[This Transcript is Unedited]



September 20, 2012

Hubert H. Humphrey Building
200 Independence Ave., SW
Washington, D.C.

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


P R O C E E D I N G S (9:07 a.m.)

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

DR. CARR: Good morning, everyone, I am Justine Carr, chair of the committee, Stewart Healthcare, no conflicts.

MR. SCANLON: Good morning, this is Jim Scanlon, Deputy Assistant Secretary for Planning and Evaluation at HHS, executive staff director for the full committee.

DR. FRANCIS: Leslie Francis, University of Utah, member of the full committee, and co-chair of privacy, security, and confidentiality, and no conflicts.

MS. KLOSS: Linda Kloss, Health Information Management, independent consultant, member of the committee, co-chair of Privacy, Confidentiality, and Security, and no conflicts.

DR. MAYS: Vickie Mays, University of California Los Angeles, member of the full committee and member of the subcommittees on population and also privacy, and no conflicts.

MR. BURKE: Jack Burke, Harvard Pilgrim Health Care Boston, member of the full committee, member of the privacy, security, and confidentiality subcommittees, and the population health subcommittee, no conflicts.

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

DR. COHEN: Bruce Cohen, member of the full committee, no conflicts.

DR. CHANDERRAJ: Raj Chanderraj, private cardiologist from Las Vegas, member
of the full committee, and member of the standards committee, no conflicts.

MS. BUENNING: Denise Buenning, acting deputy director, Office of eHealth
Standards and Services at CMS.

DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the committee, and member of the standards subcommittee, no conflicts.

MR. SOONTHORNSIMA: Ob Soonthornsima, Blue Cross Blue Shield of Louisiana,
member of the full committee, co-chair of the standards committee, no

DR. SUAREZ: Good morning everyone, I’m Walter Suarez with Kaiser Permanente.
I’m a member of the full committee, and co-chair of the standards subcommittee,
and no conflicts.

MS. MILAM: Good morning, I’m Sallie Milam, West Virginia’s Chief Privacy
Officer with the West Virginia Health Care Authority, co-chair of populations,
member of privacy, confidentiality, and security.

MS. GREENBERG: Good morning, I’m Marjorie Greenberg from the National Center
for Health Statistics, CDC, and executive Secretary to the committee.

MS. SQUIRE: Marietta Squire, staff to the committee.

MS. PLAGER: Lauren Plager, Department of Veteran’s Affairs.

MS. BUCK: Kelly Buck, America’s Health Insurance Plans.

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

DR. LAZARUS: Steve Lazarus, Boundary Information Group, representing CAQH

MS. JONES: Katherine Jones, NCHS and committee staff.

MS. DOO: Lorraine Doo, staff to the standards sub-committee.

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

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

MS. SEEGER: Rachel Seeger, Office for Civil Rights.

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

MS. KAHN: Hetty Kahn, CDC’s National Center for Health Statistics,
subcommittee on privacy.

DR. VAUGHN: Dr. Leah Vaughn, member of the working group on data access and

MR. RODE: Dan Rode, American Health Information Management Association.

MS. SAVICKIS: Mari Savickis, American Medical Association.

MR. DECARLO: Michael DeCarlo, Blue Cross Blue Shield Association.

DR. WALKER: Jim Walker, Geisinger Health System, no conflicts.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality, liaison to the committee, and staff to the standards subcommittee and
quality subcommittee.

DR. CARR: Welcome everyone. Let’s start with Denise Buenning, an update from

Agenda Item: Updates from the Department — CMS

MS. BUENNING: Good morning everyone. We have been a little busy at CMS since
the last NCVHS meeting. I’m going to update you all very high level on some of
the things that have come out since the last meeting and some of the things
that we’re currently working on. Let’s start off with our EHR incentive
program. The final rule for stage two meaningful use under the EHR incentive
program, or as we lovingly call it CMS 0044-F, was published on September 4.
The rule includes changes to stage one and lays out stage two of meaningful
use. It also addresses low clinical quality measures, Medicaid program changes,
and payment adjustments and hardships. For the most part stage two is an
obvious next step from stage one in that it moves forwards in ways such as
expanding the order types and CPOE, increasing thresholds, moving some
mini-objectives to core, et cetera.

For eligible providers under the program, the core objectives went up from
15-17, and menu objectives went from a choice of five out of ten menu
objectives to three out of six objectives in stage two. The proportions pretty
much remain the same for, once again, the total of 20 objectives overall, both
core and menu. For the eligible hospitals and critical access hospitals, core
objectives jumped from 14-16 in stage two, and menu objective requirements
remained the same as that for eligible providers with a total of 19 objectives
overall. Some other changes to meaningful use include a provision that states
you can continue to claim an exclusion if appropriate for a menu objective, but
starting in 2014, that exclusion cannot be counted toward your number of menu

Other changes include that EHRs must meet the Office of the National
Coordinator’s 2014 standards. Starting in 2014, all EHR incentive program
participants will have to adopt certified EHR technology that meets the ONC
standards and certification criteria under their final rule. The other thing
that we’d like to note on that is ICD 10 now also appears as a reference in EHR
certification criteria in that rule.

Stage two also allows for batch reporting. This means that groups will now
be allowed to submit attestations for all eligible providers in one file versus
separate entities for each eligible provider. Patient engagement is an
important focus of stage two. There are some requirements that more than five
percent of patients must send secure messages to their eligible provider, and
more than five percent must access their health information online. Of course,
this is subject to exclusions based on broadband availability in the provider’s
county. Stage two also focuses on actual use cases for electronic information

Clinical quality measures, CQM, reporting will remain the same through 2013.
In 2012 and continued in 2013 there are two reporting methods available for
reporting the stage one measures, attestation or e-reporting pilots. There are
hardship exemptions that exist for providers with access problems, new
providers just starting their practices, natural disasters, lack of follow-up
need with patients, et cetera. We could spend an entire day just talking about
meaningful use. Those are the highlights. We encourage anyone who’s interested
to review the CMS final rule as well as the Office of the National
Coordinator’s final rule on 2014 certification of EHR technology. We have links
on our website to both of the final rules, and we have a number of tip sheets
and other resources available for download on the CMS website. We encourage
everyone, if you haven’t already used it as your beach reading, please feel
free to go ahead and access them on the website.

Just a quick update in terms of numbers, as far as the program
participation, as of July 31, our last available reporting period, we have
roughly 271,000 providers with active registrations in both the Medicare and
Medicaid EHR incentive programs. Over $6.5 billion in payments have been
distributed to over 132,000 providers through both Medicare and Medicaid EHR
incentive programs.

Another small little project we were working on was ICD 10. CMS published in
the federal registrar on September 5 a final rule, CMS 0040-F, that pushed back
the compliance date from ICD 10 from October 1, 2013 to October 1, 2014. We
received approximately 600 public comments during that public comment period
after the proposed rule, the majority of which favored an October 1, 2014 date
as being feasible and fair, those entities that had already made a substantive
investment predicated upon the 2013 date. That’s not to say that everyone was
in agreement. We did have some entities that thought that we should skip ICD 10
and go to ICD 11. We also had some who wanted to push out the date based on
various events that are upcoming. When we analyzed it and had a lot of industry
feedback, this was very much a compromise, and we thought it was a fair
compromise. It kept the momentum going on ICD 10, and it gave the ones who
needed those, the small providers and small hospitals, the extra time to become

In that same final rule, CMS finally has the requirements for health plans
to obtain and use the standardized health plan identifier in the standard
transactions. As everyone will recall this is a requirement under the
Affordable Care Act. We also developed an ability for other entities that do
not qualify as health plans, but who need to be identified in the standard
transactions to voluntarily obtain and use a standardized other entity
identifier. Controlling health plans and sub-plans may obtain HPID in a way
that best fits their business model. The enumeration system for obtaining the
HPID will be online in October.

This enumeration system will be part of the health insurance oversight
system that already exists and already was used for planned data submissions,
so they’re familiar with it. We will provide guidance for determining the plan
status through decision tree functionality. Plans may begin to apply for their
HPIDs, and once it’s verified the IDs themselves will actually start to be
issued in November. Plans must obtain an HPID by October 1 of 2014, 2015 for
small health plans, but do not have to begin using the HPID in the standard
transactions until 2016.

Finally, in that same final rule, this was jammed pack, there was a part D
loophole in the national provider identifier that we managed to close. It
changes the NPI requirement that mandates that organization covered healthcare
providers require non-covered individual prescribers to maintain and use an
NPI. Pharmacies were encountering situations where the NPI of a prescribing
healthcare provider that did not have an NPI or didn’t disclose it to now get
an NPI and use it. The situation was problematic in Medicare Part D, and the
new NPI requirement addresses this loophole.

Finally on privacy, CMS’ privacy staff is currently immersed in providing
guidance on privacy policy for the administration of the new health insurance
exchange program under the ACA. We’re working with the Center for Consumer
Information and Insurance Oversight, or CCIIO, to develop information exchange
agreements and computer matching agreements with all participating federal and
state-based agencies. In addition to that, we will have responsibility for the
overall oversight and compliance of privacy standards ensuring that states are
meeting requirements in participating in the health insurance exchange program.
We’re working with other federal agencies such as Social Security, the IRS,
Department of Homeland Security, the Veterans Administration, DoD, Personnel
Management, and Peace Corps for purposes of determining eligibility for
enrollment in several different health insurance programs.

To sum up, one of the most significant things that we were able to do, if
this wasn’t significant enough, finally, the Secretary sent out a letter this
past week to NCVHS chair Justine Carr confirming the designation of CORE as the
authoring entity for the remaining HIPAA standards. This should free the way
for CORE to undertake work in earnest towards the development in collaboration
with all industry segments of the remaining operating rules.

We’ve talked about this before. We think that this is a good example of CMS
being able to be responsive to NCVHS’ requests to find appropriate ways to
continue and push forward the work needed towards administrative simplification
beyond lengthy, traditional notice and comment rule-making process. We were
very pleased that we were able to accommodate this. We’re going to be looking
in the future towards using more mechanisms, of course in consultation with our
Office of General Counsel. That’s my update for today. I’ll try to answer any
questions that you might have. Thank you.

DR. CARR: Thanks Denise for a very clear and concise and important
follow-up. Let me just apologize that I jumped through Jim, but let’s take
questions for Denise and then go back with Jim.

DR. SUAREZ: Thanks Denise for that update. I have two questions. The first
one is about the plan ID. Another was perhaps some inconsistency in the
preamble about the actual date and the language in the actual regulation of the
final rule publication, is there any intent to publish a clarification note.
And just to clarify the actual dates are the ones that appear in the preamble,
which says by October 1 of 2014 health plans have to enumerate, and then by
2015 the small health plans, I guess, and then everybody by October 1, 2015
must use — are those the correct dates?

MS. BUENNING: Thank you for bringing that up. When we published the final
rule in the Federal Register, actually we display it for seven days or so
before it’s actually published and in the display we noticed that there was a
disconnect between the preamble dates and the dates in the actual regulation
text. This was because of a change that we had made, an editing change that
just didn’t get picked up by the Federal Register in the final version that
they posted. My feeling was, well, can we make the change immediately because
we want to be able to publish the correct dates.

I guess posting to the Federal Register, displaying it is just as good as
having it published, and they said no, you can’t do that. We had to wait
actually until it was published and then put together a correction notice. You
are correct; the dates in the preamble are the correct dates. Basically for
HPID plans, large health plans, or the majority of health plans, must obtain
and HPID by October 1 of 2014 and then small health plans have an additional
year, and then everyone starts using it in the transactions in 2016.

DR. SUAREZ: And then you said the ID that will be issued to the health plans
and the way the health plans will apply to the ID is which system is the one
that you —

MS. BUENNING: It’s HIOS. It is the Health Insurance Oversight System, and
this is a system that does exist right now. The plans are familiar with it. If
they already have a listing in HIOS we’re going to try and pre-populate that
information and carry it over until the HPID enumeration system. In October
we’re going to do some run-throughs to provide a lot of education and guidance.
There’s going to be a series of webinars and other things that we’re going to
be doing in consult with our contractor to make sure that people understand how
to determine whether they need to apply, at what level, or if they’re getting
another entity identifier. The month of October will basically be spent doing a
lot of the education. You can apply at that point, but the actual ID won’t be
issued until November.

DR. SUAREZ: The other question is really about ICD 10. This is an important
point. We have now a rule that says that ICD 10 compliance ends October 1,
2014, but we have under meaningful use the regulation that says that the
standard adopted use for meaningful use stage two is — one of the standards
for a vocabulary is ICD 10 as well. It’s for certain uses only, for example,
submitting transitions of care messages, providers will be able to use either
SNOMED or ICD 10. Most transitions of care in summaries could use actually
SNOMED or ICD 10 as well. The point is really under meaningful use the
requirement is to start using these new standards that are being issued by
October 1, 2013 for hospitals and by January 1, 2014 for eligible

What it means, and this is the important point I think, under HIPAA and for
administrative transaction purposes, ICD 10 usage is required by October 1,
2014, but for meaningful use purposes for those providers that are going to be
using ICD 10 to submit some of the transactions where is ICD 10 is the main
standard, they’re going to have to be ready October 1, 2013 for hospitals, and
January 1, 2014 for eligible professionals. It’s an important clarification, I
think. I just wanted to see your reaction. I know Jodi is here, too. I don’t
know if you have some comments as well.

MS. BUENNING: As Marjorie has pounded into my brain the past number of
years, SNOMED is a vocabulary, ICD 10 is a medical code set. I know that there
is a tendency to look at those in kind of the same lump and say, why can’t we
use SNOMED instead of ICD 10 or vice versa? Our thinking on this, and again
working with the Office of the National Coordinator, was to try and offer some
optionality at this point and try and ease into the use of either/or at this
point. I think this signals to the industry that our efforts on ICD 10 perhaps
were a little stove piped. Now we’re starting to make the connections between
ICD 10 and meaningful use and quality measures and everything else that’s
coming down the road.

This was an effort on our part to get ICD 10 in there and start people
thinking about what they’re going to be needing for the future development,
especially under software products and things that they’re going to be
providing to the provider community. I wouldn’t say that this is the be all and
end all, but you’ll probably be hearing more about this as we go forward, and
this might just be the first volley over the net.

DR. CARR: That is a very important observation. If the training is set for
2014 but the expectation for the problem list is 2013, there’s a cross —

DR. SUAREZ: It is important to mention that ICD 10 is an optional code.
Providers can use either SNOMED CT or ICD 10, but in most cases it’s been that
providers use ICD actually to —

DR. CARR: Correct, I think this is something we’ll want to know more about.
I think there’s a cohort there planning to just go to 10 from 9 for the problem
list. What this is suggesting is that you need to bridge with SNOMED until
you’re up and running on 10. I do think that’s very important. I want to make
sure that we have time for Jim.

DR. FITZMAURICE: First, congratulations on a really great question three. I
have two technical detailed questions for CMS. Do you know when the technical
specifications, that is the codes for the quality measures for example, will be
available to the public? My second question would be when a hospital or
provider reports the quality information, do they report it to their carrier,
to their intermediaries, or is there another place to report the quality
information to? What standards do they use for reporting? I’m thinking maybe of
HL7‘s QRDA, but I don’t know for sure. That may be too technical to
respond to. If so, just tell me.

MS. BUENNING: I would be happy to follow up on that. I have a high-level of
knowledge of the meaningful use regulation, but I am certainly not the
technical expert. I’ll be happy to get answers back to the committee on that.

DR. CARR: We have addressed some of the issues around quality measures in
ICD 10 in the past. Perhaps we’ll revisit that.

DR. COHEN: What is CMS doing to work with state Medicaid plans and the small
providers to get them prepared for ICD 10?

MS. BUENNING: First, let me say that our Medicaid program has continued to
work very closely with the states on all of the new standards, the HPID, the
operating rules, and as we all know, especially on the 50-10 implementation,
the states had some challenges. There were weekly and sometimes daily calls
with some states that were at risk. I know that CMCS provided them with some
additional assistance in technical areas or provided additional funding so they
could get clearinghouses in place to help them. Obviously with ICD 10 that’s
not going to be an option.

We’re looking very closely. One of the things that we got back from our
proposed rule, and we’ve heard this all along, is that we need to reach the
small provider. Again, by small provider I’m looking at the two or three-person
practice in Beloit, Kansas. I’m not talking about the Johns Hopkins. I’m not
talking about the Saint Luke’s. I’m talking about small individual practices.
We are going to be looking very carefully, and in fact we have already started
this process at CMS to say — we’re actually meeting, we’re going out and
meeting with small providers and saying, how are you approaching this, what do
you need, and providing practical tools.

It’s great to talk about impact analysis, but when you walk into a
physician’s office, they say, “Impact analysis? Just tell me what I need
to do.” That’s the approach we’re taking. We’re going to tell them what
they need to do. We’re going to get it down to a common denominator. To the
very basic level, even when you walk in, number one, have a staff meeting.
Number two, ask your staff where they see these codes appear. Number three,
call your vendor, very practical tools, decision trees, and again, using every
aspect of communication that we can.

Since we’re electronic and we’re always focused on communications through
the Internet, through websites, we have to understand that a lot of small
providers out there don’t have access to it. You’ve got people all the way out
in frontier states who don’t have Internet access. We’re going to use different
methods. We’re going to use extension services. We’re going to use our regional
offices, as we’ve continued to do. If we even have to do — I’ll say it, I’ll
use the s-word, snail mail, we’ll do it.

This is a real focus for us. We want to make it as easy as possible for
those providers to become compliant with ICD 10. The other thing we have to do
is to determine what do we mean by compliance, what constitutes compliance, and
what do we mean by end-to-end testing. We saw in 50-10 everybody has a
different opinion of what that is. We’re taking this forward, and we’re going
to be formulating these in the next couple of weeks, having some brainstorming
sessions amongst ourselves.

We also have intended to have, as I think we had discussed at our last NCVHS
meeting, a listening session that would incorporate some of these questions,
but unfortunately the timing is just so difficult. We had been scheduled for
October 3 and have had to postpone it because of competing meetings and events.
We’re hoping to reschedule that here fairly shortly and get all the brains in
the room and listen and see what people’s opinions are and see what they have
to say. We’re looking forward to that feedback.

DR. CARR: I know Raj is particularly happy to hear that you’re focusing on
the offices because he’s been the voice for the one-person, two-person offices.

DR. FRANCIS: Just really quick, I’m very glad you mentioned the privacy
issues involved in exchanges, and I’m not sure there’s any role for this
committee, but if you do see one, I would love to know about it. Also, if
there’s any way that you could share what the best way is to follow what’s
happening about that, I’d be grateful.

MS. BUENNING: Maribel Franey is our director of our privacy policy group in
the Office of E-health Standards and Services. She is really taking a very
active and forward-thinking role in putting this together as well as
maintaining all of the other privacy work that we do, especially in the areas
of data use agreements. I’d be happy to give her your contact information and
see what she can provide you and I’ll also get to the committee a website and
try to keep it updated as much as we can.

Agenda Item: Updates from the Department

MR. SCANLON: Since we met in June, we have a number of activities under way
in HHS. I’m going to talk about several things today, some initiatives at the
program and policy level — this will be a 10,000 foot level view — some
ACA-related data activities. I’m going to talk a little about the health data
initiative that I think we talked about before, where we are and where we’re
heading. We’ve asked the committee to play a role in advising us on how to make
some of our data available to a wider audience and to get some implications to
improve health and healthcare in the US, then a little bit of our data strategy
where we’re looking at — we looked at all the portfolio of our data systems
and surveys in HHS.

From the point of view of technology, are we using the best technology, are
we using the quickest turnaround types of approaches, and some pilots that
we’ve developed as a result. Similarly, but certainly not last, we have taken a
perspective in our data strategy where we’re trying to align the various data
streams and systems and capabilities that we have now and hopefully will have
in L3 form and in the EHRs. We’re looking at a framework much as we’ve
discussed here in the NCVHS about how to bring that together in an aligned and
convergent kind of framework so that we don’t just develop them as silos and we
get the best out of this.

Let me start, as I always do, with the HHS strategic plan. Let me pass these
around quickly. The strategic plan, again, it doesn’t describe everything HHS
does, but it does describe the major activities that we draw out from the
consensus point of view and where most people are spending their time. I think
what we should probably do for documents, maybe we should post these on the
Workshare site. We’ll put the strategic plan and some of the other documents
that you can refer to in the interest of a paperless concept. The strategic
plan, let me tell you the goals. You have the goals and the major objectives
underneath. The full strategic plan describe what are the major activities that
HHS is undertaking in each of these areas programmatically and then also
describes the indicators that we’re using to measure progress. Not
surprisingly, the first goal is strengthening healthcare. This covers all of
our existing programs as well as health reform and the related activity
associated with health reform.

Number two, HHS contains the largest biomedical research program in the
world as well as other scientific activities where we actually approve the use
of technology and drugs. Another strategic goal are activities undertaken to
advance scientific knowledge and innovation and bring those to the bedside or
the community where we can. Third is a big prevention initiative, and again,
the theme is advancing the health, safety, and well being of the American

Goal four is more of an internal management kind of approach. It’s
increasing efficiency, transparency, and accountability of our HHS programs.
Finally, a theme I think you’ve all heard in health reform, but generally is to
look at the nation’s health and human services workforce and infrastructure to
see do we have in the pipeline and the policies ahead the workforce and the
infrastructure to meet our health and human services need. Again, each one of
these, as I said, has a data adjustment — a focus on how do we measure
progress on these areas. We have that posted on the HHS website.

I would be happy to have a full presentation to go into some depth on the
strategic plan if we want, but again, it’s always good to start there so you
can see how all the other things fit in. We also have, in addition to the
strategic plan, probably nine or so initiatives in other program areas, which
were formed at various periods over the last couple of years. These are
generally at the request of the president or the White House or agencies within
HHS. They focus on specific areas. We usually form a work group or a council.

For example, we have initiatives, and these are generally plans with action
steps, on tobacco control. We have the reduction and elimination of tobacco
use, HIV, hospital associated infections. We have these written up nicely. I’ll
post these on the committees share site. We also have an initiative, you’ve
probably heard of it. It’s called the Million Hearts Campaign, and the goal is
to reduce deaths from stroke and vascular disease by a million over a five-year
period. The trends are in our favor, so we don’t have to do much anyway if we
don’t mess it up.

We have, as I mentioned before and I’d be happy to brief you on this, our
disparities council. We actually have a very extensive action plan to reduce
disparities in health and healthcare across the US. A big part of it is the
health reform effort, but there are a lot of other parts of it as well. The
National Quality Strategy, I think you’re familiar with that, was required in
the ACA as well as the National Prevention Strategy.

There’s an interest on global health and on the human services side an
interest in early childhood health and human development, and early childcare
as well. Then disease specific, we have a working group on Alzheimer’s which is
looking at the whole array of what HHS does relating to Alzheimer’s including
the drug development area and finally on person’s with disabilities as well.

Again, as I said, we typically try to have data and evaluation experts as
part of these initiatives. They’re usually governed by a council or a
workgroup. We like to have specific action steps so we know what we’re supposed
to do and how we measure each of those. What we’ve now done is to actually have
a template for initiatives in HHS so that all of these various initiatives are
put into an overall standardized template for what we’re expecting them to
accomplish and what kind of indicators are we using.

Let me turn a little to health reform and strengthening the healthcare
system and just report on something I reported on previously. One of the
sections of the Affordable Care Act required HHS to adopt data collection
standards for certain demographic items in all of our HHS surveys, specifically
race/ethnicity, disability, and primary language.

This idea has been in the works for a long time, and we standardized the
collection of information on these demographic groups and sub-groups with the
point of view of having all of these standard items in all of our surveys and
possibly in all of our administrative data systems as well and surveillance
systems so that we always have that core of demographic items, which really
accomplishes a lot of in terms of analysis for public health and so on. That’s
all under the Data Council’s auspices to adopt, get the Secretary to adopt a
basic set of standards. We are now implementing them in our HHS programs. Those
are on the website as well.

We were able to adopt standards relating to race and ethnicity. We started
with the OMB categories, and we expanded the Hispanic sub-groups and the Asian
sub-groups, which folks have been coming to HHS for for a long time. They are
expandable beyond that. These are meant to be minimum standards. Any community
can add as many additional race and ethnicity sub-groups as it wishes, but
again, they have to be applicable back to the OMB standard.

For language, we, again this is for surveys remember and it’s self-reported,
so there we looked at what had been used in other surveys and research, and
what we adopted was a language on English proficiency. It’s the question that’s
in the American Communities Survey in NCHS, CPS. If the proficiency is less
than high, we ask about the preferred language, and it’s listed out. 80 percent
of the time it’s Hispanic in general in the US, though it varies across the US
and states and communities.

For disability, this was a very tough one. We could not find one single
question that gave you a good indication of disability. What we were able to
find was a question that had six parts as part of the American communities’
survey, and actually a lot of other surveys ask this now. It asks about
disability in six areas from vision to mobility to hearing and so on. It’s a
question that’s used in the American Communities Survey. All of the surveys at
HHS now have plans, some of them have already done this, have plans to
implement this at the next major revision, or certainly any new survey would
have to collect this.

When we completed that, and so far this is going pretty well, we were asked
to look at administrative data. It’s one thing to do surveys, and there’s a
certain approach there. You have a respondent in front of you, so you can ask
about self-response. We’re now looking at what could we do in terms of what
standards might we want to chose for administrative data. Here we’re looking
again at race/ethnicity, language, and disability. We’ve talked to all of our
agencies, to other federal agencies. We even had folks come in from health
plans who have actually stepped forward over the last few years to look at what
they can collect.

A survey was actually carried out by AHIP, several surveys with what plans
are doing. We have a good sense now of what the candidates look like. Again, we
do not seem to have found anything related to disability. If anyone has any
ideas about a disability question or measure that has been validated and we
could recommend for inclusion on our administrative data systems, we’d be happy
to find that out, not that there aren’t classification systems, but that’s not
something you can put on an administrative form. Remember, the forms we’re
really trying to keep simple. We’re not trying to add a lot more burden. That’s
the last thing the health system needs now, but we’re trying to find a few
items that would help us.

When we looked at how the plans were using some of the data, it’s really
exactly how you would have thought about it, how were they — obviously,
these folks are all insured now, they’re all plan members, but there are
considerable variations across the race/ethnicity groups as you would imagine,
even when everyone has insurance both in utilization and in outcomes. We found
this to be true in Medicare and in others, so we’re moving there now.

We’re very grateful for the committee’s environmental scan on standards for
socioeconomic status. We’re thinking of where would go next there. We were
again asked to go one more area in terms of vulnerable populations and what
kind of data we could begin to develop on LGBT populations. The major progress
here is that we have after testing and continually field-testing probably the
most tested items we’ve ever had. If everything goes well, we should be adding
questions, self-reported, on sexual orientation to health interview survey in
January, which is actually a big deal. If you’re on the health interview
survey, that’s the flagship survey, you pretty much have all the data that
anyone could ask.

One more thing — two more things out of ACA, we have launched, and we can
make this URL available, our health systems tracking project which identifies
ten areas where by consensus folks would like to monitor the progress of health
reform. We have five to ten national indicators in each of those domain areas.
Let me tell you what they are: access to care, cost and affordability,
coverage, quality, vulnerable populations, workforce, innovation, population
health prevention, and health information technology.

In each of these areas, and this was a consensus about what we should even
look at in terms of monitoring. There was a working group, and we will be
continuing the working group to look at revisions, but we’re looking at what
indicators could we follow to see — insurance coverage is the obvious one,
to look at whether insurance coverage is changing, but there are issues of cost
and affordability, access to care, are doctors even taking new patients, things
like that. They’re all part of the health systems project, which we’d be happy
to brief the full committee in terms of how we conceptualized this. Now we’ll
be moving into the second version.

Finally, we have looked at pretty much all of our major surveys at HHS as
well as the Census bureau and Labor and others, and we have added relating to
ACA data needs. We’ve added a number of questions and modifications to the
surveys. We continue to do so. We have a working paper that describes all those
modifications, which we published on our ASPE website. I think it’d be good if
we just posted this on our committee website. We have a guide to HHS surveys
that accompanies that as well.

We will be looking in the weeks ahead at the next stage of health reform.
Are there ways to measure participation in exchanges, which is a tough —
we’ve done some focus groups with Census in Massachusetts and no one seems to
know the rhythm of exchange, which is not surprising. They know what the plan
name is, but what’s an exchange? No one knows this, even if you say
“market”. Thank goodness for focus groups, but we don’t have an
answer yet.

We’ll have to see. We’re looking at other proxies. Maybe in other states it
would be clearer, but Massachusetts is the only state with a real exchange at
the moment. Sorry, Bruce, nobody seems to know there. They know about the plan,
and that’s the important thing. The ending is are there proxies for exchange
participation or for subsidies, would people know that they were getting a
subsidy when we rolled over to 2014. We’re working with Census on these
questions. They have to be tested, obviously. We really have to see that they
work and they’re getting us what we’re asking for.

Finally, the Health Data Initiative, and again, the committee has been
supporting us very nicely on this, the Health Data Initiative was created two
years ago. The idea was to liberate a lot of the data that HHS has, not that it
wasn’t liberated in many respects, but the idea was to make it available in an
easier format, largely on a website, healthdata.gov, and to make it available
to new audiences. I think the public health community, the research community,
the policy community, the quality community, those folks know the data pretty
well and they know how to get it, but you have to be an aficionado honestly.
The idea here was to liberate this and make it a little more open about what
data we had to make it easier to get.

That was part of our Health Data Initiative and our Open Government
Initiative and all the federal agencies have to do this. The strategy was to
create a website, healthdata.gov, where we would try to post data sets and
tools. Anyone could take these; generally they’re in machine-readable format,
to use these for literally any positive application in healthcare with
particular attention in this case to developers, application developers and
others who could take some of these things and turn them into something that
could be used to promote health or healthcare and particularly at the community

Some of these data sets are location-based information. Where are all our
community health centers located, something like that. There are others, where
are the grocery stores and things like that. It’s not data as we think of it
quantitatively, but often it’s location-based data, where the grantees for this
or for that and the resource in many ways. These are exactly the sorts of
things that developers can take. Location-based services lend themselves very
well for those kinds of applications. A number of applications which you saw at
Datapalooza and the Health Data Forum just a couple of months ago, and keeping
those up.

The other strategy was to sponsor those hackathons and those health data
forums to try to bring the research community, the data producers, and the
technology community together. In the latest step, we’ve asked the committee to
form the working group on data access. We got a nice mix of the data developers
as well. We’ll try to be looking at how can we promote and make the data even
more available. We have about 340 datasets and tools on healthdata.gov now. We
don’t put identifiable data — let me make this clear — we don’t put
identifiable data on an open website like healthdata.gov. There are other ways
to make identifiable, if justified, available under certain conditions. It’s a
little tricky about what you can put on healthdata.gov in terms of individual
records other than directory type information.

One of the areas we will be looking at is this whole area of
de-identification and even if the data is de-identified, if you put enough of
it out, are you creating a greater risk of re-identification because of what’s
referred to as this mosaic effect when you had different data sets focusing
more or less on potentially the same units, are there ways of re-identifying.
At the committee meeting this afternoon, we’ll have a discussion with a couple
of folks who have done some work in this area, a lot of folks have done work in
this area.

The whole idea here, and this is the first step really, is the
de-identification for hope and open health data. As you try to make the data
more available, what are the cautions and what are the techniques that one has
to think about the data as well. Health data is the main arm of that particular
initiative. It’s probably the tip of the iceberg in terms of how HHS makes the
data available otherwise. It will focus on health data, but there are a lot of
other ways that HHS makes the data available. I think I’ll stop there.

DR. CARR: Thank you. We will take questions now.

MR. SOONTHORNSIMA: Could you expand a little bit on the effort to collect
more granular data around race, ethnicity, disability, and language,
particularly around administrative data? What is that process that you’re going
through, and how does that get disseminated to the various states, through NAIC
or even state health departments to begin to do those things more,

MR. SCANLON: The authority we have is for our own data, obviously. It’s not
like HIPAA. The focus has been, and we have been getting some of this data in
some of our administrative data systems already, and in fact I think there are
HIPAA standards that are situational that include some of these data. The idea
here is for all the federal agencies, the question on race and ethnicity has
already been standardized in terms of the minimum set. It’s the OMB category.
It goes all the way back to the 1970s for basically it was civil rights
reporting in education. That has been the standard. There was a change in 1997.

That minimum set of five categories is the standard that every federal
agency has to start with. That’s what we’re starting with. We’re just looking
at — for an application form, for example, and claims data are not a good
example, but enrollment information, that’s where we would collect this,
preferably collect at once, on race and ethnicity. They’re generally two
separate questions. The question there is how much more, if at all, should we
consider in our own surveys, I mean our own administrative data.

The question on language is a new one. Plans are asking, from what we can
tell from the surveys about preferred language, preferred spoken and preferred
read. They are largely using the OMB categories. Some of them, if they’re
depending on the area of the state for the community they’re in, they often add
a lot more categories. They’re largely taking those from the census list of
categories. Massachusetts for example, California, they usually have a longer
list of what they would add to that for the language and the ethnicity.

For disability, we could not find a — we haven’t found a single measure
that would be suitable for administrative data, many of clinical data, and
there are ways you would approach — there are ADLs, IADLs, all kinds of
scales, but those are not suitable for administrative data. It would make no

MR. SOONTHORNSIMA: I guess my question is really around is there an
opportunity to have more of a reach out or more of a collaboration with NIC?

MR. SCANLON: What we did was with the survey standards, we published them
for comments for 60 or 80 days. We got a lot of good ideas. We will probably do
the same thing here. We’re not at the stage yet where we would actually do
this. I think we have to look at a few more things. If we do propose them, we’d
get public comment in some way. These would apply to our own HHS administrative

DR. COHEN: I want to follow up a little on race/ethnicity. In a response to
Ob’s question, I think there’s some really beneficial confusion at the state
level even though these standards only apply to federal surveys. When folks at
the state and community level see federal standards, they feel that they’re
required to implement them. We’ve gotten in our health department an enormous
number of questions from plans from the private sector, from communities and
other agencies whether they’re required to implement these standards. Even
though they’re federal survey standards, I think now that they’re pushed out,
they will help get the ball rolling around other uses besides federal surveys.

That’s the good news. The bad news from my perspective is when people see
these minimum standards that they take them from maximum and they take them
from the only way to collect these data. This intent even though there are sub
categories among Hispanics and among Asians certainly does not cover the entire
field of ethnicity categories that would be beneficial to collect. I’ve heard
reports from federal agencies and other folks in public health and healthcare
who are interested in collecting more data who view these standards as

I would really like to see the department make it clear that these are only
— the goal here is I think to be able to roll up into the five broad OMB
categories. I’d like to see the Secretary issue — however the process
works make it clear that the intent here is to promote the collection of more
detailed data in a variety of ways. These are the standards that you need to be
able to roll up into, but somehow encourage flexibility in collecting even more
data. I think that piece has really gotten lost in the promulgation of what I
consider very minimum standards. Whatever the department can do to promote the
expansion and flexibility of collecting even more data on detailed ethnicity
would be fantastic.

MR. SCANLON: What we thought — this was the same issue with the OMB
standards, that you can’t expand beyond them though some cases have. These are
minimum standards. Our minimum is an expanded OMB standard. The other thing
that we could do if you think it’s helpful, we were thinking of hosting our
data council website where we have the standards, we have from the Census the
ethnicity the breakouts from every state. We’re not proposing that everybody
collect everything, but we could list the top ten in each state, give a
reference to people. I think communities have even more set up. We’re open to
any ideas.

MS. QUEEN: I just want to mention that when the Secretary , when they
published the new standards in the guidance for agencies it was clear that
these were the minimum. We didn’t want to limit it and as a matter of fact it
was a concern because NHIS and NHANES already had more categories than the

DR. COHEN: That message hasn’t gotten through. For instance, I know BRFS,
your fellow colleagues at CDC, feel that this is the maximum that can be
collected rather than the minimum. They’re changing their core questionnaire.
They’re rigorously adhering to these standards —

MR. SCANLON: Which was an accomplishment by the way.

DR. COHEN: I get that, but I don’t want the fair to be the enemy of the
good. I think there’s a long way we still need to go in identifying and
targeting populations and somehow to promote that flexibility for even further
expansion I think would be an important role around race/ethnicity data

MR. SCANLON: We can’t change the standards since it’s a requirement on our
— obviously you couldn’t have 500 ethnicities as a minimum, but we did
expand the group. The standard itself has to stand, but maybe we could issue
some guidance. This does not prohibit anyone from — in fact, we’re
encouraged to collect additional data —

DR. COHEN: And here are the additional populations in your state that you
might want to consider adding. Any guidance like that would be a good idea.

DR. CARR: Vickie, then Linda, and then we’ll hear from Jodi.

DR. MAYS: I am going to also bring up the race/ethnicity issue and ask in
region nine, which is the region that I’m in, one of the things that keeps
coming up, I was just at a region nine meeting, is the lack of data for some of
the islands and territories. I think probably what’s going to happen is that as
we use the more expanded version, what we’re going to find out is who we’re not
getting data on. I want to push us to think about can our next step to be
inclusions of other populations before we reach this “we don’t have the

On Monday and Tuesday Howard Koh is going to be in LA to do a meeting on
other Pacific Islander data. It was a special data collection that was done at
the University of Michigan. I want to ask if there’s any thought about that.
The other issue in terms of race and ethnicity that we talked about here was
potentially training people, having some kind of guidance that could go with
this in terms of thinking about how to tell people to do this. I know when the
health plans did their collection of race and ethnicity they then have ongoing
trainings. I’m wondering if there’s anything that we can do from something as
simple as YouTube to actual manuals or something like that. That’s question

MR. SCANLON: The island territories are tougher. It’s not so much the
standards as it is the basic data capacity to begin with. The committee and HHS
have visited this periodically about what exactly is the capacity and the
current situation with respect to the territories. The problem there is if you
don’t have the survey to begin with, the standard is meaningless. It’s really a
question of which survey. BRFS, for example, I think some of them can do a BRFS
and have been offered to do that. There’s not an HIS there as far as I know.
There’s not an NHANES. I’m not sure about CPS or —

DR. MAYS: I think that is the push. Are there other data sets? For example,
Guam has an economic data set. There are other places where at least if —
and this has become the big issue about data linkages, the extent to which, if
you were looking at the health systems data area, the extent to which one of
the areas might be linkages in terms of surveillance of health as it goes
— these are vulnerable populations in terms of economics and social
determinants and over that. That would help those areas.

MR. SCANLON: These all came up previously. It’s been awhile now, I’m
forgetting, but we looked at what does Census do, because if anyone it would be
Census that would have presence in those areas. I’m forgetting, but there was
an economic survey as you said. I’m not recalling that there was much of a
— whether CPS actually goes there. Certainly HIS doesn’t, and others. That
would be a considerable resource issue.

DR. MAYS: I want to put that on the agenda —

MR. SCANLON: That has come up. That’s a good issue.

DR. CARR: I just want to make sure we have time for Jodi at 10:15. That will
be our hard stop.

DR. MAYS: My last one is behavioral health. One of the things I’m concerned
about is that as we really push for this integration of behavioral health and
primary care, I don’t see it in any of these in terms of either in surveillance
or anything. Is there some discussion about either monitoring it or being able
to measure it better? In terms of our health surveys, it kind of goes in and
out, yet it’s become one of the primary issues that’s being talked about both
in terms of prevention as well as in terms of the healthcare setting. Where is
the department in terms of its behavioral health data collection?

MR. SCANLON: Well, we have a working group on behavioral health. I think
some of the surveys actually — the health community survey, for example,
includes, and I’m forgetting what exactly, but there’s a section there that was
in agreement with SAMHSA to collect that data. The household survey on drug use
and health that now includes measures on both drug use and mental health,
serious mental illness and others. There are also estimates of the normal, not
just the serious disorders, but anxiety, depression, bipolar, things like that
as well.

We actually pushed during our integration plan, number one, that the
substance abuse surveys include mental health, number two, that the general
health surveys include mental health, not substance abuse particularly. The HIS
includes questions, the NHANES includes questions, the Household Survey on Drug
Use and Health includes questions, but no one has looked at what capacity. From
the claims data, from the access we have of the Medicare and Medicaid claims
data, we can do the claims data analysis as well. I don’t think anybody’s
looked at the tally. I could check with that workgroup.

MS. KLOSS: Jim, in the spirit of the learning community, I was curious as to
what is being done to capture experience with the use of the data sets in
healthdata.gov, how are they being used, what’s being learned, what feedback,
and just understanding the range of uses and any of the data issues that are
emerging because of those uses.

MR. SCANLON: That is an excellent question. I think that’s the big question.
I’m not sure anybody’s downloaded anything there. Maybe they have. I think
that’s what we’re asking the committee to help us with, the working group. We
use these hackathons and datapaloozas. They often take things off. We can tell
which ones they’ve — in fact, we have an analysis of what data they used
from healthdata.gov for these applications. I think it’s fair to say these are
— the first round was sort of student kinds of applications. The second
round was getting more into real developer kind of applications, serious kinds
of applications.

I’m hoping now that the third round, which is next June, will get into some
serious applications. I think the evaluation question is an excellent one. We
don’t have many — we have measures on the website, how many visits, how
many hits, but that’s not really — it’s an output, but it’s not an
outcome. I think that’s kind of why we asked the committee to help us think
this through and to reach out to the community. Number one is we actually have
a lot of data, a result, as you know, that’s not on healthdata.gov and it
really can’t be for an open website like that. We need data use agreements.
Heaven knows we could make that an easier process, but you can’t just put it
out there for anyone.

We’re walking this fine line between protecting the confidentiality of the
folks who provided us data and try to make it available as well. Directory-type
data usually is not a privacy issue. It’s like the phonebook or a directory of
businesses. You sort of want to get it out there. Many of them are entities,
not individuals. I think it’s an excellent question. That’s really what we’re
asking the committee to help us with and to move forward.

DR. CARR: Jodi? Thanks very much Jim. That was tremendous.

Agenda Item: Updates from the Department — ONC

MS. DANIEL: Good morning everyone, I will follow back up, first starting
with our standards certification rules that are the companion rules to CMS’
rules, meaningful use rules. We did put them out at the same time as CMS, and
just to remind everybody the way that these two work is ONC sets the standards
and certification criteria for the products and sets the rules for what has to
be in the product and what vendors have to do to get their product certified.
Then CMS sets requirements for the use of the products. We work very closely
with CMS to make sure that we’re aligning those so that when CMS puts out
requirements for use, the capabilities are present in the products to meet
those requirements.

Just a couple of highlights, our 2014 edition standard certification final
rule reflects ONC’s commitment to reduce regulatory burden, promote safety and
patient engagement, to enhance interoperability and electronic health
information exchange capability, to enhance security, to enable clinical
quality measures, data capture, calculation, and electronic submission to CMS
or states, and to include greater transparency and efficiency to the
certification process.

I’m going to give you a couple of the highlights. This is by no means
exhaustive. Steve Posniak does his hour-long presentation on the rules. This is
going to be the 10,000-foot, maybe not the 50,000 foot, but maybe give you some
of the flavor of the things you can find in those rules. One of the things I
think we did a good job of is revising the definition of certified EHR
technology in order to give more flexibility so that providers have the option
to only have the EHR technology they need to meet meaningful use and to meet
the stage that they’re at.

Before, we had a requirement that everybody had to have all of the criteria
in their certified EHR technology products. We got a lot of push-back on that
for folks who didn’t want to adopt things that were menu items that they were
not going to be complying with to meet the requirements and the like or things
where they could be exempted from them. We’ve provided a lot more flexibility
to enable folks to adopt just the technology that they need to meet meaningful
use for them.

We’ve also provided some flexibility for folks for the HR reporting periods
prior to 2014 so that folks can have a glide path to getting to 2014 and
everybody doesn’t have to adopt everything all at once. Before 2014, folks who
were meaningful users can use either the 2011 edition of the products, they can
update parts of their products, so they can update certain models or they can
do it incrementally and they can have some 2011 modules and some 2014 modules,
a mix of that, or they can have technology that meets the definition of
certified EHR technology for 2014 prior to 2014. We’ve provided some
flexibility so there isn’t this on off switch right when folks have to come
into compliance with the 2014 criteria.

On the privacy and security side we’ve adopted certification criteria that
focuses on the encryption of health information if it’s stored on end-user
devices. This is still about the capability, not about the requirements for
use. We adopted certification criteria to enable secure messaging between a
provider and a patient, and we’ve adopted new criteria to permit patients to
securely view, download, and transmit their health information. This is in our
patient-family engagement piece, and it’s really core to a lot of our consumer
engagement efforts, which I’ll talk a little bit more about after the regs
portion of my doc.

With respect to interoperability, in many instances the certification
criteria referenced single vocabulary context exchange standards for recording
and representing clinical health information for use during electronic health
information exchange. We’ve also adopted transport standards for exchange of
transitions of care and referral summaries as well as transmission of patient
summaries as part of the view, download, and transmit to third party criteria.

We’ve added some new criteria in areas that were priorities to us. One is
with respect to data portability. We know there’s a challenge for folks who
want to switch EHR technology and switch products. While we haven’t quite
solved that problem of the challenge of taking data from one EHR product to
another, we did adopt a new certification criteria to enable providers to
create a set of patient summaries. At least it will help prevent them from
having to re-enter some of the basic patient information if a provider does
chose to switch to a new EHR.

In the area of safety and usability we’ve adopted two new certification
criteria for products. One focuses on the application of user-centered design
to medication related certification criteria, and the second focuses on
poly-management systems used during the EHR technology design. Again, making
sure that folks are thinking about user-centered design, that the vendors are
thinking about user-centered design in developing their products as well as
following good quality management practices and being transparent about what
quality management practices they are use in their technology design. This was
a new area for us to take on, but it’s a growing focus in ONC on safety and
usability of EHRs. You will probably see more from us in that space.

Another area that is something new is focusing on transparency, both in
price transparency as well as test results. We heard some complaints from folks
who would buy products and assume that the cost of the product was the total
cost of what it would take to implement that product to become a meaningful
user. That’s not always the case. To promote transparency and to limit
confusion for folks who are buying these products, we require that our
certification bodies ensure that the EHR technology developer notifies eligible
providers about additional types of costs, whether one time or ongoing. There’s
more transparency about what additional costs may be on top of the price of the
product itself.

Secondly on transparency, we have required that the certification bodies
provide a link for test results for each product that is certified by them,
whether it’s a complete EHR or an EHR module, so that somebody could go back
and look at the test results for the product they are either purchasing or have
purchased to understand how that test was done and how the vendor faired in
that test. Just making more data available and very consistent with HHS’
broader goals on data transparency and the like.

That’s the nutshell of our standards and certification rule. We’re currently
working on updating some of our guidance materials. We have some new guidance
materials up there, some fact sheets and the like, but we will be upgrading
some of the other guidance materials in light of our new rules, so keep going
back to our healthit.gov website for more information, more guidance, and more
assistance in understanding our regulations.

The second regulatory effort that I want to talk about is our work on the
governance of the nationwide health information network. In our statute,
Congress has one line that we shall establish a governance mechanism for the
nationwide health information network. That’s all it says. We have been
thinking long and hard for some time, including with input from our health IT
policy committee about how best to establish a governance mechanism for health
information exchange.

Our goals were really to strengthen interoperability, particularly at the
implementation level, to facilitate the emergence of a market for health
information exchange services, including reducing risk, cost, and complexity of
exchange, and fostering trust among providers about the exchange services
they’re using as well as among consumers about the exchange of their
information. In light of that, what we did was we put out a request for
information. We were going to put out an NPRN, but we realized that we needed
some more information. I think it was a wise choice.

We put out a request for information specifically proposing a voluntary
governance framework established through regulation. It would have a set of
conditions for trust and exchange in the areas of interoperability, trust and
some business practices, a validation process for entities that choose to
participate to make sure that they’re compliant with those conditions of trust
exchange, a process update and retire of those, as well as a process for
classifying the readiness of technical standards and implementation
specifications to support those interoperability conditions.

We heard a lot and we’re glad we asked. This is government and public
participation at its best. We put something out and we got a lot of feedback,
some things that we knew and some things that were new to us and some
challenges to some of our assumptions that we were making going out with this.
We heard from a lot of folks that health information exchange is in its
infancy, and a lot of concern that regulations would stifle this emerging
market, that there are a lot of new things being developed.

There are some areas where things are working. There are areas where health
information exchange services are just coming up and new requirements would
delay the adoption and the implementation of those efforts. We also heard that
there may be barriers to entry if we create these regulatory conditions for
exchange. Regulations are not the most dynamic way of adopting requirements. If
we learned that things were changing in this emerging market, it would take
some time to modify our requirements in order to be responsive to the market.

We heard that there’s a lot going on, some of which we knew about, some of
which we didn’t know about. Folks really encouraged us to get more information,
hear more from folks who are actually successfully engaged in this market as
well as from organizations that are starting to emerge to establish this trust
framework in the private sector. There was strong encouragement for the
government to have a role in this, but not necessarily in establishing
requirements in rules and the regulations.

That’s what we heard. What we’ve announced is that at this point in time we
are not going to proceed down the regulatory path. We believe we have the
authority to regulate. It’s something that could be considered down the road.
At this point though, we have gotten comments and we are listening that there
are some things that we can do at this point in time that are not regulatory
that may be more effective in helping to lead health information exchange
efforts, health information exchange services, build on some of these trust
networks that are already being developed and work with those organizations and
see how things go.

What we’ve decided to do is take a four-pronged approach, leading through
actions, using available levers where we can to directly accomplish specific
goals. We’ve talked about establishing maybe a set of principles or a framework
for health information exchange but not for regulatory requirements, but giving
folks the north start to work toward without the absolute, you must follow
every single one of these to the “t” in this particular way, lead
through guidance.

Where we already have some requirements through other regulations or through
other programs be more clear on how they might apply to health information
exchange services and the like, giving folks some more assistance in
understanding what some good practices are that are out there, helping connect
different HIE service providers with one another so that they can learn from
one another, so the ones that have been successful can help those that are
emerging. The ones that have already had some growing pains can help those that
are starting to undergo those.

The third is to engage, listen, and learn. We are currently working with our
general council to figure out how we can actively engage with some of these
organizations, particularly those that are serving these trust functions as
well as some of the health information exchange service providers to better
understand what they’re doing, what’s working, what the real problems are, and
be a little bit more targeted in our efforts to address the problems that our
folks on the ground are experiencing, and then to monitor.

We are still, again this is an emerging market, we feel very strongly that
there are things that the federal government does well, and there are things
that the private sector does well to the extent that there are either concerns
about trust, there are any kind of issues with how information is being used
and the like. We want to keep track of that. We also want to keep track of how
things are emerging in the market and whether or not exchange services are
taking off on their own or how we can facilitate those. Our hope is to continue
to have a much more active engagement strategy to understand what’s going on
and to monitor how exchange is working without a regulatory framework, but with
us being very actively engaged in helping to lead as well as monitor.

That’s governance. I really believe, particularly having read — there were
about 140 some odd comments — having read many of those comments that we have
a lot to learn still. We can help to be a convener of stature and to set some
guidelines within which some other folks may be better suited to work out the
nitty gritty. We will keep an eye out on what’s going on and whether or not we
think that a different approach needs to be taken down the road.

Two more quick things, just our consumer program because I mentioned it and
we just did have a big event. We had our second consumer health IT summit just
during Health IT Week. It highlighted major accomplishments. I think really the
meaningful use stage two rules and our companion certification requirements
really do make large advancements for consumers to be better engaged through
things like the view, download, and transmit; secure messaging; giving
providers some skin in the game for making that information accessible to
consumers and the like.

Our ONC pledge program, which is a pledge to make data more easily
accessible to consumers in electronic form has grown more than tenfold. We now
have over 400 participating organizations. We’re now calling the pledge program
our Blue Button Pledge Program. It’s a blue button, which I think is one of the
core pieces of our consumer e-health program. It has evolved beyond its roots
in VA. HHS now is managing the blue button.

We have transferred the trademark from VA to HHS. We are taking the lead on
this. The goal is to try to make blue button more easily available to anybody
who wants to use it as a way of identifying that this is a way for consumers to
get access to their data, the “give me my data” button. We’re working
on automating blue button through our standards interoperability framework so
that somebody can set a rule that says that any time you update my information
please send it to my PHR or my secure email account or the like. We are trying
to make blue button more robust and work better for the way folks really want
to get access to their data.

Lastly, just to connect with our — to let you know about some of the work
that some of our federal advisory committees are doing, our Health IT Policy
and Standards Committee, I just want to let you know about some of the hearings
that we have coming up. I know there’s a lot of — Paul, obviously, Paul Tang,
provides some connection on the policy side and Walter on the standards side,
but just to let everybody know some of the things that we have coming down the
pike if you all are interested in listening in.

We have a data integrity and quality hearing scheduled October 25, which
will be a joint hearing of our quality measures and certification adoption
workgroups. The policy committee focusing on data integrity broadly and
meaningful use and how clinical data collectors, assessors, and intermediaries
are meeting the challenges in accuracy, completeness, and timeliness for
clinical quality measures.

Second, October 29, we have a hearing on trust and identity of patients in
cyberspace. This is a virtual hearing. It’s not going to be in person. Our
privacy and security workgroups on both policy and standards will be jointly
holding that to obtain information from the federal agencies in the private
sector on current and emerging approaches to authenticating patients when
seeking access to their own health information, particularly through patient

Finally in December, I don’t have a date yet for it, but we’re planning a
health information exchange hearing. This will be a hearing of the Health IT
policy committee to highlight the significant amount of exchange activity that
is occurring today, understand the opportunities and needs of providers in the
area of health information exchange, et cetera. We’re still working on that
agenda, but stay tuned, and that will be in December.

Lastly, again with our focus on consumer empowerment, we are creating two
new workgroups, one on each the policy and standards committee focused on
consumer empowerment to better think about how we can use health IT to engage
consumers, both by having the standards and capabilities out there as well as
by thinking about the policies that need to be in place to shift that and that
thinking on the role of consumers in healthcare.

DR. CARR: Thank you, Jodi. Are there questions for Jodi? I see Bruce, then
Leslie, and Linda. We’ll take those three questions and then we’ll go to our

DR. COHEN: So when you talk about consumers, are you talking about
individuals getting access to their information or a way that, for instance,
community groups could access de-identified aggregate information?

MS. DANIEL: We are focusing on the former when I’m talking about our
consumer e-health work. We’re focusing on how consumers can access their
information, consumers or their caregivers, and how they can use that
information to help improve either manage their own health or follow their
treatment protocols, engage with their providers.

DR. COHEN: I would suggest as part of the consideration around health
information exchanges, that would be a wonderful opportunity to expand the
notion of access to information to use that as the brokerage for providing
aggregated individual information for broader community use, if you can when
you develop your principles and guidance perhaps trying to incorporate that
into them.

DR. FRANCIS: From a consumer trust perspective about exchange, I want to
press you a little bit on the decision to pull back on the idea of rule making.
The way I want to do this is to ask whether there was thought about ways to do
rule-making in a flexible way like the HIPAA security rule, which doesn’t say
you have to do it this way, but for many things say, here’s a problem and you
have to address it in some way.

MS. DANIEL: So one thing I would say and that we heard loud and clear was
that particularly with the high-tech modifications to HIPAA and the focus on
bringing the business associates into the HIPAA scheme. There already are
requirements under the privacy and security rule that would apply to service
providers that are serving as business associates for covered entities. One of
the big push-backs we heard was you’re making this very confusing because we
have HIPAA and then we have this, and there’s flexibility in HIPAA, are these
mandatory, and how does this work together?

One of the things that we heard was if there’s already a regulatory regime
that covers this don’t add new requirements where we have to look over here for
what this says and look over here what this says, kind of aligned with — CMS
trying to align a lot of their programs we heard a lot of push-back that we
should make sure we build on the programs that are there as opposed to creating
new requirements. I think there’s opportunity to help folks understand how the
HIPAA rules play in this space.

MS. KLOSS: Just a question about status of additional privacy regulations
and where that —

MS. DANIEL: I had nothing to report.

MS. KLOSS: I thought by absence that’s what the implication was. When Joy
met with us in June, she indicated that we were at OMB and —

MS. DANIEL: I have no new news.

DR. CARR: Thank you to all three of you for a very robust, informative,
concise summary. We will take a break now for 15 minutes, which will bring us
to five minutes until 11. We have a very important discussion on our privacy
letter. I know that everybody has received it electronically. Please take a
look at it at the break if you haven’t because we want to have a very informed
discussion. We’ll see you back at five of eleven.

(Brief recess)

DR. CARR: All right we have a couple of announcements before we start in on
our next letter. I’ll turn it over to Marjorie.

MS. GREENBERG: I just want to say two things. One is that I just wanted to
remind people because I received a notice that all of you had been notified
that you will need to do your annual ethics training that’s required for
special government employees. Is there anyone who did not receive an email
about this?

DR. CARR: It is not like the other things that we have gotten.

MS. BERNSTEIN: Marjorie, are they filling out the 450 or the other one?

MS. GREENBERG: They have already filled out their 450s and everything.

MS. BERNSTEIN: Is it the public disclosure one or the one that I fill out,
which is the 450? The reason I ask is because there’s a new law that will make
that information public on the web if you’re filling out the other one, it’s
quite important. It’s a matter of privacy, so I wanted to make sure that —
that’s why I’m asking.

DR. CARR: If it’s going to be on the web, can you let us know?

MS. GREENBERG: I want to thank you all for completing your 450s. I’ve been
informed that you’re all up to date. Thank you for that. This training, which
apparently is not onerous, must be done by December 7, 2012. That’s the stick.
Now for the carrot. My husband and I are looking forward to most of you joining
us this evening. If anyone has not told me yet that they’re planning to come,
we still have a little corner in the backyard that we can squeeze you in. Let
me know. I sent you the directions. I was asked to say a little bit about it.

First of all, it’s 7:00 p.m. Dress is casual. You can come directly from
here, or you can change. Certainly, we don’t need suits and ties, jacket and
ties. It could cool off a little bit in the evening, which would be a nice
thing after the summer that we’ve had. That’s the answer to that. There are a
few ways that you could go. Some people may have cars. I am leaving at 3:00, so
I can’t join your working sessions, but I can’t imagine working until 6:00 and
then having you all over. I’m going to be leaving at 3:00.

Some people may have cars, but you can take a taxi if you want. I’ve given
you the address. I have a few copies of the directions, too, if you didn’t
write them down. You can take the subway. It’s the Red Line. It goes to
Friendship Heights, and there is a bus from Friendship Heights, but there are
usually taxis there. I’d probably just take a taxi. I did give walking
directions one other time that I had people over like this from Friendship
Heights, and some people got quite lost, so I decided not to give you those
this time. I think maybe taxis or the subway to Friendship Heights, which is
only about a 20-minute walk from my house.

DR. COHEN: So I suggest folks who are staying at the Churchill meet down in
the lobby at 6:30 and we’ll just arrange group cabs.

MS. GREENBERG: I also do remember that some cabs got lost last time. This
was quite a long time ago. Steve Seidel from CDC had his GPS with him. Just
tell them it’s between Broad Branch and Nevada.

DR. CARR: I think that is great. If you’re at the Churchill we’ll come at
6:30. Otherwise make your arrangements over lunch.

DR. JACKSON: Another option is that I’ll be staying until the end of the
second sub-committee session ending at 5:30. We’ll be leaving via metro from
here onto Friendship Heights, and I will have my own special courier service
who will pick me up there. Anyone who wants to join me after the Privacy at
5:30, we will metro and then we can go from there.

MS. GREENBERG: You can see me separately about your assessment, but we are
looking forward to your coming.

DR. CARR: Back to our agenda, you have received a copy of Data Stewardship
in Community Health Data report that was building off the hearing that was held
in May. I think what I would like to do is ask the co-chairs, either Linda or
Leslie, to frame this. Who’s the customer for the report? What is the outcome
we’re seeking and what is the recommendation we’re making? Just give us kind of
a big picture story, and then I think we need to go into details.

Agenda Item: Data Stewardship in Community Health
Data, Report — Discussion for ACTION on 9/21

DR. FRANCIS: So a couple of things, first of all, based on what was
discussed at the last sub-committee meeting, the draft was substantially
revised to take the form that you currently see. There were a couple of goals
in this. One was making sure that — the way we’re viewing this is
identification of issues, so scoping out the territory for people whether the
data use subcommittee or this committee in some set of configurations to then
follow up on. This is meant to be a recommendation for issues to consider
rather then solutions.

DR. CARR: For some folks who are new, first, what’s a statement of the
problem we’re trying to address? What’s the goal and hat’s the method?

DR. FRANCIS: So the problem is that communities are using data in all kinds
of wonderful ways. It’s not always clear that when they do so appropriate
stewardship requirements are being met. If not, if such — in our prior report
on community health data use, we celebrated the wonderful variety, but we also
said very clearly that the next step is to in fact consider trust. That’s what
this addresses. Next your question is the audience —

DR. CARR: Let me just say it again: communities are using data that may have
unintended consequences for privacy. Is that a statement of it? And they’re not
covered by HIPAA?

DR. FRANCIS: That’s too narrow. First of all, certainly many of the
community data uses are not HIPAA covered.

DR. CARR: Right, so that’s one problem.

DR. FRANCIS: But there are stewardship issues that are not easily brought
under privacy, quality for example.

DR. CARR: Okay, so unintended consequences —

DR. FRANCIS: Communication.

DR. CARR: Communities using data may have unintended consequences.

DR. FRANCIS: Negative consequences that undermine this and that therefore
make it more difficult to reap the advantages. This is not meant as a
hindrance. This is meant to surface questions that are really important to

MS. KLOSS: I would frame this in a positive way, that the community health
initiatives that we heard about need to be nurtured, but one of the concerns
that they expressed was the issue of are they doing right by the data. It is
beyond privacy. It takes into consideration the lifecycle of data as a
stewardship issue including privacy and other. I think rather than unintended
consequences, which kind of puts us in a mode of saying what not to do, what
we’re trying to do with this letter is frame essential responsibilities that
then encourage these projects to move forward more confidently.

MR. SCANLON: So this an intent to strengthen these efforts?

DR. FRANCIS: Right. As for the audience, the most immediate audience is the
Secretary, if this is framed as a letter. The way we talked about doing the
discussion was that I was going to take the lead on the first part and Linda on
the recommendations. The recommendations are much more in the neighborhood of
further work needs to be done on this rather than, here’s the solution. In
addition to that, we see as always with our letters to the Secretary , the
audience is not just the Secretary ; it’s the communities who really called out
the importance of this.

DR. CARR: Thank you, that’s very helpful.

DR. COHEN: Before we start wordsmithing, I talked both to Leslie and Linda
about this. One key thing that I think we need to incorporate into this letter
if this is going to be an actionable and practical in and of itself or lead to
the next step is a more explicit and clear definition of the phrase “use
of community data or data used by communities”.

The distinction that I make is data held by the communities versus data that
might be held by someone else and used by communities, data that’s collected
for a specific community project versus data that’s perhaps generically
collected like cancer registry data or vital statistics versus a survey of
specific communities. I think we need to make some of those distinctions clear
when we define what we mean by use. I think it can encompass all of those. We
don’t need to specify in this letter, but we need to broadly explain what we’re
talking about. That’s the first point.

The second point is when we say “community” we need to be a little
more explicit about what the breadth of that term means. Is it the local public
health agency? Is it a community coalition? Is it an NGO in the community? Is
it a university in partnership with a community? There are a variety of
possibilities in terms of the definitions of “community”, and they
all have implications for stewardship. I think both of these can be easily
incorporated into this guidance, but giving those examples about what we mean
by “community” and what we mean by “use” will really help
clarify this and move it to the next level.

DR. FRANCIS: Just to follow up on that a little bit, the other thing I was
going to say in our introduction is we’re very much modeling this on the
stewardship primer, copies of which are over there. I actually brought my copy
from Salt Lake. Who should practice data stewardship? The answer we gave there
is everyone who collects, views, stores, exchanges, aggregates, analyzes and/or
uses electronic health data should.

I very much agree with you. I think it’s a pretty easy thing to do to make
sure that we indicate that we’re not saying that a specific type of user should
do a specific type of thing, but that the territory for all of these users of
data in ways that would benefit communities, whether it’s the NGO or the local
university or whatever. These are some issues they might want to think about,
and that we might need to devote considerable attention to the different sorts
of answers that would in fact be appropriate for different communities.

DR. SCANLON: Actually, it’s the issue of definition of
“community”. I think we have to be very sensitive to what the
potential scope is here. Part of the way of — if we want that broad scope, we
have to start talking about it at the outset what we’re not recommending. We’re
not saying there’s a federal role in dictating things to different types of
entities. I think that’s very important to go through.

DR. CARR: I would just add based on Jodi’s closing comments the feedback
from the focus groups of hearing different frameworks or recommendations
outside of HIPAA and trying to keep track of them. I thought that was an
interesting segue to this as well. Are there other questions? I think to your
point about scope is that are we at the 50,000 foot view, the 15, or the 5? I
think we’ve got to pick one altitude and stay there. I think when we dip into a
detail it changes things.

DR. FRANCIS: We are at 50 and the only point of detail ever would be to
illustrate in a particular circumstance, but not at all to generalize, based on

DR. CARR: Okay, with that how would you like to proceed?

DR. FRANCIS: So what we thought we would do, we would like to be able to
have this ready for primetime tomorrow. What we thought we would do is
understanding those that — we’re going to very careful about that framework
and we will try to work to make sure that it gets set up that way in the
beginning. I think we got a comment from — I’ll just also say this — we got a
comment from Paul that was, as I understood it, along the same lines. We got an
email from Larry that was basically an approval with a couple of limited
suggestions. What I thought we would do is just go through the letter, not to
wordsmith, but to understand that we’ve already heard the comments that we’ve
just heard. We’ll be taking those into account and anything else that people
would like to make sure we do before there’s a draft circulated tomorrow.

DR. CARR: What I would say is I think we’ve all received the letter, and the
background is stuff that we’ve talked about. I think what we’ve not had a
chance to do is have a dialogue as a committee of what we believe based on the
work we’ve had done, and we are currently doing. My suggestion would be to
really move to the part where — the ten things. The first two paragraphs are
background. Do we want to really focus on the stewardship framework, which may
in fact inform what we put in the introductory comment?

DR. FRANCIS: What we were asked to do the subcommittee, and what we did was
— the question that was put to us is, are we just reinventing the wheel? We
went through, and I actually have a chart that I could send around, but it’s
way too complicated for anyone to look at, of all the stewardship frameworks
that have been out there and whether they focus — they mostly focus on the
individual health information patient record situation. What issues remain in
common, what issues are out? That’s what we did. We sent those around to the
subcommittee, so looking from what was — we did essentially an environmental
scan, what was out there, what was there, what wasn’t there. This is the list
that we came up with. If we’re off base, we really need to know.

MS. KLOSS: And a historical scan, we really looked at how this has evolved.

DR. FRANCIS: We looked at everything from the Privacy Act of 1974 all the
way up through the frameworks that Markle and others have put forward.

DR. CARR: Is it our intention to have one framework that encompasses all of
what you found in the landscape? In other words, guiding principles that apply
whether it’s a community or it’s an EHR or other?

MS. KLOSS: We were really looking at this community data use, broadly
defining community application, really circumstances in which HIPAA individual
patient identification regulations aren’t provided current guidance.

DR. COHEN: So again if we are going to move to page three, my suggestion is
going back to the top of page two where you just say, “this letter sets
out the framework for recommendations for stewardship, for information used by
communities to improve local health” the top line on page two. That would
be a good opportunity to add a couple of sentences to describe what we mean by
“community” and what we mean by “used by”. Again, giving
illustrations not prescriptively, but illustratively about the breadth we’re
talking about here.

DR. CARR: Bruce, maybe you can help give them some of those — I like the
way you did it — data from whom, used by whom, and all of the permutations of
those things, if you could help.

DR. COHEN: I guess as I read through the ten items, it’s not clear to me —
the focus seems really to be on individual data collected from health records
as opposed to broader data, like data collection must be open and transparent.
That to me indicates primary — data collection of individual records held by a
community as opposed to the use of publicly available data. The language might
need, and maybe it’s just the way I’m reading it, there are secondary data
sources that actually end up being mostly what communities use for their
activities in terms of needs assessment and planning that some of this
stewardship framework — I think it’s relevant, but I think it’s framed a
little differently.

DR. CARR: Let’s go through it, because I had some of the same concerns. I
think having identified we’re talking about communities, and their own data,
someone else’s data, be used by or given to communities, I think starting with
that is very helpful. As we go through this, I think we can be alert to the
fact that have we stayed in our scope with the commentary on these ten points.

DR. FRANCIS: Let me just ask you, as an illustration, data.gov, data.gov
puts de-identified data on a publicly available website. It’s clear, it’s
transparent what’s on the website. If somebody had concerns about a data set
that was on data.gov, they know that data set is on data.gov, and that would be
an illustration of open and transparent in that sense. Open and transparent
although it’s language that’s been used with respect to the collection of data
from individuals, we didn’t mean to have it be about collection of data from
individuals here.

DR. COHEN: That flavor doesn’t come through. Somehow earlier on —

DR. FRANCIS: Make that very clear. That’s very helpful.

DR. CARR: All right , so we want to start with “data collection and use
must be open and transparent”, so for each of these things, we’re going to
say something-something must be, because we don’t always follow that, but we’ll
get to that, but open and transparent. Do you want to just read through it? How
do you want to do it, Leslie?

DR. FRANCIS: So what we were trying to is to say it that it should be known
what data the community is making available and how the community is using that
data. The committee heard testimony, the collection and use of data in secret
breeds mistrust. There have been some examples where although this is actually
samples, but it was also the information provided by the samples got destroyed
because people got upset about that. What we say here is not a particular
thing, but the community health data stewards need to have guidance about how
they should help the public be aware of their data collection and use
activities. Then we made some suggestions for possibilities, including as with
data.gov, information on public websites, reports in local newspapers.

DR. CARR: If we go to the blood spots, I would read in the paper that my
newborn had a blood spot that was sent to the state, and the state did such and
such, who’s the steward and what do they do in that situation? That’s where I’m

DR. FRANCIS: That’s you, or whoever holds the blood spot. One steward would
be whoever holds the blood spot. Suppose that data sets have been — a question
to ask, I’m not giving you the answer on this, but a question to ask would be
whether anything about publicity means that HHS should be thinking not only
about what’s the data up on data.gov, but who has downloaded it. This is not to
say how HHS should do that, but to say that something for HHS to consider is
whether they’re going to need to have some kind of public record about who uses
the data on data.gov.

DR. CARR: I get the concept, but the example doesn’t fit with it and the
solution doesn’t seem to fit the problem that we’ve stated. We’re saying that
there should be data stewardship, so in the collecting of blood spots for years
we do however many tests on a heel stick on a new born, all kinds of things.
Are we saying that shouldn’t be done? We did that, and that information
shouldn’t be used? Where’s the lesion in that continuum from the blood spot to
the finding? Where would you — I’m trying to figure out where —

DR. FRANCIS: The only thing we are saying here is that if the data are
retained or used in some sort of community way, which is great, it should be,
that one of the things for whoever the steward or the user is to consider is
how public they need to be about what data they have and how they’re using it.
That’s all.

MS. BERNSTEIN: We did a bad job in the cases of Texas and Minnesota, I think
is what Leslie’s trying to say and that therefore they need to do a better job.

DR. MAYS: I think what we are trying to get at is based on the hearing,
there’s a lot of data that’s often collected. When the data is collected,
individuals don’t have a sense of its full use. We might start out with the
notion of this data was collected for something about my infant’s health,
therefore I think that’s great, but then after that I read a report that says
that the infants that live in central Los Angeles tend to have this particular
negative characteristic.

What has happened is it started out for very specific public health use. It
then is used for an epidemiologic kind of finding, and then the people are
quite confused as to how did they get that? The explanation of what it was
collected for is now different than the use. The implications of the use may
now in some way create problems for the communities. That’s my understanding.

DR. CARR: If you think about the Framingham study however many years ago,
they had no idea what they’d be using it for, simply that we are collecting
this for public education. I guess I’m feeling that we’re getting buried now on
this one example when in fact when you get a heel stick it’s a public health
requirement and it will be used accordingly. I don’t see that stewardship
applies because we didn’t say now we’re going to use it for “x”
because “x” might be a concern of you, “y” might be a
concern of me. I’m trying to fit in where the stewardship happens. In the
beginning, I get it, heel sticks will be used for the future —

DR. MAYS: The issue of the stewardship now is whoever is the owner of this
data, can you try to every extent possible to make sure that in the many ways
that it can be used that it won’t be used in a way that’s injurious, and that
you have a sense of who it is that’s using it for these other purposes.

DR. FRANCIS: With respect to this particular stewardship issue, it isn’t
even about injuriousness. That’s later on. It’s about just — with the
Framingham Study, it’s actually been a very public study. People know the data
that are being collected, know the ways it’s being used. Suppose you found out
as people thought they did in the Texas case that the Framingham data had been
sold to the military. You’d be surprised about that. All this says is there
could be transparency issues. It can undermine trust in community data uses if
a community finds out something that was hidden about a data use. That’s all
that says.

DR. SCANLON: I think from the discussion it’s clear that there’s an issue of
balancing here. There are various objectives. There are also the issues of
foresight. How do you know when you start something in 1975 that in 2012 we’re
going to suddenly figure out there’s a real need to look at something and we
didn’t do it? I think that suggests we need to be careful about not being so
absolute. As I look through the letter, there are certain headings in bold
where it says, “must”. The question is what does that mean? How
strong is the evidence to make that a “must”?

There are other times where the heading is simply the topic. It may be more
appropriate that it’s always just the topic and the body deals with the fact
that there are trade-offs, balancing — more prior information is better than
less, but everybody doesn’t have that vision of the future that allows it to be
perfect. I think it’s important to do that, look at the evidence in each
section and look at the heading or — there are recommendations at the end and
then there are hidden recommendations that are built into the sections. You’ve
got to worry about the evidence for those hidden recommendations.

MS. GREENBERG: As always, the committee discussion is rich and contributes
to what I think is a really solid piece of work, so I thank the privacy and
confidentiality and security subcommittee. Just following what you were saying,
this one could just be called “openness and transparency” or
something like that. The balance is very important. I do think that this —
we’re in a different world now that certainly in earlier years, in my
experience, people had a more paternalistic view. Even I think when Hitler came
on, people didn’t used to know — this was all really a good thing we were
doing, but we didn’t have to tell people before. We’ve heard that in hearings
before this committee.

I think that this principle is a very important one. I really like the way
Linda spun it in the beginning. I think if possible that should be woven in the
intro and woven throughout. The committee has obviously gone on record that
these uses of data by communities are critical, there’s a lot of innovative
stuff going on. The committee wants to support that, and of course we’ll be
talking about this in much greater detail tomorrow morning at that session from
8-10, which I encourage you all to come to. Yet, there are examples and we
heard from communities that without greater transparency, without guidance,
things that really could be very useful end up getting thwarted.

This is the positive aspect, not a “don’t do this, don’t do that”
or “you must do this, you mustn’t do that”, but the positive aspect
of how you can encourage greater use in a way that will engender trust and that
will be allowed and actually fostered, that needs to permeate it. I’ve read
many of the comments and there are some concerns that a letter like this or
guidance like this would try to stop uses of certain type of public health data
that is currently being used, and I don’t think that’s the intent at all, but I
do think this idea of doing things secretly really used to, in a more
paternalistic way, used to have more cachet and it really isn’t appropriate.
What we’ve learned is it backfires. I heard that in the testimony. I do think
that it can be framed in a way that will be helpful, but then really as you
said, a different group if you’re asked to or the working group or a group
within the department or something can flesh this out more, but that you’ve
identified the areas.

MS. MILAM: I think I would like to support Marjorie’s comments and react to
Bill’s concerns. When you look at the language, I don’t think any of us would
want to recommend that the notice, make people aware, very specific studies are
uses such that you would have to get consent down the road. We heard from the
hearings people don’t want to be surprised by later use. There’s some language
we can use. Is it in the notice? Is it reasonably anticipated? There’s some
language that can be used so that if the standard is that people would have
general knowledge of or not be surprised, that’s what we’re talking about.

This is also the non-HIPAA scenario. HIPAA covers when a privacy notice must
be given in treatment. This is not treatment. This is for a community. If HIPAA
applied you would follow the HIPAA rules. This is making communities aware —
that individuals and communities aware generally of how data would be used so
that they’re not surprised so that it’s not done in secret. The studies that we
heard at this hearing as well as the two hearings supporting the CHIP report
clearly reflected that individuals want to know and they expect to know. As we
heard with the blood spots, if individuals are surprised, they can rise up, and
they can cause the whole reason for the research to be thrown away and the
blood spots destroyed.

I think we need to step back and look at this principle in greater terms and
understand that it’s not dictating the content of the notice, that study A on
such and such day with a principle investigator, that we’re talking in very
general public health terms so that people understand when the blood is taken
that it will be used for the health of their child for the community or
whatever that is.

DR. WALKER: Great point, I just want to ask Christine’s question again. One
definition of community, I think to Bruce’s point, is you could have five
mothers who are concerned about what seems to be a rash of asthma in their
school. They might organize and go around and ask other people in the community
— that’s the point at which principles make sense. They should still be open
and transparent, and they should still do all these things, but the obligations
and how fine-grained the obligations they have are totally different that the
department of health with all of its resources. Are we trying to address all of
those? Are we trying to address the five mothers who are worried about asthma
in their community or are they not part of this?

DR. FRANCIS: At least I will speak for myself, I think we were trying to
address it, but that what we were trying to do was to say exactly what you just
said, which is just that the way we were trying to address it — maybe two
things about the way were trying to address it. First of all, it’s clearly
going to be really different in different circumstances. Second of all, many of
these different users, we heard from them that it would be helpful to them to
have some guidance. Where there’s meant to be something that’s like a
“must” in here, it’s that these are issues that need to be thought
about. As these uses go forward, it would be really important in some
circumstances to have guidance.

DR. WALKER: It seem to me if we said that clearly upfront that this
addresses a whole range of organizations from the very simplest and least
resource to the most, and that at the highest level of generality this is about
principles and obviously those have to be fleshed out often in terms of
absolute requirements or regulation in some cases. This is just about that
largest framework that everybody should function with that.

DR. CARR: Actually, maybe, to go from — what we’re saying is topics and
we’re not at the point of the principles yet.

DR. WALKER: I think there is a standard use of the word
“principles” in our language where it says you should — and maybe
there’s a better word — you should think about these things, you should have a
reason for — openness and transparency. Maybe those five mothers for some
reason have to not do that. Maybe they’d get thrown out of their jobs if people
found out that they were collecting this information, but you should at least
consider them and have a really good reason for not following them. I don’t
know about that.

DR. CARR: The Secretary is our audience and we are going to ask you for a
framework. Are we stating that we think the framework — are we stating that
here are the topics that must be addressed as opposed to, here is what must
happen on each topic?

DR. FRANCIS: No, what we are saying is openness and transparency are an
issue. One of the things for the Secretary to think about is whether in a
particular context guidance on transparency might be helpful.

DR. CARR: Just taking it up a little bit higher, this letter will have ten
things that should be thought about in a stewardship framework. We have to
decide whether we are going to say “n”, this is what we think you
should think, versus, here’s the topics and here is why they are important,
with now judgment on our part. The next step, it might come back to use, it
might come back to someone else, is to then work it down to a level. That’s why
I’m trying to get clearer.

DR. FRANCIS: You set up the second day, and that’s what we’re doing.

DR. COHEN: So again providing the context here is crucial. There is a
dynamic tension between the collection and the use of data. Following up on
Jim’s example, I’ve been in community meetings, sitting in a church basement
with kids who have childhood leukemia, and they say Mrs. Jones down the street,
her kid has health problems, too. Is that related? From the state, we collected
these data; I can’t provide this individual message. Sometimes the regulations
rules, the stewardship for state surveillance data collection systems, conflict
with community uses, needs, and requests. In fact, we’re prohibited from
providing some data. These are issues that need to be addressed. I think we
need to be clear in the letter that we understand the dynamic tension between
protecting individual confidentiality of the data and maximizing its use to
benefit communities. That needs to set the stage. Here are the issues that need
to be discussed in terms of understanding the tradeoffs between the two.

DR. CARR: Linda, did you want to jump in?

MS. KLOSS: I just wanted to come back and reiterate what Leslie said earlier
about our seeing this letter as really a framing issues letter not a solutions
letter. It’s conceivable that building on these principles, the solution is
quite different if you’re a state agency versus you’re the five women worried
about their children’s health spontaneously coming together in a community. I
think what we were trying to do is get the right principles, so no matter where
you’re at on this continuum of responsibility, you’re starting with the same
framework because this is so dynamic that if there’s six principles for this
group and twelve for that and 18 for that, wouldn’t it be great if we started
with ten and then showed how it could scale given different applications? I
think that’s what we thought would contribute something meaningful.

DR. W. SCANLON: I agree completely with Sallie. It’s the issue of the
unanticipated. I would think about changing the first sentence in this section,
to eliminate secret and talk about unanticipated. “Secret” implies
conspiracy. Right now in a season where there are literally thousands of people
that they can quote out of context, this is potentially one of them. I think a
second point would be to Bruce’s, having a broad definition for community, this
implicit broad definition, it creates a problem in a sense that there are very
different standards if you are a public body like a government.

You have so much power as government, that you have certain responsibilities
as government that are very different than the mothers have decided that
there’s a problem they really need to look into and try and worry about. They
can’t go out and compel people to cooperate with them whereas government can. I
think there’s that issue of taking into account this notion of what community
is in this broad sense. This will go to my last point. I think what we’re
asking the Secretary to do is to exercise some moral leadership on this point,
not to ever think about regulation of all these communities.

The reference at the beginning to HIPAA, we have to be careful about that.
Are we expressing the view that we’re really sorry HIPAA doesn’t apply to all
these things, which I don’t think we are, but that’s again out of context.
Someone’s going to say the national committee really wants to expand HIPAA so
it looks into every house in America and determines what you do. I think it
would be better to just talk about the importance of data, the sensitivity of
data, and forget about HIPAA being referenced at all, and given these
importance of data, here are principles, that we need a framework for privacy
in the future.

MR. SCANLON: Again I think the scope is broad now that I don’t think we
would know what to do with it at HHS. We really need a threshold, and I
certainly wouldn’t include journalistic. We have to say what do we mean by a
data user application. I don’t think we want to get into journalistic guidance
for newspaper and investigative reporting. It’s too broad at the moment and
needs much better focus. I think you’re talking about repurposing data that
might have been collected for another purpose if that is brought together as a
community resource. I’m not sure — there are vehicles suggested in here and we
clearly don’t want to go there. There are constitutional rights and all sorts
of things. You can’t tell journalists what to write about and what not to or
even how to do it.

I just don’t know what anybody would do with it. If we can’t cabin this and
get it a little more what is it, when does the threshold apply, make it a
little more so we know what the “it” is. I don’t think the examples
of newspaper articles or investigative reporting are going to further us here.
We can’t always control — I just think some other formulation would make the
case better than this. I would almost rather start with some concrete
thresholds and principles than to start so broadly where you’re sort of
implicating the Constitution and the Bill of Rights. Bad examples are fine.
There’s a whole body of literature, participatory research, on ethics in
research and public health. Heaven knows things have been done wrong, but I
don’t think it’s quite — it’s just too broad I think. I don’t know what the
“it” is, yet.

DR. CHANDERRAJ: I just completed a course thanks to the ONC on health
information technology. One of the requirements states that several community
organizations that are collecting data are required by law to disseminate that
information to state agencies and federal agencies. The framework of data
stewardship will be done by the laws of that entity. You cannot impose any kind
of uniform laws on one entity when you don’t have control over it.

In this statement, I think you should make it that every agency that’s
taking this data will be bound by their own framework of laws, how to
disseminate and what to do with this information. As far as the transference, I
think if you can make a general statement that it is only for public education
and most of the data is de-identified and it won’t be used specifically for
individual health that will cover any kind of generalistic intrusion into what
we’re doing, or any community is doing.

DR. MAYS: I just want to pick up on some of the points that Bill made and
say that I think there is some language stuff that I think would be great to
use like the notion of talking about repurposing. I think if we change some of
the language so that what we’re really doing is trying to focus on the positive
aspects — I know what we’re trying to get to is this issue of trust, but I
kind of said this for the community health report, I think if we stay off of
that at another direction we might really accomplish what we’re trying to do.

The other thing, and I had kind of put this in and I don’t think it made it
in the draft, is the word “guidance”. I was trying to stay away from
the “must” and change those to “should”, but to ask the
department for guidance. It’s a quickly changing landscape. What’s going to
change quite a bit is what happens in terms of NIH’s requirements around things
like community-based participatory research. We know that that’s changing, so
if we try and do that every time there are major changes, if we do guidance,
then I think HHS will be consistent across its own systems.

MR. SCANLON: But at NIH when we run a program where we’re giving research
funds to do something, we don’t have a direct reach to what a community might
want to do in this areas. Guidance is often taken as regulation. We have to be

DR. MAYS: We now have requirements that come from HHS to NIH about the
things that we as investigators can do in terms of — we now have to make data
public if it’s over $500,000. We always go back to the HHS rules about how to
do a lot of that. It’s hitting us —

MR. SCANLON: That’s programmatic guidance for a program we run and then
people get funds. We’re moving into territory here where we don’t have a reach,
nor do we want one particularly. I think the strength of community is that they
can do what they want. I think you’re not far off. I just think the
“it” needs to captured. Are we talking about people who repurpose
data and make it available in various ways, preferably through a website or
some other way, that when they make that data available these are the

If it’s just open, deputy investigations and public health reporting, there
are all sorts of other rules that apply. I wouldn’t know what we were adding
there. I think you’re on the right track, and I think there’s guidance for
certain things that would be helpful, but it’s so broad at the moment, I don’t
know what it would apply to. Start with what you know it would apply to, that’s
what I would do.

MR. SOONTHORNSIMA: I think these are great comments, and I’d go back to the
letter again. I think the letter is trying to do a great job in framing up
things that are less concrete. My colleague has already said, Raj said very
well, there are already laws and things that govern the things that are more
concrete. This letter gets to things that are less concrete. These that come
from multiple sources. Whatever wordsmithing you can do to take away the
“must” and what not, that’s great. We’re there.

Here’s one thing that may be missing. I don’t know. I’m just throwing this
out there. Because they are so less concrete, these data collection activities
and so forth, and marrying up data from multiple sources for public health
purposes, because it’s so nebulous, are there things we can do around safe
harbor, that context? We have that in other privacy and security concerns. I’m
not an expert in that. I’m just throwing it out there to help even it frame it
out more so that the data stewards aren’t dictated by some of these principles
that they laid out, that there are some open guidelines that are — open is the
wrong word — guidelines around here are situations that you would have some
safe harbor — what’s the word I’m looking for, Sally?

MS. BERSTEIN: I know what a safe harbor is, but usually you’re safe from
some kind of regulatory —

MS. MILAM: So a safe harbor is where you’re already regulated by a federal
or state schema or you have an IRB approval. Maybe this was guidance for
everybody who was looking to be a good steward of data who doesn’t already have
a regulatory structure to allow it.

DR. FRANCIS: Much more like best practices was the one which we were trying
to use for that.

MR. SOONTHORNSIMA: That completes my thought. That’s what I meant. Maybe
that’s what’s missing here. I don’t know.

DR. SUAREZ: Well, I’ve been listening to this somewhat painfully I guess
because I think — very good letter, first of all. I think we have a letter
that describes some reference about why we need this, which provided a pointer
of in the community health data initiative report, we said stewardship was
important, so we’re taking the next step. The next step was to lay out some
basic guiding principles, not to be — the only ones not to be followed as the
law or required, but just to provide a framework of the considerations that
communities should do or look into as they are collecting and using health

We can provide those as guidance. Then we give recommendations for HHS to
take some next steps. Those are the basic things. I don’t know that need to
really delve into more specifics about the concrete things of this should be
the only framework, this framework lacks all the other elements, because that’s
next step work that HHS and NCHS can do together. I’m concerned that I think
we’re going down the path of perfecting this letter to a level that might take
us several more attempts to do.

By the time we actually provide this letter, some valuable time would have
gone for purposes of getting HHS to start working on some of these
recommendations. I’m feeling like — this is natural to feel like this, we try
to perfect our products and our letters in many ways, but to a certain level,
we must reach a consensus that I think it’s good enough to take it to the next
step and just provide a framework as the need and some recommendations for HHS
to take some action.

DR. CARR: The struggle I am having is that we are putting it out to say this
much be research, but we’re also opining on what we think the answers should
be. I think that we’ve kind of said it, to just have the topic, not such and
such must happen, but transparency. Here’s some evidence why transparency is an
issue. Each of these things, here’s the evidence. You have the building blocks
there, it’s just restating it so that we’re not already making the framework
that we’re then asking HHS to make.

DR. SUAREZ: Wherever we use the word “must”, it’s not intended and
it’s not reflective of a mandate or anything like that. It’s a position about
the principles. When we say data stewards must involve communities, that’s —
well, should we say “should involve communities” instead of

DR. CARR: This is what we heard. This is why it’s important. If we’re going
to answer everything now, that’s fine, but right now we’re in a hybrid of we’re
going to ask HHS to opine on this, but actually we’ve already done that.

MS. GREENBERG: You’ve moved down here, as I said in my previous comments, I
think this is a really thoughtful effort here and letter. I think that it in
many ways includes useful information, and it’s well crafted, et cetera. I am
cautioned by both what I heard from Jodi in her previous presentation and by
some of the things that Jim said. Those were the ones I was looking at, about
a), at this point, it may be too broad for HHS to really know what to do with
it, and b), that even with guidance — Bruce told us sometimes it’s good.

It’s guidance, and people think they have to do it, and if we want them to
do it we don’t mind that they got a little confused that they aren’t being
required to. At the same time, there’s a lot of concern right now. There always
is concern about government being intrusive, et cetera. I’m wondering about —
I think there are a number of ways that this can be addressed and still retain
the strength of many of the observations. I think if the committee can agree on
what the view is on any one of these, then that’s fine to include it.

You don’t just have to put in what you’ve heard other people say. This is
why we’ve convened this committee if you really have consensus on some of these
things. What I’m wondering is whether you’re really ready to say that it’s time
for HHS to advance their stewardship framework in light of what we heard from
what Jodi and Jim have said, et cetera, but rather that what you want is for
HHS to engage on where more guidance should be developed.

What I really could see as a real value of this letter, even if HHS at this
point was not prepared to do too much of anything, and I don’t know whether the
department would be or would not, but you heard from communities they lack
guidance, they want to do the right thing, they’re concerned that they might do
the wrong thing probably because it would shut down their work but also because
they really care about improving the health in their communities, but you’re
laying out areas that communities — when there is an organized group in the
community, some random folks, but when there is an effort such as the ones we
heard about and others like it, and we know that they’re springing up around
the country, these are all issues that whoever is responsible for either the
data collection or the data use should be talking about, should be thinking
about, should be aware of.

This is almost as much a response to the communities as — I think you can
be very clear that that’s what it is, but at the same time encourage the
department can do right now or in the future. I think that if you address this
not just to the department but to the communities, and again, not so much with
“must” and “should”, but that these are all areas that need
to be thought through, I think it would be very helpful.

DR. FRANCIS: That’s all we intend to do. I know we are getting on towards
12:00, and I just want to say two lessons that I think we’ll, as we rewrite
this and hopefully have something we can hopefully go forward with tomorrow, we
will focus it on the kinds of community uses that are talked about in the
community health data report. That’s one thing. That does answer the scope.
Maybe more, ultimately, but that’s where we’re starting. The second thing is
that we’re certainly not saying anything regulatory.

The point about people might take HIPAA as an analogy, we’ll take all of
that out, but we do want to say there’s a best practices leadership role for
HHS. That goes back to Justine’s question. Whether what that is that maybe some
places what communities would just want is some sort of way that they can share
information about things, but when it was certainly not — anything that looks
like there’s any hint of a regulation.

MS. KLOSS: I really would remind the committee that it’s already gone on
record recommending that HHS develop some kind of guidance on stewardship. That
was one of the recommendations in the CHIP report. We’ve said that. I think the
intent here was just to follow on with what was recommended and begin to place
this guidance. When I heard Jodi this morning, what I heard was that this
output could actually be useful to where they’ve ended up with HIE stewardship,
which is getting back to principles.

DR. CARR: I want to echo what Marjorie said. This was one of the easiest
letters to read. It was very clear, very concise, very efficiently written. I
think it afforded us the opportunity to now say where on the continuum do we
want to appear. I also think that by raising these ten areas, whoever reads
this letter, communities could take it and say let’s ourselves think about
these things. I think you’re very close to what we want to do. I think what we
want to make sure is that we don’t go beyond what we said and be very clear
about who is being asked to do what. It is past 12:00, and though we didn’t get
through the letter, I think the concepts apply through, so we’ll break now for
lunch and return at 1:00.

(Whereupon, a luncheon recess was taken at 12:05 p.m.)

A F T E R N O O N S E S S I O N (1:05 P.M.)

DR. CARR: Let’s reconvene because we have an excellent and important letter
from Standards. I want to give them the full amount of time. Marjorie has one
thing to say.

MS. GREENBERG: Some of you may have noticed that in the front of the
Humphrey Building are these trailers, or maybe on the side. These are the
world-famous Health and Nutrition Examination Survey trailers. Just by the luck
of the draw, two places in the metropolitan area ended up in the sample in late
2012. One is in Greenbelt, and a number of us from NCHS have gone on tours of
the trailers. It was very interesting. The other one is right here. There are
four trailers for the regular HANES, and then there’s a fifth one that just got
special funding for one round on youth fitness.

In any event, we were trying to figure out a way if any of you wanted to
tour the trailers. It takes about an hour, but we don’t want to pull you out of
the meeting. Tomorrow morning we’re having this joint session. It’s really
quality and populations, but everyone is invited. What I need to know is if
there are any people who are not planning to go to the 8:00-9:45 a.m. session
— we start at 10, the full committee — and would be interested in a tour at
9:00 a.m. It could be arranged. No? Okay. It was the only time. We had 11 as a
possibility, but then we’ve got to be voting on things. If it’s ever in the
neighborhood near you, I must say it’s very interesting.

Agenda Item: Standards — Code Sets, Operating
Rules and Administrative Simplification — Discussion for ACTION on

DR. SUAREZ: So we are going to go through this letter that the subcommittee
on standards is submitting for committee consideration. Just very briefly some
background about the letter, this came from a hearing that we held in June of
this year. I want to once again thank all the testifiers on behalf of the
subcommittee for participating, also thank the people that submitted the
written testimony, which we included and considered and reviewed. I want to
also thank the staff that helps us put together stuff from NCHS and from CMS,
and in particular Lorraine, who has mastered the ability to pull together very
complex hearings with so many testifiers.

I think this time we counted about 30 plus testifiers. It’s not the record.
The record we still hold in this subcommittee, which is 58, for the hearing
that we had back — we were close this time. It was very important, very
engaging dealing with different sets of topics. We had panels on different
topics. The letter is going to reflect that. The letter that you have is
organized into two sections. The first section is an overview and a summary of
the observations on the various topics that were covered. The second section,
what we did this time was to pull together some common themes across the
various topics that were dealt with in the hearings and pulled out those common
themes and then made specific recommendations.

I’m going to spend a few minutes in each of the topics just to say one thing
only about each. We’re not going to go through a line by line and word for word
review of the letter. I’m just going to say one thing about each of the topics
that we covered, and then we’ll focus on the themes and recommendations. The
first topic that we’ll deal with, and which you highlighted on page two is the
topic of 5010 D.0 and 3.0. By June of this year, the industry has gone through
already six months of experience in implementing these new standard versions.
The intent of the hearing on this part was to really understand how things are

One message that came out was we didn’t crash the system, but clearly we are
still in a transition mode. A lot of things have been achieved. We were still,
and through the first six months of this year, and probably some areas and some
transactions were still completing that full transition from the old versions
of this standard, no 4010 and previous standards from NCPDP, to this new
version 5010 and D.0. The main message out there was we really need to
emphasize testing. This time around, the regulation gave us a year before
compliance to allow for the two versions of the standards to play together so
that we could do testing and we could start doing some operational,
production-level 5010 versions and D.0 permissible under the regulations.

The outcome was the testing was not overwhelmingly done, and whenever it was
done it was done at the end of the process. In fact, some of the testing
happened the day that the compliance started. That’s the biggest message out
there. There are a number of other messages that are summarized in these
observations, but that was the main point, and I think that’s something that we
extracted as a theme.

The second topic was operating rules for eligibility and claims status. The
industry is about to launch the first round of implementation of operating
rules January 1 of next year. The first set of operating rules adopted by
regulation are for claim status and eligibility. What we wanted to hear was how
is the industry getting ready to comply with these new operating rules, the
first time that the industry has to comply with required, standard operating
rules. I think what we heard — the main message again was we really are not
getting ready to do those yet. We’re certainly working towards that, but we
need to make sure that the organizations move to begin again to plan, prepare,
and more importantly test these new operating rules. Testing became also
another critical message.

The third topic was on ICD 10. At that point, the first of June, we were
waiting to hear about any delays, the rule that finally confirmed the delay
until this month. At that point the question that we asked testifiers was
assuming there was a delay, what are the most critical milestones between now
and the time of compliance that we really need to ensure the industry
implements as it transitions, trying to be ready and prepared? We heard some
very important messages out there. The most important one was that clearly we
need a road map that defines these milestones and that help the industry
understand that they really need to meet certain steps in order to achieve this

The fourth topic was related to dental codes, issues, and considerations.
There the main concern that came out was that there’s been some changes in the
ways that dental code sets, which is known as the CDT or Current Dental
Terminology, originally and currently maintained through a committee that is
supported by the American Dental Association, there were some changes in the
process and the steps that were taken by the American Dental Association to
maintain that. There were some concerns expressed by industry representatives,
particularly the dental payers, regarding some of these changes, both in terms
of the committee that now maintains the code set as well as the process for
deprecating and for adopting new codes and things like that.

We described that as best as we could in the letter. We have received since
the letter came out for public review a couple of comments from testifiers.
Basically the message has been that this hearing, at the point of when we had
the hearing, there were a number of issues that were described. A number of
those, or some of them are being worked out between the parties, ADA and the
national dental payers. Still the same message continued, which is NCVHS should
monitor and hear back from these organizations to ensure that adopted national
standard for coding dental transactions, dental claims, and dental procedures
continues to meet the expectations of openness and transparency and those kinds
of things that we have used to evaluate and to recommend standards.

That was the dental portion of it. The fifth topic was we wanted to listen
to the industry about the pending process for something that the Affordable
Care Act is now requiring, which is health plan compliance certification. As
health plans are reaching, achieving, or getting close to having to meet the
standards and the new operating rules and all these things, the Affordable Care
Act requires that by December 31 of 2013, health plans would be expected to
certify that they are compliant with all the standards, including the standards
themselves, the implementation specifications that go along with the standards
and the operating rules that go along with each of the transactions.

By December 31 they have to submit that certification and basically certify
that they are compliant for certain transactions, and then a year later,
December 31, 2014, they have to submit a second certification for compliance
with the remaining transactions. The intent was to hear what are some ideas and
recommendations and considerations that CMS as the entity that will be issuing
regulations describing and establishing the way in which health plans are going
to be fulfilling this requirement of certifying compliance, what would be those
methods, mechanisms, steps, and procedures.

We made some observations and highlighted some of the key elements that the
industry noted about this process. Some of the things included ensured that the
process is simple, is efficient, is effective, operationally doable. Those were
the five major topics that we covered during the sessions.

Now we’re getting to page six, which are the common themes across the panels
and recommendations. I’m going to go one by one through those. The first one is
a very important one. We referenced it as the road map. We noted the need to —
this is really a unique opportunity we have now to step back and to look at all
the things that are being done with respect to standards and compliance and
requirements that are coming out, including all the areas of administrative,
simplification, quality measurement, and payment reform, and work on developing
an overarching strategy and road map to help the industry and all the
organizations would have to comply with this, to understand and identify the
steps, but more importantly, also help regulators and even congress understand
that whenever they are inserting a new requirement or new expectation that
there is already a timeframe on it, on a set of activities that this will be
bumping against.

The recommendation there was to ask CMS to convene as a first step in
developing this roadmap a listening session with key stakeholders that will
help frame this roadmap concept and begin the work of developing it. That’s our
first recommendation and Justine, I don’t know if you want to stop at each of
the recommendations and get some feedback?

DR. CARR: We did hear Denise refer to this this morning. This is already in
the works and very helpful, very responsive. Any comments?

DR. FITZMAURICE: Just one, wasn’t there a listening session on some of the
same topics earlier this year? I seem to remember it —

DR. SUAREZ: The session earlier this year was specific around more of the
operating rules aspect of it. It was a different session.

DR. FITZMAURICE: So we don’t want to say another listening session, this
would be a new listening session?

DR. SUAREZ: Yes. So, the second area that we highlighted as a common theme
is collaboration, coordination, openness, and transparency. These four
principles across the board are something that are critical to ensure that they
continue to happen, that they even are improved in terms of how they happen.
The recommendation is to incorporate these four principles into this roadmap
for the work of standards into the future.

This is an important element also from the perspective of we are going to
get into evaluating periodically the status of standards. When I say standards,
I mean standards, implementation, dedication, operating rules, and how they are
going and as part of our ongoing review how much they are continuing to be the
right things or they need to be changed or updated or modified, or if there are
needs to recommend adoption of other new standards in new areas and new
transactions, those kinds of things. These are important elements that we
thought it would be important to include in the roadmap.

Any comments on that? Okay, testing was the third area. As I’ve said, this
is most critical part in the ability to transition any of this in a successful
manner. We have seen how testing has really begun to improve. Back in the 4010
years, when we had to implement that, testing was not necessarily a major focus
even though everybody was talking about testing. The second round, 5010, we had
the ability again to do it because we through regulation had the ability to do
the two transactions at the same time, the two versions of the transaction. A
lot of emphasis was put on that.

The results were clear that even if you put those together the industry
tends to wait until the last minute, as we always do, to do this testing and
this transition. In fact, as I said, some of the testing happened the day the
compliance started. Of course, people were beginning to do for the first time
these transactions and found problems and issues. They had to correct them.
They continued to find some of those.

The recommendation, I’m going to read it, it says, “Consider requiring
testing as part of the transition steps towards implementation of new standards
and operating rules. Standards operating rules must meet: testing requirements
and documentation of such testing, including findings and results, and must be
made available to the industry. To this effect, HHS should consider convening
an industry session to discuss an define a more effective and formal testing
plan including establishing the mechanism for industry to report testing
start-up and progress and share experiences and issues identified during the
testing process as well as more effective mechanisms for timely monitoring of
testing work being done during the transition period.”

I think what we’re trying to do is emphasize and put some parameters and ask
CMS to define some of those parameters and put them in place as we continue to
transition to these new versions of standards.

MR. BURKE: Was the intent to start the testing with the provider submission
of a claim directly to a payer or to an intermediary? How far upstream do you
anticipate the testing should start?

DR. SUAREZ: Well we were talking at length in March about something called
end-to-end testing. In fact, the Affordable Care Act calls for, as part of the
certification compliance, or compliance certification the health plans have to
do that end-to-end testing is one of the components that health plans have to
— so end-to-end testing goes through the entire cycle, EDI cycle as some of us
call it. It covers everything about the eight-one transactions, so if it’s
claimed it goes from end system to end system, internally and all that. It’s
also the entire cycle of the claim as well as the claim payment. Even before
the claim, the eligibility and enrollment and all those processes required,
it’s truly a more comprehensive way of looking at it. Down to the specifics of
course, each transaction as to be appropriately tested end to end, but
conceptually it covers the entire ETI spectrum.

MR. SOONTHORNSIMA: A quick answer, yes it is a lot easier said than to do,
so that’s one of the things that I think we need to talk about, how do we do it
in such a way that is pragmatic and practical. Trying to get that level of
granularity, even the testifiers were saying that as we went through the
testimonies, it’s hard to achieve, but there could be some ways, and there are
really ways of doing that, not only for ICD 10 or any future changes that
impact the entire history as well.

MR. BURKE: They may go to the notion of interchange reports where production
reports might be as evidencing as an interchange report.

MR. SOONTHORNSIMA: Of course, this has to do with your certification, all
these impact, and then testing it, impact on the certifications.

DR. FITZMAURICE: Walter’s suggestion, I noticed in recommendation three you
talk about HHS should consider convening an industry session. Really, we said
CMS should convene a listening session. What would you suggest? Would you
accept an industry working session in there to distinguish it from a listening

DR. SUAREZ: We think it would be good because they are very different.
They’re two different things.

DR. COHEN: I think this is a really fantastic document, in particular, I
like the way you pulled out the common themes across the sessions. I think it’s
really helpful. I understand that this is a report of the findings from the
session. I just had an operational question. I am concerned, particularly
around being explicit about the roadmap for ICD 10 implementation and around
testing around ICD 10. Can we ask the Secretary or do we ask the Secretary to
report back to us in a given time period about specifics around some of these
issues? These are themes that have emerged.

Frankly, when you’re talking about testing happening the day implementation
starts as being probably a little too late in the cycle, particularly if it’s
end to end testing or end to beginning testing — I would love to get some more
specificity about exactly what the department is doing around concrete,
explicit steps leading up to ICD 10 implementation. I don’t know whether that’s
our role or whatever.

DR. SUAREZ: I know that for one, the department and then CMS provides
regular updates to the committee and the subcommittee. We as a committee and a
subcommittee convene sporadically, at least once a year, a hearing to
understand where is the industry with respect to compliance, but I think what
we are looking at now is really pushing a few steps farther, not just one, but
a few steps farther in terms of we can’t really continue to be at the other end
waiting to hear and listen and see what’s going on.

We have to move more into setting up some parameters and pushing them out
into the industry. It’s truly — CMS and HHS in terms of the recipient of these
recommendations, it’s who we’re directing them, but it’s something that’s in
the industry as well that needs to push forward. Guidance and parameters can be
set up. Unfortunately, we don’t have a law or regulation that defines that
testing has to be done, except now we have the certification compliance for
health plans that say that we must certify that we are complying with the

The testing part is not necessarily something that is part of the
expectations of the requirements if you will. At that point, we’re trying to
push them out. It’s really, develop this time, a milestone, develop these
parameters, and see how much there are instruments within HHS and CMS,
regulatory and agency processes that allows them to push them into the industry
to say you really need to do this, and you must do this at some point. I think
we’re going to be passing these recommendations to HHS.

We’re going to be expecting to hear back about the recommendations and
periodically the committee and subcommittee is going to be working with CMS to
see how things are evolving. As a role of monitoring and ensuring that the
industry is moving forward, we’re going to continue to do that.

DR. COHEN: So I would just like to see more explicit language in the letter,
if at all possible, around getting that feedback from CMS and the Secretary
about explicit plans for implementation.

MR. SOONTHORNSIMA: Can I repeat what I thought I heard you say? I think you
were very specific. You said, very specific to ICD 10, so maybe the
recommendation could be a little more specific to ICD 10 in terms of testing
plans and a roadmap.

DR. COHEN: I am ambivalent because I like the way you pulled out the themes
for all standards, but specifically, ICD 10 is the one that is most immediate.
I don’t mean to dilute these recommendations only to focus on ICD 10, but I
want to make the reports specific.

MR. SOONTHORNSIMA: I think it’s a good point because on page four, the
industry outlined in the bullet points what those action steps should be,
however we didn’t include that in our recommendation. That recommendation is
guidelines or guidance towards this end-to-end testing concept. Perhaps what
you’re suggesting is to be a little more specific in even that recommendation
and point to ICD 10 as a target for this end to end. Is that what you’re

DR. COHEN: That would be helpful, and just getting and making sure that
feedback loop is closed. There’s been a lot of folks saying we’re postponing
implementation and these things should happen between now and implementation. I
really want to see evidence of these things happening.

DR. WARREN: To me, I would speak against what you’re recommending. This is a
much broader issues of every standard needs to be tested before implemented.
The ICD letters have already gone out and CMS has heard that. Those
recommendations were made. You talk about CMS should come back and inform us.
They do, because she’s sitting right there in staff to our subcommittee.
There’s a lot of dialogue that goes on in our subcommittee meetings about the
back and forth information that’s shared. I don’t know what forum that needs to
come to the full committee, whether we would invite you when those things are
being shared to come to our subcommittee meetings or whether we have a report
that comes to —

DR. CARR: We have a CMS update, so I think that’s —

DR. WARREN: Denise gave you a wonderful update of where we are with ICD 10,
what’s been followed up on. So I am still struggling with — to me, this letter
is not appropriate to call out ICD 10 because then I wonder, if we call out 10,
we need to call out operating rules for each of the transactions. We need to
call out the 5010, the 3.0, the D.0, and now we start getting down into the

What we’re trying to do here is what’s been missing and what’s been
happening all along is this requirement for testing. It’s not until we
implement that we find out there are all these problems. If we test it first,
we would know what those were, which would make implementation a lot easier.
It’s trying to be more proactive in the way that we implement our standards,
all of our standards, not just one in particular.

MS. DOO: I was going to say part of the challenge is, because we don’t have
a mandate to require that anybody submit testing status, so it wasn’t in a
regulation, I was going to suggest that we could consider adding NCVHS would
appreciate receiving specific reports on ICD 10 testing to the extent that it’s
available for consideration by the committee, but it sounds like Judy’s saying
you would end up then in this iterative process of, well, then you might want
it on everything. I wrote it down so people could look at it, but I think we do
give the updates at the full committee meetings to the extent that is known.

I think there is an HHS committee looking at ICD 10, and there is of course
CMS. There is both an HHS committee and a CMS committee looking at ICD 10 with
the expectation that there will be a significant amount of work because we
don’t want delays. This is the kind of program that you can’t. I think Walter
has identified an issue related to meaningful use that the HIT standards
committee understood yesterday as well, that there are some other pretty
significant implications that will be in effect for next year. There will be a
lot more attention being paid to the implementation issues, something for
consideration as well.

DR. CARR: Given that we do get ongoing updates, I would say NCVHS looks
forward to, if we’re going to put it in at all, which I’m not sure we need, but
I would say “looks forward to”.

MS. KLOSS: In the spirit in which Bruce suggested a little more underscoring
of the urgency on this issue as it related to ICD 10, if we don’t mention it
specifically, I think there was something that came out in the ICD 10 testimony
that isn’t captured here. That was some really good recommendations about
innovation in testing methods. I wonder if we couldn’t do two things to this. I
think they made the point that if we had a test database that was more of a
clinical database, so everybody could see how it worked and compare their
results to something, that that was a kind of innovation that’s needed for this
complex ICD 10. I didn’t think that got captured here as well.

The second thing that might help, my concern, which is the same as Bruce’s
on needing to underscore ICD 10, is to perhaps make that sentence, “to
this effect HHS should consider convening”, I think there’s some urgency.
I think “consider convening” may be a little too passive. I think
innovation in testing should come out, particularly in light of clinical data
and how it’s handled through multiple systems and then a sense of urgency.

MR. SOONTHORNSIMA: I think we had it.

DR. WARREN: I’d have to go back and look, but I think we addressed that in
the letter we passed in June.

MS. KLOSS: Maybe address it again?

DR. CHANDERRAJ: I am really confused. I think when EHRs were certified, I
understand that not all providers are using EHRs, the process of certifying EHR
in most testing cannot be certified unless they test certain measures and go. I
think if you’re having an ongoing certification process, especially as we heard
from Jodi this morning, that when stage two meaningful use certification comes
into being, you should make the vendors have tested their product for 5010 and
ICD 10 issues before they’re certified. Most vendors maybe did on their own,
they do not need it. It just has to help us.

DR. SUAREZ: The meaningful use program applies to EHRs, but they do not
cover the testing and the certification of the EHR to produce administrative
transactions like the claim 5010 or those kinds of things. It does include, for
example, with ICD 10, for meaningful use stage two, the requirement that EHR is
certified to be able to handle ICD 10 and other cultures, SNOMED vocabularies
and other things. From that perspective EHR certification fulfills at least
part of it, which is ICD 10, but it does not fulfill the certification of the
administrative part.

On top of it, the actual compliance certification required under the
Affordable Care Act only applies to health plans. It does not apply to
healthcare providers having to certify that they are compliant with the
administrative transactions. There’s a disconnect there, but the EHR part of
this supports the certification that the EHR system is capable of handling ICD
10. It does not cover 5010 or D.0 or some of the other administrative

DR. CHANDERRAJ: The implementation of ICD 10 is set as October 1, 2014.
We’re here almost at the end of 2012. That’s a very short timeline to convene a
meeting of all the vendors and get into the guidelines and testing. I think we
have to move fast.

DR. SUAREZ: Again, very good point about the urgency of doing this. We’re
going to insert that in the letter as a very critical part. The urgency of
moving quickly to convene this and to facilitate the process.

MS. DOO: Do you want to say “move quickly? HHS should move quickly to
convene an industry working session?

DR. SUAREZ: We can draft it this afternoon and insert a statement about the
urgency. All right, the other topic after recommendation three, the next one is
education and outreach. It’s important to always bring this up. We have said it
several times, but we need to continue to enhance and work towards expanding
communication, education, education outreach, because the complexity is
growing. The requirements are expanding. The direction from those requirements
is multiplying from not just HIPAA, but meaningful use and other things. The
recommendation to CMS should industry oriented communication programs and
collaborations, collaboration initiatives, which are needed to increase access
to technical assistance and encourage development of industry resources to
resolve implementation challenges early in the process. It’s a general
recommendation about increasing the industry oriented communication programs.
Any comments?

DR. WALKER: I think it would be good — communicating effectively with the
smallest organizations that have to comply with whatever the thing is, it’s a
really demanding task. One of the things that separates healthcare from a lot
of other industries is we have so many tiny organizations with very limited
resources of all sorts. I’d recommend that we say something about being sure
that the outreach and the education really is geared to the very large number
of very small organizations that will need it to be crystal clear.

MR. SOONTHORNSIMA: Maybe targeted to the highest small group practitioners,
that type of thing?

DR. WALKER: The hard thing is translating it for the people that don’t get

DR. CARR: I think we heard from Denise this morning, I think the messages
came through loud and clear. I’m going to underscore again what a fantastic
hearing this was, great representation, very crisp, targeted, value-added
input. I think your compilation of it was excellent, but it’s nice to know that
it’s already happening and planned, but I think you’re right to underscore it.
Other comments on this recommendation?

DR. SUAREZ: The next area is acknowledgments. Acknowledgements is another
area of transaction, very important transactions in the healthcare, EDI world.
Acknowledgement is basically an e-message, and electronic message, that
acknowledges that the entity received the electronic — so when I send a claim,
the payer sends an acknowledgement saying that they received the claim or sends
an acknowledgement that says I did receive the claim, but there are some
problems with the claim and here are the problems.

That’s a very critical transaction already being used quite a bit in the
industry. The industry, during the hearing, emphasized again the critical value
and role that this transaction has and the need to adopt standards in this
area. We’re recommending here that HHS should adopt the NCVHS recommended
standards for acknowledgements as soon as possible. We did a write a letter
several months ago recommending that HHS adopt a standard for acknowledgements.

It is understandable that HHS does not have on the Affordable Care Act the
authority to go and do this in an expedited manner, but there is an
opportunity, certainly as part of the authority under HIPAA where all for HHS
to consider and begin to work on new transactions and begin the process of
other standards. It will take some time because as a new transaction, there are
two things that will happen because of not being included in the Affordable
Care Act.

One is HHS will have to write a notice of proposed rule. It would not have
interim final rule authority, so it will have to go through the whole process
as the other standards have gone through in the past in adopting the original
standards for HIPAA. The second thing is that the industry has to be given two
years to comply because this is an adoption of the first time standard. It will
take time, but that’s why we want to try and push it to implementation soon.

The good news again is that the industry is adopting it in a good way, but
as soon as the industry begins to adopt it, there’s the question of the benefit
goes as far as the weakest link and the weakest link is always the one that
doesn’t use it or doesn’t do the standard or doesn’t comply with the standard
that exists. There are standards already for this. We’re recommending again, or
emphasizing this recommendation that HHS adopts this standard for
acknowledgement. Any questions or comments?

The other area is monitoring. Now with an expanded suite of transactions,
standards, operating rules, code sets, identifiers, all these requirements,
monitoring the progress of successful implementation, industry issues, and
ultimately the value is a critical activity. We’re recommending that HHS accrue
funds that enable CMS to conduct a professional, industry-wide assessment with
the option and use of the full suite of standards and operating rules.

When we prepared the HIPAA tenth report to Congress, we found that it was
very challenging to really document and validate not only how much each of the
transactions and each of the standards were being used, but what was the value,
the actual value, the canonic benefit, the efficiency benefit, and ultimately
the outcome benefit for the improvement of care to the patient. We’re
recommending here that there be some dedicated resources given to CMS to allow
for that to be done, for one of the first times, and then allow us to really
build from that information into now we understand that this is the value and
the benefit and this is the direction that we can take into the future. Any
comments on that one?

The last one is enforcement, the “e” word. CMS and OESS should
enforce what is in the regulations by conducting proactive compliance
assessments of all core entity types, and should validate that appropriate
pre-implementation testing that’s been done so that it’s satisfactory. We’re
recommending that CMS be funded sufficiently to both conduct these adequate
compliance audits in accordance with their authority and use the findings to
develop and implement outreach and education programs to address specific
industry implementation challenges. Any questions on that last —

MR. SCANLON: A friendly amendment, do you have to assess every single
entity, or a sample of it? No one does complete audits anymore. You just want a
sample. This would include that kind of a notion?

DR. SUAREZ: Well, thank you for the feedback. We will go back this afternoon
to the subcommittee and make these edits. We’ll bring it back to the committee

MS. DOO: If I were sitting over there, I’d give you a high-five.

DR. WALKER: Could I ask one question for clarification? What is NCVHS’
relationship to ADA? Do we have any? Do we have an advisory role to them, any
formal connection at all? The way this reads it almost sounds like we do.

MS. GREENBERG: We get a report from the — and the ADA data content
committee is on the designated standards and maintenance organizations. That’s

DR. CARR: That’s how it came to — you’re right. It is a little different.
It seems different from the other things that we do, but it comes to us through
the —

DR. SUAREZ: If I may just say, and this is an important point, but we at
NCVHS and particularly our subcommittee on standards are responsible for
ensuring that recommending the standards be adopted for administrating
transaction including code sets like dental function code sets. We are also
responsible for monitoring and receiving feedback from the industry as to
whether the process for continuing to maintain those standards continues to
meet the expectations of openness and transparency and all those things.

Today we rely on those standards of other organizations and data content
committees to do that work. At some point, and that’s the responsibility that
we have, at some point those organizations shift and change and might look
differently. People that have concerns about the outcomes of those changes
don’t have any other place to bring those up except for the national committee,
and that’s the role that we have.

DR. WARREN: Another way to clarify it, because I misspoke, we don’t have a
formal relationship with the American Dental Association. What we do have is
responsibility to their arm that creates the dental code sets, because that
committee is part of DISMA, which we do have — they must come and report to us
for all HIPAA code set transactions. They’re in there with 12 and HL 7 and NCPD

MS. DOO: Dave Prebble might be on the phone and may want to make a comment.

MR. PREBBLE: This is for Walter. I’d like to ask one question about
recommendation three. It has to do with the verbs that start with consider,
consider convening, consider requiring. Could you just take a moment using that
language, and I would just ask the Secretary to think about those?

DR. SUAREZ: We already talked about that word, and I think we’re going to
add it into the work of the subcommittee this afternoon. Thank you so much for
bringing it up again.

DR. CARR: All right, I’m seeing no further comment or discussion on this
letter so we’ll look forward to tomorrow, the final copy. New topic.

PARTICIPANT: This is Marie Sabecka-Steamer(?), American Medical Association.
I’ll make one brief comment with respect to the letter on the section on ICD
10. If there was a way, and I’d like to thank the committee for their previous
recommendation, I can’t remember the letter date but it was about a year and a
half ago where you made a recommendation that Medicare establish an advanced
payment policy.

That was a really helpful recommendation and something we continue to push
for, but to mention your point, Jim, about the need for help for the smaller
practitioners. They’re going to be the ones who are the most cash-strapped.
We’ve seen with every single HIPAA implementation going back to — we all have
the battle scars from 4010 and MPI and we’re getting fewer with 5010. With ICD
10 it would be really helpful, and while we continue to try and push Medicare,
I think that there’s some reluctance on Medicare, not OESS so much, but
Medicare’s concern about going down this road.

If there could be another recommendation, and even if you didn’t
specifically call out advance payment, maybe you could say “implement
policies to mitigate cash flow interruptions”, if you were reluctant to
specifically say that, but if you could say “advance payments” that
would be great. A fair, reasonable providers, in our case, physicians, who are
in good standing with the Medicare program — in fact, it’s not really an
advanced payment.

That’s sort of the Medicare term, it’s not as if it’s like an ATM advance.
It’s more, in our case, the physician has actually provided the service, but
for whatever the reason the claim is not hitting the claim floor, it’s not
going through, there’s some kind of problem that results in the lack of
non-payment. For the small physician offices, it’s very hard to navigate what
can sometimes be several months of cash flow interruptions. CMS has
acknowledged this. OESS has acknowledged it. The committee has acknowledged,
and we think that this is a fair thing to move forward and will continue to
press this, but with your support it would be very helpful to have that
additional thing that we could point to.

It’s going to be hard for us to overcome this. There are programming
concerns behind it, but if it’s a fair and reasonable policy for those who are
in good standing to mitigate — and one last thing, OESS I guess in conjunction
with Medicare had done a study several years ago that looked at what the
biggest risks to the Medicare program were with respect to moving the ICD 10.
When it came to providers, the biggest risk was cash flow interruption. Thank
you so much for these comments.

DR. CARR: Actually, Walter or Ob, can you comment? I believe we did hear
testimony about 5010 implementations? Can you review that and what were our
thoughts about opening that in the letter?

MR. SOONTHORNSIMA: I think the overall goal of this letter is to call out
to, one, whatever changes we’re trying to make we have to be mindful of the
impact on healthcare delivery, and, two, the cash flow that impacts the
providers. I think that came out throughout the testimony. We didn’t go, and
Walter remind me, we didn’t go to that specific — I remember those comments
very well that you made, but somehow we didn’t call that out. Perhaps we should
try to inject, not a theme, but an objective in here —

PARTICIPANT: Even a simple mention of it would be great.

MR. SOONTHORNSIMA: –minimizing disruption to care delivery and cash flow is
part of it.

PARTICIPANT: If you could just say the cash flow part, that would be —
because I would be able to get behind you. I understand if you can’t say
“advanced payment policy”, but just saying “mitigating cash flow
interruption”, that alone would be usable. Thank you.

DR. CARR: Jim, let me hear from you about a way to articulate that.

MR. SCANLON: For the proper wording, we do have to be a little careful
because of our integrity. We have a lot of claims changes, but I think if you
heard this coming up at your ethic hearing, and you have a basis for including
it, you could say that you heard this concern expressed and want to bring it
in. It’d have to be a recommendation.

PARTICIPANT: Obviously a recommendation is ideal, but I’ll take a bullet.

Agenda Item: NCVHS Executive Subcommittee (August 9)
Strategic Planning Session

DR. CARR: Do we have any other commentary from on the phone or around the
room? This concludes the discussion of the standards recommendation, great
work, really great work. Now onto the themes of the retreat. Do we have
hardcopy of this retreat? I think this is very important for members to have in
their hands.

So this goes back to August 9 and discussion that we had even in February
and in the spring, there was discussion of coming together, the executive
committee, to reflect on some lessons learned in terms of the path forward.
Susan, I thank you for putting together a very nice summary. As we wait for
distribution of this, let me give you a direction. We have had actually a very
wonderful discussion, very efficient. There are two themed things to talk
about. One is we talked about guiding principles, because we find ourselves
often getting into topics that are interesting and valid things, but they
compete suddenly with other things that come forward. We’ve had discussion
about what’s in the purview of the committee. We thought it’d be helpful to
articulate guiding principles that will help us prioritize as things come
forward. We’ll talk about that in a minute.

Secondly, as part of coming out with guiding principles, we recognize that
when were fully staffed, we have 18 committee members who come together for
four full meetings each year and then some work groups and that our expertise
is diverse. That is the richness of the committee, but recognizing what we can
do in the time allotted is critical to making sure that what we do we do in the
appropriate depth and get it done in a timely fashion. We reflected on the work
we’ve done, and out of that discussion came three major themes that we feel
represent the continuation of the work of the committee that aligns with our
charge and our charter.

What I’d like to do is begin with the guided principles. Even as I read them
in the draft form and though more clearly about them, and Jim as we heard the
strategic plan today also thought how we would do this. There are ten guiding
principles. The first one is that the work that the committee does aligns with
the NCVHS charter and the HHS strategic plan. I think we had initially said the
triple aim, but we took it up a little because it has to be the strategic plan.
I’m not even sure that we need to call out the triple aim because it is the
whole strategic plan that we have to do.

Of the three, and then we’ll come back and decide if we’ve had all them, the
second point is that work is actionable by the Secretary or others, and we can
talk about who others would be. The third, that the work we produce improves
data infrastructure, that’s integral to our charger, our charter. Number four,
that the work is attentive to privacy, confidentiality, and security. Five,
NCVHS, we do work that we are uniquely qualified to do, but we are not
redundant with other initiatives, other work going on by other agencies.

Number six, that the work has an identifiable audience. Seven, that the work
is directional and strategic. Eight, that the work is consistent with the
bandwidth, it is in scope, and it is appropriately scaled. Nine, that the work
is likely to have a measurable impact, and ten, that it includes a commitment
to and a plan for dissemination. What I’d like to do is now open this up to
comments and suggestions. Are there things here that shouldn’t be on? Are there
other points that we want to add? Or is it perfect, that’s fine, too.

DR. FRANCIS: Can I get some clarity on 10, which is commitment to and plan
for dissemination. Does that mean by us or in the recommendation that you want
the person to do it?

DR. CARR: My understanding, and I’ll ask Linda to speak to it, but we have
observed that we’ve done some great work, and we don’t do enough to get it out.
I think you’ve made that point as well. Linda’s been a good reminder of that
that we get it to the appropriate groups.

MS. KLOSS: My only observation about the list, and I think it’s terrific, is
that it really covers a lot. I’m not sure it’s going to help us exclude very
much. I think having done that then moving to the themes is useful.

DR. CARR: So you will see that when we get to the themes, what we decided
upon and then probably what we excluded, and why we excluded it. That’s where
we were thinking about what’s the work ahead. We held it up to these
principles, and some of the things didn’t make the cut.

MR. BURKE: Could you distinguish between number two and number six a little?

DR. CARR: Actionable by the Secretary or the person to whom it’s directed,
and number six, has an identifiable audience. I think they’re separate, but the
sequence of this was our stream of thought. It may be that we want to put those
together. We have an identifiable audience. We know to whom we’re speaking and
that when that entity gets it, something will happen. I might take that as a
recommendation that we move six up above two.

MR. BURKE: It would make room for another one if you wanted to consolidate
those two and stick to ten. If you wanted to merge two and six, it might create
room for a new ten.

DR. CARR: Did you have one?

MS. GREENBERG: I think they are different.

DR. FRANCIS: Does six infer a timeliness element, that it’s timely?

MS. GREENBERG: That might go with number two, is timely and actionable?

DR. WARREN: Strategic is not always timely; it’s ahead of time.

DR. CARR: Timely is another concept we’ll see in a minute, where to put

DR. FRANCIS: Just a quick comment on why I think those two are different.
Although we are firmly an advisory committee to the Secretary, we often
conceive of our audience far broader, and that’s really important.

DR. CARR: So I would recommend that we add “timely” to number
seven, is directional, strategic, and timely. We’ve often been on a great topic
nine months after the fact. I think that often we’ve taken more time and not be
timely, so I would recommend that we put it there. Let’s go to the themes now.
I think it will enlighten us as we look at the themes and then refer back to
how we got there. There are three major themes. The first is empowering
communities (including individuals and families) to improve health. This theme
incorporates the subcommittee on population health’s work on the community as a
learning system for health and the subcommittee on quality’s work on empowering
consumers with information for better health and healthcare choices, and the
work of the subcommittee on privacy, confidentiality, and security on
stewardship. It will also include new work on measuring health, including
health indicators and summary measures. I’ll open that up for comment.

MS. KLOSS: Justine, I think maybe the header would be more understandable if
we added, “improve their health through use of data” or something.
We’re not doing —

DR. CARR: Good point, empowering communities to improve their health through
use of data.

MS. GREENBERG: Or is it really empowering communities to use data to improve
their health?

DR. CARR: Okay, so to use data —

MS. MILAM: Consumers as well, right, individuals and the communities they’re

DR. CARR: All right, so what I heard was “empowering communities
including individuals and families to use data to improve their health”,
good? We can come back to these. Let me get you to the next one then.
Standards, NCVHS is continuing the statutorily mandated work on standards,
operating rules, and related activities. This includes work on administrative
data and processes keying off the work of CMS.

DR. MAYS: When you do each one, since we weren’t there, can you tell us a
little bit more about the “new”? The first one, will also include new
work, in each of them where there’s new work, can you tell us what you all were
thinking about?

DR. CARR: I think what we meant on that was the work of the new working
group on data use and access.

DR. COHEN: I think the idea is when we’re talking about thinking about what
we do in the future, we want to leave room to grow, so it makes more sense not
to confine us with specific tasks, but to sort of broaden our charge. The idea
of focusing on communities allows us to expand in a variety of directions as
they emerge. That was the intent of thinking about what we’ve done and where we
might be going. It really is unclear. We said earlier today, you can’t protect
the potential future uses of data. I think that’s what we’re trying to get at.

DR. CARR: What if we say this could also include work on measuring health
including health indicators and summary measures? In other words, we’re
building on what we have today from our three themes and then going forward it
could also include work on measuring health, including health indicators and
summary measures.

DR. MAYS: When you say “this”, it gives me the sense that you’re
talking about the projects that were right before it. I thought Bruce was
saying we don’t know the future yet, but this is being carved out, the area,
the topic.

DR. CARR: But I think changing “will” to “could”. This
could also include work on measuring health including health indicators and
summary measures.

DR. KAPLAN: My concern is that seems to weaken that desire to do something
on summary measures. It’s comes as an afterthought.

MS. GREENBERG: Two things, one is we actually did have, and I think it was
probably captured in the actual minutes, a fairly substantive discussion about
summary measures, indicators, different ways to measure health. Obviously, the
group discussed more things than you could have laid out individually. There
was a real interest in that area that was discussed. It was included under this
rubric. I would agree with Bob that at least out of that meeting I heard a
fairly strong interest in doing some work in that area, which is very much
related, of course, to community health data, and communities are doing that
and others are doing it.

DR. CARR: Let me take it back, Susan actually did a nice job on the detailed
summary, but I think speaking about goals and objectives framing the discussion
of how it went throughout the day, the purpose of holding the retreat was to
develop the roadmap for the next few years, as Paul said, to help create the
new world. Participants expressed their hopes at the meeting could involve
thinking creatively and expansively about NCVHS mission structure and audience;
two, identifying cross cutting interests and themes; and three, planning for an
alignment to enable NCVHS to use resources, including the new working group on
data access and use, to manage an agenda that may include fewer areas, but
afford an important opportunity to go into greater depth.

We talked about how the environmental work is characterized by unusually
rapid change and scarce resources; second that NCVHS does its best work when
synthesizing issues across population health, health services, e-health, and
other areas, connecting stakeholders across these sectors, teaming up and
shining a light on broad issues and avoiding micromanaging issues, and
providing a vision for the way forward. Members agreed on the importance of
continuing focus on population health, the ability to extract the population
health benefits from health care reform depends on having the data to both
achieve and assess these impacts. Participants know that the need to help
people and communities leverage the powerhouse of public data that the federal
government is now releasing along with the need to improve community and
population health indicators and summary measures.

DR. MAYS: Can I just comment, because it says in terms of healthcare reform
that though we respect the population health benefits for healthcare reform,
are we concern ourselves only with healthcare and not for example — oh okay.

MS. GREENBERG: Here, those of us who were there are critiquing this that we
already approved, but that’s the committee, and I’ll join the group. One thing
I wanted to say was I think these are not only overarching, but they’re
interrelated, these three. I think maybe that point should be made. I’m looking
at number two, and standards is really, if you read the wonderful histories
that Susan has written up for this committee, standards is really a
foundational theme, responsibility, of this committee from the early days,
whether it be international classifications or then uniform data sets and all

Clearly, number one and number three have aspects of the standards mandate,
agenda, desire written in them. I’m a little concerned that the way we wrote
the standards one here, I remember the discussion, and it’s clear, we have
mandates. We are going to do that. We’re not backing away from that at all, but
it seems that a) I would suggest adding “overarching and
interrelated” to that first sentence, the part where it says to identify
three overarching and interrelated themes for the committee’s work, or
somewhere indicating that these really work together and they need to.

That’s my suggestion. The other thing is that when we’re talking about
standards, I would recommend a sentence that says the committee will also look
for opportunities to promote standards in other areas, or across other types of
data. It’s not just administrative data standards. We’ve talked about public
health standards. We have the HIT committees, which are dealing with clinical
standards, but the committee has certainly weighed in on those prior to their
being an HIT policy in standards committees and continues to make
recommendations whether it be on quality measures or whatever related to
standards. I, myself, would like to see that broadened a little.

DR. CARR: So would we say “administrative and other”, or would you
spell it out?

MS. GREENBERG: You know about the statutory mandated work, although actually
there is mandated work going back in the statute to PMRI standards.

DR. SUAREZ: Not only that, when we talk about standards, we tend to confuse
standards with the subcommittee on standards. Here standards are in the context
of not just administrative but clinical and public health, quality standards,
privacy and security standards.

MS. GREENBERG: The way it is written here is a little bit too focused on the
subcommittee on standards. I would just broaden that a bit, recognizing that
some of that relates to communities, what have you.

MS. KLOSS: My comment was about that, too. Again, as this gets communicated
what the priorities are, and in the spirit of not being redundant with other
initiatives, I think it might be useful for that header to be more parallel
with one and three. Administrative and other data processes based on standards
are something that’s a little more outcome or result-oriented, not just the
word “standard”.

MS. GREENBERG: I think it needs a verb. We’ve got “empowering” and
“unifying”, but unifying isn’t exactly — it could be a verb, it
could be an adjective. Promoting, I was thinking, standards. Promoting and
facilitating standards development and implementation?

DR. COHEN: I also think the first sentence we should take out
“statutorily mandated”. I think the first sentence needs to be
broader, committed to continuing our work on standards. We can address in the
second sentence, this would include statutorily mandated standards —

MS. GREENBERG: Maybe put that in the second sentence, I agree. That was so
much simpler than what I was working on.

DR. CARR: Would it be helpful to go on to the third and then come back
again? I think we need to get the big picture and then make sure it works.
Empowering communities we talked about; standards we talked about; now number
three is unifying framework and vision for convergence within the US health
data infrastructure.

I don’t quite understand this terminology exactly, but the subcommittee
became aware that NCVHS could assist federal information policy by developing a
vision or unifying framework for convergence in the health data infrastructure.
The work will address the strengths and weaknesses of the current
infrastructure and how initiatives can align all types of data and standards.
The vision will encompass all areas of NCVHS concern including population
health, standards, privacy/confidentiality/security, and quality. Development
of a research agenda was also discussed. Jim?

MR. SCANLON: We were more specific than that, and I think it had to do with
the alignment/convergence theme we made to administrative data, public health
data, and electronic records than that would benefit from a more future-looking
framework. It was very specific, and we discussed it this morning. This was
based on the committee’s success in pulling together the vision for how things
could come together. It was at least those three things. I wouldn’t call it
data infrastructure. I would be specific about the data capacities.

DR. CARR: If we skip to page 4 where we talk about part 3, vision for
convergence: Convergence, alignment, and integration were variations on a
strong theme throughout the meeting. The discussions highlighted the
convergence already taking place, particularly in three areas: 1) individual
and community health and health care; 2) clinical and administrative dimensions
of standards; and 3) the information needs of individuals, converging with
those of health care and population health. Mr. Scanlon stressed that while
convergence and alignment are indeed happening, this process will only produce
the desired results in the presence of a unifying framework to guide the
process. He noted the historic visioning contributions of NCVHS; and with his
encouragement, members enthusiastically began to consider how the Committee
might conduct such a project.

So, key points: the contents, eight bullets here: where we’re headed
(desired endpoint); vectors (EHR/HIT, administrative/program data, et cetera);
strengths and weaknesses of the current infrastructure; current initiatives and
progress to date, what’s already going on; major gaps; key input from past
NCVHS reports and vision statements; vision for an information model; and
implications for NCVHS agenda for 3-4 years (“roadmap”). Again, step
it back, we’re saying that the themes are going to be, as we said in the first
one, empowering communities, including families and individuals, second is
continuing to work on developing, and this third one is really a finite work
product that we’re envisioning for this year to be completed before the spring
to look at what are the different themes and how do they come together to
create this framework.

DR. WARREN: I have a question, and I think it’s a grammar question. When I
see “convergence and alignment framework”, I don’t know what we’re
converging and what we’re aligning in order to build a framework. Something
needs to be done with those two words. There needs to be a “what” in

MS. GREENBERG: I think it’s suggested here, what you read on page four.
Convergence among the different streams of data, the different uses of data —

DR. WARREN: I think we need to say that. We need to convergence and
alignment of healthcare steams of data, or something like that.

MR. SCANLON: I think you are seeing these things within those streams as
well. You’re saying a call for a roadmap or administrative data. I guess you’re
saying calls for what we’re having with EHRs and public health data as well.
There’s the opportunity for NCVHS to take part in pulling this together.
Otherwise, some things will be converged by chance, but there’s no design
necessarily. It would be nice to actually have that last piece that provides
the —

DR. WARREN: I agree with all that, but I think that when we have a document
like this, we need to be sure that the selection of the words and the phrase
capture what we mean. This one has a lot of ambiguity.

DR. CARR: So the second bullet, vectors, EHR, we heard today ICD 10 is now
in the problem list — in any event these are some of the themes, and there
were more, EHR, HIT, administrative, programmatic data, population health
community data. It’s in shorthand, and you’re right it needs to be expressed.

DR. WALKER: If I could make a simplifying suggestion, if we said vision and
unifying framework for the US health data infrastructure, I think that would be
pretty clear. If we said for number 3, vision and unifying framework for the US
health data infrastructure.

MS. GREENBERG: The unifying framework is really the convergence. Then we can
talk about convergence, alignment, whatever.

MR. SCANLON: When we did the original vision, information for health, we
started off similarly, three pieces at least, maybe four we added, to the
famous Venn diagram, but pull it together in a way that actually had people
thinking beyond just the pieces. When you’re actually thinking about how A
relates to B, you tend to make it work. That’s what I think we’re — at your
end, the fact that people are asking for roadmaps I think means there isn’t

DR. WARREN: I think you get away from the converge and unify what, and
alignment, to it’s a framework we’re building and the purpose of the framework
is to —

DR. SUAREZ: I totally agree, and I think that was a great simplification of
the statement, but I do not think that this is a from-now-until-spring project.
This is several years. This is an evolution. We need some basic elements and
something to be written about it by spring, but not, this is — the fact is,
it’s not a project.

DR. COHEN: I think there are immediate short-term goals as well as the
longer-term vision. This will always be an issue as more data are generated.
We’ll need to make sure it all fits together in meaningful ways. Clearly there
are some data streams that exist now that we want to focus on as our priority.
I agree with you. I like the notion of not confining ourselves just to
immediate first tasks. I’d like to frame this with a little of both.

MS. GREENBERG: Recalling the information for health activity, which is a
potential model, the committee came up with a version one of it, and actually
then kind of rolled that out. I think we even had regional hearings. Those days
may be gone when we can do it, but they were very useful. I think we did it in
conjunction with the 21st Century Vision for Health Statistics. As I recall, I
think it was in 2000, we rolled out both of those at 50th anniversary symposium
or something. Then we got feedback. It was very structured. Then there was the
next version. I think having something by the summer is reasonable, but it’s
kind of a work in progress. It could be full employment for the best of this
committee, I suppose.

DR. CARR: I want to bring us up a little bit. We don’t want to — today
we’re just framing the work. I want to ask the question, with these three
themes, have we abided by our guiding principles, and if we agree that we have,
then how do we operationalize this and what are the implications for how we
structure ourselves?

DR. MAYS: Okay my question goes to the operationalizing issue. I was just
getting a sense of the time. What I don’t have a sense of is the difference
between how “new” occurs. For example, when we were talking about
including health indicators and summary measures, I right away asked, are we
thinking about the things that aren’t done yet for Healthy People 2020 and what
they will need for Health People 2030. Is “new” something that at
some point in time, we’re saying what we think this is, or is “new”
an offshoot of work we’re already doing and it lets that agenda be broader. I
heard about resources, I heard about trying to focus us in. If you could help
me with what “new” really is and how we have to —

DR. CARR: So I am going to comment on that a little bit because this is the
starter set. I think that the questions that are coming about are right on. I
think that that’s exactly how we use the guiding principles, when we say we’ve
said something so broad and yet we don’t have the expertise or whatever it is.
We’ll do that interplay. I don’t want to solve it right now because it’s a
bigger discussion.

DR. SUAREZ: This is tying into that. I think what we defined here is with
this vision and these themes is the work streams of the committee. In other
words, if someone asked me, so what is the committee working on? We’re working
on three major areas. One is empowering communities, another one is standards,
and another one is a unifying framework for data infrastructure. Those are
three things. The work streams — we need to create a matrix that says for the
work streams, there are these short term and long-term activities. The short
term is the current work. The long term is the new work on each of these

Then on top of it you can lay out the structure of the committee to fulfill
those work streams and those short term and long term activities. That’s my
picture of how all this plays together. We have some standards work that we
have to do now, and we have standards work in the long term. We have empowering
community activities that we are doing now, and it’s current work, and we have
new work that we need to do. Not today probably, but we need to begin to think
about how we structure operationally the committee to fulfill those short term
and long term activities on each of these three work streams.

MS. GREENBERG: I think that was a really good way to describe it, but I also
think it’s a lens through which to look at things. Somebody brings up something
and says, does that fit with any of these, and if it does, fine, and take it
from there. If we’re going to look at that, we need to keep the community
vision or lens in mind, or the standards one, or how does it work in this
unifying thing? I think to some degree it’s a way to structure thought, but
what we were thinking when we revised the agenda after this retreat was — and
so I just want to put that on the table. We were thinking the community one,
which we decided to change the way the subcommittees were meeting and not have
separate subcommittee meetings tomorrow morning.

That’s where we’re going to address number one and have — everybody who’s
interested can come to that, but definitely it’s populations and quality, but
also obviously privacy because it involves the stewardship stuff. In this
session today, the standards, there’s already a group working on that, but it’s
broader than that. It will come up in the others, but I think we’ve got a way
forward with that. I think we were hoping this afternoon to at least get an
idea, and of course, first people have to understand what it is, but as stated
over here on page four, have this full committee discussion and identify a core
group to lead this project or work on this project.

We had even talked about the possibility — our next meeting is November 13
and 14 — the possibility of maybe that core group meeting on the 15th. Again,
I’m just throwing this out as something to think about, the core group that
wants to really lead number three. It doesn’t have to, but we were hoping by
the end of this meeting we will know how we’re going to take each of these
forward, not what we’re going to do in each one, but what the structure is.

DR. CARR: So let me take it up — Jim wanted to make a comment, and then I
want to set some direction here.

DR. WALKER: I just want to reflect on guideline number five, “NCVHS is
uniquely qualified, and it is not redundant with other initiatives.” If
you’ve watched a bunch of little kids learn how to play soccer, you can put
what do they all do, they all run to the ball and so nothing good happens.
Eventually they learn they have to spread across the field in their different
roles. It seems to me if we could be really very careful about saying even
within these three, say these three are the right ones, saying who are the
stakeholders, what is the aspect of this that isn’t being paid attention to and
not drawing the land rush(?), and there’s a lot of that going on right now, I
think we really could do a great service, but I think it’s going to take some
really hard thought to be clear that there’s an open place in the field, and we
should have a middle-back in there, and maybe it’s us.

DR. CARR: I think if you look back at the visioning documents on NHII as
well as statistics, that’s what they did. That’s why those diagrams, those
constructs really endure in a powerful way. With each advance you go back to
them, and those constructs still apply in many ways. That’s exactly what we
want to do. I think we’re emerging from the hyper attention on EHRs. EHRs had
tremendous implications on all of these fields, but we had a lot of people, a
lot of agencies or committees, work groups, fracas, a lot of people working on
it. I think that that’s the kind of thing we need to look at and say, is the
depth and breadth of this committee aligned with being able to deliver a
meaningful product on that topic, or do we take it up a bit and talk about the
overarching principles, some of which we heard today.

DR. WALKER: Just to put a finer point on it, I think empowerment is the next

DR. SUAREZ: So we have these new themes, this new vision. We’re still
thinking about the same four committees. I just want to make sure that we
consider the fact that the current structure might not be the right one for
this new vision. We don’t need to try to fit a —

DR. CARR: I want to first say are we in agreement with this new way of doing
things to take a couple of major themes, building on work and going to where it
needs to be, where the puck will be, as we’ve talked about a million times?

DR. FRANCIS: It might be premature at this point, but it is related to the
same question of subcommittees. I think we agreed on two things. One is that,
what we have now are subcommittees that do reflect important themes, and
second, that they overlap in very important ways, which is why we decided not
to have meetings that conflicted so somebody would be in the awful position of
wanting to be at both.

DR. CARR: I think that is exactly right. In fact, today reminds me very much
of secondary use work. It was one of the first times we went across the
subcommittee structure and worked on this document to talk about reuse of data.
We’re back to that again. From then, this repeats all the time, that we need
all voices at the table for each of these things. Let’s think about this. Three
things, and then I’ll get to Bruce. One is, do we want to agree to have these
kinds of crosscutting themes? Second, are these the right themes? Third, how
should we configure to achieve the goals that we are articulating?

DR. COHEN: So if these are cross cutting, they’re not mutually exclusive and
they’re not intended to be mutually exclusive. All of us are a bit
schizophrenic in our lives, but if we want to be involved in all three of these
themes, or two — we have to build these themes into our work, so that implies
a different kind of structure. That’s all. That falls out from cross cutting
themes, rather than trying to create separable groups, the explicit intention
is to create some overlap and more unifying as we address different aspects of
these things.

DR. CARR: Each of these three should strengthen the other, I think.

DR. MAYS: I am struggling with one, empowering communities. Then if we go
back to the guiding principles, is actionable by the Secretary or others. I
think the issue is we typically aren’t working at the level of empowering the
community directly. We’re actually working at the level of assisting systems to
make changes that then result in this empowerment for the community. If the
Secretary, and others, is really our goal, it’s not directly about communities.
The Secretary has much more direct authority over health systems, particularly
that of health data. I understand where —

DR. CARR: I think that’s a great point.

DR. MAYS: — where we want to get, but I’m struggling with the first one.

DR. CARR: That is a great point.

DR. COHEN: My response is if we take this conceptual model and it redefines
how we do work, maybe there are more workgroups that include people who haven’t
traditionally sat at this table to be involved in our activities, which would
include more community representation around these things. Just like we’re
pulling in the application designers for our data work, perhaps we need more
community voices at the table to do more data work about — related to what
directly affects communities.

DR. MAYS: The problem is the “actionable” and “who”. We
can’t really, with the community, tell them — end up having the community do
something the way in which, if it’s to be actionable, they need resources —
there are all these things often that are needed. The Secretary can change
policy, can legislate, can really cause something to change. With the
communities, I don’t think that we can. I agree with your issue of the
involvement of the perspectives, but I’m trying to stick with what we were
asking about —

DR. CARR: I like the way you said it before, empowering —

DR. MAYS: Empowering systems of change.

MS. GREENBERG: Then you lose, to me, the oomph of it. Ultimately I think
what people were talking about doing was, yes, creating systems, policies, or
enhancing systems and polices, et cetera, that will empower communities. Maybe
that needs to be a — but that’s the goal.

DR. CARR: I think she raised a very good point. We get very expansive. It’s
the same thing we have with quality. Are we doing quality of healthcare? Are we
doing quality data to support quality or quality of data?

DR. WALKER: It changes the way we think and work. It focuses, like Vickie
says, on something that can be actionable. It maybe is more demanding. We say
“empowering communities”, and it’s “oh, god, yes”, but if
you say we’re going to figure out what are all the different ways that HHS
could create policy frameworks and data structures and data services, you’re in
a whole different game. That’s a game where maybe there’s nobody really doing
the hard work of saying what exactly would be the infrastructure for empowering
communities. I think you’re exactly right.

DR. CARR: It is not the spotlight; it’s the infrastructure blocking and

DR. WARREN: I am wondering, when I take a look at these three groups —
they’re not groups, these really are themes. Maybe it’s time for NCVHS to
reconsider how it’s organized, and we get rid of subcommittees. Hear me out,
Marjorie, because I’ve thought about this. We go to task forces. People can
pull together depending on what’s needed for the task force. As soon as I say
that, my standards part kicks in, but there are going to be administrative
standards, but it can still be managed around a task force. There’s a task
force looking at concepts. There’s another one looking at operating rules.
There’s another one looking at stuff like that, and come together around that
work product. They stay together until the deliverable is done.

MS. GREENBERG: Well, we certainly had this discussion at the retreat. First
of all, I’d say the current subcommittee structure is not in cement or
anything. We’ve had different subcommittees over the years. There may be too
many subcommittees, and we had that kind of discussion. I think we ended that
meeting saying that that group, that discussion was not going to make specific
recommendations about the structure because we felt that was premature and
wanted to have this discussion here. We did reorganize the agenda to give a
view that maybe we needed to do less siloing.

There is some advantage or some purpose to have at least a few standing
subcommittees. First of all, we actually have to report through the committee
management system when we establish a new subcommittee or when we abolish a
subcommittee, so they have some kind of status. Nobody tells us “don’t do
that” or “you can’t do it”. There also are constituencies or
stakeholders who have convened around or gathered around particular
subcommittees. You don’t want to say more than you’re saying by abolishing a
subcommittee. I guess my sense was I prefer for this to stay fluid a little bit
longer and continue, as Justine has said, the last part about how you want to
configure to address this.

You could just go forward for a while with task groups or something, but
some group has to be responsible, and you also need some leadership. You have
to think in terms of those kinds of structure things. You don’t want to be too
loosey-goosey and then everything falls on the chair of the full committee. I
think we saw the value of the leadership meeting in this retreat, but clearly,
it only can go so far because all of you are leaders obviously. I would sort of
council against doing anything too-

DR. WARREN: So the reason I brought that up was for us to think about things
because as Vickie has talked and things, I’ve been looking at group one and
group three. I’m still really unclear about what those groups might do. I’m
really clear about what standards does because that’s my background.

DR. CARR: We have to take this out for a ride. I think tomorrow morning,
we’ll do that for the first time. We’ll talk about theme one at the combined —
what would have been population and quality, come together and talk about that,
inviting others as well, inviting everyone into it. You can’t —

DR. WARREN: That was my next thing. Is the intent then that everybody
attends all three of these?

MS. GREENBERG: The way we set it up, everyone is able to attend all three.

DR. CARR: Maybe that is right. We come down here, and we spend two days just
really working. This is also another tension that we have sometimes. We want to
invite outside speakers and inform the committee, but we then struggle with
work time to develop ideas. So in many ways, this is perhaps the answer to how
you develop the ideas.

DR. FRANCIS: Adding to what Marjorie said, I think in a way, what the
subcommittees do is they coalesce expertise in a way. The standards people know
a lot about standards, but privacy people know a lot about privacy and
confidentiality. The populations people know about population health issues, or
learn a lot about it. I would say that for all the quality people, something
about quality measures. What we’re doing, as I understood it, when we’re
identifying these themes is we’re really interested in places where these kinds
of expertise need to get linked. The subcommittees reflect the expertise areas
and the themes represent the really important ways these things go together.
That’s why I really liked the idea of having — continuing to have
subcommittees, but structuring our meetings so that the subcommittees can work

MR. SCANLON: The other thing, I would caution you to read too literally into
the three themes. I think what the retreat did was you sort of looked at the
past and what could we do better and organize better, and then where do we
think — what would be fruitful areas to focus on. These themes that came up
were areas where we either knew we were required, the Secretary asked us to do
it, the statutes require us to do it, or there were otherwise daylight
opportunities and priorities where this kind of work would be engaging for the

We have the freedom to choose within these areas, but these are illustrative
of the areas we saw — we were already asked to go forward in three of these
areas already. There’s a full plate of requirements under HIPAA and other
standards that will keep us busy that we have already committed and responded
to the Secretary’s request to improve data access in user communities. We’re
going to be doing that anyway. What we were trying to do here was to find
descriptions for the kind of activity that was included.

The one area which was somewhat different — and some of these things we
don’t know yet. It’s up to the committee to decide what would be the expression
of the individual project under some of these. The one new one was the step
back, as we did previously on the vision — for health IT vision, was to step
back. Much as you heard everyone asking for road maps about this and that,
everyone is so busy doing what they have to do that how this all relates beyond
the magical thinking, I don’t think people know.

There really is a lot of magical thinking going on about EHRs and other
things. The idea here was to be serious. That’s probably the prospective look
at an area where it’s up to the committee to define it. It wasn’t necessarily
meant to be a project. It’s a set of activities that we are, to some extent,
already required to do, committed to do. That vision one is the one where it’s
up to us to fill a — there’s some daylight there to make a contribution.

I wouldn’t look at words here that mean individual projects. What we do on
summary indicators or indicators is up to the committee. The subcommittees —
they have expertise. They have a body of work they have to do. They are looked
to by a lot of folks in the industry for carrying out work and a way to bring
issues. I’d be very careful of eliminating any. We have the freedom to organize
however we want. We can create a task force, create a work group, and so on. I
think I’m a little worried that people are trying to convert the brief
descriptions here of directions to specific projects, which I don’t think we
were meaning to do here. That’s the research or work agenda.

DR. CARR: Two things, I haven’t heard from everybody in the room. I’d like
to go around the room and hear any affirmation, concern, or new direction,
briefly, so that we have a sense and have heard from everybody. I’d like to
then suggest that we have our meeting tomorrow morning, see how that goes, and
then we’re going to have some time. It sounds like the standards letter is
really going to move quickly tomorrow and we’re going to have time to discuss
where we go from here. Trying it out a little bit will inform our thinking
further tomorrow. Everybody at the table will be invited to comment.

DR. GREEN: This is Larry, and I’ve got to leave at some point, can I jump
the line and make one quick comment? My answer to your three questions are yes
to one, yes to two, and to three, it depends on the work.

DR. CARR: Okay, thank you, Larry. We’ll see you a little bit later and we’ll
see you tomorrow.

DR. KAPLAN: I agree these are the right ones. I guess to me this biggest
issue is this standardization issue but also developing meaningful summary
measures and measures that can be used for public health practitioners. We have
this continuing interest in a variety of topics around those themes. In
addition to that, we’re always interested in making sure that data can be used
for research purposes and trying to think about the next generation platforms
for epidemiologic research and also practical clinical trials.

DR. CARR: Ed Sondik, in particular, had brought that up about research, but
we didn’t get to that, good point.

DR. CHANDERRAJ: I think Jim summarized it very well. I think the statements
expressed in the document are very good. I think we’re trying to overreach and
correct and rev up this thing, but I think as it is, the document is very good
and it will stand as a good framework for the work to do.

DR. COHEN: I agree with this approach.

DR. FITZMAURICE: I agree with this approach, but I think as yet in my mind
it’s a little disjointed in some places. I think the guiding principles aren’t
set out with the same kind of — they’re not prioritized, and they don’t fit
together in my mind. Then again, it’s the problem with my mind. I see this is
as looking at what is the core of NCVHS, what is it that we’re about, what is
it that we do? How do we choose our work? We have subjects that we like. We
have mandates from Congress. We could have mandates from secretaries or
important agencies within HHS. We agree to supply expertise and principles and
advice to them.

It may not get as much into research and into methods as some would like. It
may not get as much into data uniformity and the semantic interoperability that
I heard mentioned, which may be essential for moving this data around for
public health and for other purposes, that the Secretary would want to move
around. I’m not sure I see a lot in here about efficiency. I would put
something about efficiency in there, about one of the goals is that we want to
do and we want to do it well, then we want to operate efficiently.

We want the health system to operate more efficiently. That’s a big bent of
ours, to leave resources on the table for other uses. If organizations can do
claims more efficiently, can do recording of quality measures more efficiently,
then these resources can be used for something else. I apologize for not having
a framework to give you. That’s just my impression of this. It’s a very good

DR. SCANLON: Since Mike brought it up first, I’ll do this. I’m harshly
guilty of when you’re asked the question of what’s the most important thing in
the world today, the answer is what I’m working on. This is this issue of
efficiency. I think that, to be honest, if you’ve really focused on what’s
happening with healthcare spending, it’s eating us alive. It’s perfectly
capable of totally consuming us. We’ve really got to be focused on that in some
respects first, before all other kinds of things.

I think that’s a part of where we are. I’m comfortable, in some respects,
with the themes. They can be excuses for what you want to do. I’m not going to
get too hung up on particular wording, because all of the time you get to do
what you want to do. In terms of the principles, I’ve been one that’s been
talking in the past about bandwidth, so that’s one that I think is very
important. Timeliness is important, but there’s also a balancing between
bandwidth and timeliness and sophistication. You really need to think about

There should be no sense of obligation that whatever we have, subcommittees,
working groups, et cetera, they have something actionable in every meeting.
That’s the kind of thing that you don’t want to do. You have to think about
strategically what you can accomplish, and part of that goes to the quality of
what you’re reporting out. The last thing I would say is I think it’s very
important for us to remember we’re an advisory committee to government.
Government is that 900-pound gorilla, which there are legitimate reasons to
fear and there are also legitimate reasons to say it can really accomplish a
lot when channeled correctly. We have to think about that. When we’re making a
recommendation to the Secretary to do something, there’s the power of
government that’s potentially behind this. You have to know when you want to
use and how to use that power.

MR. BURKE: I am in agreement with the thematic areas. I think the principles
are logical. They make sense. The eventual form that we take on to do this work
will follow those functions.

DR. MAYS: I would like to pick up what Mike was saying. Mike really started
what I wanted to bring up, and that is we have a lot on our plate in many ways.
There are some HHS groups that I think to some extent we need to have some
relationship with that we haven’t been working with as much. For example, the
office of research integrity — it’s the people that actually do the training
in terms of ethics and IRB and privacy and confidentiality. There was a guy
that used to be here a long time ago, and we haven’t had him at the meeting. We
haven’t had CDC, the prevention side, here with us enough. I think we have —

MR. SCANLON: They are supposed to be here.

DR. MAYS: Yes, but those are the areas that I think that — I get concerned
a little more in terms of the public health side, a little more discussion in
terms of the clinical issues. I think my other concern, and it may be an
operational one, is the silo issue. It seems to come to a head when we do a
letter. Sometimes when a letter comes before us, it’s almost like I wish I had
gone to those meetings, but I didn’t know, so that you can contribute then. You
kind of hold back a little bit because you want to get the letter finished.

If there’s some way in the structuring of this that you have to have one
member from some of the other groups or something to sit in, even though some
of us represent more than one, I think when there’s an action item, it would
really help to have — we heard about standards, we heard about everything on
it, and I think the quality of what we do would be different. Structurally, I’m
trying to figure that part out.

DR. CARR: I think someone was alluding to it before, that it’s really the
intersection. The rows are the subcommittees and the columns are the areas of
focus, a grid, in other words.

MS. KLOSS: I agree with the themes, and I think one of the ways that I
envision them, there’s a body of knowledge that says that a good strategic
framework has certain things that are core, that are new, and that wow. I
really saw one of each of those in this. Standards is part of this group. I
think the community is new. It’s a new term, mid-term. Getting this broader
framework done is kind of the wow work that we could be doing. With regard to
the subcommittees, I would just say that in a group this size, I think very
little would get done if you didn’t have groups that have that specifically on
their agenda and were small enough to get a conference call organized quickly
and things like that. We can tweak it around the edges, but I think as a body
that does a lot of work we need a subcommittee mechanism to move work through.

DR. FRANCIS: I would just add that I found the different perspectives this
morning in the discussion of our letter absolutely, wonderfully valuable. I was
going to say invaluable, but I wanted to make sure people realized what I was
saying was wonderfully valuable and priceless. Therefore, I would like to
invite anyone who is going to be around at 4:30 today, in the spirit of full —
it’s scheduled open so that anyone who wants to come and help us so we have a
letter tomorrow.

MR. SCANLON: Again I was at the retreat, and I come at it with my executive,
step-director hat on. This is one of the most successful committees we have at
HHS. It’s one of the most productive. You probably work harder than a lot of
the other committees we have, which come in and meet with the director twice a
year, and the director tells them what she’s going to do. This is a very
substantive committee. You’re all more or less chosen, hand picked. We want to
be respective of your time, the issues you spend time on and how we can do our
work efficiently.

On the other hand, the department has obligations, the committee has
obligations, some of them statutory relating to the HIPAA standards. I have to
say the committee has been immensely helpful on the whole HIPAA effort from
privacy all the way to all the standards. I really don’t think we could be
where we are without the committee. I want to recognize all of that work even
though it’s directed by staff shoots, it’s still a lot of work. It’s very
highly regarded.

Then we have other work that is more looking at the data systems, looking at
privacy more broadly, and then looking at the health information infrastructure
more broadly. The committee does unusually, not only at the very detailed level
of the X12 standards and so on, but it also does very well on the visioning
side of this. I would rather the committee spend its efforts on those sorts of
things where clearly there’s daylight, where no one is doing it to a serious
level, let me put it that way, where no one is doing it in an open fashion.

When we think about the agenda for the committee, I think we’re looking at
the areas where the committee is regarded highly, who’s products are always
viewed as not having an axe to grind and representing different points of view
and balanced reports, and having a lot of sophistication and nuance, not just
another brief on a topic. At the retreat when we thought about in the choice of
topics and these themes where we could go, and I think we’re open, anyone could
suggest another, these were the ones that meet HHS obligations, the committee’s
obligations to HHS and to our stakeholders, but leave plenty of room for
proactive thought and ideas. I love this list.

MS. GREENBERG: I agree with everything Jim said. I had really been very keen
to have this executive subcommittee retreat, so I was very gratified by how
productive it was. Justine suggested to me earlier that part of the reason
might have been because we were in a room that had zero connectivity. You can
only do one thing with excellence, and that was the only thing we could do. I
think the group did it pretty well. I obviously was involved, contributed, and
I am very supportive of it as well.

I think with these guiding principles, I’m thinking of an analogy with what
we were discussing this morning about the stewardship letter. In a sense, I’m
not sure that these are all the right ones, plus some of them are duplicative,
and you could spend a fair amount of time tweaking them around and wordsmithing
them, but it wouldn’t be a really good use of time, I don’t think. It’s things
to think about that certainly — and you might want to add some, like this one
about dissemination. I think it’s important to have that in the guiding
principles so that — and the audience and all of those.

Some of these are things that Justine has been very effective in getting —
insists when a group comes forward with a letter of recommendation they’ve
thought about each one of these things. I think that’s the way I would see
them, as a template to look at. Maybe over a period of a year they’ll get
refined and there might be some new things added, and something maybe from the
point of view of what Bill was saying and Mike, which I think relates to
improving the data infrastructure, some of the efficiency issues or what have

In my mind, they’re okay to go for now. The proof will be in the pudding. I
like what Walter was saying about when people ask, what does a national
committee do, it’s nice to be able to sum it up a little more in this way.
We’ve got this subcommittee, we’ve got that subcommittee, we’ve got this
letter, we’ve got that letter. The devil is obviously in the details. I’m
excited to see how you take these forward. We’ll support you in any way we can.

MS. MILAM: I think we got a good enough start. I think that when we look at
the guiding principles and we look at the themes, it gives us the foundation we
need to do our work. I think we’ve got a good opportunity tomorrow morning to
kick the tires and see how one of these themes work. When you listen to some of
the comments made by folks around the table, we really need to make a
difference in this country and this committee is charged with providing
recommendations around health data policy. How can we use that opportunity to
improve the lives of people in our country? How can we improve the healthcare
system? If we can think about how we have this unique opportunity tomorrow to
look at policy with respect to individuals and communities and put all of our
best thinking together, we can see how this works. If we need to add to it, I’m
sure we can go back and adjust it, but let’s take it for a ride.

DR. SUAREZ: It was an excellent discussion of the executive subcommittee,
and I think we came up with good themes. I think looking at the themes again,
there are two themes that are really high level, empowering communities and the
unifying framework. Then there are the standards, and then there’s privacy and
security. I think we chose another major element that we really didn’t have in
this as a theme, but we embedded it into all the other ones. In some respects,
however we organize the themes, I think that we’ll be fine.

The critical part is this: we are an advisory committee that produces
products. We debate and we discuss and all this gets recorded and all that, but
until we write a letter or a document that gets published, all of that stays on
a recording that maybe someone hears. The important part in my mind is really,
once we go beyond these themes, it’s almost near regularly and very
academically almost, very consistently, we have to define each year what are
the projects, what is the agenda, what is the set of products, then we can fit
them into these bigger themes. As Bill was saying, they are good excuses for
whatever decision we make. We have to define these projects or these products
that we’re going to work on and develop, and then we need to put the people
that are going to be working on them together.

We can maintain these subcommittees that we have. In other words, I’m much
more oriented towards the products and not oriented towards defining what is it
that we’re going to work on over the next year. We can talk about five year and
ten year missions and all that but ever year, we should have the agenda of the
committee. Yes, there might be issues in March that something happened and a
law was passed or something, but without having such an agenda that helps us
define the product that we’re going to produce by when and which group is going
to be working on it, we’re going to continue the way we are working right now,
which is subcommittees in some respects, being still in a silo mode. We’re
trying to work more together and bring them together more.

I think my comment is the themes are fine. The principles for prioritizing
projects are fine. They can be refined and all that, but it’s really the
discussion and definition of what are we going to do in 2013. Our subcommittee,
for example, the standards subcommittee, which maybe is not a good example,
because it’s a committee that has some requirements, we have an agenda for
2013. I think we’re going to discuss this afternoon in this new way of thinking
about things that we’re going to transfer that into something that is much more
fulfilling of the statutory requirements but more visionary and longer term,
but still defining the expectations we have for 2013.

Without having that, defining a specific product, I think we’re going to
continue debating and creating something that and then trying to fit it into
the structure — I used to operate a non-profit back in the 90s. One of the
things that we would do every year was define the annual business plan for the
organization that defined the products and the projects and the outcomes and
the deliverables and the timelines and the measures and everything.

It was a roadmap for our own organization that helped us say who is going to
work, what are the resources, what’s the bandwidth that we have to do those. We
should do that every year. We should have a meeting at the end of the year,
whatever is an appropriate time, maybe it’s the end of March or whatever that
sets the agenda for the next year and establishes the progress for that and
decides which structure and which committees and which work gets done.

MR. SOONTHORNSIMA: I agree with everybody’s comment, but it reminds me of
why we are doing this, why we are doing the summit and retreat. One thing that
we talked about back in June was this sense of convergence, lots of things
going on. The industry is inundated with mandates, changes, healthcare reform,
what not. I think it became very clear to us to convene and try to figure out
what’s the right approach for us to tackling all these things.

With that said, that’s why we came up with this theme called convergence. I
don’t want to call it a theme. It’s just an emerging word that we used. With
that as a key driver, if you will, convergence of what’s going in industry and
all these mandates, we realized as a committee that we can’t tackle everything.
The best way we can serve the Secretary and the best way we can serve the
industry is try to narrow our work based on the bandwidth that we have and the
expertise and the structure that we have. That’s how we came up with the key
principles, guiding principles, and themes.

We’re not going to be able to tackle everything, but how we align those
initiatives and projects and provide the best advice to the Secretary and the
department, that’s why we have this document, to be efficient about our
recommendation, to be efficient about our deliberation. That’s why we have the
guiding principles to help shape, and not that our recommendation is going to
be so tactical and operational, that’s why we want to put things that are
actionable but strategic, not for short term impact but longer term issues. I
don’t see anything beyond that because of the emerging changing convergence of
industry mandates and what not that have driven us to this, and it’s very

DR. WARREN: So I am still struggling with some of the things that Walter
said. What he said made me rethink the difference between the themes and the
principles. It seems to me that when I listen to Walter’s description, the
themes are the way that we make sense out of our work. We use those to identify
deliverables. We use the principles then to decide which of the deliverables we
come up with need to happen first. We prioritize.

Given that notion of how this works, we need to keep our same subcommittees.
Over time they may change their names or whatever. Certainly that’s happened
before. Given what Marjorie said about the role that subcommittees have in the
structure of HHS, we don’t want to lose that influence or power. When I think
of task forces, I think of a very dynamic organization that’s agile, where
people come together, the leadership is shared, and the leader of each task
force chimes in to make sure things happen.

I still think that could be a good approach, when I listened to the people
who were at the meeting where these are coming from, that I think we need to
stay with our four subcommittees and then use these themes for us to make sense
out of our work. One of the problems when I first read these themes is I had a
lot of trouble with one and three. It seemed in some instances they were saying
the same thing.

In other instances, if they were different things, I was still struggling
about what fell into what category. I’m comfortable with where we are. I do
think we need to think about what these themes do for us, and maybe relook at
some of the guidelines. We might want to really spiffy them up to help us truly
set a priority. Some of the words that are in the guidelines are also in our
themes, so decide where they should be.

DR. WALKER: I think this is a good framework. I have three comments. If
appropriately scaled, that’s guideline eight, I think that’s a recurring theme.
It seems to me that an operational definition of “appropriately
scaled” would be big enough to matter, small enough to be manageable, and
deliverable within several months at the outside. We need to think in terms of
phasing. It’s like the unified framework. We should put something out — spring
isn’t too early. It’s obviously not the last word.

I think phasing is a key part of that, picking things, getting them done,
delivering something that’s enough to be useful to whomever the audience is and
then if it needs more work, doing the next work. I think it’s good that we have
themes, and I think these are the right ones. I think that if we, and we’ve
already started talking about that, if we defined more carefully how the three
of them interrelate and strengthen each other, I think that would narrow them,
focus them, make them much more compelling. We’ve already started going that.

Subcommittees and teams, I think subcommittees make sense besides the
trouble changing them. I think it would be useful to think of them as
experienced skill sets that know how to work together. We always need to have
them. They obviously have all kinds of functions that are continuing functions,
but I think we also want to be able to say, right now we’re going to double
down and do whatever it is for four months or six months and we’re going to
make a team of these two subcommittees or some other conglomeration of things
and they’re going to drop everything they can drop for the next six months and
work on this cross cutting, this cross cutting theme. I think we can do both
and do it really effectively.

DR. CARR: All right with that, I always think there’s another way to say it,
but I never fail to be inspired by the wisdom around the table. Thank you all.
Walter, good start, and we’ll do our work for this afternoon and tomorrow
morning, and we’ll have a chance to revisit this tomorrow afternoon.

MS. JACKSON: As a logistic, in order for this to work, we’re just using this
one room for all of our sessions. Be respectful for all the sessions that are
after, coming before and after, we can always chat after the session is over.
We’re trying to get straight to standards and from there straight to privacy.
Same thing for tomorrow morning.

(Whereupon, the meeting adjourned at 3:30 pm)