[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
November 14, 2012
National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782
Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
caset@caset.net
TABLE OF CONTENTS
- Call to Order, Review Agenda – Dr. Larry Green
- Privacy Community Health Data Report – Dr. Leslie Francis
- Standards as a Continuing Theme for NCVHS – Dr. Walter Suarez and Mr. W. Ob Soonthornsima
- Role of the Working Group – Justine Carr
- Remarks by the Chair and Feedback – Larry Green
- Summary Steps and Future Directions – Larry Green
P R O C E E D I N G S (8:15 A.M.)
Agenda Item: Call to Order, Review of Agenda
DR. GREEN: Good morning. A quick count, we are one shy of a quorum. I bet
that solves itself momentarily. Let’s do our usual routine here. We’ll start
with Lee over here, and run around and do the introductions.
DR. CORNELIUS: Lee Cornelius, University of Maryland, professor, I have no
conflict.
DR. CHANDERRAJ: Raj Chanderraj, private practice, no conflicts, member of
the full committee.
DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the
full committee and member of the subcommittees on population and privacy, and I
have no conflict.
DR. COHEN: Bruce Cohen, Massachusetts Department of Public Health, member of
the full committee, co-chair of population committee, member of quality
committee, no conflicts.
MS. MILAM: Sally Milam, West Virginia Health Care Authority, member of the
committee, no conflicts.
DR. CARR: Justine Carr, Steward Health Care, chair of the working group, no
conflict.
DR. GREEN: Larry Green, University of Colorado, chair of the committee, no
conflicts.
MS. GREENBERG: Good morning, Marjorie Greenberg, National Center for Health
Statistics, CDC, executive secretary to the committee.
MR. SOONTHORNSIMA: Ob Soonthornsima, Blue Cross/Blue Shield Louisiana,
member of the committee, no conflicts.
DR. FRANCIS: Leslie Francis, University of Utah, co-chair of privacy, and
member of the full committee and member of populations, and no conflicts.
MS. KLOSS: Linda Kloss, member of the full committee, co-chair of privacy
confidentiality and security subcommittee, no conflicts.
DR. SCANLON: Bill Scanlon, National Health Policy forum, member of the
committee, no conflicts.
DR. GREEN: Before we go to our guests, anyone on the phone? Okay, let’s
continue here.
MS. BERNSTEIN: Maya Bernstein, I work at the Office of Assistant Secretary
for Planning and Evaluation, and I’m the lead staff to the privacy subcommittee
of this committee.
MR. LAZARUS: Steve Lazarus, Boundary Information Group, representing CAQH
core.
MR. BARTO(?): Pete Barto, Price Waterhouse Groups
MS. KHAN: Hetty Khan, National Center for Health Statistics, CDC.
MS. FLEEGER: Lauren Fleeger, Department of Veteran Affairs.
MS. PHELPS: Ruth Ann Phelps, Department of Veterans Affairs.
MS. KANAAN: Susan Kanaan, writer for the committee.
MS. JACKSON: Debbie Jackson, committee staff.
MS. COOPER: Nicole Cooper, staff to the committee.
DR. GREEN: Okay. Well, we have got, in some ways, a potentially busy
morning, and in other ways, a potentially less intense morning than we had the
day yesterday. What we are going to get done this morning is we have two other
groups that we are going to hear from, in terms from our themes of communities
as learning health systems, the convergence and standards cutting across
everything.
I will remind that you we are in a transition of our process. We had pretty
discussions of it yesterday, where we are transitioning to a period of work, in
which we need to work mostly as a committee as a whole, bringing perspectives
of quality, privacy and security, population health, standards, to the work. We
will complete an open and public discussion of the viewpoints from those four
perspectives before we leave today. We will have heard from each other, and had
a chance to have conversations among ourselves about how this looks.
The Privacy and Security Group, and the new Working Group, will be
presenting their viewpoints today. The first thing we are going to do is wrap
up this letter. It is my intention that we will be done 20 minutes from the
time Maya starts talking. I ask your help in meeting that deadline, so we can
get on with the other important stuff we need to do.
MS. BERNSTEIN: How about from when my co-chairs start talking?
DR. GREEN: As I alerted the members yesterday, towards the end of the
morning, as we start heading toward adjourning the full committee, I am going
to ask you to let me run the table, where each of you weigh in as to what you
have heard over the last day and a half, and to flag anything that you
particularly want to flag, raise any issues you wish about either the content
of the work or the process of the work.
Another thing we’re going to do today is review a template for the steps,
making the steps explicit that we expect to put ourselves through when we are
preparing a letter for the Secretary. A rich oral history, a rich tradition
over decades, the committee doing its work, this is not an abrupt departure
from the ways things have been done. It’s more of trying to codify it and
everyone have a shared understanding of where we are in the preparation of the
letter, and how we’re going to get it done.
That is it for the morning, I think. Marjorie, anything else? Oh, also,
don’t mishear this, but Marjorie said that maybe we should have a chairman’s
fund. When we meet here, the amenities are, let’s see, I need to choose my
words, sparse. We’re indebted to our staff for having coffee and some snacks
here. Given the policy that we need to meet in government space, et cetera,
many times we are going to be here, and one of the things we might want to do
as a committee is just all make a personal donation into a fund or something,
that the staff could spend on arranging us to have juice and coffee and stuff.
Actually, anyone opposed to doing that? This would amount to levying a new tax
on the American public.
MS. GREENBERG: This is common apparently among some NIH committees, where
they just have what they call a chairman’s fund. It’s modest.
DR. GREEN: Someone blurt out a number from the membership about what could
be our initial seed funding for this, per person?
MS. GREENBERG: We can almost always meet here, because we are not restricted
in reserving the space in advance, et cetera. The Humphrey Building is very
uncertain. It’s usually our first choice, because there are a lot of people who
report to the committee from downtown and all that.
We also always reserve this space as a backup. We are required to use
government space, unless we get a waiver, and I would say we would have to save
that for a really good reason. Other government space that we’ve been told
about, because we’re not affiliated with those agencies or those organizations,
it’s not available to us. This is pretty much what you see is what you have.
DR. GREEN: By unanimous consent of the committee, so we are not talking
about where we are going to meet. We are talking about establishing a fund to
finance coffee. Some of us who are not particularly morning people, actually,
this is like throwing a lifeline to some of us. We will declare our intention
that it is a voluntary contribution of $20. Marjorie will be the treasurer of
the fund, and we can start it today before you leave. You can hand her 20 bucks
if you’ve got it, or you can do it next time.
She will be our official manager of this. She will inform us when we have
drunk that much coffee or whatever, and that it needs to replenished. If you
don’t want to participate, that’s just fine. I mean you say, I never drink
coffee and I never eat a coffee cake, or I never eat oranges, that is totally
fine. No harm, no foul.
We have some other folks. Walter, do you want to do the routine?
DR. SUAREZ: Good morning. I am Walter Suarez with Kaiser Permanente, member
of the committee, and no conflicts.
DR. GREEN: I think it is about 8:28, and we were going to start with the
Privacy Community group at 8:30. Let’s start two minutes early.
Agenda Item: Privacy Community Health Data
Report
DR. FRANCIS: We had time yesterday and hopefully have taken everyone’s
comments into account. I think the sensible thing to do is to just go quickly
through the letter, and show you what we have done.
MS. BERNSTEIN: Forgive me. I am a little bit under the weather. Some of the
small editorial changes had been given to us by Vickie, and we hadn’t yet
incorporated them. You will see some of them, for example, here in the letter.
In the third paragraph from the beginning, there is some language here that was
given to us, I guess, by Justine, in cooperation with Marjorie and Jim, after
the meeting yesterday, to kind of give some more umph. I don’t know how that
came about.
DR. CARR: It wasn’t with Marjorie and Jim.
MS. BERNSTEIN: Okay. Justine gave us some language yesterday, which we
incorporated in the beginning, to give a little more support to the reasons why
we are doing this now, what you see up here on the screen in red and purple.
DR. FRANCIS: The red is as you gave it to us. The purple was, there was
something that just didn’t quite work grammatically.
MS. KLOSS: Maniputable. We changed it to flexible digital.
MS. BERNSTEIN: Does anyone have any comments or questions about that
addition?
MS. GREENBERG: Do you think maybe you should read it?
MS. BERNSTEIN: That paragraph now reads, communities today are using digital
data to tackle important health issues, in ways that were not even imagined a
few years ago. Dramatic changes are occurring in the use of data by and about
communities. Digital data are growing exponentially, and data formally stored
in static documents are now being made accessible in flexible, digital formats.
Communities are eager to leverage these resources to increase understanding
about themselves, and opportunities for improving their health. These
developments should be cultivated and guided by responsible data to stewardship
practices. Okay, and then, it goes on. We had a comment on this section, to add
a footnote with increasing the emphasis there, but we actually added that
footnote in the recommendation section, we will get to when we get down there.
DR. FRANCIS: This was Vicki’s suggestion about referencing the recent IOM
report. We were trying not to footnote in the introductory paragraph, which is
why we put the footnote in later.
MS. BERNSTEIN: Moving along.
DR. FRANCIS: We decided not, just in virtue of length, not to put in the
list of the framework elements up front, Justine. Although you had suggested
that, we just thought the punch added the punch, and that was enough.
MS. BERNSTEIN: In the introductory paragraphs, before we get to the
elements, we took out the word, principles, which we had decided before, we
just missed that one.
MS. KLOSS: We searched the rest of the document for principles, to make sure
we had transitioned. This was a little confusing, as Justine pointed out, that
we were using words interchangeable, elements and principles. We made sure that
that was more consistent.
MS. BERNSTEIN: Right, and here, at the end of the second section on purpose
specification, Bruce asked us to alter the language that was here, here at the
very end. What we realized when we saw that suggestion was that we had
duplicated this language in two places in the section.
You go back up in the earlier part of purpose specification here, we
specifically took out the example that was there, in favor of a more clear
example, having to do with asthma data, collected in community, later used in
combination with other data, to explore potential allergens or toxins in a
community. We just decided that that example was more clear and didn’t raise
some of the problems that had been raised by the other example. For some
reason, it got sort of tacked onto the end of this purpose specification
section. We actually just took out that sentence. Hopefully, that relieves the
language problem that was there.
Here we have some corrections from Vicki, and a conforming change to the
following sentence, to make it flow better, about how we refer to American
Indians or Native Americans, and so forth. In the data integrity section, data
integrity and security, most of these changes are mine. What happened was we
were talking about adding the concept of evaluating your risks in advance, and
then incorporating mitigation of various kinds. We just reordered this section
a little bit to make that fit.
We still have the concept of integrity, I mean, most of this is editorial.
We still have the concept of integrity and security, but we wanted to
incorporate the idea that you start with an evaluation of your risks, the ones
that you can anticipate, and then make a plan for mitigation of those risks.
And that those things should be evaluated somehow on an ongoing basis. We wrote
these risks should be evaluated periodically.
Essentially, this section is the same, it has just been moved, that second
paragraph. We go onto talk about data integrity, as we did before, and then,
end in the same way. I changed the word deidentified to not identifiable, just
so it doesn’t get confused with the HIPAA standards.
MS. KLOSS: I think these changes also bring more emphasis to security in how
we have covered this.
MS. BERNSTEIN: What I tried to do actually was say that integrity is one
aspect of security, that there is confidentiality, integrity and availability
of data, that it should be there when you need it. Each of those are three
parts of security that are important, and we had focused mostly on integrity. I
wanted to make it a little more balanced, which the co-chairs agreed.
DR. FRANCIS: This was primarily the discussion with Ob and Sallie.
DR. CARR: Could I ask a question? At the end of that section four, much of
the use of data goes onto talk about deidentified and data merging. Yet, that
is a whole separate section, two other sections, protecting deidentified and
risks of enhancing data sets.
One of my suggestions was to just collapse actually six and seven, which is
really protecting identity, either through small data sets or through proper
identification. I didn’t realize you actually also mention it up here. It is a
long letter.
DR. FRANCIS: I will tell you why we mention it here. The data integrity
question is whether you handle the data in such a way that you don’t, for
example, destroy accuracy or validity. What we talk about later are issues of
risks of being able to draw inferences about individuals, which is a quite
different issue. We wanted to call out in this section the security issues that
are raised by data aggregation.
DR. CARR: One other friendly suggestion is just that, as you go through the
eight headings, they start out with attributes of a steward, and they go on
things that can go bad. I was just thinking of it in terms of an attribute is
protecting identity, as opposed to calling out what you say protecting
deidentified data and risks of enhancing.
It is like we have changed the types of elements, from openness,
accountability, et cetera. Then, we have taken a new concept, which is to
introduce risks. I would just see collapsing those things that the attributes
we are aspiring to are openness and transparency, and protecting individual
identity. That was what my thinking was, in terms of that, because all of those
headlines, they are not quite the same.
MS. BERNSTEIN: You mean six and seven are not the same as the earlier ones?
DR. CARR: Well, seven, in particular.
DR. FRANCIS: Seven, we could just say, attending to the risks of, and we
have done it.
DR. CARR: Or protecting identity.
MS. BERNSTEIN: That is not the same thing.
DR. GREEN: Let me weigh in, Justine. The impurity of the classification
scheme of the eight things, I don’t see as a problem. I mean, the concepts do
vary, just exactly like Justine is saying. I don’t think it weakens the letter.
We are at a place that knows a lot about classification. By definition, all
classifications are arbitrary.
If we want to let our classification scheme morph a little bit, about
whether we are dealing with an attribute or something else, I don’t see that as
a fatal flaw of the letter, personally. Let’s keep looking at these and that
adjustment you just made, Leslie, maybe we will do another one of those
someplace. Let’s keep going, Maya.
MS. BERNSTEIN: We are in the section on data integrity and security. Do you
want me to read it? The section on data integrity and security, data stewards
should ensure the security of their data, including availability for their
intended use, their integrity, and when appropriate, their confidentiality.
Responsible data security starts with an evaluation of risks that can be
anticipated, and a plan to mitigate those risks by including protections that
prevent loss of confidentiality, alterations of data that would make the data
unreliable, or the unavailability of data when needed. These risks should be
evaluated periodically.
Mitigation techniques include physical, administrative and technical
safeguards to ensure the integrity, availability and, where appropriate, the
confidentiality of data. Implementation of these safeguards varies with the
data in question and the context. For example, encryption is a technical
safeguard that may be applied to health information of identifiable patients,
to protect both confidentiality and integrity, but may not be needed to protect
the confidentiality of population-level data. Nevertheless, even
population-level data may require protection against physical destruction or
malicious alteration.
The next part reads as it was. I can continue reading, but you are good. The
rest is as it was. This just got moved. Are there any more comments or
questions about that section?
In accountability, we had a question that Paul raised about enforcement, and
we actually added that. Where did we add that?
MS. KLOSS: Redress. We added it.
MS. BERNSTEIN: I might have messed this up. I’m sorry. In some cases, when
we agreed on a correction, I removed the comment about it. Now, where did it
go? We added a sentence in the first paragraph of accountability, that said
these responsible entities. Let me go back. We had already stated in the first
paragraph under accountability that accountability requires identification of
the person or entity responsible for stewardship at each point in the life
cycle of data, from initial collection and use, wherever it is safeguarded, and
following through dissemination of results, and if appropriate, the safe
archiving or disposition of raw data.
Then, we added, these responsible entities should consider mechanisms for
enforcement and redress, in cases of failure to meet data stewardship
responsibilities. We wanted a general statement there, that identified, without
being too specific, some mechanism for redress, and that the entity that is
responsible for stewardship at the point in the life cycle would be the
appropriate entity to consider whatever those mechanisms might be at that
point.
DR. FRANCIS: We were also careful to say just should consider, not anything
stronger than that.
MS. BERNSTEIN: And mechanisms, leaving it open-ended, what type in
particular.
DR. FRANCIS: Maya, I just noticed something. It should say Arizona State
University not Arizona State.
MS. BERNSTEIN: Okay. In the recommendation section, if we can move on.
MS. GREENBERG: Just read the recommendations.
MS. BERNSTEIN: Okay, I will do that. Recommendations. NCVHS recognizes that
the Department is making unprecedented efforts to facilitate the use of data.
The Department is also playing a leadership role in establishing public-private
partnerships to advance data use. NCVHS believes now is the right time for HHS
to advance a stewardship framework for community health data uses.
Communities are innovating in their use of health data, and governments at
all levels are increasing efforts to disseminate their data. These efforts can
help communities promote improvements in health, health care and other
meaningful quality of life issues. Do you want me to read them paragraph by
paragraph, or the whole?
The committee recommends that HHS, one, facilitate the development and
promulgation of models for stewardship of community health data. HHS might
facilitate this development through pilot projects, demonstration projects,
grants, case studies and the like. Two, support the development of dynamic
guidance resources that compile best practices, this is awkward actually, but
we will fix it. That compile best practices, experts, communities and other
data users are learning about stewardship.
NCVHS has identified the following high-priority areas for resource
development. How-to examples in case studies about deidentified data, data use
agreements and their enforcement, risks of disclosure in data reporting,
including information about risks of data aggregation and the methods for
protecting small groups, when data are analyzed in small cells. Methods and
best practices for openness and transparency, community engagement, and closing
the loop with communities.
DR. FRANCIS: We tried in this just to disaggregate different concepts. That
is all that is going on. There is no change in the recommendations. They are
just separated out.
DR. GREEN: Let’s go to number three.
MS. BERNSTEIN: I can go on. We can talk about the beginning part, if you
like. Three, compile case studies of results that communities achieve through
their uses of data, so other communities might learn and be inspired. Four,
promote the creation of training materials for researchers who collect and use
community health data.
Where is the footnote that we dropped in here?
DR. GREEN: Committee members’ responses to those? Bill, are you comfortable?
MS. BERNSTEIN: We will just end with this paragraph. It says, data-supported
health improvement is a nationwide concern and a priority for the department,
but stewardship underpinnings remain weak. NCVHS is committed to advancing the
stewardship framework, and is considering how it can continue to help the
departments study and implement these recommendations. Sincerely, Larry Green,
M.D. We can probably take out his quotes from yesterday, which I put there,
because I wanted to remember them.
DR. GREEN: Marjorie, do you spot any critical issues to surface?
MS. GREENBERG: Copy the Data Council and, once approved, we will get it off
to the Secretary and the Data Council.
DR. GREEN: Leslie and Linda, any other things you wish to surface?
MS. BERNSTEIN: We normally send it to the executive committee, just to make
sure that it’s neat and clean, before we print it, right? Okay. I will be happy
to work with the executive committee on doing that.
DR. GREEN: We would welcome a motion to approve this letter.
(Motion passed)
DR. FRANCIS: Thank you, everybody.
DR. GREEN: Again, we will follow the usual process that has been used for
years about this. Marjorie and Maya, they will get this into proper shape to be
transmitted. We will use the usual transmittal procedures.
DR. SUAREZ: I guess the question is what is next?
DR. GREEN: Thank you very much, Walter. I think that is what we should do
next.
MS. KLOSS: It is fortuitous that we didn’t get to this agenda item
yesterday, because the set of recommendations that will trigger the discussion
of what next changed a little bit at the end of the day. I think this is
actually the right time to be having this discussion, after we close our work
on the letter.
Just for the sake of completeness, what we did hear was step back and look
at the subcommittee’s assessment of, we called it recent activities and future
directions, but we did a year ago take a look, was it a year ago?
DR. FRANCIS: Yes, it was about a year ago. Maybe it was last February, but
anyway, it wasn’t June or September.
MS. KLOSS: It was a year ago because it triggered, so last year, at the
November meeting, the subcommittee met. We really went through a 10-year
retrospective. We looked at everything that the subcommittee had done over the
past 10 years. Maya pulled out from all of that work, and prior letters and
prior reports, sort of the key themes, which we walked through, and we are not
going to dwell on those.
For background, know that we have done that inventory of where we had been
and where we have come, looking at key themes and all the stakeholders. Again,
we won’t discuss each of these. The prior work of the subcommittee on
identifiable health data that is not in the medical records, secondary uses of
data, recourse in the case of inappropriate secondary uses, the new business
arrangements, considerations there, international ideas, and here we were
incorporating some of the brainstorming of issues that certainly were emerging
and of interest.
Deidentified data, governance of exchanges, surveillance systems, extending
the community health data report, best practices for privacy, lessons from
Gina, public health emergencies, breach notification and discussion of patient
identification. We did a full assessment, both through historical work, as well
as brainstorming, on what the contemporary issues are.
DR. FRANCIS: This was the template from which we worked to then get going on
what we have done this year. We thought it made a lot of sense to go back and
see what the subcommittee had brainstormed a year ago.
MS. KLOSS: We settled on moving forward with taking the next steps from the
community health report. As you know, and as you have seen this slide before,
we held hearings. We learned some very fundamental lessons that we hope
certainly are well-represented in the letter that you just approved, or at
least we are setting out on that journey.
We came out of that April hearing with some new insights into issues that
communities were dealing with, leading to this set of recommendations that we
just looked at. Our co-chairs actually, because we actually didn’t have an
opportunity to have a broad discussion about this with the full members of the
subcommittee, so we hope that we can do that now, as a committee of the whole.
Leslie and I, as we thought about this, we think that the logical next step
for the subcommittee in a convergence spirit would be to facilitate or tackle
the description of models, so recommendation number one. Through collaboration
with the population subcommittee ideally, and our thinking is that, to the
extent that the subcommittee on populations goes back and updates the vision on
what is happening, and how the community projects are evolving, the issues with
regard to privacy, confidentiality and security would be one dimension.
I think as we have thought about this over the last period, that that would
be the next logical large chunk, not to design models, but to describe models.
DR. FRANCIS: What we were thinking, and we would welcome input from members
of the subcommittee, as well as from the full committee, what we were thinking
was that, first of all, it is something that we are urging the Secretary to do.
Second of all, it is something that we have the bandwidth to do. Third, what we
could do is we could actually identify some communities. They might be beacon
communities, they might be other communities, where we could actually look to
see almost as use cases how elements of the framework are being implemented.
The plan would be to have a hearing sometime in April, hopefully in
conjunction with, if Populations is also doing something like that. That is
where we are. I am going to be in a position to have some law student research
assistance in the spring, so at least that places some additional bandwidth,
although we probably, depending on how far we go, need some staffing to do
things like contact the relevant communities, and work with them and talk with
them about what they might have to say about addressing aspects of stewardship.
I think our experience, when we did the initial report, the CHP report, was
that we asked communities about whether they’d had any issues with privacy.
They all said no. It just wasn’t a salient question. I think one of the things
we are going to find is that it actually is an issue, but it is an unrecognized
one in certain ways. They are doing really exciting things, but that they
wouldn’t conceptualize it that way, and so, we are going to have to have some
conversations with communities, to see what is out there.
The goal of doing this would be to see what’s out there that might be
helpful to other communities.
MS. KLOSS: Also, to use this framework that we have just approved, as a way
of getting to those discussion questions, at a more granular level, than just
asking them, do you have any issues with privacy? If we ask questions about how
do you implement or integrate accountability, what are the issues? What process
do you go through before you make a decision to merge data bases?
I think we can get to a set of questions now, keying off the framework that
would make that a richer discussion.
DR. GREEN: What are your questions and comments?
DR. MAYS: I guess my question really has to do with what the community wants
and needs, and what this committee wants and needs. I kind of came in late to
the community report, so I think I was starting by the time it was written. As
you were saying, there were some other things that seemed to be high priority
for them, that were in there.
Things like their data being linked, things like I think, in terms of, at
least what I hear, things like electronic health records and how much things
are sent around. I think, to some extent, I guess I am asking the question of
the way you are posing the question may not be the way the community has major
interest, as opposed to the way the community is really pushing the question.
It may not be about population and community health data. It may actually be
more about administrative data, and being interested now in how their EHR data
is used and sent, and all of that. I am just asking based on what, at least I
remember, was discussed, as a priority for them. I sometimes think it’s hard,
if you get the community going, and they ask for things, if they respond to
what they want.
DR. COHEN: I would like to follow up on that. I think it might be more
useful to try to educate communities around these issues, and raise these
concerns, rather than trying to get feedback from communities. I totally agree
with you, communities aren’t focused on this, and it is a hidden issue. I think
our role would be trying to figure out how to improve the visibility and
concerns around these issues, rather than try to get feedback from communities,
who have already started.
I think that would have more long-lasting impact, to bring this to the
attention as folks move forward. I think we really are in the infancy of
communities using the kind of data, where these stewardship models are really
important. Most communities still focus on secondary data, in many cases where
these issues have already been addressed, as we have discussed before. I think
really the focus here is on dissemination and education for communities.
DR. FRANCIS: I think what we were thinking, and maybe this isn’t
inconsistent with what you said, is that part of the way that you educate
communities is you have examples for them to follow, or for them to consider
what pieces of the example they want to use themselves. That is what we were
thinking about doing, because if you just hand them this stewardship framework,
that is not going to work to educate them. They need to have some sense of how
it works on the ground.
I was using the idea of a use case, maybe even developing use cases.
DR. COHEN: I think that makes sense. I think it is going to be difficult to
identify communities that have grappled with this issue. That should be the
primary direction, and then trying to expand that, or even create some models,
synthesis, of folks who have worked on different aspects of this.
MS. KLOSS: I think we heard in the testimony last April, an understanding of
some of the issues. No community, perhaps understood the breadth, but they had
had some experience with some of the issues. I think it would be a composite.
We thought the models were important, because part of the struggle that this
committee went through in this letter is that the breadth of types of
communities that are being covered, and so now, if as you say, we have sort of
some clusters or some use cases with how the framework applies in that
circumstance or in that sort of circumstances, it might come to life more.
DR. GREEN: Sallie and then Marjorie, and then I want to give you a heads-up.
Susan, I would like you to comment about what you are hearing here in just a
minute.
MS. MILAM: A lot of what I had been thinking, Vickie and Bruce have already
said. I like the idea of hot topics. Like Vickie mentioned the linkage issues
and those other issues. I think they find a home nicely in our framework. I
think we can attach it to that. I don’t think we need to go through every
element of the framework, because some are more obvious and are well-settled.
Others are more challenging.
I guess when I look back to the testimony we had from the communities,
privacy wasn’t a huge area of discussion for them because it hadn’t been
something they focused on. When you look at literature for communities and
support, privacy and security has a small line, a sentence, a paragraph. It
hasn’t been a focus. It hasn’t been a risk that they’ve been actively analyzing
and assessing and mitigating.
When I think back to some of the testimony, in one community in particular,
it was interesting just from a personal standpoint to follow some of these
communities, through list serves that you are on and through articles that you
read. One of the communities in particular, who felt like consent was not a
huge issue for them, I saw later, like maybe a year later, had to retrace their
steps and then implement consent, because of objections that they received.
When you look at our framework, it takes resources to implement. It is
privacy by design. You put in the beginning of a project, you can bolt it on at
the end. If you don’t understand the advantages of doing it and the importance
of doing it at the front end, why do it? If you haven’t had a risk or an
objection, it is a large resource load for a project.
I think it would be interesting to hear from communities who have actually
grappled with it, and had to appreciate the risks, and to understand why do
these elements exist, why are they important, what is their function, and to
maybe illuminate some of that. I think that could be a pretty hot topic, along
with the linking of the databases and the issues around anonymization and
aggregation, and those other topics.
MS. GREENBERG: I just wanted to support that, and say that I think what we
are hearing is that the principles, the framework, in some ways, they seem sort
of abstract without a context. This started as a joint project, and we
discussed yesterday how this stewardship, framework and these activities and
issues really need to be integrated into the overall theme on communities, as
learning health system or empowering communities.
I know part of the overall work plan that Bruce and Sally mentioned
yesterday does involve, at some point, bringing back in communities, some ones
that you met with, and possibly others. That, I think, would be the opportunity
to try to do some of this. Rather than sort of, in the abstract, to be in the
context of the issues about data, and data use and engagement, then,
stewardship is a piece of that.
It is a use case or it is a case study, where you are not sort of abstractly
discussing these things, but you are actually working through how the
principles apply or don’t apply. I definitely would recommend that, as opposed
to separate hearings, just on the topic.
MR. SOONTHORNSIMA: I am reacting a little bit. I like what Sally is saying,
and trying to hone in on some of the points she was making. Perhaps, stepping
back and looking at what are we proposing to do, and with whom, and what
problems are we trying to solve with that entity, whoever it is.
If you start with that, and whether that is going to help accelerate our
cause here, because we are trying to figure out what the next step would be. I
don’t want to get in the weeds, but maybe the committee can think about what
problem are we trying to solve right now, and with whom, that is really going
to matter for them.
Right now, to your point, you were saying, oftentimes it is an afterthought
when it comes to security, let alone to stewardship. I wonder if it is even
doable for our group, or the staff, or whomever, to come up with, here is the
targeted audience, or the with whom.
DR. GREEN: Let me try to connect what I have heard the four of you talk
about, and then pass this down to Susan. Some of you weren’t involved in the
organic work that actually produced the material that led to this letter. It is
very much like the way that Vickie was talking about this.
We didn’t make this up. What actually happened is, we sat around the table
like this, and we looked at each other and said, who here knows of a real
place, a town, somewhere in the United States, where they seem to be working on
figuring out how to use data and improve the community’s health? Before we left
that day, we had over 40 nominations, just from the people sitting at this
table.
We then prioritized those in rank order, to look for some dispersion of
different types of communities, geographic dispersion and that sort of stuff,
and deputized someone to go to the trouble to call people at those communities.
We had our top list, and then we had a secondary list. We made the assumption
that on short notice, and unprovoked, and then having no clue what NCVHS was.
We called them up and they say, are you kidding me, and hang up.
To our surprise, the first 14 communities we called said, you are damn
right. When is it, where is it, and we will show up. We never got to our second
list. Those folks came in, and we asked them, tell us what you are doing. What
problems are you facing?
Then, Susan, in the midst of that study period, she actually called
leadership at each of these places, and did intensive interviews on these
folks. I would like to ask you to make any comments you want about this.
MS. KANAN: Thank you. I think the first thing I would say is, sort of in the
abstract, I think, well, first of all, yes, the topic of privacy and
confidentiality was very definitely a non-starter in these long, very lively
conversations. There really just wasn’t much, communities just didn’t have much
to say, that is absolutely true. We had a whole block of questions that we
wanted to pursue, but it just was not a fruitful topic. That much is very much
true.
I think there might be some potential to frame this in terms of prevention
now. We have a positive reframing, which is much more fruitful, because you are
talking about actions, rather than reactions. Public health people understand
the notion of prevention, and so do health care people. I think there is some
really good potential there.
I do remember that Minnesota, I imagine you are probably thinking about the
Minnesota, Olmstead County, I think. We did have a couple of interesting case
examples. One of them was there, where they have had a long-standing alliance
between education people and public health people, where they are actually
sharing data around child health. They had to reconcile two different sets of
privacy regulations. That is one of the communities to call to your attention.
The other thing that I was going to say that I see kind of in the abstract,
and also in our work in my own community in Mendocino County, is I think there
are some interesting disconnects or challenges around the fact that communities
are getting more and more access to very valid, reliable, secondary data from
state and national sources.
That, at the same time, is helping them identify gaps in what is known about
their local communities. Stimulating people to gather more information at the
local level, to fill those gaps. I am not a statistician, but I suspect there
are all sorts of issues around validity, reliability and privacy, and all sorts
of issues, as communities try to plug in these holes, with data that are not
the equal of the other data. That is another issue that seems like it has some
interesting potential.
DR. GREEN: Thank you.
DR. MAYS: One of the things that I think would be useful is to think about
what does the community want, and what does the community think about what we
have done? I think at various points, we have talked about how do we package
things to go out. The community hasn’t really responded yet to the report. I
mean, and I don’t want to get too innovative here, but I mean, just some
communities would respond if there is a YouTube. Linda was the person who
really gave us a lot of ideas about how to get it out.
I guess I am a little concerned, before we get too far down the path, of
deciding kind of that this is a great stewardship model, maybe they like it or
maybe they don’t. Or we get too far down the path of selecting a topic, based
on kind of the narrow 14 that you heard from. If there’s a way to make this a
lot more public, and I am not going to suggest to officially solicit, because I
thought that was a very onerous process.
MS. GREENBERG: We have done that in the past, sometimes on a draft or a
pre-final, or on a final. I think this segues very nicely into the topic of
dissemination. We agreed, well, even actually to start with the end in mind,
just like privacy by design, dissemination by design, should become sort of the
modus operandi of the committee. Of course, the member who helped us think
about dissemination and start thinking about it more, in a more systematic way,
was Linda. She has met the enemy or whatever.
I think it would be perfectly reasonable, and you don’t have to stick with
just those 14, because I think we have had relationships with well beyond that.
We will finalize the report, we will submit it to the Secretary, it will go to
the Data Council. We talked about Jim, it would be an opportunity to present it
to the Data Council and get feedback from agencies, as to what their reaction
is and their buy-in or partnerships that they might want to work on training
materials, models, I don’t know, whatever. I think some of them might
definitely be interested.
Then, send it out, I mean, we will post it on the website, but send it to
these communities with nothing onerous, maybe a few questions as opposed to
just let us know what you think about it. I think it would be worth it to spend
a little time, thinking about how you would want to disseminate it, and you
could definitely solicit feedback from them. It’s only appropriate, really.
DR. MAYS: I agree. I just didn’t know if we had the resources to do that. I
think that one of the easiest things to do is the community campus partnership
network has hundreds of different groups on it. I think for what you are
talking about, that’s probably one of the best networks.
DR. FRANCIS: I think it would be enormously interesting to put out something
that says we would really love feedback about where did this strike a chord,
where are you experiencing issues, where could you use help. And would you be
interested in participating in a discussion about this issue, sharing your
experience, helping us think through what kinds. The idea about models is not
prescriptive, it is illustrative. Helping us think through what kinds of
illustrative models might be helpful for other communities. Sort of putting
that out, almost listserve, I think would be fantastic.
DR. MAYS: I would suggest you make it very focused. The expectations that
you will create, people will tell you their problems in the government, they
will want you to intervene. I would just be very specific, and make it about
what the product is that HHS could really handle.
DR. GREEN: I have a question. Does anyone not want to put your tent up?
MS. BERNSTEIN: I just want to reflect a little bit. My sense from the
hearings that we had in the April, and before that, was that when we talked to
communities about privacy, that they don’t think of privacy in the same way we
do, that they have a narrow view of this as confidentiality, for example, or
de-identification or consent. That what this work that we just finished really
talks about is the way I view privacy, which is more like fairness.
When you think about openness and transparency, or when you think about
purpose specification, for example, those things don’t have anything to do with
confidentiality, per se. They are part of a whole panoply of things that gets
you fairness. I think that’s not the way we necessarily approach communities.
They don’t think about it in a sort of an organized way that we did.
They were thinking about all of these different things somewhere. It
resonates with me to say, well, maybe if we either ask them for things that we
could make into case studies, that then we could go back to other communities,
and say, here is an example of where these things might come up. A concrete
example, so that you can attach these ideas, so maybe we could get a broader
interest in it somehow. Maybe that is a place to start.
DR. CHANDERRAJ: The most resounding need at the hearings from several
communities was money. I think that is what they need most. They were very
enterprising in each community that can identify the problems and template them
into the needs.
What the need is money. Maybe we should advocate to facilitate a stewardship
to see if we can get that money to them, to private partnerships, with some of
the foundations. Most solid data from Olmstead County was because of the
participation with the Mayo Clinic and some place in Washington, I think, had
collaboration with the University. I think we should have a stewardship in
guiding some of these people.
The people like Johnson Foundation or somebody can provide them with the
resources that they need, that can generate most of this data. I think most
communities have very talented individuals, who can recognize the problems and
produce the data.
DR. SCANLON: I am having some difficultly in this conversation, sort of
trying to answer the question, what is the federal role here. Being a federal
advisory committee, it seems to me that that is a preeminent sort of issue,
sort of for us.
It is certainly not going to be one, as we talked about, that is
prescriptive. What we are talking about is being a facilitator in a variety of
different ways. The federal government is a collector of a lot of information.
We have talked about that at this committee over the years.
We have also talked about access to data sort of over the years. We actually
sort of seemed to be on sort of an upswing, in terms of improved sort of
access. We have, through this letter and sort of in this effort, have really
kind of set out sort of models. They are talking about setting out models that
are going to be good, in terms of use of some of this data.
The question now sort of in my mind is where do you go next, in terms of a
federal role. I think, as Vicki raised, there is an issue that we are kind of
also on the edge of transformation, in terms of information that is going to be
available, both in terms of what is linked, which dramatically changes sort of
the nature of information, raises up much different privacy, sort of in
security issues, than have existed in the past, as well as the potential
collection of new information. It is easier to collect these days than it has
sort of been in the past.
I think it is a very good thing that privacy and security were not sort of
these hot button issues, sort of at these things. That is the way we want to
keep them. The issue is in keeping them there, you have got to take
precautions.
You have got to think about sort of, as we are moving forward on a lot of
fronts, we have been very excited, there has been a lot of excitement at this
committee about sort of the dissemination of data, but ict is also raising sort
of new risks. Have those risks been appropriate factored into decisions, and do
we have the appropriate protection. Those are the kinds of questions I think we
need to be asking.
My only comment is, constantly keep in your mind what is the federal role
sort of in this.
DR. GREEN: Jim.
MR. SCANLON: I was thinking along the same lines as Bill somewhat, but I do
want us to be careful here. As we said previous, I am thinking of who else is
doing things in these areas at what level, and where is this something that is
needed, and where it is not needed. The last thing we want to do is make it
look like we are creating regulations, to make it even harder to do things. You
say it is not a regulation, but sometimes it is viewed as regulation, where a
formal federal body is sort of promulgation on what is stated.
Now, again, having said that, there are other folks who are working in this
area, I think obviously, but it is largely from the federal side out. ONC is
trying to figure out some of these issues in terms of electronic health record
information, de-indentification, governance. When we get to the point, if we
ever do, where we are sharing information electronically on a large-scale. They
are approaching it in terms of sort of modules, and clearly, they haven’t
solved it. Again, that is from the federal side down.
Then, CMS and other places are trying to use their data and make it
available. Again, that is the federal side. When you accept the data, you
accept all of the data stewardship, which is more than privacy, as well.
This is really meant for a different audience, it sounds like, at the
community level, who, for whatever reason, isn’t bound by or unaware of these
other data stewardship principles that either come with the data, or you have
to know about to begin with. That is not the research community, either,
because they are aware of this funded research. It is not the public health
community, because most public health agencies, at least many of them anyway,
are aware of these, as well.
I only want us to be careful in the messaging here, that these are not
regulations. This is the best thinking of a group. It is the first step at a
framework. It requires iteration. There is nothing wrong with information
sharing, and getting some of the groups together at workshops and hearings and
so on. I guess I would suggest a much more iterative developmental sort of
characterization of what these are, lest we almost look like, here we are,
trying to get people to use the data. I don’t want to make it look like we are
setting up what they might perceive as a number of barriers and regulations.
Again, I think this has to be almost one level for the communities. These
ideas that we have come up with, fair information, practices, they are familiar
to policy like us, they are not familiar to community leadership. Again, I
would just caution to sort of focus this in terms of messaging. It is not
regulations, it is the best thinking at this point. It is subject to revision.
Use it if it makes senses. Information sharing and convening are legitimate
roles.
I just wouldn’t want this to be interpreted as close to federal regulation.
Information is sometimes interpreted as regulation, as you know. I think my
concern is more the message in that we be somewhat cautious, and that we are
open to other ideas, having communities share their experiences and their best
practices, and reacting to this is fine.
Again, I don’t want this to collide with our very large, apparatus of
privacy and human research protection, and research methods and data quality
and all of that, that we already have underway. Again, in HHS, I am trying to
think. Bring this to the Data Council and what are they going to say? They are
going to say, we do this already.
This is really a different audience, right? This is not a funded research,
this is not grab research. It is not what CDC does, that is not what CMS does.
Again, we are sort of proposing some sort of protective framework for those
other audiences, which we don’t think are aware of it. I think it is a
messaging issue. I don’t think the principles by themselves are problematic at
all.
Again, I remember when AHRQ published a set of guidance for secondary uses
of data. It was largely interpreted as a regulation, and everyone was furious.
Number one, why is AHRQ doing this, and number two, if you make it so
difficult, we will never have electronic record, secondary. I think a light
touch is needed here. That is what the point I am trying to make. It is
information, use those mechanisms of convening and sharing information, and not
make the assumption that this is the final version. Other than that, I think
the substance itself, for these communities, makes a lot of sense.
DR. GREEN: I don’t be annoying to you, Jim, but it sounds like you have had
teenagers. We are actually going to need to wrap this up and get going with our
next group.
MS. KLOSS: Thank you for your comments, Jim. I think this is certainly in
the spirit in which this has been developed, and we are clear about this not
being a path to requirement of any kind.
I like iterative. I think that is a good way, when we are not sure what the
next step is. It seems to me that we have got some clear stakeholders for this
work, and that is the communities that took part in the hearing, and the
communities that took part in the April testimony, or the experts that took
part in the April testimony. If you look at that, we’ve got a most immediate
group of 30 stakeholders, if you will, or something like that.
It might be that step one on dissemination is to craft a letter and perhaps
some response to that inner circle, and say, we heard you, and we have tried to
wrestle with the issues that we heard from you. How well have we done in
articulating that? Here are some thoughts we have about where the committee
might move next, and just see if we could get some feedback. Maybe a series of
conference calls, or some other mechanism that gives us the ability to have a
conversation around these issues.
DR. MAYS: I would actually like to make a suggestion, which I think may get
at what some of the community’s needs are, and it kind of crosses the agenda,
at least in terms of population. We actually had hearings about this a long
time ago. That is the issue of security and confidentiality of data for small
communities.
One of the issues that often comes up for many communities is that we can
collect data. Let’s say that we are going to do it for Vietnamese women, or we
are going to do it for even African-American women in a certain community, in a
certain geographic segment. Well, what happens is that we can’t give them much
back. This is a major complaint by the community. We can’t give them much back,
because we have these rules of confidentiality, security, privacy. Sometimes,
when we have had some of the lawyers look at it, it is kind of a little further
than maybe is necessary.
The issue of trying to release data to communities, I think is a critical
issue that this committee could be very useful on, that then gets at a very
local. It is a much less of a national issue. It is an issue for the community
more so than it is. As researchers, we can get special permission. As
researchers, we can go in a secure data set. Even the Department of Public
Health can do those things. It is when the community groups want to use what
they think. This is why they talk about being frustrated, is we get asked
several times, but we never get it back.
I just think that that would be a major contribution to talk with the
community about those issues, as well as to work on looking at whether or not
we have kind of reasonable measures of protection. Most times, they are kind of
overdone, and they are inconsistent.
MS. GREENBERG: I agree that that is a fruitful area. Just getting back a
little bit, though, to this discussion about dissemination, et cetera. I think
I like Susan’s use of the word, prevention. I think a big aspect of prevention
is education.
First of all, I certainly think this is a valuable letter. I question the
assumption that everybody really, even researchers, communities, everybody
knows the right thing to do and does it. I am not saying that I think people
have ill intent, not at all. I think that all of these sort of stories that
show up in the press, et cetera, are just anecdotal evidence that everybody
doesn’t know the right thing to do, or doesn’t always do it, or doesn’t even
think about some of the stuff. I don’t think we should underestimate the value
of education and information. Not regulation, not top-down, but really, I think
that is a major role of the committee.
One thing you talked about maybe, and you even said a teleconference,
sending out a letter, whatever, maybe having a webinar, a small webinar, with
that group that did that other webinar for us on the community health data.
They might be interested in this, also, down the road. You have to be concerned
that we are not saying, we put out this framework, everybody has got to follow
it.
Another suggestion might be, Vicki had referred to several different
networks. They have meetings. There could be a national meeting, or even from
an education point of view from the committee, a state meeting where you could
present this. It is fairly low-cost. You send one or two people to present and
get feedback, have a seminar, like we did around the 60th
anniversary. We tried to kind of embed community things in meetings that were
already taking place. AHIMA might be interested. There are a lot of different
groups.
I think if we think of this as an educational, an awareness, and an
opportunity for us to learn, as well as to share with people our thinking, that
I think this would all be to the good, and not top-down, not threatening.
DR. SUAREZ: I am going to take it back to the beginning, because I am trying
to understand, if someone were to ask us, what is NCVHS going to work on with
respect to privacy and security. I am trying to pin it down to these are the
one, two, three projects.
It seems that the last 20 or so minutes have focused on specifically the
topic of the follow-up from the stewardship. Are there any other topics beyond
data-specific, very focused, narrow focus activity, with respect to activities?
I mean, I am saying narrow focus in the sense that it is very concrete. Are
there any other large categories of topics, or specific topics, that we are
going to be working on, with respect to privacy and security. The list that you
had of about 10 or so topics, was very good. I think some of them will need to
bubble up into a priority for next year. Is that something that has been
discussed already?
MS. BERNSTEIN: Leslie mentioned yesterday about the upcoming, if I may, the
rulemaking that Sue MacAndrew talked about forthcoming, and whether the
committee would like to make comments on that. We were talking about the timing
of when the closing is at, but of course, the committee can make
recommendations to the Secretary at any time, even if the comment period is
closed, you can still make recommendations to the Secretary as long as the rule
hasn’t come out.
DR. SUAREZ: That is not a rule. You are talking about the request.
MS. BERNSTEIN: No, I am talking about the rule-making.
DR. SUAREZ: No, no, this is the Request for Comment from the policy
committee on meaningful use, day three, related to privacy and security.
MS. BERNSTEIN: No, I am talking about the final we are making for, and we
comment on that, on any of the other rule-makings that have not come out yet.
DR. FRANCIS: The specific issue was the meaningful use stage three request
for comments. It is very clear. I mean, there are a whole lot of issues that
have not yet been, in some cases, the Notice of Proposed Rulemaking hasn’t been
issued. There is even the possibility of an ANPRN, who knows.
Since I don’t know what the department is going to be doing or when, that is
something I would certainly be interested in, making sure that we monitor,
because it is certainly possible that we might want to.
DR. SUAREZ: Yes, there is no question that one area, but I am talking about
things like consent. There is no ANPRN, so there is a number of topics. Some of
them relate to the upcoming final rule. Some of them might relate to upcoming
requests for comments on meaningful use stage three, privacy and security. Some
of them might relate to upcoming regulations from OSCR on things like account
of disclosures and things like that.
Then, there is also other topics, like the famous patient identifier. No,
but there are other topics. I am just wondering, and maybe it is not so much
what are the topics, but what is the process to come to a consensus.
DR. FRANCIS: I think what we were going to do was try to convene a
conference call of the subcommittee. We will make sure those slides that Linda
did get sent back around, with our brainstorming of a year ago, and follow up
on whether there are other issues. We will also try to learn what we can about
the Request for Comment on Meaningful Use stage three, and on any projected
rule-making, where there might be something of relevance, that we are
monitoring, and look forward to a conference call hopefully within the month.
MS. KLOSS: We will also have hopefully the new information on
de-identification. I think there will be a little more clarity when we see the
regulations and the reports, and begin to identify where there are some
additional areas.
MR. SCANLON: It would also be useful to us, and I don’t know if it is the
privacy side or this mosaic effect that we talked about. We really have been
asked to look at that, this so-called mosaic effect, which is the sort of the
cumulative.
When you begin, as we are proposing in our data initiative and elsewhere, to
make data more available, so you can release, say, hospital discharge data, but
also available might be motor vehicle information and other information. So
that even though the data set that you have made available is protected and you
have pretty much screened it for de-identification purposes, the potential for
this other information, and looking at this other information, some people
believe that that sort of increases the risk of re-identification.
There has been some work on, so what do you do? What do you do about it? You
can’t not release the information. How much of a risk is it? I don’t know what
sort of experts there are, because it is relatively early in the process where
people are doing this. We have to look at this, in addition within HHS, and
sort of with their own data. Down the road, that might be worth a look in terms
of there is an area where clearly some principles and some ways and some risk
analysis would be helpful.
DR. FRANCIS: There actually are two aspects of the little recommendations
that we had. One is the whole question of thinking about the risk. The other is
what sort of downstream protections one might want to have to guard against
those. That could be a different question.
Yes, we were thinking about that. We thought we would wait and see what came
out about de-identification.
DR. GREEN: Okay, we are almost on time. We need to hear from this next
group. I just want to observe the last exchange that Walter precipitated. I
want to see if I can properly reflect the message that was in that.
In our enthusiasm for communities is learning health systems, it is an
iterative exploration of territory that we think would be an unduplicated
exploration, that is bottom-up, community perspective. All sorts of issues may
surface there. Some may not, and some of those other issues, we are going to
need to tend to.
You just called out a couple of things. I think the word I want to capture
here is non-exclusivity. When we unite around the community as a learning
health system theme, we need to share the understanding that that does not
excuse us from paying attention to what is going on elsewhere. We need to
recognize that our work plan needs to be adaptive, an adaptive work plan that
steps in to things that evolve. Is that a fair representation, Walter? Walter,
you are on.
Agenda Item: Standards as a Continuing Theme for
NCVHS
DR. SUAREZ: Thank you. This is the perspective of the Standard Subcommittee
on sort of the work items coming up. I am going to go through a few slides
about the charge of the committee, just to bring back some nice memories about
what we are supposed to do, and are doing and have been doing. Where are we
today, in terms of some of the pressing needs and new requirements, as well as
our role and responsibility in this. Then, some of the themes and topics for
the future with this convergence theme, cutting across our subcommittee and the
rest of the subcommittees, and how they relate to.
Let me start with recognizing our current members of the subcommittee, Raj
and Bill and Ob, myself, Linda served as a liaison member, as we, I think, call
it, corresponding member, that is right. We also acknowledge our subcommittee
staff and liaisons to other HHS agencies, Lorraine and Mike, Michelle, Jim,
Vivian, Susie. I might have missed a few, so I apologize for those that I
missed.
We had some departing members in the last few months, so I do want to take
the opportunity to acknowledge Judy. Judy Warren who is not today with us, who
couldn’t make it to this meeting, but she has served as a member of this
committee for eight years, at least, two full terms, and served as a co-chair
of the standards subcommittee for many of those years. She was really a leading
force in shaping the work of the future for the subcommittees, so I want to
acknowledge Judy.
Justine was also a member of our subcommittee, not just the chair of the
full committee, but I think you were really part of our subcommittee, too. We
really appreciate your leading direction in where we were going, and always
remember your three questions about what to do with things. Why are we doing
this, who is this affecting and why is this important. Thank you for those.
We are looking, and really hoping, for some connection with some new
members. I am already putting some names here. You heard about Alex joining the
committee, and we are very excited about that from a standards perspective. She
is truly a very knowledge person and leader in this area, as Jim mentioned
yesterday. She has been very active in the past, and currently in health IT and
standards. We are very much looking forward to convincing her to join us, as
well as inviting other members, new members, to consider joining us.
Let me talk about a couple of framing points. The subcommittee really has,
as most of you know, come to life and became a major component of the
committee, because of the HIPAA law, which charged the committee to do very
specific things related to standards on all of the HIPAA administrative
simplification provisions, the transactions, coaches, identifiers, security and
privacy.
Then, they were expanded under the Affordable Care Act, with the additional
requirements of standards for health identifiers, operating rules, the entire
operating rule world really, additional standard for new transactions like
claim attachments and other new areas for standardization. This sort of
expectation that the Secretary would identify a review committee, that could be
the national committee, to periodically, every two years, monitor the status of
standards and recommend any changes as necessary, which is something that we
have been doing over the last 14 years or so.
This is the current charge of the committee. I am not going to read it and
you are probably quite familiar with it. It is basically to make
recommendations to the full committee on all of these areas of administration,
publication. It included some associated subjects related to the development of
the Nationwide Health Information Network, back in the time when this was just
getting started.
In our website, we have some very specific points about the charge of the
subcommittee, which again, relates to and goes back all the way to the specific
aspects of HIPAA. It also covers some other areas, making recommendations on
strategies to promote continuing process improvement and development,
coordination, adoption, presentation and maintenance of standards, providing
the full report to the Congress, which is part of our function. Those are some
more specific charges that we have today, and currently we have in our charge.
What of the present? Today, well, we basically have this as the most
critical pressing deeds, with respect to timelines and expectations. First of
all, 5010 D.0 and 3.0, this is the new versions of the HIPAA transactions
started to be implemented January of this year. At this point, we are sort of
in the role of monitoring the evolution. Again, as a rule of monitoring
industry adoption and the status of those, we are doing that through annual
hearings, if you will, to listen to the industry about what issues are
occurring with respect to these standards. The most recent one we held was in
June of this year.
The first set of operating rules are coming up January 1st. We,
as cover entities, are going to be required to implement and comply with the
eligibility and claim status of operating rules, related to other billing and
claims, so that is one that is coming up. Again, our role there would be more
monitoring and listening to the industry about how things are evolving with the
first compliance of these operating rules.
EFT standard and EFT area operating rules, so the final rules have been
published. Now, the next deadline for this is the compliance date of January
1st, 2014, when again the industry will have to comply with the EFT
standard adopted regulation, as well as the operating rules for EFT and ERA.
The health plan compliance certification, you heard yesterday, Denise talked
about it from CMS, about the requirements. CMS is preparing regulations and
proposed rules that expect to come out sometime in the first quarter of next
year probably. The deadline for compliance for health plan certification is
December 2013, the first deadline, and then the second deadline is December
2014.
Their role is probably going to be more looking at we already provided
feedback to HHS in our most recent letter, about recommendations on the health
plan certification process. Those were actually mentioned yesterday by Denise.
ICD-10, again, this is an area that we are also working on, looking into
periodically. I mentioned yesterday, what I am calling the meaningful use
effect on ICD-10, this fact that meaningful use, too, adopted ICD-10 as an
alternative standard for electronic health records. That is something that is
an important item to consider.
Unique health plan identifiers is something that is already moving along.
The final regulations came out, and so the initial deadline will be October
1st of 2014 for health plans to complete the numeration process.
Then, the compliance will start after that.
Then comes claims attachments standards, which is the next set of
regulations, along with the operating rules for claim enrollment, premium
payment, pre-authorization and claim attachment. All of these are sort of now
in a common bucket, if you will, in terms of the compliance. The expectation is
that regulations will have to be published by January 1st, 2014.
Then, the compliance date is January 1st, 2016. Next year, we are
going to be asked to make recommendations about the adoption of a standard for
a claim attachment, and the adoption of operating rules for all of these
transactions, so that regulations can be drafted and prepared.
The new area for standardization, we have talked about it and we had made
recommendations about those already. There is also health reform and
administrative standards. The effect of health reform on administrative
standards like enrollment and eligibility transactions, that we will need to
look into. Right now, there is the expectation that same administrative
transaction standards are being used for eligibility in enrollment would be
used, except with some patients. That is something to look into. Then, this
monitoring and evaluation of industry progress is an activity that we are doing
annually now, for the Affordable Care Act calls for that to be done every other
year.
Those were the current pressing needs. These are some of the roles and
responsibility that we have identified under those pressing needs. With respect
to the operating rules for claim, enrollment, premium payment, prior
authorization, we expect to receive these operating rules, and review and
recommend those next year, the first half of next year. With respect to claim
attachment standards, and the operating rules for claim attachments, also
expect to receive and review the recommendations about those. Then, make our
own recommendations back to the Secretary in early next year, or during the
first half of next year.
The other thing that we do every year is receive a report from the
Designated Standards Maintenance Organization, DSMOs. That we expect to happen
also next year, around June, usually we get those reports around our June
meeting. Then, the monitoring of the industry status of implementation of
various elements of administrative publication, we expect to continue to do
that. Sometime during the June session, also next year, we would probably
consider convening the hearing, to listen about how things are going with all
of the things that are being implemented at that point.
As well as the monitoring of the industry planning for upcoming compliance,
like EFT standards, EFDRA operating rules, the health plan identifier, those
are things that we will continue to monitor during 2013. Then, we will need to
consider what we would do with the HIPAA report to Congress in 2013, the
decision to prepare and submit one. Those are sort of our present needs and
responsibilities, and sort of the plan for next year.
Now, let’s talk about the future. We have, over the last several months
actually, as a committee, been talking about the many things that are sort of
forming another one of those perfect storms, if you will, of convergence of
factors. The convergent theme that we have brought to the committee in the past
are summarized basically here.
There is a triple aim direction of improving patient experience and
improving health of populations, reducing costs. All of these are forces that
are driving our industry today. The entire high-tech act with the option of EHR
standards and the Meaningful Use program, establishment of a health information
exchange, all of those are additional converging factors to this
transformation.
Certainly, the healthcare reform, in both the care delivery reform, the
formation of ACOs, health insurance exchanges, patients who enter medical
homes, as well as payment reform, in terms of bundled payments and other forms
of payment, the effect of these changes on health plan medical loss ratio.
Certainly, economy pressures, the federal and state budget challenges that
everybody is facing today, and all of these new areas that have been driving
health information technology lately, mobile health, personalized health care,
the heath social media, the entire effect of the Facebook and Twitter and all
of these things in health care. The concept of big data applied to health care,
virtualization of health systems, genomics, all of these are factors that are
converging also to create a true, what we see as a major health care
transformation over the next few years.
Certainly, the public health role, which is changing in front of us
basically, along the lines of all of these changes in health system reform and
the role of public health agencies, changing and expanding, in addition to the
traditional way of conducting public health work. All of these are converging
factors that created an opportunity really to go back, step back and say, okay,
as an organization that looks at the standards for information exchanges
between providers and payers primarily, and between providers and payers and
others, as well, or public health and others.
What would be those changes that are going to shape the future of the
standards? This is, again, the key element is what is the future of the
standards for supporting this transformation. The opportunity is really to take
a new and kind of a more holistic view of the future of this information
exchanges, building on the changes in the business and administrative processes
that are happening, the enrollment and eligibility being modified, based on
health reform.
Population-based care management, becoming a major component of the
functions that we are all doing, quality and outcome measurement, and
reimbursement effects, also the changes in the data needs to support this
business transformation. What are the new data that is going to be needed, and
how is that data going to be exchanged?
This convergence of the transaction, the standard, the codes and
vocabularies, the ones that are being used for electronic health records now
being used, also for administrative functions to support administrative
functions. Then, the convergence of public health data standards, and the need
to meet those, as the rest of the industry is doing.
All of these are sort of the effects that are allowing us to really look at
this, and step back and see that. The first step to do that is really to begin
this dialogue with what is going to be happening tomorrow, our first roundtable
on this topic with stakeholders, to talk about the effect of this
transformative changes on the information exchange needs, and ultimately, the
standards that are going to be used to do this.
We are going to be looking at conducting this roundtable tomorrow, and we
are very excited about the participation and the engagement of industry leaders
in discussions. Looking at follow-up, tomorrow is going to be the beginning of
a dialogue really of these changes. Really, the effect is what are the short,
medium and long-term opportunities to begin to roadmap this new information
needs, and align them with the current things that the industry has to comply
with today?
Today, we have to still comply with HIPAA administrative requirements, the
claims and the claims payment, and all the transactions under HIPAA. How are
those changes in the health care system going to change those same standards,
and how do we roadmap those into the future, so that we are beginning to get
ready to the ability for standards to support those transformations.
That is what we are going to start to do tomorrow. We are going to really
kind of move in this concurrent process of fulfilling our current
responsibilities, as well as beginning to look into the near and long-term
future of how this transformation is going to affect the standards.
This last slide that I have is really more about the opportunity for cross
membership work. I mentioned yesterday how really in all of the things that the
committee is doing nowadays, standards relates to them. When I say standards, I
don’t mean the standard, for example, quality measurement. I mean more, because
those are topics that relate to content expertise. We are talking about the
standards for electronically communicating the quality measures, for example,
the actual electronic standard that is now being called for, to be used to
collect and submit electronically quality measures to different organizations.
Or for example, in the population health side, we are not talking really
about the work that the content expertise of the work that is being done by our
population health subcommittee, along with the privacy subcommittee. We are
talking about the electronic messaging standard being used by public health, to
communicate all of that information.
We are seeing these four areas of activity, where we are going to be
focusing on. The first one, of course, is continue to fulfill our
administrative simplification responsibilities. The second one is this area of
the public health, population health standards, the electronic messaging and
reporting standards, using population and public health. There, we see a lot of
synergies with our population health subcommittee.
The third one is the privacy and security standards. Again, this is not the
policy side that the Privacy and Security Subcommittee has been focusing on. We
are looking more at the electronic standards, and the advances in the
electronic standards being done and used in privacy and security.
There, we see synergies, of course, with our privacy subcommittee. Then, the
quality standards, and again, here not the quality measures, per se, but the
actual electronic standards being used to submit those measures. We see
synergies with our quality subcommittee.
The last two points, we made a little notation that they do relate to the
work that is being done by the HIT policy and the HIT standards committees.
They both have roles and responsibilities on these areas, as well, the quality
measurement standards, and the privacy and security standards, the technical
standards.
Let me stop there, and ask Ob if you want to say a few additional words, or
any of our members of the subcommittee, anything that you want to add before we
open it for more questions.
DR. GREEN: Could you just identify yourself, if you are a member of this
subcommittee? Just raise your hand.
MS. GREENBERG: We could use a population health person on this subcommittee,
actually.
DR. COHEN: Thanks, Walter. That was fascinating. I am trying to think about
communities in the context of what you talk about in Standards. I think, in my
mind at least, communities think about standards differently than how you are
using the word, the concept of standards.
When you are focusing on electronic messaging and reporting, and
transactions, that is very different when we go into communities and they think
of standards, they think of common definitions and exchange of information in a
very different kind of way. I think it is a conversation that is worth
pursuing, as we try to move towards a community orientation, thinking about
standards, how do communities think about standards, in terms of information
exchange, and whether there is any commonalities and convergence of what we are
trying to do, to stimulate the impact of our work in communities, and how
communities think about standards.
DR. SUAREZ: Really, Bruce, that is a great point. An example that I was
going to bring specifically on this was SES. The committee has been asked to
work on that, and have worked, and I actually was engaged and a member of the
population health subcommittee, and was engaged in the discussion. Defining the
concepts around SES, and what are the standard elements, and what are the
standard definitions, that is what I consider to be a content expertise kind of
a focus? That is not the standards, as you point out. That is not the standard
we are talking about here.
Here, what we are talking about, is okay, now that we have defined the SES
standards, how are we going to incorporate those into electronic messages, so
that whenever I am reporting to public health on anything, that specific
standard that was defined for socio-economic status, whichever it was, is going
to be actually in the electronic message in a consistent matter with that.
That is the topic that the standards subcommittee would be focusing on more,
in terms of the actual electronic message and messages that will include those
standard data elements. We are now in the process of defining those standards.
We rely upon the expertise and knowledge of the content committees and
subcommittees, to define those. When those are defined, then the question is,
are they included properly in the electronic messages that people send to
public health.
Now, with respect to the community health data initiative, yes, there are
questions about how this would apply to them. In the community health
initiative, the data collection happen in many different ways. In many cases,
this aggregation of data that exists already have been reported some place.
There might not be a very direct relationship with respect to the electronic
messaging associated with community health data. In some cases, there could be,
because some of the reports that I use in community health data initiatives are
reports that are sent and collected, data that is collected, using electronic
mechanism. There could be some overlap in their connection.
MR. SOONTHORNSIMA: Just to add to that comment, maybe another view from the
data standards perspective. When you talk about population health, what is
happening around the country will all payer database, for example, that is a
very rich set of information. Now, there may not overlay directly over the
public health sort of arena, but certainly, it is a source. We want to be
concerned about that and see how we can alleviate any bottlenecks, or making
sure that proper governance and stewardship apply.
This is where you have multiple sort of application of standards come to
play. I just wanted to color that a little bit.
DR. GREEN: Just to amplify that, my email last night, we have an all payer
claims database in Colorado. I got two emails from those folks saying, we could
use a little help here.
MS. KLOSS: Thank you. I look forward to participating in tomorrow’s
discussion. It seems to me that, and I guess I want clarification on the PRN’s
electronic exchange, as it relates to standards, because it seems narrow. I
think, for example, that as we look at what is an enabling standard is the kind
of greater focus on code sets and vocabularies, and how they underpin so much
of what we do.
I think we talked at one point about wanting to focus more on what happens
after ICD-10 gets implemented, and how do we start envisioning the leveraging
of that. I think there is a whole issue related to code sets and vocabularies
that came before this committee, probably five years ago now. I keep bringing
it back. That is, thinking ahead to what our whole process is for maintenance
and dissemination of code sets and vocabularies, using new technologies and
thinking ahead to really ICD-11.
I think that is an area that, as we look at the role of the committee, we
need to surface and give a higher visibility to going forward, and not see that
as code sets that come up for evaluation, but really look at that as part of
the process for changing and advancing the whole underpinning of all of the
data we have. I guess I will probably be making that point again tomorrow, but
I don’t see that encompassed in electronic exchange. I think it is much
broader.
DR. SUAREZ: Absolutely, that is an excellent point, Linda. I think in many
respects, the standards subcommittee has not just focused truly on this part of
electronic change, but as you point out, we have made specific recommendations
on code sets, for example, ICD-10. Yes, I totally agree. I think this should
not be perceived as a limitation, but it should be expanded, I think.
MR. SOONTHORNSIMA: I would like to respond to Linda’s point, maybe in
another context. I think we are more concerned now, as we look forward, and
interested, in the business model that is changing. The business model should
drive how the standards, the practices, and Walter kind of talked about this in
previous slides. We were talking about payment reform, we were talking about
care delivery models and changes there. At the end of the day, the data, it’s
kind of your core asset here, will change accordingly, because those are the
business models that are changing, the PCMHs, the ACO.
I don’t want to get into the weeds, in terms of the code set and the data,
but I think we need to come up 60,000 feet, and looking at, all right, for
example, SNOMED versus ICD-10. How they might bridge the gaps? Maybe NLM
mapping could be some of the things that we look at. Those are the different
tools and levers we could use.
The committee, personally, I am not sure we are going to get into the weeds
of the code set itself.
DR. GREEN: Not only are business models changing, so are the ontologies.
There are two moving things in space. They have gravitational forces, both of
them, it is going to be kind of hard.
MS. MILAM: Coming back to Bruce’s comment about the intersection of
population health and standards, and thinking about some things Jim said
yesterday, people are talking with HHS around meaningful use stage three, and
further integration of population health and meaningful use. To the extent that
we need any sort of standards to support those messaging, that needs to be a
priority. Beyond that, the example you have up there, Walter, around electronic
messaging, that is a huge functionality for public health to the community, to
the providers and to others. A message for the communities that have HIE, when
we heard from beacon communities and other communities, public health has an
important message.
It needs to let the whole health care community know at once. You do that
through electronic messaging. Is there a need for standardizing that
transaction, that message? With that, we need to hear from communities. How
else are they starting to use HIE, separate and apart from the functionality
that is pooled into meaningful use. What is a priority for them, where do we
need standards? How does that fit into the support that we need to give to
meaningful use?
DR. MAYS: I am kind of struggling a little bit, and it is getting better and
better. At first, I put my card down because I thought Ob would explain it, and
then other questions came up. Sally is raising even more. I am really just
trying to understand.
Part of what I am trying to understand is that, it seems like there really
is kind of, maybe it is not big, but there is a very significant population
health agenda here that has to do with two things. One, Sally was trying to
talk about. When we did our hearings and we talked to, for example, American
Indians and kind of with the whole notion of what happens in that particular
population around the use of any kind of messaging and especially if it is
being transmitted in terms of computers, et cetera. They really warned us about
the fact that they think they are being left behind, because they don’t have
the capacity.
They also talked about these special needs that they have. This is where I
am worrying about the coding and the code sets. I am sure I am going to say
this wrong, because I don’t understand coding well enough. I understand it as a
practicing psychologist and that is it.
For example, there are these alternative and non-traditional health
activities that are actually being put into primary care settings. Part of what
communities are starting to really be concerned about is how to bill for those
things. Indian Health Service has been successful, but other primary care
settings are struggling with this.
I think there are some issues here, and I am going to need help to kind of
formalize it. I think in terms of population health, there is probably a
significant role that goes beyond just the transmission issue, that goes to
coding that is specific to populations, and an assessment of how well they are
going to participate in some of these rural and ethnic community errors about
being a part of this transmission activity.
MS. GREENBERG: As always, you have all stimulated my thinking so much. I
will try to be brief. I was sitting here wondering if I should even verbalize
ICD-11, when Linda did. I can tell you, though, although it is premature to
recommend that we quickly move to ICD-11, because I ICD-11 does not really
exist in any implemental form right now, it is in an early beta phase. There is
still on the books an official plan to take it to the World Health Assembly in
May of 2015. Essentially, six months after we have implemented ICD-10 CM.
Now, this doesn’t mean that even after it is approved by the World Health
Assembly that we can just go and implement it. We all know what it takes to
implement a new version of ICD. Certainly, NCHS, for one, and I would say the
department more broadly, is going to need to engage this committee, if you are
thinking down the road, on a glide path to start taking on or finding how we
can begin to benefit from many of the things that, if it works out right, will
be improvements of ICD-11.
I would say it is going to be a number of years because those can be
realized. One is the direct linkage with terminology. Not just mappings, as we
are doing now, which are important, and value sets and all of that, but
actually the organic integration of definitions and terminology from SNOMED CT
and other terminologies into ICD-11. Vickie triggered my thinking on this,
because there will actually be a chapter on traditional medicine in ICD-11.
WHO, we know we have two reference classifications, ICD and ICF, but there
is a third one that they are working on, which is ICHI. It has nothing to do
with dermatology. It is actually ICHI, but it is an International
Classification of Health Interventions. In this country, we have sort of too
many classifications of health interventions, not too few. There are countries
that have none.
One of the things that it is looking to do is meet the needs of countries
that do not have an updated classification of interventions, meet the needs of
countries who are using ICD-9 volume three, because we are not updating it
anymore. The U.S. isn’t maintaining it anymore, so they need something. It is
also going to include public health interventions. It is quite an ambitious
activity. The U.S. has not been that involved. The Canadian partners in our
collaborating center have been more involved. As I said, we don’t see ourselves
as implementing it.
One of the ideas is to be able to at least map our intervention
classifications to this ICHI, which it gets developed, so that we can do
competitive statistics, which we have never been able to do globally. We can
hardly do them in the U.S., because we use different intervention
classifications in different settings. There is a lot of work going on there
that the committee has played a really important role over the years with ICD
from 1949 really on, and with ICF and ICN, and has also made recommendations
related to procedure classifications.
I think your letter that you approved last meeting already indicated you
might be looking at maintenance of code sets in a broader way, so that is
something you have already dealt with. Ontologies, I mean, the first question I
ever asked Judy Warren, when she came to testify to the National Committee
before she was a member, what are ontologies? That was quite a few years ago. I
still think there is a handful of people who really understand what they are,
and I am not one of them. It is a major focus of WHO right now. It is a way to
try to. Convergence definitely requires understanding in working with
ontologies.
One other thing, and that is, when you are talking about standards for
population health, one of the groups that you heard from was NIOSH at your SES
hearing. NIOSH is very actively working with the Public Health Data Standards
Consortium now. They have a very energetic effort, more than energetic, I mean,
they really have committed resources and people to try and get the standard
occupation and industry codes into standards, possibly into meaningful use.
They are hoping to get it into meaningful use stage three.
If you look at the things that are of great interest to communities,
employment and the lack thereof are critical. I would say this full employment
for this subcommittee, as well.
MR. SCANLON: There are so many things happening, just to lay them out and to
put a timeline on, and to begin to think of how they relate to each other, I
think is a valuable contribution. In many way, standards are the way you help
to link all of these things.
A couple of things, in terms of the upcoming health reform ACA
implementation, Walter, I think you identified most. In general, for
administrative data, folks would be looking at existing standards where they
exist. There will be a single, simplified application for eligibility for
states to use. In general, on the demographic side, we have suggested some
standards, as well.
The other areas where, and I am just not sure to what extent, the federal
data services hub, which is planned, which will be operated by the federal
government, will include IRS and HHS and Homeland Security, and basically the
states or the counties, or those that would be enrolling folks, would be able
to query that database eligibility. Literally, IRS would be part of it, in
terms of eligibility. I just don’t know, and everyone has been fairly quiet
about the nature of the data services hub obviously up to now. Again, that
might be an area where we could at least look into it and see, to the extent
existing standards are available, they should be used, again, in meaningful
use, as well, which you pointed out.
When you look at stage two and stage three, in many cases, for the public
health side, for example, there are placeholders put in that don’t quite have
standards or may have standards. Several of them were demographic items, I
think, for race ethnicity, disability, a couple of other items. Again, I think
we will be getting to the point of standards. There are places there that don’t
have standards yet and I think that could be a place to help the department, as
well.
I am thinking that in meaningful use, there were a couple of areas relating
to the problem summary, individual problem list, and the summary of care
record, which may or may not have standards. I am not sure, or maybe it is just
a placeholder at this point. The other area, again, for public health would be
the area of the ability to transmit lab findings.
There are opportunities for the public health community. Again, we need to
worry about the infrastructure to receive that information in the public health
departments, but in terms of the standards, there are, I think, in many places
in meaningful use plans, there are placeholders rather than standards. That
might be a place where we would look, as well.
MR. SOONTHORNSIMA: May I ask you a quick question, Jim? Specifically, I am
not sure with the timing for the federal service hub, maybe there is an
opportunity for the committee to look at that. There is not a whole lot of time
because now and October 2013. Maybe you can suggest what it is that we want to
look at.
MR. SCANLON: I think the best thing would be a kind of a briefing from the
CMD folks. Clearly you can see what the requirements are, but when you try to
go below that level, it is very complicated.
The other thing is, I would second the area of all-payer databases. I don’t
know if it is a standards issue or a population issue, but a number of folks
are trying this. NADO has been laboring in the vineyards for a long time. We at
HHS have been trying to develop a national all-payer database. It is very
difficult. I don’t know if it is a standards issue, as much as an analytical
data.
DR. FRANCIS: It is actually a very interesting crosscutting issue because,
for example, the beacon community in Utah is using the all-payer claims
database to deal with reducing incidence of uncontrolled diabetes.
MR. SCANLON: I should probably brief the committee on this. At HHS, we are
actually trying to pull together. We are in a beta test now of an all-payer
database, that includes all of the Medicare claims data. In addition, we are
getting some claims data from other aggregators and abstractors. Again, it is
not so much a centralized approach, as it is a decentralized. There are a lot
of issues related to how do these function, what should you be aware of.
Again, these are the areas that would fill in. We have a lot of Medicare
data. We are getting better at Medicaid, but the whole middle area is private
pay, where we are having some difficulty.
Then, the third area, again, this is more of a populations issue maybe. A
number of folks have thought about a new idea, and it is not meant to conflict
with Healthy People 2010. The idea at the community level is a set of health
indicators that may be a core set, optional, that every community would want to
have to keep track of their own health status public health, access to care.
I know we have had the IOM look at this previously. You could argue that it
is a subset of Healthy People, but I am not sure that is the case. Really, a
smaller set of indicators that communities would have, not so much as a
standard, but kind of this is what every community should know as a core. They
are largely indicators, and these are other indicators that a community might
want to know about, depending on the makeup. Again, I am not sure if that is
not so much a standards issue, as a health population.
MS. GREENBERG: That was actually included in community as a learning health
system report. We talked at the executive subcommittee retreat about summary
health measures, and that is part of, I think, the overall research agenda, at
least of what was laid out yesterday.
From the point of view from the all-payer claims data set, it is definitely
a standards issue there. In fact, the NCHS and AHRQ have funded work with the
Public Health Data Standards Consortium and the all-payer database community,
to put all of the states that have all-payer claims databases, all of their
data elements into USHIC (?) 2:17:54, which Mike Fitzmaurice maintains, which
is this kind of meta database, just to try to harmonize those, because they
aren’t all identical. I am sure, I mean, you have found this out in trying to
build a national data set. There is definitely standards work going on there.
MR. SCANLON: There should be, I mean, theoretically, they are based on the
HIPAA standards, but very varied, as well.
DR. GREEN: Bill Scanlon, you have been remarkably patient.
DR. SCANLON: I feel like my assigned task for this meeting has been to be
cautionary, so let me live up to that, and sort of talking about this issue of
the scope of standards. I think if you go back, and I guess I am assuming there
wasn’t a standards subcommittee before HIPAA, and it grew out of the fact that
HIPAA had, as one of its objectives, to reduce administrative costs through
standardization and simplification.
Kind of faithful to my prior heritage at GAO, I would say that progress has
been made, but more work needs to be done. One could say much work needs to be
done. I think that is in part sort of why within the Affordable Care Act there
are basically mandates to go revisit a number of these issues.
In some ways, maybe sort of the message is, let’s get serious about it this
time. Let’s really try and do this. The IOM has identified administrative cost
as the second largest unnecessary cost within the health care system. In some
ways, it should be the lowest hanging of the fruits that we can go after.
Though, maybe we are not tall enough for even that low-hanging fruit. That is
kind of some of the context.
The other thing about the standard subcommittee, at least, I have been on it
a couple of years now, the altitude is incredibly different. To say it is in
the weeds would be somewhat of an understatement. It is probably working on the
roots of the weeds.
Everything is detailed. Take the word, envelope. You might think of this in
an ordinary English word that you might have some sense of, not a clue. To try
and translate some of the discussions there into things that we can understand,
for them, to people in the standards world, an envelope, a question, is it a
white envelope or is it a brown envelope? Does it have a clasp, it is
self-adhesive or do you have to lick it, all those kinds of things.
They won’t use words like that. They’ll say it is a 990 or it is a 22, or
something like that. That is sort of the kind of discussions that we have sort
of that the standards meeting. That is the context.
The other context that is going on is right now, we are at a point, and this
is what Walter talked about. We are at a point where the needs for data are
very different, and the potential for collecting is very, very different. The
question is, how do we expand our horizons, and that is what tomorrow’s meeting
is about, to start a discussion about expanding our horizons.
Given the base where we are starting, you have got to think about sort of
how far we are going to get, sort of within any sort of short amount of time.
It is not that it is not important to lay out sort of, okay, here is kind of
stretch goals, or here is sort of some ideals that we might try on and think
about, and we don’t want to do things that would interfere with them at some
future point, but they are not going to be immediate. There is going to be a
lot of work that needs to be done, just to kind of move somewhat forward from
where we have been. We have been stuck sort of in this low level for a very
long time.
DR. GREEN: You know, Bill, you just gave me a new idea. If there is a public
nomination process for someone to host Saturday Night Live, I think we should
do that.
MR. LAZARUS: I want to thank the Committee for taking public comment on this
issue right. I am Steve Lazarus from Boundary Information Group. My
observations are my own. I often represent CAQH Core, but these are my
observations on this topic, and it fits right into what Bill Scanlon just said.
We have two issues that I would like to bring forward in your thinking. One
is that we have transaction standards, but we don’t have data standards. We
have some standard data code sets. We have clearinghouses doing a lot of
mapping. We have health plans doing a lot of mapping, all of which is expensive
and distorts the data as how it is being used at the other end. It is now being
repositioned, whether it is in personal health records or community data
analysis, having been mapped several times, its original meaning lost.
The future of EHR’s data exchange, ACO’s population health analysis, big
data analysis, all assuming that this mapping is all precise and inexpensive,
or it doesn’t even have to exist. I think we have to move the table to the
point where it doesn’t have to exist, by defining the data elements in a
standard way. If we do that, and create XML tags for those data elements that
are standard, we almost don’t have to worry about the transactions of the
messages anymore.
If, in a community, whether it is an HIE or an ACO, and all those data
elements are available because permissions have been granted for the users to
use that data, and it is all standardized, then it doesn’t matter what the
message is. It is the data that is important. We can move it, share it,
whatever the ground rules are. Unless we do that, we are going to spend a lot
of money on mapping and a lot of value of the information is going to be lost.
That is the first message.
The second message is, in the ACO world, we heard just a few minutes ago
how, from the federal government’s perspective, these are the issues that are
important. Guess what? Those ACOs and medical home organizations have internal
operating issues, too, which are not among the initial purview of the federal
government. They have to move and share the data.
If the data isn’t standardized, they have a problem, and they don’t even
know what their own business transactions are going to be internally because we
haven’t fully deployed these models yet. Unless we standardize the data, they
will be doing a lot of mapping, and value will be lost.
I just went to the ACO Congress two weeks ago in Los Angeles. Margaret A.
and I were the only presenters that talked about data in a three-day program.
Everybody assumes that data is going to be there when it is needed, and it is
all defined the same way. It is not so.
This committee could influence how we move from where we have been to where
we need to be. I might say that this is not a ten-year project. This is now,
the next six months, the next 12 months. If we are talking about administrative
simplifications, and moving to where the puck is going to be, we have to get on
this. I think this committee is the appropriate place to talk about this.
DR. GREEN: Thank you, Steve. Anyone else?
DR. SUAREZ: I would just like to mention next steps. Tomorrow, we have this
meeting, as a subcommittee. Just like with privacy and security, we, as a
subcommittee, are going to go back and get together, take all of these notes
and input that we received today, and continue to formulate sort of the future
work of the committee, as a whole, and the input from this subcommittee, as
well as the other subcommittee. Thank you.
DR. GREEN: Thank you.
(Brief recess)
DR. GREEN: Let’s reconvene.
Agenda Item: Role of the Working Group on HHS Data
Access and Use
DR. CARR: I wanted to thank you for the opportunity to update you. I will
give you a couple of things. The membership of the working group on HHS data
access and use, and I put it up here with the kind of description of the
members that are not members of NCVHS. I will have to move myself over to the
other side.
I think we have a very extraordinarily rich group that brings expertise from
IT decision systems, geographic mapping, technology applications, triage,
wireless health solutions. We also have folks in community health informatics,
community public health, consumer health interest, social media resources for
public health.
This is a group that doesn’t often come together, that combined with the
folks from NCVHS. I would say one of the key learnings from this committee is
just to try to broaden our perspectives and understand even the taxonomy and
the language that everyone uses, but we are getting there. Then, of course,
liaison to the committee, Susan Queen, has done a wonderful job, and Ed Niles,
Jim, Marjorie.
I thought I would just take precisely from the charge to the committee, and
then some of the details, to kind of set the context, because I know we are
sometimes thinking about what is the intersection of the working group and the
full committee. The charge to the working group, broadly speaking, is to
monitor and identify issues and opportunities, and make recommendations to HHS
on improving data access and innovative use, including content, technology,
media and audiences.
Second, to advise HHS on promoting and facilitating communication to the
public about HHS data. Third, facilitating HHS access to expert opinion and
public input, regarding policies, procedures and infrastructure, to improve
data access and use. I think we are well-configured with the composition of
that committee to do that.
These are the actual seven specific asks in this charge, and I just wanted
to put them up here, to highlight kind of where we are and where we are headed.
The first is review the current portfolio of HHS data. I will show you we are
halfway through that now. Second is identify and monitor trends regarding new
information dissemination, data access strategies, including social media.
Third, identify and monitor types of data and information needed next to
improve data access and application. Next, promoting and facilitating creative
communication to the public, then access to expert opinion and public input,
and also advise HHS in understanding an evaluation of how HHS data is being
applied, and the value it is generating. We need to post this.
DR. GREEN: Justine, we have a quick clarification here.
DR. FRANCIS: Going back to the slide before, advise HHS. My understanding of
this, and I just need to be sure I understand, is that this is a working group
of NCVHS. The structure of it is that, if they are going to be formal
recommendations, or formal advice, given to the Secretary, it comes through
NCVHS. Not to be a roadblock, but just to understand the structure of this. If
I am wrong, I think as an advisory committee, that is how it has got to work
legally.
MR. SCANLON: We are asking this workgroup, number one, to serve as kind of a
reactor panel. When we present ideas to them or discuss things with them, we
are looking for their technical advice. It will be, as it is taken away from
the meeting, I don’t think we plan to have that come through the full
committee, because I don’t think it will be recommendations.
If they say, oh, you should use Google Data as a platform, think about it,
that is the sort of thing we are at now. I think, as Justine said, we are
looking at the supply side, which is what the information, what is it, that is
the supply side. The demand side is what is needed. As long as they are working
in this reactor panel mode, we don’t plan, unless it rises to the real level of
formal recommendations, we are just taken away from the discussion.
Down the road, and I think we are still in that early stage, Justine, where
we are sort of everyone is getting acquainted with the other side, if we get to
the stage where they have a formal set of recommendations, then clearly, we
would bring them in for the full panel, but we are still at that early stage.
Remember, the situation we were in was that we were asked to create a whole new
FACA to advise on this. It really, in our view, made no sense to do that.
Actually, to be honest, there is no reason why, and in many cases, the full
committee serves as a reactor panel. The product of a discussion is not
necessarily a report or a set of recommendations. It may be the best thinking
of the group, in terms of, well, probably the better way to do that would be
this. It doesn’t rise to the level.
When it does, and down the road, Justine, I think that is where we may be,
then we will bring them through the full.
DR. CARR: This is good because it is new. We have not worked like this
before, and we are just developing. Where we are ongoing, we have actually had,
today will be our third meeting, and we have had two webinars in the interim.
We have used most of that time to review the portfolio of HHS data. You can see
the various groups that we have seen already today will do CDC. Jim tells me
that, with all of this done, we are only halfway through.
Today, in addition to the presentation from CDC, Mo Kaushal I think was very
helpful in having us have a structure of how to think. First, we will talk
about supply side. This gets to one of the charges of identifying study areas
of opportunity to improve data access and application.
Our goal today is to have at least five tangible reactions. Is it wrong to
use the word recommendations, perhaps we will call them reactive reactions, or
next steps, next steps perhaps is the next thing. Josh Rosenthal did an
excellent outline going through the data sets that we had looked at, and
pointed out that for a developer, who does not dwell in this world of health
care and so on, there are very fundamental things that are needed, like
taxonomy, like a learning center, data definitions.
In addition to that, we talked about data browsers, we talked about Google
Data and how again, for folks who are going onto these sites, even though the
data is now in an accessible, digital fashion, sometimes it is hard. After you
click the first thing, and then the second thing, and then you are not quite
sure what to do from there, just speaking for myself sometimes.
I think they are pointing out to us, front end browsers or platforms that
can really take the data very quickly, to give visual displays or the kind of
displays. We will be doing that today, the front end platforms.
Bill Davenhall also put forward six kind of recommendations, I won’t use the
word recommendations, just suggestions, I guess, to identify a candidate data
set that would be useful for a pilot, to kind of take that data set and look at
what are the supply side issues, and how could we, with little effort, make it
more readily usable, and likely to attract early adopters.
Then, Susan was pointing out today that there is some work that we need to
do to look at survey data availability and usability, which is a little bit
different from some of the other data. Then, upcoming, we will spend time on
the supply side, but then we will look on the demand side. Here, it is just our
concluding comment at the last meeting, that what do individuals and
communities need to make better decisions and improve health, which curiously
aligns with what we have been talking about yesterday and today. I am happy to
take questions.
DR. GREEN: I’ll ask a question. I will make an assertion and the question
is, is this assertion correct. I think I just heard very succinctly that the
role of the working group on HHS data access and use is to be a reactor panel
directly to HHS, including NCHS. Its sweet spot, focal point, is data access,
getting data, making data accessible, figuring out how to get that done, so
they can be used.
On occasion, this reactor panel may come to a conclusion that something
needs to be turned into some sort of formal recommendation to the department.
When it does that, we can expect to see you showing up here on our agenda, so
that that recommendation can be deliberated and again moved forward.
Otherwise, we can expect that we will want regular reports about what is
going on in this workgroup. It will be a routine part of our agenda that we
meet. How is that? Is that close?
MR. SCANLON: Remember, we have about four or five members of the full
committee, who are on the group, as well. Larry, I would even focus more that
the perspective of the group is using technology. The data we have is the data
we have, so it’s a matter of, are there better technological platforms or
capacities that we could use, to make the data available, including
communities.
The strategy at HHS is to put all of our data on Healthdata.gov, and let the
developers and the apps and communities and everybody else go there. Well, I
know that is a big part of health data, and it is sort of the portal to start
with. I think we are beginning to see that the technology community is way
ahead of us. Google, Socrata, all of these other groups, they can take our
data, without statistical software, they can actually allow tabulations to be
calculated about a community or a population. I have seen census data there, I
have seen some, I think it was, SAMSA data there.
It is almost, Larry, a focus on the technology. Clearly, we are not using
the most advanced technology, in terms of dissemination. The community is way
ahead of us. I think that is the first part, I think, we are trying to find
out.
There is no reason in HHS that we would even be aware of some of these
things, at least for now. We are very comfortable with the public health
community, the research community, the health care community, those folks who
get our data fairly regularly. Reaching some of these other audiences, I think,
it is really social media and other platforms that they are giving us sort of
less.
We were not even aware, I think, of some of these approaches. It is even a
narrower focus on the technology at this point and what the advice is. Then, we
can look at it in HHS and see, is this the way to go.
DR. COHEN: I think that was an excellent summary. I have got a couple of
things that I would like to talk about this afternoon in the data group. I
think there is still an issue of speaking different languages. It will lessen
over time. When I read the comments from Josh about taxonomies and hierarchies
and relationships, it took me a while to understand, what I think he was trying
to describe.
At the same time, I think it is incredibly useful to go through the
different data sets that the department has. I am still not comfortable with
the technologists understanding the different nature of the kinds of data that
the department has, which I think really has an impact on how we apply
technology. I mean, just the concept of survey data and its limitations, or
clinical data or claims data, or administrative data or surveillance data.
There are different types of data, some are census, some aren’t census, some
have addresses, some don’t. I think understanding the dimensions of data and
different types of health data that are possible to apply technology to would
be a useful next step for the committee. That will help translate some of their
ideas about data structure into the kinds of data we have.
DR. CARR: That is a great point. I think what we have found, though, is just
getting a basic communication. It is really two different worlds. I think
Josh’s points were great. We don’t have data definitions. If you are not in the
health care world, you wouldn’t have any way of knowing what these even mean in
general, let alone a very precise definition.
I think Todd Parks had an exciting future vision, but I think it is you
walking before we run, and getting the building blocks in place, baby steps,
whatever it takes. I mean, understanding what we have, how it goes together,
and then a few meetings down the road, begin to take it out for a run.
DR. FRANCIS: Could you go back to either the third or the fourth slide you
had up? My first question for the full committee is, is your vision that
people, such as Bruce and myself, who are liaisons, that part of what we should
be thinking about is helping the working group understand what issues really
are issues for the full committee, and what issues are reactor issues, if I
want to call it that way. Should my role be, to be thinking a little bit about,
this is something that would be really important to report to the full
committee about. That is a sort of question.
With that question then, maybe it would be interesting to ask you to share
with the full committee right now, just as an illustration, what the substance
is, for example, one of Bill’s or one of Josh’s suggestions.
DR. CARR: We are posting everything on the SharePoint site.
DR. FRANCIS: I need to apologize because without my knowledge, I got bumped
off SharePoint. Fonda has apologized to me, but I was unable to read anything
on SharePoint.
DR. CARR: I think Josh put together a very nice PowerPoint, showing how the
terminology, just taxonomy, certain words are meaningless to developers, and
they need definitions. Then, hierarchy, what relates to what and how we should
do that. Then, he had suggestions about we should have perhaps a learning
center online, webinar, whatever, to bring together these groups, so that we
all understand what we are talking about. Right now, we have people that know
how to make data move around, and people who understand the content of what it
is saying, and getting that intersection of knowledge.
Then, he had suggestions about data browsers. We have talked about data
browsers, which is a platform. You just import the data and now you can display
it. Then, there is the other piece that is more what the Datapalooza does,
which is to take developers, who then create an interface with data, and bring
disparate data sets together. That is yet another part.
Then, he also mentioned what are the business incentives for that, how do
people become engaged in that, these various prizes or these new start-ups that
are happening, to do just that. Then, Bill Davenhall had a number of
recommendations that we will get to on the demand side, but I think that his
idea of taking one data set, and perhaps we will even do that today, is just
pull up one data set and look at what would the front end look like, and how do
you do it. If somebody wanted to make an interface, what information do they
need, that is not currently available, and how do we make that public?
DR. FRANCIS: Just to follow up, that is actually where I think questions
potentially would arise for the full committee, because I am going to go back
to the discussion that we had at the last full committee meeting, with El Amen
Kalib(?). He was thinking about how to operationalize de-identification of a
clinical record set for the prize that they were developing. There were some
very real and complicated choices that went into that.
If the recommendations are ones such as how much granularity of data or what
kinds of data sets that might be interrelatable and so on, rather than what I
will call sort of, for want of a better word, format issues, as opposed to
content issues, it seems to me that those are really tough substantive issues
that are probably ones that would need to be talked about more widely.
DR. CARR: I think the beauty of this is the configuration of the working
group. Having the presence of each of the subcommittee co-chairs is exactly
that connection.
MR. SCANLON: I would say the job of the full committee members is not to
sort of censor or police. It is to ach in your capacity as experts, privacy in
these deliberations, public health and other dimensions. We will know, I think,
again, it is hard to define an advance. These are areas where we are kind of
experimenting. I don’t think we need to know all of the answers or where we are
going to end up. I think we would rather keep the reins fairly loose at the
moment, but we will know when we get to the area where there is something more,
that we need something more deliberative.
DR. CARR: I think it is the building blocks. Right now, regardless of the
content, it is the building blocks of how do you define them, how do you move
them around, et cetera. Then, down the road, and this is going to take more
time to get these building blocks understood and addressed, then, when we have
a functioning infrastructure, then we begin to get to what would be the
questions or how would you use them. I think we will be addressing some of
those issues later on.
DR. MAYS: The working of this committee is just exciting. I mean, so I have
really appreciated how open we have been. I sit, usually I will stay, and I
just want to say I really appreciate that.
I am trying to get a little understanding also, the way that Leslie is. So
far, it just seems like it is great. If I sit, I can ask or talk or contribute,
so it doesn’t seem to be a problem. Is it possible also to be able to access
the shareware, if we really want to read some of the stuff?
MS. GREENBERG: I apologize to those of you, here and not here, who have had
some problems with the SharePoint. It was just very, very recently that we
learned that you have to change your password every 90 days. This was not
originally what the situation was or what we were told.
Furthermore, we were under the impression that you would be notified that
you needed to change your password. That is common practice, as opposed to just
being told your password is invalid, which apparently is what has been
happening.
Part of the complication, I think, as CDC employees, we have to change our
password every 90 days. We know that we use our network password in SharePoint.
It was sort of like working for us, but we are not the most important ones,
obviously, except for putting stuff on.
I apologize for that. There was a glitch, obviously. I am now informing you,
you do need to change your password every 90 days. If you are a regular user of
it, hopefully you will be notified of that. We are looking into that with
Fonda.
Anyone who is having a problem with their password or with getting into the
SharePoint, or with downloading documents from the SharePoint, or any of the
above, please email or talk to Catherine Jones, or to Fonda. The team for Fonda
is for the whole center, but for the team, Catherine is the team leader. We
will really try to work through these with you, because we have tried a few
other sites of this type.
This is the one that we really need to stick with. Those of us who have been
able to use it, I think, have found it quite useful. I know I am still learning
myself. I am on other SharePoint sites, too, and I know they have their
challenges. I do think it can be a benefit to the membership and to the
committee. You have access to everything on that site, including anything from
the working group. All the subcommittees, I mean, remember, we are trying to
get rid of silos.
You can get to the site directly from the NCVHS website. It is at the very
bottom, under Reports, Recommendations and then it says there is a private site
for members and staff. You should be able to get into it. You should be able to
get your password straightened out. Then, other more complicated uses of it, we
will try to address.
Catherine, did you want to say anything more about that? No?
DR. GREEN: To spare everyone sending Katherine emails, let me just say the
following and then you guys object. This is a hard website to use.
DR. COHEN: There is a learning curve, but after you achieve some basic
knowledge, you can use it at different levels. Just to access documents and
read documents, first of all, wherever you are at work needs to allow you to
get access to the site. Then, you need to know your password and your logon
information.
DR. GREEN: That is good pushback. Without a card to remind you of what you
have to do to make it work right, it is easy for this site to go awry for you,
and for you to not be able to use it effectively. Most of us probably use
SharePoint in several other places in other shared systems. This one is not the
most intuitive website we deal with.
Given that it is the one we have got, I suggest we do the following.
Everyone just get a cheat sheet, that tells you not a lot, and send that out to
us periodically, and remind us about, this is how you do it. Remember, this
sort of thing, and these are the things you need to do to stay current.
Then, I would suggest also that, for meetings and for meeting materials, we
put a safety net under this, and not assume that because it’s listed on
SharePoint, that people got it. Put it in a PDF, the book for the meeting, and
we just email it to everybody in advance. Is that okay with everyone?
MS. GREENBERG: The eAgenda book, which is current on SharePoint, you would
like us to email it to you?
DR. CARR: The limiting factor is if we are in the Humphrey Building and we
can’t access it, then you really do have to end up printing it up. If you can
save it to your local drive, then you can use it paperless. I think that would
be helpful.
DR. SCANLON: It would eliminate the step of us logging into SharePoint, if
you just email it to us. Instead of an email that says it is there.
DR. COHEN: SharePoint can also send out alerts, to remind you to change your
password. I don’t know whether the alerts have not been enabled.
DR. GREEN: This reminds me of an EHR. It should do a lot of things. You just
have to click that button first and then go to here. If you don’t tap it here,
it isn’t going to happen. This has a lot of characteristics of EHRs. Okay,
thank you for the ventilation moment. Dr. Carr, thank you very much for
allowing the digression to the care and feeding of the committee.
MS. MILAM: It was not on the SharePoint topic. Justine, you were giving us a
brief overview of Josh Rosenthal’s observations about health data. They nicely
align with the areas that population might focus on next. I am wondering, and
we will talk more about that tomorrow, but I am wondering, might the workgroup
also sort of be a reactor panel to populations. They work together, and perhaps
a partner, because if we are looking at going all the way from defining data to
gaps and metrics for communities, to getting it into an app for immediate use,
it sounds like we need to be more in a partnership relationship probably.
DR. CARR: I think this working group is rich with expertise. I think given
the kinds of things that we are thinking about, that this is a group that could
come and just give some great advice.
DR. GREEN: Along those lines, Justine, I have a question. It is an opinion
question. As I hear where you are, you are seeking common language or just
about figured out what is up, you are getting to at least five tangible
recommendations as the next steps, what is your thinking? Do we have this
meeting structure set up right?
Sally talks about this needing to be more of a bidirectional consultative
sort of thing. Having joint members on both, that come and then attend two
meetings, do you have any ideas or thinking about how we facilitate that joint
consultation stuff, or do we have it right? Do you feel like we have it right,
at least for now?
DR. CARR: I think there are many models that can work. This one can work, as
well. What Susan and I talked about is, because this meeting occurs after the
full committee, if we can get together, and we will do this today, sort of here
are the five things, suggestions that we are coming forward with, and get that
out, so that we don’t lose momentum. I think the advantage of the way the full
committee is set up is you would do work on day one and the morning of day two,
and then we would come together, and now we process it. I think what is missing
with this group is that we do our work, and then what happens.
As we have pointed out, some of that work is more, I have talked with Jim
about getting HHS folks forwarding those kinds of detail data oriented issues
along to HHS. We are working on that today. I think we are better than we were,
and we have some good ideas coming along. I think that getting a quick summary
out to, here is what was discussed and here is next steps, to inform the
Executive Subcommittee at least will help with continuity.
MS. GREENBERG: These five tangible, quote/ unquote, recommendations are not
recommendations that you would take to the full committee. They are sort of
observations you would make as a reactor panel.
DR. CARR: Yes. They are going to be reactor suggestions, is our new
taxonomy, just to make it very clear so that we don’t dilute the terminology of
recommendations.
MS. GREENBERG: If you identify the need for a standalone or a full-day
meeting of the working group, I mean, once a year, I think that would be
reasonable, at least. That is something we can work on. Obviously, with the
overlap in membership, not to mention mission, it makes sense to have some
sequential or timing. At the same time, I think form should follow function.
DR. GREEN: Thank you, Justine.
DR. CARR: Thank you.
Agenda Item: Remarks by the Chair and feedback from
membership
DR. GREEN: I think we are going to adjourn early today. Some other business
items, realizing that some people hadn’t seen everything that was on the
SharePoint site, we just made photocopies of something. I would ask you to take
a quick look at this.
As I was saying just a moment of ago, you will have to indulge the fact that
I am a physician. We physicians spend a lot of time constructing our brains the
way we construct our brains. Then, a lot of times, that is good, and some other
times, we just become problems.
One of the things as I practice, I am a family physician. It is a wonderful
thing to be because of the rich biopsy of life that you get. Over 25 years or
so of practice, one of the things you notice is how many ways human beings can
be dysfunctional, the inventiveness of the human race in self-harm, also, their
amazing creativity and the resilience.
An enduring thing that is sort of hardwired in me is I am sort of opposed to
needless pain and suffering. Five years into working with this committee, it
has been my own personal experience that the production for the letter for
Secretary is unnecessarily painful, and is accompanied by avoidable suffering.
This need not take long, and you guys can just say, yes, he is just crazy and
we will just go right by this.
I probably missed it in orientation, but it took me a while to figure out
what it took to produce a letter. It is pretty complicated, actually, and it
has got a lot of steps. Recently, I have been trying to figure it out and see
if I could write it down. I would like to walk you through this just for a
minute, and then ask you for your reactions.
The first thing is it seems to me that we, as a committee, would do well to
realize that a letter to the Secretary is just one of our deliverables and
potential products. I am not trying to talk here about every possible product.
I really want to focus just on when we decide that a letter to the Secretary is
a deliverable. It seems to me that the approach to that should be systematic,
both in terms, and this is an important idea here, of the process we use to get
to the letter, and then secondly, also the format of the letter.
Now, what you see coming next I didn’t actually make up. I have heard this
from lots of people. I have quite a bit of input from individual members, and I
have talked with Marjorie and others about this. It really helps if the
committee affirms that we need to do a letter and that we are agreed about
that. I have observed times where we are down in the weeds, trying to finalize
a letter, and what is really going on is there are people sitting at the table
that don’t think we should be writing this letter in the first place.
I think a really good process step is we reach an agreement that we need
one, and we reach an agreement on what the purpose is going to be. This is
hugely important. You can see it in what happened yesterday, in the letter we
approved this morning. It is easy to lose track about what the purpose of the
letter is, when we are down and trying to make it as good as we can possibly
make it.
That is a really good thing to do at the full committee. It seems to me that
we should establish the need and the purpose. We need to do proper public
postings. We are a public committee. We need to alert the world that we are
thinking about doing this sort of thing. What we usually do is then we get a
subgroup that gets assigned responsibility for preparing the letter. That
really came down to being Leslie and Linda and the case in point for this
meeting. We work with Maya, we decide who the staff, et cetera, we get that
subgroup established.
Under Justine’s guidance, we got, I think, pretty good about having a
PowerPoint presentation to the full committee, as really the first deliverable
the group is going to produce the letter, that includes the points that I wrote
down here. That we get a chance, as a full committee, to see that, and that can
be pretty galvanizing. That helps us understand where we are headed.
Then, the group actually develops the letter, reviews it usually through
email. They have calls among themselves, and they do teleconferences as needed,
in order to get to what they consider to be a darn good draft of this letter.
They think that they finally got their arms around it and meets the purpose.
What typically happens, what has grown up over the years by habit, is then
the executive subcommittee reviews this on an executive subcommittee called
where the co-chairs of all of the groups review it. That group decides when it
is ready to come here to the full committee.
The presentation to the committee has been wildly variable over the years.
You see here now that I am taking some literary license here. It seems to me
that the presentation of the committee should just basically focus on three
things. A remind of the purpose of the letter, number two is the presentation
of the findings, we often refer to these as observations from the work. Then,
the third thing is the recommendations. What is the purpose, what were the
findings, what are the recommendations?
It then seems to me that the subgroup and staff then work together to
prepare a final version. They work with Marjorie and the secretariat here. What
eventually happens is, following the Justine Carr rule, she said that I should
never sign something I couldn’t understand. Then, we find out if Larry can
understand it, and if I can understand it, then I sign the letter. Then, it
goes into a transmitted protocol process that NCHS uses.
Now, a quick word about the format. The letters have been widely variable
over the years, when you go back and look at them. I am suggesting that at
least for the next stretch of the road that we adopt a sort of template for
writing the letter. One is a standardized opening paragraph, who are we and
what are we doing here.
Then, a concise background explaining the purpose of the letter, and the
context of it, why are we writing it now and why should this matter. If you
look at the letter we approved, it does exactly that. Then, the findings, and
many of you have suggested that we do those in more of a bulleted format, where
you really call them out and say, this is what we think is reality here.
Then, recommendations, again, numbered or bulleted, but are listed there.
Then, we often have a need after we have done that, to have a little bit of
additional discussion to clarify and just to call out the salient issues and we
saw that happen in the letter that we approved today. Then, we have a pretty
much standardized closing paragraph that says, we are still here, we are
available. We would be happy to respond to follow-up. We like to hear back
about what happens with our recommendations and that sort of thing.
Enough of my talking, what are your reactions to this?
DR. CARR: I have the Chair Emeritus priority. I want to make a couple of
points. On number four, the PowerPoint presentation, that is helpful. What I
think is critical with that is that it begins a dialogue across the committee
of different end perspectives. I think we have all done it, when our own
subcommittee has had a hearing, and we come away with exactly what we want to
say. We are very wedded to that, and we put it out there.
There is always the Bill Scanlon question that challenges your whole
fundamental premise, that makes you better. Bill and I, I think I might have
the record for the most number of revisions of equality letter. Even Bill said,
why don’t you give up on me? I said, no, because that is how we leverage the
expertise of the committee.
I think it is critical that you come with that PowerPoint in all humility,
expecting all the tires to be kicked, all of the assumptions to be questioned,
so that you come away with confidence that we did in-house, as opposed to
having something go out and having missed something. I would say, yes, it is
the PowerPoint, but the time should not be taken up with 20 slides. The
PowerPoint should be, this is what we heard and this is what we think we need
to do.
Then, just like we said, when we had the claims attachment and we were all
focusing on how many hearings we had here. Then, Bill said, will we ever need
claims attachment, and it opened a whole new door. That is where I think we
have the opportunity to make a great impact.
One other thing we had at one of the quality hearings was about measures
that matter. As Paul said yesterday, what we learned is that none of them were
anything that we would bring forward, because the point was there was no
standardization. I can’t emphasize that enough.
Then, two other things. Yes, it is true that it is the Secretary that we
think that is getting the letter. The whole world reads these letters. People
refer to them, I am amazed at the things that people come back and say, I saw
you said. I am thinking, what did we say, paragraph two, sentence three, so
words matter. I will always be obsessive about words, because you want to make
sure that they convey the meeting that you intended.
Then, the final thing is, I think especially as when our letters are long,
we might assume that readers are only going to read the first page. Yes, we
have our standard NCVHS paragraph. I think the next paragraph should not be
background, but should be, here is what we think and now let’s tell you why.
Bullet, bullet, bullet, right up front, because then the stage is set. They
know what you are going to say and now this amplifies it.
DR. GREEN: I know that Jim Walker agrees with your third point about saying
what you think up front. I also know that other committee members think that
their minds don’t work that way, and they want to develop the case and then say
what they think.
DR. CARR: What does Jim think, as perhaps a reader of letters for the
Secretary?
MR. SCANLON: We have sort of unwritten rules in HHS, where we almost have to
assume that anybody will read this letter, number one, or memo, to the
Secretary. Generally, we try to keep memos, or the equivalent of letters, to
about two and a half or three pages. If it is longer than that, we basically
make it a report or an attachment.
We didn’t do it, and we couldn’t do it, with the letter yesterday. It is
almost a freestanding report at some point. What you really want is a cover
memo that summarizes the background and the recommendations, and then it is a
separate report that stands. We have done that certainly, as well. No, I think
this is fine. I think just assume that obviously it is not just the Secretary.
The Secretary will read it, HHS folks will see it. But it really becomes a work
for the community. You see it referenced in other work. You see the opinions of
the NCVHS reflected in other justification for other positions. You have to
assume everyone will.
Again, the importance of words, we have not escaped from the situation where
someone takes a sentence or two out of our letters, and sort of misinterprets
it or thinks it means something else. Really, as a whole and in every sentence,
it has to clearly say what we mean. It is amazing how things can be taken, and
particularly in a privacy area, as you know, and just sort of interpreted in a
different way that we didn’t intend.
I agree with all of these. The only friendly amendment would be that, when a
letter exceeds a certain length, that we think about a report instead, which
would be the same as the letter basically, but it would be a self-contained
report.
DR. GREEN: And three pages or less is a good criteria?
MR. SCANLON: As a general rule. We assume executives don’t read anything
more than two and a half to three. At HHS, we have rules, depending on who it
is, it is a one-page summary or a three-page summary, or a full report, so we
don’t need to do that.
DR. CORNELIUS: Jim, it is funny you should say that, because my first
reaction to the letter was that it was long. I am used to the concept, both
because of my eyes and writing, that short letters would highlight where you
want people to read and the topic, like writing the paragraphs, what have you,
really draw people in and capture their attention.
More importantly, I think those points there, some of those items that sound
like they would fit in the assumptions that are sitting here. Think about the
fact that everybody will read those.
I have two sets of comments. One quick one is, as a writer, I always think
about the flow that is in front of me. As I saw the two pages, I said to
myself, as we move forward, it might be helpful to think about this in three
areas. One, I would say the charge. For me, the first point really is the
endpoint of whatever charge that set in motion the letter that you are about to
produce.
The second piece that covers a lot of this is feedback, the process that we
are engaging in that leads to the third item, deliverable products. A lot of
the times, I was sitting here asking myself, what is the goal and the milestone
of whatever we are doing. Even as I think about the letter, in the end, this
whole two pages, seeing a template that says, as you are thinking about this,
you need to first think about how do you walk into this. What is it that you
are doing over a period of time, and how do you know when you are landing the
plane?
Then, there is a second piece. I guess the honor of coming in at the end of
one group, and the beginning of another, and also being a faculty member, there
is a dreadful thing that happens in committees with wonderful, talented human
beings, there is an aversion to editing a document in live time with many
people. As I watch this unfold, honestly, I thought, for the record, I was
like, wow, there is a process.
There are two pieces, one, I have to ask myself, what is my charge. Do you
want me to provide the conceptual understanding for this and the guidelines,
and then you have a subcommittee, and you go and you work it out and you bring
it to the large committee, and the process and then you do the final editing.
Or do you want me to wordsmith this every time we meet?
I always think about that, whether it is here or whenever I am back at my
host institution. I find that that might be something that may help down the
road. A lot of the time, I just sat back. When the letter came out, I separated
in my head what was the most important thing I needed to contribute to the
discussion, as opposed to talking about eight other items I could have talked
to for two days. I know how to be a faculty member and talk, for 30 years. I
don’t want to do that, and I think that is something we have to wrestle with in
terms of the best use of talents and giftedness.
MS. MILAM: I want to validate something I think I am hearing. We are
slightly changing the style of our letters to shorter and harder-hitting, if we
are moving to bulleted findings. We are getting rid of a lot of verbiage and we
are just laying out the facts mostly.
DR. CARR: Sort of the first paragraph, boom, boom, boom, here is what you
are going to hear, and then have the rest of it thereafter.
MS. MILAM: I am looking at, Larry, what you had put together. Like number
three, we have findings, at five, we get to additional discussion where it is
particularly salient. It really presents or proposes a different style. Is that
what we mean to think about, or am I interpreting interposing too much of other
discussion into that?
DR. GREEN: You are interpreting it right, from my perspective. I suspect
that we will have a hard time staying under three pages, with some of the
topics we have got in mind. I suspect that Jim will cut us a little slack. If
it winds up spilling to page four, I suspect it will be okay.
I just think we are crazy to think that the longer the letter, the better. I
think brevity is a huge virtue here. Most of the time, my experience is, if it
takes you eight pages to say it, you don’t know what you want to say. I also
don’t understand why we decide to have page-long footnotes and that sort of
stuff. Maybe there can always be an attachment that has references in it and
that sort of stuff, I don’t know. Yes, basically yes, it seems to me that we
should do the hard work of making it to the point.
DR. FRANCIS: Larry, could I just jump in on that. I think that you will
find, if you look back at the letters, and I don’t oppose this, but we are
probably going to be moving towards producing more reports on that. I think
that is an implication, and I am totally fine with that. I mean, often the
reason they get longer is that members of the committee want explanations.
I have felt often that the letter format is weird, a kind of a peculiar
hybrid. I welcome the thought that we would be in a way encouraging ourselves
to think more in terms of report formats.
MS. GREENBERG: Well, since Larry just told me that the staff and I will be
responsible for finalizing this, I do want to do clarification. As anyone who
knows me, you know that I embrace standards. A standardized way of operating, I
am certainly in favor of. At the same time, I don’t think we should be too
rigid, because I do feel that form should follow function, or what we are
trying to.
For example, I think in retrospect, probably the letter that we approved
should have been a short letter with an attachment, or a report. Even if we say
that is going to be, and so, I think moving more towards that, I absolutely
agree with Jim that a lot of times, people see a letter is more than one page,
they don’t want to read it. I am not that much of a minimalist. I do think that
is probably a better way to go, certainly in the bureaucracy or in the
department.
In fact, it was funny, because I am not quite sure how we evolved into this.
We used to have mostly reports with cover letters. I think it might have been
standards, with all of those standards recommendations that we were required to
do.
DR. GREEN: I think we should blame standards for everything.
MS. GREENBERG: Yes, we can blame them for everything, no, that we started
doing more of these detailed letters. It is funny, because after we approve the
letter today, after you approve the letter, I started thinking, well, what kind
of transmittal letter do we need. Then I said, oh, no, it’s a letter already.
Really, I would say until recently, but maybe recently is 10 years or
something, our pattern was reports with cover letters.
Maybe going back to that more, or the cover letters were often kind of bread
and butter letters, as I refer to them, here you are. As Jim likes to say, I
quote him many times, we don’t make policy and letters. In a sense, a letter is
not the right place to maybe put a lot of letters and recommendations and stuff
anyway. I think we have some agreement on that.
I think if you look at this, really, it wasn’t so much findings in this
letter, and it doesn’t exactly fit that. I mean, you could spin it into
findings, or you all do observations. I think we should have a little
flexibility, but I think that agreeing that basically letters are going to be
two to three letters, and anything else is a report or an attachment or
something, is a good policy to go with. We will work towards that.
Although I had reviewed this with Larry, I just realized something that
didn’t hit me before. That is, if you talk about a subgroup obviously, and I
agree with Lee, writing by committee is pain and unusual suffering. It can be
torture, and it may be unnecessary.
On the other hand, every once in a while, when it is wordsmithing, we should
reduce it. Sometimes, it is because, and maybe this gets back to what Justine
said about don’t sign something you don’t understand. People start questioning,
and you all, as experts, start questioning what do you really mean here, or is
this what you mean, or this is the way it sounds to me. It is really valuable
getting it right. I am a writer, so words are important obviously, and I think
we all feel that way.
If we can somehow differentiate between wordsmithing and adding value, that
is probably our challenge. The most important place to add value is probably in
the recommendations, and I think your suggestion that we really focus on that
as a committee, and particularly that they are worded right. Then, make sure
that what comes before is aligned with it.
That leads to the question of whether you put your recommendations first or
last. There are people of both schools, and we have heard them expressed here.
My personal preference, but I think this is for the committee to decide,
though, what Larry has suggested as findings and then recommendations, is that
you preview the recommendations right up front. You tell people what you are
going to be telling them.
Of course, if it gets to be beyond a letter and a report, then it is a
different story. But that it does follow logically. Your findings or your
observations lead to your recommendations. Otherwise, they just kind of come
out of the blue. I, myself, am not for putting all the recommendations in
detail right up front. People can have different opinions on that.
The other thing is that we do have a process, when we finalize this, we will
bring that process into here, that we came up with a number of years ago. It
was when Simon Cohn was the chair. Some members expressed concern that letters
got to the full committee, maybe they had even gotten to the executive
subcommittee, but without the entire subcommittee being on board or having had
an opportunity to express dissenting views or whatever. Actually, we laid it
out pretty clearly what the process is.
I think we should look at it again, but that means we can’t go from the
subgroup to the executive subcommittee, which is the way this sounds. There is
always a subgroup, whether it be the co-chairs and the staff person, or some
other person, the lead staff, whoever, the writer. In any event, there is a
subgroup that has to write it, because you can’t write some 20 people can or 10
people, five people, it’s hard to sit down and write something.
Then, it has got to go through the subcommittee. That step isn’t really
mentioned here. You talk about development review by responsible subgroup.
Then, it has to get a signoff by the subcommittee.
DR. GREEN: The reason I chose the word subgroup because of this transition
we have between working as a committee as a whole and the subcommittees, and
working toward deliverables and that sort of stuff. Subgroup could be a synonym
with a subcommittee.
MS. GREENBERG: It could be, except you have referred to the subgroup who
writes it, so it sounds like it is the same subgroup. I would say there is a
broader group who needs to review it, before it goes to the executive
subcommittee. Whatever is the working group, the subcommittee, the task force,
whoever is responsible.
It is never going to be a few people. It is never going to just be
co-chairs. It has got to be some kind of structure, and that group, after it
gets drafted, has to go through it and contribute before it goes to the
executive subcommittee. Those are the other things I wanted to add.
DR. GREEN: I just want to reinforce, before we go to Walter, Justine’s point
that the real purpose of the PowerPoint presentation, that step is to elicit
these different perspectives across the full committee. We don’t want to get
down to finalizing the letter, and then discover that we –
MS. GREENBERG: Yes, and that used to happen.
DR. SUAREZ: Thank you, just a couple of comments. I understood a subgroup to
be subcommittee. Number three is the process by which the subcommittee is
assigned the responsibility to prepare the letter. Of course, within the
subcommittee, there are one or two people that prepare the first draft. Then,
it gets shuffled, and then it gets inside the subcommittee is the group. I
think that is step number there, is really the subcommittee/subgroup, whatever
we call it.
MS. GREENBERG: Maybe that is the way I read it the first time, and then I
didn’t this time.
DR. SUAREZ: I think that is the right process. I do have a concern about the
steps. We meet every three months, and I don’t think that we would have a
chance to do all of this in the way that we have been doing it in the past. Let
me explain the process.
We agree, at some point, as a committee that we are going to hold a hearing
on some topic, either because as a full committee like this, one of the
subcommittee’s report, we are going to hold a hearing this day. I don’t think
we ever just stopped taking that full action. Everybody agrees that we should
have a hearing, and everybody says yes or not. It is reported that there is
going to be a hearing and then it happens, the hearing happens.
After the hearing, the subcommittee looks into that and decides where they
should write a letter with only observations, or whether they should write a
letter with observations and recommendations. Or whether they should write a
report, or all of the above, I mean a combination of them. It really comes to
that point of when the hearing has been done, the subcommittee, or whoever
hosted the hearing, maybe it is two subcommittees or whoever; they really get
together and say, what are we going to do about this. Normally, we do a letter,
we do this.
They decide at that point that they are going to write a letter. Then, they
begin to prepare that. If it happens that the full committee is going to meet,
then they will present a draft of that letter. If it goes through, it goes
through. If it has a lot more work to be done, then it goes back to the
subcommittee. Until three months later, the full committee will hear it again.
I am concerned that some of these very structured processes might not play
well with the fact that we meet every three months, that we usually decide
about a letter after we held a hearing to determine whether there is a letter
or not. I think it will be helpful to build some flexibility around that.
MR. SOONTHORNSIMA: I am not going to repeat all of the great comments from
everybody, but I want to chime in on what Lee has said. I think he just
described an experience that he just went through in two days, and that is an
experience that I have gone through in a little over a year that I joined the
committee.
What I learned in the past year alone is that we have gotten better. I was
astounded the very first day, when we were editing. I didn’t have anything to
add, quite frankly. Linda was there, too. It was a report, that is right.
The point is this, reflecting back on what everybody is saying. I took what
you said earlier. This is one of several products. Let’s stop where the
production begins. If you really think about the production itself, most of it,
whether we are doing through editing or wordsmithing or whatnot, it is
deliberation, I believe.
Like yesterday, we were still deliberating, I think, even though we
understood the eight points. With that said, that is just a feedback on what
actually transpired in some of these meetings. Not necessary, it doesn’t say
that we weren’t on the same page, but by that time, when the letter is being
written, we had better be on the same page. I think that is a guidance that I
heard said from Justine. That is what you would think about in terms of let’s
get a PowerPoint.
Let’s really express what we really believe in, and what are we advocating.
Long before we get to the letter, that is what I heard, is that correct? Long
before we get to the letter because that is really our production. The final
product perhaps is whatever formats you want to use, and we can leverage the
experts. I think it is a deliberation that is rich. That is where all of the
opposing views, complementary views and so forth, come into play.
The last point I want to make is if we just break that down to this is
production now, this is after the hearing and everything else. Maybe we can
time box that process. I believe that if we couldn’t figure out six months,
because we are going to meet four times, if we couldn’t deliberate in the six
month window, it is going to be too late. Why, because things are moving very
quickly out there.
DR. GREEN: We are going to run the rest of the table here.
DR. FRANCIS: I want to raise a couple of implementational worries that I
have, and just surface them for the committee to think about how to think about
them. One problem that is endemic is at the subcommittee level, subcommittee
members who either cannot make meetings, or subcommittee members whose comments
do not come in on time, even with repeated requests. That is an endemic issue.
I don’t know how to handle it.
I think what has happened more than I care to think about is that those
issues have been surfaced at the full committee, when they should have been
aired and were given an opportunity to have been aired at the subcommittee. The
subcommittee then ended up feeling a little blindsided because they had not
anticipated, because what do you do when you have got silence.
I just think we have to be aware of that issue, and think through what we do
in that context. It may be that the only thing to do is simply to recognize
that it is going to be frustrating, and better late than never, but it still is
hard.
The second issue that I think is ever harder, that I also don’t know how to
deal with, but we go through the PowerPoint. No matter what else, no matter how
you think about it, it is going to be at a fairly high level. In addition to
that, it is always possible that there are going to be committee members that
are not present. I will make up an example, but it is actually very close to
what just happened in the discussion, which is why I will use it.
We asked very specifically at the last meeting, whether we should transform
this into a report. We asked that because we knew it was getting longer, and
because we were specifically told to put more stuff in it. Now, people very
graciously stuck with it as a letter. Can you imagine how we would have felt if
having gotten the, it’s a letter, and the other thing we asked very
specifically about, are these the eight elements that we should stay with. We
got a yes answer to that.
We went over and over and over again, does anybody want to take any one of
them out? Does anyone want to put something new in here? We are going to be
very careful to say it’s not an exclusive list, something else, but it is our
starter list. That is why we went back and wrote it as elements, and why we
went back and made very clear that we are just proposing eight elements. We are
not proposing an exclusive framework.
I can easily see those decisions having been revisited at this meeting, even
though they were made explicitly, had there been different sets of people here,
had people chosen to push things. Now half of me says, speak once and forever
hold your peace. Half of me says, if something needs to be revisited, it should
be revisited. Whatever we do process wise, and I think all of this is super, I
think that those two factors are where the real frustration lies.
I just want to alert people, and maybe I will say one more thing about the
wordsmithing. To go back to Justine’s point, people care a lot about how the
language is going to be read. It turns out, we have tried it, not to have the
letters read at the committee, and it has failed. Maybe for good reasons, maybe
for bad reasons, but there is a certain sort – I mean, I am now in my fifth
year on the committee, and I feel a certain sort of inevitability about (French
comment).
MS. KLOSS: Just another observation on process, and I think we have to
acknowledge that everybody who participates in this works a little differently.
I do have some concern that what we agreed to on the PowerPoint will get shaped
and worked differently as you start developing the arguments and putting the
data together.
The letter itself, or the report itself, there is still a possibility that
everything we signed off on at the PowerPoint will have changed and adapted. I
think the lesson to that is just to understand everybody does work differently
and that we give ourselves permission to say, this has changed a little. We
have had new insights as we developed this argument. We ask your permission to
go back and revisit some things that we know you have signed off on before.
I think there were just insights along the way. Having said that, I think we
are well advised to move, not start this dialogue until we are really ready to
press forward because that amount of time lapse is why we revisit. We are
starting over.
I think this was an object lesson where we first outlined what we were going
to do in June, we gave a first draft in September, and we are back again. That
is a long time for anybody to even remember where we started this. I think we
have got to be ready to move and then acknowledge that everybody works a little
differently.
DR. MAYS: Very much like Ob, I am not going to try and go through all of the
comments. I think that what has been talked about is very good. There is just
two things.
One is, Susan Kanaan is here during the whole meeting with us. Maybe one of
the things we could do, if it is okay, is that when there is a letter, allow
her to be able to go through the letter. One of the things that we sometimes
end up doing is just really getting the letter structured, getting the letter
so that there is parallelness in it. It might just help us, for her, to write,
because it is not like we have tons of letters during the meeting. We usually
have two, at the most. If maybe Susan could do that, and clean that up, that
would actually take one layer off.
Then the other thing is, I think is kind of what Linda is also alluding to,
is different people work in different ways. We also have to understand that
this committee is really not doing wordsmithing as much as people keep saying
it is wordsmithing. People come to this with really different values and
expertise. Sometimes the notion of changing two or three words is really the
difference between being embarrassed in public and not.
I think I am kind of like Justine on this, which is people really do read
these letters. They do hold you accountable. I mean, I have had people,
particularly on the race stuff, come up. They are like a sentence, and I am
like, gees, what did it say. Some of us get a little, you know, it looks like
overbearing here. Technically, we are really trying to make sure that what we
are doing is at our best. We are also trying to make sure that we bring in the
perspective of what we have the capacity to be able to represent, be it the
community, be it a professional organization.
I just want us to kind of really get at it. A lot of times, what is going on
isn’t wordsmithing. It really is a quality improvement.
MS. MILAM: I will be quick. I am thinking of two things. Somebody at the
last meeting made the observation that it wasn’t clear that we all had done our
homework, that that could add to the frustration, in terms of new feedback, not
remembering issues and not being clear.
You couple that with the benefit of being together. All of us have different
areas of expertise. When somebody reacts to something, even if it is within an
area of your expertise, you may think of it in an entirely new way, and come up
with new issues.
I think we have two things going on. I think we have that, when people come
up with new ideas. I also think we need to underscore our personal committee to
engaging early, understanding the issues, and giving feedback in a timely way.
MS. GREENBERG: I just wanted to say that I am going to dig out those older
rules, because they do at least set the expectations for timely review coming
prepared, all of that. You can’t force people. The fact is, even if someone
never shows up at these meetings, it is Secretary’s decision at the end of the
day, whether they should still stay on the committee. It is not like we just
sort of set this group up ourselves, and we can control it.
At the same time, I think most people, the vast majority of people, do
follow norms and try to. It was set out what is expected. I think it is time to
revisit that and bring it out. Yet, I would agree with Leslie that, at the end
of the day, life is not perfect and it is not fair.
I think what really helps is to know that something, as Ob mentioned, needs
to get out there. If these things don’t need to get out there, this year, next
year, two years from now, we probably shouldn’t be working on them. Nothing
focuses a mind like a deadline. I think although sometimes the process is
painful, if it is preventing things from getting done in a timely way, then it
is more of a problem, I think.
Frankly, a lot of the things that were mentioned, I think, can be handled by
the chair, just in trying to enforce proper behavior.
DR. GREEN: Thank you for your patience.
DR. SCANLON: No problem. Let me start, in some ways, reinforcement, Sally
said. I think this process here, which I very much support, does put an
obligation on the members of the committee. You have to do your homework sort
of for this, to make this work. If you don’t, you have no right to object. That
is the simple thing. You can come and complain to Larry, and Larry can tell
you, well, you didn’t read it in advance. You didn’t sort of offer any
comments, tough. That should be sort of the way we operate. You just have got
to do your work if you want to have your viewpoint expressed and reflected. I
think that is a part of this.
Let me talk about sort of this issue of wordsmithing. I agree that there are
times when we have had valuable changes that have come about, sort of because
that letter is projected on the screen. I think we could probably have most of
those changes occur through a process of having comments on draft letters, or
maybe comments on sort of draft bullet points about findings.
I think number eight should be that the presentation involves a PowerPoint
with three things, a purpose of the letter, the findings and the
recommendations. It is another PowerPoint. This committee survived before we
had projectors. I was on this committee before we had projectors. I don’t think
that if you went back and looked at those reports that they were so awful
because we didn’t have them.
There is this issue, if you offer suggestions, you should have a chance to
see sort of what the response has been to your suggestions. Before a letter is
issued, it should be circulated with the full committee, and then Larry can
sign it, sort of knowing what is involved, or knowing that he understands
everything that is involved. I think that is sort of an appropriate compromise,
as opposed to putting up sort of the letter on the screen.
Every time I may have heard, let’s not wordsmith, it is human nature, it
creeps in. Then, particularly when somebody is trying to change a point, there
is like, well, if we change that word, it would satisfy me. Well, wait a
minute, what about this, and that definitely is wordsmithing. I think that we
have got to find a way. Our precious resource is time, and we spend a lot of
time on this.
I have been on a number of other advisory committees, and none of them put
their letters up. None of them put their reports up. There has been more
editing in my experience here than on all the others combined. I think what we
have got to do is think about deliberation. That is what we really should be
sort of focused on.
There have been some preferences expressed about sort of different styles. I
like to sort of have this style versus that style. You have got to be concerned
about what your audience wants, not sort of about what you really like. What we
are talking about, and as Jim has identified, we are talking about sort of an
executive audience within the department, and potentially executive sort of in
other sectors, as well. They don’t read a lot.
The one-pagers are really very valuable. I could see, and again, not being a
slave to my former job, but at GAO, they now have a format which is a one-page
highlight, followed by a letter. The letter can be 100 pages, it doesn’t
matter. There is the one page, that anybody that wants to get the essence of
the report, because a 100-page letter is a report, they get it out of that one
page.
The thing that scares me a little bit about the word report is whether there
are format styles for reports. One of the reasons that GAO has 100 page letters
is because the report format became too unwieldy, and so we started to just
write long letters. We didn’t have to sort of have chapter one and here is what
we are going to do, chapter two, here is what we are going to do, that kind of
thing. We just said, okay, we are just going to write this letter, and then we
will summarize it up front.
That is a compromise. I am not proposing it, but I think there is this issue
of you have got to worry about your audience and you have got to think about
sort of how do we most effectively communicate with them, and the maximum share
of them. Because if we don’t, then maybe Jim writes the one-pager that goes to
the Secretary’s office. That is something to think about.
The last issue is this issue of sort of timeliness. I think that having sort
of this two-step process, I am not sure is going to be a handicap in almost all
circumstances. I have been working on health policy since 1975. One of the sort
of nice features about it is, you never have to learn new issues. We are
dealing with the same ones, all right?
This issue of sort of if we have a presentation about what we are about to
do, and then, three months later, we have sort of a discussion of the letter
that is involved with it, at most, we are talking between the hearing and the
letter, a six-month delay. That may, in most instances, not be sort of too long
of a period of time for deliberation, especially if we are talking about sort
of a lot of communication in between, sort of among the committee members, to
be able to sort of incorporate sort of ideas. That is it.
MS. GREENBERG: Can I clarify one thing? When did you say it should go, the
letter should go to the full committee?
DR. SCANLON: I think the letter needs to go to the full committee sort of
before we have our meetings, sort of after the subcommittee. Then, I think the
full committee, or maybe just people that have commented, should get that
letter to see what happened to it before it goes up.
MS. GREENBERG: I have to disagree with that.
DR. SCANLON: Well, there is the issue of sort of ultimately, and then Larry
can send them the email saying, I hear what you are saying, but here is what we
are going to say. I mean, you endow in the chair certain power, ultimately to
sign the letter in saying this is what we are going to say.
MS. GREENBERG: I think once the letter has been approved, if you are not
prepared to approve it, then there are different ways to finalize it. You can
finalize it with the Executive Subcommittee, you can finalize it with the full
committee. Once you approve a letter, I really would be against sending it back
out again, because people are going to wordsmith, you cannot stop them. People
are going to raise issues that they didn’t get in before.
I mean that is one of the reasons why we go over the letter actually, before
it is approved. It is not just a concept you are approving. You have approved
that letter. Now, any edits that are made are completely editorial, no change
in recommendations. There are people, not so much maybe this letter, but with a
standards letter, they are waiting for those letters to come out. The minute
they are approved by this committee, they want a copy of it. We can’t do that.
We have to put it into the right format and get it to the Secretary. As an
advisory committee, you don’t want the Secretary to be the last person to hear
what advice you gave, when she is the person we advise, or he.
We are under tremendous pressure to get those things posted on the website,
which we can’t do until we have actually finalized it and sent it. I really
would strongly advise against giving the full committee another shot at a
letter. If you are not prepared to approve the letter at the meeting, then
don’t approve it. Once it is approved, it has to go into a process.
DR. SCANLON: I was going against my nature in being kind at the rest of the
committee saying that you have a final shot at it. I am comfortable with that.
The other thing that I think is involved here is we are not approving letters
at meetings. What we are approving are the recommendations. Every other
advisory committee that I have been on approved recommendations. The
recommendations were then transmitted to the Secretary, and to others, sort of
in the form of a report or a letter that had other material in it, to sort of
justify that recommendation.
That is, I think, the distinction that we are talking about here. We really
are voting on the recommendations, as opposed to the letter itself.
Agenda Item: Summary Steps and Future
Directions
DR. GREEN: Thank you for your indulgence in having that conversation. No one
else appreciates it, I do. Let me offer two quick reactions, and then we will
do it again. I will start over here with Lee, and I would just like to ask all
of you to be thinking about two things. One is any comments that you want to
make about the meeting, any reactions, suggestions, whatever. Also, you
co-chairs, you spit out key next steps that we need to get done between now and
our next meeting, that sort of thing.
Here are the reactions that I want to offer. In light of both the content
and the tone of that discussion, I wish to commit to you that I am going to see
it as my job to move us through that process expeditiously. I will apologize
right now individually for offending you at some time or another. I am going
to.
I am going to look at you and say things like, great idea, should have
happened last November, we are going on. With a little luck, you can get me
fired, and someone else can do this. My view is just that my job is for the
committee to get its work done. I am an RT squared guy, the committee’s work
has got to be relevant and it has got to be targeted, and most importantly, it
has got to be timely.
I think some of the process of the committee precludes our work from being
done in a timely way. I am opposed to that, and that will be a characteristic
that you can expect out of me and make me pretty predictable.
I think Justine’s version of this was she said, get clear about what you
want to say, say it briefly and say it once. I would just add to that, and say
it at the right time, in the process for the product we are trying to get to. I
will tend to manage the committee, not with an eye to the standards
subcommittee or the populations committee. I will tend to manage the committee
toward its deliverables. That is what I see as my job. That is part of the
reason I don’t want to be officially identified as belonging to one of the
subcommittees or workgroups. I will just work hard on the process, and get into
deliverables. That is what I see as my job, that is what I see as my goal. I
seek your help.
I also want to acknowledge what I think is our fundamental problem. The pace
is unusually quick. The environment we are working in, for which our work is
relevant, is moving, as Jim said, at about three times. It is moving quicker
than we mere human beings and our organizations can move. We can’t change that,
but we can do our best with the hand we are dealt and with the environment we
are in.
The other part of it is it seems to me that, as far as I know, each of you
has a job. Being on this committee is like getting another job. I want you to
know that I understand that and I am sympathetic to that. That is part of,
again, what I see as precious resources, each of you, as an individual. I don’t
want to waste your time on staying up a couple of nights to write a letter,
only to have it blown apart a month later, and someone say, now, go back and
fix it again. I am opposed to that. That doesn’t mean it won’t happen.
Remember, I am just a doctor. I made a lot of decisions for a lot of
patients that I wish I hadn’t made, because I didn’t know what was going to
happen next. After I did, I wish I could go back, and that will probably happen
here, too. I will also rely on you for judicious forgiveness when it misfires.
I am going to work very closely with Marjorie and Jim about moving these
products along. Another thing on my next steps is I want to have a conversation
about reorganizing the agenda and the way the agenda looks. I am inclined to
move us toward an agenda. That fire hose that we drank from yesterday morning,
that I am convinced is absolutely critical.
We have got to have that, to make sense out of the world and what we are
working on. I don’t see that going anywhere. If anything, we may need just a
little more time for it, because of the rate and pace of the implementation of
the ACA, the deadlines. Everything is accelerating right now.
Then, I am inclined for us to move toward the agenda being around the
deliverables. What is it we are trying to get done, and have the agenda focus
on the products that we are trying to get to. Thereby, I think, that can help
us with this problem of working as a committee as a whole, instead of seeing a
sequence of reports, and that sort of stuff.
I don’t know exactly how that will work. I just wanted to give you a heads
up that I want to work with Jim and Marjorie, and the co-chairs. I expect the
agenda to maybe look a little bit different next time.
DR. CORNELIUS: I would kind of nail my comments down to three words. One is
deliberation, the second inclusiveness and the third accountability. I really
appreciate the time that we spent, because it is a nice synergy occurring. We
were going through some very tough issues and how to continue building bridges.
The piece about deliberations, that is definitely a rich nugget that we have.
I would task us how to figure out how to use that, the best way we can, when
to wait and when do we step back in favor of something that the whole group
develops. The inclusiveness piece, I keep thinking about that, yes, it is
important for us to move the processes along. Yes, inclusiveness and
accountability go together, that we each have a role to participate and not
sabotage something, because we were not at this email or what have you. I think
that is going to be important in any group, to keep us to that.
I also appreciate your leadership in saying that we really have to stay
focused on the deliverables. That is going to keep us moving.
DR. CHANDERRAJ: Like a physician, I think like you. I can see that we are in
the minority here. I think the discussion about this process has gone on longer
than the letter itself. I like to keep it brief and I will pass.
DR. MAYS: I guess I am going to start by picking up a little bit with what
Lee was talking about, and that is the issue of deliberation. My concern is
that we not strip ourselves down to deliberating about the product, to the
point where we lose the substance.
I think that, at least the time I’ve been back on the committee, that what I
actually felt was two things. One, that the quality of the deliberations,
because there was a lot of prework done on how to do it best, actually was done
very well in the sense of trying to do it from an integrative standpoint. I
mean, I think that coming back, there was no longer these silos. I think the
transition from moving from silos to an integrative approach, actually is going
to require a little bit more deliberation and frustration, et cetera.
I don’t want to see what we have begun as being something which I think is
hard to do, getting cut to some extent for efficiency. I think the quality is
what we are getting from it. To just be very honest, that is what I was really
impressed about, in terms of coming back as that. The silos are moving away,
and I thought what I was actually learning is even how to run a meeting, and
how to participate in a meeting, in a way in which what you get at the end of
the day is something that most walk away with as being a part of, and then come
back to contribute, to make it even better than before. I am really going to
hope that we don’t lose that.
I think part of what you were seeing is we are working differently and we
are working hard at it. We are all trying to help. I don’t know, I mean, I
don’t have the painfulness of this letter in that sense. I am just hoping that
the judgment is not a little too quick about that we are not going in the right
way. That is the deliberation issue.
The second, I think, in thinking about how to move forward, my sense is that
it is less about an agenda, and it really is about a planning. I think that has
to do with a lot of work outside the meeting, before we come to the meeting.
The meeting today was mostly the work in the room, because it was a whole lot
of discussion, as opposed to, and I am assuming this is the role of the
executive committee, is a lot of thought about, well, here are the issues and
how to accomplish it.
Honestly, I do think today was different, and I am getting a little nervous
about being too radical in our decision-making. It was a lot of open time, a
lot of kind of trying to figure out where we are going. That is a different
process. That is not usually what we are doing.
We usually come in here and there’s like boom, this is the six things we
need to do, here is how we are moving, here are the people. I don’t want to
lose that, as well. I know change is good, but I just want to make sure it is
the not the baby and the bathwater both.
Then, the third thing, and you used the word inconclusiveness, and I was
going to use the word like diversity. Diversity in the sense that, we come here
with such richness, that we have to make sure that whatever this deliberative
process is, that it is going to allow that. Very honestly, I think to keep the
level of individuals who sit around here, if we don’t learn new things and kind
of expand our horizon, it is kind of like a little less interesting. That is my
comment.
DR. COHEN: It has been a fascinating two days for me. I am trying to reflect
on these two days and the context of being here for a year now has been very
valuable. Clearly, organizationally, we are in transition. We are thinking
about how we structure our work, and what the process of our work is. I think
one thing is clear, in order to meet our goals, we need to be more prepared and
use our time more efficiently. I agree with Vickie, it is going to be a
struggle as we transform this organization, and we come up with a different
process.
What I really enjoy about this committee is, in my day job, I don’t get a
chance to think grand ideas. I am so busy trying to keep the trains running on
time. There is not a chance to sit back and reflect, and share my thoughts and
ideas, and learn from others who have very different perspectives, and bring
their knowledge base and their experience. That is the real value of this
committee, is just fruitfully exchanging and fertilizing these ideas, and
translating these grand ideas into practical realities, to provide important
advice and direction to folks who don’t have the luxury of sitting back and
thinking about these things.
I want to keep our eyes on the prize, so this is a place that generates
ideas and that translates ideas into strategy for implementation. We need to
mold the process for how we do business, to keep that in mind. I am comfortable
with change and doing things differently, but I don’t want to lose the richness
of our conversations and our debate and discussion over different points of
view, and having the space to think.
MS. MILAM: I guess I would like to talk about two things, first, the
process. What I am hearing is we all agree that we need richer deliberation,
that we want the agendas to allow for more deliberation and be focused on our
deliverables. I keep going back to what Bill said. I think we need to tease
apart deliberation from wordsmithing.
As I read the process here, it reflects Bill’s recommended approach. The
process, as I read it, does not include bringing the full letter to the
committee, and going through it on the screen. It includes bringing the
purpose, the findings and the presentation. I want to check my understanding,
is this a new approach to approval of letters, not going through the entire
letter on the screen, but really going through these three areas?
DR. GREEN: That is what I would like to see. Again, where I think we need to
leave this is, we have statutory requirements, we have informational transfer
requirements, and all sorts of things. I want to get back and work with Jim and
Marjorie about what we really need to do about that. That is the right
direction, that is conceptually the direction that I believe that we have got
endorsed here. I think most people want to mostly hone in what is the issue
here and what do we recommend, as opposed to worrying about the second sentence
in the third paragraph.
MS. MILAM: We will focus more on debate and issues, and get the issues out
earlier, instead of bringing our letters in so early as we have, and getting
focused on the content.
DR. GREEN: Unless you guys rebel.
MS. MILAM: I like that. I just want to make sure I am understanding and
hearing what I think I am hearing, is accurate. It sounds like I am.
MS. GREENBERG: I would think that there still will be an opportunity. It is
not like the whole group is going to agree on purpose, findings and
recommendations, assuming that somebody else is going to write the letter. At
least, I wouldn’t recommend that. There will be an opportunity, by your
participation, either in the subgroup, that is doing the letter, or the
executive subcommittee, if you are on the executive subcommittee, or when you
receive the letter. I mean, we have to build some time in.
If you are not on the subgroup, and you are not on the executive
subcommittee, right now, you only get that letter really a few days, often at
most, a week before. This may say something for, what do we call it, the
corresponding members. If you really want to have input to a letter, even if
you are not on that subcommittee, you should ask to be a corresponding member,
so that you have an opportunity. I would think by the time the letter has gone
through all of that development process, and the executive subcommittee, it is
really not such a good time for this group, or not the best use of time, as you
have all said, to be wordsmithing it.
Now, if we can get the letters out a little earlier, that would give you an
opportunity to send some comments. Generally, we could certainly try to get it
a week before, which would mean you would get a chance at least to send the
co-chairs, if you had some edits, suggestions or whatever. I think we need to.
I don’t want anyone on this committee reading a letter that has gone out,
reading it on the website and saying, oh, my gosh, I didn’t realize it was
going to say that. I think you all have to generally agree with the letter. As
you said, there is a difference between deliberation and wordsmithing. This is
something we will kind of work on. Obviously, I think Larry and I, as executive
secretary, hear a general consensus about what you would rather not be doing.
DR. GREEN: In a way, Sally, you are crystallizing the analog that we talked
about in the communities of learning health system in the chain of trust. If we
can agree to our process, we can decide that we can trust each other. If we
have got a subgroup that is putting this letter together, and we have agreed on
what the recommendations are going to be and what the point is, that sort of
stuff, if we respect each other, and everyone holds their own and pulls their
weight, I don’t feel like we have to have 18 inspectors to make sure the
product is quality.
I see that as a different issue, Sally, from what Marjorie is saying. It is
only courtesy and professionally correct for you guys to see the final
products. You should see them early, not late. You shouldn’t discover them
after the fact, and that is what Marjorie is really emphasizing.
MS. GREENBERG: I just wanted to say that I have been on groups where we
seem, maybe even in the group, to agree to something. I haven’t actually seen
the wording, and I then I see it when it was finalized. It often isn’t what I
thought it was. I don’t want it to go that way, but I think we understand.
MS. MILAM: Another thought about process, one of the things that I thought
was interesting, particularly yesterday and some today, started with the
community as a learning health system discussion, and moved with sort of the
dance we did between the committee as a whole and the work of the individual
subcommittees as a laboring war and the interplay of the roles.
I just wanted to mention for everybody, to remind folks that while standards
is holding its hearing tomorrow, we will start work from the population health
perspective, on the community as a learning health system, at 9:00 across the
hall. To get ready for that, Bruce and I, with Jeannine’s help, have put
together a couple of PowerPoint slides as a frame to start that discussion,
showing the community as a learning health system. With each of the
subcommittees and the data work group under it, capturing initial thoughts of
what we had.
We put a TBD for each committee. We are going to use that to help us
structure our discussion, so that we see how we fit as part of the whole. We
offer that up to you, Larry, and the rest of the committee and the co-chairs,
to use it if they find it helpful as a starting point. Maybe we have an
anchoring slide for each of our themes, or at least an overarching schematic
that shows where we are focused and how they fit together.
DR. CARR: Before I make my meeting comment, just a point of clarification.
Are we posting the drafts and various letters on the SharePoint?
DR. GREEN: Yes. Your point?
DR. CARR: I couldn’t find one. I think that addresses the issue of, if you
are not part of a subcommittee or a group working on something, that you are,
at least, able to read it and view it.
My comment was just that the committee does its best work when it focuses on
concepts, commits to deliberation, and adopts the mindset of seeking input,
listening to input, and having the capacity to integrate disruptive input.
DR. GREEN: I have never heard that before.
DR. CARR: That is because I just wrote it.
DR. GREEN: You came very close to writing that down and giving it to me
about three months ago. This is test reliability. You are very consistent.
Jim.
MR. SCANLON: I think I have three things. Number one, the process, I think
Marjorie and I and Larry, we are the stewards of the committee, from the HHS
side. We are interested in any suggestions you have about streamlining
operations, as long as we follow our normal FACA processes. Anyway to make your
work easier, let us know and we will try to see what we can do.
As I said before, this is certainly one of the hardest working committees
and most productive committees that we have. We ask you to do a lot more
deliberation and looking into the future, and looking into a fair amount of
depth than many other committees who were simply sort of reacting to what the
director of the agency is telling them that day.
Again, any way we can help you, let us know. I think we probably will like
to reserve the possibility that you will be serving in a reactor panel mode for
some things, where it won’t be a report, but it will be your reaction to what a
CMS or an AHRQ or an NCHS or ASPE would be asking about. That would be it, more
or less, other than the summary.
Then, I think third was, we have the process, but I think we just have to
keep in mind, as in any parliamentary process, there will occasionally be the
need where I can think of comments on a proposed rule or an (?) 1:55:14 or
something like that. We will sort of be in between committee meetings, so we
have to allow for the process of when we want to, again, it is a committee
decision, to be able to respond and provide comments on things that are sort of
in the intermeeting stage.
I guess there are ways to do this, as long as we have a deliberation.
Certainly, other groups do this. It is not just individual responses, it is
sort of there is still a deliberative part of this. This will probably be
coming up a fair amount in the months ahead, where probably regulations and
other positions that have been held up in the queue for a while, will be
emerging.
MS. GREENBERG: I think I have said enough.
DR. SUAREZ: First of all, I think this meeting was just really, really good,
in terms of helping us begin to shape the transition that we are going to go
through as a committee. I think there is a lot of work to be done, and probably
most of the work will have to be done through the executive committee, to help
continue to shape that and define that.
One of the recommendations I would suggest to you, that I mentioned earlier
to you, Larry, was we should probably convene a meeting of the executive
committee before the end of the year, so that we can just continue to refine
and shape this for next year. That would be one specific recommendation I would
have. By phone, I would say, not in person.
The other thing I want to say is, and this goes also along with some of the
things that have been said about the letter, the process, is we, as a
committee, and then as subcommittees, have been trying to meet as often as we
can. Sometimes, we find challenges to get together. My concern is we don’t have
defined monthly meetings of all of the groups that are meeting. Now that we are
going through a transition, I wonder if we would want to do that.
Before, we never had a monthly meeting of each of the subcommittees, and a
monthly meeting of the full committee. We had a monthly meeting reserved, a
time reserved for the full committee. In some cases, we didn’t felt we needed
to meet. It seems to me that are going to have to consider to be more probably
structure in the way which our groups meet, so that it doesn’t generate the
process of having to pull together everybody, and try to see if everybody is
available this day or this time, and all of that, for each of the groups.
If we have defined times that we know we are going to meet, and we reserve
that, and if we can’t, or if for some reason, we are not going to be available
that day or whatever, or there is no need to meet, that could be canceled. But
at least we have it on the calendar and we know that that is the time for, not
just the full committee, but the Executive Committee, and I am talking about
the workgroups. I can assure you, being in other, and many of you are also in
other advisory committees, but my experience with others have been that, as
long as we have that in place, it helps to structure and maintain sort of the
rigorness of the process.
Those were my comments. The one thing I wanted to say about the subcommittee
on standards, which I think is one of the things you asked, is when are we
going to do a subcommittee next. You know we are going to meet tomorrow.
We said during our report we are going to be convening a meeting on the
subcommittee to continue to give shape to the work of the subcommittee, and
particularly the intersection with the other subcommittees. We will be bringing
that back to the full committee in February. AS we have said in the past, in
February, we already reserve, and intend to have a hearing, on at least one
topic, but there might be a couple of more. I just want to make sure that that
is on the record.
MR. SOONTHORNSIMA: Just to reflect back on the past couple of days, I think
it is probably better to reflect on the past year that I have been a part of
the committee. I have become keenly aware of maybe, yes, we are advising the
Secretary, that is our job number one.
Number two, I feel that my job, and the job of the committee, also is to
provide to our audience, being the industry, sort of perhaps the voice of
reason, glide path, whatever it is that we wanted to do, because there are so
many things. In the past year alone, we have seen so many changes, so many
mandates and more to come.
I think what I have learned over the past year, there are more dots for us
to connect than I ever thought. At the end of the day, I am the implementer,
among hundreds and thousands of people in the industry. That is sort of the
voice of reason that we need to bring to the table, and try to help our
industry and our country navigate through all of this.
I think our best role is perhaps to try to connect these dots that need to
be connected. Not all of the dots, but find the right dots to be connected in
the right sequence. That is probably going to be the best deliverable we can do
over the next few years.
DR. FRANCIS: Slightly in a mocking tone, as a lawyer, what I am trained in
is process, as in due process. I was sitting here thinking, there is Sally,
talking about process, the other lawyer in the room. My apologies if I get a
little too process-oriented here and there.
As for next steps, what Linda and I are going to be doing is asking Jeannine
to find a good time, so we can have a conference call on next steps, both with
respect to where to pick up the recommendations in the letter that, thank you
all very much, we just approved. Also, to go back to that longer list that
Linda had, about what the subcommittee was reflecting on earlier on.
MS. KLOSS: Thank you. I feel like I have finally been through the sorority
rush now. I have been through my first letter. I have learned a lot and I have
to commend everyone because throughout that process, I really felt very
comfortable, and didn’t feel that anybody was making suggestions that weren’t
in the best interest of a good product. I still see some ways to streamline
that process, but we learned a lot and we are happy that we can move on.
I guess my takeaway, and I know this is still a work in process, I still
feel sort of uneasy that I don’t have a vision for what the priorities are.
There still seems like there are a lot of them. I like, Sally, what you said
about starting to frame that picture, that may be a unifying picture.
I really think we should press for perhaps even at the next meeting, of
having a unified picture, and perhaps that can start from, but bring this
together. One page says here are the priorities of the national committee, with
the understanding that there will be intervening issues that we need to respond
to. I think what happened with our letter, when I step back and reflect, is
that the letter prompted great debate. In some ways, it should be just the
opposite, that the debate should then suggest what the letter is.
If we say, here are the five goals for the next 12 months, leaving a little
capacity for intervention. Then, changing it as things change, but at least
have us all on that one single page.
DR. SCANLON: I think that our biggest concern should be being efficient,
which Bruce brought up. I think we do have sort of limited resources. That
involves some parts, sort of the issue of process. I think some of the
discussion that we have had here today sort of is moving us positively in that
direction.
It also relates to content, and that is the issue that Linda brought up,
with respect to priorities. To appeal to the clinicians in the room, I think of
it in some ways as a triage exercise. There are important topics out there that
the committee cannot influence, and we need to let those go by.
There are other important topics that the committee can influence, but they
are not as important as other topics that need to take sort of priority. I
think it is the identification of that last group, the ones that are most
important among the things that we could have an impact on, that we select the
limited number that we can deal with, sort of within any sort of timeframe. To
meet Larry’s goal of timeliness, we have got to sort of have sort of a
reasonable enough sort of workload that that becomes sort of feasible.
We need the time, I think, to make sure that there is enough education of
the committee. We all bring expertise to this, but we also don’t all bring the
same expertise and the same sets of experiences. Some of these things are very
foreign, sort of as I learned when I went to standards subcommittee for the
first time, and as I go every time to the subcommittee. It is like going to
sort of into a new world.
I think what we need to do is sort of have enough preparation education, so
to speak, so that we can have a thoughtful deliberation of the issues. I think
that would producing sort of a better product. That goes to virtually
everything we do. It goes to, I think, the topics that we are going to report
on. It goes in part to the fire hose that we talked about, in terms of those
briefings on what is going on in the department. Too much is going on in the
department for us to really comprehend what it is.
Having a set of bullet points, where terms are put out there and that there
really isn’t much understanding about the import of that might mean, is not
very helpful. We need to sort of think about sort of the people we are asking
to brief, to concentrate on a few things that are most important for this
committee, and most important in sort of what they are doing, so that they can
talk about them in enough depth that we can understand them.
Setting of priorities, I mean, talking about this whole new process issue,
putting obligations on different parties, I think puts an obligation on the
executive committee and the leadership of the committee, in terms of preparing
for meetings and preparing for an agenda over the course of six months or a
year.
MS. JACKSON: Thank you so much. My comments are I appreciate being able to
be at the table to represent the staff. The respect and the consideration for
lead staff, liaison staff has been very considerable. We appreciate that.
Following up on Bill’s comments, I am working with Marjorie and all to get
as much, as far as precise information that you need, from the HHS staff and
other presenters, because you are right, there is so much. We need to dovetail
that in, so that you can get what you need when you need it.
If Lee is an example of incoming new members who are coming on board, then
you have got three more who will be as provocative and wonderful, as far as
comments. Just so you will know, we will be getting bio sketches from all of
you, updated bio sketches. One of the things for the communication and
effective communication, is, as you said, knowing each other and trusting each
other, and listening and engaging, is knowing where people are coming from. I
will be getting your updated bio sketches, getting theirs, and then you will
have that for the next meeting.
DR. GREEN: Thank you, all. Four quotes from today and we are done, I think,
at least some of us are done. Some of us are going to stay for a workgroup
meeting. I love this thing from Bill, that we should be about deliberation, not
editing, focused on our audience, not on our preferences.
I like Lee saying I have been a faculty member for 30 years, and I know how
to talk. I like this recent statement of we need to provide a voice of reason
to connect some of the dots. Marjorie said she has been on the committee since
before there were typewriters. You may not have heard that. She said she has
been on the committee since before there typewriters. Probably my favorite is
from Bill, about the good thing about working health policy is you don’t have
to learn new issues. Have a good afternoon.
(Whereupon, the meeting was adjourned.)