[This Transcript is Unedited]

Department of Health and Human Services

National committee on Vital and Health Statistics

June 11, 2014

Hubert Humphrey Building
200 Independence Avenue, SW, Room 705-A
Washington, D.C. 20024

TABLE OF CONTENTS

P R O C E E D I N G S (9:00 a.m.)

Agenda Item: Call to Order, Welcome, Review Agenda

DR. GREEN: Good morning. I want to welcome everybody to the next NCVHS
meeting. It is so wonderful to see reinforcements from yesterday. Amazingly
enough I think most of the folks from yesterday may be back. It was more like a
marathon than a meeting yesterday. I think Walter was saying that we got out of
here at about 6:40 last night. We are very grateful to the spectacular
presenters that conducted a graduate course yesterday. Some of you are back
still playing professor here and keeping us going here.

I have some quick housekeeping things. One is to fill out any updates on
your conflict of interest form and turn it in. Also, we discovered yesterday
that physics does apply and there is a thing called interference from these
microphones and your cell phones. It will be really helpful if you keep your
cell phones off of the table.

Again, for the record, I want to note that we actually met virtually since
our last meeting face to face. There were actions taken there that have been
recorded. We will go back over and wrap those up and emphasize them later in
the afternoon.

Otherwise, the agenda is pretty much structured the way that it usually is.
I want to remind all committee members that we hope everyone will be able to
attend the portions of the meeting that are organized and operated by our
subcommittees. Let’s turn left here to Jim and run the table and introduce
ourselves and explain our conflicts of interest.

MR. SCANLON: Good morning everyone. Jim Scanlon, Deputy Assistant Secretary
for Planning and Evaluation at HHS, and Executive Staff Director for the Full
Committee.

DR. STEAD: Bill Stead, Vanderbilt University, member of the Full Committee
and co-chair of the Population Health Subcommittee. No conflicts.

DR. MAYS: Vickie Mays, University of California Los Angeles, member of the
Full Committee, member of the Populations and the Work Group and no conflicts.

MR. BURKE: Jack Burke, Harvard Pilgrim Health Care in Boston, member of the
Committee, member of the Privacy and Security Committee, and member of the
Population Health Committee. No conflicts.

DR. CHANDERRAJ: Raj Chanderraj, member of the Full Committee, no conflicts.

DR. WHITE: Jon White, AHRQ, liaison to the Committee, no conflicts.

MR. ALBRIGHT: Matthew Albright, Acting Deputy Director, Office of E-Health
Standards and Services sat CMS.

DR. GREEN: Are you masquerading as Todd today?

MR. ALBRIGHT: I am. Do I look like Todd. I don’t have his hair.

MS. MURPHY: Judy Murphy, ONC liaison to the Committee, no conflicts.

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

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

DR. WALKER: Jim Walker, Siemens Corporation, member of the Full Committee
and the Population Health Committee, no conflicts.

MS. KLOSS: Linda Kloss, Health Information Management consultant, member of
the Full Committee, co-chair of Privacy, Confidentiality and Security. Members
of the Standards Subcommittee and no conflicts.

MS. GOSS: Alix Goss, Pennsylvania eHeath Partnership Authority within the
Commonwealth of Pennsylvania. Member of the Subcommittee on Standards, member
of the Full Commmittee, and no conflicts.

DR. SUAREZ: Good morning everyone, I am Walter Suarez, Executive Director at
Kaiser Permanente. Member of the Full Committee, co-chair of the Standards
Subcommittee and no conflicts.

MR. SOONTHORNSIMA: Ob Soonthornsima, Blue Cross and Blue Shield of
Louisiana. Member of the Full Committee, Subcommittee on Standards, no
conflicts.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC,
still having fun as Acting Executive Secretary.

DR. GREEN: Do we have anyone on the phone.

(No response)

DR. GREEN: I am Larry Green from Denver, Colorado. I have no conflicts.

MS. MILAM: Sallie Milam, West Virginia Health Care Authority, no conflicts.

(Introductions around the room)

DR. GREEN: Okay one other item of business before we turn to Jim. I have got
a deal for all of the committee members. You just won’t believe this. At no
extra charge, you can join the Standards Subcommittee. They could use another
member. There is plenty on their plate. There is no indication that there will
be any change in pace.

Linda, Ob, Walter and Alex, you are teed up now go after them.

DR. SUAREZ: We do offer full benefits and a safe environment.

(Laughter)

DR. GREEN: Leslie, welcome. Who are you and tell us about all of your
conflicts?

DR. FRANCIS: I am Leslie Francis. I am from the University of Utah. I have
no conflicts.

DR. GREEN: We are going to manage to a 10:45 break. We are going to have the
Jim, Todd, Judy, Joy and Rachel show, or approximately that. Jim is going to
start us off.

Agenda Item: Updates from the Department

MR. SCANLON: Good morning, everyone. It is a pleasure to be here again. Let
me update the committee on a number of activities that have occurred since we
met in February. We have new personnel in HHS, new leadership. I am going to
talk about that, where we are with some of our policy and planning and
programmatic initiatives, some of our data initiatives and projects. I think we
have time on the agenda later today to discuss the requirement of the ACA
related to a review committee which the Department is asking NCVHS to tact that
capacity, but we will talk more about that later.

As you all know, we know have a new Secretary of Health and Human Services,
Sylvia Mathews Burwell. She was sworn in as the new Secretary on Monday. She is
right at work and getting updated on a lot of issues. In ASPE, we have a new
Assistant Secretary for Planning and Evaluation who was sworn in on Friday,
Richard Frank, who comes to us from the Harvard Medical School where he was an
economist and a health services researcher. We are happy to have him as well.

In terms of our planning and programs I have a quick update. As I mentioned,
we updated our strategic plan, the HHS-wide Strategic Plan. It covers the
period of 2014 to 2018. All of our other strategic plans will be aligned as we
go forward with that. We posted it on the HHS Website. As I mentioned, there
are four overall goals and 21 objectives. At the break, I will send around the
summary of what they are.

Each of the objectives is accompanied by metrics to see how we are doing and
a strategy for how to do it. In addition, we released version II of our Open
Government Plan, which is posted on our HHS Website. That deals more with
initiatives in innovation, data transparency. Some of our health data
initiatives are included there. At data transparency, we include the health
data initiative, data liberation. Of course, the committee plays a major role
in advising the department. The committee is mentioned in that Open Government
Plan as well for advising us on some of our open data and data access
initiatives.

As I mentioned before, in addition to the overall Strategic Plan, the
department typically develops strategic plans and initiatives in specific
areas. They all align with the Strategic Plan, but they are separate and go
into more depth. For example, tobacco control, HIV infection, reducing and
controlling healthcare acquired infections, reducing minority health
disparities, the National Equality Strategy, the National Prevention Strategy.
We have an initiative in global health and a newer initiative for safe
prescribing for reducing opioid overuse, morbidity and mortality. In the Human
Services area, it is early childhood health and development. There are a number
of others as well.

As I said before, we try to ensure that each of these Strategic Plans has
clear objectives and metrics so that we can tell where we are. Then our office
and ASPE operates a strategic planning system for the leadership and HHS where
all of these major high visibility plans are included. We try to align all of
the objectives and measures and track these plans as well.

For the budget we are now in the third quarter of Fiscal Year 2014. Congress
is considering the President’s Fiscal Year 2015 Budget at this very time. As
usual, we start our Fiscal Year 2016 Summer Budget planning process. We are
always looking ahead as well.

Quickly on health reform, you all know we completed the first open
enrollment period for the ACA. We published the enrollment data for the whole
period. ASPE published the month by month figures. Now we put together an
overall report for the whole period, which is up and on our website as well. We
were using administrative data largely supplied to us by CMS from the
healthcare.gov website as well as some of the states that run their own
state-based exchanges.

In terms of measuring and monitoring the progress of ACA, in the data area,
anyway, we have two dimensions. One is the reliance on administrative data to
see how we are doing. The second is on population survey data. The data that we
published on enrollment is based from the standard simplified application. It
included enrollment by mental level, by age and gender and so on. We actually
published one report that had a bit of information on race and ethnicity as
well. There was a lot of non-response to those items on the application.

For the 14 or 17 states that run their own exchanges, we have less
information that we have to rely on for what they report to us. On the survey
side, again, we should have estimates from the National Health Energy Survey
for that first quarter of the year, January, February, and March, coming up
from the early release. That should be available. I think we are planning
September. That will be the first glimpse from a National Probability Survey of
what the enrollment looks and what the insurance coverage profile looks like
and so on. We will be looking at that later in the year.

Just as an aside, you remember that a number of foundations and other groups
that run telephone surveys, web surveys and other sorts of things, they publish
their estimates in the meantime, month by month. You have to have very large
sample sizes to be able to do a month to month change in insurance coverage. A
number of those surveys ultimately they have very low response rates and
ultimately they are not necessarily probability-based. Nevertheless, they are
publishing them and they seem to show where health insurance is going and so
on. We will see how it all comes together in September.

I think I mentioned previously we have made enhancements to most of our
surveys to monitor the implementation and the impact of health reform. We
continue to work with the Census Bureau and our major survey agencies here to
look at what we are planning to publish ultimately from a health report.

We have very good news at least for HHS and users of HHS data. This is long
in the making. We now have a NCHS Research Data Center here at Humphrey. It is
in ASPE, but we are calling it a HHS Research Data Center. Remember when we
released data some of it was public use. It can be made available literally
without conditions of the very small.

Then we have various dimensions of restricted use. We can have data that can
be given to you for research purposes after review subject to a data use
agreement. We have other even more restricted approaches which require access
only through a designated agency research data center, in which you submit an
analysis request. It is done under very secure conditions. No one ever gets to
see individual records and you walk away with your analysis. You don’t walk
away with any records. We sort of have the full spectrum of data release here.

The NCHS Research Data Center is one of those where you walk away with the
analysis. You don’t walk away with any records. CBO has already gotten three
jobs in there. We are trying to find out what they are up to. HHS downtown will
be using it as well.

I wanted to mention that OMB has launched an initiative. I think many of you
have heard about this. It is on making better use of administrative data that
the Federal Government holds for statistical purposes. The statistics agencies
like the Census Bureau and some of other agencies could really benefit. In
fact, the Census looks at ways to actually substitute administrative data
ultimately for what the decennial census would look like, having access to a
variety of administrative data.

Such data can often be used for sample frames and research survey frames as
well as for linking. We have all linked Medicare claims data to our survey and
research projects as well. We have used data from Social Security, the
Continuous Work History File as well as the Debt Master File, and the National
Death Index. We have use data from agriculture and the supplemental nutrition
program. We haven’t actually cracked IRS; that is a tough area to get.

The idea here is to take a renewed looked at administrative data holdings of
our federal agencies and to put together the statistics agencies as well as the
programmatic agencies and put everyone’s heads together to see if there are
opportunities for cost savings, for efficiencies and for enhanced analysis by
using some of the administrative data, where the privacy and the programmatic
statutes permit that. In a sense, it is within the government operation for the
moment. The link data could ultimately be made available under secured and
restrictive circumstances as well.

We continue to look at data that we might need for measuring the health and
the impact of programs and policies on vulnerable populations generally. I
think we did our standards earlier which expanded the potential for information
on race ethnicity, on primary language, on disability and so on. More recently
we are trying to improve data on the LGBT population.

We are in the process of adding additional questions to a number of our HHS
surveys. We will be at the point where probably half a dozen or more of our
surveys will include questions on sexual orientation. Other vulnerable
populations are the disabled population and rural populations and minority
populations as well.

I mentioned this before. We are in the process of updating the data in our
Health System Tracking Project. We will be moving it to a new platform that is
a little more user friendly in the months ahead. There we have five or so
measures. The goal here is to monitor some indicators in the health system to
see how we are doing over time with the various policies and programs that are
now in place.

The domains that are included are Access to Care, so there are five or so
measures in each one of those areas; Cost and Affordability; Insurance
Coverage; Quality of Care; Vulnerability Populations; Health Workforce;
Innovation; Population Health Prevention and Health Information Technology. So
we have at least five measures in each of those areas. This is a public facing
website, so you can see. We update the information as soon as the agency
produces it for that time.

I will highlight what I talked about previously and then I will talk about
some of our projects. About a year and a half ago, the HHS Data Council was
asked to look at our Portfolio and our plans for data collection activities and
to see the areas where we could improve access, improve turnaround and improve
availability and so on. The Council put together a data strategy, which I would
be happy to brief the committee on by the way full-time to get your feedback.

One of the goals was to address all of our high priority data gaps in a
coordinated fashion. The second focus was on primary data collection. It is
very expensive. Response rates are falling. The data is never available when
people really seem to be asking for it. We looked at areas under the general
rubric of research and development and technology that we could apply some
newer technologies to some of our HHS data collections. This would include
web-based data collections; there are telephone collections, and obviously
health records.

We had a number of projects developed under that initiative. Many of them
are in the nature of piloting some of this technology for some of our surveys
and research. For example, we are working with a National Health Interview
Survey to see if we can’t develop a web-based component of this survey.
Clearly, you could not have an entirely web-based survey now given the
representative that has access to the technology. There are ways to fit that in
and other technologies and turn around things quicker.

Most of our agencies now have programs where they have improved the release
time. It used to be two years. They are probably with a year or less now.
Several of them have early release programs that are six months, quarterly data
within six months of the quarter. That is what we using for the Health
Interview Survey. We are looking at other areas as well.

The third leg of the stool was on the theme that the committee has been
using as well. It is how do we align and integrate these various data sources
and resources so that we are moving forward in a way that enhances them all and
provides data that we can actually use and can we pilot that.

Here we are looking at how we align our survey data, surveillance data,
research data, administrative data and what will increasingly become available
through EHRs. How do we plan? What sort of framework do we need to be sure that
as we move forward on each of those they are cognizant of the others? Standards
and conventions help a lot here as well as timelines. We started on that. I
think the committee is using this as the same concept here as well. In that
regard, we are engaging in several pilots.

An example: How can we use the fruits of electronic health records for our
healthcare surveys, the emergency department survey, the ambulatory care
survey, hospital discharge survey and so on? So we have a number of pilots
going on now.

We are trying to get beyond that it is more than a proof of concept. It is
assuming for some part of the issue that will work and we are now trying to
actually do that in partnership with NCHS. We have also looked at where there
are primary care research networks that are agency-sponsored and others that
have VHRs. We are looking at how we can use those resources to do research and
surveillance.

One area is on hard to reach populations. A second one was on small
populations. For example, several race ethnicity subgroups that would be hard
to reach generally in a survey or a study. Those are going along. I think we
are about to publish the roots of that latter study on our website.

Of course underlying all of this is what good is the data if nobody gets it.
The whole idea of data availability and dissemination is probably one of our
highest priorities. Many of you were at the Datapalooza. There were a lot of
interesting things there. It is really progressing nicely from the first one
where many of you attended to now where we are beyond the graduate student
stage of projects and we are into the adolescence and even beyond in some case.
There were some very nice activities there. HHS has published over 1000
datasets and tools on healthdata.gov, way beyond any other agency. We continue
to identify datasets and to do so.

Quickly, I will just mention a couple of projects that we have in the works
now. I think I mentioned previously that we are trying to track the low income
population and how the population fairs in the era of health reform and other
initiatives. We are using MEPS and Health Interview Survey there. We are trying
to add a large sample of about 1000 additional low income households to the
MEPS that we would follow over time. In addition, we created a longitudinal
component to the MEPS insurance component where they go to insurance plans and
get a survey of the plans themselves. We even a state there I think.

We have a project in the works with NCHS with the Healthcare Division there.
It is really looking at transition to ICD-10. Here, we are not looking at how
the bills get paid and how the reimbursement changes. There, the idea is
looking at does the move to 10 from 9 changes, how does it change our
population health indicators, so our health profiles, our health data, our
health statistics. We are just starting that with NCHS. It will involve coding
information from probably the Ambulatory Care Survey both ways in doing the
analysis and see how it might change. That is an interesting one as well.

We have added a number of a large group of community health centers as well
to our Ambulatory Care Survey at NCHS. We have a good look at how that fits in.
We were asked to look at the impact of the Affordable Care Act on public health
on two areas, on public health service programs, the community health centers
for example or the breast and cervical cancer program at CDC. These are service
programs. They provide screening. Sometimes they provide follow-up and
reimbursement as well.

As the insurance coverage expands and Medicaid expansion occurs as well, and
insurance is the source of a lot of the reimbursement how does that affect our
grantees both as providers and as economically as well. We have a project going
on there. In addition on the public health side this is based on case studies
and states and how ACA and other developments in health policy are impacting
state and local health departments as well. There is a lot of concern in the
public health community about how this all fits together and what the role of
public health should be. We are generating some studies and some original data
there as well.

We were also asked to look at within the public health sphere if there are
ways to improve the linkages between the public health communities. This would
be the state and the local health departments and the clinical community for
greater potential for integration. Let me stop there, Larry. We will talk later
about the request from the department for the committee to consider designation
as the review committee and ACA, but I think we have reserved time.

DR. GREEN: Questions for Jim? Obviously, there is nothing going on. There
are no changes. Vickie?

DR. MAYS: First your presentation as usual, is exciting, particularly in
terms of thinking about becoming a data center and also in terms of a lot of
the alignment issues. One of the things I wanted to remind us about is that
when we did the hearing on social economic data, we had several recommendations
of ways to bring these the stat agencies together to improve the data. That may
be there in thinking about some of the actions to take.

MR. SCANLON: We had discussion at the Data Council. It turns out for some of
those demographic items; we were actually very close to a standard. There was a
small amount of variation. Income was a little harder because some of these
income levels are defined very specifically in the program. I think on the
other demographics we are very close as a practical matter to having a standard
at least in the conventional way to do those demographics.

Some of the others where you are asking about risk behavior, smoking
cessation or alcohol or substance abuse or things like that and different
people seem to ask that differently. There are recommendations for how you
would do it depending on what you wanted to know.

DR. GREEN: I think I can speak for the whole committee. I suspect the whole
committee would appreciate it if you would extend our welcome to Secretary
Birdwell and to Richard Frank. It is nice to have them aboard and have people
in those positions and wish them well for us.

DR. SUAREZ: I have a quick comment. Is there an opportunity to have a
meeting with the Secretary in terms of introducing NCHS to the Secretary?

MR. SCANLON: I am thinking of that, Walter. We are in the process now of
setting up briefings on everything she has to deal with in five days, 10 days,
and 30 days. We were thinking briefly about the committee and maybe have her
come to another meeting. Maybe we can have the committee member chair visit
here as well. That is definitely in our plan. We just have to get it on our
calendar.

DR. GREEN: Matthew?

MR. ALBRIGHT: Thank you full committee for this opportunity to brief you. I
would like to give a pitch for the recruitment to the standard subcommittee.
Yesterday was very exciting. There were many debates and many controversies. I
think that is a good thing. I think it is excellent that we are hearing
opposing sides and that we are in controversy because that means people care.
It is a very exciting place to be. There are lots of exciting decisions to be
made. I would echo that is great place to get your feet wet.

I would like to talk a little bit about leadership changes very quickly.
Some of you met Todd Lawson yesterday. Todd is our new Director of the Office
of E-Health Standards and Services. He is replacing Rob Tagalicod now at the
Department. I am the acting Deputy Director under Todd. Most of you probably
know Denesecia Green. She has been kind of leading the ICD-10 charge for CMS
and for the industry. She is now the Director of the Administrative
Simplifications Group. That is like the new squad.

I would like to say we heard a lot of good news and bad news yesterday. Some
good news that we have been hearing is a couple of weeks ago we had an E-Health
Summit. CMS had an E-Health Summit. This was the fourth over the past year or
year and a half. These are listening sessions where we invite industry
representatives and associations in to talk about E-Health issues. These
particular all-day sessions, probably four panels, most of them were on EHR,
Meaningful Use and Quality issues.

There was on session on Administrative Simplification and Operating Rules.
We had two health plans and a provider, a hospital organization. There were
some great anecdotes about the administrative savings for those particular
entities that came about through the implementation of Operating Rules. For
instance, one of the health plans talked about two years ago they were seeing
90 million requests over a six month period of eligibility requests.

Now that the Operating Rules have since been put into place, has doubled for
them in the last two years to nearly 200 million. They said it was a tremendous
savings. They would not have been able to handle that kind of manual workload
of 100 million for eligibility through the telephone. The hospital said the
other end of that which was they are doing many more eligibility request which
clears the pathway for a clean claim to make sure that a claim is paid with
less denied claims. They were able to take three or four of their personnel
that are usually in administrative work and shift them to providing healthcare.

Anecdotes: Unfortunately, we don’t have good data on broader ROI across the
industry. This is the work of this committee. This is the work of the
discussions and the controversies and the recommendations of the Secretary. I
think we all deserve a little pat on the back.

The other thing is we talked about unintended consequences of regulations
yesterday. An interesting unintended consequence of the EFT under the ACA and
under the recommendation from this committee, the healthcare payments, we
standardize the form and format in which a healthcare payment is paid
electronically. We worked in coordination with no NACCHO, the financial
institutions. It turns out that one of NACCHO’s complimentary rules that they
added on to the Operating Rules was that all originators of healthcare payments
had to label their payments as healthcare payments.

Now, as of January, we are getting a monthly report of the dollar amount and
the number of healthcare payments that are made electronically on a monthly
level. The numbers are staggering. I have no idea what to do with this data. I
am in a roomful of data wonks, so if anybody wants this? It is interesting that
the Operating Rules just went into effect for NACCHO in November and for HIPAA
in January. They have seen a 30 percent increase in healthcare EFT payments.

I was very excited when I first saw that. I am not a data guy. I thought
this means 30 percent more providers are using EFT to pay. It is really that 30
percent more are implementing the operating rules and are following the rules.
Still you can see that increase and I think we are going to continue to see
that increase. There is some data that somebody out there has got to be
interested in. These are interesting numbers. I will summarize what Todd gave a
briefing on, some of our admin-Sim regulations and some of our work there.

Certification of Compliance: The proposed rule came out earlier this year.
We thank the industry and you all for your comments on that. We expect a final
rule later this year. ICD-10, as you are probably aware, April 1, 2014 set the
date back one year. HHS expects to release an interim final rule in the near
future that will include a new compliance date that will require the use of
ICD-10 beginning October 1, 2015. It also clarifies that up until October 1,
2015, ICD-9 will continue to be used.

Attachments: There was a very interesting conversation about attachments, if
you could follow what it was. We all learned a new word, “no flavor.”
Try asking 31 Flavors for that. It is our opinion at CMS and the Office of
E-Health Standards of Service that there is still significant work to be done
in all standard areas related to clinical attachments.

We do not feel that attachment standards even on the messaging level,
operating rules or clinical document station levels are mature at this time or
ready for adoption as national standards for clinical attachments. We will
continue to work with NCVHS and industry to achieve consensus on a national
standard and utilize processes established by NCVHS and HHS regulatory
processes at the appropriate time, as we consider the adoption of an attachment
standard. We said at the beginning of the day yesterday and it kind of echoed
where that conversation was during the day on attachments.

Health Plan ID: I think we might have heard a little bit about that. We are
expanding our outreach in education to help health plans and other stakeholders
to think through those key concepts with HBID enumeration. We posted a number
of webinars. We developed frequently asked questions and blogs. We can say the
same about the EFT issues that we talked about yesterday. We believe our role
is enforcement in education and we will continue to do that.

Dr. Green talked. I think it was circling all of the conversations yesterday
of that convergence between administrative data and clinical data. One of
OESS’s other roles is the implementation of the Meaningful Use Incentive
Payments for Medicare and Medicaid. We have got some hot off of the press
statistics. As of June 1, nearly 95 percent of eligible hospitals have
registered for incentive payments, the Medicare or Medicaid Incentive Programs.
Ninety-one percent of all of those eligible hospitals have been paid something.
Seventy percent of eligible professionals have registered for incentives. About
70 percent of them have received incentive payments. To date, June 1, nearly
400,000 eligible professionals have received incentive payments.

One of the more striking stats that came out yesterday was that only eight
eligible hospitals have attested to Stage 2 at this time. To that point, CMS
and ONC, Office of National Coordinator, are working on a rule. The proposed
rule would let providers use the 2011 Addition Cert or a combination of the
2011 and 2014 addition of the Cert for the EHR reporting period in 2014 both
the Medicare and Medicaid EHR incentive programs. So that rule came out May 23,
2014. The comment period for that rule closes July 1, 2014.

In addition, the other thing that OESS is working on is a proposed rule on
Stage 3 for Meaningful Use for the EHR Incentive Programs. That is currently
under development. We are hoping publication is expected probably in the fall
of 2014. That is it for me. Thank you very much for this opportunity. I will
take any questions.

MS. KLOSS: In the interest of getting some metrics on the impact of the
administrative simplification, would there be a possibility of quantifying the
savings from that 30 percent and starting to trend that as a way of building
the argument and the results of these changes? It seems to me that we could
have a whole set of metrics from these new standards as they go into effect.
That could be useful.

MR. ALBRIGHT: I think the EFT is a good example of that. I would also point
to CAQH which took over the Healthcare Efficiency Index. I am not sure of the
dates on that, but they are going to look very carefully at that electronic
versus manual use of each of the transactions. If we tracked that metric
according to dates, I think that would some very interesting data.

MS. KLOSS: It may be something that the Standards Subcommittee could look
into and see if we can’t build a case to continue the momentum.

DR. CARR: I think looking ahead to next year’s report to Congress; this is a
very important piece to begin to flesh-out to tell the story. When we did the
tenth report, we talked about if only we could connect the dots. I think this
is one other piece that we have connected. We should be able to demonstrate the
tangible efficiency or return.

I think we should keep going on that theme in the report to Congress. Even
though it takes a few years, connecting all of the dots is going to get us
there. Each year, with this kind of progress and all of the hard work that was
done when the ACA first came out is now really showing returns. I think it
would be a great segue from that report.

MS. PRITTS: I want to make sure the committee had their chance to raise
questions. I did want to point out one issue on the EFT. It is just like a
yellow flag. There has been a lingering question since 1996 about what rules
actually apply to financial institutions when they are processing EFTs? The
more that they get involved in managing the data, the more questions it raises.
There is that carve out under HIPAA.

There has been a long controversy over what those carve outs actually means
and the extent to which financial institutions do or don’t have to abide by
some of the rules on Use and Disclosure. We have received some of these
materials in through clearance. We haven’t skated right up to that line yet
where it is going to become a real problem.

I just wanted to raise the issue. It is something that we need to be looking
at in the future of some of the things that have already been addressed in the
EFT. I just wanted to make sure as we are moving forward that we keep that in
mind. Linda, you are shaking your head. That issue has never been resolved, has
it? That is a no for those who are listening in.

MR. SOONTHORNSIMA: There is concern because industry is trying to monitor
the adoption of it and trying to understand if there are any abuses out there
or excessive fees. To your point, I think that is between financial institution
and health plan providers and trying to wrestle out who are really governing
this.

DR. CARR: I remember that we did talk about this in the hearings that
summer, fall or winter, whenever it was. We should look back to see what we
said. I agree. I think it is something that fits very much with what we are
already doing and what we have done.

DR. SUAREZ: I am not sure that it has been resolved and there is a definite
answer to it. It is operationally functioning right now. The concepts are if
the financial institution is a routing mechanism just like Verizon is routing
all of our electronic health records and exchanges then it is a conduit. In
some instance of the financial institutions they do capture and translate and
transform some data potentially. There are questions to what extent those
financial institutions become in contact directly and manipulate or manage
health information.

Where does it get maintained? Who handles it? How does it get disclosed? Are
they associated? All of those questions become important? Yes, that is very
good.

MR. ALBRIGHT: So I think that is an excellent point. It falls under the
rubric of medical banking. It is worth having a whole session on medical
banking. Clearly, the financial institutions are getting very involved in
payment, billing and remittance. You are right. We have actually skirted around
this one. We found with the EFT standard that it wasn’t our problem yet because
it was very clear that this was payment information. It fell on very clear
lines.

I think we even said if a banking entity or any entity acts like a clearing
house and actually goes beyond that and generates the remittance advice or
anything like that then clearly they are a clearinghouse. We didn’t get much
pushback on that. What is coming though is some of the more efficient kind of
payment processes like a standard which joins the payment and the remittance
advance that you can shoot through the financial institutions at the same
place.

These will be tremendous efficiencies, but bring up everything that you are
talking about. Then you are really having the banks. Fed Wires got a standard
that can do that. ACH, NACHHO has a standard that can do that. We are headed
towards a place where that discussion absolutely has to take place.

MR. SOONTHORNSIMA: There are actually real issues today around health
reimbursement accounts, for example. I don’t think there is an efficient way of
doing that today in the industry. FSA, HSA and HRA, especially HRA have
reimbursement account. That is where you see the joining of claims and is
typically is handled by a financial institution. That has been around for years
and hasn’t been resolved.

DR. GREEN: I realize that it doesn’t connect directly, but we have got to
deal with the information flowing through the health insurance exchange and
adjudication of that and the verification of it, non-HIPAA covered entities.
This is really straight-forward and really simple. No issues here.

DR. SUAREZ: Maybe jointly we can work between the privacy and security work
and standards.

DR. GREEN: Anything else? Judy, it is nice to see you.

MS. MURPHY: Thank you. I am following the vein of the simple. I am going to
cover the things that are on the screen right now. There have been lots of
other things going on of course since we last met. I thought these are the
things that I would focus on. I will talk a little bit more about the EHR
Adoption Statistics, the Vendor Certification Status. JASON Report, PCAST
Report and the Interoperability Report were released just last week by ONC.
There is a new Health IT Dashboard following up on the Open Data Initiatives.
Then I will talk a little bit about our functional realignment within ONC.

So this is where we are standing. I have used this particular graphic
before. On the left-hand side are the professionals. On the right-hand side are
the eligible hospitals. Where we are at with the professionals right now in
terms of those who have been paid either from Medicare or Medicaid is 70
percent. These are the statistics as of the end of April. Then again there is
up to 88 percent with those who are registered with the denominator of about
537,000.

On the right side, there are total eligible hospitals. We have paid 91
percent, either through Medicare, Medicaid or both. The total number of
hospitals registered is 407,027. Again, the hospitals continue to do better in
general than the professionals, but you are seeing clearly a good tipping point
here.

In terms of the dollars that are paid out, again, as of the end of April, we
are up to 23.7 billion. It is lots of money that has been paid out. You can see
the month over month on here as well. This is an interesting graphic that was
used yesterday at the Policy Committee that I thought might be interesting to
those of you. What is important here is the definition that you probably can’t
read at the bottom. The categories are Hierarchical and Mutually Exclusive,
meaning if an eligible provider fits into one of the categories they then are
subsequently eliminated from the subsequent categories.

The dark blue, the 59 percent have attested to meaningful use and received a
payment. The next percentage, the 15 percent have only done the AIU part or the
Medicaid part, which is the Adopt, Implement and Upgrade. That is not where you
are actually demonstrating meaningful use, but you are on the journey. You have
purchased EHR and you are in the throes of implementing or upgrading. Again,
you can see this is a little bit of a different way of looking at that simple
threshold that was on the thermometer graphic before.

Then that first orange, 17 more percent are registered for the EHR Incentive
Program. Then we have a small slice that is not yet registered for the program.
They haven’t been paid, but they are enrolled with a Regional Extension Center.
The idea is they are at least interested and they are participating. These are
the professionals now. There is only 3 percent that are pretending this isn’t
happening.

Really, this tells a different story than that 70 percent on the previous
slide. There is a level of engagement here at different kinds of thresholds if
you will. Definitely everybody has got us in gun sites, us meaning the
implementation of electronic health records.

If we go to the next one I have absolutely no idea how you do this in Excel,
but I was so intrigued by this graphic. I actually had to bring it here. This
takes a while to digest. I am not going to go through the gory details. I do
believe we provide these slides to folks if they want to dig down later.

Basically, what this shows is for those who attested in 2011 and what
happened to them in 2012 and then what happened to them in 2013. When they
dipped down into the orange they are actually leaving the program. If they come
back up into the green, they are coming back into the program. Again, if
anybody knows how to do this in Excel, let me know and I will it to somebody
else.

What is intriguing is we did have a dropout of folks in their attestation in
2012, but a good chunk of them actually came back. The percentage there was
that 16 dropped out, but 7 percent of them came back in. Rest assured that we
are tracking this for the purpose of understanding where the pinpoints and
there are issues that people don’t understand or need help in the program
itself. I love this graphic to make sure that we are explaining that.

This is exactly the same information that Mathew talked about. The only
difference here is that in the little graphic, in the upper left-hand corner
there, it shows week over week. I think that is important. We are starting to
see a trend. This is those folks who have implemented 2014 Certified Electronic
Health Record System Code. The threshold was that you had to at least get that
code installed. Then this year you use it for either Stage 1 or Stage 2
attestation.

The columns are broken up by out by the eligible professionals, State 1, who
are on that code. Eligible professionals Stage 2 are on that code and that is
where that number 447 is an important one. That is how many eligible
professionals have already attested to Stage 2 on new 2014 certified code. If
you look at the number right below that 252 it doubled in one week. I hope this
is a trend that we are going to start to see that folks are realizing that this
is doable and accomplishable.

In the two columns for the eligible hospitals, interestingly, the hospitals
are not doing quite as well. You will see we are still dealing with a
single-digit number when it comes to Stage 2. Again, I am a little bit
heartened that it went from 3, 4, 7, and 7 to 8. Okay, I get excited about
small things.

On the right-hand side it is just showing the graphic of that. The red is
the Stage 2 and the blue is the Stage 1. Do note that the scales are different
in the two, so don’t think that they are equal. The hospitals are lagging
behind. The scale is a much smaller scale. I think we are seeing some positive
movement.

In terms of certified products, those that are certified for 2014 are 940.
Again, we are getting the critical mass. There was a lag in actual vendor
certification. We are seeing that it is a lot better. An interesting note on
this, those eligible professionals at 447, we do know what vendors they
actually are. That dataset is available for anybody to look at. We don’t really
advertise that on the ONC or CMS website, but we know that.

One of the things I will say is a lot of those early attesters are on
cloud-based solutions. So they are on the newer technologies, those that have
common code that is accessed wherever you happen to be using that electronic
health record as compared to a traditional legacy model where you install the
software in a local instance and use it. The different kinds of products that
are available especially for eligible professionals I think have really been a
boon for the industry.

If we go to the next slide, 2011 certified products continue to be quite
high. I will remind you of a statistic. I should have looked up the exact
statistic. It is in the 30 percent of the products here that have never been
used for attestation. Although we have a lot of products that got certified at
2011, some large percent of them have never been used for a provider, either a
hospital or professional for attestation.

I was going to talk about the NPRM. Beth Myers from CMS yesterday at the
Policy Committee had some interesting slides in terms of really differentiating
the options that are available now for attestation at Stage 1 and Stage 2. If
the NPRM goes through there are three different sets of options. It was a good
way of clarifying. I wanted to point you all to those slides and show you them,
if you all could point to those too.

I think there some confusion right now about what you are allowed to do in
2014. The long and the short of it is that NPRM talks about the fact that you
do not now need to attest to Stage 2. If you are having some issues with your
vendor in getting your code installed, you actually have the capability of
using the Stage 1 certified code and actually selecting either the 2011 Stage 1
criteria or the Stage 2 criteria. We will see if I can show that to you in a
minute.

Again, because lots of folks look to you to try to understand this, if the
NPRM goes through, again, I will remind everyone we are in the comment period
right now, for Stage 1 here are your options. This year you can attest on 2011
code. You can attest on a combination of 2011 and 2014 code or you can be on
2014 code.

Correspondingly it then points out for folks to understand what their
options are right now. If you go to the next slide at Stage 2, you actually
have some of the same options. The barrier that folks were concerned about was
the ability to get their vendor code. We are hoping that this NPRM if it is
approved and goes into regulation it would actually relieve some of that.

These slides were also stolen shamelessly from the Policy Committee
yesterday from Jon White. JASON Report folks, have you heard about it? I just
wanted to point you to it. I am barely going to talk about it other than to say
if this isn’t on your radar you might want it to be on your radar. It was a
report that was sponsored by AHRQ in collaboration with ONC and the Robert Wood
Johnson Foundation. JASON is actually an independent science group that
provides consulting services.

I have a couple of key findings on the next slide. It is pretty much about
the technology and interoperability. I know that has been a word that we have
talked about here quite a bit. If you go to the next slide, it talks about two
key recommendations in terms of thinking about what ONC can do in terms of
helping with an overall architecture and then moving the EHR vendors along.

This is particularly important because we have talked about interoperability
being a bit of a building block and having options. This starts to talk a
little bit more about defining the architecture more clearly and not letting
1000 flowers bloom, but creating a garden maybe with rows. Again, it is a very
interesting report. If you want to look at our website under the Federal
Advisory Committees and the Health Information Technology Policy Committee,
there are probably about 20 slides out there that John used yesterday. There
are links to the reports as well as Karen DeSalvo’s blog is listed there.

There was a follow-up PCAST report to the one that was published in 2010.
This came out in May. Again, the link is at the bottom here. If we go to the
next slide, I just pulled in one slide summary and conclusions. This particular
one is really about how we need to be looking toward systems engineering. It is
focusing on better care at lower cost; this is a theme for those of you who
follow the IOM reports. Certainly, it is has been something we have been
talking about since that IOM report in 2012. For the sake of time, this is more
to peak your interest so that you go and look at the report if you haven’t
already. It is much more digestible than the first one that came out in 2010.

If we go to the next slide, again, shameless advertising about a release of
the ONC vision for interoperability. I have a link to both the report and Karen
DeSalvo’s blog about the report where she highlights why we are doing it. By
the way, I know she is coming tomorrow. If you are having a dialogue, this
might be something that you would want to ask her about. This is very near and
dear to her heart. It is fairly high level, and it is actually not all that
long. It sets out goals for three, six and ten years in this space of
interoperability.

I wanted to advertise the fact that the Health IT Dashboard has had a major
renovation. There are all sorts of new pieces of information out there along
with the open data in government aspects. There are probably those tab things
that you see there, those three, if you scroll down on this particular home
page there are probably 50 of those. There are all different kinds of data
briefs, different graphs, and different datasets that you can download,
different graphics of the United States where you can drill down by state and
even by county in terms of the Meaningful Use Data. If you haven’t spent the
quality time on the Dashboard site, you might want to do that as well.

I will wrap-up on my last slide. Again, if you are following things that are
going on in Health IT, you probably know that we have had a restructuring over
the last couple of months in terms of the Health IT Policy Committee and the
Health IT Standards Committee and their work groups. Some of have been sunset.
Some have been created. Some have been sort of repurposed. There are a new set
of them. There are 12 of them now. Some are cross between the Standards and the
Policy Committee. Again, I knew I wouldn’t have time to go into the gory
details, but just to let you know that that did happen.

Also, over the last couple of weeks, the ONC has had a functional
realignment and a flattening of our organization where we now have 11 offices
and all of those offices report directly to the immediate office, which are
both Karen DeSalvo and Dr. Jacob Reider. Again, I didn’t want to have a
specific graphic related to that, but just know that that happened as well. If
you have questions about that you can certainly ask Karen as well.

MS. MILAM: This may be a question for Joy as well. Let me pose it to you.
You mentioned the certified EHR providers and a lot of the newer ones are
cloud-based. In my experience, in dealing with other cloud services, the
vendors will offer a variety of packages from the consumer to the enterprise to
government. You get different controls in these different packages.

Have people looked at the kinds of controls with cloud-based services and
given recommendations to the professionals or the hospitals purchasing them so
that there is a standard well beyond what is required in HIPAA like the detail
in terms of what you need for security with cloud-based services. What is a
minimum in terms of a business associate agreement, but beyond that and what
you have to look at when you make that purchase?

MS. MURPHY: That is a really good question, and I will turf it to Joy. I
know she is looking at it.

MS. PRITTS: Cloud-based services are one of the things that are on our
agenda of things to look at. There is not agreement as to the “best
practices” in looking at those items now. It is not one of those things
that either OCR or ONC could just come up with a list. It is an item where
there will need to be work done to gather information.

As you know, HIPAA is scalable and flexible. It does allow some degree of
range in those services. Most services recognize if their name is on the front
page of Yahoo or something like that on the Internet for their data breaches
that is not a good thing. There is a lot of awareness for many of these
providers. They need to have very strong security pieces in place. Having said
that it would be very good for providers to have a little bit more information
about at least the questions they should be asking.

As we have seen in much of our other security work that work really needs to
be done primarily by IT security specialists. The providers, even if they ask
those questions won’t necessarily know what the answers mean.

MS. MILAM: It is a complicated discussion even around non-EHR products.

MR. SOONTHORNSIMA: The real challenge that we are dealing with today is when
you have comingled a dataset, when you have a multitenant environment. Most of
the EHR vendors are multitenant. When there is a breach you have to be
transparent. The challenge is when you are in a multitenant environment you
don’t really know where the breach occurs. Let’s say you have 100 practices
sharing that environment. Does that mean that all 100 entities have to announce
that there was a breach? How do you hone in? Those are some of the gray areas
that everybody struggles with.

MS. SEEGER: I will of course get into this during my discussion. It is so
important to move past the risk analysis, the simple documentation, a potential
threat and risk using something like a cloud server to actually going forward
with the risk management. What we are seeing is a bit of disconnect. When we do
go out and audit or we do go out and investigate many covered entities have
taken the steps to document what the potential risk is, but have not gone ahead
and executed on those threats and hazards. Risk management is just critical.

DR. CARR: Your jump up on hospitals on meaningful use is probably going to
jump up in about 2.5 weeks. You had to wait for delivery of the software and
then you’re 90 days. You can count at least six coming up.

MS. MURPHY: So for those of you who aren’t tracking that we are moving into
the last quarter in that you have to do a quarter’s worth or three months or 90
days of measurement. That is what she is alluding to.

DR. SUAREZ: A great summary. One question that has always been in my mind
about eligible professionals is that in this country we have about 1.3 million
physicians when it comes to licensed practitioners. This is true for many
physicians who have passed away; they still have active licenses by their
family.

When you take out that and you take a number of other duplicates perhaps on
certain specialties that maybe are not eligible, maybe cosmetic surgeons, we
still are about half a million physicians below when it comes to your max of
eligible physicians of 537,000. Where is the hole in the rest of the physicians
in this country in terms of being eligible to participate?

MS. MURPHY: We get those numbers from CMS. I am not trying to say I don’t
know, but I don’t. A good chunk of it is related to the thresholds that have to
be met for the Medicaid or Medicaid participation. That wouldn’t account for
all of them. I suppose if you add that with the specialists and everything, we
painstakingly come up with that 537,000 number and it varies. It changes
dynamically month over month when this data comes out. It is pretty much based
on data that we get from CMS.

DR. GREEN: Let’s set up the tents and then let’s keep the transition going
over the Joy. Raj?

DR. CHANDERRAJ: I saw a lot of laughs when you said only 3 percent think
they are not aware of what is going on. I think the 3 percent are the smart
physicians who refuse to take the payments and refuse to see Medicare patients.
The cost involved in implementing the EHRs is so expensive they are willing to
take the penalties that they have to pay rather than assume the cost. I think
you will see a trend more of the physicians falling out of the CMS data.

Physicians I talk to in the community feel onerous Meaningful Use 2
requirements. They take the incentive payments for Meaningful 1 Use, but they
are saying no way will they go to the Meaningful 2 because the vendors are
imposing such prohibitive costs on them that they cannot afford it. Unless you
see the government allows them to be reimbursed more money, I think you will
see more physicians falling out.

It showed only 16 percent falling out and 9 percent coming back. You will
see when Meaningful Use 2 comes into play; there will be more and more
dropouts. A lot of independent providers, people who are part of a hospital
chain or a large group, they are willing to assume that because companies
company’s afford it. Individual practitioners are dropping out.

DR. GREEN: Alex, you may want to sculpt this and correct this, but it became
apparent in yesterday’s meetings that there is a real credibility issue. That
came up over and over again. The icing on the cake was the ICD-10 delay and the
cost associated with that in both directions. Also, around this upswing of
adoption of Meaningful Use and EHR things is now we have got.

Then there was this intense disappointment about what that EHR can actually
do that helps clinicians practice medicine. I think we need to heed your on the
ground sense here that these statistics may not be all that they appear to be
and that there very well may be some interesting times around the corner. I am
sorry to mouth-off. Jonathan?

DR. WHITE: The mid-team’s chunk of eligible providers that had achieved AIU
have they received a payment as well? I thought so. I wasn’t totally sure. That
is it. Thanks.

MS. MURPHY: I think somehow Meaningful Use became like the end rather than
the means to an end. That program wasn’t meant to be if you meet Meaningful
Use, you are done and done and your life is good for the next 20 years. It was
really more to get the infrastructure in so that we could do the things that
you all were talking about at the beginning of the meeting. It is the floor and
what we need to have in place so that we can do the analytics so that we can
understand best practice so that we can become a learning health system.

No matter what happens to the Meaningful Use Program, I certainly hope that
we don’t lose track of the fact of what automation can do for us and even think
about going back to the paper record kinds of things. If we could separate that
conversation in our heads from the “Meaningful Use Program” to
automation of health care and why we need to do that. They are not mutually
exclusive; they overlap, but this is where we need to be going.

DR. GREEN: Judy, that is well-said. Don’t you think there is a parallel
process with the re-design of primary care practices? PCMH Standards suddenly
became the end in themselves. There were practices that could get a checkmark
in all of the boxes, but they still practiced medicine the same way and they
weren’t transformed. There are parallels there. It is really about building the
infrastructure and the payment models and the information models and the
design. It is a transformation that we are after here. Jim?

DR. WALKER: I want to propose a slightly different way of categorizing this
issue. There is some number. I think it would be neat to know what the number
is. I have never seen it. Maybe nobody knows it. There are a certain number of
eligible providers for whom the new world was never a smart business
proposition and could not be made a smart business proposition. Those people,
if they are smart business people, will practice the way that they practiced 10
years ago or 15 years ago, until it becomes untenable and they retire. That is
just what they are.

There is everybody else who is younger and can probably string this out 10
to 15 years or something like that. If you can’t retire in 15 years then you
have to live in the new world. Or as we said, if you work for an organization,
which is becoming the dominant model, which is a large practice in integrated
delivery networks, some kind of very large organization for whom sophisticated
information systems and progress redesign and a whole set of things that go way
beyond EHR that are expensive pay for themselves. They pay for themselves at
large scale.

That is the question. How many people do we lose and how fast because they
have made a rational choice and said they were going to do it the old way until
they can’t do it anymore. What does that do to workforce? What does that do to
access? Then how rapidly is all of the rest of the world becoming an employee
of one of these large organizations for whom this is all just ho hum. It is
like voice. You have telephones. Nobody gets all hysterical about whether we
are going to have phones or not. You expect them to work and you expect them to
be cheap.

DR. FRANCIS: This is a question about the NPRM. What are we losing by
allowing the flexibility of the different 2011 combo or 2014? Is this another
example of people are having a hard time getting where they need to be so we
are really just putting things off again, but paying people anyway?

MS. MURPHY: The biggest difference between Stage 1 and Stage 2 is in the
space of interoperability, both in transition and care documents being
exchanged between providers and in the ability to view, download, and transmit
from providers to patients. Those are the ones that the providers are having
the hardest time achieving. That is what we are losing.

DR. FRANCIS: So the 2011 folks won’t have that.

MS. MURPHY: Correct.

DR. WALKER: No we are not losing anything. All of this did its intended job
which was to get all of this started. What is going to drive this forward now
is market demand. There are big organizations with thousands of locations
around the country who are getting killed by the cost of interoperability that
is now just handwork. That is a huge market opportunity worth billions of
dollars. It will be solved by the market. Standards can be usefully created to
make this faster and smoother. I don’t think we are losing anything.

DR. GREEN: So Joy and Rachel, I would like to do both of your presentations
one right after another and see if we can build a wall around this committee to
not pepper Joy with questions. Then we will pepper you with questions together.

MS. PRITTS: Given the time constraints we have, I am going to try to give
you a very brief overview of the status of what we have been calling Data
Segmentation for Privacy Initiative. With this time limit, I know we have a
number of new members on the committee. How many are familiar with the
background of this? Should I do a one minute? Okay, we will get you the longer
version.

Before I get into the details, I would like to do a little context setting.
This is the ability to share information and what choices patients might have
with sharing that information and how technically you are going to be able to
do that. It has been on the table since before this committee. I think I got
involved with this committee back in the day in about 2000. It has been around
a long time and it is a very naughty issue.

As you all know under the HIPAA Privacy Rule, provider’s may use and
disclose information for certain core purposes such as treatment, payment and
healthcare operations without the individual’s expressed consent. That alone
was controversial when the rule was written. Under the statute, HIPAA
establishes the framework for how preemption and how federal law interplay with
state law happens.

Under the statute and the rules, HIPAA says laws that are more privacy
protective for health information remain in place. That means if you have state
or federal laws that actually require that the patient’s consent or express
permission be provided before their health information is exchanged. Those
rules remain in place.

Where we are right now is we have HIPAA as it was intended to be the
baseline of privacy protections across the nation. We have many state laws that
committee has reviewed in the past that provide additional protection because
they require patient permission to exchange certain types of information, many
of which would fall into what people call “sensitive information”
because we all know that varies from individual to individual.

There are also a few federal laws that protect certain types of information.
One of the primary ones is the statute and the regulation that protects the
confidentiality of information that is generated by certain types of behavioral
healthcare providers, in particular those who provide substance abuse
treatment. An issue, which I would note, for those of you who read the paper
closely, has really come back to the forefront in the last year with all of the
increasing use of heroin. That itself is a fascinating issue.

The requirement exists at the statutory level in the federal realm for
patients to be able to give their expressed consent to share their substance
abuse treatment information. If they give that consent, the protection of that
information flows with the information. There is a notice that must be given
along with that information that the recipient can’t re-disclose it without the
patient’s permission. There are many state laws that are very similarly
structured. The protection pretty much follows the information and the provider
has to give notice of how to do that.

The issue that we have seen developing is that as health information
exchange is taking off, this information that is being generated, particularly
by behavioral healthcare providers and other providers who focus on this
“sensitive health information” is being excluded from the systems. As
a technical matter, it has in the past been somewhat difficult to do this.

We had a hearing back in 2010 before the HIT Policy Committee where we had a
number of different organizations that mask or protect data along these lines.
They came in and told us what they were doing. There were some back in 2010
that were using technology. It wasn’t aligned. There weren’t standards. We
heard from the Policy Committee that ONC needed to do more work on policies and
standards. That is what we did.

We have been focusing on the technology primarily and not the policy. The
reason we are doing that has been very intentional. What we are trying to do is
ensure that providers are able to implement these existing legal requirements
in an electronic environment. We have been focusing. The term has come out Data
Segmentation for Privacy. I did not invent that term just so you know. I know
people don’t know exactly what it means. The idea is that you can send some
health information, but not all health information related to a patient.

We have been focusing in our technical efforts on this, primarily on
substance abuse and behavioral health for two reasons. The first is there is a
very clear intent from this administration to enable the integration of
behavioral healthcare information more in primary care. We recognize that. The
other one is a more practical consideration, but also I think a very important
one. One of the reasons we are encouraging adoption of electronic health
information technology is to help reduce costs. When you are looking forward
you have to ask yourself if you can really afford to exclude the 20 percent of
the market that many people say is responsible for about 80 percent of the
costs from health information exchange.

Given that, we initiated the Data Segmentation for Privacy Initiative in the
Standards and Interoperability Framework. It would take me an hour to go
through the whole history of everything that we have done. The long and the
short of it is where we are now is after having a public/private initiative
where the private sector drove what they wanted to address, how to address and
what standards existed and how they needed to be massaged in order to work
better together, this is where we are. The initiative has pretty much come to
an end. They developed a set of standards. What they do is they tag data.

In the pilots that were conducted, it was done at the document level. The
focused on using the CDA document because that is a document that is very
integrate to achieving Meaningful Use. There are three major types of metadata
that are associated with this. I am not the technical expert on this. If you
are getting that far down into the weeds, we will have to get somebody else to
help you with how they technically accomplished this.

The Confidentiality Codes convey how the information has to be handled. At a
very high level they didn’t want to disclose that this is HIV information, or
this is substance abuse information outside of the document. So it says this
document is restricted or it is not restricted or it is very restricted. It is
kind of a generic coding so that it can be used across multiple types of
information. It has a section of it for purpose of use say treatment, emergency
treatment and obligations, including not re-disclosing without consent.

The pilots utilized these standards and they finessed them. At the end of
the project, the results of the pilot were fed into HL7 and IHE, both of which
are standard setting organizations. HL7 has developed an implementation guide
for these. These are the detailed standards that have been incorporated as part
of data segmentation for privacy for those of you who are technical.

In essence where we are right now is these standards were tested. They were
piloted. The Implementation Guide was revised a couple of times. They are now
what they call normative standards, which means they were voted on by the
standard setting organization. They were approved at the highest level. Just
last month they were approved by ANSI as an accepted standard. So we have the
standards in place.

The standards that the standard setting organization set go beyond what were
used in the pilot. They actually facilitate tagging at the document and the
section level. It is good because it is flexible. It is something that is
beyond what was tested really in our pilots. That is where we are.

I want to tell you a little bit about the pilot just so you know how these
were used. We had six. I am only going to focus on two given our time. One of
these was a Netsmart Pilot. It was undertaken in Florida. They worked with a
lot of behavioral health providers to do essentially transition of care
documents to community care providers or community network services.

They have a 211 system there where they will refer somebody for housing or
for other kinds of services. They were transmitting information from behavioral
healthcare provider to somebody outside of that system. They were able to do
that with the data tagged as required by law when they sent it.

They reported at the Policy Committee Hearing out on their pilot
accomplishments. The hospitals that utilized this system actually saved
millions of dollars because they were able to get the records electronically to
the community health centers two weeks quicker than they were doing in a paper
format. They are live. They are not a pilot. They have implemented. They are
using this in their day to day business right now.

There was also a VA SAMHSA pilot. The primary piece I would like to point
out here is that they are moving on to the fire standards. They are looking
forward. They used different ways of sending the information and making sure
that this works not only through a direct exchange but also through the direct
protocol, the other types of protocol.

To show the industry reaction, we have had at least one major vendor that
purchased one of the pilots during this process. They have reported that the
behavior health solution has data segmentation for privacy using direct
incorporated into production for spring this year. They are moving to be able
to share that information with what they call their hospital solution, their
Cerner Millennium Solution later this year.

That is where we are with the pilot. The next step we have is that this
issue has come up before the Policy Committee. We now have some standards. We
now have some testing in pilots that have been accomplished. ONC, as you all
know is contemplating expanding its certification program to voluntary
certification for ERHs for behavioral health and long-term and acute care. Of
course, the aim of this is promoting exchange of data with primary care
providers.

For behavioral health certification the question came up. They were looking
at the different components that might be required for certification. Of course
data segmentation came up and should you require this for certification of an
EHR product that you are going to be marketing. People would be marketing to
behavioral healthcare providers. The long and short answer is yes, but.

The Privacy and Security Tiger Team actually put a ton of thought into this.
They came up with a glide path for how they thought this should be approached.
They thought their needed to be two components. You needed to look at not only
the behavioral healthcare component but also the general EHR component to make
sure that the recipient would be able to use the information when they received
it.

As you can see from this chart, they have listed everything from level 0 to
3 where they think we need to head on this. They see as the initial step on
this including level 1 for Meaningful Use. These were recommendations that were
presented to the Policy Committee yesterday so they are brand new. I won’t go
into all of the details because of time, but they are included in these slides.

Overall, I would say an item that should be of most interest to you is that
they made a recommendation. They think this is a direction we should be headed.
It will next go to the Standards Committee for assessment as to whether these
standards are ready.

DR. GREEN: Let’s keep going with Rachel. We will plan on taking our break
between 11:00 and 11:15. We will still preserve an hour for the HIPAA.

MS. SEEGER: So before I get started I should mention that we have had some
significant change at OCR. Our longtime Deputy Director for Health Information
and Privacy, Susan McAndrew, retired at the beginning of May. Christina Hyde
who is our Senior Advisor for Health Information Privacy Policy is acting for
her. She has both jobs right now. Work continues as always.

Today we publicly released our 2011/2012 reports to Congress. As you may
know these are both required under HITECH. One of these focuses on breach
notification. The other focuses on the status of compliance with the HIPAA
privacy, security and breach notification rules. We have been very busy with
respect to compliance and enforcement. We now have 21 settled agreements that
include very detailed corrective action plans as well as monetary settlements
and one case that has resolved with a CMP.

As of yesterday, we have well over 1000 breach reports affecting 500 or more
individuals with 116,000 reports of breaches affecting fewer than 500 people. I
will talk about audit a little bit more in a few slides. As you know we have
completed Phase 1 of our audit program. Now we are in the planning stages of
Phase 2. We do have a notice out through the Federal Register of our intent to
survey covered entities and business associates regarding the next phase of the
audit program.

Recent enforcement highlights: There are over $8 million worth of them, New
York Presbyterian and Columbia University most recently. These are one of those
joint relationships that we were talking about earlier where we have a medical
school with a teaching hospital associated with the two different entities that
share the same network. We had an employee here of Columbia University, a
physician and app developer, who attached a rogue server onto the network of
New York Presbyterian.

Both covered entities new this was a high profile project. Both covered
entities knew that his Rogue server existed. They had documented in their risk
analysis the potential risk of server attaching onto a network and didn’t do
anything about it. Then there was an incident and a disclosure of information,
where the patient’s information was publicly accessible on the internet on any
search browser.

This resulted in a 3.3 million dollar monetary settlement for New York
Presbyterian and 1.5 million dollar settlement for Columbia University. This is
our highest HIPAA enforcement action to date. For the purposes of time, I am
going to skip down to Concentra. This is a large covered entity that has a
number of different healthcare functions that they perform throughout the
country.

Here we had a stolen laptop that was unencrypted. It is just the basics of
what we continue to see all over. This laptop was left visible in the
employee’s care that went into a sports bar. They came out and low and behold
the laptop was gone. While we did receive a breach report affecting greater
than 500 individuals for Concentra there were 16 breach reports affecting fewer
than 500 individuals for Concentra. They were what we call a frequent flyer. We
went out and conducted a compliance review on this entity. Again, this resulted
in over $1.7 million monetary settlement and corrective action plan.

In fact, our regional offices are very aware of who these frequent flyers
are. We see them a lot. We do actively look at these breaches that come in
annually affecting over 500 individuals and multiple breach reports coming in
for the same entity. What we are really seeing through audit and through these
enforcement investments is a pattern, lack of risk analysis and risk
management.

The risk analysis might have been done in 2005, but it has never been
followed up. There are no new policies or procedures when new mobile devices,
for instance, are implemented. Then we also see a lack of security and control
on portable devices. These are the unencrypted laptops, the stolen mobile
devices, the tablets.

Proper disposal continues to be a major issue for us. My inbox is blowing up
right now with press queries. Spring cleaning just happened evidently and
people are going out to dumpsters at recycling centers to dispose of whatever
they have got. They look inside and what do they see, thousands of medical
records.

This is like an epidemic right now across the country. Again, there is a
lack of proper disposal of medical records, lack of access control, simple lack
of training of staff, lack of understanding of the rules, lack of senior
leadership attention to those rules and an overall lack of a culture of
compliance.

Audit and what is to come: More robust enforcement and audits are coming
from OCR. We are in the process right now of revising our audit protocols to
reflect the changes from the Omnibus Rule. Then you can expect to see business
associates being included in our next round of audits. Again, this is a process
that is very much in development.

What ONC are doing to try to educate the covered entity and business
associate community about their obligations: I thought ONC was going to give an
update on the security risk assessment tool that they released a couple of
weeks ago. It is outstanding. We worked together collaboratively on it. It
definitely is a good refresher for covered entities who are looking to dust off
their initial risk analysis. Perhaps they have never conducted a risk analysis.
It is a great place to start.

We also collaboratively with CMS to develop a new Medscape Module and this
brings us to six. This on EHRs and HIPAA, Steps for Maintaining Privacy and
Security of Patient Information. I wish that Leon looked happier there. I could
go on and on talking about this, but in the first month of its launch we had
over 13,000 learners with close to 5000 test takers. That is in a month.
Overall these modules have had almost 140,000 learners with about 40,000 test
takers. They really are doing quite well. For the sake of time, I think I am
going to wrap-up. I know there will be lots of questions for Joy.

DR. GREEN: Okay we are going that way, guys, just keep passing it to the
right.

MR. SOONTHORNSIMA: Rachel, since you talked about the changes to the rules,
the disclosure rule, we just talked a little bit about cloud-based solutions.
There are more of those out there now. That is going to be certified. Are there
going to be changes around the process of breach disclosure when it comes to
off-prem multitenant? I am not sure these vendors are ready for any of those.

MS. SEEGER: Even when we began to roll out as a department enforcement of
the HIPAA privacy and security rules. We really did so in a phased approach,
trying to bring about voluntary compliance through technical assistance. I
think cloud is really the new frontier. It is going to take some time for those
vendors to understand their obligations under the rules and also for covered
entities to work with their business associates and the vendors downstream on
these obligations.

We are working in collaboration with NIST, the National Institute for
Standards and Technology. I should mention towards the end of October, we will
be hosting our Annual Cyber Security Conference with them here in D.C. I
anticipate more guidance will come on this issue. I do think when it comes to
enforcement we are really looking to the basics of the rules right now.

I would say the majority of our last enforcement actions that have risen to
the level of monetary settlement have all focused on this lack of the basic
risk analysis and the lack of risk management processes, the lack of policies
and procedures, especially with Stage 2 Meaningful Use. It is so important to
have these basics in place and have it be a regular part of the organization’s
activities. You are not just having your binders up on the shelf. It is really
part of the process and part of conversations that you are regularly having
with your vendors.

DR. SUAREZ: A quick question for each of you. Joy, to me this is one
component with larger contextual element or domain, which, in my mind is the
whole spectrum of E-consent in general. It deals with how to not just consent
for disclosures generally in specific states, but also to do more granular
things like segmentation. Could you say a few words about where things are with
respect to that?

Also, one of the interesting things about data segmentation for privacy it
highlights the need with a specific federal regulation 42CFR Part 2. When it
comes other state regulations, one has to do some specific consent. Then that
data has been consented and disclosed but only for certain purposes. When you
give it to another provider in another state that other provider in that other
state is subject to other less stringent laws. That other provider might not
acknowledge or necessarily abide by the requirement at the first stage. Can you
talk a little more about the E-consent concept in general?

MS. PRITTS: So we recognize that what many people are doing with respect to
consent now is essentially faxing or using a computer to essentially
electronically send a PDF of a consent form. That is not sustainable in the
long-term. We recognized this issue a while ago. We conducted an initial pilot
with the Western District of New York looking at some means for capturing
consent electronically and sharing it. That material is available on our
website. We also recognized that there are a lot of different mechanisms out
there right now for capturing consent. Some of them are electronic and some are
not.

We are committed to looking at consent from a technological perspective in
this upcoming year and exploring it more. The way we normally run most of our
work in my office is we do a landscape analysis first to see what the current
state is where there are issues, what people are doing and where we think the
most work needs to be done. That is not something that we can do alone. We need
to talk to a lot of people in order to assess that. That is where we pretty
much are with that. We have looked at it.

ONC has looked at that E-consent issue as you know in the past at the state
level doing a lot of pilots and things of that sort to see things that work
with people and things that don’t. One of the key components of that is making
sure the individual actually understands what it is that they are consenting
to. We see education as being an integral part of that whole process. I am glad
you mentioned that, Walter.

The work that we have been doing on this is just really part of all of the
work that we are doing in consent. There are a lot of issues that exist with
respect to this. I know that there has been a lot of pressure from some to
change all of these state laws.

Where we are with that issue is when the Congress considered changing the
preemption framework in HITECH which was in 2009, it expressly came out and
said they were not changing that. I would like to tell people that we can
progress or we can spend all of our time fighting about that issue. It is what
it is now and we are trying to operate within those confines.

DR. SUAREZ: Quickly to Rachel. This is a very quick question. Can you give
us a status of the accounting of disclosure?

MS. SEEGER: I don’t have an update at this time.

MS. KLOSS: Mine is more of a statement. This is an advertisement for the
full committee. We have asked Walter to help us follow-up on this topic of data
segmentation at this afternoon’s breakout meeting for PCS. We want to dab a
little deeper into it. We really ask the question if there is any work that our
committee might do on this having looked at the sensitive data issue in the
past and now looking at what the stewardship issues are beyond HIPAA or some of
the community uses of data. These issues are highly relevant. We are going to
send more time on this topic today.

DR. FRANCIS: Could I just add to that? For new committee members, we went
through a very long, laborious process crafting a data segmentation letter that
really focused on legal requirements. I think it was a very helpful early
document in getting this. It is very nice to see what developments have
followed.

MS. GOSS: Walter, you are spot-on in talking about the larger E-consent
issue. That is why I put my card down. Coming from a state perspective where
our provider community wants us to become HIPAA-aligned. Our state has some
more stringent rules than the federal rules, but the federal rules still play.
Yet, the HIT Policy and Standards Committee is really focused on rules related
to EHRs for Medicare and Medicaid. We still have a huge gap in issue that needs
to be solved in respecting the diversity of citizen opinions about data-sharing
and enabling good quality outcomes. This is a huge issue. It is a painful one.
I will stop there.

DR. CARR: I echo that. I have two questions. One, do you have an inventory
of what these state rules are? Secondly in your pilots is there an assessment
of the utility of the clinical information once it has been filtered through
the segmentation as required both by federal and state rules.

MS. PRITTS: I am going to answer the last question first because it is
shorter. When you look at this chart that they have in here about the Stage 0
through 3, they are really only at Stage 1, which is what they did find useful.
It was to send a CDA document in a document form that was tagged very high
level, which they dealt with partners they were very confident would know how
to handle the information. They did not incorporate that information into an
EHR.

There was a long discussion of that in one of the health IT policy committee
workgroups. We had probably 9 to 10 hours of discussion on this. That is one of
the things that informed the approach that they took. That was taken into
consideration in the recommendations our Privacy and Security Workgroup made to
the Policy Committee and that they adopted.

Yes, they are aware of that issue. They were looking at that issue. That is
why they were taking very small steps. Having said that they also recognized
this was very useful for the people who work in this area to get that first
step of getting that information in the electronic form to the people who
needed it as quickly as possible.

Do we have a list of all of the state laws? Yes and no. One of the important
things to recognize is states like the federal government regulate in a very
sector-specific way. I know this very painfully because I have conducted this
survey about two or three times now before I ever got to ONC. They have
different laws and regulations that apply to MDs and to hospitals.

Depending on what state you are in, you can have a different regulation that
applies to just about every different kind of healthcare provider. Most of
these rules are under the licensing laws. There is still on our website a
survey that I did when I was at Georgetown in 2009 that focused on medical
doctors and hospitals.

I think there might have been one other category. That was the only way to
scope it and make any progress. We dealt with some of the major categories of
information. It is a very complex area. Some of it isn’t in licensing laws.
Some of it is under the public health law. It is very difficult to even know
where to find this information sometimes.

MS. GOSS: Joy, shouldn’t we be able to get that information from all of the
HIE Cooperative Agreement Reports since we had to all track to the National
Framework for Privacy and Security? Having led the initiative in Pennsylvania,
we had to dive deep into that and use the great tools from HISPAC to do it.

MS. PRITTS: I would say there is variability in the reporting on that.

DR. CARR: Thank you for all you done so far and keep at it. We all know how
difficult it is and we appreciate it. It is the asynchrony as you move to get
Meaningful Use 2, you can find yourself at an intersection of this topic that
you were talking about today.

DR. WALKER: Rachel thanks for your important and great work. The fundamental
issue in this is not ignorance. It is not lack of training. It is not that this
is complicated. It is that it costs money to do it right. You are doing a great
job, but you can only do so much to make the cost of not doing it right closer
to the cost of doing it right. I just wonder if it is committee’s role.

Can you think about any other ways that we could create incentives or
disincentives for doing this right? Could there be a voluntary association of
high reliability care delivery organizations who would say these are best
practices that we commit ourselves publicly to follow.

Are there other things? Could JC do anything? Could payers have any role in
providing incentives for organizations that protect security? I think if it
were part of our role, I think it would be useful for someone to think of the
other parts of this besides the one thing that can never do enough to make it
expensive.

DR. GREEN: Leslie, you get the last word.

DR. FRANCIS: This is a related question. Is there any work going on about
sharing civil monetary penalties with people who have been harmed?

MS. SEEGER: Yes, that is in the statute. Currently we are working on a
process for how to make that happen.

DR. FRANCIS: Would there be any interest in having any help from us?

MS. SEEGER: I can certainly take that back and get back to you.

DR. GREEN: Mathew, Judy, Ob, Joy and Rachel, thank you very much. Walter and
I will reconvene us in 9 minutes.

(Break)

Agenda Item: Eleventh HIPAA Report to Congress —
Submitted for ACTION

DR. GREEN: Okay we are going to reconvene. Do we have any new attendees on
the phone? Walter?

DR. SUAREZ: I suppose the first thing I should say is we are very excited
that HHS now has HHS visitor Wi-Fi. Anybody who wants to join the Wi-Fi worked,
you can click there and go to the various networks that you can see. One of
them is going to be called hhs.vistor. There is no password or anything. It is
just a protected and secure access to the internet. We are back in the
21st Century here.

I am very excited to present to you all of the work that has been done. I
went and actually checked the first time we presented the outline of the graph
of this report. It was September 3 of last year. Our September meeting we
introduced to the full committee our draft of the outline of what would be the
11th HIPAA Report to Congress. Since then, there has been a flurry
of activity over the last nine to 10 months, up to the point today.

Very briefly, to review the process, we created that outline. We started to
work with the subcommittee on the content. At the November meeting, the Full
Committee decided that this was really going to be a report from the committee.
We needed engagement of the other subcommittees. We actually have dedicated
sections for not just administrative part of HIPAA since this is a HIPAA Report
to Congress, but also the privacy and security. Then we added a special section
on standards and public health and population health. So we really have a
reflection our three major components of work of the Full Committee into the
report.

From November up until today, the three subcommittees have been working
diligently in developing the different sections of the report going through
much different iterations of drafts. They have all of the drafts compiled into
one single report. Then we distributed that to the entire committee for
additional feedback. We received a lot of very incredible feedback in terms of
detailed edits and corrections.

We still have a few more items to adjust in the report. Overall, I think we
have in front of you a very amazing report. I do want to acknowledge the person
who is sitting to my right. Terri has been our lead staff. She joined us in
February of this year. Terri just joined us not too long ago and we wanted to
immerse her into the work of the subcommittee with a little project called the
HIPAA Report to Congress.

She took that on. She really is the heart of this report. She put all of
these things that we were sending her in terms of content and elements into a
very easy to walk through and fill with references. When you think about all of
the specific citations of the specific things that we wanted to mention, they
were all there as references. This is actually another one of those reports
that can be published as a book.

In any case, we posted the final draft of the report on the NCVHS website. I
am actually going on our web to open it. This is the report that you all have
seen. This is the clean copy of the latest version of our report. I am going to
walk through a couple of things.

In the report, we have our standard cover and our cover letter is from our
Chair, Larry, to the Speaker of the House. The report goes to the various
committees named both in the Senate and the House named in the legislation to
be submitted that should receive this report.

We have page of the reference about the National Committee and the members
of the National Committee. Then in Appendix C, we have a full roster of the
National Committee members and then the table of contents. Really just to
remind or refresh, we have five more sections. We have an Executive Summary,
which we have shortened quite a bit. That is the good thing. We started with a
very long multipage, 22 pages Executive Summary. Now we are down to really
eight pages of Executive Summary.

We felt that the report itself, the part that everybody is going to read, is
Executive Summary. The full report is going to be a detailed description of all
of the things in the Executive Summary. That is really the context. The
Executive Summary ideally is one page long or two at the most and bulleted. In
this case, the Executive Summary becomes more of the actual report if you will.
Then the rest of the report is really the details.

The main sections are Administrative Simplification. We framed the report in
2012 and 2013, so by December 2013 is what we were reporting. Things that
happened after December 2013, we tried to avoid putting a lot into it. There
were two major things that we wanted to bring into this. One of them happened
just before December 31, 2013. The other one was significant enough to really
reference it; at least that is an editor’s note.

The two things were public health hearing that we had in November which
produced a letter that we will be reviewing and hopefully approving next after
this report. What we wanted to do was to include in this report that key themes
and messages that we are now going to elaborate much more in the actual letter.
We wanted to connect the two and not just simply be silent on the public health
hearing and themes and findings and recommendations.

We included some of that in this report even though most of the work was
done in 2014. The second item was a little thing called ICD-10 delay which
happened in April as we all know. Because this report included hearings and
recommendations and advice on ICD-10 in pretty much all of the letters that we
sent to the Secretary they said not to delay and stick with the deadline. Then
we had to delay it.

We had an editor’s note included in the report, highlighting the fact that
in April Congress passed the PAMA. Somehow PAMA spells AMA in it. In any case,
PAMA is the law that created the extension for this new delay of the ICD-10. We
included a little note that said we are now under a new delay according to the
law. So we are going to be working on what the priorities are to do in-between
the time that we are now on the new deadline which was announced by the
Department of Health and Human Services to be October 1, 2015.

Rules are coming out about it. At least that has been formally announced. We
included those two items since that happened this year. Really the frame is
what happened in 2012 and 2013. There were a lot of things that happened on the
Administrative Simplification side. We had a lot of Administrative
Simplification activities happening, starting with the implementation of the
brand new standards including 5010 and D.0 and 3.0.

These are the pharmacy transactions and 5010 is a new version of an
Administrative Transaction that we are now implementing since January 1, 2012.
It is very much in time. We have adopted the standard for electronic fund
transfer. It has, as you have heard already, created a number of interesting
developments and perhaps unintended consequences about that.

Then we have the other standards that are in the works. Then we have the
entire operating rules world which came about because of the ACA and having a
provision that says now we have to establish national operating rule standards
to be followed by corporate entities. So we have a description of those and all
of the things that are happening with the three sets of operating rules that
are being developed.

The first one is Operating Rules for Eligibility and Healthcare Claim
Status. The second round is Electronic Fund Transfer Operating Rules and
Electronic Remittance Advice. The third round is the Status of Remaining
Operating Rules, the five transactions for which there are operating rules to
be developed such as claims, coordination of benefits, enrollment, premium
payment, attachments and prior authorization.

Then we have a section on codes, certainly ICD-10 was the biggest part of
it. Then we had a section on identifiers, the state of adoption of health plan
identifiers which was the biggest activity in 2012 and 2013 with some
adjustments to the national provider identifier. We highlight end to end
testing and then highlight some of the compliance and enforcement with the
Administrative Simplification provisions of HIPAA. That is Chapter 1, then
entire chapter around this topic about Administrative Simplification and
advancements in 2012 and 2013.

Chapter 2, Section 2, was Advancements in implementation of HIPAA Privacy
and Security Policies and Standards. This was developed by our Privacy and
Security Subcommittee. This covers basically the development since 2012
including the publication of the Omnibus Privacy Rule, highlights of some of
the remaining yet to be finalized activities including accounting of
disclosures, highlighting some of the things around HIPAA and the ACA with
respect to privacy and security.

Then a lot of the outreach activities were done by the department. Even
though there are a lot of things said here that are related to activities, the
department has implemented outreach with respect to privacy and security. A lot
of it has come out of the advice and work that has been done by the Privacy and
Security Workgroup. It was valuable to include all of this in this report.

Then Enforcement was another section that we had in each of our major
topics. So Enforcement of Privacy and Security was included. Here, it included
a lot of the various activities it highlights and the most significant cases
that happened in privacy and security.

The third major section was Standards and Population Health. Here we
highlight the two most significant efforts of our population health. The
subcommittee has worked on the Community Health Data Initiative as well as the
Public Health Data Standards which the Standards Subcommittee did with the
Population Health Subcommittee.

Our last section is the section dealing with a vision of the future. It is a
vision for the future of administration simplification and E-health. Here, we
took the opportunity to highlight some of the key themes that we have been
focusing on and identifying and working on related to this entire area of
administration simplification. Of course, the biggest one, with the
transformative changes that the healthcare industry is going through including
all of the healthcare delivery reform, the payment reform and all of the
changes under the ACA and all of the changes under the HITECH Act as well. All
of that transformation that we are going through implies that we need to really
transform the way we do business in healthcare and the way we are currently
doing business which is in terms of administration transactions. These are the
usual suspect transactions, the claims and the payments, and all of these
mechanisms. We need to begin to think about how they are going to be different
in the future as all of these transformations happen.

Data Stewardship is a major theme that we have been working on and the
conversions of clinical and administrative standards is another major theme in
terms of into the future. This wrote the roadmap for E-health. That is
something that we continue to hear is a critical element that we need to
continue to work on, particularly aligning and sequencing all of the new and
upcoming requirements around the administrative transactions and other things
that affect the people that have to comply with those requirements.

We also talk about E-health standards and Health Reform. Some of the
interrelation is between the entire ACA and electronic standards being used to
exchange data to support the ACA. Then we really measure success. The biggest
part of all of this, are we doing a good job of trying to understand if all of
the things that we are doing are achieving the ultimate goal of administrative
simplification. How do we quantify that? How do we monitor the achievement of
that?

We are going to be looking even more into the future onto that as we get
more specific into the task that the ACA provision called for which is the
Review Committee function that we will be looking at working on into the
future, measuring success and measuring the effect of all of these activities.

That is our report. The goal and intent today was more to go through the
general content and highlight some of the key themes as I just did. I do have a
redline document with all of the changes that happened. Ninety-five percent of
those changes were primarily editorial in terms of grammatical and
typographical changes really and corrections and things like that.

Then there was about 5 percent true content in terms of clarification of
certain statements, but none of the changes changed the core concept that we
have been documented in the report since March or April of this year. So you
have seen and you have reviewed the report. You have provided us with feedback.
I am now ready to turn it back to our chair to continue the discussion and see
if we can move it forward for publication.

DR. GREEN: So I am not serious, but I would entertain a motion to approve
it. We could just get going.

DR. CARR: This is an unbelievable work of brilliance. I think it captures
everything in it in an extraordinary way. I would just add on the
10th report that they sent it back because there wasn’t a wet
signature on it.

DR. GREEN: What constitutes a wet signature?

DR. CARR: They had to send it to Boston. I had to write it and send back.

DR. GREEN: I think we share a deep understanding of the complexity and
amount of work this represents. The floor is open for further discussion and
particularly attention to any details that are spotted that are incorrect or
unclear or say this doesn’t seem quite right to me. This is your opportunity.
We will start with Leslie.

DR. FRANCIS: I also wanted to add a thank you to Maya for all of her hard
work on the privacy part of it. In addition to that I went through it to try to
make it a little easier to read in a lot of places. You have my comments on
that. It is a tour de force, and for somebody who isn’t as familiar with it, my
guess is that it is not light reading. Let’s put it that way. Of course, it is
not supposed to be.

When I was doing that, I also noticed that we were a little bit cautious
about what we said about the ICD-10 delay almost as though it hadn’t happened.
It seemed to me that some comments being straight-up that this committee urged
that ICD-10 not be delayed in the past. It has happened, but there are some
clear issues about what a delay means. It might be a good thing.

DR. SUAREZ: This is specifically on the Executive Summary. This is the
statement that we added in April.

DR. FRANCIS: I think it should not be in the form of an editor’s note.

MS. KLOSS: The reason was sticking strictly to the timeframes. This report
was through December 31 and this happened after. We did debate it. Like you,
Leslie, I would have been diving right in with both feet to say that this
represented a setback.

DR. FRANCIS: I think the way the editor’s note should be crafted would be to
say we are not saying anything about that because this report governs the
earlier timeframe.

MS. KLOSS: It is because the timeframe.

MS. DEUTSCH: I was also going to say that perhaps what we have to do is add
a statement in that editor’s note that we will discuss in more detail in the
next report to Congress. This is capturing the period of October 2011 to
December. Then I think that will cover it.

DR. CHANDERRAJ: The fact that Congress overruled the committee and CMS
objections was that physicians groups lobbied Congress. I see a lack of
physicians representing in the committee hearings. We did not hear completely
the physicians point and perspective. That is why the physicians are so angry
that they went to Congress and brought about this delay.

I mentioned this several times. Not only the AMA but the sub-specialists
organization, the physicians that represent these organizations or the
organizations that represent the physicians we should have them come and
address the hearings here. They don’t come here, but they go to Congress.

DR. SUAREZ: Good point. Actually we have in all of our hearings about ICD-10
specifically invited. We have been fortunate to have the representative from
the AMA. In fact they were here yesterday too. Although AMA was meeting this
week and they were reassessing their current position regarding ICD-10,
reassessing doesn’t mean that they are reconsidering it. They are just deciding
whether they continue or not to have their same position.

As it was reported yesterday the AMA official position has been that they
are not in support of changing to ICD-10. That has been stated. It was stated,
and we reflect that in the description of the ICD-10 perspective. We did hear
two very distinct positions. One was relatively the rest of the industry
represented by health plan vendors, coders, and a lot of organizations saying
we are past the decision. We are already doing it. We are getting ready to
comply with it. Let’s keep the date firm. Let’s continue to push towards that.

Then we heard from two constituents specifically, AMA and GMA, representing
the American Medical Association and the Medical Group Management Association
with respect to their position about ICD-10. It was clear that they are
continuing to be in that position. It is so much so that they reflected into
Congressional action.

Yesterday during the hearing we were beginning to see some new possibilities
with respect to bringing the two perspectives together and trying to address
the issues and concerns that AMA has consistently raised about adoption of
ICD-10 and try to continue to move forward and maintain in some ways and
reinvigorate the momentum that we might be losing because of the delay. AMA has
consistently been represented in the hearings and we have reflected that
position in all of our views. They are two very different views.

DR. GREEN: I think Raj’s comments here are consistent with what we heard
yesterday about two things. One was the urgent need for robust educational
outreach to clinicians all across the country that just doesn’t have a clue.
They don’t accept the premise about why this is important. They don’t even know
what the premises are. We heard repeatedly that they just feel beleaguered.
They are tired and they are beat up. They are disillusioned with Meaningful Use
and what EHRs can actually do and all of that sort of stuff.

We heard a consistent story all day long yesterday about the need for
outreach from Medicare and HHS to the clinician community, particularly the
physician community to get a better pulse and blood pressure check about what
the heck is going on out there with this. It is a factor that Raj is pointing
out here for us. This is something that we probably ought to come back to help
understand what those perspectives are.

I believe what is in the report is accurate and balanced from where we were
in December 2013. I didn’t hear you, Raj, saying that you wanted to see
something changed in this report. I think you were just explaining why this has
happened. I think we would do well. Alix, what do you think?

MS. GOSS: I think there is also a theme from yesterday that the outreach
that we have been doing so far really isn’t hitting the mark. We need to step
back and get creative about how we are leveraging the information flow into the
provider community through the associations and through the specialties. We can
also change the messaging to make it much more evidence-based.

Here is the value proposition. Here is what you can do. Here is a clear
simple thought process about what you should be looking at, considering and
moving forward with. It also applying our lessons learned. It is not all just
about Medicare. It is going to have payment implications. There is a larger
issue for education related to what the vendor community is doing.

I also think that Raj made a comment about we are not hearing from boots on
the ground on this committee. It has been a longstanding problem even when I
sat on the other side of the table to get the practicing clinicians to want to
come and testify and be involved at this level. They tend to use, in my
experience, their instruments that go directly to Congress because they see the
value that will give them the outcomes that they want balancing their
objectives.

DR. SUAREZ: The other big message that we heard was that we need to also
educate or inform Congress and not just the providers. We as an industry need
to also inform Congress about this. Certainly, as we approach March of next
year when it ends, Congress will be debating this again. I think we need to
bring this message as well to them. We are hoping that this will serve as a
base for informing Congress.

DR. WALKER: A quick note, the American College of Physicians, the American
Academy of Family Practitioners and the American Academy of Pediatrics all have
on their websites what look like fairly carefully designed educational
materials for their members. I think one of the issues that we need to pay
attention to is that AMA isn’t the only organization representing physicians.
Physicians are not a solid block opposed to ICD-10 setting aside the wisdom of
ICD-10 entirely. I think there may be more under this. Just calling for more
education is not going to change anything.

DR. SUAREZ: To be fair, we shouldn’t make this an AMA issue. Clearly, AMA
has taken a position. GMA has taken a position. Everybody has. I think it is
more of an entire industry. We really need to bring the two together. That is
what I realized yesterday. It is really bringing the two together in a much
more forceful and directive and collaborative way. I think that is the charge
that we have next.

DR. GREEN: Ob attended yesterday’s meeting virtually. Maybe we will have to
create some type of new NCVHS award for anyone that can go through a 10 hour
Standards Committee virtually.

MR. SOONTHORNSIMA: Just a brief comment. Walter, we just got an email from
CAQH to make some adjustments.

DR. SUAREZ: We referenced the report and something called CORE. You all know
CORE is the acronym for the organization that developed the operating rules.
The appropriate reference they are requesting us to include is CAQH CORE. So in
every place that we see CORE, we will just adjust that.

DR. GREEN: Okay we have got our first adjustment. What is the next one?

MR. SCANLON: It is a wonderful report and it really is a reference report.
We will use it in HHS to brief the Secretary as well. As an annual report, we
report what we know and report it to us. We observe and make some conclusions.
We did make recommendations. We had that as a rule. I just wanted to confirm
that we don’t have any recommendations.

DR. SUAREZ: In this report we do not make recommendations. We summarize the
things that happen. In fact we highlight the recommendations that we made in
those.

MS. DEUTSCH: It is a retrospective review so anything that was in any of the
letters summarized what the aim and the goals and the recommendations that were
made, but nothing for the future or anything that is current.

DR. GREEN: Walter, I would suggest that we get everyone to go to page 53 I
think it is where we do a Section 6, the conclusions. We have two paragraphs
there. These are not recommendations. There are two or three observations here
that I want to make sure the committee knows are being made. I want all
committee members if you have any concerns about these conclusions, it would be
nice for you to surface them now.

DR. FRANCIS: It should say highlighted.

DR. GREEN: My own personal reaction to this is the first sentence in the
second paragraph. That is a mouthful. That has, from my perspective, very
important implications. We are required by statute as is noted in the Appendix,
there is a list of things that we are required to do about this. One of the
things the work of this helped me understand is how different the world is 20
years later.

We talk about this in our subcommittees and in the hallway with one another
and each other. There is stuff in this law that we are not sure makes a whole
lot of sense anymore. That second sentence is this unknown future that affects
our role as a statuary advisory body. Is everybody comfortable? There are
implications here that there is more to come. There is more to come that
doesn’t necessarily look like HIPAA.

DR. FRANCIS: I actually went back and forth a lot on that sentence because I
think we want to convey that it is the unknown future that everybody is going
to be called on to address, if we could say that. The way it is put right now,
it sounds like an open invitation to change our role. That is what it says. If
it said something like it is the unknown future that NCVHS, the department and
other relevant bodies will need to address.

DR. GREEN: The first thing you said is the “It is the unknown future
that will affect everyone that in turn will affect the role of NCVHS.”

DR. FRANCIS: I wouldn’t say role that will raise the kinds of issues that
NCVHS will need to.

DR. WALKER: I just wanted to follow-on to Jim’s comment. If I were reading
this I would like to know that there are no specific recommendations in this,
but that there are recommendations somewhere else that this references. I would
make that the first sentence in the report.

MR. SCANLON: Those are probably in the individual report.

DR. WALKER: All I am saying is that sort of roadmap. There are no new
recommendations here. There are recommendations here, here and here. With an
executive you have two to three minutes. If we did that first and then
everything else followed, everything else is great.

MS. KLOSS: Do that right up front. It may be in the cover letter.

DR. GREEN: Are we okay with these still?

MS. DEUTSCH: We should add instead of NCVHS department and other relevant
parties?

DR. WALKER: I think it should make NCVHS’ role even more important. I would
say.

DR. SUAREZ: Could you repeat that?

DR. GREEN: “It is the unknown future that will make NCVHS’ traditional
role even more important.”

DR. WALKER: What Leslie was saying was that the original sounded like we are
questioning the role and it needs to be changed. What I am proposing is what we
are really trying to say NCVHS’ role is even more important in this dynamic
uncertain future than when things are just rolling along. Maybe not.

DR. FRANCIS: We will make the kind of advice and guidance even more
important.

MR. SOONTHORNSIMA: Maybe it would require NCVHS and other entities to be
more vigilant, engaged and essential.

MS. GOSS: We are in a new world of collaboration. We don’t even know the
problems we are creating yet that we are going to have to solve. We are getting
down to the hard stuff.

DR. FRANCIS: Can I also cavil about the third sentence?

DR. GREEN: Let’s see if we have this one agreed.

DR. SUAREZ: I haven’t changed anything yet.

MR. SOONTHORNSIMA: That would require NCVHS and other entities like us.

MS. KLOSS: I think it is important to keep the statutory advisory on health
information policy to the department there.

MS. GOSS: How about it will underscore the role of NCVHS.

DR. SUAREZ: Underscore the importance of the role of NCVHS.

MS. KLOSS: Well, NCVHS in what role? It underscores the importance of NCVHS
as the statutory advisory body.

MS. DEUTSCH: So I think what we have now takes in what everybody else has
been talking about. We are not talking about other entities.

DR. GREEN: Leslie, your other sentence.

DR. FRANCIS: I don’t think we are just a venue for industry stakeholders,
and it reads that way in the next sentence.

DR. SUAREZ: The next sentence, “NCVHS will continue to serve as a
venue.”

DR. FRANCIS: Well we are a venue for the generation of advice on all of
these kinds of policies and some of that comes from industry stakeholders, some
of it comes from patients, some from communities, and a venue for deliberation
to come together for deliberations and recommendations about these difficult
and evolving issues.

DR. WALKER: There is a fashion right now to be a convener and that is fine
and conveners are needed. Obviously we convene hearings together. What I hear
Leslie saying is NCVHS is fundamentally a deliberatively recommending body,
which obviously needs to be listening like crazy. We are not just a convener.
We convene as a part of our work of deliberation.

MR. SOONTHORNSIMA: Recommendations about these difficulty and evolving
issues?

DR. WALKER: I think venue is non-data. You could just say continue to
provide deliberations and recommendations.

MS. DEUTSCH: The reason that venue was put in was because NCVHS is perceived
by the stakeholders to be a place where they can come and bring their ideas and
their discussions. We wanted to make sure that we continue that. We should put
in collaboration on top of that.

DR. SUAREZ: We have a venue for convening, deliberating and recommending.

DR. GREEN: Why don’t we see if we can stop right there. Don’t we pretty much
have this?

MS. GOSS: Except we need to change this to these.

DR. GREEN: Leslie, did you have another issue? Does anyone else have another
issue?

MR. SOONTHORNSIMA: The changes we will make here will go to the summary as
well.

DR. GREEN: Let me ask a policy and procedures question to Debbie. Is there
some reason why we have to wait until tomorrow to approve it with these
changes?

DR. STEAD: We are having the next round of discussions around the public
health standards discussion in a little bit. There is direct language in this
report from that. If we approve this and if we make changes in that they need
to be retrofitted. I don’t know how you handle that process point.

DR. GREEN: I bet we could do that.

MS. DEUTSCH: Do you envision that it would be substantive changes?

DR. GREEN: Bill is just reserving the right if, before out meeting is over,
if we make some changes our reference in here we will come back and make this
report concordant. We will make the conforming changes. I love the language
that you have mastered.

MS. KLOSS: One more on these, the word “these.” Could we have
deliberations and recommendations about complex and evolving health information
issues? Would that be clearer? We don’t only talk about HIPAA. Since this is a
report on HIPAA, I think that would be limited.

DR. GREEN: Alright, by consensus we are comfortable with the edits in the
Conclusions Section. I think we need to go back to Jim’s point about wanting
another sentence at the beginning in the Executive Summary, correct? Can we go
back to the Executive Summary? It think that was the first sentence that Jim
said is at the beginning.

DR. SUAREZ: So which change?

DR. WALKER: The idea is to put business in first. If I pick this up, I am
asking what am I supposed to do with this and what are the questions I need to
answer if I am the Secretary or whoever. It seems to me that it is wise in
documents like this to put the business in first. I guess from what Jim Scanlon
said there are no new recommendations in this document, so that would be the
first sentence and then a period. The second sentence would be, “I guess
there are specific recommendations elsewhere,” and maybe identify where
they are so that the person knows what they are doing here.

DR. GREEN: Terri, do you have a suggestion for how to do that?

MS. DEUTSCH: Would you do that after the first sentence when you say this is
the second sentence. It would be the second sentence, and you would say,
“Within this document there no new requirements or new recommendations;
however, we do summarize or we do reference recommendations within the document
that we have made during this time period.” They are so they are footnoted
throughout.

DR. WALKER: Then you have primed the reader to be looking for something.

DR. GREEN: I think it is a good thing. Do any of you object to adding this
sentence in?

DR. FRANCIS: I don’t object to it, but I don’t like the way that it is
phrased.

DR. GREEN: So we want to do it, so Vickie and Leslie and Linda?

DR. FRANCIS: I sent you a whole variety of things, but there are a lot of
sentences that are longer than they could be if we wrote directly. Take the
first sentence. It could read, “This 11th Report describes the
advances included. Included in the description are recommendations or summaries
of earlier recommendations, but the purposes of this report is descriptive and
no new recommendations are included.”

DR. SUAREZ: “Including the description are summaries of recommendations
made by NCVHS during this period.”

DR. FRANCIS: The purpose of the report is to describe developments rather
than to make any new recommendations. I would make it all one sentence.

MR. SOONTHORNSIMA: We already got the recommendations.

MS. DEUTSCH: Does that address what you wanted, Leslie?

DR. GREEN: I would personally prefer to get rid of “This is a
descriptive report.” I think we should just say, “This report
contains no new recommendations.” That was Jim’s starting contention that
needed to be made clear.

MR. SCANLON: You need a transition sentence.

DR. GREEN: So, Terri, how do you want to do this?

MS. DEUTSCH: We started out putting the word “while” when we were
saying “While this report is descriptive,” so it seemed to make
sense. We could say that “While this report contains recommendations of
summaries from the past, it does not provide any new recommendations for the
future.”

DR. SUAREZ: We can skip the “while” and just say, “This
report contains summaries of recommendations made by NCVHS during this
period.”

DR. WALKER: Walter, it makes it easier if we say “While this report
includes” and then go all the way to summaries.

DR. GREEN: This is reminding me of days gone by when we wrote as a
committee. It was like a Rorschach you could see our preferences for active and
passive.

MS. GOSS: Larry, from the future perspective, we have had a tremendous
amount of work done here and we are now introducing a lot of last minute
variability in writing style. Maybe what we need to do is sit back and take a
lesson learned. It is very difficult for the person pulling all of this
together to create a synthesized, edited, crisp version of it. Maybe we need to
look at some additional support. This was hard to pull together, and I think
the feedback is great.

MS. KLOSS: I do like Jim’s suggestion that references recommendations would
be better than summarizes. That is changing what they were.

MS. DEUTSCH: I am watching to make sure that any of the suggestions that are
made do not change the flow or the tenses in the document. That would be a
nightmare to do at this time. I do think it is a good suggestion that we are
right upfront saying that there is nothing new. This is what the objective of
the report is. That is good.

DR. MAYS: Can we get in the notion of past and future? To me when you say,
“It does not contain any new recommendations.” Somebody might think
they don’t need to read it. It is recommendations for the future and the others
are in the past.

MS. DEUTSCH: We have just added that in. We talked about them and it was
just left out. We are saying that we are summarizing recommendations that were
made in the past or during that time.

DR. GREEN: So it is 12:13. We have the opportunity to go to lunch if you are
ready. We have consensus edits that we have now talked through that frame the
frontend and the conclusions at the backend. That was just my doing here. I
want to make sure the committee knew the setup and knew where it then landed
and that we were agreed about that. We appear to be. Are you ready to vote? All
in favor? All opposed? Any abstaining? I think we can reconvene at 1 o’clock.

MS. JACKSON: We want to know who is going to be joining us at Oya
Restaurant, hopefully at 6:30. I know you will be finishing at 5:30. There is
some logistical plans for how you all are heading over there. We do have the
address. Anybody interested, I will get a count. Again, we might have a special
guest and all kinds of guests.

DR. GREEN: So we will reconvene at 1:00. Thank you very much.

(Whereupon, luncheon recess at 12:15 p.m.)

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

Agenda Item: Public Health Data Standards Letter –
Submitted for ACTION

DR. GREEN: Welcome back. For those of you who were here yesterday don’t you
find it interesting when we are talking about next topic here, Public Health
Data Standards Letter look at what a crowd we have drawn, as compared to the
crowd that came in yesterday. I am just noticing the environmental conditions.

Welcome back. Do we have anyone on the phone? Would you let me know if we
need to introduce anyone or if we have any of our members that have called in?
We are back to Ob and Walter again for 1 o’clock Public Health Data Standard
Letter and also submitted for action.

DR. SUAREZ: Thank you. I have a couple of points with respect to the
background of this. This is very special because it is really bring us as a
National Committee back to one of our original goals from 60 years ago. The
mission and purpose of the committee was to be the National Committee advising
on vital and health statistics and in many respects policies around data and
standards in this field.

As a National Committee, in the last 12 or so years or more, since we took
over HIPAA, we have not done much about public health standards. We have done a
lot of work outside of the National Committee.

Of course, there has been a lot of work done in the public health standards
arena starting in the late 1990s with the creation of the Public Health Data
Standards Consortium which served really as the voice and the vehicle to
connect the public health community with the standards development world that
was developing standards for administrative transactions. A lot of the public
health data was derived from claims and other administrative data exchanges.

Back in those times it made a lot of sense to say to public health we need
to really pay attention to the standards that are happening in this area, now
even more so with respect to the standards that are happening in the electronic
health records. We are all in the Meaningful Use arena and EHR arena.

It was very timely and very special for a number of us to be able to convene
a hearing at the end of last year to talk about this and bring all of the
people that have been working in this space of public health data standards for
many years and bring them together to testify on where things are with the
standards in public health. By that we use different words for public health
standards. There are different ways of interpreting. What we were talking about
was really public health informatics standards.

In the letter, put some references and definitions about it. Basically, the
electronic standards used in the messaging between entities that submit data to
public health and public health and bi-directionally, going to public health
and coming out of public health. The electronic message standard just like we
have claims going from a provider to a payer. You heard the word CDA this
morning from Joy. This is the standard HL7 message for electronic clinical
exchange of data going from one provider to another.

We have the claim going from provider to payer, the HL7 message going from
provider to provider. What are the messages that we have going from providers
to public health and providers and payers to public health and all of that? A
lot of that work came to this hearing in November. Really we heard two
important messages. One was that there was a lot of work being done and a lot
of maturity in some of the standards being used in public health and data
exchanges.

We heard about immunization data standards. We heard about public health
laboratory messaging standards and others. In that area there is a lot of work
to be done in other exchanges of data. For example, there is the reporting of a
public health event or a public health case report. There are already some
standards available there, there are a number of opportunities to extend the
work in a number of others. Environmental health, maternal and child health are
other areas. That is one set of messages, the standards.

Then we heard a significant message about the current state of public health
information systems in the country and the challenges that public health
agencies, state and local agencies face in terms of their information
infrastructure. They see how the evolution in the clinical world with the
adoption of the EHR goes trying to keep up and stay close to the developments
in the EHR side and the clinical side. Those two were the driving messages that
we heard.

In the letter, we decided to take the second one first and really focus our
attention on that. Through that we really highlighted the importance of
enhancing and advancing. At some point, we even used the word modernizing the
public health information infrastructure and investing in that. Through that we
really helped advance the development of standards in public health, standards
as in electronic message being sent.

That is the focus of this letter. I think this is the second pass that we
have with the national committee. The first one we reviewed and got feedback,
as a full committee during the May 15 full committee virtual meeting. We went
through it. We read it paragraph by paragraph. We got some important feedback
that we want to communicate here with some changes. I wanted to give you all
that background.

In the letter we start with our traditional introductory statements and then
the purpose of the letter is to provide observation and recommendations
regarding the current state of health informatics standards using public health
and population health programs. Then we bring in upfront a summary of the
recommendation. An overview of our recommendations follows. Then later in the
letter we provide the actual recommendations.

The recommendations, when we presented it back in May, we were thinking big.
One of the things that we heard during the hearing was that we should all be
pursuing a national health informatics improvement act. It was referenced in
the hearing as would you pursue a public health information systems or public
health systems improvement act or modernization act. We really liked the idea
conceptually and presented it in a regional draft of the letter.

It created a number of reactions because public health systems mean a lot of
different things to do different people. It was very clear and gave the
impression that public health systems, as in state and local systems, but not
the technical side or technology infrastructure side, but the systems
themselves, the resources and everything that happens in the state and local
agencies needed to be modernized. That wasn’t the intent.

We modified that and changed it. With input from Jim Scanlon and the two
chairs of the Population Health, Bruce and Bill, we came up with a change in
the language. The first recommendation reads “HHS should pursue the
development and implementation of a new national public health informatics
standards strategic initiative.” We are replacing “The enactment of a
health statistics systems improvement act to advance and bring to par public
health information systems with electronic health record systems.” That is
just a summary of the actual recommendation down in the letter.

The second summary of recommendations was that “HHS should establish a
public health information infrastructure trust fund that will serve as a
dedicated funding source to enhance the information infrastructure needed to
support all public health functions.” Then, “HHS should work with the
public health community to establish a national public health informatics
standards collaboration initiative to accelerate the adoption and
implementation of standards in public health.”

Then, “HHS should leverage policy programs and initiatives including
the Affordable Care Act and the EHR Meaningful Use incentives programs to align
incentives for public health reporting, stimulate vendor engagement in adopting
and using public health data standards and ensure public health requirements
are incorporated into clinical systems.”

The last one is “HHS in partnership with national public health
collaboration organizations, public health informatics organizations and public
health professional associations should develop a new national strategy for
public health informatics capacity building to increase the number of skilled
workers in the public health workforce. Those were the four core
recommendations.

We are then going to provide background. This is regarding the hearing,
regarding some of the messages. At the bottom of the first page of the letter,
you can see the definitions that we give. By informatics standards we mean
these. By public health we mean these. By population health we mean these.

Then the second page of the letter is pretty much background and really
referencing some of the key messages that we heard during the hearing. The
third page highlights the overarching themes. They again highlight the concerns
about the current state of the public health information infrastructure that
needs some attention and sustained investment and a few other key themes and
messages.

The recommendations came down to basically the ones that I just mentioned.
This is in more detail the actual recommendations. Recommendation number one,
“HHS should pursue the development and implementation of a new national
public health informatics standards strategic initiative.” Again, we are
replacing the reference to a Public Health Systems Improvement Act.

Then under recommendation 1.1, “HHS is to establish a public health
information infrastructure trust fund to be jointly governed by CDC and an
organization representing the states and local practice communities. This fund
will serve as a dedicated funding source to enhance the information
infrastructure needed to support public health functions.”

There is of course more detail about the areas we believe this fund will
help to provide this needed ongoing financial support. I am not going to read
all of those details that we went through and read them during the May 15 call.
Recommendation 1.2, “HHS should also leverage public health infrastructure
trust fund to provide sustained funding.” The only thing we did here was
add the word “and” in the last statement. That was recommendation
one.

Recommendation two, “HHS should work with the public health community
to establish a national public health informatics standards collaborative
initiative that will help accelerate the adoption and implementation of
standards using public health programs.” We made a few clarification edits
during the May 15 full committee call work towards harmonization and
appropriate linkages of demographics in public health databases.

We wanted to include a statement about the appropriateness of the linkages
basically expressing some cautionary notes about making linkages to databases
established by the programs that clearly document and demonstrate the
importance of bidirectional information exchanges between public health and
clinical care and a few others. That is the second recommendation.

Then we provided some more background for the third recommendation, which is
“HHS should leverage several different policy programs and initiatives
including the Affordable Care Act and EHR Incentives Program to align
incentives and develop new components of the value proposition for public
health for the public health agenda that includes identification of abuse cases
and significance of adopting and using public health informatics
standards.”

The last recommendation was recommendation four. “HHS in partnership
with national public health collaboration organizations, public health
informatics organizations and public health professional associations should
develop this national strategy for public health informatics capacity
building.” I think that is the last recommendation.

Really, we are reflecting some of the key big pieces that we thought were
needed to be advanced in order to pursue these goals of improving public health
informatics, public health information systems and then advancing that option
of standards in public health. It was a national strategy for public health
informatics standards, information infrastructure trust fund, a national
collaborative involving public health, federal and state and local public
health and professional organizations and advancing workforce.

Those were our four core elements that we wanted to recommend to the
Secretary to advance and move forward. I am going to stop there and turn it to
our chair and open up for some questions.

DR. GREEN: I will entertain a motion to approve. Discussion, Leslie?

DR. FRANCIS: I apologize for bringing it up now, but when the original idea
was statutory it would have been in the statute to establish the trust fund. I
don’t know whether HHS itself has the power to establish a trust fund. I am not
sure that we want to say it should take that particular form. Maybe support
funding mechanisms rather than a specific trust fund.

MR. SCANLON: It is true. We need statutory authority to create a trust fund.
I think a similar word like dedicated word or a similar concept.

DR. MAYS: I was really concerned about that. The second thing and I am not
sure about this. This comes from thinking about the workgroup. Should we be
adding technology to this? You have a whole thing about informatics. If there
is not enough development of technology to have these things be linked and
disseminated. I was very ambivalent.

DR. SUAREZ: We cover technology through the words information
infrastructure. The technical information infrastructure is what we are
referring to. When we say public health information infrastructure, we are
talking about the technology behind that infrastructure, the information
systems and technology.

DR. STEAD: I like the idea of this, but I still don’t think we have got the
name of the initiative right. I like the idea of a strategic initiative, but it
is much more than standards. If you look at all of the bullets that you have
got under that and even, Walker, as you play with what you just said, you are
talking about public health information infrastructure. I would advocate that
it be called the National Public Health Information Infrastructure Strategic
Initiative. Then Standards has a sub-bullet. Funding has a sub-bullet.
Workforce has a sub-bullet.

DR. GREEN: I see a lot of agreement. Anyone opposed to what Bill just
proposed.

DR. WALKER: If we did what Bill then the virtue would be we could say what
are the components of that infrastructure? There is policy. There is
technology. There is a set of standards. The thing would really hang together
really cleanly.

DR. MAYS: That for me takes care of the concern that I have that they may do
the other parts and not think enough about that.

DR. GREEN: Let the record show that Bill Stead relieved Vickie’s concerns.

DR. SUAREZ: Back to Leslie’s point.

DR. WALKER: All I said is you accept Bill’s top level frame then you can say
the components of that infrastructure are part of your sub-technology.

DR. SUAREZ: I am going to make a note here, policy, technology, standards,
workforce for now. We can add that statement. We specifically referenced
workforce in recommendation 9.

MR. SOONTHORNSIMA: Is informatics a separate component of technology? That
is the intention in the beginning.

DR. SUAREZ: Policy, informatics, technology, standards, workforce and other
resources. Now, Leslie’s comment to establish public health information that is
why we are putting this in capitalized form. We really want to name things and
be impactful in naming and not just the generic should find different public
health funding sources or different funding sources. We really want to try to
capture elements. If you see in recommendation 3 national public health
informatics standards collaborative, all of these are capitalized titles for
initiatives.

MR. SOONTHORNSIMA: It connotes something that is more permanent. I remember
talking about this. We went through this several times. We are like you. Why be
so specific? Then we talk ourselves into this.

DR. FRANCIS: My question, which I have not legally researched, is I do not
know whether HHS has the statutory authority.

DR. SUAREZ: Jim just said that the Department has statutory authority to
establish a trust fund. Didn’t you say that?

MR. SCANLON: No. We can dedicate funds. We can do a lot of things, but a
trust fund is very formal. We don’t have many of them.

DR. GREEN: Jack?

MR. BURKE: I did have a question. It is not a content question. It is a
packaging question. Is this the first communication the new incoming secretary
will receive from us? If so –- I don’t know what happened the first time
Secretary Sebelius received a note from us, but is it appropriate to use our
standard cover letter or should we say something different? This is the first
time she will be hearing from us.

DR. GREEN: We can have a sentence that opens up and says, “Now that you
have been here so long, we want to introduce you to one of your problem
children called NCVHS.”

DR. SUAREZ: You mean the introduction of the letter?

DR. BURKE: That is our standard letter. When it is the 16th or
17th, I guess that is okay. When it is the first one, I wondered if
we did anything different when Sibelius got in her first letter.

MS. GOSS: Does this go back to the conversation about maybe we use this as a
meet and great opportunity and set some context before we deliver the letter.

DR. BURKE: I think that is what I meant, some bridge from what wasn’t to
what is.

DR. GREEN: How would you that we do that?

DR. BURKE: I am sure you will be hearing more from us and we would like to
hear more from you. This is paraphrasing, but this is our first opportunity to
share some recommendations with you. It is something other than the standard.

DR. GREEN: That is great suggestion.

DR. SUAREZ: You are saying this is our first letter.

DR. GREEN: You want this to be the very first thing, “Dear Madam
Secretary.”

DR. BURKE: I am sure other people will read this before she does, but she
will probably eventually read it.

DR. GREEN: So Walter is prepared to be your scribe as if he is using an
unfamiliar electronic health record for you on your behalf.

DR. BURKE: Welcome to your new job. Good luck. Best wishes. I will leave
this to Jim.

DR. SUAREZ: Our first letter to Secretary Sebelius was introductory about
the committee.

DR. BURKE: That should stay. I am looking for something between Madam
Secretary and the National Committee on Vital Statistics. Something a little
more substantive than that but with that message, but with the notion that she
will be hearing more from us, but this is only the first one.

MS. DEUTSCH: I have never seen a letter addressed that way. I understand
your concern, but any letters I have seen the only thing we make sure is we put
the right name.

DR. BURKE: We should probably change that too.

MS. DEUTSCH: I have not ever seen that we went through this is our first
letter to do.

MR. SCANLON: I think we could add a sentence at the end of the first
paragraph that says a little bit more about what we do and then say we are
pleased to forward this first set of recommendations.

DR. GREEN: We are going to put that at the end of the first paragraph.

MR. SCANLON: Then you will go into all of the detail. I think you want to
say that we provide reports of recommendation and advice to the department in
these areas. It will be obvious this is the first set of recommendations to
her. We look forward to working with you in the future with healthcare and he
usual. We can help you with that. I think you need it upfront. You don’t want
that at the end of four pages.

DR. SUAREZ: Maybe not the right words, but “As the new Secretary of
Health and Human Services, we want to introduce you to one of your advisory
committees, the National Committee on Vital and Health Statistics” and
then give some more background about the National Committee first. Then explain
the purpose of this letter is this. We can draft this. We can bring it back
tomorrow morning to take action if the committee feels we can handle that part.

MS. JACKSON: Either way, I agree with what you were saying Jim. This letter
is going to be posted so you don’t want to make it extra personal. You can add
more content where you mentioned so you are getting across your point. This is
the first communication with her even though we will hopefully be having some
other things before the next meeting.

DR. SUAREZ: So we have motion and we have a second. It is a matter of
deciding whether we table the motion until tomorrow or we approve the letter
with whatever introductory edit we do.

DR. STEAD: One more thing if I may. I have one more thing I have been trying
to figure out how we address. This says to advance and bring to par public
health information systems with electronic health systems. I am on page 2. I am
right in that first bullet. It says to bring to part with electronic health
records. Then in the fourth bullet it talks about “aligning public health
reporting, Meaningful Use and public health reporting and ensuring public
health data requirements or incorporated clinical systems,” which I like.

I think we want to bring to par and align public health. What I am trying to
do is not have these sound silos. That is all I am trying to do.

DR. SUAREZ: Bring to par public health information systems and align public
health informatics standards with electronic health records systems. In
reality, we are bringing to part the public health information systems. We are
trying to align the informatics standards themselves. Does that work?

MS. MILAM: Did you want to bring to par the systems of the public health
information systems and electronic health records systems and align the
corresponding standards? Without that, you are aligning standards to systems.

MS. KLOSS: Is it only aligning standards though?

DR. CHANDERRAJ: Electronic records already have public health systems and
standards with syndromic surveillance systems. The EHR certification requires
syndromic surveillance. They have public health record systems in there.

DR. STEAD: All the stuff that we are doing in the IOM committee on social
and behavioral determinants of health these worlds are unaligned. There are
connections, but they unaligned. Our goal is not to have them homogenized, but
to have them aligned. I am not smart enough to know if that alignment is more
than at the standards level.

MR. SCANLON: I think similar concept, Bill, Mike was just telling me that he
has completed a study looking at health IT needs in the public health
community. Aside from funding, it is the idea of interoperability and exchange
between the clinical communities and among public and across the clinical
community as well. The linkage and the alignment would be with the EHR and
other standards. The interoperability linkage would be another feature of the
initiative.

MR. SOONTHORNSIMA: If we keep digging deeper and deeper it gets really
convoluted. To your point, Bill, I thought you nailed it. We could bring to par
public health information systems with electronic health record systems and
align the two. That is it.

DR. GREEN: How do you feel about align and link? Linkage, I believe, is a
different concept.

DR. SUAREZ: We could say also to insert here because the interoperability
part is important, “To bring to par public health information systems with
electronic health records.”

DR. GREEN: Is it align and link or omit exchange?

DR. STEAD: I like align and link. Simple is better sometimes.

DR. GREEN: Maybe we could all get T-shirts. Our job is to align.

DR. SUAREZ: We need to say “better align and link the two.” Today,
in some places and in some ways they are linked. It is really better.

DR. MAYS: I just want to follow-up on what Mike was saying to you. I get a
little nervous about this just being the electronic health records systems.
Can’t we say something a little broader? Mike just said it was about the
clinical care side. This is very specific. I don’t know if it would par as
another bullet. In some way, I think we should we be talking about clinical
here.

DR. GREEN: So you want to replace the word electronic?

DR. MAYS: I don’t know. I think that is very specific and we definitely need
that. It is almost like calling attention to the EHRs. I think that is very
important. We have a body of hearings that has helped you reached that. The
clinical care maybe should be separate or another sentence in that bullet or
something. I don’t want to misalign the EHR record systems. There should be
something about clinical care. I am not sure where to put it.

DR. WALKER: I agree with you, Vickie, absolutely. One option would be to say
“clinical information systems (including EHRs, PHRs).”

DR. MAYS: Yes, that is better.

DR. WALKER: It is probably valuable to call out ERHs as kind of the core. It
is certainly not the only. I would vote PHRs in also, but whatever.

DR. SUAREZ: PHR?

DR. WALKER: PHRs are prone to be the doctors’ or hospitals’ information
system. Patients increasingly will have them. Care managers have them. There is
a whole care team. The more that we leave it open it is the whole care team and
not just one part of it.

(Laughter)

MR. SOONTHORNSIMA: That implies personal health record is clinical and far
more advanced than public health systems, which I disagree.

DR. WALKER: There has been a lot more money spent on EHRs and more people
suffering from them. I don’t think that is a particularly useful kind of
assertion to make even if there was some sense in which it is true. I find that
odd. That is why align and link seems to me like a good way to say it.

MR. SOONTHORNSIMA: I don’t disagree. I simply suggest that maybe we don’t
include personal health records.

DR. WALKER: There are personal health records that are extremely high
functioning and they have tens of millions of users. There are personal health
records that have been withdrawn from the market because nobody could use them,
like Microsoft’s. The same thing is true of EHRs.

We saw this morning that there were 1200 to 1700, some incredible number
that made MU1. Now there are only 600. There are only 12 of them that are
viable, so what are we talking about. I think saying better or worse, advanced
or more advanced just isn’t the point. That would be hard to justify in any
careful way.

DR. SUAREZ: So one thing is that personal health records are not necessarily
part of clinical information systems. Personal health records in many ways are
outside of the clinical records system.

DR. WALKER: That is definitional. If the patient is the core of the care
team then they are not. If the patient is just some innocent bystander then
they are. That is part of the point. I would say what we want to say is there
are information systems that are used to help the care team do a better job. If
the patient is part of the care team then PHR is a part of that.

Certainly in some PHRs, patients receive clinical decision support. They act
on clinical decision support. They update their official doctor record, all of
the stuff they do. It seems to me to be simpler to say clinical information
systems. If you want to leave PHRs out it is no big deal, but I think it would
be smart to drive to the whole care team.

DR. GREEN: I have a suggestion. I am going to defer to you guys about this.
Anything we list here creates a level of specificity that I am not convinced we
are prepared to do. This is our critical idea. We have got to state it in a way
that it understandable.

The problem public health hasn’t had the infusion of capital that it has got
to have in order to be in a position to partner with the clinical healthcare
delivery system for the new world. That is our problem. We need to advance and
bring to part public health information systems. Why don’t we say with rapidly
evolving clinical information systems and better align and link them.

DR. BURKE: How about “link those, link the two, or link them.”

MS. DEUTSCH: He is bringing up a grammatical point that is correct. It is
about the use of them. It is a personal pronoun. These are not personal items.
They are objects, so it shouldn’t be used with those.

DR. GREEN: So this would be these?

MS. DEUTSCH: That is why I was trying to use another thing to link the two.
There is an objection about the two.

DR. GREEN: We will leave that to you guys.

DR. MAYS: For the purpose of better alignment.

DR. GREEN: Okay what else? Bill is calling a question. Let me ask your
preferences here. Would you like to table this until tomorrow morning? We have
got time where we can take a look at these revisions. Or do you want to vote
now.

MR. SOONTHORNSIMA: Can I add one more edit? The very last sentence on page 8
says “Adequate resources are required to achieve real and actionable
values.” Isn’t it to achieve real value and actionable items?

DR. GREEN: How about real values. Okay this side of the room wants to vote
on this now. How about this side of the room?

DR. SUAREZ: We will clean it up and add the introductory paragraph.

DR. GREEN: All in favor? Anyone opposed? Anyone abstaining? Since I going to
sign the letter, I am going to reserve the option for Terri to do some final
editing as necessary related to grammar. We will not edit the concepts and the
ideas.

DR. SUAREZ: Thank you very much, everyone. Good work.

Agenda Item: Full Membership Strategic
Discussion

DR. GREEN: Okay, we are to our 1:30 item, but we are actually well ahead of
schedule because of the space we have created for tomorrow.

DR. WALKER: If there is no new money, at some point are we going to come
back to this and say these are the things that we recommend doing in the
absence of new money six months from now or a year from now?

DR. GREEN: I suspect we will.

MR. SCANLON: Strategic initiative can work either way. There can be new
money. That is why I like the idea of a strategic initiative. It can be new
money or it can be marshalling your current resources towards these priorities.
You kind of get action items.

DR. GREEN: Jim, what I hear you asking is how we will know if there is any
progress on this? That is a recurring thing. About once a year we have an
extensive discussion about it. Let’s think about putting that on the agenda
sometime for a review of the responses to our recent work. We will put this on
the list and come back to it maybe.

DR. STEAD: The other thing I will asked to get in that category at the right
time is really a formal briefing of the committee on HHS’ response to the IOM
report on measurement for the public health that recommended that number. I
would like to know what has and has not been done relative to that. At that
some point it should really be a pretty extensive briefing.

DR. GREEN: If you agree, we will put this on the next Executive Committee
call to talk with Debbie and Jim about how we could go about doing that.

DR. GREEN: Debbie, could you help us get on the public record now a reminder
to everyone about what we have been doing lately when we weren’t face to face
and we were doing these virtual meetings?

MS. JACKSON: I put this on the agenda. We may need to take a deep breath and
realize that the May 15th call was pretty important. We have had calls of the
Full Committee and maybe have taken action. The original purpose of that May 15
call was jam-packed with three action items that were proposed that were
approved at the time on the call because we had a quorum.

It was because had a federal registry notice this call was treated like an
actual meeting, which it was. It was just a changing of the venue, which we
might be seeing more and more. I just wanted folks to feel comfortable with
that and provide any opportunities for feedback if you like. The findings from
the February hearing I wanted in the record.

It was already posted for the pharmacy benefit, prior authorization; all of
this was from standards and health plan identifier, trying fund transfer and
ERA Operating Rules. That was a very content-packed letter. The fact that we
were able to cover it on that call was very significant along with having the
timeliness to response to ICD-10 delay. It was pretty important for that one to
have gotten into the record when it did. So we appreciate that.

I think the fact that you were able to cover this public health exchange
this information letter the way you did today is a testament to the
conversation you had May 15. All of that is a communication and dividing some
way of connecting between the early year call and the summer call. That has
kind of been a zone because of the committees’ effectiveness and productivity.

Walter mentioned considering that as maybe something we might do on an
ongoing basis. We already have our 2015 dates lined up on the agenda. We are
not going to schedule anything now of course. Everything will depend on timing.
It doesn’t look like things are going to recede anytime soon as far as workload
and effectiveness.

Consider that we might be plugging you in and doing a poll in February for a
call in April and May. I wanted to get that in the record and see if there is
any feedback or any commentary or any comments about May 15, the process, the
procedure, how it worked for you. We had public comment.

It was logistically amazing as I mentioned on the call from Marietta and
Janine and Catherine to pull that together. I just wanted to provide any space
if you had any comment on that.

DR. GREEN: Yes, particularly if you have concerns that made you
uncomfortable in some way and it is something that we need to address.

DR. MAYS: It didn’t make me uncomfortable. I thought that it was really and
advancement in terms of the way in which we could work. Anything that we can do
to figure out how to do that even at a next step, one of the ideas I had –
I don’t know what the federal capacity is when other people have to plug in.

In terms of thinking about these collaborative technology tools, we bring
people in often for meetings using Google Hangout Plus. You need something else
to do it at that level. It allows you to run the slides. It allows you to see.
People can indicate when they want to talk. I would say that was the only point
at which it was sometimes hard. It was when you had a point and you needed to
wait. You weren’t sure if somebody could see that you had a point.

With the other we might be able to do that. At a federal level, I don’t know
what you can use, but there is software where we are buying some where you can
have as many as 500 people participate at a time. If we did that I think it
would make it even easier. We could look at a letter being edited in real-time.

DR. GREEN: So that is a statement of support. Walter?

DR. SUAREZ: I just wanted to add to that. I think we are more and more going
to see the use of this. We all probably participated in many other similar
calls. To just name a few, there is WebEx or GoToMeeting type of technology
that accommodates 200 people. There are ways to ensure that only certain people
have access to certain things. Only certain people can speak. All of that is
already so much used that I think we should really consider as more of an
operational way of doing our bidding critically. Certainly I expect that we
will be meeting virtually more often.

DR. WALKER: Two thoughts to Raj’s point much earlier. If we did hearings
that way, it would make people that are far less well-funded able to
participate in ways that are hard when they have to be physically present.

The second thing is there is emerging science of virtual team work. I think
we could at least start to be smart about when we are face to face and when we
are virtual. The more something is new, the more we are still making sense of
something together, the more it needs to be face-top-face. The more it is a
follow-up to face-to-face, the easier it is to do it virtually.

MS. GOSS: I concur that the telephonic approach is great for editing a
document if we get those tools like Vickie discussed. Many of us use them on a
daily basis. They really do help. I am concerned, however, that some of these
topics or conversations do warrant in-person hearings. I think they could be
augmented for the communities that cannot travel maybe as a secondary set of
opportunity for us to get input. I do think there is a tremendous amount by
sitting around a table and looking at a each other and working through the
hearings testimony. I think we need to give ourselves more time to do that
effectively.

DR. STEAD: I want to tag on to Jim and Alix’s points. I thought it worked
very well. What in essence we did is we took something where we had a really
good discussion here. That would give feedback and we could finish it. We had
the first discussion of something with feedback that we were then able to
finish here.

I don’t think we could have done this last conversation around those two
sentences on that first bullet any way but face-to-face, at least as well. That
sentence was about our convergence thing. It was a cross discipline. I at least
find testimony to be very ineffective when you cannot have eye contact with who
you are testifying to.

I think we have got to be very careful, but I think it works as part of a
process.

DR. GREEN: I agree completely. If we ever really want to gang up on Ob and
Walter, we can ask them to do the meeting they did yesterday virtually.

DR. SUAREZ: Believe it or not, I have been in virtual hearings of 5.5 hours
where there are six panels, each panel with three or four testifiers. It has
happened on some very difficult topics. Leslie and Linda could probably
remember the hearing that we had with the Tiger Team.

There are ways to get some things organized. If people want to speak, you
can raise your hand electronically. The chair will see or whoever is
facilitating. I would not replace that with a real person hearing. Yesterday,
we had three testifiers finish up on the phone. We were able to bring them by
phone. It was helpful. It was a lot more dynamic to have people in person.

DR. GREEN: To connect the comments perhaps sometime. When we bring those
three people in they will be on the screen. There is really no reason why we
don’t do that. In a way it does disadvantage the testifier that is not in the
room. The consensus opinion is that the committee is revved up and ready to go
for meeting virtually, but we wish to be strategic about when we do that. We
all recognize that there are some things that need to be sequenced properly in
order for the virtual meetings to work correctly.

DR. MAYS: What I was going to suggest is that it might be nice to bring a
technology consultant to us and to either do this through someone in the
department or for us to look in the workgroup. People can tell you the stage of
what kind of work to do that is face-to-face versus using technology. Even on
our project we have some of those rules. If the work is this, we don’t when we
need face time for certain things.

Sometimes we make mistakes. I think it might help to have some guidance on
doing that so that we can actually do the most productive things, particularly
if we are talking about reaching out during the hearings or anything like that.
We need to thoughtfully know that we are doing it in a way in which both of us
get what we want, but that the public is also able to participate as well.
There may be people in the department that can do this. We can ask within the
workgroup.

MR. SCANLON: We have technology. In fact, the Health IT Policy Committee
normally has those meetings in person. I would say more than half of the group
participates by phone. The technology allows you to use this, to see the Power
Points. You see people raise their hand and it restricts it for the members.
Then it opens it up.

There is a fair amount of technology available. Again, we have to be careful
as an advisory committee to be sure that there is an opportunity for public to
come in. If there is a draft being discussed, we post it on the website. I
think we give them probably 10 days. The public can see if they could comment
via phone or write in.

DR. GREEN: I want to underscore Jim’s last point. This was the only
apprehension I had about this meeting was the amount of time that was available
for public review and comment. It is back to British trials. The trials should
be fair, but they should also look like it is fair. If we are going to do this
one of the things that we really want to service is we do not want to use this
as a method that gets so accelerated in reality it doesn’t give the opportunity
for genuine reaction and input in a transparent way.

We find ourselves constrained to put something off because we just can’t get
it posted and out there. I want to have this discussion in public today so that
those people that are critical for us to engage they need to be aware that we
are anticipating doing that more and not less. That is part of due-diligence in
light of day sorts of conversations.

MS. KLOSS: I think one of the issues is notice. I don’t know how robust our
list of NCVHS participants and those who want to be notified is. If that is
something that we work and maintain well we can take a little more assurance
that we have really given notice as far in advance as we can.

DR. JACKSON: Let me respond to that because that was my next point about the
E-blast, one of the first times that we upgraded our listserv. We have a term
for that now. It is Gov-Delivery. If you are on Gov-Delivery, you will have
gotten notice about this meeting and notices about the letters. If you have not
received notices about that let us know because we need to get you on the
Gov-Delivery itself.

We pulled our major players who always come to the meeting. We pulled the
folks who identified coming to the last couple of meetings and looking at
standards, all of those folks that are on that distribution for Gov-Delivery.
We felt really comfortable about that. As far as having the material posted, we
looked at the calendar very carefully to see when and how long. The items were
up. We have had no negative feedback.

Things really worked nicely so I wanted to make sure to let you know how
much we appreciated the material coming in an amazing timely manner thanks to
Terri and then Walter. It was like to the hour, whether we needed something to
get posted that day, it was guided in and guided up. We could say in the
transmittal and put the link in here and the information is posted. Please
review these letters and provide.

MS. MTUI: We had upwards of 77 people on the WebEx session yesterday. That
is the most we have ever had.

DR. FRANCIS: If we anticipate these being regular meetings, I think it would
be very nice to schedule them in the same way we schedule the regular meetings,
now for the two we anticipate or one next year and do the kind of polling
around of people. This is not a comment, but I got completely out of the loop
on the population framework because several of the calls were maybe a week’s
notice. My schedule was uncontrollable so I didn’t get to participate.

DR. GREEN: That is not a good thing about our culture as a committee. We
basically expect each other to participate in what we sign up for and
contribute to your viewpoints. You can’t do that without proper notice. Every
now and then we will find ourselves where we back something up; it has got to
happen by now. Then we wind up accepting representation from the different
parts of the committee. We settle for that so that we can keep going and do
something.

I think that is a good place for the chair of the committee for the time
being, as me, to be a point of comment. If you feel like it is not working then
we have got to make this work for all of you as members of the committee. We
will do our best to do that. Every now and then it would be my inclination to
say as bad as I want Bill Stead on that call, it is more important that call
happens, and I will talk to him before and I will talk to him after. We will do
x, y and z. We will wind up doing some calls where you say I told you I
couldn’t do it. Then you should feel fine about it. You should bother me if you
don’t.

DR. WALKER: There will be emergencies. That is fine. To Leslie’s point, with
a group like this, I find it better to schedule slots that we may not end up
using. The problem is we say we had this slot, but we don’t need. So everybody
doesn’t know what to do what to do with their time.

DR. GREEN: So some people have virtual meetings and we will have potential
meetings.

DR. CARR: We had for a couple of years, scheduled Fridays 3:00 to 4:00;
Susan will remember. Sometimes we used it. Sometimes we didn’t. I think that
really helped.

DR. GREEN: Okay, we have until 2:30 now to hear from Jim about another
strategic planning thing that is a relatively big deal. Pay attention.

MR. SCANLON: Okay, one of the sections of the ACA, you will remember this. I
think we discussed it briefly. It directs the Secretary to establish what is
called a review committee. It says maybe the NCVHS or maybe someone else. We
had been within the departments talking about how we wanted to do this.

It is in the section on Administrative Simplification in ACA and it follows.
I think what we want to do today is test the waters in terms of is the
committee interested and receptive to this idea. It would be the committee and
NCVHS would serve as the review committee. The Secretary would designate NCVHS
as the review committee outlined here in Section 1104.

Basically the function is the following: It would be the NCVHS doing what it
normally does. We want to avoid mission creep here. What the committee does is
perfectly suited to what is the main part of what is required. We want to be
sure that the committee is okay with it. The general wording is not later than
April 1, 2014 so don’t worry about that. It is like many deadlines. We have
done memos.

The Secretary acting through the review committee shall conduct hearings to
evaluate and review basically the HIPAA Standards and the Operating Rules. I
think the idea here is the totality of that. This is bringing the overview of
and the evaluative perspective to the individual standards that we have been
dealing with and recommending now.

I think we are getting into this, this morning, already with the annual
report. It is a step back to say we have done all of these. We have done this
standard and that standard. We have done this in terms of privacy and security.

Now, based on our own deliberations and bringing in representatives from the
industry and all of our stakeholders what is the sense of where we are and
where we go next. Then the committee says to prepare a report biannually to
provide recommendations to the Secretary on the Standards and improving and so
on, which, again, I think is what we would normally do anyway.

The only other addition is that there is one more provision. It basically
asks for coordination of the administrative simplification standards with the
Health IT Standards, the clinical side and the EHR Standards. Basically it
would say, “In developing recommendations under the section, the review
committee shall ensure coordination as appropriate with the standards that
support the certified EHR technology approved by the national
coordinator,” which is what we have been thinking about anyway about how
these standards fit together.

Our own view is we wanted to be sure that (1) we have the bandwidth; (2)
this is budget neutral. I want to be clear about this. We talked to CMS and
others where this is basically doing this focus within our current operations
and our current mechanisms and so on.

Again, it would be based on what the committee normally does like you did
with standards and like you did with other things. The focus would be on the
totality, exactly what we were talking about today. What is the impact? Are we
moving the needle in a global sense towards administrative simplification and
what were thought to be the goals and so on? Again, we are not going to do
original research for evaluation. I think the idea here is that committees’
deliberation plus the stakeholders coming in as well.

We talked to CMS and others. If the committee is receptive we would have to
go through one more step of getting the official designation from the
secretary. I don’t think that would be difficult. This is something within HHS
and I think within the industry too as we have talked about it has come up
about where we are now. How does it look beyond the individual standards? What
is the total impact? Where do we go? Where are we strong? Where are we weak and
so on? We make recommendations to HHS to carry forward from there.

DR. GREEN: So the question Jim is putting before us is if asked are you
willing to serve.

MR. SCANLON: We did discuss it with the co-chairs of the Standards
Subcommittee and I will let them speak for themselves. We want to have the full
committee think about this.

DR. GREEN: Justine, I would like to put you on the spot. I would really like
to hear your reaction to this.

DR. CARR: I am trying to think if it is my place to comment. I am so glad
you asked. I think it is really important to make sure we have 18 members of
the committee. This summer we were doing the first assignment from the ACA. I
think we had 13. It was a very extraordinary amount of work that had to be
done. Walter’s leadership as always was tremendous. I would put that out there.
I know that we are in a time of change.

We have to get these appointments through. I would be thinking preemptively
of who is coming up, who is staying on and who is filling in. It is very hard
to do 13 people. That said I think it makes tremendous sense for this committee
to continue to be involved. I think we understand this is a way that has depth
and breadth. I think it fits very well.

MS. GOSS: I echo your sentiments about being at a full committee level. I
also think we need some more shameless plugs for people to come with a
Standards background and participate in the Subcommittee. I am already feeling
extremely stretched in our ability to handle the variety of topics that are
being crammed into one day of hearings.

Maybe it will mean that we need to step back and have a little bit more of a
refining approach to what we accept to take on and how it really helps us to
achieve the convergence manta that we have all been speaking to. My sense is
that this committee has already agreed that this is a natural fit for us in
past discussions. I do think there is some resource dynamic here. There is a
project management effort. I think we need to look at where the roadmap is and
how this fits into it.

DR. FRANCIS: I just want to say I think the way the committee has been
working together as a whole is a really nice model. This is an overview kind of
thing. For example, although I went to the Public Health Standards I haven’t
routinely gone to Standards. For something like this, I certainly would because
of the privacy kinds of questions.

I would also say that I think this is something that HHS needs to recognize.
The importance of staff support you just can’t say how important somebody like
Terri on the HIPAA report or Maya on the HIPAA report, there never would have
gotten done without that kind of work. Wherever this happens within HHS, I
certainly think it should happen here, that is critical. I think HHS knows
that.

DR. GREEN: I see no other comments. Let me say this back to you. I think our
answer to Jim is very nice to be asked. Yes, we are willing to serve in this
role if asked. We want to make sure that you understand that doing this
requires the committee being fully populated and a continuation of strong
staffing? Is that close?

PARTICIPANT: Walter is not allowed to be term-limited.

DR. GREEN: I will second that. You make the motion. All in favor? It is
called a life sentence.

(Laughter)

DR. SUAREZ: It has been incredible, he support that we have had. Terri has
been an invaluable member of our team. It has been incredible. The
participation of the members of the committee that we have, certainly as Alix
has been commenting on before, we definitely need additional members to join
us.

I wanted to mention two things. One is the incredible support of the
industry. In terms of the industry, I mean the people that are really coming
and sharing their perspective and their expertise. Yesterday, by my last count,
we had 40 testifiers. They all were passionate. They all wanted to. We couldn’t
actually have everybody who wanted to. We opened a few of the times to have
others testify. We received a lot of testimony in writing.

It is with that regard that I really feel that the committee is seen really
as that forum that place to bring in issues. The reason we ended up having
seven topics in seven hours as I called yesterday was because we went out to
ask the industry and see what the key issues were. Every June we have this
major hearing, so what are the key issues that we need to be bring as an
industry to the table in front of the National Committee? These were the core
topics that the industry really thought we as a National Committee needed to
hear. It is very much in line and aligned with the request from the Secretary
and the provisions in the ACA about this Review Committee.

In fact, I wanted to mention that the DSMO, the Designated Standard
Maintenance Organizations which involves HL7, X12, the NCPDP and UBC and UCC,
the Content Committee, all of the bodies, they submitted a letter in support of
designating the National Committee to be the Review Committee. I just wanted to
mention that because I think it is important to also note that the industry is
very much in support of that idea. We very much appreciate and really thank the
industry for that.

MR. SCANLON: I think the NCVHS was envisioned as what the Review Committee
would be in the law. I think the efforts to let the Secretary decide they
always give you an alternative. I can’t imagine any other committee. I wouldn’t
want to create another committee. It will be a long time before it ever
achieved the knowledge and the expertise and the trust and the credibility that
we already have.

DR. STEAD: To play back our previous discussion a bit, would there be a way
that we could have a virtual session of some ilk including written submissions
with the right staff support that would let us aggregate the things that people
think we ought to be looking at? Then we can go through some form of a
prioritization process to say out of this set, which we can identify and list,
so we will recognize them, these are the ones which appear to rise to the level
that we need face-to-face briefing and discussion at the full committee. Some
process like that would let us be open. It could use the virtual piece while
giving us an ability to manage to work the gate.

DR. WALKER: A useful way to think about a group like this is to say we need
to add the leading 10 percent. I don’t know what percent of the committee’s
work we think this will be, but at least 10 percent I think. To do that, you
have got to say what is the trailing 10 percent? I think it would be smart for
us to at least entertain the idea that it is unlikely that we end up with more
resources or that the current resources can do very much more work on any
sustained basis. The question becomes what would we do less of?

MS. KLOSS: I don’t have a specific suggestion but it may be something that
we think about as we develop some process. Because this is a specific set of
duties, it might be done through a mechanism that crosses subcommittees or is
really a convergence where we take off our NCVHS hat and put on this review hat
for a period and have a process that engages all of us to step back and take a
look. We may want to talk that through some.

DR. SUAREZ: I think it becomes even more important now to define and
maintain a well documented work plan. As much as possible for whatever
timeframe it really helped define. We tried to do that in our own subcommittee.
This is the work plan for the year. We know about the June hearings, which are
big hearings that we know about. Normally we have a February hearing and a
November hearing.

We normally don’t have a September hearing. Those things could change, and
we can adjust. It will be very critical based on this responsibility that would
have as a review committee to establish an even more defined work plan for the
year and have some defined expectations about this. That will help staffing.
That will help our own program from a programmatic process.

DR. MAYS: I was going to suggest something similar to what Linda was just
saying. Maybe this isn’t something that stretches all year. Instead you can
look at the calendar and say this review work is going to be done during this
time. There is a parking lot for things that come up as you go along. That way
you could also expand and temporarily get staff from other places that might be
useful. If we look at the work plan it may be that during the months of
February to April that is your review time. It fits with whatever it is that
you have to do rather than a constant all-year long kind of process.

DR. SUAREZ: The review part is one of the activities that our subcommittee
will do during the year. That is why in my view the work plan for the year will
include whatever portion we designate to be the review committee function
during whatever month in the entire year. The other activities that we have to
do as a subcommittee across or throughout the year will also be highlighted.

DR. MAYS: One of the things I heard is that you are going to have to do a
report. If you think of what it took you to get the HIPAA Report done, part of
what I am saying is to some extent being able to have a parking lot and then to
bring in more resources will help you. If you didn’t have to do a report, it
might be very different.

MR. SCANLON: It is not a report to Congress. The title is reporting. It is
basically a recommendation like the committee normally does. It is not an extra
step or an extra report. It is what we would normally do, except the
recommendations would be of this nature. In a sense they are almost part of
every hearing, this kind of perspective. It says in two years, but we are not
going to worry about this first year. I think we have a good baseline.

MR. SOONTHORNSIMA: When I first looked at it, I thought this dove-tails
really well with what we are doing. When you look at this through a more
strategic lens and talk about convergence and talk about roadmap, this really
is the venue and really is the vehicle for us to really shape now. Before, it
was more reactionary. I just want to make sure that people get that point.

DR. GREEN: I think we are good to go on this.

DR. SUAREZ: What are the next steps on this?

DR. GREEN: One next step is I want to get an update of our empty seats.
Where are we with recruiting the new members?

MR. SCANLON: We have two seats we were filling. I think it was Bill and
Paul. We have two candidates. I don’t want to mention the names because if it
doesn’t work out. They are in the queue now for the new Secretary to sign. One
of them would be helping with the data standards and the public health side as
well.

The other we are looking at potentially the technology world of
representative of the working group from that community. It is tough to find
someone who might fit in. At any rate, those are in the queue now. They are
working their ways through the levels in HHS. Hopefully within three weeks
maybe we should get them.

DR. GREEN: They could be here in September.

DR. SUAREZ: Are those the only two open?

MR. SCANLON: Those are the only two until next December.

DR. SUAREZ: The total number of members of the committee is 14 or 16?

MR. SCANLON: Eighteen. There are two for two from Congress. Then 16 from
HHS. I am pretty sure we have four absences today.

DR. SUAREZ: One suggestion I had in addition filling in the positions
considering expanding number of members, I know there are implication issues.
That will give us potentially more people to bring in.

MR. SCANLON: Part of the problem is it is statutory.

DR. GREEN: I would observe that we have proof of concept of the working
group that we can expand in ways that don’t require a statutory adjustment.
Anything else, Jim, we need to cover here?

MR. SCANLON: We will run this through the department. We seem to have
unanimity within HHS. Our worry was that there may be a group or two on the
outside that would not like.

DR. SUAREZ: I just did it. At some point we will receive a communication
back if everything goes. That will give us the opportunity.

MR. SCANLON: We want it on paper so we don’t have to argue about it later.

DR. GREEN: One last small business item is I would like to look at tomorrow
morning before we head to the subcommittee box. If I am keeping track
correctly, we have already done our 9/10 action items. However, I would just
express personal opinion that when I looked at the Population Health Block at 8
o’clock and what they need to get done, I was not convinced at all that that
was going to fit into 45 minutes.

I would propose with your concept that the Population Health Block commence
at 8 o’clock. At 9 o’clock, we technically welcome everyone and do Conflicts of
Interest again for the morning meeting, et cetera. The populations group should
be prepared if they wish to spillover to part 2 of their meeting. We could use
that time if you need it. If you don’t need it, that is fine.

DR. STEAD: It is a good idea. The more we do that, the better chances are
that we will have Bruce here at least for part of the discussion. He arrives at
Reagan at 7:20 or something like that.

MS. JACKSON: Did you want to start it at 8:30 then? Would that help?

DR. SUAREZ: It was already announced at 8:00 a.m. The public knows that
there is an 8:00 a.m. meeting.

MS. JACKSON: We are subject to change. Your call. We can start at 8:00 or
8:30, but Bruce comes in later.

DR. STEAD: I can chair it. I am prepared to. Susan is doing the first part.
We are good to go at 8 o’clock in the morning, don’t misunderstand me. This is
right in Bruce’s wheelhouse. Therefore, for him to get here at least before we
finish, which we will do if you just extend it would be fine with me. I am fine
starting the day.

DR. GREEN: I have a clear and present memory in one of our earlier previous
meetings of when I was absolutely convinced that we could shorten something and
there would be plenty of time. We lived to regret it. Why don’t we just hold to
the schedule?

MS. GOSS: Larry, in regard to the schedule for tomorrow, I noticed that we
have the half an hour for Karen DeSalvo tomorrow. Considering some of the
discussions we have been having over the last couple of days, especially the
one we just finished, do we really think that is enough time for that
discussion interaction on where we are headed?

DR. GREEN: I think if she can come for 10 minutes that is how long it will
be. If she wants to stay longer, and she might, we will be well-positioned.

DR. SUAREZ: I mean before 11:00 there is a 50 minute update on the
Datapalooza. Is that really sufficient?

DR. CARR: I think that really what are important are the themes that emerge.
This was a very different Datapalooza. I was just going to take 15 minutes and
welcome input from others who were there. To really talk about 2009 to 2014, I
am writing my notes now. This whole convergence theme and everything that we
heard today resonated with what we are seeing there. We start with data
elements and it builds from there. If we wanted to talk about everything there
we would be here for another two days. I think it is sufficient to just
highlight how the progress.

DR. SUAREZ: If we start at 8:00 with the Population Subcommittee and from
8:00 until 10:30 that is 2.5 hours. If we really go from 8:00 to 10:00 and take
a break at 10:00 and then at 10:30 to 11:00 we can have that discussion and
that at least gives us 30 minutes. I am sure there are a number of questions
that will come up on Datapalooza.

DR. GREEN: So we will take an adaptive approach to tomorrow starting at
8:00.

DR. MAYS: Can I make a comment? Justine, what got left off was the ability
to be able to discuss how the working group is going to work and how it would
be converging.

DR. CARR: We were going to do that in the afternoon. You are right. I
probably should be at the Full Committee. We can talk a little bit about that
if we have a little extra time of the kind of redefinition.

DR. GREEN: So everybody comes assuming that there is no extra time. Public
comments?

DR. RODE: Dan Rode, I think the best title I can use right now is NCVHS
groupie. I have been attending these meetings since 1996 with a few exceptions.
I have just one comment and one suggestion. My comment is to someone who was
involved in putting language together for 11/04. We definitely thought this was
the group that ought to do it because it was an extension of what you are
already doing. It is very important to have that continuity to bring another
group in.

It would then probably require a third group to do a combination between the
two. I appreciate you following through with what we hoped would be acceptable
when we were playing with that information. Just a suggestion from years of
sitting in on this meeting, it has always been kind of informal at the
subcommittee level. If the public had a comment, you kind of slid up to a
microphone or somehow waved your hand and got involved in the discussion.

From my recent attendance of some of the HIT committee meetings, I would
like to suggest to this committee that you consider public comment after each
of your major subject issues. It is very frustrating to be following an issue
and then get to comment at the end of the day when essentially the issue has
either already been decided or the committee is too tired to listen to one more
person. No offense. If you are putting process together, I would really like to
suggest that. I don’t think it will overburden the process. I think it would
help get additional outside comments in.

Likewise, while the agendas are always very well put together as far as
being able to see them before the meeting, I think it would not hurt to have a
note on the agenda that if you cannot attend and if you wish to comment, please
send your comments to and give a location on that. I think things are changing
rapidly. We can’t always have everybody here, but we certainly can give them an
opportunity to comment.

DR. GREEN: Thank you very much. Great suggestions. Anything else? Leslie and
Linda, what do you think about 2:50 for reconvening? Thank you all for a
productive morning.

(Whereupon, the Full Committee adjourned at 2:45 p.m.)