question is how is it best to do that. In some cases, if you are the
second researcher, it is not practical to go back and talk directly or have
that communication, but it is something that I think the letter says you have
to consider. What is the best way to do this? Maybe we cannot go back to those
people at this point, but maybe there is some other way. Maybe there is a way
to talk to the community. Maybe there is just a way to think about what happens
to that data and just to be responsible with it understanding that at the time
it was initially created there was a different message or we did not anticipate
what is happening today.

DR. CARR: That is the group I am talking about. The people who applied for a
grant and they have a study and they develop it and it goes through various
oversight boards and they clearly state I am studying this to do that and they
abide by what they said. That does not seem to be the focus of what we heard
from the communities. I am seeing it more as when that exists and someone else
wants to reuse it that repurposing or linking of whatever is what we heard —

DR. FRANCIS: Actually, we did hear some discussion on that because we heard
two things. First of all, some communities said they get really tired being
restudied and restudied and restudied. One of the problems that they sometimes
see is that researchers do not think ahead.

The second thing that we heard is that — of course, it is not always the
responsibility or always something that researchers should do, but there are
certainly circumstances now. Remember, all we are saying is these are issues.
We are surfacing the issues. We are not making a recommendation about
researchers must or anything like that. It is certainly the case that now there
are context in which researchers have some ability to anticipate what might be
some later uses and do and build that in. We just simply wanted to have that as
an open possibility. That is all.

DR. GREEN: Please correct me if I am wrong. I do not think we have
disagreement about the concept that this is important to researchers and
communities. It is not just about researchers in that we do not want to
overweight toward the needs of researchers. We want it to be a balanced calling
out. I deferred to Maya and the two co-chairs about this. It would be possible
it seems to me and the scoping at the very beginning of the letter before the
background to make this point that it is also seems to me that that first
paragraph under elements of a useful framework for — stewardship sentence to
make just the point Justine just spoke to be inserted there too. One of those
two places where it scopes it out better and strikes that balance.

MS. BERNSTEIN: I think what we tried to do is some of that. I am not sure if
it directly answers Justine’s questions. But we tried to say that at the time
the person who was the initial creator of data there is a tradeoff between
being more specific about your research projects so that later uses are going
to be more narrow or you have to go back and do something else, and being
broader in the first instance so that you anticipate that unanticipated things
could be included. We have now the possibility of going out for consent, for
example, in a research project in getting very broad consent. There are some
tradeoffs with that as to whether people want to participate, whether they
understand what you are doing or whether you are very specific and they
understand it and then later you may have some more constraints. We tried to
point that out as well.

DR. GREEN: Of course, you are right. We have been trying to strike the right
balance for this letter for four or five months. I just heard Justine’s point
being she — it is a sentence. It is basically another sentence that needs to
go into the letter that makes this point. If you could draft a sentence or two,
I bet we can find a place that it stays with the tone, the level of the letter
and get this included.

DR. MAYS: Mine is on this point. I think one of the issues is that it is
like setting guidance on top of guidance. The issue is that if you are the
originator of the research, believe me all the things you are talking about we
really do already have the guidance for it. It is a fallacy to think we cannot
get through the IRB, for example —

MS. BERNSTEIN: We are talking about situations where an IRB does not apply.
This is only applies to funding that is federally funded. Some of the funding
does not — IRBs come from federally funded research. Some others have IRBs.
They are not falling under the common rule.

DR. MAYS: Then I am really confused.

MS. BERNSTEIN: What we heard is that not all the research that is happening
in communities is covered by an IRB. That is one of the reasons why we have
this letter.

DR. GREEN: Vickie, I think your point was that researchers already are
living with a pretty well developed rulebook about their data requirements,
consenting requirements, and sort of stuff. It is less clear about what the
requirements are for community’s use of data. Am I hearing you right?

DR. MAYS: I think there is kind of an important point. I do not think it is
just a letter. It is a tone and it is an emphasis. I think to me that is what
has been confusing throughout. There is some data that has a whole lot of
regulations, but once it leaves the hands of usually the first person. Even
when the community talks about data, I am not even sure they have a sense of
all of it where it came from.

DR. GREEN: That aligns with Maya’s point. It is amazing how tight and
complex the researchers’ rulebook is and how vague the community’s rulebook is.
That is how it connects to Justine’s comment. You said it connects to that. You
can see that. But we can capture that. We can get that in there.

DR. COHEN: The same issue strikes me. Data do not make decisions. People
make decisions. What is our responsibility as data collectors in terms of
stewardship providing that sense of responsibility? I did not have the benefit
of hearing the feedback from the community. There are communities who are over
studied and there are people who misuse data that they have access to as well.
As a data collector, I cannot prohibit nor do I want to people reusing my data
and drawing maybe different conclusions from it than I might agree with or
might feel are appropriate. My responsibility as a data steward is to make sure
that the data is collected in the proper manner and that they are secure and
protect individuals. My stewardship does not apply to interpreting or using the
data. It does apply to using the data appropriately, but it does not apply to
using it in a way that I might not have thought of as a data collector as long
as people use the data.

DR. GREEN: I think that we have that tone throughout. That comes across. It
is really consolidated in number eight. You have to be careful how you use this
regardless of what is its initial intents were.

DR. COHEN: I just want to guard against the notion that as data stewards we
have an obligation to protect all of the uses of data. I do not want to change
the language. I like the language. I do not want to be overly prescriptive
because we are liberating these data for uses by communities that we would not
anticipate. That is their right and privilege.

DR. FRANCIS: That is right.

DR. TANG: Just a question. We have been talking about responsibilities. Is
there any mention of enforcement? We used the word once in a recommendation.

DR. FRANCIS: There is a mention about data use agreements and how they do or
do not fully work. I think that is as close as we get.

MS. BERNSTEIN: We do talk about accountability. We say that someone has to
be responsible for the stewardship. We do not say who that it is. It might be
different in different context, but that entity should be identified in advance
for each point in the life cycle because it might change across the life cycle.
The person who initially collected it might have a different accountability
entity than a later use, for example.

DR. TANG: It could be something that we — the data use agreements and
especially important topics. This is under our second recommendation. We did
not say a whole lot of how you get authority for that. Maybe we do not need to.

PARTICIPANT: I do not know that we can.

DR. TANG: We are struggling with so many words on what you need to do and we
did so little on —

DR. GREEN: Hold that thought for discussions about where you might want to
go next.

MS. MILAM: The second paragraph on accountability speaks to downstream
consequences where you do not have stewardship in place. They say some mild and
some quite serious. It alludes to it. You could call it out more specifically.
I think accountability is the place that would go.

MS. BERNSTEIN: We talk about a mechanism for redress although it is not
specified.

DR. GREEN: Okay. I am on the verge of closing discussion about this letter
up to the recommendations. We are not planning on going back into the body of
the letter now. What we want to do now is make sure everyone is comfortable. We
have four recommendations. We have looked at. We already have some suggestions
about changing the verbs there. I think we have already accommodated that and
are ready to go. What else?

DR. TANG: It is still in that first recommendation. We are using the word
facilitate development. And then a number of things were mentioned. Maybe we
can go comma including and start enumerating some of those things that need to
be done.

DR. GREEN: Do you have nominations for that?

DR. TANG: Leslie or — what you wanted to do was give examples. Here might
be the place where you would put included in the models are enforcement
mechanisms. It is like here is the speed limit, but please do not do that. I
think that is an important part of trust that we did not quite catch in the
actual body.

MS. KLOSS: But would you also see giving examples such as through additional
development of case studies as ways to bring forth —

DR. TANG: I almost think that this is new work. I don’t almost think. I
think it is new work. We are really good about getting out the principles and
the things to consider, which was the purpose of the letter. We should advise
the secretary that in addition in order to have these principles come to life
in these stewardship models, there needs to be some thought about enforcement.
Either it can be internal in the community or it can be external. Part of what
we said is a lot of people could use some external forces that are just the law
of the land because it just makes it easier for all the individual communities.
I do not know whether we want to take a stab at it. It does seem like some
mechanism for enforcement is required to have our principles live up.

DR. GREEN: Bill, did you have some that you wanted to suggest?

DR. SCANLON: Leslie and Linda both —

MS. KLOSS: He said the ones that we discussed earlier giving examples such
as research.

DR. GREEN: No one has a tent up. Are you taking a nap? Maya, do you have any
clarifying questions you wish to ask the committee? Are you good to go?

DR. TANG: These principles live up to the trust I think is a better phrase
there. It ties back to our theme.

MS. BERNSTEIN: I was wondering if we did not say something when we talked
about using local governance mechanisms that those governance mechanisms might
already have woven into them redress principles of some kind.

PARTICIPANT: Where there are governance mechanisms.

MS. BERNSTEIN: Where there are governance mechanisms. Obviously, we have to
abide by them or dovetail them. Certainly, we are not going to impose some new
governance mechanism on tribal entities, for example. It is particularly
touchy.

DR. SUAREZ: I guess the question is what are the next steps. Are we going to
approve today the letter to go out with the modifications? We need to take
action I think at some point.

DR. GREEN: It is on the agenda for tomorrow morning.

DR. SUAREZ: I did not see it on the agenda for tomorrow.

MS. BERNSTEIN: If the committee would be ready to take action today, that
would be fine with me. We have some time now if the committee is ready.

DR. GREEN: Let’s see the final product. We will take a look at it in the
morning and hopefully it will be a short item of business.

DR. CARR: Do we want to in the closing comments make reference to the
liberation of data that is going on in HHS?

MS. KLOSS: It has been in this letter and in and out. It is on the first
page, isn’t it? It is right there at the opening.

DR. CARR: I guess if the secretary had a bold step of liberating HHS data, a
lot of which is about communities, and we are writing a letter about the
communities and the data. If you think about Datapalooza, is there anything
that goes on at Datapalooza that we would address here or some kind of
guidance? I am just trying to — I get it that it is in the background, but it
is really the elephant in the room. We have just finished doing that and now
what.

PARTICIPANT: It is actually stated in the letter.

MS. KLOSS: Here it is on the front page of the letter.

DR. CARR: I was talking about the recommendations.

DR. TANG: I think the first consumer of this is your work group. And in
fact, I would hope that this is the filter to which your recommendations get
passed. That would be the first test of can you apply these principles when you
harness this new open data.

DR. CARR: What if you did not take my recommendations. I am just kidding. I
have this feeling. As we think about all the data that is out there and we
think about one application or anything with Datapalooza, is there anything
glaring that comes to mind that bumps up against these recommendations? You are
right.

DR. GREEN: I do not think the Datapalooza bumps up against this at all.

DR. MAYS: I think there are a couple things. One, I kind of circulating it
— I guess maybe it was the wrong committee — populations committee is there
is a brand new report that is out about community prevention and a lot of it
discusses community data that just came out from the IOM. It also bumps against
the CDC’s.

DR. GREEN: I just realized. I do not know what you mean by bumps up. I
thought you meant that we are making them problematic. Were you saying that
illustrates the need for these principles by bumping up?

DR. MAYS: I thought what she was saying is again — earlier I said this
needs to be hooked into something that gives it really a compelling reason for
her to pay attention to it. That is what I thought she was trying to do. What
are some of the things that are compelling that we are answering and making it
relevant. If not then I think it is just a letter out there that can be gotten
to whenever.

DR. GREEN: I am not worried about that because of how evocative this letter
is. I do not think there is any chance that this letter is not going to connect
up to that sort of stuff. Just listen to ourselves.

MS. BERNSTEIN: Are you suggesting that we drop a site to a recent report? We
can certainly do that and say that it is another — we could say that it is
another driving force although it did not actually come out before we started
this work. If there is related work going on, we could maybe drop a citation to
it at the beginning and say this is related work. Is that useful? I am not sure
what you are recommending if anything.

DR. GREEN: Was there a recommendation?

DR. MAYS: What I was recommending is at the beginning and also at the end
where we talk about the recommendations, it is like doing this addresses
something. This is consistent with the following things that are on the table.
I think what I am trying to do is to have it have a reason to move on this
faster rather than slower.

DR. CORNELIUS: As I am listening to the conversation especially as it
relates to the discussion about the data liberation, I come back to the
recommendations and ask myself it does not seem that what we have done is to
affirm what the Secretary has already done as it relates to data
liberalization. The recommendations talk about what should happen as in
stepping up, but there is still another piece out here to the extent that the
concurrent activities that are going on right now start to speak to that. It is
also good to say that we appreciate that this is already occurring in whatever
form or fashion and it should continue. If that is really what the committee is
seeing as well. But I do not see that as an affirmation in the recommendations.

DR. FRANCIS: What we are trying to do in this letter if you go right back —
go to the very beginning. I know we should not go — we are talking only about
the recommendations. What we want to say is the communities are using digital
data. This is really important. These developments should be cultivated and
guided, but they need to be guided by responsible data stewardship. That is all
we are saying.

DR. CORNELIUS: I want to loop back to what Jim was affirming. For me when I
read the letter, everything is well and good, but what happens is the
recommendations —

PARTICIPANT: We need to reprise that thought.

DR. COHEN: My suggestion for doing that would be to essentially say to the
Secretary we would like the Department to apply this framework for stewardship
to all of its data initiatives and all of the data liberation. We have
developed the principles for the framework here. Have all future activity and
data releases, all the CMS work, all the work that this committee does.

DR. GREEN: I thought we had the unanimous consent that we do not want to put
the words all in this letter.

DR. COHEN: Apply this data stewardship framework to the release.

MR. SCANLON: Where such a framework is lacking. Because the 90 percent of
what folks that were probably — I think what I would do — I think you do need
to reprise — appraise the Secretary’s, not personally, but the efforts at data
liberation and getting the information out there, encouraging its use to
improve health and health care at all levels, some of these. This is meant to
support those efforts where they may be lacking.

You do not want to pretend that they never occurred. In fact, they may occur
most of the time. You found instances in your hearing where there were
problems. It is a general framework. You certainly want it to apply. You should
not give the impression that you believe that no one is applying these now. I
think the closing needs to say something like, many people know about this and
are doing it already and this is meant to provide additional information for
those that are not aware, but not to paint everyone like they have never heard
of this before.

MS. MILAM: I would echo Jim’s comments about being careful because they have
taken similar frameworks and issued specific ones like for HIE and other areas
of privacy. They have done a lot of work in different areas, but this is an
area that has not received focus yet.

DR. TANG: Our recommendation for part of the recommendation and next steps
for NCVHS and a pilot of this, which is to use Justine’s Working Group. We
close with we have recently convened a working group on data access and use as
an important starting point. Instead of just leave it there why don’t we — and
we will apply these principles to that group because it is addressing — give
us some guidance on this open data and how should we manage the open data
initiative. What that does is it gives us a pilot with our own — it is going
to be hard to apply. We might as well experience that firsthand, and probably
figure out other ways to revise it. This is an action that we can do. It
integrates into other work and it goes straight to HHS.

MS. BERNSTEIN: Can I just ask a question about this? My feeling about this
has been that the department in that its research happens under the common law
and it is covered by the privacy act generally complies with these principles
now when it collects data. It is required to by law. Applying that to the
collections and dissemination of the department’s data might not be a real
tough thing to do. I am trying to think on my feet here about whether I am
missing something about that, but I am pretty sure we are required to do many
of the things that are in here already. And that the point of the letter was
that there are communities and other entities that are not covered by the same
things that the department would be covered by at the federal level and we are
trying to use similar principles to apply to that. Am I missing something
there, Jim?

DR. TANG: But part of the department’s stewardship is to advise people who
receive its data on stewardship principles I think.

MS. BERNSTEIN: But we also do not give our data out willy-nilly.

MR. SCANLON: I guess we exercise it. It is a little tricky here. This is not
just departmental data. We have limited control once it is out other than data
use — this is the model of where there really are no data use agreements
probably at the moment. It is not so much federal or even state, though the
states can just like a federal agency can — this is really meant to cover
those areas where we do not believe there is — we are looking to extend the
same protections and frameworks that we believe now governs federal research
activities and probably state public health activities. They are largely
community level I think, where there is no governing, there is no governance or
framework —

MS. BERNSTEIN: Right, although I think it is true with our public use data
files we do not really have control over what people do with them. It is our
job, I think, to emphasize what the limitations of those data are where we know
the limitations, but otherwise we really have no control of what people do with
them.

MR. SCANLON: We do not want to suggest in the letter that we do not believe
that the full federal sphere is not abiding by these. I think if we could just
point it towards the community. The new efforts that are to be applauded, but
at the same time may not be — I would say may not be aware of the protections
and stewardship principles that are available to other efforts. That is exactly
what we are aiming for. For the federal government to make an error like this,
it does not happen often. Even states, it is fairly rare given the oversight,
as well, not that it does not happen. But it is really these others.

When other folks who may not be experienced, may not be knowledgeable, they
are now able to access some of this data and that is what we want to do. They
may make a mistake. They are looking for some sort of framework. What should I
do? Let’s point it that way so that it does not look like it is a big issue at
all levels. It is really fairly directed.

MS. GREENBERG: I am hearing these two different streams. The people who do
not want the letter to go as far as it is has gone. There are people who want
the letter to go farther than it has gone. I have just been sitting here and
listening to this discussion. I think the bottom line is everybody thinks this
letter is — most people think it is ready for prime time. That it has really
done a good job. That it is well written, et cetera. I would not end with
saying we are going to apply these principles to anything at this point.

Let’s remember what this letter says here. On page 2, it says this letter
reports findings from recent NCVHS work, identifies eight elements of a
framework to guide community health stewardship. It does not lay out the
framework. We agreed to that last time. And makes four recommendations as to
how HHS could initially facilitate effective data stewardship at the community
level while preserving local autonomy and creativity in the use of
health-related information.

I think that a lot of the things people are discussing would be in the next
round. Right now, we are just trying to get this out there to leave it a little
flexible, to not be definitive and saying this is the framework or the
principles we are going to apply or you should apply these or you should apply
those. I think actually, with a little tweaking around the edges here with
things people have recommended this can reach that balance. I just think we
have to be aware that we are trying to go in between those who think we should
go further and those who think you have gone too far already.

My feeling is that we can achieve that, but we should let the subcommittee
deal with these comments and bring it back tomorrow. I would certainly hope
that it could then be approved and we could move on. We are not saying that
this is the beginning and the end all. I do not think the committee is
criticizing anybody. It is saying people are looking for guidance and we would
like to contribute to giving them guidance. We would like the department to do
that as well.

DR. SCANLON: Somewhat very similar to what Marjorie was saying because I
think that in the conversation we were creeping back a little bit to where we
were at the last meeting. It was this idea that the federal government has a
role here in imposing standards. There is no statutory basis. There is no
regulatory basis for that. I think we are really calling for the department to
exercise a leadership role, sort of moral principles in some respects. These
communities are defined so broadly. There are going to be communities that are
going to choose to ignore that. Until there is such a problem with that that
there is a public response there is nothing the department can do about that.

Following up with what Marjorie is saying is keep it at the level that we
have it now which I think is setting the right tone that you really want the
department to move forward, but you understand their limitations.

DR. CARR: Let me land the plane on this for the working group. If I go to
CMS data and I take the HCAHPS data, did you have a good experience at your
hospital, and I look also at the quality data, the core measures. If I make a
chart, put this data out, juxtapose it, reuse it, and show that in certain
states the core measures score very low. The satisfaction is very high. And in
other states where the quality is high, the satisfaction is very low. That is
data that is available. If I made an app like that or I disseminated that,
people could draw their conclusions. They could say in such and such a state
people are satisfied with bad care. That might have implications for the
community. It might have a lot of implications. What am I supposed to do? If I
want to make that app, if I want to send it to Datapalooza or something like
that, I have not consulted with the community. I have used public data that is
available through them. I have put something out there. Maybe I do not even
draw the conclusion, but other people might or maybe I put it out there and I
say isn’t it amazing. People with the worst care are the happiest. How do I
apply these principles?

DR. GREEN: That would depend on where you lived. This is community focused.
Our basis for this is local use of data that is meshed up, linked up, and so
one of those two states. If you live in one of those states where this fits is
if there were — remember, a fundamental conclusion was when we listened to
these communities, they are missing a stewardship infrastructure. They do not
have it.

If that state was one in which they had come to an understanding of a
stewardship framework for the use of those publicly reported hospital data that
is how it would relate to that. But if you were doing a map of the United
States, I am not sure this letter has a purchase to establish the national
stewardship there. If it is Tishomingo, Oklahoma, they haven’t a clue. This
letter is really about what they would do with local data that was about them
that they did not even know was being collected, et cetera. That is where we
are trying to get to.

DR. FRANCIS: If you just think through what the various — remember, these
are just elements that somebody might need to think about. The description that
you gave is at such a high level, but just imagine that there is more data that
gets out there and then we can figure that a particular hospital is one where
this is true. Something that eventually Datapalooza is going to have to
consider is the question of how they are suppressing small cells, things of
that sort. That is where this might link up. We are not giving an answer, but
it is certainly a question out there. The kind of example app you gave would be
an example where I do not think this framework would have anything to say
critically about it other than make sure you do not put the data out in such a
way that you have forgotten the risks of re-identification, which you are not
doing.

MS. BERNSTEIN: I think there is a little more to it than that. You could as
a user of the data it is incumbent upon you to understand how the data were
collected and what context they were collected and what people were told when
the data was collected and to understand whether you are using it for a use
that does not fit with the original purpose of the collection. What were people
told at the time? Are you making inferences that are inappropriate for the data
that was collected, which could happen? I am not saying because of the purpose.
I am saying because of the limitations of the original data. Those people who
were surveyed were told something at the beginning. They were told something.
We got consent or some other way of collecting data from them. If they were
surveyed, they knew they were giving their opinion. It is incumbent upon you as
later research to understand what was the context of that data collection. That
is all.

DR. GREEN: This exchange re-convinces me that we have done enough with this
letter. We can look forward at the working group and the privacy committee and
the populations committee are going to have a very good time in the next few
months about wrestling with exactly these issues. I think we are done. I think
we have beaten this up enough. I do not hear dissent about the recommendations
or the concepts. I hear us discussing a lot about its implementation and its
use and how it can go forward and what happens next. If we had gotten it
approved at the last meeting, we would have been talking about that more in
this meeting. I am in favor of calling it a day on this assuming that you guys
know enough to bring us back a finished product. We will look at it in the
morning. You have a last chance if there is something that is wrong, erroneous
that you say that is a disaster to put in this letter. That is incorrect. We
have to hear that tomorrow. Let’s not argue what the implications of the letter
are tomorrow. Let’s just come back prepared to vote it up or down and it is
ready to go or not go. One o’clock. Reconvene.

(Luncheon recess was taken)

DR. GREEN: The 1 o’clock agenda item. The community’s learning health
system. Bruce Cohen is going to lead off presenting this topic. We have a
quorum.

Agenda Item: The Community as a Learning Health
System

DR. COHEN: Thank you very much. The title of our presentation is the
community as a learning system using local data, crafting the vision, and
developing research agenda for the committee. We were not trying to be
presumptuous. Our initial intent is really to focus on developing a work plan
for the population subcommittee. To the extent that the issues that we talk
about collaboratively will help organize work for the entire committee and all
of the subcommittees that is our intent. We have a dual purpose here.

First of all, I really need to thank my co-chair Sallie. Her diligence and
thoughtfulness is a real compliment to my impetuosity. You keep me well framed.
Thank you very much.

We have an exciting committee and that is expanding. Casey and Tamara, are
you there? I saw her earlier. Our new NCHS staff folks. We are actively
recruiting. We have one new member already. Anyone else who gets excited by
what we do please join in. We are going to have a lot of fun.

I will briefly try to run through this. I really want to have plenty of time
for discussion. I will give a little overview of where we are, the process that
we have engaged in, what our outcomes are, and where we want to go from here.

First, our goal is to develop a proactive short-term work plan and a
longer-term direction for us and the population subcommittee and to the extent
that it works for the entire committee that is fantastic. Clearly, we need to
integrate and we need to adhere to the principles that we are focusing on, the
three strategic themes: empowering communities, facilitating standards, and
shaping the vision.

We are very fortunate to be able to build on our historical foundation. Here
are some of the building blocks that we use to help provide context to our
discussions. From the community is a learning system report, leveraging
multiple data sources, linking clinical and population data, focus on
dissemination is a key. Information-driving action, and certainly trying to
improve the relationship between academia and local health.

Another incredible potential building block for us is the Folsom Report
Revisited. Larry turned us onto this document and we are hoping to use this as
a foundational piece that will help us move forward. If you have not had a
chance to read this, please do. There are some key insights in the Folsom
Report Revisited that really converges and I will be using that word several
times with what we are doing here in the national committee.

The insights from the Folsom Report are really an expansion of primary care
and family medicine and the impact that has on the nature of the delivery of
medical services focusing on patient centeredness, medical homes, and the
explosion of IT in the health area and what impact that has. That is really
called for a redefinition of the relationship between medical care and the
public’s health.

The Folsom Report also laid out some grand challenges and certain principles
creating a national network of community partnerships, fostering integrative
practices, expanding the role of individuals and care, and most centrally
really developing communities of solution, which is bringing together common
elements of individual, personal, and community health to help us figure out
how to improve the lives of us all.

This focus on communities of solution really dovetails perfectly with some
conceptual work that the national committee has already done. And thanks for
Sallie for reminding us about this particular conceptual convergence diagram,
which is very powerful that I think not only the populations subcommittee, but
the entire committee can use focusing on health care providers, personal health
and the intersection and union with population health.

Given this context and this rich historical background, how did our
populations subcommittee move forward in our ideas? We have been very active
since the last meeting. We have had an executive subcommittee’s strategic
planning session. We have had ongoing calls. As part of our last meeting, we
had I think a fantastic session on empowering communities, which led to some
really detailed recommendations. We have had subcommittee calls. We have had
input. We have created a decision matrix. This decision matrix was laying out
some options and trying to use the matrix to develop an internal survey to
focus our ideas and evaluate the practicality of our approaches. This is what
the decision matrix looked like. Debbie and Casey and Tamara translated this
into an online survey.

I was really happy not only to not have to analyze all the data from
handwritten comments, but this is part of us adapting technology to meet our
needs. I think developing these surveys to get feedback from members and staff
is a way that we should move forward. We have the SharePoint site that
everybody can access. This is a perfect way to help us prepare for these
discussions at our meetings. I heartily endorse the notion of trying to use
this technology to help us build consensus and get feedback.

You can generate some really nice diagrams and essentially what you see here
in red is we laid out options and all the options that averaged from the scale
of one to five, five being the highest, the options that seemed most important
are highlighted in red. These options include exploring — these are survey
results still — exploring in-depth one of the attributes that was in the
Community as a Learning System report. Bullets numbers two and number five.
Operationalizing the 21st century vision and disseminating — three and five —
disseminating our plans for this operationalization came out as an important
theme. Providing recommendations for the secretary about how the federal
government can operate better in this space was also one of the themes. As we
discussed this morning, integrating data stewardship into data dissemination
and community data. We got positive feedback. And last is continuing exploring
the work that we began on SES. These are results from the survey. Where do we
go from there?

PARTICIPANT: These are in priorities?

DR. COHEN: No. These are all the ones that had at least a rank of four. For
those who might not be familiar we have talked about this report. When we
talked about operationalizing this vision, this is the basic, the seminal
diagram that we talked about operationalizing, making active for community use
and disseminating.

What we came up with — the results of our generative thinking based on all
of our discussions and all of our feedback in the survey we came up with a menu
of essentially eight options. This was our generative approach. Those are
performing and then enhanced environmental scan of community health indicator
needs. Some of these are broad and some of these are specific. Again,
operationalizing the influences’ diagram, using the Folsom Report to focus on
concepts of convergence, crafting a vision of community data, access, and use,
reviewing the literature and data sources. In order to develop standard
consensus variable definitions for SES, social determinants and health risk
variables. This could integrate standards development in a different kind of
way.

And the next recommendation came from some of our federal partners really to
assess the comparability of the data collection efforts going on. The seventh
recommendation is to develop recommendations about linking communities and
health care providers and researchers together in a more thoughtful kind of
manner. I mentioned working more on SES. Last but not least is really
identifying specific needs for local infrastructure to support using data. That
was our generative notion.

Our next test was really to synthesize those ideas into a more coherent
explicit strategic plan. Of course, we wanted to do it all and we want to do it
all by next May, but I doubt that that will happen. Susan Kanaan is to be
thanked as having the greatest vision here about how to put together and phase
in some of our ideas.

Essentially, we came up with three key issues that can highlight our work as
it moves forward. First is crafting a vision of community health that includes
operationalizing the influences on health diagram and integrating the work on
social determinants and measures of SES as part of operationalizing that
diagram. Another theme that we heard was developing summary indicators of
health and well being for communities and individuals.

The second major piece of our work is we need to make sure that whatever
vision we develop needs to resonate with communities. We need to make sure that
communities invite communities not only to participate in item one, but help us
evaluate what they really need and where gaps remain.

The third major theme would be conceptualizing this infrastructure for data
use that would contain some of the concepts of the Folsom Report and what
really the federal government can do to provide technical and analytic support.
You can see the second bullet under that is small area estimation and web data
dissemination, something that Jim talked about earlier today and certainly
focus on converging and synthesizing federal data sources.

That was our effort to synthesize our generative thinking into a strategic
plan. Where we go from here is certainly getting feedback from the entire
committee today and as we move forward. In the morning of November 15, Thursday
morning we are going to have a planning session to help refine these ideas and
really try to hone in on some specific explicit paths that we can move forward
to ultimately craft our final work plan. That is where we are at.

DR. GREEN: Sallie?

MS. MILAN: I agree.

DR. GREEN: That was so clear. I want to thank you for that. Let me say this
back to you. You are on the verge of being able to answer questions that
Marjorie is likely to ask you about. What kind of meetings do you need to have
next year? What are we going to have to do? You are getting very close. After
this discussion to take that to Thursday’s meeting. Then you are planning on
laying out work for probably the next one to two years. Is that correct?

DR. COHEN: That is correct.

DR. GREEN: This is the committee’s opportunity to steer this one way or
another and state preferences. That is the question on the table. Reactions and
recommendations is what you are looking for.

DR. COHEN: Yes. Hopefully and for the other subcommittees’ work that is
integrative across not only a focus for us is the Populations Subcommittee, but
points of connection for entire work.

DR. GREEN: We have -– each of the subcommittees and the working group
points of contact that we are looking to tease out here. The floor is open.

MS. JACKSON: I will add a little bit to that. Thank you so much for
mentioning the ever present and wonderful Susan Kanaan who is here whose work
has been instrumental in providing infrastructure. Tamara just walked in. Your
name was mentioned earlier. I do not think you were here at that point. Tamara
pulled together this survey. She is the ultimate survey monkey queen who
organized it and analyzes it and pulled so much. It was totally out of my — I
wanted to make sure give her credit. Casey helped to pull together that
graphic, I think, at the end. It was such an amazing team product all the way
through.

When we put this on the full committee agenda as you can see several other
subcommittees will be responding and offer your own take as well on the
community. But what I saw including — project is it was one of the first time
that one of the subcommittees is kind of finally branching out and getting out
of a silo, something that our current chair has been trying to do for the
longest. We look forward to getting input along this line even developing some
of the slides. We were in a tension spot of are we talking about populations.
Are we talking about the full or some hybrid in between? And the meeting on the
15th is really going to help tease a lot of that out too. I just wanted to give
appreciation to the subcommittee for its openness and inclusivity as well as
opening it for the full committee to see we are creating a whole new hybrid
here and having a good time with this. Thank you.

DR. GREEN: Thank you. I do not think it is a breach of protocol, but if
Susan and the survey queen or any other staff that were involved with this,
could you just come up to the table for this discussion and join us?

MS. GREENBERG: Just following up, I would say I was out the country for two
weeks. I think it made them even more productive. There was really a lot of
energy and synergy and all of the above. I think that if you look at the title
of Bruce’s presentation, it is crafting the vision and developing the research
agenda. There is a lot here obviously.

As Bruce said, it cannot all be done at once. It does not necessarily all
have to be — certainly not in light of, as Debbie was saying, it does not have
to be done by the Population Health Subcommittee or the Quality Subcommittee.
Parts of it could be done in a cross cutting way across subcommittees. It does
not all have to be done by the NCVHS either. It is not really feasible probably
for it all to be done by the NCVHS both from the point of view of resources and
bandwidth and other reasons.

I do think what would be as others have said really helpful today and of
course if you are able to come on Thursday, but I knows Standards is holding a
meeting as well on Thursday and some of you will not be here for either of
those or you will be over there. We have been involved with this so much that
those of you who may be hearing this a little bit more for the first time or
have not been involved with the survey and everything else is to where you
really feel the committees as Harry Reynolds used to say. Sweet spots are. From
a point of view of prioritizing, what you feel is most advanced the themes that
the committee has committed to.

DR. GREEN: We will start with Sallie and come right around this corner.

MS. MILAM: I have a call for some feedback. I reviewed Susan’s literature
review, which I found really helpful to see what the committee has said around
these three themes in recent years. I was particularly intrigued in the area of
quality. I know, Paul, you have a conflict and cannot be here Thursday. But if
we could get your feedback so we can make sure we include quality in these
discussions and building other project to be helpful particularly if you see
where you see quality at the community level.

MS. GREENBERG: You have an opportunity to do that at 1:45, but I am not
going to say you have to wait until then.

DR. CARR: Nice work. I think following on that what we talked about of
having the themes developed it becomes the work of the community as you pointed
out. I do not see anything about stewardship in here. I thought we were going
to be cross cutting.

PARTICIPANT: I assumed that was the work plan for populations and that the
stewardship — that is actually the point I was going to make that the
stewardship, which was one of the top five in the survey analysis actually is
where privacy is going to be coming in.

DR. CARR: I guess the question and Paul would probably be asking this is
whether we need to be organizing this around the subcommittees or whether it is
around the work so that we do not lose sight of those important themes all
together.

DR. GREEN: One response to that is we have learned to actually change the
structures in the subcommittees has some bureaucratic issues.

DR. CARR: We do not have to do that, but I mean the work product continuing
to work together so that we have one work product that captures both the
privacy and the quality.

DR. GREEN: Until you guys push me off of this, we are going to use this as
the way to assign accountability and responsibility for forward progress. We
will let the accountability for moving the agenda reside with whatever gets
settled over the next couple of days with the co-chairs of one of the
committees. I think we have already reached agreement about this. This theme of
convergence basically is going to require the whole committee and the working
group to coalesce around this sort of stuff. It is not to say populations is
going to go off. They are going to hide somewhere in Southwest Idaho and then
they will come back with it. We are planning on trying to keep converging this
into where — actually it is not my inspiration. It is like the agenda is
driving us. We have just arrived at a point where the committee is going to
need to work very much like a committee of the whole for the next couple of
years. I think that is what you are looking for. That is what we are aiming
for.

DR. TANG: I am still a little confused. I thought we were working on this
project as a committee of the whole. I would have thought the survey would have
gone to the committee as a whole. I am a little confused, but then that the
fact that the meeting was scheduled for populations on the 15th, and
then — we cannot change our travel. Somebody could clarify that for maybe more
than one person, but I am not sure it is clear that this is a work product of
the community of the whole. And if so, we need to have the logistics around
that. That is all.

My clarifying question was of the menu of options for outcomes, is it the
intent that we do all of these or these are just some chosen? Which one are the
real outcomes?

DR. COHEN: Out of the menu of options, we sort of broke that down and tried
to synthesize those into these three broad categories. From these three
proposed work plan areas, we will develop a more specific work plan. We started
with eight and we tried to synthesize these into three work areas that covered
most of those.

I apologize for — it has been tricky as I said in the beginning whether our
task is to form the work plan for our smaller subcommittee or whether for the
entire committee. We were very schizophrenic in our approach. I thought
Thursday morning for those who could stay would be a chance to get more
feedback. Our intent was not to exclude anybody from these discussions and if
this framework is valuable for the full committee, there is no reason why
everyone cannot if this survey is helpful either use this survey or a refined
survey for the full committee to help create the space for us all to take our
pieces of it.

DR. TANG: I do not think we know what we are — what kind of —

DR. COHEN: I am still not clear.

DR. GREEN: Well, ask questions about it.

DR. TANG: Well, start with Justine’s question.

DR. COHEN: I guess when Sallie and I were putting this together, we thought
we needed to develop a plan for our populations subcommittee to move forward
and we wanted to make sure it was collaborative and integrative with the plans
for the data work group, the quality work group, standards, and privacy. We
thought that the kinds of themes that emerged from this discussion would lend
to all work in this space. That was sort of our intent not to tell each group
what piece it needed to do, but hopefully everybody could find projects that
would move us all forward together. That was the context.

DR. FRANCIS: What I was going to say is that first of all, I noticed and I
participated in the discussions. The stewardship point — it focuses on two
aspects of it. I am not sure that they would be the ones that I would grab
first, but they are certainly important parts of it namely data dissemination
and community characteristics. They are clearly important in any discussion of
stewardship.

This is just speaking for myself, but when Linda and I were talking a little
bit too, what we were thinking we would do is pick up on the stewardship
discussion and then interplay with populations and the full committee think
about where from the stewardship letter what is the piece that we can most
readily and usefully pick up. My assumption was actually when I looked at this
and from the discussion that in a sense what you were doing was you were
setting the stage for other committees to think that way. You have a tent and
then you have one pole and another pole and another pole and we are the
stewardship pole. The way you are thinking about is you were the what is the
data we really need pole and where don’t we have it.

DR. COHEN: It is a great way to describe it. To the extent that we stimulate
other folks to think how they fit into this broad framework of the vision for
the entire committee that is perfect. These were our brainstorming words. The
folks that we got feedback so far do not have the richness and perspectives of
the folks who are focusing on stewardship and quality and standards. To the
extent that this stimulates them to think about how to build their pole and
have us all put up the tent that is perfect.

MS. MILAM: Some of the other sub-issues on dissemination that were in the
survey, but not reflected in this report had to do with health literacy and
uses of social media and some other aspects of dissemination that probably are
outside the typical things you would find in the stewardship report.

DR. CARR: I was just going to say that I think we are learning how to
implement this, what we talked about as a road ahead. I think maybe the work of
the committee is describing the vision, the full committee. And then the work
of the subcommittees is taking the part that best maps to them. But I think
Paul maybe was saying is we are doing it now. It is getting everybody’s input
on is this everything. Does this capture the contributions of the full
committee?

DR. GREEN: By the end of the meeting tomorrow morning, we are hoping to have
gotten all the perspectives. The process of this is awkward and we are
transitioning from siloed work to more coherent integrated work. But coherent
integrated work is still going to require us to break off into work groups and
smaller groups that are taking the lead on stuff. We are just trying to massage
ourselves from where we were to where we want to land in 2013.

MS. KLOSS: I think back to the thought of convergence I really agree with
what Justine has said. I think it is important that we identify the overarching
goal or vision for the work that the committee is going to do. It may be in
this area and I think we talked about standards and harmonizing and laying out
that process and then plugging in the specific strategies or tactics underneath
that.

When I looked at this, I thought where is the work of the stewardship? I
would expect if we were crafting a vision for community health data use, one of
the explicit elements would be the — it almost feels like we still need to
step up another level and look at not only this, but what is the other three —
I think you come out of the retreat with three overarching goals. I think we
need to nail what those are and then start drilling down. I think that is the
way most organizations handle it. They get the high level vision and strategy
laid down and then start looking at how the organizational units will take
pieces of it, but work toward a cohesive —

DR. GREEN: Really well said. Walter?

DR. SUAREZ: Thanks. Something similar to what Linda has said. I think at the
end of the day when someone asks what is the NCVHS doing then there is three
major projects, areas, whatever we call them whether it is empowering
communities or the title that is used in this presentation, the community as a
learning system, whatever we call that, that is one area.

And then we have standards, which incidentally we will discuss. It is not
just HIPAA standards anymore. It covers public health data standards. It covers
standards and privacy and security. And it covers standards in other areas.
That is a way of turning around the traditional way in which we have been
working which is very compartmentalized with some cross connections on the
subcommittees and now be focused more on these are the standards domains and
this is the empowering communities’ domain. This is a specific project activity
and there is going to be a group leading that activity. That group could be
called a population health subcommittee or a joint population health privacy
subcommittee or something like that. But at the end, it really identifies the
specific work areas within the structure of the three themes. It builds on a
much more dynamic organizational structure. It is called project oriented
rather than subcommittee oriented.

I am hoping that when we talk later about privacy and security and when we
talk about standards, we will see that kind of context of saying the standards
subcommittee is not anymore sort of the standards subcommittee that way it was.
But it is more the — that facilitates or links work around standards and
privacy standards and public standards and HIPAA and other things.

DR. GREEN: We will have to have a contest to name our teams. Instead of
tiger team, maybe we have a kangaroo team. Survey monkey. I think I want to be
a koala team.

DR. MAYS: I have changed my mind for a moment because Walter was saying so
much and then there were just a few other things that I wanted to add. It may
be one of these things that what we are wrestling with is that the committee
has its full complement of 18 people. In having everyone, the ability to maybe
operate differently than in the past may be something to think about. And
Walter was starting again at something that I was going to discuss and that is
it may be the need for project groups, subgroups, or something and ways in
which like they started using a matrix, ways in which they come together at
certain points. But we cannot do that until I think at the high level.

I think that sounds like what we are struggling with now is we need
agreement from everyone as to what the priority is. Then next I think it goes
to the subcommittees to then say pieces that they think are important and then
I think the third thing is to then see how we would do it. Maybe we won’t do it
in the traditional is the whole population subcommittee, but maybe there is a
smaller ad hoc group that is one from every committee that is working on
something.

Then that way the notion of making sure that all the pieces are represented
in terms of having a voice will allow the work because we are really trying to
do work in an integrative way. I think that is what we want to try and do
structurally is to allow it to happen. I feel really bad about Paul’s comment.
I did not even think about it either. Everybody may want to do this. Now I feel
really bad for you. I really think that maybe we should still tonight or
something let people at least see it and say. It is pretty easy to redo that so
that we have it for tomorrow so that if those voices change the nature of that
then it is good. Let’s just do it early in the process. Thank you, Paul.

DR. TANG: First, I want to start by saying thanks to Bruce and Sallie for
doing this. I think it was a wonderful process. They came out with excellent
results. I think they were just as uncertain about how we want to structure
ourselves as we are right now. It was an excellent job of what they do. We just
need to figure out where you want to take us.

The other is going back to our discussion of the stewardship letter maybe we
should be the first to even pilot. We are trying to advise secretary you have
to do this. You have to think about this. You really ought to think about it
all together. That is a pretty tough thing to do. We are just experiencing
that. Maybe we ought to take a crack at how would you consider stewardship at
the same time you are considering standards and trying to get the information
useful to the community with quality. We ought to take our first crack. This is
a great opportunity just like Justine’s committee was a great first test of the
stewardship letter.

In order to avoid being picks in a tent, which to me sounds siloed, why
don’t we rename the project what community as a learning health system? It is
fine for Bruce and Sallie to take the lead, but it is just like our secretary
used and many projects. It has a name. It does not get confused with is this a
population or isn’t this. And instead of everybody having input it is sort of
and what are the stewardship considerations and what is the quality of the
community as a learning health system project. That just helps us get our —
because I think they found the trap of I think they had objective one, but it
was the populations subcommittee so they didn’t really know how to make sure
that was all inclusive.

I think we can use some of these structural ways to get our thinking a
little bit straightened out and clearer.

MR. SOONTHORNSIMA: Maybe my question is a little bit more fundamental. I
like the outcome section where you write everything down into three succinct
outcomes or deliverables. Maybe key questions. One, as you vet it through this,
do we know for sure that the work that we are about to embark on is not being
done already somewhere. If it is unique, great. If it is not unique, is it
complementing some of the things that are going on across the department?

MS. GREENBERG: As the executive secretary, that was a big input of mine
certainly. As I said, I came in a little late on it, but came from Susan too. I
do not know if it comes across so well because you start with crafting a
vision, but certainly the idea was. If you go back to here, menu of options was
to perform this, enhance environmental scan, and to review the literature. You
are still thinking in terms of that as a first step, right? It wouldn’t be that
you couldn’t do anything until that was done, but that was, as I understood it,
for the very reasons you said kind of an essential part of getting started. You
can be working on the vision at the same time. You might be able to start some
other project. I think we have agreed that that is an important step.

DR. COHEN: Yes. Susan has actually admirably started that with her review of
some of the literature, which was great. Yes. To answer you clearly, we do not
have the resources to duplicate stuff that has already been done. We will try
to identify where there are gaps and address those.

Paul, thank you for your comments. They were very helpful. I think this
whole discussion captured the issues that we were struggling, how to answer the
small O in our job as part of the population subcommittee and the large O in
our job as part of the full committee. And your comments really showed that the
options that we focused on were really small O options although the framework
was the large O. I agree with you that now is the time for us all together to
essentially — whether you use this or something else to really get very
explicit and clear what the large O is so that all of us can figure out what
our small O’s in our projects are.

DR. GREEN: I want to go to Linda. I want to give you heads up. I would like
to just ask for all the committee members for dissent about the content that
you are seeing. This group’s presentation was laden with content. We spent most
of our time figuring out our process. They need a heads up about things to work
on after tomorrow. I want to give everyone on the committee a chance to say I
am concerned about this or whatever before we move to Paul.

MS. KLOSS: I will use this then as an example. If the community health data
use is one of our several overarching committee-wide goals for the next couple
of years then I would expect to see underneath it a quality and perhaps a
standard and a stewardship dimension. But the goal is clearly a committee-wide
goal within dimensions. I would love to try that survey, but I think it would
be richer if the survey were blown out and included the priorities and the
thinking of standards and the other groups and we started looking at that a
little more holistically with the belief that form follows functions. If we can
nail down what the key goals are then it will be pretty apparent how we divvy
up the work.

DR. GREEN: Thank you. Comments about the scope of work that were laid out,
the ideas that were there.

DR. TANG: The tweak of that is instead of wearing one hat, why don’t we
bring multiple representatives but one project team? It is not only divvied up
work amongst siloed groups in one tent. Just like the committee is formed. You
are formed because we have backgrounds, where we are supposed to be people
representing the things that we know about, but not stay in our silos because
then we are just limiting the output I think.

DR. FRANCIS: I want to ask a question actually and I do not know if it is a
dissent, but it is an observation. When you look at the outcomes menu of
options that you all have put together for populations, it really looks like
you are focusing on how do we do the good data development. That may be the
right way to focus for you all. For example, what I do not see — I see, for
example, developing survey questionnaire bank. You are figuring out how to do
the kinds of surveys that are needed. But I do not see is anything here that
addresses the gap side of it.

MS. GREENBERG: If you operationalize the influences on health schematic —
excuse me for interrupting, but I will — as a conceptual framework, that is
where you start seeing gaps.

DR. FRANCIS: Maybe that is it, but it does not say that. Identify needs for
local infrastructure. That could where you are identifying needs, but what
isn’t here is questions about where don’t we have data as much. Maybe it is
just how I am reading this. Instead of troubleshooting problem solving trying
to stimulate what is missing discussions, it looks more like this is well we
are going to go out there and design the surveys.

DR. COHEN: I will take a quick first if that is all right. On the outcomes
and our synthesis, item two is studying leading edge communities to see what
they are doing around needs assessments and identify what gaps need to be
filled. There are different levels of abstraction. Some of that menu list was
high order and some of it was really specific tasks. It was just all kinds of
generative ideas that folks had that we just listed. They were not in any order
of priority or hierarchy or consistent level of abstraction. Clearly, there is
stuff that got left off that could have been on that list.

DR. MAYS: This is kind of I guess piggybacking really on what Leslie has
also talked about. In terms of the scope, Marjorie had made a comment about the
doing the literature review stuff could be done and other things at the same
time. I honestly think that the review is critical because there is a
tremendous amount of work in terms of community health even in the area of data
that is currently going on. I think on my survey I even threw some of that out.
I think it is like identifying the gaps that fit within what this committee’s
purview are is probably the most critical thing for us to do because there is
lots of need, but in terms of building on.

I was just looking at this health indicators report, which goes through and
talks about all the different measures of community health that have been done
and they identify all these different survey and stuff like that. CDC has a lot
of work in this area in terms of community health and they have been concerned
about the data. There is big funding that goes on for match. The place that has
done a lot of the work also is in terms of the IOM has been asked quite
frequently to comment on this. I think we really have to find a way to
synthesize a lot of that to then see the gaps or to see where the policy needs
are that the committee would be well posed to really recommend to the
secretary.

MS. MILAM: I just wanted to thank you, Vicki, for your thoughtful comments.
We did see your comments at the end of the survey where you identified the work
that others have done with communities. We called those out and did discuss
them. We recognize that the gaps are critical, but it sounds like we did not
highlight that enough in our slides and we will definitely — on Thursday when
we develop the work plan, we will make that explicit. I know you will be on the
call, but want to thank you. You identified two or three other groups, areas
that had done research and we do want to make sure we fully understand what
they have done.

DR. SCANLON: This is going to be a broken record. If I any issue of dissent,
it is the issue of our bandwidth. I have said that how many times. You are
hearing it again. Maybe the other word you can use for it is our altitude. The
more global we get the higher up we are. The question is how useful is that to
the department. As an advisory committee, what does the department need from
us? It needs in some respects our collective expertise and the work that we can
provide to the department, which is where our bandwidth comes in, which is
relatively limited.

There is a need for a global perspective or a global vision. But at some
point, you have to be in a silo working to solve the practical problem. And if
the silo is big enough, you actually make a contribution. You have to worry
about whether or not when you are the solving the problem in that silo, you are
creating some externalities that are negative with respect to the rest of the
world, but you got to get down to a level where there are things that are going
to in some respects move the vision forward. But if we stay at too high of a
level all of the time then we do not move anything forward.

Now this notion that we are going to divide up into subgroups and come back
and consider things as a body, I think that is illusory too. This meeting is a
good example. It is a typical agenda for our meetings. We basically have seven
and a half hours here as a full committee focusing on things that we are doing.
That is seven and a half hours.

Larry, you used the phrase that we got the information this morning out of a
fire hose. I would not want to take the quiz in terms of how much I understood
coming out of that fire hose. To me one of the examples was there were several
references to data for the exchanges. I actually spend not a huge amount of
time, but time working on issues relative to exchanges. I could not define for
you what data that were being talked about that are going to flow through those
exchanges. I can talk about what health plan gets in terms of claims and how
things are paid. Exchange is not going to be paying claims. There is a risk
adjustment function that is built into the law that the exchanges are going to
be engaged in. But the data are not necessarily going to flow through the
exchange.

There are these issues of these things that are coming for us and there is a
question of how much we can collectively understand. In my mind, there needs to
be enough focus that as the body of 18 that we can actually deliberate on it
with enough content to be able to come an informed decision that is helpful to
the department. As I said, it is my old broken record and I apologize for
saying it again, but you called on me.

DR. GREEN: With pleasure.

DR. MAYS: This is a little different, but it is a suggestion that eventually
I wanted to put out and that is as we do this focus on community data, is it
not possible for us to have a community representative that is at the meeting?
There are plenty of national community groups that are in DC area. I would like
to throw that out as one of the voices that if we are going to do this work, it
may be that we do not always need to have to bring in people in a hearing, but
we need to have a representative of groups that represents these groups.

MS. GREENBERG: Certainly, we need to engage as the committee has during its
development of the report and have to continue to engage. We cannot actually
add a member to the committee. We have 18 members. We cannot add somebody. We
do have some people on the working group who have a community focus. I think we
should look there first. I do not know exactly what you have in mind. We cannot
identify someone just who will then just keep bringing to all the meetings. We
have to be — integrity of the committee. But certainly making sure that you
get the input you want is essential.

The bandwidth thing kept being my — I kept going back to during this
process once I returned and got involved. I want to reiterate that. I do not
want to talk about process really because Larry said we are not talking about
process right now. And the forum should follow function and all of that. I
think some combination of the visioning and then moving the vision forward. I
thought that was a very good way of putting it. I do think that we have to be
really conscious as you are deciding. I think this is a nice research agenda
and yet we heard it was incomplete because it was by necessity from the
perspective of the population health subcommittee, which was appropriate. But
now that it is why it is being brought here and you are getting more input.

But then I think at the end of day we do have to figure out what would move
it forward. What would be the highest priority, one or two things? On the one
hand, I like the idea of smaller working groups, et cetera. That assumes that
we have really more resources than we do because if you split — instead of
having three or four subcommittees you then have maybe eight groups. Each one
of them might want to have a hearing or something. We do not have that kind of
bandwidth or those kinds of resources.

Part of the survey was looking at what sources. Not only do we think this is
a great thing to do, but we actually think it is something that is doable. You
have to balance it back and forth. And like often happens instead of making it
smaller, we have made it bigger, but I think that is okay at this point. I
really did see this as beginning to lay out a vision and a research agenda for
that first theme, then standards and convergence sort of fit in. But the most
topical theme is this one, community. I think that we are getting there.

DR. GREEN: We are right on track actually, but we are out of time. We have
40 minutes. We must honor the agenda and turn the meeting over to Walter and Ob
at three. I ask for your indulgences and your cooperation. What we really want
to do is hear from Paul and then Leslie and Linda with a particular focus on
the content areas that they are talking about and the issues that they want to
surface. Listen carefully to the issues.

Agenda Item: Incorporating a Quality
Agenda

DR. TANG: I will try to go through this quickly. I believe the assignment
was to review some of the past letters from quality and see what the agenda has
been and how that might apply to this committee. I am not going to talk about
the hearing per se. It is in your hand out. We started out with a hearing in
October 2009 talking about the meaningful measure supply chain. Taking quality
measures as they exist today knowing that they are not fully meaningful. What
would it take to make them meaningful?

Out of that we had letters. This does not look like it has the updates that
I had. The testimony really highlights. You see that in bold. The good news is
there are a lot of efforts going on in quality measures. The distracting use
was that they were not actually coordinating at all with each other. This
created silos. What is the penalty of silos? Lots of redundant work, lots of
lack of comparability and lots of burden for the provider. Not greatest of
outcomes despite the wonderful intentions of all the work being done.

Observation number one was that we do not have a national strategy for how
would we get a few good measures in a sense. Measures that matter to the people
they are trying to serve. At the same time, decrease the burden on the
provider. The recommendation was that HHS developed a national quality
performance measurement strategy and/or designates somebody already in the
business, for example, AHRQ. We did not say that, but some entity that we did
not want to create a new thing, but something that would organize the national
effort in quality measurement.

A second observation was lack of standards. If you have lack of standards
then even everything you report on cannot be compared for your own benefit or
for the benefit of the country. The recommendation there was to create a
library of specifications, a place where the measures’ definitions and the data
elements would reside in a standard format.

One example of that actually is the NQF at the time was called quality data
sets, not quality data model. But we just needed some place where everybody
could draw from. An additional value would be if they had a place to draw from.
There hopefully would be less temptation to create new because that is the
situation we have now. Everybody is creating new for the best of intents.

Observation three was that the EHRs even though they captured theory, a lot
of this rich clinical data, it is not easy to get it out. The recommendation
was for ONC to require EHR vendors to make it easy to get out. As you know,
that is one of the goals of meaningful use.

Another hearing in 2010 had to deal with what is the information we really
need that we might be missing. Whom do we need information from and whom do we
need to serve? Here, the bottom line is that health reform is talking about a
new way of delivering care. It is team based. It is patient centered. It
involves coordination of care. And lo and behold, our measures are provider
centric and none of the above. We found ourselves in a quandary saying we have
the opportunity to reform care. We have the opportunity to pay on something
different. We just do not have anything to measure the something to pay on
different. It is set up an urgent need to get away from the legacy measures.
That is a big statement. It is not to tweak them. It is really we have to
actually change from the legacy measures. We would love to leverage the new
electronic capabilities we are putting in place with the EHR incentive program.

Observation one is consumers, one of the biggest consumers of this
information, actually do not have information that they would like to have to
make their decisions whether it is what plan or what provider or what
treatment. We have to give them some information. You are seeing how this going
to apply to community learning system. Once again, most measures are directed
toward providers. How are we going to turn that around?

The recommendation was to prioritize the development of measures that are
going to be meaningful especially to consumers rather than continuing on the
same path that we are on, which delivers process measures for providers. That
is a huge task, but it is the one that came out of a meeting that started out
looking at how do we serve the needs of health reform and saying we better make
sure we have the consumers, the patients satisfied.

Observation two also in the name of reform is we have very few measures that
measure value. That is the benefit to the patient considering the cost and we
rarely have access to, which is one of the reasons we do not consider the
indirect costs. For the patient it is all the time it takes to get off of work,
loss of productivity, loss of income, et cetera, to get what we call care. The
recommendation was to fund development of these new kinds of measures that are
going to serve us better under health reform.

Observation three is that despite the fact that much — there are whole
departments in even a hospital let alone the health system that works on
quality measures. It is not feeding anybody. It is not feeding the providers.
It is not feeding the patients. We really need to fundamentally change the
kinds of measures that are developed and that is where the recommendation comes
in to assess the accountability and hit one of the biggest gaps we have which
is care coordination. That again is under the principal need under health
reform. If we are going to team-based care be accountable for us, we have to
nail care coordination. That is one of the biggest voids we have in the
measurement system.

Observation four has to do with the comparability of quality reports.
Reports are really helpful to the extent that they are credible with the people
you are trying to change and that they can track themselves compared to other
people they consider their peers. Lack of standards, lack of common
definitions, even lack of the way it is implementing EHR goes against us. And
yet nobody in the measurement supply chain wants that to be true. The
recommendation was really to convene all those folks in the quality
measurements domain to work together to find a way to create an infrastructure
that everybody can live off of. That is a need that people recognize, but
nobody goes to recommendation one or the very first letter, which is there is
no overarching national even standards let alone coordinating organization.
People individually in their silos like we were talking about would like that
to happen. That was a recommendation.

Next hearing and the final one we talk about is measures — we just sort of
label it. Measures that matter to consumers. Part of the reason we did this is
you have the previous work for the quality subcommittee saying we do not
actually have the right measures and the right measures have a lot more to do
with consumers than we have been paying attention to. Here, we are asking what
would matter to you as consumers. We have a number of different perspectives.

The key observations. One is that consumers, the people we are trying to
serve are flying blind. What information is coming out whether open or
transparent is not the stuff they need to make their decisions. The second is
that part of the reason is that we have not done the underlying research to
know how would we design measures for consumers. One of them was to use
user-centered design when you both design and test these measures to see if
they are useful to consumers. Some of the observations that came across loud
and clear from almost the get go is what is the first thing a consumer has to
decide. What health plan to choose because that actually cascades. It affects
who can they go to and then what procedures can they get. In a sense people are
getting hung up from the very start on open enrollment, whom do I choose from.

We turn that into lemonade by saying there is something called insurance
exchange that is coming on board right now and there are standard reports that
are being specified. Can’t we write these so that a consumer can digest them?
This basically was one of the biggest ask. Can we write measures and
information in a standardized format so consumers could just like they can turn
around the soup label and see the nutritional information? Can we, one, make it
that standard across all the plans? And, two, could someone like the insurance
exchange make a comparison tool so you can see here is for the 30 top
conditions here is how it would look in these five plans and this very
standardized format. If we are going to standardize, which we are for insurance
exchange, why don’t we help — somebody come figure out how it would be useful
to a consumer making their very first choice, which is what insurance company,
what insurance product to choose from.

Our recommendations follow from that. The first is to say HHS should take
advantage of this insurance exchange rule making process to specify measures
that are going to help consumers make those decisions. Second, have model
reports so they would have both the information, the data, but importantly the
tools to compare the different plans so they can make those decisions. In
addition, since each plan essentially limits the provider, the providers
covered by that plan should be linked. These are all fitting in the model from
the consumer’s perspective. How do they get decisions made that are going to
affect their health and the health of their families?

The third recommendation is that HHS — it piggybacks off our initial letter
— should find a way to help encourage the collaboration needed by the entities
in this business so that we get more standardized measures that are going to be
comparable across plans and providers.

You can see that the theme is that the legacy measures we have are not
serving the initial purposes. The reason they got there is because they dealt
with the data that was already there, which was claims and administrative data.
If we are going to put in the EHRs, we are even paying for a lot of these to be
put in, if we are going to stand up insurance exchanges, let’s take this timely
opportunity to really reset and actually do new measure development of the kind
that is going to help the population to individuals and the population. That
seems like that could dovetail as part of the learning communities. I think
everybody is hungry for data that could alter their decisions. I guess the
upshot you are hearing from these letters is we do not have it there. We need
to start now. There is a long need time and HHS should play a major role in
somehow instigating and facilitating this effort.

DR. GREEN: Thank you, Paul. What a tour de force to travel over a lot of
territory in a hurry. Thank you. Reactions, comments, clarifications?

DR. TANG: I want to thank Matt for preparing the drafts of these slides.

DR. GREEN: Thank you, Matt.

DR. CHANDERRAJ: I think Paul’s comments are very well made. I also like to
reinforce the point that he made earlier this morning. You have to have a buy
in. The term was — I learned it from my wife recently being a controller. Buy
in by different people that are involved in this process. The consumer, the
provider, and the community. All of them have to have a stake in what is in —
the only reason EHRs have been successful because of the incentives given to
the doctors and in spite of that some of the physicians are opting out of it
and refusing to take Medicare patients because the penalties for Medicare
participants is minimal. They say it is less expensive for me to take the
penalty rather than participate in the process. It is so ornery. It is so
redundant. It takes away from what the provider is there. The physician has to
do with the patient. There are so many complaints coming out now that most of
the providers are paying attention to the computer screen than what the patient
is talking to them.

Rather than enforce and put penalties on the providers for not providing
them, you incentivize them. Unless you do that which is a herculean task, I do
not think any of this will provide any meaningful change in the outcome of
people’s lives.

And the third part, the biggest player I think is the media. The media is
publishing all kinds of information to the patients. They have to be a provider
or they have to be a stakeholder in this discussion to what is meaningful to
the public to consume. That should be a big role.

DR. GREEN: You are not Jim Walker. Matt?

PARTICIPANT: One of the things in looking through this that struck me is
that when we had our first hearing on this topic back in 2009, this was on the
precipice of meaningful use and what we saw was measures, measures everywhere,
but not a drop to drink. I see such a convergence of this document. The
community is a learning system using local data to improve local health and
what we were doing there. Our number one recommendation from that was
coordination.

I think the real challenge for us as we do this is we have identified
communities and we have great examples from this hearing of where communities
are serving as that lever or that engine for improvement and change using data,
using trust, using their unique role at the community level to actually improve
and impact health outcomes and that is unique. We have said that not too high,
not too low, right here in communities.

The challenge is that among infrastructures, pieces of the infrastructure
that are missing or are nascent or are uncoordinated, our quality measures
there is also the trust framework that we talked about this morning. There is
also just how to work together. There are standards issues. I view this as a
really practical kind of project where these two come together is to build on
what we have done here and said here are some recommendations.

The challenge I think though is that some of it is going to be
recommendations to the secretary to fund research or to do this or to do that.
Others of it is actually coordinating activities that are going on at HHS and
elsewhere and us serving as an entity to do that perhaps holding hearings and
saying folks in this part of HHS are doing this and folks in this part of HHS
are doing this and they are both doing similar things, but not exactly. By the
way, there are these folks that are doing — these folks not connected here who
is perhaps doing it better or doing it in a way that has achieved results.

I think the thing that has been rattling around in addition to the
governance mechanism for how we approach this is the role of NCVHS in doing
this. At the end of the day, what we all want to see is turning the vision of a
community as a learning system into a reality. How do we as the committee
actually make this happen? Some of it is going to be hearings. Some of it is
going to be bringing things together that we know are the right way and saying
we should do this and others of it is going to be gaps where no one really
knows how to do it and recommend funding or something else.

DR. FRANCIS: It seems to me that one of the interesting open questions is
the extent to which improvements in the quality of care or in the information
given to patients about the quality of care do or do not and I emphasize the or
there correlate with improvements in community or population health. I think it
is at least possible that you could have quality improvements that do not
correlate particularly well or that possibly even correlate negatively with
overall improvements in community health if there are distributional questions
about who gets access.

One of the really interesting questions posed by the data issues that Jim
was bringing up this morning that are of interest to the department over the
next few years is is there going to be a translation between improvements in
access and improvements in community health. What are going to be the links
between access and quality? It does seem to me that I do not know where you
take this, but it seems to me that a very interesting possibility is to
consider what information and structures for dealing with that information HHS
needs to get its hands around those problems.

MS. GREENBERG: Leslie said better what I was trying to formulate, and that
is — what I was trying to formulate was obviously all of these recommendations
and it was very useful for you to bring these back in this way and thanks to
both of you — are ones that the committee voted on and agrees with. I do not
think we have gotten much feedback on the other hand as to respond from the
department.

There are two pieces here. Mike Fitzmaurice was not able to be here. He was
providing testimony somewhere else today. I really think it is important for
the committee to engage with AHRQ, but they have the lead for quality of care
agenda in the department. What is needed to take some of this forward or where
is it misguided from that point of view? Where should the priority be? That is
one piece. I think we have that responsibility as a committee not to just put
recommendations out there, but to see which ones have resonated and which ones
have not and why and whether there is something we can do to push things along,
et cetera.

Saying that, the question I was having was how do we fit some of this or the
highest priority parts of it or maybe the parts having to do with health
information exchanges, maybe the parts having to do with consumer focus. How do
we fit it into this big vision we are talking about on the community as a
learning health system? It clearly fits. That is a part of a learning health
system is you learn from what you have done and hopefully it improves what you
do the next time or you also inform what needs to be done. I think it has to go
into the vision if part of what is done is building this vision and scenario.

I think that is the challenge if we really are going to do future work
primarily related to these three big themes, which is really the community and
then of course the standards and the convergence. There is lots of standards
stuff going on here. There is clearly convergence stuff too. I think that will
be the next challenge with you and Matt and others who have worked with the
quality agenda and then hopefully the quality subcommittee and one or more of
our new members to work it in to empowering community’s agenda.

And in fact, that aspect of it is less daunting than trying to get everybody
on the same page in the country because we have not had too much luck with
that. I think it could relate to the models. It could relate to the case
studies. It could relate to a lot of different things. I would hope that that
would be the intention to try to bring it into that theme.

DR. TANG: Two comments. To Marjorie’s, I think one of the adds is we do even
when we consider community. We are talking about it from a population health
point of view and we may be under playing the benefits to individuals in the
communities. That is probably one of the things that we should insert.

MS. GREENBERG: And that theme was including individuals and families. It is
not just populations.

DR. TANG: I understand, but it is very tempting to take only a population —
and the other piece about — an interesting point about Leslie’s point is the
quality measures — first, the administrative quality measures on process — we
just have to throw that out. But the basis for thinking about quality measures
in the future is to have the population in mind because we are looking at a
model of “ACO”. When you are managing a population that incorporates
access because you cannot actually manage your population. I just wanted to
point that out. The new quality measures have a lot of these things that we
have to strip out and have silos that will be all in one because its outcomes
oriented at a population level, at a community level really.

Marjorie, I was just going to make a quick comment and say that although
AHRQ is probably the lead with regard quality measures and quality indicators
projects there are lots of other HHS entities that are funding directly
community-level quality improvement or transparency or improved health system
projects — communities from ONC, lots of stuff from CMS, Indian Health
Service. There is this panoply. I do not know the extent to which they are
coordinated, working together, using the same measures, et cetera.

MS. GREENBERG: That is something we should try to get into our environmental
scan to understand better.

MS. KLOSS: Paul, you touched on the point I was going to make. I think the
focus of the quality activity in our health care organizations is on the cusp
of major change away from the highly cleaned up measures of accountability to
the population health management and cohort analysis and all that goes with
that. That has huge data overlays and new skill sets. We heard from Todd Park
when he was here the last time that we do not have the data analysts and the
capability to really do that kind of work. I think it has implications to our
agenda as the advisor to the secretary on issues of data. There is a whole host
of new issues surrounding population health analytics and clinical analytics
and BI and all of the things now that are just really becoming a core focus for
most health care organizations.

DR. TANG: I forgot to bring up a really important point that came out of the
hearing. We work at population and it is basically average of aggregates, which
of course it means it pertains to no one. From an individual if I am a
diabetic, I am either a brittle diabetic, I am well controlled, I am a type 2
and type 1, but that is how the individual feels, how do I make decisions about
where to go. Yet we have stratified everybody to a nobody, and that was a
really interesting perspective that came up at the hearing.

Quality measures ironically should not be risk justified. They should be
stratified so I can see “patients like me”. And then I can make
better decisions that I would think apply to my family. I just wanted to make
sure that that message got back.

MS. KLOSS: I would just make one more point here. I think that the analytics
is moving toward identifying anything to heighten variation for a better
analysis of data. I think we are moving away from those very vanilla measures.
Then that brings up a whole new set of —

MR. SOONTHORNSIMA: If Jim Sorace was here, he would say there is no patient
who is exactly alike. We reviewed all this before and I think we are pretty
much in agreement. Here is another thought. Maybe our call to action is trying
to look at this thing as glass half full. Looking at all the things we already
have whether it is AHRQ, NCQA, or whatever they are not perfect and maybe this
is how this committee could help connect the dots leveraging the opportunities.
For example, HEDIS report — can that be useful? Not today, but maybe you can
call — I do not know. But the point is maybe that is what you were saying,
Matt.

MR. QUINN: Communities today are struggling to do this and they are going to
do it. They are doing it. We just want to give them the tools to do it —

MR. SOONTHORNSIMA: How do we take little steps where little steps are really
necessary instead of just trying to reinvent everything? And leverage. On
Thursday when we talk about convergence, when we talked about administrative
data and clinical data to help transform whether to support ACO, whether to
support the health care reform and what not. That is, I think, where the leap
we can make, but in the mean time you are kind of stuck in the middle. We are
not completely using all the quality “information” that is available
in the data. But it is not going to be perfect. Maybe there is a way for us to
define little steps, connecting the dots, something that might be helpful.

DR. TANG: We would want to reuse all of the infrastructure. You already give
reports to your folks. We just want to keep incrementally replacing the
measures inside of HEDIS that align much more with the consumer would use or
the provider.

MR. SOONTHORNSIMA: To your point, you do not give a HEDIS report to a
consumer. You transform it somehow to make it meaningful. That is all it is.
That is connecting the dots. I should also be on the ball for the future stuff
five to ten years from now what that quality information whether it is going to
come from SNOMED, how much of that is going to come from ICD-10. I think that
is where the real opportunity lies.

MS. MILAM: I will be quick. I keep coming back to the concept of community
of solution. And think about how quality measures define community or what
community is defining what quality measures. I keep coming back to the health
plan or the health care provider with their market share. I wonder how that
interfaces with it at the community or population level. The quality measures
we have been talking about are based primarily on the clinical encounter. When
we look at what impacts health and health care at the community level, it is so
many other things. The environment, socioeconomic status, a number of other
factors.

A report that Vickie circulated to populations in the past couple of days
talked about how to value — what are the community’s value and a visioning
process for getting to that value. I think that would be something interesting
for us to explore further with Vickie’s help on Thursday about — I love this
slide. I keep coming back to it. The convergence slide. The intersection. You
have an individual component. You have the provider component. You have the
population. When we talk about communities, I see that as subsuming the
individual, but as a separate issue for quality, separate from individual
quality or the impact on the individual and the impact from the provider.

DR. CARR: I am sorry. I stepped out of the room so I may be completely off
the point. I actually wanted to respond earlier to Leslie’s point about quality
and population health because I think they have been almost not minimally
overlapping in the past because what we measure is silos, certainly the bulk of
measurement in the hospitals and that. I do think with the measurement set that
came out of the Accountable Care Initiatives really begins again. There are
four parts. One part is the patient experience and the other parts are health.
Keeping people healthy and preventing complications and then managing high-risk
patients. But I think that for the first time if we do all those things and
prevent hypertension, prevent renal disease, prevent all that end stage, we
will affect the health of the population. It comes together nicely.

DR. MAYS: Unfortunately, Bob Caplan could not be here today because he has a
conflict with NSF and I just want to kind of put something out that I know his
office is doing. They are trying to make sure in terms of electronic health
records that there is this behavioral electronic health record part to it. And
pat of this goes to this whole notion of the patient’s value, the patient’s
encounter, and the patient’s satisfaction. And the focus really is also going
to be in terms of well being and quality of life.

I just want to make sure that as we are thinking about this because once you
were talking about really needing to have — the legacy of data being more for
the provider, but now that we actually have to do it for the consumer that is
one of the things that we really should keep in mind. I do not know if he is
going to be here on the phone for Thursday or not, but there is a whole
development underway at NIH. His office in terms of EHRs and the National
Institute on Aging in terms of developing these measures of well being.

MR. SOONTHORNSIMA: I think quality is a nebulous thing. There are so many
areas that we have established in medicine as quality factors like tight
control of diabetes will result in better morbidity and mortality. Time and
again, any study that looked at it has shown that not to be true. Obesity, for
example. Obese people live shorter lives, but they survive better with cancer
and better with heart attack. What are the real factors that influence a
particular individual with — it is published and studies are good. But
individual counseling with a physician is the best way of reaching any
population or patient. There are several studies in and out showing vitamins
are totally unnecessary for anybody. The problem in this country is not under
nutrition. It is over nutrition. And still 90 percent of people want vitamins.
I might offend somebody by saying this, but this is a fact. Physicians are
bought into it because of the money factor. A lot of physicians do not know
what to do with a patient with dizziness. It is a frustrating symptom. They
just say take some multivitamins. You will be fine.

What I am saying is that buy in of the patient or buy in of the population
has to be incentivized and the best way to incentivize is to protect the hub of
the health, that is, the physician and — each individual patient has a better
response or he behaves better when he hears it from his own physician, which
whom he trusts rather than any governmental standards or any public health.

DR. GREEN: We seem to have reached a propitious moment. No tents up. No one
grabbing a microphone. Let’s wrap this up. First of all, I want to thank you
all for what I thought was a delightfully constructive and wide-ranging
discussion. For you guys that stimulated it with your slides, thank you very
much.

I have a feeling over the months to come I will be doing this over and over
again, but Leslie and Linda, I have to ask your forgiveness. I think we need to
skip what we were going to do here and put it off until tomorrow morning. I am
going to be optimistic that in that time slot that we have we will start off
with the letter and then we are going to approve that letter relatively quickly
and then we will resume the conversation. We have two of our groups that we
have heard from today and we will hear from two of our groups in the morning. I
think we can get that done.

Two other comments and then we will take a break and I will turn the meeting
over to Walter and Ob when we come back. Maybe you did not hear what I just
heard. One of the underlying themes was all of us are saying after a century of
breaking things up into parts and doing all sorts of stuff here, there, and
everywhere, we have reached a point where we need to put it all back together
so that we can have healthy individuals living in healthy families living in
healthy communities. There is a time for reduction and drilling down and
getting to the smallest parts of things. There are other times in the rhythms
of life where you have to put all these things back together again so that they
are meaningful and they lead to better lives.

We have run across a lot of proven concepts like it has been a while since I
heard quality and access come up as triangulated pillars of effective health
policy. It happened here again today. The references back to the Folsom Report.
How many of you know what the name of the Folsom Report was? It was not called
the Folsom Report. The name of it was Health is a Community Affair. Sallie
called out its core concept and it is problems sheds compromise individual and
population health. But the problems do not know how we are organized. What
communities have to do is they have to organize themselves into a community of
solution depending upon the nature of those problems and these problems tend to
be local just as some of you physicians were talking about individual people.
They are not an average diabetic. They are a particular diabetic. That is the
way communities are too. It is not just every community. It is a particular
community.

I have the sense that our convergence theme has been served to some extent
today. I am getting to this point of feeling pretty good about where we are. We
have also done a lot of nitty-gritty work about everyone staking out how they
want the process to go moving forward. From my perspective, we got quite a bit
done today. I want to express my appreciation.

As many of you know, I collect quotes in meetings all the time. I will
probably afflict you with these over the months to come from time to time. But
I want to share three that happened since noon. Paul Tang said we are supposed
to be people. Someone else said you do not give a HEDIS measure to a consumer.
I love this one. We have risk stratified everybody to a nobody. You guys are
quite articulate and I appreciate the passion and the insights you bring. We
will take a break and we will come back at three and move to Walt and Ob
reconvening us.

(Whereupon, the meeting adjourned.)