Transcript of the September 26, 2007 NCVHS Full Committee Meeting

[This Transcript is Unedited]

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

September 26, 2007

Crowne Plaza Silver Spring Hotel
8777 Georgia Avenue
Silver Spring, Maryland

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
(703)352-0091

Call to Order, Welcome, and Introductions – Simon Cohn, M.D.
NCVHS 2005-2006 Report – Review and Action
Other Committee Actions – 5010 – Harry Reynolds
Other Committee Action: Quality Measurement – Justine Carr
Committee Scan – Projects, Issues, and Plans – Simon Cohn, M.D.
Secondary Uses of Health Data – Harry Reynolds
Committee Operations – Simon Cohn, M.D.
Meeting Reflections, Concluding Remarks

P R O C E E D I N G S (10:00 a.m.)

Agenda Item: Call to Order, Welcome, and Introductions

DR. COHN: Good morning. I want to welcome

everyone. I want to call this meeting to order. This is the second day of
meetings of the National Committee on Vital and Health Statistics. The National
Committee is a statutory public advisory committee to the US Department of
Health and Human Services on national health information policy. I am Simon
Cohn. I am Associate Executive Director for Kaiser Permanente and Chair of the
committee. I want to welcome committee members, staff, and others who are here
in person and also welcome those listening in on the Internet. Let us have
introductions around the table, and then around the room. For those on the
national committee, I would ask if you have any conflicts of interest related
to any of the issues coming before us today, would you so please publicly
indicate during your introduction. I want to begin by observing that I have no
conflicts of interest.

[Introductions around the room.]

DR. COHN: We have so much on our plate today that I am sort of anxious to
get started. Let us go over this talk about the various items and activities
that we have for the day and just make sure everybody will do a time check and
priority check. What we are going to be doing is starting out with a variety of
action items. Now the first action item relates to the 2005-2006 report, which
we will take up with sort of the review. From there, we move into first an
update on the 5010 letter the Standards and Security Subcommittee is bringing
forward that has had significant revisions and streamlining hopefully as a
result of the discussions this morning. Then we will move the Quality Workgroup
report, which I think Justine will be seen a little late on this morning. Then,
we want to reflect and discuss Tab Four, which is the Committee Process
Document. From there, and this is assuming that everybody is okay with a change
in the agenda in the sense that we will move into the secondary uses discussion
up until lunch and then continue on after lunch. We will try at the end of the
day to have the subcommittee review primarily focusing on subcommittees and
workgroups that have not had action items coming before the committee today.
The intent, I think, is still to be finished by 2:45. Obviously, the Ad Hoc
Workgroup report is not going to be an action item today, but part of this
afternoon’s conversation based on where we are, we will be discussing next
steps related to that report and moving into what will be a report that is
suitable as an action item either later in October or beginning of November.
So, we will talk more about that based on sort of our sense of where the
document is.

Agenda Item: NCVHS 2005-2006 Report – Review and
Action

DR. COHN: Now, having said that, let us turn to Tab 3, which is the
2005-2006 report. I think I mentioned this yesterday, and I think that Susan
Konan has done an exceptional job of putting this together. Other than my
– I do not have a preface yet, but we will work on that soon. I thought
that was actually in comparison I think to previous years, actually has had a
wonderful combination of reflecting 2005-2006, but also making just enough
reference to our 2007 activities that it feels like it is current and not
already outdated. She has my great appreciation on that. I guess I should open
it though for questions, comments, do any of you see need for revisions to this
document or otherwise want to comment on it? Paul?

DR. TANG: I think it was very well done and readable. I think both of those
are goals that are hard to achieve.

DR. COHN: Do you want a motion for approval? Is there a second? Is there
any conversation? Comments? Leslie?

DR. FRANCIS: Just a question. Is there an opportunity to send a couple of
wordsmithing suggestions?

DR. COHN: I am sure that Don would amend his motion to say “with
wordsmithing” by the executive committee as needed.

MS. KANAAN: I am Susan Kanaan. At the risk of looking the horse in the
mouth. I wondered because of the question yesterday about the discomfort with
the term secondary uses, I had in my first draft of this, I had actually
labored to use other terms because I have heard this issue raised before. Then
the draft that you have uses the term. It takes it at face value. I wonder if
you might want to at least put the term in quotations without doing anything
more laborious just to be consistent with what you are recommending in your
secondary use report.

DR. COHN: That sounds fine. That would be great. That was not too hard, was
it? Any other comments, questions? Obviously wordsmithing will be gratefully
accepted probably for the next ten days. Marjorie what happens to it then? It
gets published I think.

MS. GREENSBERG: Susan and Simon will work on the forward, and once it is
finalized, we can post it on our website, but then actually we will publish it
in the same format that we have published the reports since 1949. We will have
to decide on the color for this year, but that is about it.

DR. COHN: Carol?

MS. MCCALL: A question about just notification of when that will happen. Is
it something you will also send to committee members so that we might be able
to get a little —

MS. GREENSBERG: Sure, and we will also send you the published version. We
can also e-mail it to you electronically. As Simon said, it is just historical.
I think we might want to think about disseminating it.

DR. COHN: Jeff, you had a comment?

MR. BLAIR: Actually, my question has kind of been answered by Marjorie now
is that you are all preparing it to be published and disseminated and I am glad
because I think this is actually the best overview of what NCVHS is and has
accomplished and is doing. If I could get multiple copies? There are a number
of important individuals I would want to share this with.

MS. GREENSBERG: If you can let us know people in particular you want us to
send it to, we can do that, or if you just want to get a number of copies, that
is fine. I am not quite sure how many we are —

MR. BLAIR: Maybe we can just run a pole of the committee members as to how
many copies we would like, then when you are distributing them, you would know
if some of us would need more copies.

MS. GREENSBERG: It will be electronic, yes. It will also be a nice
publication.

DR. COHN: Paul?

DR. TANG: I am almost thinking it is such a nice overview and forward
looking that it would be nice to almost have this as testimony into AHIC. There
was an opening, so you could do a brief update on what NCVHS does. I am not
sure all members of AHIC know about that, are aware of it, and understand. You
might find these synergies between these two entities.

MS. GREENSBERG: I know that Simon will be presenting to AHIC in November.
It won’t be published by then. It should be finalized by then.

DR. TANG: If you would be able to present this kind of a summary overview
as an appendix to the document, certainly.

DR. COHN: When will it be published?

MS. GREENSBERG: Debbie Jackson does the magic on this.

MS. JACKSON: The documents that come out in the fall have a particular
cumbersome timeline because of the holidays. So, we are not looking forward to
anything really coming out until January or February. We will get enough copies
for everyone. We can also pull together something in the intro that we have
done before. That is to have a hard front cover. I do not know how early you
are talking about having something for AHIC. It is something that can be
carried. It can be stapled. Not on the printed format, but something that a
little more weight than just a going —

MS. GREENSBERG: I mean, if you feel a need, yes. We could probably have
that and put a nice cover on it. It won’t be through publications, but I
appreciate your good response and good suggestion. We are really very fortunate
having someone working with this committee for 17 years. As I said, she has
recently reviewed our report and website. We are going to try to standardize
things more. She has a wonderful perspective on it. I think we are really at a
unique position that way not having to get a new consultant every time.

DR. COHN: I do not mean to break in, but we do still need to vote on it.
Before we plot it too far, let us make sure that it passes. All in favor of
this report? Against? So it passes. Susan, thank you very much. We appreciate
this.

Agenda Item: Other Committee Actions – 5010

Okay, the next item of business is the 5010 letter, which has been handed
over to you, but it has been extensively revised based on the input from the
committee from yesterday.

MR. REYNOLDS: Considering your spirit of compliments and approvals –
if it helps, Susan actually rewrote this.

DR. TANG: So far so good, Harry.

MR. HOUSTON: What you should have done was simply made this an appendix to
the report.

MR. REYNOLDS: I tried that at 10:05. It did not work. Moving right along.
Before we start, you have the document in front of you, but I want to go
through the sections first so you understand the flow that we have now gone
with. Obviously, the background and the X12N standards and the NCPDP standards
paragraphs are still the same. Then we get the observations and
recommendations.

The first one talks about asking the secretary to put out the NPRM. Then we
moved up on the second one. We moved up to the second observation, this idea of
the timing of standards implementation is critical to success. Then we moved
three, which is the various types of testing. Then we moved to four, which is
the outreach to all stakeholders. We changed the flow based on what you said
before. So, just so you are aware of that.

DR. COHN: Gosh, I am hoping we can avoid you reading the entire letter. Do
you want to just point out on the screen at least if there is sort of major
wordsmithing or —

MR. REYNOLDS: Can you put the redline version up?

MS. BENNINGS: I do not have the redline version loaded. I have it on the
drive.

MR. REYNOLDS: Okay, I will start you through it. First, you see the
tagline. The revisions to HIPAA transactions standards needed is our tagline.

MS. BENNINGS: The drive that the redline version is on is being retrieved.

MR. REYNOLDS: That is fine. At the end of the first paragraph, we added the
sentence, the purpose of this letter is to summarize these hearings and make
recommendations. Nothing of significance there.

DR. COHN: I think observations are recommendations.

MR. REYNOLDS: Yes, that is the one we are going to observations and
recommendations. So, I will make sure I read those. That is probably the best
– Yes, I think we should do that on those. So, observation one – And
the other thing I do want to mention, we took a lot about the business page. We
heard a lot of discussion about that. So, I believe we captured all of the
notes, and they will be out. So, as you listen through, I am comfortable that
everything was given to us – and I would like to thank Jeff, Steven, and
Judy for really taking this up.

MS. BENNINGS: The mark up version is now on the screen.

MR. REYNOLDS: Okay, good. We are going to the observations. Go to
observation one. Again, I will read from the current letter. I just want you to
see the kind of things that we did. I will read from the letter in front of
you. Based on the testimony to the Subcommittee from providers, vendors,
clearing houses, pharmacies, and other industry segments, the industry supports
— and we think we probably should change that based on our earlier discussion
to the testifiers’ support to X12N Version 4010A1 and NCPDP Version 5.1 to
Version 5010 and Version D.0, respectively. The majority of the changes and
modifications to these updated standards are as direct result of requests by
testifiers to address demonstrated business needs and, in their totality,
reflect a long list of positive changes. There appears to be a widespread
consensus on the business case for adopting D.0. While there seems to be more
work to further quantify the overall business case for adopting Version 5010,
there was general support for the move. Moreover, there are specific business
drivers, for example the need to accommodate the ICD-10 codes that justify its
adoption. There is support for adopting the new Medicaid subrogation
transaction, which will standardize the subrogation process across states.

Recommendation 1.1: The Secretary should expedite the development and
issuance of a Notice of Proposed Rule Making to adopt NCPDP D.0 and its
equivalent batch standard as modifications.

Recommendation 1.2: The Secretary should expedite the development and
issuance of a Notice of Proposed Rule Making to adopt the ASC X12N Version 5010
suite of transactions.

Recommendation 1.3: The Secretary should expedite the development and
issuance of a notice of proposed rule making to adopt the NCPDP Medicaid
Subrogation Standard Version 3.0 as a new HIPAA transaction.

Any significant comments? Observation 2. Testifiers acknowledged that there
were no implementation issues with NCPDP Version D.0, but there was a need to
test Version 5010 in real life settings to ensure its interoperability and
ability to support the transactions for which its adoption is proposed. The
process for pilot testing and the parameters of the testing remain to be
resolved. Three types of testing needs were identified: One, testing of the
standards themselves for workability; two, conformance testing of products and
applications that send and/or receive the transactions; and three, end-to-end
testing to assure interoperability among trading partners. NCVHS has observed
that in previous HIPAA transaction implementation these three types of testing
occurred unevenly resulting in delays. These delays may be minimized or avoided
bys tagging the various types of testing.

Testifiers expressed the need to test and verify Version 5010 before
implementation of ICD-10. Stakeholders testified that concurrent implementation
of the Version 5010 standard with the changeover to ICD-10 would be burdensome
to the industry and result in errors, escalating system change cost and other
barriers.

Because implementation of the ICD-10 codes set is dependent on the
implementation of Version 5010, it is critical that the industry is afforded
the opportunity to test and verify Version 5010 a minimum of two years prior to
the adoption of ICD-10. IN addition, the compliance date for the new Claim
Attachment standards, for which a Final Rule has not yet been published, will
also necessitate significant system changes, and should not be done at the same
time as Version 5010 or ICD-10.

Testifiers discussed lessons learned from prior HIPAA implementations, and
identified potential barriers and resource issues. The importance of vendor
compliance was stressed, as practice management system vendors are key to
provider compliance, and delays in vendor rollouts of compliant products have
delayed end-to-end testing. The resource-intensive nature of testing,
particularly end-to-end testing, was also noted.

A variety of options for staggering the implementation of the Version 5010
and D.0 modifications were offered. For example, the compliance date for plans
and clearinghouses could be a year before the date for providers in order to
facilitate end-to-end testing. Alternatively, different compliance dates could
be assigned to different transactions, for example implement the claim and
related transactions first. Testifiers also attested to the importance of
allowing dual processing, old plus new versions, for a sufficient period to
allow end-to-end testing.

Testifiers indicated that it is important to engage industry in end-to-end
testing as soon as possible. It was noted that widespread use of compliance
testing services, which allow entities to test products and applications to
assure that they can create and accept compliant transactions, could simplify
end-to-end testing by assuring that individual products are compliant in
advance. An alternate to staggering implementation would be to phase in
compliance by establishing consecutive periods of compliance testing and
end-to-end testing.

Recommendation 2.1: HHS should consider establishing two different levels
of compliance for the implantation of HIPAA transaction and code sets. Level 1
compliance would mean that the covered entity could demonstrate that it could
create and receive compliant transactions. Level 2 compliance would demonstrate
that covered entities had completed end-to-end testing with all of their
partners.

Recommendation 2.2: The implementations of Version 5010, ICD-10 and claims
attachments should be sequenced so that no more than one implementation is in
Level 1 at any time. HHS should also take under consideration industry feedback
indicating that for Version 5010, two years will be needed to achieve Level 1
compliance.

Comments? Leslie?

DR. FRANCIS: Does it make sense anywhere here to clarify the need for being
relatively quick getting things ready for ICD-10?

MR. REYNOLDS: The thing we put in, we changed in Observation one was we put
in the word expedite because it is a prerequisite.

DR. FRANCIS: Yes, it did not actually indicate that the reason for
expediting is the connection to the importance of having ICD-10. That is what I
– It is that link that I was not fully clear was stated and I thought
aught to be stated.

DR. TANG: That was actually my identical comment. You moved too quickly,
which is fine. Since you added the word expedite to all of those
recommendations, I went back to look whether there was any justification why it
urgently needed. I did not see something in the pretext. So, it seems like some
tie either with two or some reason you put expedite —

MR. REYNOLDS: If you look at the third paragraph of observation two —

DR. TANG: Sorry, your recommendations from one. There was not justification
for the word expedite. I think the word is good. It is appropriate, but there
was not a justification.

DR. COHN: I was going to comment. It says moreover there are specific
business drivers, e.g. the need to accommodate ICD-10 codes. That could be
strengthened.

DR. TANG: You could say this is a specific and urgent business driver that
we need to give it justification.

MR. REYNOLDS: Where does that move from in two?

DR. COHN: That was right before your recommendation 1.1.

DR. TANG: Moreover there are specific and urgent business drivers, e.g.
that need to accommodate ICD-10 codes. Then you should prepare your final
revisions. You might just make sure there might be a sentence for that to help.

MR. BLAIR: You want to wait a minute and give Denise time to be able to
capture this properly?

MR. REYNOLDS: She noted it.

DR. COHN: Don actually has his hand up. Don?

DR. STEINWACHS: A very small thing, Harry. Third paragraph under
observation 2, third line. The way you talk about the 2-year interval there
sounds like it is two years period. When you come to the recommendation, you
say, testifiers say it may take up to two years or something like that. So, it
is just very small. I would soften that.

MS. BENNINGS: So the recommendation is to change the word minimum? Is that
what you are saying Don?

DR. STEINWACHS: Some wording to soften that because it comes across as
hard. It has to be up to 2 years. I do not know what the committee heard, but
up to 2 years.

MR. REYNOLDS: Observation 3: Various types of testing are needed. NCVHS
recognizes the value of compliance testing services as a precursor to
end-to-end testing of system changes, and the need to pilot the use of the
standards within organizations, as well as between partners as was done with
the claims attachment transaction standards. We also recommend that CMS and
industry stakeholders work to standardize commonly used terms as “pilot
testing” and “compliance testing” so that all entities can make
decisions based on universally-accepted definitions.

Recommendation 3.1: HHS should develop a plan to work with the industry and
the standards organizations to collect and analyze requirements related to
testing including defining the process of pilot testing, determine under what
conditions pilots should be conducted, and when this testing should take place.

Recommendation 3.2: HHS should advocate the use of compliance testing
services for software and/or applications that would demonstrate a covered
entity’s ability to create and receive compliant transactions. Don?

DR. STEINWACHS: I must be your problem child this morning. I did not quite
understand what advocate use of compliance testing services.

MR. REYNOLDS: In previous implantations, services were offered by companies
and entities and others to each other to be able to go out to a website or so
on to test without actually having – they knew the rules. They knew they
could test as many times as they wanted to without actually each entity
touching each other. The reason we say advocate, we had originally talked and
Bill Scanlon was very helpful. We had recently talked about things like support
or other things which people took as to pay for it. So, that is why we changed
the word advocate because they are good ways of moving industry along faster
without everybody having to do things one-on-one.

DR. STEINDEL: So the use of it is really industry uses and compliance
testing.

MR. REYNOLDS: Okay. Observation 4: Outreach to all stakeholders is
critical. If you remember yesterday, people thought we were a little too
focused on exactly what we told them to do, PowerPoint’s and other things. As
you hear this, you should hear that not be quite as prominent as it was
yesterday. The Subcommittee hears from stakeholders that the need is great for
education and outreach regarding the adoption and implementation of Version
5020. Taking lessons learned from its experience with the National Provider
Identifier, testifiers reiterated the need to cast a wide net to better inform
and educate all industry segments as to how Version 5010 will impact their
workflows, operations and other aspects of their respective businesses, as well
as critical implementation dates. Special initiatives, such as a joint
CMS/SDO/stakeholder Version 5010 education summit, may be needed to target
small software vendors and other hard-to-reach groups.

Testifiers proposed that HHS should undertake steps to collect and analyze
data about the version 5010 process, business impacts both cost and benefit,
return on investment and other information and make it available for
dissemination. As this is the first update of HIPAA standards and NCVHS also
has heard testimony in favor of streamlining the process to adopt modifications
to the standards, possible changes to the modification process could be
examined.

Does everybody feel we stepped it up?

Recommendation 4.1: HHS should identify communication approaches and
strategies to educate and inform interested constituencies by partnering with
responsible persons and organizations.

Recommendation 4.2: HHS should develop materials to education the industry
regarding these standards, and in particular Version 5010 to enable industry
and stakeholder implementation efforts.

Recommendation 4.3: HHS should consider a summit or other similar event for
gathering input regarding the adoption of these standards, as well as a
“lessons learned” exercise at the conclusion of this implementation
process to identify best practices as well as issues/concerns to be applied to
future standards adoption efforts, which also could include ways of streamline
the adoption process for modifications to the standards. With that, I would
like a vote on the letter

DR. COHN: Paul?

DR. TANG: Just a reinforcement. I think your organization makes a whole lot
more sense. Again, back to the timing, in Observation 1, instead of industry
supports, you could say industry urges. That adds a strength of the industry
requests for this and the timing. So your tagline could say, HIPAA transactions
standards urgently needed. All of that fits in with the story you are trying to
tell, it seems to me.

MR. REYNOLDS: Everybody good with the tagline change? Larry, I saw your
hand up.

DR. GREEN: I am very happy with the letter and applaud your efforts. Thank
you very much. I want to go back to Recommendation 2.2 on page five and seek
reassurance that the statement about no more than one implementation as it
relates to claim attachment 5010 and ICD-10 that that is really a solid
statement. It is not going to come back to haunt us that the industry or
someone in the industry might say, well if we have got to all of these things,
the way we are going to approach this is we would like to be doing two of these
at once. Are we confidence that this is the way people want to do it and insist
that this is the way they want to do it. If you just say yes, then I am quite
happy.

MR. REYNOLDS: The answer is yes, but I will add to it. We had significant
debate about this. If you notice that except for 5010, which we heard specific
testimony on, we did not put a timeframe on Level 1 or Level 2 for anything
else. Level 1 can be decided as the secretary would decide it. So, Level 1
could go faster in the future. Level 1 could go whatever they decide. The point
we did with all of these was to make sure we set a prescriptive structure, not
a timeframe.

DR. COHN: I should add that in January, the Subcommittee on Standards and
Security is actually going to hold hearings to sort of get industry input on
which of the implementation timeframes for ICD-10.

MR. REYNOLDS: The other thing we discussed at length is if you remember in
the letter, we reference claims attachment. Although claims attachment is not
really out. There have been pilot tests going on. None of this precludes that
there could be people working on pilot testing on ICD-10 and other such things
in advance to gain knowledge and information about these things that would
help. Again, the whole process is, how do we get better pilot testing? How do
we get some of this other stuff so we can move these along a little faster as
we – that was our debate.

DR. TANG: It seems like there are two components. One is what Larry brought
up in terms of what did the testifiers representing industry, what was their
belief in terms of what would facilitate things and speed up the timeline? The
other is, what does NCVHS believe the nation’s strategy should be in moving
forward? In your opinion or NCVHS’s opinion one, I see ICD-10 is very critical
to documenting and improving the healthcare in the United States. You see an
opening with he 5010 to accomplish multiple goals in a sensible and timely way.
It is a combination, and maybe we will be able to break it out, but I do not
know that we want to – It seems like it would be useful to include the
overall overarching strategy for dealing with code sets transaction standards.
Does that make any sense?

MR. BLAIR: I think that the testimony that we received indicated that
ICD-10 is dependent on the implementation of 5010. Therefore, there was a
dependency that was there. Of course there is industry desire. A lot of folks
have indicated that the want to move forward to ICD-10 as quickly as possible.
We cannot do that until 5010 is installed. 5010 has its own business drivers
for implementation. I do not know that this reflects a grand industry strategy
beyond those two elements. If so, it is also the opinion of the subcommittee
and committee that there is no linkage except that they need to be done
sequentially. That is fine. If there is a way to do in that order, but also
speeding up the total process of getting to ICD-10, a comment may be warranted.

MR. REYNOLDS: I think that would be a letter that could come out of what we
hear in our January hearing. That will be focused on ICD-10, so we have started
a structure because are going to hear about attachments later on. So, our
subsequent letters could build off of that, but I think we are jumping out
there a little bit if we try to make this a grand strategy.

DR. TANG: That is fine, but if it as a grand strategy, that makes sense
that this would be a missed opportunity because it steals a little bit of
thunder about the urgent need and why it advances the overall strategy for
coding systems and importance in measurement and improvement.

MS. GREENSBERG: I think just building on what Paul has said, and we talked
a little bit in the previous meeting about how to frame the hearings in
January. If the focus could be how to expedite in light of the needs to get the
standards implemented in a rational and timely and feasible way. How to
expedite within that the movement to the new code sets and how that relates to
implementation of development cross walks and all of that as part of that
strategy. It might be a good focus for the hearings in January.

DR. TANG: Let me give you an example. Y2K. You could either go do Y2K by
itself, or do Y2K in other things that needed to be done as you pour through
all the code. So, I am thinking about there is the build up of understanding
the need for 5010 revision, et cetera. Then you come back after all that work,
and then you have this IC9. Is there any way of overlapping these? I do not
know. I am just asking whether that is true.

DR. COHN: No, I think that is a very good question. I think you should join
us in our hearings. I think that is a very – you have absolutely asked the
great question. If we have had recent testimony specifically focused on that, I
think we would be including it in the letter. But Paul, could we introduce you
in additional subcommittee?

MR. HOUSTON: I think Paul would be a great co-chairman as well.

MR. REYNOLDS: If the industry can decide on a crosswalk well in advance of
anybody using Level 1 or Level 2, then everybody is position to move
dramatically different. If discussions like that continue on into after an
NPRM, then I promise you the whole group will struggle. So, I think we can move
forward to that, but that is not the hearing we had, and that is not the
testimony there. Any other comments?

DR. COHN: Jeff?

MR. BLAIR: I would like to make a motion that we approve this letter with
the changes that have been noted by Denise during this session.

DR. STEINWACHS: Second.

DR. COHN: Any further discussion? Okay, all in favor? Opposed? Okay, the
motion passes. Jeff and Denise, thank you very much. Good job.

Agenda Item: Other Committee Actions – Quality
Measurement

DR. COHN: Now, our next action item is the report from the Workgroup on
Quality. I think we all have copies of it. It looks like a redline version.

DR. CARR: That is right. Ready? Okay, thank you from the input from the
committee yesterday. Starting with the top of the title, which perhaps we will
morph into a read when we get clarification on how this will be a letter. We
deleted the word hospital because we recognize that we go – the quality
measurement observations that we make will be on hospital and to address that,
if you look down under scope and purpose, we added a sentence to say that
although the hearing testifiers reported on hospital data, the Quality
Workgroup was attuned to themes that are generalize-able the quality
measurement in an array of settings. So, that is how we address that. Any
questions?

Second, Leslie had raised the issue about whether we should clarify under
what quality data is collected, aggregated, and reported. As we reflected on
this, we actually heard an array. Some of it is under TPO. We also heard about
HCUP data, which is in a different venue. It was the conclusion of the
committee that we would prefer to stay silent rather than introducing that
topic in this particular letter. Okay? Any questions about that? Good.

Now, moving on to page four, just above recommendations, you will see that
we have added a paragraph that tries to tie what the testimony says and link it
to the recommendations. So, I will read that sentence. It says on the basis of
testimony, the Quality Workgroup concluded that there is both progress and
promise in using public reporting for quality improvement. The Workgroup also
saw that a number of institution-specific burdens and infrastructure barriers
at local and system-wide levels that today prevent these examples from becoming
the norm for the entire healthcare system. So, that was our way of tying it
together.

Under recommendations, we added this sentence, NCVHS recommends that the
Department initiate and/or accelerate actions as outlined in the
recommendations below. So, let me pause for a moment. Any comments on the
concluding paragraph?

DR. FRANCIS: Examples is a weird word. Uses maybe?

DR. CARR: Yes, uses. Right. Why do not we change examples to uses.

DR. TANG: You can almost comment on, and I do not have the words right, but
it is despite their intent. In other words, people are bought into the culture
and the goal. It is administrative barriers, some of which can be addressed by
policy that prevent that. It is sort of the industry urges kind of thing.
People want to do this, but actually it is stymied by the systemic barrier.

DR. CARR: Do you have – Carol?

MS. MCCALL: I hear you, and yet I am quite sure that I agree. The reason is
we did not hear testimony on that. We only heard from people where they had
already bought in. Specifically, the first point that we made was that it is
possible when people do buy in. We recognize burden. We recognize barriers.
However, if in fact everybody had bought in, then there might have been more
evidence. So, I think some of what we heard actually calls into question the
conclusion that everybody has in fact bought in.

DR. TANG: I did not say – I just said despite the interest in
anticipating. There are so many barriers.

DR. CARR: So you are recommending that the workgroup also saw that despite
—

DR. TANG: You said that today prevent these best practices from being the
norm for the entire healthcare system, despite the – I do not know what
the adjective is. Again, what Carol just said is the broader interest in
anticipating – the desire.

DR. CARR: Under the recommendation, we added this sentence because as we
began to add the identification of what AQA was doing and so on, we grew
concerned that going forward, it is better just to acknowledge that there are
activities going on because we do not know going forward who all is going to be
doing this. Therefore we say the recommends the department initiate and/or
accelerate actions as outlined in the recommendations below. The changes you
see are, we moved two of the data quality recommendations under performance
measurement. In fact there change on number five, define a corse set of data
elements, and that should say for electronic health records for assessing
quality of care. Then number six, ensure that EHR certification criteria
supporting includes support for capturing and reporting core quality measures.

We deleted the recommendation about incentives because Bill helped us walk
through the financial implications of that. We decided, although as for the
concept, we are not in a position right now to make that actionable.

MS. CONAN: Justine, excuse me. Where is the added reference to the EHR?

DR. CARR: Number five, define a core set of data elements.

DR. OVERHAGE: I guess I strongly object to saying for the EHR in that
because it is not necessarily from the EHR because that is one possible source.
Why restrict it to that?

DR. CARR: In fact I agree with you. I think if we do not say for EHR we are
not – we are being inclusive.

DR. SCANLON: I think what we are trying to do is to distinguish the
effort-developed measure from an effort to develop building block is something
that we heard about within the secondary uses. Building blocks that can be in
an electronic system that make it very easy to assemble measures. One of the
things that we actually heard that was this hearing on quality reporting was
that while something might be a measure, but we cannot get it out of the way of
electronic data. We have to go in and abstract it. What we were trying to get
at is, how do we get it to the point where information is retrievable in an
easier way? That is what this number five is trying to say. We would like
people to move in that direction. Whatever words work to do that – So it
might be something like consider the implications of efficiently capturing
these data elements in the EHR. What that is doing is saying —

PARTICIPANT: You cannot say in the EHR. That is way too limiting.

MS. GRANT: Why not just say EHR or and then put something in?

DR. CARR: Can I just reflect what we heard? I think that the testimony that
we heard is about the utility of clinical elements added to administrative
data. Now, that can be added by pulling it right out of an EHR. It can be added
by transcribing it and submitting it. I think that as we think about trying to
describe the hybrid world and how we get from here to electronic, the concept
of adding a clinical element was the improvement. How we get it is the burden.
So, I do not want to lose sight of those.

DR. STEINWACHS: How about in addressing Marc’s point is reassessing quality
of care in EHR’s and other quality of care data sources. You want to highlight
the EHR but you do not want to limit is, I think, Marc’s point.

DR. FRANCIS: Yes, if you use or, that works better than and.

DR. SCANLON: I think Marc is raising a more fundamental point, which is
what are the other sources.

DR. OVERHAGE: Well, no, I think there are a lot of other sources. I just
worry about – I think sometimes we put too much emphasis on the EHR as the
solution. I think it is misleading to people because we are not going to be
there for 10 years. I think if you say EHR’s are the source of quality data, I
think we are dooming ourselves to not having quality data in a useable form for
a substantial number of the population for a long time.

DR. STEINDEL: I still have not heard any compelling argument to change from
what we have now.

DR. CARR: I think I agree with you. Larry?

DR. GREEN: Again, I fear that what we are doing around this right at the
moment is trying to be too explicit and complete. On recommendation number five
without placing it into the context of the whole letter – the
recommendations now follow a newly inserted paragraph where we are trying to
tie our recommendations to what we heard in the hearings, what we learned. We
learned in the hearings that there are key barriers to advancing this issue.
One of those barriers is the manufacturers and vendors of EHR’s do not have the
quality measures in front of them that they need to accommodate and
incorporate. We also heard that this is a very promising rich resource for
completing the data set. So, we are actually, in my view, trying with this
recommendation to move toward further clarification and standardization of what
the quality measures are, and we are trying to acknowledge that we heard very
clearly that EHR’s are expected to be an important source. So, we should not
lose both of those is what I am contending.

DR. STEINDEL: My contention is that recommendation six captures that.
Recommendation six is specific towards the certification of EHR’s and it says
EHR should be certified against that core data set. So, that implies that EHR’s
must be made able to express that core data set. So, I think those two
recommendations are fused together.

DR. CARR: Paul?

DR. TANG: I think Larry is right on the money. So, let me try to word
something that may help bridge this, which is consider implications of moving
to electronic sources that can lead to efficient capture of core data elements.
What that is doing is not prescribing – you also should not decide on core
data elements without thinking about how they could be captured electronically
in the future.

DR. STEINDEL: I could go along with that.

DR. CARR: Define a core set of data elements for assessing quality with
consideration of how it would be captured in the electronic health record?

DR. TANG: Or you could say in reference to what Marc was saying, consider
the implications of moving to electronic sources that can lead to efficient
capture of these core data element.

DR. SCANLON: Substitute completely for what we have —

DR. STEINDEL: Actually, I would like to see it worded in the opposite
direction. You worded it that – what we found is a problem is the people
that are developing quality measures do not develop them with precise enough
definitions that that can be expressed. What you are kind of saying is that we
should take what the quality people are doing and try to figure out how to do
it electronically. I think we should work together. I think that is what I am
saying.

DR. COHN: Maybe another wordsmithing option? Maybe to find a core set of
data elements for assessing quality of care to recognize the increased
computerization of clinical data?

DR. CARR: I like that Simon because we are describing the Hybrid state. The
majority of places do not have electronic. We want them to think about those
elements as they look at the reporting and capture it and then move on to
electronic.

DR. COHN: I probably do not have it right.

DR. TANG: The only piece is when you said and then, I think that is the
point that is being raised across the table, which is it is like doing the
policy after you have designed the entire system. The idea is to put the policy
ahead of the system design. Here, you want to think about the implications of
capturing things electronically as you design the core data.

DR. COHN: Do maybe rather than use and we use that?

DR. TANG: That, I think.

DR. COHN: So, Susan, get rid of and, and put that.

DR. SCANLON: Maybe that is too much in terms of what is currently in
computerized data. I think this is Steve’s point. You want to move forward and
vote. We want the computerized data to be more robust in terms of what we can
do. Also on the quality measure to take more advantage of the computerized
data, we want them both.

DR. TANG: I think we can do that wordsmithing a little bit later, but I
think we agree on the content? Yes?

DR. OVERHAGE: I thought I heard suggestion that we split this into two
explicit recommendations. I won’t say this right. One, it says as quality
measures are being developed, the availability of electronic data should be
considered and incorporated into that thinking. The other which says as
clinical data systems are developed, they should support and enable the capture
of the data that is identified in the clinical quality measures.

DR. COHN: I think the second one is number six.

DR. OVERHAGE: I heard comment here that the other one was one that we
wanted to express as well.

DR. COHN: You mean the first one? Yes.

DR. OVERHAGE: So, the question is, do you see this as one, or do you see
them as two? We do not have the first one explicitly represented. So do we add
a bullet to explicitly represent that or not?

DR. COHN: How does five differ from what you were just thinking?

DR. OVERHAGE: I guess it is being explicit in the sense of saying who is
acting. I think the piece that might be missing in the bullet is who are we
– obviously we are addressing this recommendation to the secretary, but at
the end of the day, we would like the secretary to input the quality
development activities to recognize, anticipate, and layer in the availability
of electronic data. We would also like the secretary to create rules or
whatever that – We do not want HHS to define a set of data elements,
right? Or do we?

MS. GRANT: Let me add some clarity. The recommendations of the AHIC Quality
Workgroup put forth in March, recommendation 4.2 specifically stated that the
National Quality Forum for its endorsement process should apply criteria that
reinforce these as standardized data elements and measures to allow quality
measures to be imbedded in EHR’s. The current status of that is that the
current NQS endorsement application criteria will begin to require vendors to
identify their data sources when they put forth new measures to be developed. I
think that may get to this point, which as you start to think about developing
new measures, you need to take into consideration that they will be
electronically implemented. I just wanted to clarify that that is something
that has been put forth to the secretary and is underway.

DR. CARR: Steve?

DR. STEINDEL: I am happy with this except I would like to change the word
capture to use.

DR. CARR: So define a core set of data elements for assessing quality of
care that recognizes the increasing computerization of clinical data for
efficient use of these elements.

DR. TANG: Can you explain that because I think you have added a different
– We are trying to capture it from the clinicians. You may also want it to
be easy to use from a reporting point of view.

DR. STEINDEL: No, one of the problems that we found and actually I am
reflecting on a recent conversation with somebody on whatever that panel was.
What we found was while they had very specific ideas of what we should –
what the quality measure reflected, when you actually started to talk about it
from a standards point of view, there was an interaction between what the data
element was being what they were thinking of and the information model that was
associated with that data element and how it would be expressed in quality
reporting. That needed to be expressed in the information that is coming from
the quality control organization. So, they do not just need to consider what
data elements they are capturing, but how the system will go on and use it for
quality measures.

MR. BLAIR: Maybe it is both. Maybe it is capturing uses?

DR. STEINDEL: Capturing uses is fine. I just wanted to have the concept of
the use in there.

DR. COHN: That certainly doesn’t look right at this point. Justine, can you
help us?

DR. CARR: Let me read it again. Define a core set of data elements for
assessing quality of care that recognizes increasing computerization of
clinical data for efficient capture and use of these elements. Let me read six.
Ensure that EHR certification criteria include support for capturing and
reporting core quality measures. I think that these began as one and were
separated. I feel like we are making five redundant with six.

DR. TANG: I do not think so because one deals with the development of the
core data element with certain considerations. The other is we also have the
cooperation of EHR vendors to make sure it is captured and used in the way that
we –

MS. MCCALL: Maybe one small enhancement to number five. I should say I
agree with keeping them separate. So, define a core set of data elements for
assessing quality care that harness the increasing availability of computerized
clinical data. The rest of the sentence seemed to get into number two, which I
think can be kept separate.

MR. REYNOLDS: On number six, should we add something that EHR’s and other
appropriate systems? The reason I say that is if you just look at the EHR
vendors, you may have a lab vendor that is sending something to the EHR. If
this doesn’t go all the way down the chain, or everything that gets certified
through CCHIT or anybody else. If a lab system doesn’t pick it up, it may not
get into the EHR.

DR. OVERHAGE: At the risk that I will probably need to be carried out of
the meeting here. I actually really hate including the certification criteria
in here. I guess the question I would as is, is that what the committee really
wants promote and support?

MS. MCCALL: Can you explain more about your hatred?

DR. OVERHAGE: I guess the question is, is the committee’s position that
certification criteria for all relevant clinical information systems is what we
would like to recommend to the secretary? I think that certification is a not
only challenging, but perhaps detrimental process.

MS. MCCALL: So, it is the word certification that you are concerned about?

DR. OVERHAGE: Well, it is. It plays into an existing process.

DR. STEINDEL: I do not have a problem with six worded the way it is. Ensure
that EHR certification. I do have a problem with the suggestion that Harry made
about expanding the scope even just slightly because right now we have an
established procedure for EHR certification.

MR. REYNOLDS: Is this a letter just for today?

DR. STEINDEL: If it is a letter beyond today, I agree with Marc. I am
uncomfortable with expanding the certification process beyond what is
prescribed today for the EHR.

DR. TANG: What is prescribed today? AHIC’s instructions I think are to
include —

DR. STEINDEL: Exactly, that is why I do not have a problem because the
system is going down exactly the path that we say is in six. It doesn’t
encompass any new burdens. If we start talking about expanding the
certification process to include a lot of existing information infrastructures
into the certification process that we start going backwards to the labs and
start talking about including them. I have a problem with that. We need to
explore it much further before we can make any recommendations.

MR. REYNOLDS: I will go with explore. Not in this letter, but just like we
talked a little bit ago about ICD-10?

DR. STEINDEL: I have no problem with that.

MR. REYNOLDS: Because sometimes we get a little myopic about picking the
most recent three lettered acronym and saying, let us fix it. We are building a
structure that is going to be changing dramatically on a regular basis. So, I
am good with that if that is going to be the continued focus of the quality
committee to continue to do that. I am fine with that.

DR. CARR: Marc?

DR. OVERHAGE: My only question for Harry is that it implies a certification
fixes something.

DR. CARR: Let us stay on the letter.

MR. REYNOLDS: Marc, remember, I was working on adding to it. I am not
fighting it one way or the other.

DR. TANG: I would agree with the way it is written.

DR. CARR: I am going to read it again. Define a core set of data elements
for assessing quality of care that harnesses increasing availability of
computerized clinical data. Six, ensure that EHR certification criteria include
support for capturing and reporting core quality measures.

DR. OVERHAGE: This I actually a proposal for an addition to five. I think
we should add a sentence that explains what we mean by core. It gets into the
issues of workflow and cost and who pays for what. Something as simple as
implications smoke or not has tremendous implications for clinical workflow as
one of the core data elements for example.

DR. CARR: Take the word core out. Did that make it better, Marc?

MS. WARREN: I thought you were trying to target some of the core quality
measures?

DR. OVERHAGE: What is core, is the concern. What makes it core? If a data
element is used in 20 quality measures, good thing. Right? We would like to
encourage hat to be captured in a structured consistent way. I think the other
aspect to core probably has to take into account respecting the impact on
clinical workflow, cost, and challenges for the organization that has to
capture that data element.

DR. STEINDEL: This gets to the point that I made yesterday about including
HSPE in this because one of the charges to HSPE is to take into account all
those considerations when core data elements are selected. Now, the workgroup
decided yesterday to remove working with HSPE which encapsulates that, the
concepts that Marc is talking about. I was comfortable with it because you
removed all of the other groups as well. That was the only reason I was
comfortable.

DR. OVERHAGE: But HSPE shouldn’t be specifying what the content —

DR. STEINDEL: HSPE is not. There was some discussion back and forth between
the quality groups, and what you will see coming out on the IS in HSPE in the
quality area is describing the interaction between quality groups and HSPE in
defining these core data elements.

DR. CARR: I think what we are hearing is this work is ongoing. Our purpose
is just to reaffirm, not to define it.

DR. TANG: Maybe the history of the word core, I believe, came from the AHIC
Quality Group, which asked NQF to define a core set. The definition of core
there was considered the high priority, clinical conditions for which there are
quality measures and define a core set that should be incorporated in those.
So, in that sense, it is almost like initial first kind of thing.

DR. OVERHAGE: The reference was to say as defined by – In other words,
what does it mean?

MS. GRANT: Would it be helpful to use a specific description from the
recommendation was a set of common data elements?

DR. CARR: I think question is, do we wan tot make it clear that we are
supporting what is ongoing, or do we want to introduce a new concept?

DR. COHN: Not a new concept.

DR. CARR: Not a new concept. So, therefore, would it makes sense if we keep
in the terms that are familiar with what everybody is doing as defined by AHIC
was the recommendation, no?

MS. GRANT: As defined by the recommendation that came from the AHIC Quality
Workgroup.

DR. STEINDEL: You use the preface sentence, NCVHS recommends that the
departments initiate and/or accelerate actions as outlined below. Maybe we can
just say, in five, support the existing development of, and not name groups.

DR. TANG: You know what? Common has two meanings. One is common, but the
other is to unify in common. I think actually they meant both of those that was
the intent of the Quality Workgroup of AHIC. I think it is a nice term.

MS. CONAN: It is not a core set of common. Is it support the existing
development? Is that what you said?

DR. TANG: I was suggesting not doing that. Then it tethers it to something
that you do not know.

DR. CARR: Support the development of a set of common data elements for
assessing quality of care that harnesses increasing availability of
computerized clinical data.

DR. TANG: May I suggest a friendly suggestion to Carol’s word of harnesses
to consider the implications of because harness puts on in difference to the
other. It sounds like, let us see what is available in the EHR and go use it
versus let us consider what can be in the EHR and get that to be the –
That can work both ways.

MS. MCCALL: I think that can still go both ways.

DR. CARR: Support the ongoing development of a set of common data elements
for assessing quality of care that considers increasing availability of
computerized clinical data.

One other thing that I wanted to mention here.

On number three, we had said accelerate US adoption of ICD-10 by publishing
the required notice of proposal making. It doesn’t say proposed rule making.

MS. CONAN: I changed it to take the tagline —

DR. CARR: Right, is that the right citation? I think that is it.

DR. OVERHAGE: You want quality, right? Two things, go back up to
recommendation four for a minute. Where we see, including risk adjustment of
administrative data, first of all we are not interested in risk adjusting
administrative data. We are interested in risk adjusting quality measures or
scores. So, you do not necessarily want that qualifier. On the first one on
recommendation one, I think there are a couple of adjectives that we probably
want to think about. One is, we say promote public reporting of quality. Again,
we want to report quality measures or quality scores or something. I think when
you do that, you also want them to be credible. I think that is critically
important because there are a lot of quality measures that are being reported
that are not credible. I do not think it is good to report that.

DR. TANG: Would another term be comparable? The reason is because that acts
again double-loaded because it says it would obviously have to be credible to
be comparable.

DR. CARR: Promote public reporting of valid quality measures in a
consistent format to promote —

DR. TANG: Would you accept valid, comparable? The reason is that everybody
could have their own valid measures and we do not get any —

DR. OVERHAGE: Isn’t that what we are trying to get with consistent? Is it
consistent and comparable?

DR. CARR: Yes, in a consistent format.

DR. STEINDEL: What is a valid measure?

MR. REYNOLDS: Aren’t they accepted?

DR. STEINDEL: By who?

MR. REYNOLDS: Somebody is saying they are valid. Usually when you do
something like this, you would have –

MR. STEINDEL: Any group can create quality measures and they could be
considered valid quality measures.

DR. COHN: I have to say I do not think we are helping by this particular
wordsmithing. Marc, I do understand your issue, but valid – I think this
is a level of nuance that is probably lost on everyone.

DR. OVERHAGE: I guess my concern is, and maybe I can just disagree and shut
up, but I think it is unfortunate if we recommend to the secretary the
reporting of any quality measure that somebody happens to think of that is
consistent. They do not think it is a good thing for us to recommend.

DR. STEINDEL: I think the key here is the public reporting. If you start
reporting this in a consistent fashion to the public, people will start talking
about people who are using quality measures that really aren’t appropriate and
will put pressure on removing them from the system.

DR. OVERHAGE: Perhaps after doing great harm

DR. STEINDEL: We are adding some stuff later on that says define what these
elements should be, et cetera. I think we have to just stick with the necessary
first step, which is what is defined in one.

DR. OVERHAGE: I am strongly opposed to that because I think it is a high
risk to recommend it.

DR. CARR: I think what we are saying is how many levels of referencing do
we do? If we say valid, who is validity? If we say validity, what is the
authorization? I feel that is what is taking us down the road. I personally
feel that the word valid is a strong word and adds value to that statement. I
do not feel that we need to then define valid and reference with footnotes what
would —

MS. GREENSBERG: I am okay with valid, but how about accepted quality
measures?

DR. FRANCIS: I actually like valid because it has a recognized scientific
meaning, which is that it measures what you are trying to measure. Accepted
sounds much more like what you are doing is trying to get consensus on it, and
that might be bad.

DR. CARR: If we leave the word valid in, are there any strong objections to
stating it as promote public reporting of valid quality measures in a
consistent format to promote consumer understanding and otherwise enhance
comparability and learning.

DR. STEINDEL: That is a strong objection.

DR. CARR: Could you suggest an alternative language?

DR. STEINDEL: If you are going to put any qualifying word like valid in
there, I want to know valid by who. That is my immediate question.

DR. SCANLON: This is a recommendation to the secretary. The secretary is
trying to achieve an objective called valid measures. It is not that we are
saying there is a particular body that is going to certify valid. It is going
to be the secretary moving in a direction with results and valid measures that
may be coming from a variety of sources. The same thing with respect to
consistent format. We are telling the secretary, please try and promote this.
There is going to be all kinds of people developing formats. There is not going
to a single body that is going to specify the format. These are objectives for
the secretary. The how is not something we are working on. It is the objective
that we are trying to state.

DR. STEINDEL: Then we need some sort of statement in there that somebody is
going to select valid measures.

MS. FARQUHAR: Valid for performance measurement sake is an accepted term.
Paul, I think you can speak to this. That is how we speak about measures. They
are valid. They are consistent. They are precise. They are scientifically based
as an accepted term as this young lady overhere had said. Basically, when
people say that, that is what they mean by it.

DR. CARR: This letter is within one word of completion. Let me just read
this again and ask the question again. Promote public reporting of valid
quality measures in a consistent format to promote consumer understand and
otherwise enhanced comparability and learning. Is there further discussion?

DR. OVERHAGE: One more word I think and the question is consistent format.
Do we also want to say something about meaningful or interpretable? Because
when you go to public reporting in particular, there is a lot of things you can
say in a way that doesn’t help.

DR. STEINDEL: By who?

DR. OVERHAGE: The public.

DR. CARR: That is right. The concept is there to promote consumer
understanding. Again, we will perhaps defer to the secretary that he would work
with that.

MS. CONAN: I had a question about number four. I went ahead and made the
change that Mark recommended, but we really did not get discussion on that.

DR. CARR: Support research for improving measurement accuracy and validity
including risk adjustment and risk of quality measures by the addition of
clinical elements.

DR. OVERHAGE: So do we just believe that by addition of clinical elements,
that is not the only way to risk adjust in that.

DR. FRANCIS: I thought the point here was that administrative data require
more. So, that was the specific reason for adding a reference to clinical
elements.

MS. KANAAN: How about “such as?” Such as by adding clinical
elements to administrative data?

DR. TANG: There was direct testimony on precisely that point.

DR. CARR: So, if we have the general as suggested by Marc and we have the
specific as included in a such as by adding clinical elements to administrative
data and Mary Beth?

MS. FARQUHAR: I was thinking too as the nurse, the nurse sensitive measures
do not just use clinical data. That is what I think Marc was getting at here.
There are other sources that can be used and will be used in the future with
regard to performance measurement. We just have not gotten there yet.

DR. CARR: Do you want to add another example?

MS. FARQUHAR: Well, you do two administrative data and other sources.

DR. CARR: Support research by improving measurement accuracy and validity
including risk adjustment of quality measures such as the addition of clinical
elements to administrative data or the incorporation of nurse sensitive
measures.

DR. TANG: Now, we are going beyond the testimony.

MS. FARQUHAR: You might want to put not just nurse sensitive measures. You
might want to say something like, or other data elements obtained from other
sources such as human resources, financial records, or something like that.

DR. CARR: I accept that concept. We will spell that out because that is the
testimony, but the wordsmithing I think I would like to defer from if we agree
with the concept.

MS. GREENSBERG: If you give an example, that doesn’t mean you are
precluding other examples.

DR. CARR: However, I do think that this was novel that we heard with the
nurse sensitive, hours of care ratio.

DR. COHN: Was that included in your document? It is referenced in here?

DR. CARR: Yes.

DR. COHN: Okay.

DR. CARR: So, my suggestion would be that we work with Mary Beth to get a
parsimonious statement that is inclusive. Any further discussion?

DR. COHN: Okay, I guess with the executive committee having some latitude
for wordsmithing, was there a second here? Any further discussion on this
document? All in favor? All opposed? Okay. Justine, thank you.

DR. CARR: I commend my colleagues. I learn more every day. I appreciate the
input.

Agenda Item: Committee Scan – Projects, Issues,
Plans

DR. COHN: I do want to take a minute. I think our

last action item has to do with tab four. Let me just have you go to it. I
think this is actually an action item that we need general consensus or
agreement on. This was developed at a member request and basically is intended
just to sort of go through what I think most everybody sort of understands is
generally the process of subcommittees and workgroups about how issues are
brought up, prioritized, considered, how the hearings, how draft documents are
discussed and referenced, and how things then get to the full committee and
move on from there. I think this is a practice that I think most every
subcommittee or workgroup has followed, but I think it was helpful for us to
sort of sit down and I started writing through what I thought were the overall
processes. Now, if you like to, I can sort of run through this very quickly
since I know some of you are new. Once again, this is not required that we go
into this level of specificity, but once again is a sort of a general process
that I think most people are using. Do you want me to go through it or what?

DR. FRANCIS: No, I had a couple of questions about it. You do not need to
go through it with my questions. I am a newbie, so I had two questions. The
first is, it is always hard when you are a newbie to appreciate the context for
something. So, I am not sure why. Leaving that aside, I like the idea of
something informal of course with federal advisory committees, there is always
the question of whether things like this should be actually posted on a website
and things of that sort. If it is just informal and kind of our normative
understandings, then obviously the answer to that would be no. That is a
concern I think if this is something like our procedures, then it is going to
need to be at some point public. The third thing that I guess the one thing
about it that bothers me a little bit is the one that starts where a member who
has serious concerns that his or her points of view are not being addressed
should bring this concern to the attention to the subcommittee or workgroup
chair. If the concern continues, the members should address the issue with a
full committee chair. I do not like the idea of people sort of going around
behind people’s backs. The one thing I would encourage about that is that we
should have an understanding that it is fine to raise something with the
committee chair. The way it should be raised is with the full knowledge of any
subcommittee.

So, if the subcommittee is really reaching an

impasse and the subcommittee is going to recommend something that there is a
dissent, I think it would be a really bad process to have people without having
the holds of committee know just call the committee chair and say, there is too
much opportunity for backroom dealing that way or torpedoing or something. If
what is occasioning the need for this is a worry, so I would want to say that a
member who has serious concerns that his or her points of view are not being
addressed should bring this concern to the attention of the subcommittee and
workgroup chair. If the concern continues, the member should let the
subcommittee know that he or she is going to address the issue with the full
committee chair.

DR. COHN: John Paul?

MR. HOUSTON: I have a couple of comments too. I would tend to agree with
Leslie. I also think that that actually isn’t just committee members. I think
some of that dealing goes on in certain subgroups with some of the staff that
is actually on the committee too that it seems like certain things happen in
back channels. I think that we need to have transparency within the
subcommittee. That is the first comment I want to make.

The second comment is that since every committee

member really is entitled to go to any subcommittee meeting they want to go
to, I do not see any reason why they should not be privy to drafts that are
circulated. I think that if somebody has an interest, it might be good for them
to read it and maybe even propose some comments to it even while it is going to
the subcommittee. It might expedite getting things resolved. There are other
cases where some of us do not watch closely enough some of the other
subcommittees and all of a sudden a letter comes up that somebody might have an
interest in. I have seen that on a couple of occasions myself. It is only when
the letter is being finalized. It really is something I might have had an
interest in. I might have said, I want to get involved in this had a I known
the letter was being formulated.

So, I think there is a value in having committee members see that. Maybe
just as an e-mail. I would rather get too much information and not participate
and have the opportunity to see what is going on. Again, we are all entitled to
participate. I do not know why – I feel like we are being excluded from
the process in the subcommittee.

DR. COHN: I guess the question is, is the issue that the second bullet
where the topics are presented to the full committee before they are
investigated? Is that part of your needs? Or is there something else here?

MR. HOUSTON: I do not know if that always occurs. Maybe that does occur.
That is helpful. Also, I think through the process, if we are copied on, things
are generally circulated to the subcommittee. If we have forgotten about it or
if something has taken a long time to sort of get substance, than I think it is
a value. I do not think there is any reason to keep it away from the committee
at least as an FYI.

DR. COHN: Okay. I just wondered if that addressed that thought. Paul?

DR. TANG: It is a little bit interesting because I think Leslie and John
are actually taking opposite points. You are actually saying two different
things. I think to Leslie’s point, it does look like this is a backroom thing.
I think what is implicit and could be made explicit is that all the discussion
is done with a full subcommittee. If the draft does not represent the views of
the full subcommittee, and I think it actually addresses John’s concern too,
then you have an escalation procedure. So, it is not to bypass the full
discussion within subcommittee. So, I think the intent here is to comment on
what you said.

To address John’s message, it is actually the same point. In other words, I
think what is meant by essential is that it is essential that drafts that get
circulated beyond the subcommittee reflect what is going on in the
subcommittee. So, disagreement would be the thing that needs to escalate is
when there is business between what is getting out and what is not representing
what is going on in the subcommittee.

MR. HOUSTON: I understand that. My point is to the extent that I, as a
member of NCVHS, has a right to come to any subcommittee meeting, I believe.

MS. GREENSBERG: Within budgetary constraints.

MR. HOUSTON: Let me just say this. Let us just assume that I decide on my
own nickel to – actually, I am in a full committee meeting and I decide
that I am not doing – like this morning, I did not have any meetings until
10:00 am because I am not on the other subcommittees. I may have decided to go
to Standards and Security, or I might have decided to go to Quality.

MS. GREENSBERG: Any member of the public has a right to come to any of
those meetings.

MR. HOUSTON: My only point is to the extent that I could sit in on a
meeting. I do not know why I should be excluded from certain situations of
them. It might be as a carbon copy on an e-mail. This is my preference. I do
not think there is harm in early drafts going out.

DR. COHN: Let me make the final comment. This is something that is not
here. I think what you are telling me is that we are still in a sort of draft
stage of this thing.

MR. HOUSTON: This is a very good document. I think it is incredible value,
so do not get me wrong.

DR. COHN: No, I am saying that I think what you are referencing is almost
something a little different that may be that a member can request to a
subcommittee or workgroup chair to sort of be a corresponding member. I think
that is what you really are referencing.

MR. HOUSTON: I think maybe what I am reacting to is the 5^th
bullet from the bottom. The chair should have agreement from the subcommittee
workgroup members before circling it to the full committee.

MS. GREENSBERG: It means the entire full committee. First of all, it can
certainly be revised. As to whether this needs to be posted on the website or
whatever. Everything we are doing is in public. Anything we are discussing will
be in our minutes, et cetera. This is for the members. It doesn’t control the
way we interact with the public. It is really sort of internal working. Other
than being documented in our minutes, I see no need to post this in some sort
of formal NCVHS policy. Particularly if it is at the subcommittee level where
we have a fair amount of flexibility as to how we function.

Secondly, the idea was with the chair of the subcommittee verses the full
committee is that you should try to get things resolved within the subcommittee
or the workgroup and start there. That is obviously the way most things go.
Then as for the issue of getting things going to the full committee. It is not
a question of whether anybody on the full committee can get copies of anything
in draft or whatever. They certainly can, but the idea was that if a draft is
sent to the full committee, it gives the impression if it isn’t clarified that
this is what the subcommittee has agreed on now what do you guys think. If in
fact a draft is going to the entire subcommittee, it really doesn’t have any
level of agreement within the subcommittee then that needs to be indicated
because it would give the false impression to other members that we have all
agreed on this – so those are some of the ideas behind it.

MR. HOUSTON: Then maybe my concern would be addressed by a bullet simply
saying that any subcommittee member though is entitled to be asked to be on the
distribution for the subcommittee.

DR. COHN: Yes, we will add a bullet. So, I have Justine, Larry, Harry, and
then Leslie.

DR. CARR: Thank you. I would like to observe that just as with this quality
measure, how many know valuable input for this letter at the full committee. In
terms of our process, if we have a letter that is in dispute within the
workgroup or subcommittee, it is guaranteed that when it gets to the full
committee there is going to be a significant amount of discussion. I wonder if
we might just be more transparent about the fact that we have a division of
opinion in this subcommittee and we need input from the full committee right
away because you may find that the one disagreeing voice turns out to be a
majority when other people come into it. I wonder if that might be a way to
leverage the full committee early on to say we cannot come to closure. Could
others weigh in? I would do it proactively because what happens is it becomes
very difficult to manage in the full committee then and introduces delay. So,
if we already foresee that we have something very controversial that needs more
input that we would fast track that part of the full committee.

DR. TANG: I do not think that any of this that you are describing doesn’t
permit or prohibit that. Let us go to this quality letter where there are
multiple, almost daily outputs. If that got circulated to the full committee,
it would be really hard to manage, even the consensus generating. This is
trying to say, let us make sure when it gets out of subcommittee – anybody
can come into a discussion, but when it emerges to wider distribution, it
should be reflected on what is going on.

DR. COHN: Or at least there should be agreement from the members of the
subcommittee that it is suitable to get all of that. I think that that is
– at the end of the day, what we want is everybody to agree with something
as opposed to having 7 to 5 votes.

DR. CARR: I am just saying though, if what precipitated this was a
situation where there was not agreement to water down a letter or to modify to
take out everybody’s concerns and say something that might in fact mask a very
important issue that needs input from the greater committee. That is my
concern. In terms of secondary use, there is that whole thing that would go
around. There may be one or two things we cannot come to closure on. We ask for
specific input and get broader expertise and broader thinking.

DR. TANG: That is why I think what Simon said is helpful. It is not that it
emerges with consensus. It emerges by agreement of the group.

MS. GREENSBERG: I think this one really should be modified then to say that
in such cases the chair should have agreement from the subcommittee workgroup
members to circulate it and should indicate the level of consensus within the
subcommittee on the areas of disagreement. So, it is not like you cannot
circulate it until you have everybody agreeing on it, but the subcommittee
should say we agree this can go out to the full committee. It is just truth in
advertising.

DR. COHN: Yes, I think that we need to note that and make the changes.

DR. GREEN: I want to express appreciation for this. I was a newbie. I think
that is over. I take this document to be an important decision on our part. I
want to express appreciation for it for two reasons. One is that it informs and
also it gives us the chance to improve. The important thing is that as a new
member of the committee there had been a piece of paper like this that someone
had handed me. It would have been very, very helpful. I think for subsequent
members of the committee, we are very close to having a document that is useful
to explain the committee operations and process and whoever is doing this is on
track with what I now know. I appreciate it.

I want to draw attention to the third bullet. In the spirit of attempting
– so, in terms of the process, after the third bullet, I think there is
something very important missing. It has to do with distribution. It has to do
with operations. I find I may be alone here. I am about to hush, but I find it
difficult to function effectively as a committee member when there are multiple
versions of what we are working on being distributed in diverse ways in
unpredictable manners. I am sitting in Denver, Colorado Saturday night at 11:30
trying to figure out my e-mail, and that is when I discover the distribution of
a 19-page document that is extremely complicated. I want to come to these
meetings prepared to contribute. I want to do my homework. When I get here and
then discover that we are actually going to discuss a different document, one
that is not clear to me how it is different. I am suddenly placed in a position
that I find awkward. Here is where I am headed.

I would like to propose that in the next version of this that there be
consideration to there be something akin to what I would call a closing date
for distribution of prefatory materials for a meeting. With a clear expectation
that participants in the meeting are expected to come prepared, that we do not
spend our time reading this to ourselves and to each other, but that we spend
our time focusing on the critical issues that we need to be together to
discuss. I think such an event does not have to be absolutely rigid. There can
be compressed workloads. I think at the digression of the chairman and the
committee, there can be last minute revisions. I would so appreciate knowing
that by seven days prior to the meeting, whatever I have got is what I have
got. I need to get ready as opposed to wondering what else is going to happen
between now and then? Am I wasting my time in reading this? Am I the only
person that experiences this?

DR. COHN: No, you are not. I think I am reflecting on the differences
between being a family practitioner and being an emergency physician. I think I
have a little more chaos in my regular life.

MR. BLAIR: As you know, I am blind. A lot of times when I get to
Washington, there are not readers here for me to read the last minute
materials. I have been on the committee for more than 10 years. So, I am
probably one of the folks that over the years has requested that materials be
sent so that I could have my readers read them to me on the weekend before the
meetings. Everything is done to accommodate that. I guess the reason I am
commenting here is that you are not alone. I am particular, because I am an
example of being able to function more constructively when I can read the
materials beforehand. I would only say that I think this should be a practice
and a goal from the standpoint that – you said the caveat yourself. You
said that you do understand that there is times when there is very short time
frames and people are working right up till the end. When that happens, there
is a frustration. I think there has to be some latitude for the fact that
sometimes there are last minute changes and that they are going to be
frustrating for you, but you are not the only one. There are a number of us. It
has been generally respected that there is every attempt to try to get things
distributed the weekend before. So, you are not alone. I think the general
practice here is to respect that fact.

DR. COHN: I am going to give it over to Harry. This is an issue without
trying to solve this particular one in the moment. I do think we need to bring
back the executive subcommittee and propose what are some reasonable things. I
think everybody is trying, but I think it is once again reality coming against
what we all recognize need to be really legitimate timelines. I did not mean to
make so wide of it, but I think everybody would like to get it in. I think we
just need to refocus and double our efforts on that.

MR. REYNOLDS: As I read the document, the document and all the requirements
for the committees and the limits of the requirements of the participants. I am
playing off of Larry’s. As these subjects are getting more complex and more
lengthy in time and also some compressed, there are open calls for the full
committee. There are copies that go out. What becomes hard is that if you are
on a lot of committees and you work enough that people do not come prepared. I
agree with Larry that timeliness is important. If people do not come prepared,
then it really becomes almost disheartening to spend all the time and effort
because you hear questions at the beginning of a document that you know there
is a whole section on it. That means somebody did not even look at the section.

I just think as part of our ground rules is that

if it is that important that you want to comment, then spend a little more
time looking at it. So, if we are going through other things that you get the
message. It is great to get all the comments about specific issues, but get the
message. If you do not get the message, then I promise you most of the
committee chairs and others would be happy to spend time ahead of the meeting
or do whatever to help with that. I just think that would be helpful because
starting – if you take four people that have not done it, well you start
right at the beginning again sometimes when there have been opportunities for
people to engage or please call if you do.

DR. COHN: Leslie?

DR. FRANCIS: It was official protocol. Is it bad manners? I wanted to just
follow up with what Paul said. You got me right. I am trying to urge as full
transparency as we can have because that is what really helps all of us to be
functioning participants. Part of why I was puzzled by all of this actually was
that so far I thought there was a whole lot of transparency and I like that.

DR. COHN: Paul, you are next.

DR. TANG: I would just like to combine Harry and Larry’s comments. I think
the elegance is that what Larry proposed is what Harry is talking about. We
certainly do owe the subcommittees and the workgroups our full attention. What
Larry is saying is that it is really hard to do when you get the 19-page
document the third time and there is no redline. You just feel defeated. So,
the concrete piggyback on to what Larry says is that in the exception or
whatever rare chance that work goes on right before, at least give us a
redline, we can focus in our attention and not have wasted a Saturday effort.

DR. COHN: Carol?

MS. MCCALL: A couple of additional comments. One is just on our engagement,
our roles, and the second is something you may want to consider as you get into
the executive subcommittee. I do think that our roles are about our promises to
each other. I think it is about what we accept and expect and permit in terms
of what we do when we step into this room. So, coming in and reading things
expects that people have not done it. So even simple changes with things like
that that says we are going to start the game starts and where we are going.
So, that might be one change.

The second is that if you are not part of one of these groups in the kind
of immersed activity. It is tougher to catch up, right? Because there has been
a lot of conversation that has gone deep. Playing catch-up in my experiences is
on the kind of Ad Hoc group for enhanced uses. I recognize that I am behind,
and yet I try to play a different role by using an naïve view. So, it is
just that game. It feels like crack the whip when you are trying to be the last
person on till the end.

The third is there are technologies that helps us guys. I would recommend
that you look at some of those. They are very easy to use that not only provide
a HUB and an easy way to find that document. I do not have to go through my
e-mail in this kind of serial way, but also naturally track all the different
versions. So, if you want to take a Saturday and go, I am going to have to
reconstructive thinking because I am the last one on the whip, but you can do
that. I have used them in a variety of different venues. They are very helpful.
They work cross organizationally. There are other things like that. Take a
look. It could be really valuable.

MR. REYNOLDS: Is the fact that we read part of it because we are on the
Internet and other things?

MS. GREENSBERG: One is to accommodate anyone who is visually impaired and
cannot be reading things or changes that were just made or we are not in the
version that were available before. The other is because, yes, we do not post
the documents on the Internet, and often we do not even have the documents
available for everyone in the room. So, that means that everybody who is trying
to participate, not just the members, but the public, has – here are the
recommendations or how they are. So, I do not think we can eliminate that
entirely or should.

DR. COHN: I think it is very appropriate for us to read important things. I
do not think we need to read every part of every thing as we have seen. You
will be the last comment on this one.

DR. STEINDEL: Just a quick comment. A number of the comments that have been
made here have been more comments to ourselves on process and not necessarily
rewording this document. In fact, my comment is not directly related to this
document, but the amount we spend rewording a lot of documents. I think it
would help us a lot when we engage in these exercises is if at the very
beginning we state to ourselves or maybe formally or informally who is our
audience? What are they going to do with the document? What do they most need?
I think a lot of our word crafting ends up being for ourselves to help us
refine and understand the issue, but for the reader of the document, that is
not what they are going to walk away with. I am looking at the Secretary’s
letter saying thank you for all you have done. Yes, I pushed forward the
adoption of the standards you recommended, and I have sent this other
recommendation on to a committee. That is what he took away. He may not have
paid a lot of attention whether we used the word valid or not. I think it would
help us in the time we spend on the letters if we keep in mind who our audience
is and what they need. Even if we write it to the secretary, the secretary is
– sometimes we really want to write things that people really need to read
because they need this information of what is going on. Sometimes we just need
a secretary to make a decision. I think it would save us a lot in the process.

DR. COHN: I think we need to reflect on that a lot. My view, and I think
most others would be that wordsmithing is welcome but is offline from full
committee. Where it relates to content and understanding that is where it
becomes important. It is more like change the meaning. That is the important
wordsmithing that we need to be engaged in. I agree with what you just said,
and we need to be reminded of that. Paul, I think you will have the last
conversation.

DR. TANG: This might be introducing another enhancement to process. I am
thinking back to what Larry and Carol said. It does draw back onto this. In
some sense, what we are saying is the stuff that comes out of subcommittee by
agreement should have a certain sense of there are some people who dedicated a
lot of time to figuring this out. That should be almost an expectation to the
rest of the committee. Anybody could come and participate in that process. That
makes it open. As it emerges, it seems like we should take it here up instead
of back down here. I think that is what Larry and Carol are saying. That might
be a slightly different way of approaching documents that come out of committee
whether for final approval or for draft comment. Is that helpful?

DR. COHN: Okay, I want to stop the conversation at this point because we
need to break. What is going to happen with this document is it is going back
to executive committee for further conversation. We will be adding some bullets
and probably bringing it back. We need to reflect on what we want to do with
this. So, we will talk about that in November. I mean to cut things off. I
think we have had a lot of good input. I do think we need to get some lunch.
Then we need to go back and talk about the secondary uses document again. So,
with that, we will give everyone an hour break. We will come back right at
1:15. We will handle committee updates at the end of the meeting before we
adjourn.

(Whereupon, the committee adjourned for lunch.)

A F T E R N O O N S E S S I O N (1:15 p.m.)

DR. COHN: Okay, why don’t we get started. Will everyone please be seated. I
have been notified that despite my pleas, I think that people are going to
begin to bail out here a little bit after two or so. Now, as I said, I think it
is very important spending some time talking about the Secondary Uses report
knowing that we are up to Recommendation 5, I believe. So, Harry, I will turn
it over to you to sort of move us through the last of the recommendations.

Agenda Item: Secondary Uses of Health Data

MR. REYNOLDS: Okay, in the spirit of making sure that we at least have some
discussion on each of these, if we would make sure that we hold our comments to
substantial issues related to it rather than wordsmithing on some of this right
at this moment. So, if you go to our slide up there. It talks about number
five. We are starting on line 1114.

Under the problems, the clearinghouse definitions

is limited to transmission of financial and administrative transaction.
There is uncertainty as to whether new forms of clearinghouses such as HIE
entities, network, service providers, switches, banks, and e-prescribing
gateways is what they are. So, our recommendation as it says up there for 5.1
is that there be guidance that clarifies that any clearinghouses is a business
associate and must be bound by the requirements of the business associates.
What it basically says in the actual wording is that right now under HIPAA they
are considered covered entities, but they are covered entities as we have tried
to look at this. They are not covered entities that patient or other people are
aware of. We talk about transparency and other things that there is not even a
good way for them to be transparent. Now, some of those break down, yes. Others
of them possibly not like the switches and some of the others that move
transactions. That is kind of the flavor of the issue that we have on the
table. With that, I will open it for discussion.

MR. BLAIR: I would like to support the way you crafted that. The reason I
have, I do not know if it is the same as the one that your taskforce had, but
the reason that I support it is because my initial take was to expand the
domain of covered entities. When I look at clearinghouses and networks, what
they are doing is they are transporting data for other people to use. Now, that
is not completely entirely true, but in many cases it is. They are enabler as
opposed to a user in themselves. At least some of them are. So, if you wind up
referring to these entities by bringing them in as business associates, I think
that is appropriate.

MR. REYNOLDS: Let me make one comment before I move to Paul and then Mike.
The actual recommendation even though up there we mention HIE and other things.
In the actual recommendation, we do not identify specific entities
purposefully. In other words, this is a subject rather than saying any
particular way of doing business by any of these people is right or wrong or
indifferent. So, the actual recommendation doesn’t really pull out any
particular item even though our slide is – Okay, now we have Paul and then
Mike.

DR. TANG: I understand your second bullet on the left meaning there are
lots of in between folks that could or could not be called clearinghouses. I
guess I do not understand why on the right we demote them to a business
associate. What I mean by demote is they seem to have – they used to be
covered entities when I used to know the term clearinghouse. Along with that
were very specific responsibilities that a “covered entity” has. As
we discussed yesterday, business associates have a lot of free reign and almost
no enforcement. So, it seems to me that this actually puts less on the
responsibility or the enforcement side.

MR. REYNOLDS: We are still not changing their status as covered entities
for the HIPAA transactions under which they were set up as a covered entity. We
are talking about this item being further use of the – remember, this
subject is not the transactions and code sets and what it was set up for. This
is the new world where different things will happen to this data that will use
secondary uses that we said about. That is why we are bringing this up as an
item of consideration because if you think of the individual as we have had our
discussion was the individual as a contract – if you take the three types
of covered entities, the payers, providers, clearinghouses – If we think
of transparency, that is where we are going.

DR. TANG: It certainly leads to the question associate of whom and is hence
responsible to whom? So there are examples of business associates who are a
part of a large organization that are clearinghouse. Then can they use the data
they get by virtue of being a clearinghouse in all of their other commercial
ventures? That is a big question. I do not know if that answers this question.

MR. BLAIR: Can I weigh in a little bit on that? As a representative of a
health information exchange network, we have business associate agreements with
the health care providers in our community. We have to stipulate exactly what
functions we will –- So, there is translation. There is patient
identification. There is communication of the data. As of right now, we have no
objective of using it for pay for performance for example. We may in the
future, and if we do, we have to change that business associate agreement
because there will be a different use. Within the business associate agreement,
all those things have to be specified in those agreements.

MR. REYNOLDS: Marc, if I remember correctly, you have business associate
agreements. So, Mike?

DR. FITZMAURICE: Well, it seems to me that clearinghouses are covered
entities under HIPAA. If you ask whether they are business associates or not
depends on whether they signed a business associate contract or not. If the
problem is, are they business associates? You know whether they are or not by
whether they have signed a contract. So, that doesn’t seem to be the problem.
The problem I would think is what rules govern what they can do with the data.
Now, clearinghouses take the data from a provider, translate it into a format
required by HIPAA, and then send it on to a health plan. That is their
business. They can legitimately do that with out a business associate
agreement. If the data stop in the middle of the clearinghouse and somebody
opens up the envelope and pulls out some of the data for some other purpose,
they are bound by additional rules, the rules that govern whether they have to
audit what they do with the data and report back to consumers for example. We
issue data for the following purposes. We have a file of your data, and you can
ask us, is it accurate that you can correct inaccuracies in our data if you
open it up?

That is why a lot of clearinghouses would prefer

to be just switches. Some incorporate billing services and they would
probably have to be a business associate. They are doing something for the
provider that the provider could do for him or herself, not just translating
the data. Clearinghouses also parts of the hospitals, parts of health plan, and
it is not clear what the responsibilities are as part of the health plan. For
example, a health plan might say, you have to deal through our clearinghouse.
It is a clearinghouse that we own. As a provider you are tied to that
clearinghouse. You may want them to be subject to different rules than a free
standing clearinghouse that does normal covered entity operation and does not
need a business associate agreement.

MR. REYNOLDS: You said you left out that we heard in testimony. There are
plenty of clearinghouses that do far more than just be clearinghouses. The
reason we use guidance up here, and maybe some of the other words need to be
looked at is this is a subject that at least needs good considerable debate
because there is a covered entity out there that is not really related. We say
transparency through here and we talk about the person should understand. The
clearinghouses are out in that middle land. It is good for the HIPAA
transactions to move it around. How does that fit in this whole subject?

DR. FITZMAURICE: If we are talking about them being Rios, and if you are
talking about Rios getting 50 percent of the revenues from the secondary uses
of data, you are getting into a large and a different area then what
clearinghouses set up to do.

MR. REYNOLDS: That is exactly why we are bringing this up.

DR. FITZMAURICE: It may not just be clearinghouses, it may be all of these
things.

DR. SCANLON: I just want to reaffirm some of these other points. Remember
when the HIPAA privacy rule was – there was this very debate about what
exactly – are clearinghouses simply switches or the information that
passes through. There is no other information service. Are there other services
in terms of repositories and other uses of the data. Based on the comment at
that point, it was concluded that for the most part, clearinghouses would in
essence get a lighter HIPAA. As we indicated, they do not have some of the
provisions of authorization and notice that others do because they do not see
the patient. But HHS said that to the extent that these functions, and we use
the word clearinghouse more generically. The extent that entities do more than
just switches for example. We would have to revisit because the protections we
needed there as well. This would be extremely – clearinghouses as
technically defined and clearinghouses and information exchanges as broadly
defined are really almost at the heart of the matter in the world of health
information networks and the guidance around these lines would be very helpful.

DR. GREEN: This question may be for you Mike. I am not sure. This broader
conceptualization of clearinghouses in the one hand plus what Jim just said
about what this is really about are these data transaction centers. As we are
messing with this, can someone explain – actually, what I am looking for
is reassurance that this is a –

MR. REYNOLDS: When we use guidance we do not have a lot of reassurance.

DR. GREEN: I am looking for reassurance that our conceptualization of this
problem and this recommendation is not perturbed unnecessarily a group research
enterprises that are fundamentally investigating multicenter research that
might go to a data to be used in a health services research project. Maybe just
to crystallize it, if an investigator at CMS needs to work with 16 hospitals
and 27 practices, to do so effectively, they are going to draw data from them
and establish a central clearinghouse for those data for that project. Do they
have to have business agreements with each of those practices at each of those
hospitals? Is that what we are saying would be the case?

DR. FITZMAURICE: It would seem to – you said a researcher at CMS? It
is easier if it is at Duke, because CMS is part of a – if it is Duke, then
you are getting data that comes from a covered entity. So the rules set up in
the exceptions to HIPAA for research. If you follow those rules, then you have
no problem. You may have a problem with IRB’s approving this. You have to go to
multiple IRB’s, so maybe the logistical problems, but if you followed the
research rules for HIPAA, you are on solid legal ground.

DR. GREEN: And if it were called a QI project, would the Duke investigator
still be on solid ground?

DR. FITZMAURICE: You might not be able to get the data from the physician
unless you set yourself up as an organized healthcare arrangement. That is a
group of providers, not a group of researchers.

DR. GREEN: Harry, you were right. I got guidance. I did not get
reassurance.

MR. REYNOLDS: The point is, as Jim said it so simply, clearinghouses all
said immediately they were covered entities, but then Paul said covered
entities light. So, they had a little less requirements, and then by the way,
they are going to be data rich. So, the point is, as we are painting this
subject, it is just an issue that the subcommittee heard testimony on.

DR. TANG: What I interpret Jim to say is the switches are covered entities
light. Once you start to open up data, it seems you almost become a covered
entity in a sense that you need some more responsibility and accountability. I
guess I am still wondering why we are calling them business associates?

DR. COHN: Maybe I can follow up on that one because I am looking at this
one and I think we need to do some further fine tuning of this one. I think
what we were talking about is making sure that something inadvertently doesn’t
happen where there is a gap. Somehow we are not saying that here. I think we
just need to fine-tune this one a little bit.

MR. REYNOLDS: That is correct. Leslie?

DR. FRANCIS: I assume part of the fine-tuning is also to link this to the
earlier recommendations about certain standards and business associate
contract.

MR. REYNOLDS: Yes, anywhere we would use business associate going forward.
All the other things that are included in the letter would come along with
that.

DR. TANG: A finish concept to it is who are they a business associate of?
Why would not they be a business associate of the subject of the data? In a
sense the accountability is what they should and shouldn’t do with their data.

DR. FITZMAURICE: Because the patients are not covered entities. The covered
entity is the data steward for the data and the patient.

MR. REYNOLDS: That is exactly why we pulled them out of the other covered
entities because the patient is not aware of them. As soon as this new world
continues as it is, that is the whole reason we put it up there as an
initiative, not that any of us have the answer. Marc?

DR. OVERHAGE: One of the things that has helped me is the tendency is to
think about having data in your hands as meaning you own the data. I think it
is helpful to me when I go through these things to think about you may have
control of the data. You do not own it. You have some – so in the scenario
of a clearinghouse that opens something up, it is still not their data just
because they opened it up and it is sitting in a database in a repository and
their data center that their programmers can write queries. That doesn’t make
it their data in any way shape or form. So, to me that says, who is accountable
for that? Well, the healthcare organization they came from who wrote the VA
agreement with them is who aught to be accountable for that data because that
is who controls it. It is not helpful framework because I wrestle with and
forget the idea of owning data. Just the fact that you have it and the
programmer has access means nothing.

DR. DEERING: This may seem like wordsmithing, but I am wondering if it
would help clear it. I am wondering whether the use of the word clearinghouse
in the recommendation is one of the things that is tripping us up. On the prior
page on line 119, we explain that there are broader clearinghouse functions. I
do not think broader context is going to help. I think you have to do away with
the word clearinghouse since it has a legal term and immediately set up
expectations as to what you are getting gat. So, it is not as effective to use
the term in this context when you are trying to describe things that may do
things quite different than clearinghouses.

MR. REYNOLDS: Well, I think our intent was to absolutely discuss that
clearinghouses are listed as covered entities, but they are not covered
entities as everybody around the room assigns covered entities.

DR. DEERING: I understand, but my interpretation of what we are getting at
was those entities that aren’t clearinghouses that literally do not fall under
this rubric.

MR. REYNOLDS: No, I think it is all of the above. I think it is the people
that do fall under that now.

DR. VIGILANTE: So, clearly, there is a category of things we call
clearinghouses that are defined as clearinghouses that perform functions that
we anticipate clearinghouses under HIPAA perform. Those have a certain status
as covered entities. Then there seems to be emerging on the horizon a new set
of entities that you are shaking your head over already. Okay. There is a new
set of entities emerging on the horizon such as HIE’s, network service provider
switches which were not envisioned as the definition of clearinghouses when
HIPAA was originally conceived, but they have clearinghouse like functions.
Maybe the point of confusion is actually using the word clearinghouse when
defining these. Maybe we should use an alternative word. Clearinghouse is
already loaded with covered entity sort of laden status. Let us deal with these
separately, and you may decide to make some of them covered entities, but they
are a different case.

MR. REYNOLDS: I agree with the second part of that. The reason I am still
leaning – the committee talked about the reason we are talking about
clearinghouses is those clearinghouses now that just do HIPAA and also move
into these other businesses because of the fact that the data is coming through
there. When they do that, they cannot be a business associate. I mean, then you
start really getting – So, they are already in the stream where the data
is coming through.

DR. VIGILANTE: So, there are three cases. There are things that are
clearinghouses that function as clearinghouses and that has already in a sense
been defined. There is a new set of entities that do not start their lives as
clearinghouses, but they do a bunch of things that for which there is some
concern. Then there is third case where clearinghouses evolve into these other
functions. That creates another level of complexity. I think each has to be
dealt with separately.

MR. REYNOLDS: That I agree with.

DR. FITZMAURICE: Clearinghouses are pretty straightforward. If you look at
Rios and health information exchanges, they cannot get the data from a covered
entity without being a business associate. They must legally sign a business
associate contract. It is illegal if they are not. We should be recommending
something like, enforce the rules.

DR. COHN: Well that was actually what I was going to say. I am just going
to observe on this one that this one definitely needs to be talked about by the
Ad Hoc workgroup because there is not even a common understanding, much less a
determination that this should remain as a recommendation is what I am hearing.

MR. REYNOLDS: Okay, we are moving on to number six. This is health data
uses for quality. The problem our quality measurement reporting and improvement
activities, health care operations, or other quality activities outside of
operations require special attention. The second bullet is distinguishing
between quality and research. Uses may be complex and confusing. So, our
recommendations are that there needs to be guidance for oversight of health
data uses for quality activities by governance of the organization that assumes
that uses are — that they do not evolve into research and that they are
protected through data stewardship principles. Then 6.2 is widespread
dissemination of quality. Research guidance should reach beyond the research
community. With that, I’ll open it. John, you had a question?

MR. HOUSTON: A comment. First of all, reading through research and quality
and QI-code activities sort of spread throughout a number of sections here. So,
I am going to make one set of comments as I have to leave. The first thing is
clearly an issue that I see in my institution all of the time. Word is research
and people try to gain the system by putting things under quality for a certain
period of time. While the IRB has a great control over research that goes on,
quality is much less structured, and I think most institution has the same way.
So, I think that to the extent that there is a recommendation to try to better
align quality and research from an oversight perspective I think is a great
value in trying to make sure that the same attention is paid to quality as it
is to research. The IRB, as soon as they determine something to be quality,
they are done. They only involve themselves in research. They keep your hands
busy with the research, but nonetheless once that happens, it is really a much
looser process then to do a quality study or do quality related activities. So,
I think there is some value in considering a recommendation that does with some
type of umbrella oversight, over quality, and research because even though they
have different purposes, they often are very similar in the data they act on
and the types of things they do try to accomplish. I understand there is a
significant difference. That is one point. There is a way to think about some
layer of oversight maybe involving the IRB’s, maybe otherwise. I do not know. I
just think there should be some consideration paid to that.

The second thing I want to comment on is that I think we are also missing
some areas here. One area that I see all of the time is the decedent research.
If you go to the IRB tomorrow and see I want to do research on people that have
died. They will tell you, that is great, but we only worry about human
subjects. Once somebody dies, it is no longer human subjects. Then they come to
me as a privacy officer and say, I want to do the same research. It is not
quality. This is actually research. How do you manage that because the IRB is
not concerned about it because it has got its hands full with human subjects
research. I think that there are also other classes of investigation that we
need to be concerned with here. It is not just QI. It is like IRB research. You
also do have another class of research goes on the IRB oversight, which is
industry sponsored trials and things like that that sometimes have a different
life to them inside organizations.

Overall, I think the more we can provide oversight for what all are termed
to be investigation involving data, I think the better I think we are going to
be. That is my comment.

DR. FRANCIS: I was going to say 611. Wait a minute. I have a different
version because mine says, do not evolve into research activities for which the
common rules should apply. Then it should also say, I think, without
appropriate attention to the requirements of the common rule because what you
want is something that accounts for the appropriate protections without making
it – sometimes things do evolve. So, what you want is a uniform protective
regime.

DR. SCANLON: This is very similar to what John

said. For me just drawing a distinction between research and quality is not
the right distinction. That what we are talking about is the use of a new type
of data, much more comprehensive, much richer. Sometimes quality is the
objective of research. Sometimes the data can be used in operations for things
other than quality. The real dichotomy for me is operations, which is governed
by one set of principles and research, which is governed by another. The
question is, how much should they be the same? It may not be sort of a single
oversight body, but it may be that there is a set of rules that apply to each
because there is a set of risks that apply to each. There is a set of benefits
that apply to each. So, we should be thinking about it in that context, not
–- the way 611 is written almost sounds like research is a nefarious thing
if it evolves – my God, we have got to stamp this out. Okay? That is not
the case. We have risk on the operation side. The question is, are we
appropriately sort of addressing those?

Now, in this version, in 6.12 does move in that

direction but we are only talking about stewardship guidance. It carries
much less weight than potentially what we have on the common rule side. So, I
think we need to ask ourselves the more fundamental question. Are we protecting
ourselves against the risk of operations appropriately? Are we protecting
ourselves against the risk of research appropriately and make sure we are
comprehensive in both dimensions. These are what the concerns are about this
new data capacity, which is our charge. We have to make sure all the
investigations are done in a controlled way that we minimize the risk while
gaining the benefits.

MR. REYNOLDS: I have got Paul and Mike. Then we are going to move on to the
next one. Again, I think the goal today is to really hear substantial stuff so
we can keep moving.

DR. TANG: I want to continue this building process. My goal is that so
Larry can sleep and not just by reading these documents. He was asking for
reassurance and he got none. He later asked for guidance of which we offer
little. So, I am building up on the committee –- I am just setting our
bar. I am just more and more less than happy with telling somebody else to
provide guidance when we are the ones starting the problem. So, in a concrete
way, although I did not read the Hastings report, I understand that it has a
nice model for laying out investigations and how to distinguish what rules
apply to what. If it is clear that it is publicly funded research, we have a
rule. For the others, I will just make this up, let us have something that has
a way of deciding using this matrix, this model deciding what level of
investigation it is and then apply a set of rules to the protection of that
from a privacy point of view. I think we just need to get to that level before
we are done with this report.

DR. COHN: I do agree with you though you do have to realize that sort of
almost by definition and forever more there is going to be slippage and things
are going to be slipping back and forth between quality and research. You do
not want to inhibit in this conversation that Bill and I had. If there is
important information that is discovered through quality or quality improvement
activities, you do not want to stifle the publication or the entrance of that
information in a generalizable knowledge. I think we have seen examples of that
with drug surveillance and drug safety and other things like that. So, we just
need to make sure that we are in this model handling that recognition.

DR. TANG: So, the best way to do that is to have careful rules that
basically are fairly seamless from one to another because that is the way it
is, and that is the way it will become more in the future. The policies have to
be – the more discreet and more operational they are, the easier it is for
everybody to follow and administer.

DR. FITZMAURICE: I think Paul and Simon have it pretty well right. The
preamble right into to the recommendation has it pretty well right. What I do
not think is right is the 6.11, do not involve research activities. I think it
is desirable to have that evolve. So, there aught to be some guidance to say,
you find something, you aught to get it out to everybody.

Secondly, there is a lot of quality improvement that turns into research
that would never be covered by the common rule. So, I think if you want to
avoid violating law, you would put the privacy rule in here. The privacy rule
is much more stringent then the common rule and more applicable to quality
improvement activities.

PARTICIPANT: It seems to me the recommendation is a covered entity should
adopt – but I am not sure we know how to specify something beyond that.
Should adopt an oversight process – then it would be common even in cases
where the common rule does not apply. So, we are not really specifying what you
do in place of that because we have this issue that Simon raises about the
evolution from one activity to the other. We have not really got to the final
point of deciding we want to set up some sort of IRB for any of these other
activities. We just sign you up to adopt a rule even when you should have to
sub-process even when the common rule doesn’t apply. What I have in wordsmith
is what you would have to do in 6.12 if you adopt it that way. It seems to me
the recommendation is adopting the oversight process. And 6.1 is really the
parenthetical even in cases where a common rule may not apply.

MR. REYNOLDS: That is fine. We have captured that as an item. Let us move
on to number seven. We will get through seven and eight. Again, everybody, the
Ad Hoc Committee is going to be holding plenty of opportunities for everybody
to look at it again. We will continue to get it out to the full committee. So,
I just wanted to make sure we get a little bit of input from everybody on this.

Now, we are moving into research. The problems are, the variations exist
between requirements that afford research accountability. Second, with greater
availability and richer data sets, health data use for quality measurement
reporting and improvement are increasingly evolving into research without the
protections of the common rule. So, our recommendations for 7.1 is to harmonize
a research regulations among HIPAA, common rule FDA and VA. And 7.2 is provide
guidance on research definition that also aids distinguishing research from
quality. And 7.3, enhance guidance on institutional review board, IRB
consistency. So, you can see the actual wording of these starting on line 1235
of the actual letter. With that, I will open the floor for comments, questions,
issues, or concerns.

DR. FITZMAURICE: On 7.1, HHS should promote harmonization of research
regulations within HHS and with other departments with regulations on human
research protections to ensure consistent privacy protection. I would suggest
consistent privacy and human subject protection. I would bring in both the
privacy and common rule. Both things need to be protected.

MR. REYNOLDS: Any other questions? Obviously this whole quality research,
this whole line between it and exactly what we want to govern it is really what
we are talking about. Okay, moving on to eight.

Uses of the NHIN are not totally defined, nor is it clear how health data
uses will significantly differ from today. How individual choice should or
could be exercised in the NHIN is not clear. These are the kind of issues. So,
the recommendations, continue to pursue the definition of NHIN; 8.2, ensure
adoption of NCVHS recommendations for functional requirements to support any
NHIN demonstration or trial use; 8.3 NCVHS will continue to provide the
recommendations. As you know, we are all working on a privacy letter and some
other things right now that also have a significant impact on such objectives
as this. They actually start on line 1263 if you will look at those.

MR. BLAIR: Usually when I speak it is because I have a position and a
particular view to set forth. Now that I am looking at this from this slightly
different perspective, I have a conflict. I do not have the answer. This is the
conflict, before we talked about HIE networks for example. I wound up saying
yes, I think that they should adhere to business associate agreements. When I
looked at it from that perspective that made sense. Here, if we have a
physician asking a patient for authorization or permission to go on that health
information exchange network and assemble their records from multiple
healthcare facilities so that physician can do patient care. That seems more to
me like a covered entity type of function. The same network, it is a switch,
but now in this context the health information exchange network is being used
for patient care. It is accessing either electronic records or lab records or
whatever from multiple facilities. So, I am conflicted. I thought I would raise
that as an issue. Maybe some folks could have insight on that.

MR. REYNOLDS: Jeff, so it is good for the record, you are personally
conflicted. This is not a conflict of interest. Just for the public record. You
are personally having an issue with this?

MR. BLAIR: Yes, depending on the perspective. I could see different answers
for it.

MR. REYNOLDS: Okay, thank you. We have Larry.

DR. GREEN: Last time I asked for help, it did not go so well. I could use
help from somebody who actually knows the Albert Einstein quote. The adage is
that the problem we are trying to solve cannot be solved at the level of
thinking we were at when we created the problem. It is something like that. It
is close. For this letter, so much hinges on these terms of what is quality
improvement? What is research? What is a clearinghouse? It seems to me that
these are words that we created ourselves in another time in another era and
that we are having a very hard time organizing the National Health Information
Network and healthcare in the information age using these terms that we
invented before we got here.

The comment I want to make for the preparation of the next letter is to ask
for consideration of their being some paragraph stuck in here that emphasizes
that these recommendations are transitional in some way or another. Because of
our lack of clarity that these distinguishing terms are going to hold up and
that we may actually have to come at this in some new and different ways. I say
this with less trepidation then I would have if we hadn’t had that wonderful
discussion yesterday where we covered the discussion of data stewardship. Now
that I have seen several versions of this and had the benefit of two days of
discussion, I am warming very much to the notion that we may need to go to this
letter is in fact towards this concept of data stewardship with these specific
recommendations that are urgently needed for various reasons. Mostly to protect
people, people’s information, and people as human beings. It seems to me that
this letter may need to be framed such that it is seen as part of the process
where we create some escape hatches for us to come back and say, well we know
that is what we said back in 2007, but we are headed this direction. Now, we
know that recommendation doesn’t make sense anymore.

MR. REYNOLDS: Leslie?

DR. FRANCIS: This may be somewhat along the same lines. Eight sounded
anti-climatic to me. Something about the tone of it. So, one thing, probably at
some point there needs to be a final wrap up, something or other, that might
strike the kinds of themes Larry is. It also seemed to me that what eight is it
is about the specific recommendations with respect to an NHIN. So, it seems to
me that it aught to say that the NHIN poses a number of way in which there
might be secondary quota. This is an example of a cold variety. So, I would not
frame it to be just about individual choice. There are other secondary uses out
of – – I hate to use the term, but there are other non-immediate patient
centered uses out of NHIN that might raise some of the other harms that have
been discussed earlier in the document.

So, I guess the way I would reframe this is to say that the NHIN raises a
number of the kinds of issues that we have seen earlier. Then, you could
reference even things like group harms that might turn up here or problems
about mis-aggregation of data. It is not just about choice. It is about a bunch
of those.

The other thing is that I think instead of saying, instead of ending that
on a note of we couldn’t agree, we aught to end it on a note of we are
continuing – we think these issues need to be on the forefront and we will
continue to monitor and provide advice as things develop.

DR. FITZMAURICE: I guess three points. One, Jeff’s puzzle that he posed to
us, I would suggest that when a physician ask NHIN, where is this patient’s
data who has given me permission to get it? The physician needs a business
associate contract with the NHIN as do each of the physicians who supply the
data. The NHIN doesn’t have the inherent right to do anything with that data
expect to respond to the physician’s request unless the physician in the
business associate agreement says, I want you do to this for this data, and
under HIPAA, I have the right to do this. So, I am asking you to be my agent or
doer to do this.

Secondly, on the recommendation 8.1, how to balance the benefits of health
data uses within NHIN. I do not know what those uses are because if the NHIN is
a business associate, it has to be spelled under the business associate
agreement. They do not have the right to do anything with the data that is not
conferred by the covered entity giving them the data. The covered entity has to
have the right to do that itself.

Thirdly, on 8.2, we recommend that HHS should require NHIN demonstration
projects and trial uses to adopt the functional requirements described by
NCVHS, et cetera. I would suggest we might want to replace adopt with evaluate
the functional requirements. Rather than force them to put it in every
contract, how about ask them to evaluate. Are these useful? Are these
effective?

DR. DEERING: Something that Larry said really sparked this for me. In
looking ahead, the way individuals are framed in this letter is only as having
– they only play a role to the extent that they may or may not be as
exercised choice in how others use the data. I would possible bet my next
child, which is easy to do, individuals will be aggregators of data.
Individuals will be actors in the secondary use of data. You can already do
this on some websites now where they pretend to give you – if you go to a
BMI site, some of those are actually aiming toward collecting other people’s
data in mass because you are giving it voluntarily to them and then allowing
you to see how you match up next to others. I believe that that trend will only
increase as individuals themselves have access to other people’s data. So, in
the spirit of what Larry said and in the context of number eight in particular,
I would like us to highlight the fact that we do not know yet to what extent
other individuals may have other roles to play other than how they exercise
their choice.

DR. TANG: Well, I have a concrete suggestion to accommodate the last three
comments. One, I think I would actually delete section eight. I do not think it
contributes to anything. The anti-climax is to continue doing what is going on,
which is really an anti-climax. What I would do to substitute would be what
Larry proposed, which is to introduce to transition the discussion over to the
new world and for the possibilities of data stewardship bridge so much more of
these concepts than haling people into either a covered entity or a business
associate. It actually allows us to introduce the concept of choice and what
consumer’s role is into this whole environment, this whole ecosystem of health
data moving around. I think it would be a really nice bridge and contribution.

MR. REYNOLDS: I think if we do that, I think it is key that this is the
only place we really talk about individuals. We did hear significant testimony
on people wanting to have transparency and some other – what you said is
– I am agreeing with you. If you take it out, I am saying we got to put
something else back in, which you recommended. But I am just saying that we
cannot miss that key portion of the testimony.

PARTICIPANT: This actually is a comment that goes all the way back to
something Paul mentioned. I am not sure he mentioned in the committee or some
other place. There are a lot of recommendations in the back here that really
some of them are not recommendations at all. I think they make the document a
bit noisy and not really as usable for the secretary. If you look through 8.1
through 8.3, I think the only real recommendation there is 8.2; 8.1 says we
have studied an issue, and we do not really know how to resolve it. We should
think about it too; 8.3 says will continue to monitor. That is not a
recommendation. So, I suggest that when this goes back that you really focus on
what are the recommendations that are really actionable items. Separate those
out from the areas where you actually think you advance knowledge a little bit.
You say, by the way, here is an issue that needs to be further studied.

MR. REYNOLDS: All right, if you all pulled your one-page paper again. The
subcommittee’s goal was to put together this very large subject in some kind of
a format that we could discuss it and some kind of a format that we could
really have a good honorable debate by everybody. I think this is exactly what
this committee does best. What we did is it doesn’t matter whether that is
right or wrong, it matters that we all discuss it. We all know it. We all
understand it. We all debate it.

So, basically coming out of here, I think

everybody that is on the committee has a dramatically different view of
this, dramatically different thinking about it. So, now we also on the
committee feel more comfortable that we have further input and can go back and
continue this lengthy deliberation we have already been in, but with a renewed
idea of how to approach it because you have helped us kind of pick the details
and other things as we move forward. You kind of wrapped them up in a little
different package for us with key subjects, and that is what we have been
trying to do. That is what we do best as a group because we are not afraid to
get part way and then debate it. So, our job is to take it back and close it
out and then bring it back and have you adjust it again and move on to better
things and make a difference. With that, Simon, I would like to turn it back
over to you.

DR. COHN: Well, thank you. Harry I want to thank you, and Justine I think
did some great work in moving us through these conversations.

Now, what are the questions that we have not really answered because we
have been so involved in looking at all of this? You do not have to answer it
now, but this is something we would very much appreciate any thoughts by e-mail
or other, which is really the issue of, what are we missing? We heard on eight
that maybe we are sort of missing the new world. I think that is an important
concept here. I guess I would sort of say, the question that we are constantly
asking ourselves on the workgroup is, is there something big there that we have
not even touched on? I guess I would sort of stop for a second and just –
once again, you can talk now, send e-mails as you reflect on it, but that
really is the other piece here.

DR. FRANCIS: I mentioned surveillance moving over into other kinds of
activities such as what New York is doing about diabetes.

DR. COHN: Okay. Well, without trying to pull things out of you, I would
just have you – especially as you look at the next version of the letter,
just sort of keep that one question in the back of your mind of, is there
something here that is important in this area that we have not touched on? I
think we are all thinking that we are getting a pretty good document, but I
think that is an important screen that we all need your help around.

Agenda Item: Committee Operations

DR. COHN: Now, let us talk a little bit about the next steps of getting
where we are now to hopefully what will be a finished document. I think as many
of you heard, we are going to be having another meeting at the Ad Hoc workgroup
next week both on Thursday morning and Friday morning with the Privacy
Subcommittee meeting on Thursday afternoon. I think by that time, we should
probably have another version of the document and will sort of figure out
whether it is ready for the full committee to adjudicate and provide input in
or not. It depends on how quickly we can get the document out. Margaret, do you
have any concepts around all of that?

MS. FARQUHAR: My understanding is that for Thursday and Friday are on the
revised document. Revise lines for the Quality Workgroup, which will not be as
comprehensive as all of this, and a coversheet that says this is how we have
addressed the issues, sort of a guide to the new document. On October 17, we
have got the workgroup call. Then you wanted to send it out to further
reviewers?

DR. COHN: I was just asking about whether we would have a document for the
– if we had time in the next week to get it out to the full committee for
the next stage of review. I guess we will figure that one out probably Monday.
I presume that the full committee would like to see the next version, probably
not so much redline, but yellow highlighted changes, questions, open issues,
and all of that because out of all of this, everything is going to be redlined,
which is a limitation to redlining.

MS. GREENBERG: We are going to send something to the full committee prior
to your meeting next week?

DR. COHN: Yes, exactly. Obviously your input into that would help us
adjudicate when we get together on Thursday and Friday and obviously we will
spend a lot of time on that. Now, it is also our interest, and let me just say
this that we do want to get public input. We are going to need to figure out
some way to do that to review. This may be I the form of an open conference
call or two where people who want to see the document can get a chance to look
at it when we think it has gotten to a certain level of goodness and ask people
to provide input during a public conference call would help us further refine
this. I think it would be very useful as we continue to try to improve the
document, getting a wide range of input. I think we will be inviting that.

Now, the intent will be in early November for us, and we will obviously
begin to check with people about their schedules to have an open conference
call with full committee to do a review of the document. The question at that
point will be all of our determinations together is, is this document that we
can agree to and basically act on during that call, or is it at some point
something we have to do in person at our November meeting? I think the hope
would be is that with all of your input and ongoing input, this will move into
a document that we can actually affirm during a conference call, but we will
have to see during that conference call. I would ask that you try to be as
helpful to her as you can knowing that I know all of you are extremely busy. I
am sure this is going to be a two-hour call. We are all just going to have to
do what we can to make it work so we can fully participate in that one. I guess
I would ask, does that make sense to everybody?

I think we have worn everyone down. Good. Consensus by being quiet is
probably a good way to go. So, that is the overall game plan. I think the
expectation is, we will be having further conversations and into November.

Now, I did want to take a moment, and I know – there are two final
issues that we wanted to handle. One was brief updates from the subcommittees.
This is meant to be a short update. I think in November we can spend a lot more
time talking about what subcommittees and workgroups are doing and maybe take a
breath and not work ourselves to death and have a nice end of the year. I do
think it is important to have at least a brief update.

Now, I will start with Privacy and Confidentiality. Unfortunately, we have
asked John Paul to present since Marc is not here.

DR. FRANCIS: I suppose I could just say it. We are working on a draft of a
letter that would concern the question of whether there as a electronic health
interoperable records get increasingly developed, what additional privacy
protections and how those might be implanted I think would be – I think we
are getting closer. There are many drafts of this letter. I think there is
going to be a face-to-face meeting, which I am going to be calling in on. The
agenda item for that meeting is to finalize a draft of that letter or get
closer to that for the November meeting. We also heard a very interesting
discussion yesterday about several datasets Ann Haines and some of the genetic
data and the question of – the subcommittee may be asked to weigh in on
that. I think there was some thoughts that that would be a very good idea to
do. I am sure others know more.

DR. COHN: Okay. Don?

DR. STEINWACHS: Just to give you a progress report, one of the areas we
have been dealing with is surge capacity, preparedness, and there have been
some processes going on subsequent to the workshop hearings we had to try and
interview and get more information about what actual measurements are being
used, where are the gaps in redundancy? I know Doug has talked to you Jim about
the Katrina activity there was some sort of inventory done of some of the kinds
of measures, and how good they were. That is sort of the next step.

We are hoping when we meet in November that we would be working on a letter
that would pull together what came out of the workshop and subsequently, so
that is the target.

We got a chance to meet Michael O’Grady and his new capacity as the liaison
between the BFC and the committee here and the Population Subcommittee. The
discussion has been going on, and Bill can fill in things. It really deals
with, are there some areas in which we can collaborate in terms of joint
interest between the Population Subcommittee and CBHS and the BFC. He brought
to us for our consideration the issue around vital statistics, the concerns
about harmonization across the states and territories, and with WHO. The other
was a linkage to EHR especially with death certificates is a new vision of how
the death certificate could be fed in terms of cause of death by an EHR. So,
that was put on the table for us to consider. He also brought the concerns
about vital statistics.

We are also considering next steps on the data linkages activity and
particularly the question of how do we really promote productive data linkages?
So, there are a number of suggestions that came forward about things we might
do. Gene was pushing us toward trying to figure out how we have the one point
of the data linkages that failed. Then were to the facilitator, and then we
decided that the data council had to do it all. The real job was data linkage.
It was not all these other things you are doing. I think the real concern is
how do you keep things moving in ways that benefit the public, make good use of
the resources, and not sort of just happenstance?

We also talked about potential new work in other areas because we are
trying to figure out what is our agenda for new things. I mentioned the vital
statistics. We talked a little bit about the idea of updating the Vision For
Health Statistics of the 21^st Century. I would like to see us talk
some more in that context as someone pointed out. There needs to be an effort
to integrate EHR’s into that vision, which is not there.

The other part which Larry brought to us, which

is really integrate the ideas about system transformation, the IOM. So, how
does that affect our vision for health statistics? Larry took it further that
there is a convergence of thinking on transformation American healthcare system
around the medical home. So, we have alignment of a lot of special groups and
others that see the medical home as a set of common characteristics as part of
that transformation process. So, also on the political side, you hear the
candidates also talking about as part of their thinking.

So, one thing that we are thinking could be

on the table is examining, how would you measure? How would you assess
whether or not there is a medical home? In part, I would think both the
provider and patient would have to agree. The other is there are
characteristics about what makes a medical home. Whether you think of those as
quality metrics or you think about that as a measure. The other, from a
population point of view is an argument that everybody needs a medical home
whether they are healthy or ill.

So, those are the things that are on our table. We are going to have a
conference call in October to try and settle on which ones are on top of that
priority list and start to try to move ahead with those, at the same time
trying to finish up or continue as appropriate with the things that were on the
agenda before.

MS. GREENBERG: Once again, I was unable to be two places at once. It sounds
very interesting and it sounds like my agency was well represented. I think
Virginia Cain was there as well?

DR. STEINWACHS: Virginia was there and Ed was with us. We also talked about
the issues.

MS. GREENBERG: I just wondered from the idea of the health statistics
vision, which is obviously a vision for more than health care statistics. Then
you are talking about the medical home, et cetera. I mean a population view on
that, if there has been any talk on a health home, or it really a medical
model?

DR. STEINWACHS: The only reason I use the word medical home is that is what
is current in the literature. You are right, if you say everyone needs one,
then it is a health home, more broadly. Certainly, for a lot of public health,
we rely on personal medicine to provide risk identification, risk management.

DR. COHN: Well, we will look forward to a more substantial update when we
go into November. Hopefully, we will have a little more time. Harry?

MR. REYNOLDS: Hey, ours will be a sound byte compared to that. Thank you
for passing our letter. In January, we will be passing deliberations on ICD-10.
We may here some ROI comments back on claims attachments, pilots that are going
on, e-prescribing NPRM. We need to continue watching the journey of NPI as it
continues to try to complete itself. That is where we would be headed.

DR. COHN: Justine?

DR. CARR: Also thank you for passing our letter. The Quality Workgroup has
a particular interest in holding hearings on the differences between quality
and research and methods that institutions have employed or even operations in
research, particularly quality and research. So, we wanted to put that out
there. That would be of help in developing some of the issues in the Secondary
Uses Report.

DR. COHN: Well, thank you. Let me just talk a little bit about November for
a second. Knowing that November will be an opportunity for us to take a breath.
I am actually hoping that we are getting some people, especially since we love
talking to each other. It is nice to occasionally have somebody from the
outside come in and share with us. If you remember two or three meetings ago,
we were talking about how everyone felt that there was just so much knowledge
and skill around the table. I think there is probably a balance to all of this,
and I think with Secondary Uses, it will be nice to come up and take a breath
from that a little.

Now, I think we have talked about this before, inviting Chris Shoot to come
and talk about the ICD-10 revision activity the WHO is beginning to work on. We
should invite him and see if he is available. I think we also will likely have
a privacy letter of some nature as an action item. We also heard about in our
updates from the department about this work that is starting on PHR
evaluations. I think maybe we can get a briefing on exactly what is being
contemplated and how that is going to be approached. Hopefully we will hear
from CMS a little more.

DR. DEERING: If you are interested, there is reference in the letter report
on secondary uses about work being done by OHRP on guidance. I have a meeting
on Thursday or Friday with them to find out what the timetable is a little bit
more about it. If the committee wanted to pursue that direction and hear from
OHRP about the work that it is doing on some of the issues that we have touched
on here. The timing may not yet be right in November, but I will know in a
couple of days.

DR. COHN: Okay, great. We will look forward to that. Final comment, Jeff?

MR. BLAIR: One of the things that I think would be good for us to look at
because it is becoming more clear now. For years we have encouraged standards
that would enable interoperability. ONC has put forth the NHIN trial and
limitations. They have done that along with AHIC and HSPE. One thing that has
come out of that is a set of standards for interoperability, which is really
very assertive, very dramatic. I think it would be helpful if we have someone
from HSPE talk to us about these set of profiles that are going to be
implemented under this NHIN contract, which will be done in 9 months after the
November piece. This is transformative. This is a huge step forward on a very
aggressive plan, and I think we need to be aware of this major change. I think
it would be appropriate to be at the November meeting.

MS. GREENBERG: In particular, since I think those contracts through the IRP
or whatever does reference several things that the National Committee has
several recommendations made by the National Committee specifically to hear
–

MR. BLAIR: All those contracts are building. They explicitly state they are
building on our NHIN recommendations. They are building on our privacy
recommendations. They are taking a bit step forward based on those.

MS. GREENBERG: Do you think November is the right time or February?

MR. BLAIR: Well, in November, they will have let the contracts. I think
they are so busy right now that it is really hard for them to come up for air.
I think that point, they could say, what are their expectations out of these
trial implementations?

Agenda Item: Meeting Reflections, Concluding
Remarks

DR. COHN: Now, we have about three minutes left. I always try to end it
just on time, and we are very close. Just a question for people about how the
meeting went, suggestions for improvement, and we obviously already heard from
Gene that we need to not wordsmith. Larry has made a comment about making sure
about expectations about getting things out on time and having people read them
prior to coming to meetings. Beyond that, any thoughts or suggestions for
things we can do to improve the meeting? I think the next thing we will –
we will be at the Humphrey building.

MS. GREENBERG: Well, it is all dependent on the Hubert Humphrey building.
That is always our first option.

MR. BLAIR: Is Hubert not cooperating with us again?

MS. GREENBERG: They do not have a space in November? Okay. Do we know where
it is going to be? I guess not. We would not mind hearing also how you found
this location.

DR. FRANCIS: It is a great location only if we know in advance so we can
actually book here.

DR. COHN: Other comments?

DR. GREEN: Denver is a great place to have a meeting.

MS. GREENSBERG: Have we ever had a hearing in Denver?

DR. COHN: Well, we are always open to suggestions for improvement. As I
said, hopefully November will be a little lighter on the schedule and a little
more time for discussion with some of the outside people. If you have some
thoughts about other people we should be hearing about, any reports being
developed that would be useful for us to be briefed about that we can discuss,
I think that would certainly work well.

With that, the meeting is adjourned. I want to thank you all for your
participation.

Whereupon at of 2:45 pm the plenary session was concluded.