[This Transcript is Unedited]

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

December 2, 2010

Marriott Washington Hotel
1221 22nd St., NW
Washington, DC

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

CONTENTS

P R O C E E D I N G S

Agenda Item: Call to Order, Review Agenda

DR. CARR: Welcome to day two of the NCVHS Full Committee. I am Justine Carr.
Is someone on the line?

MS. DOO: Yes. This is Lorraine. We are trying to figure out if we have
dialed into the right number. Is this the call for us to present EFP?

DR. CARR: It is indeed.

MS. DOO: Excellent.

DR. CARR: Lorraine, would you like to introduce yourself and whoever else is
there with you.

MS. DOO: Let me make sure that they are on. We went to a conference room and
there were two different numbers.

PARTICIPANT: Lorraine. We can hear. We are on.

MS. DOO: Perfect.

DR. CARR: I am Justine Carr, chair of the Committee, Caritas Christi
Healthcare, no conflicts.

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

DR. WARREN: Judy Warren, University of Kansas School of Nursing, no
conflicts.

DR. SUAREZ: Walter Suarez, Kaiser Permanente, no conflicts.

DR. SCANLON: Bill Scanlon, National Policy Forum, no conflicts.

DR. GREEN: Larry Green, University of Colorado, member of the committee, no
conflicts.

DR. FERRER: Jorge Ferrer, no conflicts.

MS. EDWARDS: Brenda Edwards from NIH, liaison.

DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente, member of the committee,
no conflicts.

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

MR. LAND: Garland Land, National Association for Public Health Statistics
and Information Systems, member of the committee, no conflicts.

DR. OVERHAGE: Marc Overhage, Regenstrief Institute, Indiana Health
Information Exchange, member of the committee, no conflicts.

DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the
committee, no conflicts.

MS. MILAM: Sallie Milam, West Virginia Health Care Authority, member of the
committee, no conflicts.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality.

DR. MIDDLETON: Blackford Middleton, Partners Healthcare, Harvard Medical
School, member of the full committee, no conflicts.

MS. JONES: Katherine Jones, NCHS staff.

MR. BIZZARO: Tom Bizzaro, First DataBank.

MS. JAMISON: Missy Jamison, NCHS, staff.

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

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

MS. KOCHER: Gail Kocher, BlueCross BlueShield Association.

MS. SAVEKAS:(?): Mauris Savekas, American Medical Association.

MS. WEIKER: Margaret Weiker, Hewlett Packard.

MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug
Programs.

DR. BICKFORD: Carol Bickford, American Nurses Association.

MS. THORNTON: Jeanette Thornton, America’s Health Insurance Plans.

MS. VIOLA: Allison Viola, American Health Information Management
Association.

MS. WILLIAMSON: Michelle Williamson, CDC/NCHS, staff to standards.

DR. CARR: And folks on the phone could you introduce yourselves please?

MS. DOO: This is Lorraine Doo with the Office of eHealth Standards and
Services, no conflicts.

DR. CARR: Thank you. I want to just make sure we have our agenda correct. We
are going to start with Lorraine. Very good. We have your slides all set. Take
it away.

Agenda Item: Overview of Upcoming Standards

MS. DOO: Excellent. Thank you all very much and we are sorry not to be there
in person, but we will certainly be there tomorrow. We wanted to give the full
committee an overview of what you will be hearing about tomorrow to help ground
you in some of the terminology and the concepts because I think that often
times we have all gone into these things with some preconceived notion based on
what we know or think we know and even we have learned over the past couple of
months that the electronic funds transfer is a whole other world until itself
and how it applies to health care has some interesting nuances and
opportunities.

We are going to have Matthew Albright who is on our staff give you that
overview. You have the slides. And then of course we will take questions
assuming that there is time, but I think it will really help you in terms of
what you hear tomorrow and help you with the questions that you will be asking
of the other people who are testifying.

And if I could ask after Matthew has finished if you do have questions,
speak directly into your mikes because we can hear really clearly when that
happens. I will now turn it over to Matthew and then we will turn it back over
to Judy and Walter and Justine.

MR. ALBRIGHT: Thank you, Lorraine. Can everybody hear me all right? Good. I
am working off of a PowerPoint, the title is Tale of Two Transactions.

As Lorraine said, today we are going to briefly give an overview of the two
transactions that the subcommittee will hear testimony on tomorrow: the Health
Care Payment and Remittance Advice transaction and the Electronic Funds
Transfer transaction. And the tongue in cheek title of this presentation is
meant to communicate the idea that these two transactions are inexorably linked
and they really must be coordinated when we think about standards and operating
rules.

We will start with a quick summary of what the NCVHS is being asked to do by
the Affordable Care Act with regards to these two transactions. If we go to
slide two, three things that the NCVHS is being asked to do. One, recommend a
standard for the Electronic Funds Transfer, the EFT, two, recommend an
operating rule for the EFT transaction, and three, recommend an operating rule
for the health care claim payment and Remittance Advice Standard Transaction or
the 835. And I will be referring to the electronic health care Claim Payment
and Remittance Advice Transaction as the ERA, the Electronic Remittance Advice.
ERA, for this presentation for the sake of brevity.

Now let’s go to the Affordable Care Act on slide three and see where these
charges come up. On slide three you will section 1173 of the Affordable Care
Act as a tenth transaction to the nine previous HIPAA electronic transactions
and that tenth transaction as you see is the Electronic Funds Transfer or EFT
and of course because it appears in this list, the secretary must adopt a
standard for it. As well the Affordable Care Act mandate that operating rules
must be developed for all of these transactions including for our interest
letter E, the ERA, and the new letter J, the EFT.

The Affordable Care Act also has a particular requirement for the operating
rules for the ERA and the EFT transactions as you see quoted on the bottom
right hand corner call out. These two operating rules must “allow for
automated reconciliation of the electronic payment with the remittance
advice.” Now hold that thought because we will come back to this idea of
automatic reconciliation.

Let’s go to slide four. We move now to discuss how plans send money to
providers today and how plans send payments and remittance advice to providers.
But let’s back up and talk about when these two transactions happened.

First, a provider of course sends a claims bill to the plan. The plan sends
the provider two things, two transactions that are either transmitted
electronically or sent in paper form. The first is the dollars. That is the
actual funds transfer. This is the financial transaction. This is the money
itself.

The second transaction is the data. This is the payment and remittance
advice. The payment and remittance advice contains provider and patient level
adjustments, the amount that the provider billed the plan and justifications
for those adjustments. For example, let’s say a provider has sent a batch of
claims totaling $10,000 to a plan and the plan sends back a payment of $6000.
The payment remittance advice would justify why the plan is only paying $6000.
The payment remittance advice might indicate that part of the $4000 difference
is being withheld because some claims had incomplete information or there were
duplicate claims or portion of the claims the patient owes because of
deductibles and coinsurance. Still other claims might be covered services and
so on. Those are the two transactions: dollars and data.

An analogy to these two transactions might be made to when we are paid our
salary. On the one hand, we are paid money. Funds are somehow transferred to
our account. That is the dollar. That is the financial transaction. And then a
paystub on the other hand is a kind of payment and remittance advice. Our
paystub gives us payment information. It tells us how much we got paid, who
paid us, and when and then it also gives us remittance advice. It tells us why
there are adjustments or deductions in what we thought we would get paid.

Just like the money we earned is more than likely sent separately from our
paystubs that describes that money. The health care payment is usually sent
separately from the payment information and admittance advice.

Let’s go to slide five. Slide five simply demonstrates that Health Care
Payment and Remittance Advice are sent both electronically and in paper form.
And I heard you all had a conversation last hour about adoption rates of
transactions. Surveys vary as to the adoption rates of electronic payment and
remittance advice, the 835, but the US Health Care Efficiency Index for one
reports that a little more than half of payment and remittance advice is still
sent in paper form. For the half of payment and remittance advice that is sent
electronically then it is theoretically being sent in the HIPAA standard X12
835.

Now a quick note on this slide, we are simplifying the electronic
transaction of payment and remittance advice in the illustration of the bottom
box. In most electronic transactions of the payment and remittance advice
today, the ERA, there are one or two clearing houses between the plan and the
provider and they are either translating a nonstandard payment and remittance
advice into an 835 on the plan side or on the provider side translating a 835
into a format that is more useful for the provider.

Let’s go to slide six and look at the actual transfer of funds. This is the
actual financial transaction. This is the dollars, the movement of dollars. And
again as we see here payments can be sent by paper check or by EFT. And as we
probably have experienced when we pay household bills, sending payment via
paper check is costly and time consuming for both the payor and the payee and I
am sure we will hear more about that with the testimony tomorrow. Even so
according to many surveys significantly more than 50 percent of health care
payments are still made with paper checks. In fact, the adoption rate of using
EFTs for health care payments appears much lower than even the adoption rate of
using the 835, the remittance advice.

Let’s look at how an electronic funds transfer works a little closer there
in the bottom box. In the first green arrow the EFT is initiated when the plan
sends an electronic transmission to its bank authorizing its bank to transfer
money to the provider’s bank. And the second green arrow between the banks the
actual financial transaction occurs. Money is credited to the provider’s
account and then lastly the provider’s bank sends the provider a notice that a
deposit has been made.

Let’s go to slide seven and go a bit deeper into this EFT transaction. Now
when people say EFT, they mean the whole transaction from the payor, in our
case the plan, which initiates the transaction to the actual transfer of funds
across banks, to the notification of deposits to provider. However, in the
context of health care payments the EFT transactions has a more specific
meaning and that meaning is the mechanism that payors, i.e., health plans, use
to instruct one bank to money from one account to another account. In other
words, in the health care context an EFT is that first leg of the broader EFT
transaction. It is the red line in our illustration.

I want to repeat that a different way. EFT is the whole transaction, but
what we are concerned with from a HIPAA standpoint is the standardization of
how a plan initiates the transfer of funds through the ACH Network.

Let’s move on to other elements of the EFT. If you look at the second arrow,
the green arrow between the financial institutions in the illustration, you
will see it says that the EFT is processed through the ACH Network. The ACH
Network is a lot more complicated of course than a straight green line and we
will hear a lot more about the ACH Network tomorrow, but here is a quick
summary.

The ACH Network is the plumbing. It is the processing and delivery system
that processes EFTs. It operates through a series of legal agreements and it
uses existing telecommunication systems.

The EFT we might think of as of water that is coming through the pipes. That
is the individual transaction itself. And then the National Automated Clearing
House Association or NACHA is a maintenance crew and sometimes architect of the
plumbing. NACHA is a nonprofit entity that oversees the ACH Network and
establishes the standards, the rules and the procedures that allow the
Electronic Funds Transfers to work.

What is important at this point? It is to see that an EFT HIPAA standard
will not require a change in how banks do businesses with banks. It will not
change the plumbing. Instead as we have said in the health care context, we are
concerned with that first red line; a standard that health plan must use to
initiate an EFT. Right now there is no clear single standard on the format,
contents, or timing that a plan must use when initiating an EFT.

Let’s move to slide eight. Why do we need a standard for initiating health
care payments through the ACH Network? The key is re-association, the
reconciliation or matching of the payments with the remittance advice. The blue
and green arrows on this slide, again, show the different ways that a plan can
make these two transactions by paper or electronically and probably a
combination of those. But no matter how the payment and remittance advice is
sent and no matter how the payment is made the provider has to match the
payment to the remittance advice. The data must be re-associated with the
dollars. And you will remember that the Affordable Care Act recognize this and
specifically said that the operating rules for the ERA and the EFT have to
allow this to happen.

Again, we can use the analogy of a paycheck and a paystub. Imagine that you
have 20 different employers paying you everyday either by check or direct
deposit. That would mean that you would have 20 different credits being made to
your bank account. And at the same time you are sent 20 different paystubs
either electronically or through the mail. Now imagine some of the paystubs
arrive a few days or weeks before or even after your deposit and imagine that
some employers are paying you for work you did 3 months ago or 2 weeks ago or
yesterday. You would have to have some way of matching each payment with the
individual paystub that gives you the payment and remittance advice about that
payment. It would be even better if you had a way of automatically matching
each payment with the individual paystub so you wouldn’t have to go through
them manually and even better if you are automatically told who still owes you
money, how much, and then were able to automatically bill them.

The best way to re-associate the data with the dollars is in the middle of
this slide, the double line, the blue and the green line where some or perhaps
all of the payment and remittance advice data traveled along with the transfer
of funds, the EFT. I will repeat that. The best way to allow for automated
re-association is to send data along with the EFT that either references or
actually is the payment and remittance advice information.

Now this is actually allowable today through a number of formats that we
will hear about tomorrow. Medicare actually requires specific formatting and
data content in an EFT when it initiates payments electronically with its
banks, but to our knowledge beyond Medicare this is not clearly mandated. It is
happening, but probably not happening on a broad scale.

If we are sending some or all of the payment and remittance advice data
along with the EFT, the financial transaction, then it is evident that other
entities including financial institutions may have access to this information.
Clearly privacy issues arise. However, the HIPAA Privacy Rule is quite
prescient in this regard and gave detailed guidance on a number of EFT-specific
issues.

Slide 10 summarizes some of the EFT issues that the privacy rule
specifically referenced. And I won’t spend any more on this slide, but I would
be happy to come back to it if you have questions.

Slide 11 brings us back to what the Affordable Care Act requirements. One,
an EFT standard, two, an EFT operating rule, and three, an ERA operating rule –
three intersecting circles. The EFT standard as we have seen will probably be
directed at that first leg of initiating an EFT. The format and content,
perhaps the timing of how a plan instructs its bank to send an EFT, or not just
be how a plan initiates an ACH entry. We have seen that in order for
re-association with the payment and remittance advice to work there has to be
certain data sent in an EFT.

The EFT operating rule will have more or less the same direction as the EFT
standard if we imagine. The operating rule will theoretically make the 835 more
attractive and easier to use.

We will probably see tomorrow but there are different levels of automating
the broader accounts receivable reconciliation process by using EFT and the 835
and EFT operating rules may help toward allowing the most automation possible.

And the Health Care Payment and Remittance Advice Operating Rule we have not
talked about much in this presentation. We will probably hear that there is
inconsistent implementation and use of the 835 among trading partners including
inconsistent use of codes that are used to describe adjustments. Operating
rules will probably be directed at requiring more consistent use of the 835.

And that is really the end of the overview. Slide 12 has some other issues,
some issues that we have already touched on and some others that may come up,
but that it is. Thank you and we will open it up for questions.

DR. CARR: Thank you. That was really excellent. Paul.

DR. TANG: I don’t think these slides are in the book.

DR. CARR: Can we send them?

DR. SUAREZ: We will send them to the full committee.

MS. DOO: I don’t know that we sent it to the full committee. We probably
sent it to standards and to Marietta, but we can actually bring it on a stick
tomorrow too if anybody wants to download them.

DR. TANG: Did you want it today?

DR. TANG: No. I just want to say how extraordinarily clear that was. I have
never had standards presentation that was — for 10 years I have never heard
that. Thank you.

DR. CARR: Walter.

DR. SUAREZ: This is a little bit more context. Thank you, Matthew and
Lorraine. I know we worked at making this clear for all of us because we all
were learning a lot of new things with respect to this.

A couple of comments I guess with respect to what we will be expecting to
hear tomorrow and what the committee will need to make decisions about. First
of all it is clear that the effect of deciding about EFT with respect to the
standard and the operating rules of EFT will affect the communication between
the health plan and its bank and then carry forward into the communication that
at the end of this stream the provider receives.

But the clear relationship within the plan and the plans’ bank is the core
of this and the fact that we will be again heard all the way to the provider.
It is an important point because I think at the end when we decide to recommend
a specific standard for EFT, this is not going to be like we are going to tell
banks how to do business between them as was pointed out in the presentation.
EFT in the context of health care is about how health lines communicate the
payment to the bank to transfer the money to the provider’s bank. And again the
effect will — the end of this change will come down to the provider and how
the provider receives the information from the provider’s bank and then be able
to re-associate this. That is just emphasizing that important point.

The second point I wanted to make is with respect to the operating rules and
the 835. This presentation of course focuses a lot on the EFT part and didn’t
focus too much on the 835. But the 835 is a massive transaction. It is a very
extensive and large complex transaction that is not just certainly about
transferring the money. It is about explaining a lot of the payment then to the
provider.

Usually the 835 goes from the payor to the provider whether it be a clearing
house or directly, but the provider receives that 835 and then as was pointed
out re-associates that with a payment received in the bank statement. The
operating rules will apply to the 835 and will be expected to apply across the
whole transaction, the whole 835’s, not just about EFT, but the 835 has a lot
of other things that the operating rules will be looking at addressing or we
expect that the operating rules will need to address.

I think in the slide if you go back to the slide that talks about — a
little forward actually. The three concentric circles. The 835 has something
called RARCs and CARCs. At the bottom if you can see in the right bottom side
of the slide in the square there those two, CARCs and RARCs. Those are codes
that explain the adjustments made to payments done to providers. Remarks, codes
and claim adjustment reason codes are what they stand for basically. There is a
lot of variability. There are a lot of codes around that and how they are used
and how they are reported is a matter of a lot of this debate and discussion.

The operating rules related to 835 will be looking at those kinds of areas
as well as others probably, but not just EFT part. I wanted to decouple the
operating rules of the 835 from the EFT concept because it is not just
operating rules about EFT. It is operating rules of the 835 that covers the EFT
part as well as a lot of other things on the 835. We will hear more about those
tomorrow hopefully during the hearing and what are those other areas on the 835
that the operating rules will help simplify and standardize.

But I wanted to make those two comments just to provide a little more
context around this.

DR. CARR: Walter, when the operating rules are decided upon and enforced,
what is the — who will experience the greatest change in work flow and what
will — who will have more work and who will have less work at the end of this?

DR. SUAREZ: Anybody that pays and receives payment. Meaning basically the
health plan and the providers. Everybody will be affected by the implementation
of this. I will give you a quick example. In Minnesota, which is one of the
states that have developed a common companion guide that looks at standardizing
some of the elements that we expect will be what would be standardized through
operating rules.

The industry worked a lot. The payors and the providers worked a lot on the
standardization of the 835 companion guide. A lot of work was done actually on
these CARC and RARC codes. And everybody was going to be affected by virtue of
the fact that the payor will have to change whatever they are currently doing
to meet the new standard companion guide or what could become later on the
operating rules and then the provider would have to do the same. It is a
negotiation kind of a decision between the two. But it will affect both. It
will not affect more the payor or the provider.

In the EFT side, in the EFT operating rule side itself and the EFT standard
side I think it is clear that the health plan is the one that will be basically
implementing, decided or the required if we are going to recommend the adoption
of an EFT standard and then it becomes regulation then the health plan will be
the one implementing the EFT standard and the EFT operating rules. But then
they will be carried all the way to the other end of this.

DR. WARREN: I think a better answer to your question is the work will be
different. It won’t be what it currently is and so both sides will deal with
the data differently.

DR. CARR: And is it that some have a companion guide and that
standardization has been done but now it will be re-standardized and others
don’t use it fully or don’t have a companion guide and they will have new work?

DR. WARREN: Realize what Matthew said is 50 percent of the people do this on
paper. They don’t do any of this electronically because there is no support for
it. Once it becomes electronic and people follow the standards then the work
will shift and hopefully the ROI will increase because there will be different
services that will no longer be needed and so those things will have to happen.
We are talking about a change in software that can harvest data out of
management plans, out of financial software, and to populate the standards and
to send them on.

The work will shift. How it will shift? I don’t think we really understand
that yet because we don’t have a tipping point to really show us how it is
going to change.

DR. SUAREZ: We will hear more about it tomorrow during the hearing as well
how will this affect. If we are talking about the EFT itself, that is what I
was talking about is really in the health plan side. If we are talking about
the 835, it is really both sides will be affected.

DR. CARR: I have Don and Mike and Leslie and Paul.

DR. STEINWACHS: Part of my education is we don’t have the patient up here
and the patient essentially gets information that sounds like the 835 too in
the explanation of benefits. Could you talk a little bit about that because
eventually the patient we may get the 835 if that is essentially the
explanation of benefits and when I get it electronically instead of by paper or
is this totally in a different ballpark?

DR. SUAREZ: Yes. The explanation of benefit is a separate element. It is of
course coming out of the —

DR. STEINWACHS: The 835 wouldn’t give me the same as an EOB, an explanation
of benefits.

DR. SUAREZ: Well, it will feed into it but it will be a document that will
contain limited information for the patient to let them know what is paid and
what was owed by them. I don’t know if you are talking about are we
standardizing the EOBs as well.

DR. STEINWACHS: I am trying to understand the impact.

DR. SUAREZ: The impact on EOB.

DR. WARREN: What is in it for me?

DR. STEINWACHS: For the patient because you are talking standardizing codes
and other things. I am just wondering how the patient and the EOB gets
reflected in the transaction —

DR. WARREN: At this point the patient is not in this loop, but that doesn’t
eliminate it for us thinking about it in the future and I think that might be a
good question for us to ask tomorrow. Is there any potential for the patient
getting information out of these exchanges? And there probably is but it will
require other kinds of manipulations to get up there, but a very good question.
None of these standards have been developed with the patient in mind.

DR. STEINWACHS: I understand that. That is why I am here. I am the patient
advocate.

DR. FITZMAURICE: I guess the way I understand it is that Aunt Millie may be
in trouble. The tech comes in and then later on the remittance advice comes in
and Aunt Millie is sitting there at her desk trying to match up the checks with
the remittance advice and the numbers don’t reconcile so she may have to get on
the phone back to the plan to get some explanation. This comes in
electronically and if the practice management vendors incorporate this standard
into their system, it comes up on a screen. It is reconciled automatically and
anything that can’t be reconciled may be there in red and maybe you call about
that. But maybe half of Aunt Millie’s time just isn’t going to be used.

DR. CARR: Can be redeployed for other more important things.

DR. FITZMAURICE: Yes. I wouldn’t want to see anything happen to Aunt Millie.

DR. FRANCIS: I need the privacy slide which was right near the end and went
through very quickly. It is not that I didn’t like it. Here is my question. As
I conceptualize it when I read the EFT with minimal data, no diagnostic or
treatment information is supposed to go with that just equivalent of check
number, transaction number.

Now take me to the next slide, the last slide. Financial institutions may
become business associates and perhaps covered entities if certain approaches
are used. Here is my question. Why if no PHI is going conceptualized for me why
that that second bullet.

DR. SUAREZ: The simplest way to answer that and I know probably Matthew and
others will have answers to it, but the simplest way of thinking of this is
there are two ways to communicate the EFT from the health plan to the bank of
the health plan and then all the way to the provider. One is the health plan
sends the message with the financial information and then a number. No PHI. The
second version is they send the message to the health plans bank with the
financial information and then a copy of the 835. The 835 is a transaction that
contains the detail of the payment and with the information about the — this
was the service. It includes any identification of the patient. It includes
PHI. In that case normally and currently the health plan will establish a
business associate relationship with the bank because they are disclosing to
the bank PHI. Embedded in the message that goes to the bank is PHI information.

DR. FRANCIS: That is what I was guessing the answer would be and that is the
answer I didn’t want to hear because —

DR. SUAREZ: But it is already happening though.

DR. FRANCIS: But my question is why can’t it be set up now that we are doing
it electronically so that the rule and the standards are that because of what
was said in that earlier thing it doesn’t — all you need is the association
number. Why take the risk of letting the PHI go to the financial institution
because it is really not a — first of all, don’t multiply transfers of PHI
beyond necessity because any transfer there is always — any time it is new
hands there is always a risk. And secondly one doesn’t really want financial
institutions getting —

DR. SUAREZ: But there is another important point to be made and that is
banks are not just financial institutions to some of these providers and
payors, some of these cover entities. They are business associates that perform
other kinds of functions beside the financial part of it. They can do
reconciliation of the payment and they can do a lot more. In fact, some of them
may act as clearing house in the same way that — do they — perform function.
Some banks own clearing houses in the way that clearing houses do work to the
health care clearing houses so that the health plan sends the transaction to
the clearing house. The clearing house sends it to the provider. The bank could
be the clearing house.

DR. FRANCIS: In which case it is a covered entity.

DR. SUAREZ: In that case. That is why the message of — says they could be
covered entities if they are a clearing house or playing a function of a
clearing house on behalf of a payor or provider. Or they can be a business
associate if they are receiving PHI from either of the two in order to conduct
those transactions.

DR. FRANCIS: From a privacy perspective what I would like to have out on the
table is that to the extent that what we are talking about is the EFT as
technically defined in the beginning rather than standard old clearing house
functions. We really should not — what I can foresee is a world in which all
the banks turn out to be business associates and because it is easier all the
PHI goes along with the — then you never have to even have a number to match
them all up because they are all the same document. That has me concerned from
a privacy perspective.

DR. SUAREZ: It is part of the decision that we would make. And certainly
tomorrow that will be one of the points of discussion with the testifiers
because as I was saying what we will hear tomorrow is some entities are
currently and would want to continue seeing the use of the CTX. That is the
technical term of this message that includes a copy of the 835. And some other
covered entities, providers and payors would say no, we are not using the CTF.
We are using the CTD which is another version.

We will hear the two perspectives and we will have to make a decision as to
which recommended standard will be the one to go with.

DR. FRANCIS: And when that comes up I would just request that privacy get
involved in that loop. I hadn’t planned to be here tomorrow and can’t be
actually, but I will read the testimony and would like very much —

DR. SUAREZ: Privacy is near to my heart.

DR. FRANCIS: I know that, Walter.

DR. CARR: We are scheduled to conclude at 10:15. Paul, you had a comment.

DR. TANG: It is the same as Leslie’s. Let me just clarify. Why is this
passed the minimum necessary when they send the PHI to the — is it because the
ACH is a clearing house and got exempted?

DR. SUAREZ: Yes. If the bank plays the role of —

DR. TANG: Then it is not playing any health care role. It is just a bank.

DR. SUAREZ: Or it is clearing house bank or is it clearing house function or
is a —

DR. TANG: Is that what is going on? That is why you are passing the minimum
necessary —

DR. SUAREZ: Good question. Minimum necessary and they are the HIPAA
regulation includes the concept that if you are using the standard and the
standard today supports CTX then you are meeting the minimum necessary. You can
use today either the CTX and still need the minimum necessary or you can use
the CCD and need the minimum necessary. Because the standard today, the 835
standard supported both CTX and CCD.

DR. TANG: But having banks receive that information without — is it because
they are acting as a clearing house where they are allowed to have this without
— is that what is going on here?

DR. WARREN: Some banks function as clearing houses at least that is our
understanding —

DR. SUAREZ: Whenever payors sends the bank a copy of the 835 embedded in it
there is a business associate agreement established.

DR. TANG: Every bank that does receive the CTX has a business associate
agreement.

DR. SUAREZ: They better.

DR. CARR: Thanks. Now I wanted to just clarify. I know Karen busily assuming
her role covering for Tony Trenkle who is taking a new role. Initially we had
planned for Karen to give us a CMS update and Lorraine, is that postponed or
was that something —

MS. DOO: — do it.

DR. CARR: You are going to do it. Perfect. My question — we also have the
quality letter, but I think while we have you on the phone if your time is
constrained we can go into that now or not. Are you pressed for time?

MS. DOO: No, I am fine. I am going to go to a different phone, but it is
already on the line just because someone else has this room at 10:30. I am
totally prepared for that, whatever you want and I have the time to wait if you
want to do the quality letter next.

DR. CARR: We will move then to the quality letter. Thank you.

DR. TANG: We want to take the input from the full committee and the work
group and the subcommittee and redraft it and revise it and put it through the
process we described.

DR. CARR: I didn’t know if you had any updates.

DR. MIDDLETON: No, that is it.

DR. FERRER: Justine, can I ask a question since Paul is giving us more time?
On the CTX and the CCD clause I am assuming sort of a continuity care document.

DR. SUAREZ: No. Thank you for bringing that up. CCD does not stand for
continuity of care document. I know I am going to fumble on what it stands for.
It stands for something related to the disbursement. I don’t know if anybody —

MS. DOO: Matthew might be able to answer.

DR. SUAREZ: I have it in my notes because it is something — I can open it
and read it. It has nothing to do with continuity care document.

DR. WARREN: Which tells us that when we write this letter that we are going
to have a glossary and we will spell things out because it is actually CCD plus
is the name of the transaction.

PARTICIPANT: It is continuity of dollars.

(Laughter)

DR. SUAREZ: It is corporate credit or debit. It is actually cash
concentration or disbursement, CCD.

DR. WARREN: Now we are bringing in acronyms from the banking industry and to
the acronyms of the health care.

DR. CARR: I like the crosswalk on plumbers and plumbing. That was very
helpful.

DR. FERRER: Walter, one last question is — paper based now to electronic.
Is the goal of the standard to pretty much go away with the paper transaction?

DR. SUAREZ: With a paper check?

DR. FERRER: Yes.

DR. SUAREZ: The EFT standard is to define the standard to conduct funds
transfers electronically. Yes. Would there be a requirement to only do EFT? I
don’t think there is.

DR. FERRER: — the administration simplification —

MS. DOO: Well, Walter, for Medicare there will be.

DR. SUAREZ: The law doesn’t — the AHQA doesn’t say thou shall establish an
EFT standard and everybody shall use that and only that as the way to do the
EFT or the only way to do payment. Private payors could decide whether they
will just do EFT and everybody has to accept the EFT or they will do EFT and
then for some small providers they will still send them a check. I don’t think
there is still that type of a requirement. In some programs Medicare —
Lorraine just pointed out that they will be doing. The thing about Medicaid
they deal with very small providers that still send claims on paper and they
still are able to send claims on paper in some states anyway. They don’t do any
electronic transactions. They don’t do anything. They can receive the payment
on a check as well, but the goal is ultimately absolutely to try to pursue that
everybody uses the standard of electronic funds.

DR. CARR: Lorraine, actually we are going to move then. Are you in the room
that you are supposed to be in? Excellent.

Agenda Item: CMS Innovations and Updates

MS. DOO: Thank you for letting me do this for Karen and obviously she is
disappointed not to be there also. And what I have is a general update on a
number of CMS initiatives so hopefully it is the right information or the kind
of information that you were hoping for and I will just go in order what I went
over with her yesterday.

Let me just get a sense. How many of you and Justine, maybe you can just
tell me from a show of hands, are familiar with this project we have been
working on called the Blue Button for MyMedicare.gov which gives access to
Medicare beneficiaries to their data.

DR. CARR: Actually we heard a bit about it yesterday from Todd Park.

MS. DOO: That project is actually run out our office and the Office of
External Affairs because they run the MyMedicare.gov website. He may have told
you. We have done no promotion for it. It launched in September. We have done
no promotion to beneficiaries for it, but it has been — we have 25,000
downloads. People have opted to download their information to their own
computer. There have been 25,000 unique individuals that have done that.

What we are working on — we have given people the beginnings of
understanding what it is like to access and have and control their own
information to the extent it is MyMedicare.gov. Most of it is self entered.
Some of it is from claims. It is not electronic record. It doesn’t have
diagnostic information. It doesn’t have procedures, but it is a start.

So then someone downloads this and then the natural question would be so now
what do I do. What do I do with it? And we have been working with AHIMA and I
know one of the Allison’s from AHIMA is there today. There is another Allison
we have been working with. On AHIMA’s website for PHRs which is myPHR.com has
many good features to it: educational, how to use a PHR, how to select on,
privacy and security issues, what kinds of functions and features you should
look for.

And then there is a search component where you can look up either fee based
or free and also whether it is web based or if it is downloaded. And we are
going to have a — part of that directory there will actually be a blue button
selection so that as PHR vendors come forward that are capable of uploading
that data that the beneficiary has now downloaded that they will be able to
upload into a more formal PHR, if you will, like No More Clipboard or Google or
Microsoft really help all of these that are out there, Health Trio, so that
then they will be able to import data from other sources if they want to and
begin to build a genuine personal health record and all of this of course is in
advance of what may come as portals get developed for electronic health
records. But it is a way of giving people more access to do more and learn more
about their health information.

Right now the only personal health record tool that has stepped forward and
actually can upload that downloaded data is Microsoft. They were one of the
first people to really develop an application that enables it. We are putting
up work through AHIMA and through our other contacts to see if any other
vendors are going to come forward because we can’t really establish a directory
with only one tool.

DR. FRANCIS: This is Leslie Francis. I have a couple of related questions on
that which may or may not be relevant at this juncture, but are you planning to
have any special kinds of disclosure information or any kinds of restrictions
on what sorts of PHR functionalities would be acceptable in conjunction with
the Blue Button mechanism. For example, if a PHR vendor showed up with what —
I will just say with no privacy protections in it, but Blue Button
functionality. Would there be any issues about that?

MS. DOO: It is a great question and one we have talked about a lot because
once upon a time we actually had a work group under CCHIT where we talking
about PHR certification. And HL7 also has a PHR functional model which
incorporates some of those things, but nothing has been approved. Part of the
reason that we will link to the PHR, the AHIMA website, is that Medicare cannot
condone or recommend any tools. On our website and on the AHIMA website it
tells people what to be careful for and what to look for. But we do not have
standards that we can apply to a PHR vendor to say you have to have a privacy
policy on your website and you have to have X, Y, Z type of authentication.
None of that exists for us to even consider adopting or recommending. We really
don’t have that other than caveats to the individual of the kinds of things
that they should be looking for before they use any such tool and that exists
on both our site as well as the AHIMA website.

DR. CARR: Just visualize it for me. Is it just on the Blue Button website or
are there — how will the Medicare beneficiary be aware before they push the
blue button?

MS. DOO: There is information — they can only access it through
MyMedicare.gov. They are a registered user. There is a description of what the
Blue Button is and what they should think about before they download it. Our
first concern was when you download that data from us and it goes on your
computer, you are now responsible as you as the individual doing the
downloaded. The first caveat we give before they push the button is make sure
you are putting this in a safe place on your own computer and that, for
example, you are not downloading it at the library. We have that kind of
guidance before you do anything.

DR. CARR: A quick question. Is this fee for service only data?

MS. DOO: We don’t have claims for Medicare Advantage or Part D. That
information isn’t available through MyMedicare.gov because those are private
plans and we don’t get their data. Now some of those plans have their own PHRs.
Aetna has a really robust PHR so people are — anybody enrolled in an Aetna
Medicare Advantage Plan would have access to a PHR through that as well.

DR. SCANLON: This is Bill Scanlon. I thought there was — first of all, the
Part D data do eventually come to you.

MS. DOO: We don’t have it in MyMedicare.gov.

DR. SCANLON: I guess the question would be would that be a future plan. And
then for the Medicare Advantage Plans there was a requirement that they submit
encounter data starting I think next year.

MS. DOO: I can’t really hear you very well, but I think you were talking
encounter data.

DR. SCANLON: Right. That is correct.

MS. DOO: Yes. They submit encounter data, but again that is not loaded into
MyMedicare.gov. Those systems are not connected. The only people that use
MyMedicare.gov are fee for service.

DR. FERRER: I think it is probably just educational, but the VA is very
active with Blue Button. It is going to be actually very much looking forward
to allowing the events to — that is part of our PHR.

MS. DOO: They have had something like 80,000 downloads through My
HealtheVet.

DR. FERRER: We have had quite a bit more that we just claimed.

DR. FITZMAURICE: Lorraine, will this take information from my eligibility
file and can I access the information of my eligibility file as well as getting
claim information through the Blue Button?

MS. DOO: No, because that is not part of the downloadable formats right now.

DR. FITZMAURICE: Okay. Thank you.

MS. DOO: When the two groups got together, VA and Medicare, and looked at
what data is available on their various tools. For what people download there
is something called an On the Go Report and that information is not part of
that now. When we do a more formal implementation, a “real”
implementation, and begin to get feedback from beneficiaries, it is conceivable
that additional data would be pulled in. For example, perhaps diagnosis of
procedures perhaps will be able to import the Part D pharmacy data so that it
is not just self-entered. Those are things that are not yet on the list because
we really haven’t vetted it with the beneficiaries. That will be the next step.

DR. CARR: I don’t think there are other questions at the moment. Why don’t
you continue, Lorraine?

MS. DOO: All right. The next piece of the update is on the HITECH program
for meaningful use. And again as you have probably heard the registration
process for the incentive program is slated to begin in January of 2011. They
are going to have a single system for Medicare and Medicaid providers to
register and information is going to be obviously widely distributed both to
the states to communicate with the Medicaid providers and then on a more broad
basis. All of that is coming. You can imagine the systems people are working
very diligently to make sure that the testing is all completed successfully and
that all of this work from that standpoint because they want to begin being
able to make incentive payments in May of 2011.

People will be able to register in January and then the attestations will be
able to begin happening in April and then hopefully payments will actually be
made in May. All of that is underway. One of the groups in our offices is
seeing to that.

For ICD-10 and 5010 there are really two outreach efforts under way. One is
specific for Medicare which is handled by the Medicare Fee-for-Service program.
They are on schedule. They are going to be doing their testing beginning in
January as is expected based on the regulations for what they are calling
original 5010. And as you heard I think at one of the last meetings, there was
some errata for maintenance changes to the X12 standards and NCPDP actually
that were recently approved and Medicare will begin to test the errata version
starting in April of this year. They have a communication plan for that.

And then CMS, separate from Medicare, is doing outreach and education for
the industry at large because we have a responsibility for that as well. There
have been advertisements placed in medical association publications and a slew
of other trade publications. And there is a media campaign and experiment
outreach on the CMS website. That is all under way, and they have continued to
have open door forums and stakeholder meetings to identify how things are
going.

We had some surveys done earlier, and as you can imagine people were very
concerned because ICD-10 and 5010 were happening and then of course on the
heels of that was meaningful use and then on the heels of that health reform. I
think there is genuine concern about how this will move forward, but we haven’t
heard anybody saying that they wouldn’t be able to at least begin the testing
process and a lot of entities really have begun doing a planning for ICD-10
which is required for October of 2013. That is moving forward.

And then for the Affordable Care Act you all are fairly up to date with what
we are working on clearly the two regulations based on the July letter or the
September letter for the plan identifier which is expected to go out in July as
there will be an interim final rule and for the operating rules based on what
happens tomorrow. But our plan is to have an interim final rule that gets
published in June.

And the next publication data again depending on what happens tomorrow and
the letter, but our plan is for the interim final regulation on EFT standards
and operating rules and also for operating rules for remittance advice would
actually be December of next year because of mandated publication is January 1
of 2012. It has to go out in December.

There is just a tremendous amount of work going on here with respect to
business processes here, the beginnings of an outreach strategy, the systems
work that has to go on that we can at least begin to build the initial
requirements and design even though final policy decisions are probably a good
3 weeks away.

And some of you — I don’t know. Walter, you may have been keeping up but as
you will hear tomorrow, CAQH CORE has been doing a lot of work on outreach for
their presentation for you tomorrow on enhancements. NCPDP will be presenting
on what they have been doing in terms of looking at the operating rules that
exist to determine if any enhancements are needed there. A lot of work has been
done since the last set of hearings and the letter.

The administrator’s offices are very actively involved as is the White House
in really monitoring what is going on with all of health reform. We are some
small piece of it, but there is tremendous engagement and we get questions even
on the administrative simplification provisions just as the Office for Consumer
Information is getting questions on the very large programs that they are
implementing to get people access to insurance.

That is the net of the update. I don’t know if there are questions or if you
needed any other information that I can provide.

DR. CARR: We do have some questions. I have Mike and then Paul.

DR. FITZMAURICE: Lorraine, ICD-10 isn’t to come until 5010, but is CMS
investing in a golden rule mapping of ICD-9 to ICD-10 and investing in a new
DRG group or based upon ICD-10? And also, will these be publicly available?

MS. DOO: From what I understand that the mapping exists. They ICD-10
coordination and maintenance workgroup had a meeting in September and they have
been receiving feedback from industry about any issues or corrections that
needed to be made and are working on that.

The DRG, I believe so and I can get you more information from that group if
you would like it. But all of that work has been underway for some time. They
will be made publicly available.

DR. FITZMAURICE: And the last part of my question is when will it be
publicly available.

MS. DOO: I don’t know the when, but I can certainly find out for you. I may
be able to find out today.

DR. FITZMAURICE: Thank you, Lorraine.

MS. DOO: I know that the current will freeze in October 2012 I think. The
mapping is available today publicly, but then of course they will be making
these modifications and corrections. I will find out what the projected date
is.

DR. TANG: Thanks Lorraine. I have two areas to question. One is on ICD-10.
Is there going to be a SNOMED ICD-10 mapping?

MS. DOO: Not to my knowledge, but someone was just talking about that
yesterday. I did not think that was part of the mapping that was being done
here, but before I get anybody disappointed let me check with Cindy Hake who is
in charge of that whole mapping project.

MS. GREENBERG: I can respond to that, I think, Lorraine. There is now a
formal agreement what they are calling a collaborative arrangement between
IHTSDO, the proprietor/owner of SNOMED CT and the World Health Organization —
responsible for ICD-10. There has been work that has been done on a mapping,
but it was prior to this formal agreement being made. That is now being
accelerated and kind of the rules and how this is going to be verified, et
cetera that they are actively meeting, holding the policy groups and the
technical groups.

Once we have that map which is ICD-10, not 10 CM. This isn’t relevant to
10-PCS. Anything that is going to be done with 10-PCS would have to be a US
effort obviously and maybe Judy knows something about that. Once the ICD-10 to
SNOMED CT map has been agreed by both sides which is one of the standards for
doing mapping then the National Library of Medicine working with NCHS and
others can produce a 10 SNOMED CT to 10 CM map. And hopefully that will all
happen before we actually implement.

DR. TANG: One is the win, but also then that would be a legitimate endorsed
authorized mapping that could be used to convert your clinical terminology to
payment codes.

MS. GREENBERG: These are not payment codes. This is a statistical —

DR. TANG: Well, I understand but that would be used for payment codes in —

MS. GREENBERG: It will not be automatic. I don’t think they will be —
because ICD-10 is not based on SNOMED. You will not be able to put — I don’t
think you will be able to put your SNOMED codes or content into a black box and
produce your transaction. But this humanize will still need I think, to verify
that the ICD-10 CM codes are the correct codes, but it will certainly greatly
facilitate that. Some of it will be one to one. I think if you are looking for
totally automated process that shouldn’t be expected.

DR. WARREN: Right now what they are doing is there is a work group between
WHO and IHTSDO, that are looking at the problems with mapping. The issue is in
many instances there is a mini-to-mini code match. And so what they are trying
to do is figure out is this a limited set, are there rules that can then parse
these out, and so all of that is being done as part of the work plan for
creating this map to ICD-10 and then back again to SNOMED. It is a both ways
map.

Jim Case at the National Library of Medicine is the touch point for the US
on this project. And one of the things that I know that Jim is looking at is
once this is done, can we then leverage the learnings off of the activity in
order to create a SNOMED to ICD-10 CM map. It will be based on the generic 10
map.

DR. TANG: And the timeframe for this?

DR. WARREN: I don’t know. I think the current project that we are looking at
just to ICD-10 I believe I saw something like 12 months so sometimes toward the
end of 2011 unless they run into some major glitch or problem.

DR. TANG: And what about CM?

DR. WARREN: CM is on hold until they figure out how to do the 10 map.

MS. GREENBERG: I will say that like everything else in the government there
are resource issues on NLM and we will need adequate funding in order to do
this, but it is certainly part of the plan. I know it is something that ONC is
very supportive of. I am not saying that they are providing — it is something
that I think we might ask for an update on this at the February meeting. Either
it could just go to the standards, but I think it is probably of interest more
broadly.

DR. TANG: Could standards offer a recommendation at least to be approved by
February? And the reason is because that really is a gating activity to make
better use of ICD-10 CM than we have with ICD-9. And then the downstream
effects on everything we are trying to do with quality measures, quality
performance is all dependent on this.

MS. GREENBERG: Everyone understands that. The question though is — current
environment. I think the committee making clear that it is important so that it
could be useful.

DR. TANG: That is what I am saying. In the committee help because it is
clearly and I know everybody understands this too the vast amount of money that
is going to be reworked will pale. The development cost, the incremental
development cost today in the next 12 months will pale in comparison to the
rework that would have to be and the opportunity cost. That is my ICD-10.

The next one was to follow up on privacy because I just didn’t want to
interrupt at that point. There are two areas, Lorraine. One is what — let me
just put it in the rubric of patient education.

MS. DOO: Unfortunately I can’t hear you.

DR. TANG: Of patient education. At the time you click the blue button that
is one act and you get a conversion and download. When you are making the
choice of what to do with it, that is, I guess, where I am concerned. Clearly
there are different generations that deal with this capability and the risks of
essentially distributing your personal health information. One is what is the
usefulness and the benefit of the data itself. We understand that Medicare has
the claims data.

There is a famous case that e-Patient Dave made with the Boston Globe that
says well actually it is not just that it could be inaccurate. It could be
harmful. You could end up in the emergency room. You need to have thrombolytic
therapy either for your heart attack or your stroke, but this claims diagnosis
of upper GI bleed because of the confusion with respect. It was really just
GERD. And that could prevent life-saving and brain-saving therapy because of an
inaccuracy in a code, which is nothing anyone did maliciously but it is one of
the dangers of having claims data which we appreciate to be inaccurate appear
on “health records”.

That is one thing that it would be pretty hard to explain to the public and
especially the Medicare population where not only do you have the risk of
having the heart attack, but you are not as used to dealing with this
information.

The second part then is the privacy thing. It is still related to how can
you give inform consent to people who are just pressing a blue button and the
next one next to it which could be upload to this vendor X application. The
application could be called anything. It could be called your health helper. Is
it enough to say be careful or what can we do to make sure that the privacy
risk, but also the health risk, the consequential decisions made on this
so-called health data don’t cause inadvertent —

DR. FRANCIS: This is Leslie. Could I just add to that? Some of the upload
capabilities now are not just the computers, but they are the Smartphones.

MS. DOO: Right. That could happen and as you know there was this developer
— well, you may know. Todd may have spoken about the developer’s challenge
where people were talking about applications for phones because that is what
people are using. And part of this is in preparation for the next generation,
not solely today’s beneficiaries, but really looking forward to tomorrow’s.
These are all very important concerns. Obviously we talk about them a lot here
and it is part of the reason we haven’t launched a big formal program so that
people begin to do it and we don’t know what all of the ramifications might be
that we need to put safeguards in place for. Clearly your comments will be part
of what we provide to the group that is going to be working on this now more
intensively.

Did you bring your concerns up with Todd yesterday as well?

DR. TANG: Not in specific details we just enumerated, but we talked about
the privacy concerns or risks of this wide dissemination of —

DR. CARR: We talked about collaborating with him. As we brought up quite a
number of things and he was very enthusiastically writing them all down and
welcoming the opportunity for some deliberation and input on these things. We
expect that we will be hearing from him.

DR. FRANCIS: This is just a follow up that is directly relevant to Medicare.
You still have the demonstration project going I know in Arizona and Utah and I
think one of the PHR vendors that is part of that actually has a Smartphone
app. What I am curious about is whether you have done anything to analyze the
South Carolina demonstration project data or if you are doing anything with
respect to the Utah/Arizona data that might be illuminating on the privacy
front along the lines of some of the questions Paul asked.

MS. DOO: Not on privacy and not on the data content, but on the usefulness
and the satisfaction we have done studies and we do have reports and a fair
amount of information about that. As you know, Utah and Arizona has very low
uptake because there has really been no promotion. I don’t know which one of
the vendors has a phone app so I don’t know if they are uploading it for our
PHR or for the beneficiaries or if it is for other clients that they have
because I hadn’t heard about that. And there is a privacy question in our
surveys, but it is a question or two. It was saying overall are you using this,
in what way is it helping you, are you confident about the information, have
you shared it with your doctor, those kinds of things to help us understand
more about what functionality beneficiaries would like.

DR. FRANCIS: It would be really helpful if you could send us the links to
any of the published reports you have.

MS. DOO: Sure. I would be happy to do that.

DR. CARR: Anything else from you, Lorraine.

MS. DOO: No.

DR. CARR: Thank you. This is how I see the rest of the day going. One, we
have a brief update I see here on ICF and functional status and also on our web
cast and then public health data standpoint. I think we can take a break now.

DR. FERRER: What happened to CMS innovations?

DR. CARR: We had to postpone it. We can take a 15-minute max break and then
come back. We will get a brief update on that, but we actually have some
additional time to hear the report outs from the subcommittees and then I want
to wrap it together with what our focus and plan going forward. I am actually
appreciative that we have this additional time because 20 minutes isn’t going
to cut it. By my watch it is 5 of 11. Bill, what is it by your watch? At 11:10
we will return. Thank you.

(Break)

Agenda Item: Updated: International
Classification of Functioning, Disability and Health and the Public Health Data
Standards Consortium

DR. CARR: Alright. Next step will be Marjorie updating us on some activities
that occurred since the June meeting. My name is up there but so it yours. Will
you talk about this?

MS. GREENBERG: You have these and I guess if you want to — I don’t know
that I need to go through all these slides, but you have them in your agenda
book under five. These activities are ones that the committee to some degree
help sponsor in relationship to the 60th anniversary and long-term
interest. One of them was the meeting of the North American Collaborating
Center, the conference, the 2010 conference on the International Classification
of Functioning Disability and Health which has been an annual meeting between
the US and Canada for a number of years. This was actually the 15th
conference.

It was agreed that the committee would help sponsor this year’s meeting
which was in Washington, DC. And Justine provided the keynote address or one of
the keynote addresses. To get to the bottom line she agree that and this is the
second to last slide on page eight under tab five, but that NCVHS will continue
to monitor this topic through its subcommittees and functional status as we
heard yesterday being relevant really to all of the subcommittees, the
collection of functional status. At the end of the day we were talking about
its importance to the patient-centered focus of quality measures. It clearly
has a standards component. We are dealing both an international classification
and transactions and standards written all over it.

It is very relevant to the populations’ agenda. And also let me just finish
this sentence. Of course there are privacy issues and then we said that NCVHS
will receive a report on the conference at the September or December meeting so
that is what we are doing.

DR. CARR: What I did because I am not really conversant in a room full of
experts in this area. I was the least conversant person, but I just tried to
take it to my daily life in terms of understanding functional status and apply
it to issues about safety. I don’t know. I came out of the meeting wondering if
I had been too concrete. But we talked about functioning status, enhancing
inpatient care and how the New York Heart Association Classification is
integrated into understand strategies for care and similarly in terms of safety
priority, national safety initiatives, prevent falls, transitions of care it
could be impacted by functional status in terms of vision, mobility, cognition.

I went to electronic health record challenges, the challenge of capturing
and we talked about this yesterday and quality functional status for structured
data collection, patient-centered care, and electronic capture and does it come
from the EHR or the PHR from the provider or from the individual. And how to
integrate — if we were to incorporate functional status into dataset, how do
you get that into the work flow?

Then I heard a number of presentations. This international classification of
functional status is extremely granular and related to —

MS. GREENBERG: It all depends on your perspective. It is much less granular
like with ICD. And if you are really using it in a specific area, it might not
be granular —

DR. CARR: If we were to just say we want to capture functional status so
that we knew that a patient had a vision impairment or mobility impairment and
that were part of the initial assessment of a patient and then we would provide
a safer environment. We probably would do it anyway, but this would codify it
and ensure that we could take action to keep the patient safe in the hospital
and obviously at home as well.

I see that as a big challenge. I know Lisa Iezzoni spoke to us about this
about a year and a half ago. And we talked yesterday about the importance of
functional status and as we get the patient’s perspective or the individual’s
perspective either as their chronic condition or as their outcome from some
intervention. I am not clear on how we get from this formal entity to
electronic health records.

MS. GREENBERG: Let me just say a few things about that and then we can open
it up. I think as you know Lisa did speak to the committee, I think it was a
year ago June, in which she said perhaps the stars are aligned. We are always
talking about maybe the starts are aligned. They don’t fully align, but they
get a little closer. As Justine said, she reviewed what the initial
recommendations had been and then what progress had been made. I would say the
main area of progress has been that we have gotten ICF into the standard
infrastructure. It was CHI and then HITSP adoptive standard for the functioning
and disability domain.

We have actually now got it recognized not only in HL7 because those were
more HL7 transactions or standards, but as a — my informatics group has done
this. We have actually gotten it as a recognized external code set in the X12
standards too. That was just recently accomplished.

It is not like something that isn’t part of the standard, but that is a
different thing than people actually using it and implementing it. A lot of the
work and this is what the meeting was about the way it has been incorporated
into education for like physical therapists, occupational therapists, et
cetera. It is the framework for that in disability statistics.

It is permeating the environment, but at this point I would say most of the
information on functioning that is captured is still not codified. It is
primarily free text.

Now like any classification, however, it is hierarchical so you could
actually just say at least we can find out whether there is a mobility
limitation, a vision limitation, a cognitive limitation, and you could code at
that level like there is a heart problem or if you could actually use it as in
some countries they are trying to do in a much granular way like a
classification.

I think what is really important is that if you go to and if you go back a
few slides, these topics for continued research. These were identified in 2001
and they are still relevant. These are identified by the national committee.
They were again sort of supported in various reports whether it is the
21st century vision report in the CHI recommendations that were made
to the committee that the committee validated and then sent its letter to the
secretary. And there has never been any funding of this. I am looking at
Garland and I am thinking too we are looking at the standards for electronic
health records relating to vital statistics and all of that foundation is being
developed now and it is actually much more complicated. You obviously have to
do demonstration projects in these areas. You can’t just on a wing and a
prayer, say we are going to do this.

I think Justine pointed this out as well that all of these questions —
there is some experience in other countries, but other countries have different
payment systems, have different electronic health records, have different
administrative systems. You really have to do some work locally. And we have
had conversations with the VA. We have had conversations with DoD. This is
totally aligned with their goals, with SSA as well. Disability eligibility and
the Wounded Warriors program, the whole thing.

The main thing is now that actually really begin collecting functional data
at either a high level or a detailed level in electronic health records or in
specific transactions for which it is relevant. You need to do demonstrations.
You need to do some of this research. I think that is where we are right now.

As we speak here, my lead person on the ICF has been holding webinars this
week. We are doing training as a pace is an introductory ICF e-learning tool
that we have been working on through our WHO-FIC Network and that will be
released within a few months. I will send you all the link when it is. It is
also an ICD-10 e-learning, web-based learning tool that is being released as
part of that process. We are doing the education. We are doing the standards
embedding it into the standards, but then to go to the next step of can this be
used.

Actually the German Collaborating Center which is probably has the most
robust research agenda related particularly to core sets so depending upon what
your diagnosis is what would be the core set. And they have done a very
systematic way of getting these recommended. They have some findings that it
really does influence the — we know that the DRGs are sort of an imperfect
method of doing risk adjustment that it does make a difference. But we haven’t
done any of that research here either. We can build on some of the research
they have done. The literature is getting quite robust on ICF. We are not just
starting from scratch here.

That is what I leave you with from the point of view of next steps and I
think it can fit into several of the things that you will be hearing about now
that are the committee’s agenda. I don’t see any resources going forward to
move this to the next step.

DR. CARR: Paul then Judy then Larry.

DR. TANG: Just like we were working from these clients that were PC kinds of
base solutions a while back and then there is this web and everyone jumped on
that and then all of a sudden these phones appeared. Sometimes there is like a
leap frog. Is it possible that extracting things from the provider maintained
records like whatever format there is being it close by access to real people’s
opinions as if distracted by whatever it is? EHR might be one instance of a way
to check. Is that a possibility here and should we be also in parallel doing
research on that kind of direct —

MS. GREENBERG: Are you talking about coding?

DR. TANG: I don’t know whether — well, structured ways of capturing what is
going on with the functional status of the patient we rendered by the patient.

MS. GREENBERG: Sure. There have been a few research projects I think funded
by CDC in Atlanta about using technology to capture the information and the
coding is under the hood in a sense. Sure. That is definitely an area for I
think promising research, but again it needs to be — it is a research agenda
at this point.

DR. TANG: Have they also started comparing it to ICF extracted from medical
records to see whether it is —

MS. GREENBERG: It is different.

DR. TANG: It is different. Is it useful?

MS. GREENBERG: What abstracted from medical records?

DR. TANG: ICF is abstracted from medical records, correct?

MS. GREENBERG: Well, functional data can come from the patient and a PHR or
whatever just reported to the clinician. We do know that there is very little
functional information in like a hospital record and it may not be very much in
an outpatient record either unless it is specifically physical therapy,
occupational therapy, mental health encounter.

DR. TANG: It is a combination of where — I thought the slide said you
extract it. Part of it is to look or how you extract it from the current
medical records. The other is it always has a bias of the source, the reporter
as being one of us, the health care provider side. It seems we would like to
know what is useful about the patient generated input, how it can be — one,
how it compares to the provider’s source information, but also how can it be
directly — how can it influence care decisions or recommendations on literally
a day-to-day basis?

MS. GREENBERG: And I think Lisa Iezzoni would say you probably want both
because for various reasons patients often classify their functioning
differently, first of all, depending upon how they think the data is going to
be used and also their own perceptions. There is a rich agenda here for
research. And I guess it just seems like we keep giving lip service to the fact
that functioning and functional status is very relevant to patients and it is
very relevant to outcomes, et cetera. But there is no work going on. There is
in other countries, but there isn’t much going on here.

DR. WARREN: I think one thing — I think this will help answer Paul’s. You
have to look at the ICF. It is a very different classification structure and in
many ways to me it is not even a classification. It is a dataset all by itself
because you are not only identifying what the deficit is. You are quantifying
it so the second part of the classification of severity.

It is also one of these things. It is very much about what the patient can
do. It is not linked in any direct fashion to a disease state and in this
country we only reimburse for disease. We don’t reimburse for anything else.
There has not been any kind of motivation to collect the data. I have been
working with our physical therapy department because their national association
has just adopted the ICF is their terminology that they want to use.

MS. GREENBERG: They didn’t have another classification, but they had another
model. This was a big accomplishment.

DR. WARREN: It is changing their huge thing. The problem that we are having
is that there is not a lot of knowledge about how to use this clinically. The
physical therapists and the OTs that I have been working with know how to
evaluate their patients and they evaluate their functioning in much the same
way that nurses evaluate functioning on the floor, et cetera, but there has
been no effort to really document that or build by it and so trying to learn
how to use this particular classification we need a lot of work on how that
would happen. Does it mean if we start trying to capture it from the EHR? I
could see how we could develop some very standardized assessments. That could
be conducted by practically every member of the health care team at some point.
And if in the back end of the EHR it was then coded to an ICF code so let the
magic of database stuff work for you so that the clinician wouldn’t have to
pick the code. It would be automatically done on how the screen is built for
you to document. Then we could start getting stuff like that.

But that is an awful lot of standardization that we would have to have from
our clinicians which will change dramatically how they are taught. And I know
right now most of the PT and OT curricula are being looked at for revisions in
order to support this, which is one of the reasons why it was an uphill battle.

DR. TANG: I feel like I may not be clear in my point. The reason I use this
was to try to say how much of a leap frog it would. I am not confident that
what I record for the New York Heart Association functional status
classification for heart failure is what really reflects the functional ability
of the patient to live their life. I am not sure at all. No matter how you code
it. No matter how you extract it. I feel like we might be missing the leap frog
getting understandable information from the patient that would make far better
characterization of how they are living their life and influencing the
treatment that we recommend.

MS. GREENBERG: They could fill it out themselves. The ICF —

DR. TANG: I don’t know whether it is the same even thing. I just feel like
we — I am not saying don’t do this. I am saying we need more work on
understanding what real people think about their real lives, not the way we
have translated because of the —

DR. CARR: That is the ICF. Can you walk? How far? Can you climb a flight of
stairs?

MS. GREENBERG: It is also do you feel comfortable when you move your joints.
I think we could have a separate meeting obviously on this and probably that is
what — ICF captures the activities of daily living, but also it captures
people’s participation, how they live their lives. That was really — and the
environmental factors that either facilitate that or serve as barriers. It is
what they call the biopsychosocial model. It really has to do with can you
work, can you vote, can you religious things. It captures the whole thing. I am
not saying the physician would be, but it really relates to goals which we
talked about yesterday. What are your goals? Are your goals made —

DR. TANG: Just make one more attempt and this is something I just learned
this week. So the mode effects and surveys, the conduit by which we gather this
information has a huge effect on the results and that is all I am saying. And
that is my last attempt to try to say, what is the problem I am trying to point
out.

DR. CARR: Judy, were you answering —

DR. WARREN: That was part of my comment. I think that as we go forward one
of the challenges is going to be in standards is not only is it the messaging
standards, but it is the terminology standards that we need to make in order to
make meaning clear. And right now when you take a look at the terminologies
that this committee has recommended to HHS and to the CHI initiatives, it may
be time for us to go back and relook at how useful some of those terminologies
are and where the barriers are in learning them and why aren’t they coming out
more and more. Part of it — ICF, I think, is a good example because I was
unaware that the physical therapists didn’t fully embrace ICF initially because
I thought this is made perfectly for their practice. In beginning to dialogue
with faculty who are pretty active at the organization they are having some of
the same problems of this are totally different.

The ICF has fundamentally changed from when it was first started where it
was a disability index and now is gone into a functioning index. It has flipped
from being disease oriented and disability to being functionally oriented and
what can I do today and what is my satisfaction with that and what are my
preferences with that, et cetera. It is to me a very robust way of capturing
what our patients can do.

And I think back to Paul if you really look at it and add in some of the
initiatives that we saw yesterday that Todd was talking about from the
community, there could be some really great phone apps that would pick pieces
up and what you would then put in is to send those codes off to your primary
care doc if they can receive them and then they would know what some of your
choices might be in looking at preferences for therapy and therapy approaches,
et cetera.

DR. CARR: We have a lot of folks in line. We are going to move through.
Larry, you are next.

DR. GREEN: I think this committee should celebrate any forward movement with
classification such as this because the neglect of the classification needs of
datasets are so profound that even what may be seen as small and insufficient
forward movement is worth some celebration because you have to get in glacial
timeframes about moving a classification in the United States. I wish to just
give voice to the fact that everyone should just have three seconds of pleasure
out of the fact that there has been some advancement of a functional
classification scheme somewhere that might affect the United States.

I want to go back to just two words that I heard a moment ago and it is lip
service. I would flag for this committee as important the recognition that our
website to be very specific about one of the neglected classifications going
back to when John Lumpkin was chair. This committee or its entire history has
attempted to create ordering principles that can improve the health of the
population through the proper use of classifications for clinical care and
scientific inquiry. It is at the heart of what we are supposed to be about. It
is not tangential. It is central.

As Justine just said at the quality subcommittee hearing yesterday, once
again we talked about goals. And in this conversation in these exchanges we
just heard assessing function against the goal. Now there’s a concept. And that
concept relates directly to patient-centered care. Not everyone in this room I
have heard agree to the fact that we are trying to transform the delivery
system and that we have a set of rules from the IOM to follow and that the
first rule is make it patient centered. Where we may not be agreed is that we
are making no progress on patient centeredness. This is a very serious issue in
my view and I think it is wrong to be a member of a statutory advisory
committee and remain silent when this moment goes by.

We have this multi-billion dollar industry designed to do the technical
aspects of classification and coding to be sure money flows and is auditable,
but we lack. We lack in that system the capacity to learn about
patient-centered care. We lack the basic foundational atomic elements to do
that. This to improving the health of the public is the same thing as NIH basic
biomolecular research about genes, epigenetic phenomenon, and proteins and how
they fold. We are neglecting this. We have been neglecting it not on our watch.
It has been neglected since the birth of the committee.

We are a long way down this pike to not have a functional classification and
use in the United States. We are a long way down the pike to not be able to
classify the goals or organize them in some way. We are a long way down the
pike and not enter patient force about why they enter this overly expensive and
underperforming health care system. We do not know why they come.

And Paul, if I heard his message that he tried to deliver three times and
just may have to try a fourth time after I say this, but what Paul is saying
maybe we are just going about this entirely the wrong way. Maybe if we know
what the people’s goals are. Maybe we want to know whether they are getting
better or worse and can function better or worse. And if we want to know why
they want health care and what they expect out of it, maybe we are going to
have to approach it with a different data acquisition system and a totally
different approach because the one we have been trying for six decades is an
abject failure on these counts and we are hearing why it can’t be done now
because ECA is forcing certain decision to be made about getting interoperable
records in place, interoperable for what purposes.

And there is not a purpose articulated that says that they will be capable
of assessing whether the functional status of the population is stable or
worsening or getting better. And this is a mistake and it is an expensive
mistake and Paul said that also. We are going to spend a ton of money on
reformatting this thing and about 2016 it is going to be very difficult to
think that the industry is going to decide let’s do that again.

DR. CARR: Larry, as the co-chair of the population subcommittee, do you have
a recommendation? Are you making a recommendation?

DR. GREEN: Yes. I have actually not a recommendation of action. I have a
suggestion that this committee put on its classification progress on its agenda
as a routine item of business and that the purpose of that is actually for us
to think about what needs to happen that they use — what a classification is
is a set of ordering principles. Classification is not coding. Classifications
connect the codes. Classification is a set of ordering principles. This
committee should make another go in a sustained way about what are the ordering
principles necessary to have a patient-centered health care delivery system.

DR. CARR: Thank you. Here is the way the list goes. Don, Jorge, Leslie,
Bill, Blackford.

DR. STEINWACHS: Just a couple of comments because I think both what Paul and
Larry have said are very important. My bias has always been that we fail to
capture the information from the patient and that gets back to the idea of a
partition in electronic health records for where physicians can get patient
reported information and enter it in. Research is being done on that, but I am
not sure that that is something that is any way near a concept where you can
say, yes. It could be reported either voluntarily by the patient, or it can be
requested by the physician, and responded on your cell phone and you fill in
the data.

We talked eloquently about the clinical uses which I think are tremendously
important, but I am expecting Bill so I am trying to set Bill up to talk about
the payment issues because as we try and move toward episode-based payment
structures, functional status is about the only cross-cutting outcome for
chronic disease that we have and changes in functional status drive costs. They
drive risk of mortality. And it seemed to me in the absence of actually having
a way to capture that. So the research could be done more in a payment context
and the capture of this could be done initially to be driven by the payment
which is how we get the ICD diagnoses and so on. We ought to not cut that off
as a driving force.

DR. FERRER: Marjorie, I am actually leading a patient’s center medical home
national relation project at the VA. It is not lip service. If we need — and
actually we have the capacity to take free narrative with the natural language
processor and convert it to structure data. It is done. We do it. Is the ICF
informs, for example, how extensive is it? Is it 30 forms, 20 forms, 100 forms?
If you look at decompose what the ICF is like for a clinician to have to fill
out. For example, we did this exercise exactly with the NDF version three. We
took it and we incorporated it exactly as it is required for October deadline
for CMS.

MS. GREENBERG: It is not an assessment form. It is not an assessment tool.
It is a classification. You can approach this in a few different ways. You can,
as Judy suggested, you can actually build an assessment based on the ICF, which
then there is no mapping almost, it is just the codes are associated with it.
But since all the professions, clinicians already have assessment tools that
they use and getting them to change them is nontrivial and maybe not even a
good approach, you also can do this mapping between and some of that has been
done for major assessment tools map between the assessment tool and the ICF.
Again, just like you are mapping 9 CM to 10 CM or SNOMED then the codes are
produced out of the mapping.

There are, I think, something like 1600 codes but that is before you add the
qualifier and that is what Judy was saying, that although it tells you about
domains in which there might be a problem. The code really doesn’t have meaning
without the qualifier because that tells you whether it is a mild, moderate,
severe problem or as I said with environmental factors whether it is a
facilitator or a barrier.

There is, by the way, a clinical manual for clinicians that is being
finalized by the American Psychological Association, but it included all of the
different therapy groups, et cetera about how to use. There are tools that
would facilitate it.

It is not a form, but it is a classification. It is much smaller than ICD,
but it does have this different aspect of severity.

DR. FERRER: Because one of the things that we are running into with the
medical national is that when the care manager that is responsible for the 1200
panelists, we don’t have a structured way to do exactly what Larry said. It is
great. We have care managers that are doing medical home managing. They are
responsible for like a zillion lives and now we have the content, but they are
still very free narrative and there is no structure around it.

I loved the ability to document narratively, but I would love the ability to
do that and drive the structure content equivalent. That is really what I would
want to do. We can do that. If you can just let me know who I need to speak to
so we can work out because if you are talking about demos — we have an
innovation project that is exactly past to do this. We have written the
requirements. Just send me an email who I need to speak with so that — it is
not lip service. Just send me an email.

MS. GREENBERG: VA and DoD could lead the way here.

DR. FERRER: Unless they will lead because there is a whole lot of people
last year leading, but we would be happy to make — to actually get it done as
opposed to lip service.

MS. GREENBERG: One of the things we have looked at doing and done a little
work on but again there has been no resources is to linkify all these codes.
That was recommended too by the CHI process. We worked with the people at
Regenstrief, somebody probably on your staff as I recall. That is not rocket
science but it requires that some preliminary work has been done. But it
requires some resources to do it. That is one way to get it into a standard
too.

DR. FERRER: We have an innovation sandbox initiative within the VA, $80
million to $120 million that is exactly designed to rethink how we are doing
medical home initiatives across the country. We have tapped into the people
that have led the medical home movement in the country. We know what the
problems are and a lot of the problems are that trying to use electronic health
records that we have today to do medical home is an unapproachable dilemma. It
is never going to go away so you really need to think because it is a house
that is broken.

DR. CARR: That is great. This is really a very rich discussion. I have
Leslie, Bill and Blackford. And Marjorie, as I am looking at the agenda, it
looks like there are two other things that you wanted to get to and I want to
have one full hour to talk about our plans. That gives us 15 minutes. Are we
going to be able to get to all of these things?

MS. GREENBERG: I will be very brief.

DR. CARR: I ask everybody in your comments remember as we said yesterday, a
headline and a question as succinctly as possible. No need to repeat.

DR. FRANCIS: An observation functional status assessment include social
factors and that adds a new and interesting dimension particularly with respect
to what people might think the significance is of those assessments either
rightly or wrongly. I just want to point out this is sort of sounding a note of
caution that the interest in a functional status categorization or clinical
care purposes might be very different and the interest in a functional status
categorization or a decision about let’s just say whether to fund ongoing
therapy because some insurers will not pay for therapy that doesn’t improve
functioning. A categorization of a certain level of cognitive functioning
deficit one wouldn’t want a quick judgment then made that — oh, well if you
are in category two we can just infer a loss of competence.

DR. CARR: That is happening right now.

DR. FRANCIS: But the goal is to have individualized determinations. My only
point here is to sound that you mention privacy as an ongoing area of
consideration and this is being certain that judgments are not being — that a
judgment that is appropriate for one purpose isn’t being used for another
purpose is particularly important in this area so the privacy questions are
huge.

DR. CARR: I would say this gets back to what we heard yesterday about
meta-data with the theme that we have heard all day. Paul brought up the fact
that if you include an ICD-9 code that says GI bleed, it might have been any
number of things but that is the limitation of the language, the taxonomy
available to us. And without that meta-data of knowing where it comes from
translating to another patient or provider can have very different meanings. I
think that the theme thematically is recognizing the constraints that we have
when data leaves its home and travels and you said it yesterday, Paul, data in
motion. I think you said it. Somebody said it. That when it has traveled to a
new place, it is has lost all of the context that it had in the beginning. I
think it is true in ICF and in relation to privacy. It is true in relation to
clinical care. It is true in relation to patient’s experience of that
description of their condition. That is the theme I think that we need to be
cognizant of and think about how meta-data may in fact at least improve or
minimize that risk.

DR. SCANLON: Not to disappoint John I will mention payment. I think first of
all having spent a lot of time working with ADL and IADL data sort of that.
There is a big difference in terms of using this kind of information for what I
will call statistical purposes versus payment or performance purposes. And even
though the statistical use maybe safer, they are not without some peril.

One of the things that we found in doing analyses of different surveys about
ADL and IADL was huge differences in the prevalence for populations that you
would have thought was very similar. And you ask yourself the question why was
that the case. And the only thing that we could ever come up was that the
context of the questions was very different depending upon whether the survey
was about disability or whether the survey was broader, but the person being
asked was the person that was reporting on their own functioning or somebody
was a proxy. Just those kinds of things, creating huge differences in terms of
the responses. That is the issue that one needs to face when thinking about
using these data for statistical purposes.

We actually are using ADL and IADL today for payment for nursing homes both
Medicare and about 35 states have case mix stems which are the core of which
are really ADL and IADL. We use it for home health.

The nursing home is the biggest application. Huge amounts of money at stake.
But in some ways probably not totally in peril because there are other ways in
which the payment to nursing homes are constrained and so it is a more relevant
payment as oppose to affecting the overall level of use.

In Medicare it is different. In Medicare in some respects it is an open
checkbook and there are concerns about how does this coding impact the
increases in payment — in particularly with respect to home health or we have
asked ourselves the question of why is it that some agencies are able to make
40 percent profit on Medicare patients and it turns out that their patients are
“sicker”, less functionally instead of able and yet they provide
fewer services than the other agencies. How do these two things work together?
I think that is something to be resolved.

I think that when we talk about functioning well — I mean I agree with Don.
It is in some respects the critical outcome that we are interested in, but the
question is how do we get good objective data on it. And again we had this
discussion yesterday. When we look at functioning as a potential outcome, we
have to acknowledge that there are some people for whom the outcome and the
only outcome that is possible is going to be a decline in functioning or even
somewhat better to maintain the status quo.

Let me say something that is more general than this discussion, but it comes
up in my mind a lot of times. I think we need to focus on the entire US
population. This has come up in the health care versus public health discussion
of who is in the denominator. I think it also needs to come up when we are
thinking about alternative modes particularly with those that involve
technology.

This room is full of people that are on the cutting edge. There are disabled
people today who if they have an income of $2000 are not eligible for Medicaid.
That is the kind of circumstance that we have in this country and we need to
think about how do we reach all of these people who are potentially the subject
of what we want in terms of health care and health yet they are not anywhere
near the kind of conversations that we have about the potentials for
measurements and observations.

DR. CARR: Thank you. Blackford.

DR. MIDDLETON: Very quickly. A very rich conversation I think actually helps
connect the dots to some of the things we were talking about yesterday in the
quality roadmap conversation. And to elaborate those dots or connect them a bit
further I think part of the challenge is to balance, if you will, the ambition
of a quality roadmap with practicality. One the one hand we want to include new
assessments of patient experience including functional status, cognitive
abilities, context of the home and community, et cetera. We have to do what is
tractable or implementable at a level or digestible by the system. We will have
to sort out what is the right level of vision here.

I think also there are some notes of caution. We think about the functional
status assessment and — preferences. It is extraordinarily subjective. Before
we start making payment determinations and clinical determinations, people
using these instruments know how variable they can be so there is a lot of
science I think that we need to elaborate further on preferences, functional
status, cognitive status, and then relate that to the clinical status.

And lastly I guess, it is not my area, but the observations of daily living,
ODLs, would be something to consider part in parcel with the ICF project health
design and the ODL work that Patti Brennan and others are doing I think adds a
new dimension to a functional status assessment with observations of status. It
is complementary.

DR. CARR: Thank you. Marjorie, you get 4 minutes.

MS. GREENBERG: You are so generous. Everyone knows this last discussion was
one of my passions and I really appreciate everybody’s involvement and input
and of course Jorge will be hearing from me. I am not at all unhappy about
that, but another one of my passions and also of course Walter has been the
public health data standards consortium. The bottom line here — a few bottom
lines is that the committee has been supportive of its goals and objectives
from its initial founding about 11 years ago and modestly, but graciously
helped support its recent annual meeting with the quid pro quo being that the
consortium would report on its recommendations or the results of that meeting
because it was looking at something of I think direct interest to the committee
which is maximizing health IT standardization and meaningful use of health IT
in public health. That seemed pretty aligned with what the committee was
interested in.

We didn’t have time during this meeting. I would like to ask that they be
allowed to make a short presentation at the February meeting, but I did ask
them just to provide this brief which is under section four here and I commend
it to you. But again I think that the bottom line is that the type of effort
that is going into HIT implementation in the clinical arena is not being
matched by a similar effort in the public health arena is certainly similar
resources. And that even the meaningful use stage one that does address public
health addresses it in a very siloed way which is one of the longstanding
issues about the way public health is funded and carried out in this country so
that it doesn’t necessarily enhance an integrated public health perspective or
implementation and it also doesn’t support building the infrastructure which
clearly we have been working on in public health now for a number of years, the
IT infrastructure. But when it is only specific to particular siloed programs
and HIT is often also specific to those programs and they are not interoperable
across programs then you don’t have the capacity in public health that you
need.

I think that is sort of the bottom line, but I am going to exceed 1 minute
which I probably already used but to Walter if you want to just say anything
that I missed there.

DR. SUAREZ: Just one comment. I think how this links to our work here in the
community specifically and I would submit to the chairs of the population
health. In page three of the document we have the series of next steps. The
consortium’s priority has always been trying to bring the voice of public
health into the standards world and the standardization world and trying to
bring the standards and the standards world not technical into the public
health arena to serve as that bridge.

We found a series of things that I think are going to be important. One of
them is ensuring that we don’t create what I have been calling a digital divide
between clinical health with all the meaningful use initiatives and all the
work that is being and investments that are being made in that arena. And how
public health resources in terms of information technology are so limited and
continue to be restricted and probably cut down. At the end of the day we are
going to have a very robust clinical world with a lot of information and
technology capabilities to send messages to a state agency that might not have
yet the capability to receive them.

Creating a program or a series of programs and initiatives to help fund and
help support the enhancement of information technology and public health is
going to be one priority.

The other one is creating what we call the public health information
technology architecture reference model, a way of helping public health
agencies understand how to best use the information technology resources they
have in an integrated way with interoperability inside their walls rather than
keeping those silos that Marjorie mentioned.

And then the last one is really this emphasis on allocating the public
health workforce. That had been one of our mantras as the consortium in trying
to reach out as much as possible public health workforce in terms of educating
them in informatics and in information technology and in data analysis and
those areas. We are looking at a number of initiatives around that.

I think this is sort of an idea that I would hope that population work group
or the population subcommittee here in the committee world will take into
account in developing its agenda for the coming year.

Agenda Item: Subcommittee Report Outs and Next
Steps

DR. CARR: I appreciate that. We will have this discussion at the next
meeting, but we have to have a hard stop now and move to our summary of our
subcommittees and our plans.

By way of introduction I want to say how much I appreciate the privilege of
chairing the committee. I am in awe of the knowledge, the expertise, and the
collegiality and the ability to work together that is demonstrated by this
group and I think that is what makes NCVHS very special. It really is
remarkable to me because I thought this would be a quick add on and yet look at
the richness of the discussion we had and the insights that we got. I thank
everyone for your commitment and your participation.

Following on that I think that this has given me a certain insight in terms
of how we leverage the diversity of the committee. Traditionally we had
co-chairs in the same field for a particular area. And to be a little
disruptive but really in a way to leverage the expertise we are trying a new
model in two of our subcommittees. We thank John Houston who was off the
committee as of this meeting, but thank him for his work with Leslie on
privacy. And his successor will be Marc Overhage. Marc and Leslie will co-chair
privacy. In addition, Don will be leading a committee at some time in the next
6 months. He will be succeeded by Sallie. Sallie brings a wealth of expertise
in community as well as in privacy. I think it is a great match similarly. Marc
has a lived experience in how we translate EHR into everyday life. I appreciate
both of your willingness to take this on. I think we will see that it further
enhances the way NCVHS works. Thank you.

(Applause)

DR. CARR: Now for a very disciplined focus, and effective report out of
where we go from here. What I would like to do is the sequence of presentations
will be populations, privacy, quality and standards. I would like you to start
by a headline of the themes that we have talked about. Articulate the
overarching NCVHS theme that your plans address and then again in kind of
headline format because we had a lot of discussions and we don’t want to get
into details. What is it that we are going to do? What is the timeline and next
steps? With that, Populations.

DR. STEINWACHS: It was a fast set of walking orders. I can see that we move
quickly. We were working on a title for the initiative and this was my
suggestion. I am sure that it needs more work. That we are thinking about
focusing on community health information systems and efforts to both facilitate
the development and the use of population health data or health data in the
community. This is what I think Charlie describes to the next 12 to 24 months
at least in the current plan. This is a joint undertaking at this point between
privacy and population health. It certainly has standard issues in it too. Judy
reminded me of that at dinner last night. Standards, standards, you have to
have standards done, and I agree.

The first step and I think this came out of our discussions yesterday is
almost what could be characterized as a discovery process to try and understand
what is going out there. This is the population health side. Leslie — we are
talking about some plans for hearings on the privacy side and we see these as
synergistic. Questions of privacy will certainly be part of — comes up in
this.

And the discovery side is really trying to identify some of the leading edge
communities that are developing and using community level health data to
monitor and improve health, to understand barriers that they have experienced
and benefits they have achieved, lessons learned from failures as well as from
successes.

To do this and to do it in a timely way we are talking about having a
hearing maybe the day before the February meeting and I don’t know if that day
is still open, but the idea of having a one-day hearing before the February
full committee meeting, and to have at that hearing maybe three panels. One or
it could be divided in two panels would really represent the selection of six
communities who are actually have gone through a process of using and trying to
make use of health data for the benefit of the community.

I thought a panel on HIEs, health information exchanges. I see Marc as one
of those. There may be a couple of others. Trying to think of this as looking
from the point of view of electronic health records and a collection of data,
how is that coming back and being used or made available to communities? Maybe
the best thing might be to have a community spokesman working with an HIE. Marc
might identify someone in one of the committees who is really involved in this
process of how can I make this data useful.

And the third was state level. Since in many ways it seems to me what was
being talked about before by Garland of populating datasets with all these
characteristics. Marc was trying to help me with the concept of freeing the
data. I remember the libres part in Spanish, but it was datos libres, free the
data. We think there is going to be a tag line under the community health
information systems of datos libres.

I think many of the things are being done now and certainly Garland’s
resource on this are probably more coming out with state level because many
local health departments just don’t have the resources and the capacity for
doing a lot of these things.

The first part is to identify which places would be invited. We have been
talking with Susan Kanaan and hoping that Susan could work with us, and looking
at all the members of this committee and all of our liaisons as the initial
resources to start sort of a snowballing process to identify candidates for
these panels recognizing that this is not necessarily a representative
activity. It is much more trying to see people who have actually, I think Larry
was telling me, have gotten their boots dirty out there and tried to really do
something with the data.

DR. CARR: As I see it, you can have February 8.

DR. STEINWACHS: Okay. Thank you. Would you hold February 8 for us?

We are hoping that and we think we need to be able to issue invitations
before the Christmas holiday start up and with the idea that we would take a
step further between now and then also be working on a set of questions so that
there would be a limited set of questions we would be asking each presenter to
address from their perspective to enrich this and to try and facilitate more
interaction at what we are calling the workshop instead of a hearing at the
workshop that would be held.

The idea was to once we have identified who the participants are is to have
Susan actually conduct an interview so that there would be available a
paragraph summary on each of these questions so that there would be material
made available before the actual workshop and so the person wouldn’t have to go
through as much in terms of describing what they are doing. They could amplify
it, but it could open up much more of a conversation, which is I think what we
are looking for now is trying to figure out where the sweet spots of the NCVHS
could pursue. What are some specific things that would come out of this that
could lead to recommendations that could really help facilitate the effective
community health information systems?

I also want to thank Missy. She said that she would help us out. Mia, I
know, will be also working across the committees and it is great to have
Sallie.

DR. CARR: That is great. Give me a headline then of the theme that we heard
yesterday. It is NCVHS advising on data strategy by learning about the uses of
health information at the community level. Am I saying that correctly?

DR. STEINWACHS: That sounds good. We are really trying to support,
facilitate, and grow community health information systems. I sort of like the
— I don’t know if it is the right terminology, but I sort of think of the
community health information system. They exist today in varying degrees. It is
how do we move that up so the communities are empowered to really use data to
improve health.

DR. CARR: Larry.

DR. GREEN: Justine, to go to your headline question I think there are two
ideas that need to be in the headline. One is we are going to take a community
perspective. The perspective we seek in this hearing is not what researchers
want. It is what are communities trying to do to improve the health of their
communities and when they try to use data effectively, they develop information
about that. What happens? A community focus is really a critical part of it.

And the other part is it is a scoping exercise. This is an exploratory
hearing because we know no one who can answer the question basically. The
question is we want to ask people that are trying to do this about how is this
going. Where do you get tripped up? Where did the privacy regulations protect
you and help you? Where do they stop your project?

We want to really just listen a lot and we are not confident at this point
that this necessarily leads to a letter, but it very well might into what we
learn. I have been bothering my good friend, Bill Scanlon, over here saying
please listen hard to all of this so that you can spot a hook and where this
belongs and the ACA and other aspects that are going on to where this belongs.

DR. CARR: Excellent. Mark.

DR. HORNBROOK: Just a thought for us to consider for the committee members.
One of the things we are seeing in the health care sector is the increasing
marketing of high deductible health plans. People who tend to buy those health
plans of course are looking at their payroll deductions very carefully so they
select it which means lower income people are getting into those plans. One of
the things we are going to be looking at and we should be looking at is the
extent to which people when they get sick are facing high deductibles and
therefore are very strong economic choices about their health care and whether
indeed our community health information measures can track that. Leslie, it was
kind of the question we were having this morning about price discrimination
against low-income people. We are setting up our health care system to
deliberately hurt our health for low-income people.

DR. CARR: Excellent. Privacy.

DR. FRANCIS: I am a little hampered by not having the opportunity to consult
either my former or my co-chair so I will say welcome. Bottom line headline.
What are the available and maybe best privacy models and practices as for the
use of data in the community health context?

In particular issues to be looked at there are new sources of data. We heard
about one yesterday, crowd source data. We also heard about linkages between
community, the kind of publicly available data and individual patients. We know
that there are all kinds of possibilities from clinical records now and what
are the implications, what are the appropriate privacy practices, what are some
of the different privacy models that are out there.

What we would want to do would be to scope out identifying some of the new
sources or combinations of data. What are the kinds of privacy protective
models that are there? This is not to have privacy to be thought of as a
barrier, but I see anyway appropriate privacy protection because of the kind of
trust it engenders as critical to improved community use of data for public
health purposes.

There are a couple of other issues that I don’t want us to lose sight of?

DR. CARR: Can I ask a question before you finish that one? Did you have an
idea of how to partner with —

DR. FRANCIS: Right. We have been talking and actually the original plan and
I am hoping that there is time available would be to have our best practices
scope out meeting, hearing, workshop, whatever we want to call it be continuous
with the population committees’ hearing. One day for them and one day for us
whether it works to have that be directly on either side of the meeting in
February I don’t know.

PARTICIPANT: Maybe the same people.

DR. FRANCIS: I think it is a lot of the same people. The ideal thing would
actually to have it be 2 days back to back. I don’t know whether given when the
February meeting is.

DR. CARR: It is a Wednesday/Thursday. We could Monday/Tuesday.

DR. FRANCIS: We could do a Monday/Tuesday.

MS. GREENBERG: I would think that if you are going to have Susan — it
sounded like where somebody interview people. You are going to come up with a
structured set of questions. Some of those questions should come from the
privacy subcommittee. I think Sallie would be receptive to that.

DR. FRANCIS: We are actually planning a conference call next week that would
work on getting clearer on some of those questions. And we are planning to work
— we met at breakfast this morning and we are planning to work to both
identify questions and identify people. It may be that the communities that are
doing some of the most innovative things with the data are also doing some of
the most innovative things with privacy too. We don’t know about that.

MS. MILAM: I have a scope question if I might. It started when Larry and Don
were talking and it is still rattling around in my head. When I think about
some of the biggest uses of community and state level data by people in the
community, it is for their own market share. It has to do with expanding their
services and looking at what their competitors are doing. And that they would
argue goes to their own viability and place in the community. Is that part of
this or are we talking about more community-focused population health type
efforts. When we hear from these folks, they will be responding to a lot of or
they could be responding to a lot of data use by health care facilities and by
payors with respect to market share type of data use.

DR. GREEN: I will take that on. From the scoping perspective I think our
challenge will be to remain disciplined to take the perspective of a real,
honest to God community as opposed to a competitor. I picked on researchers. I
could have picked on payors. I could have picked on the local, largest
employer. I could have picked on whatever. There are a lot of perspectives that
we want to explore here.

I am assuming that if we on the basis of this group’s and others’
recommendations about who needs to be invited to this, I think that we can have
a very rich trove of information that is grounded in real-life experience in
some American communities when I try to do this. And I bet that issue comes up.

DR. CARR: I would suggest the RWJ aligning forces for quality so that they
have identified communities that really have decided transcending whatever
entities and competitors that they are working together. Some of that is in
quality, but others — that they have that mindset, I think, would be a good
group to do. Leslie, back to you.

DR. FRANCIS: A couple of just things not to lose track of. I just want these
on the record. One question is ongoing look with Todd who we heard from
yesterday about new kinds of data sources and the privacy questions. The two
that were raised there were the kinds of public use datasets, what those mean
and crowd sourcing. I want for those of us on privacy to have an ongoing
dialogue with Todd about what the privacy — what scoping out ways in which
privacy advice from this committee could be helpful to the enterprise that Todd
was describing. That is something — this is a micro-start on, but it is a
longer agenda.

The second thing that is potentially on the plate and I don’t know where to
go with it was the question that was raised at the executive subcommittee
retreat about whether HHS would like specific advice from this committee about
accountable care organizations and privacy protection. I want us to follow up
on the question of — because Jim wasn’t here yesterday, I wasn’t able to ask
him but I don’t want us to lose that and I want us to follow up on what might
have been in mind and what we can do to be helpful there.

A third very quick observation is that what I — it has been very hard on
the meaningful use side to get the public health voice in there. I am following
up on what Walter said. And I would just want to note as a possible agenda item
whether we should as a committee be asking the question of what kind of advice
— we are about the kind of data that it is really helpful to have. What kind
of advice, if any, might be helpful from this committee with respect
specifically to the intersection between meaningful use and the public health
side of things?

DR. CARR: That is a lot of things there.

DR. FRANCIS: I am thinking 3 years out, Justine. I try to think in 3-year
plans and shorter year plans, but those are the threads that I think we should
be following.

MS. GREENBERG: The last one wasn’t really privacy.

DR. FRANCIS: No. That was just my observation sitting here as a committee
member about a question we should ask about can we be useful in that context.

DR. CARR: Two things. What we are seeing is the technology is moving
extremely rapidly and even as we heard from Lorraine in terms of myPHR, their
questions that they have not yet been able to address. I think the same is true
with Todd Park data. I think the fact that he was really clear in asking for
the partnership I think is terrific and it is very public.

My other question to you is will be following up with Joy Pritts because I
think that they also had an interest in being part of this and I think it is
important to just make sure that we are aligned in whose doing what and that
they participate if we are having the hearing.

DR. FRANCIS: One of the suggestions that has been made to us which I think
just needs to be regular is that Joy should be on the distribution list for the
privacy subcommittee. And I believe she did not get the notice of those times.

DR. CARR: Thank you for that.

DR. FRANCIS: Can I also just say at some point we need to have a
conversation, I don’t know when we will, about the type of staff support and
how you ask for it and when and so on. It would just be — it is sort of a
committee chair orientation question in a way and you kind of learning by
doing, but I think —

DR. CARR: When Audrey said yesterday when you need help, ask for it, and
then we will adjudicate after that.

DR. FRANCIS: I will send a list then.

DR. CARR: It sounds like Susan is going to be a resource actually to this
upcoming hearing on both sides and I think that will be tremendous in getting
that pre-worked. And Missy. Right.

DR. FRANCIS: And Mia and we need a coordinator and we need to be able to ask
questions about whether there is any research support and so on.

DR. CARR: Make your list of questions. Paul.

DR. TANG: It seems like we have to decide about the hearing date which is
December.

DR. CARR: Seven eight.

MS. GREENBERG: Well, the seventh and eighth has been proposed.

DR. CARR: When did populations last have a hearing? When was your last
hearing? Populations.

MS. GREENBERG: I don’t think you had one in 2010.

DR. CARR: And privacy, your last hearing was June and we know about you and
quality was in October. I think we are going to also — that will help us in
our algorithm.

MS. GREENBERG: — have a hearing, but when they had a hearing in conjunction
with the full committee meeting.

MR. LAND: I might just mention that there is a coordinated approach now with
public health and meaning use through what is called JPHIT, the Joint Public
Health Informatics Taskforce, which is an organization that represents seven
major public health organizations and they had a meeting in Atlanta I guess
about 3 weeks ago in which we talked about the public health meaning use
suggestions for 2013/2015. And we have a very good relationship with CDC now,
the former director of the Wisconsin Health Department is now at CDC in charge
of the informatics unit and we also had an individual from Medicaid who
obviously has a very strong public health background and is very helpful in
understanding how we can relate to Medicaid and the suggestions that we had.

We were behind the eight ball I think with the 2011 meaningful use, but we
are much further along now with the next go around.

MS. GREENBERG: I might just mention the last populations’ subcommittee
meeting was February 27, 2009. This document that I referred you to on the
Public Health Data Standards Consortium specifically includes working with this
joint taskforce and their framework. And the consortium is part of that group
as is NAFIS and NADO and others. I was just amazed by the way that Todd Park —
he was very interested to hear about NADO. They are all part of this group.

I did want to point out though that Paul’s subcommittee or workgroup or part
of the policy group had an excellent hearing on where does public health fit in
and somebody, it might have even been Paul, said it sounds like what we need is
a meaningful use for public health. I think everyone in public health agrees
with that.

DR. CARR: Perfect segue, Paul. You can answer that and then you and
Blackford speak to quality.

DR. TANG: So one just like any other federal committee it is limited by the
statutory charter and in this case meaningful use is a statute and public
health was not included.

MS. GREENBERG: I thought population health was mentioned certainly in ACA.

DR. TANG: But not as part of the meaningful use incentives, i.e., the money.

MS. GREENBERG: I see what you are saying.

DR. TANG: They were delighted to be at the table to try to get some
connectivity. We are trying to push connectivity, but it is almost like lab and
there is no money — and public health agencies were saying but we don’t have
the money to do it. We get stuck there. In fact, you mentioned the silos. Even
with one silo you can’t find it even a minority of the country. We are just
sort of stuck. We are trying to get the exemplars out there and we are even
pushing for the exemplars of bidirectional. We are pushing that it is with
people who do not have the resources to do that. That is where we get stuck. It
is not a lack of interest.

But we are doing though the offshoot of what we are doing which I think
people are appreciative of is when we create the objective it becomes a
requirement in EHRs. That is what meaningful use can do, but we can’t get it to
flow – the public health departments having that capability.

DR. MIDDLETON: I think after the conversations over the past 2 days we
envision based upon the roadmap recommendations as they are refined perhaps
three hearings over the next 24 months focusing on these specific areas of
inquiry and partnering with population standards and privacy perhaps in a new
model, cross-cutting, integrative team to align the inquiry with needs of ACA,
CMS, IOM, et cetera and fundamentally get at the goal of the learning health
care system.

Headlines, I guess, Justine, in very rough form and not reviewed by my
partner in crime — I think number one the NCVHS can focus its attention on
extending the quality measurement framework from the historical provider and
population-centered domains to really pay attention to the consumer domain, the
patient-centered consumer focused health measurement and improvement for the
headline number one and to take the three circles we have, integrating the
three circles and say we have activities going on here and here let’s really
bring attention to the consumer, the patient circle. That is headline number
one.

Number two, to bring NCVHS’ attention to extending quality assessments, to
include notions of health care system performance from the stakeholders’
perspectives of provider in network and payor principally but to think about
system performance, efficiency, efficacy and value.

And then last headline. NCVHS to focus on simplifying the use of health care
data both clinical and administrative to meet the needs of oversight,
accreditation, licensure, regulation and payment.

DR. CARR: Do you see any potential connection with regard to functional
status conversation?

DR. MIDDLETON: That is number one. It is part of the patient centeredness. I
didn’t go into all the —

DR. CARR: But I mean again pulling together themes so that each of the
important themes that came out has a home. I think reaching into that a little
bit more would be very helpful at least to understand where there is potential
for a crosswalk.

DR. MIDDLETON: From my point of view maybe mine alone but we had that there
already under patients’ grants. That would include functional status.

DR. CARR: But did you have my presentation?

DR. TANG: So maybe Justine that calls the question of the work you presented
as far as the cross cutting versus we are now developing not only projects but
hearings that are siloed when in fact they maybe more natural to be cross
cutting. What do you think about that?

DR. MIDDLETON: That is why I suggested right at the outset this has to be
cross cutting. This is an integrative —

DR. CARR: Where were you going with that?

DR. TANG: I have been hearing about hearings that are siloed.

DR. CARR: Well, we heard that privacy and populations are combining and
blending. Just give me an action step.

DR. TANG: The action step would be to have when you discuss public or
community-based data that we have — it really turns out to be a joint — it is
an NCVHS —

PARTICIPANT: We would be wide open to that.

DR. CARR: I think that is right that we have —

DR. TANG: So the theme was public datasets. That is one big theme. Another
theme is about some kind of patient orientation. It is a functional step. We
have just absolutely — we now have the power. It is not that we didn’t want to
before but on paper you just couldn’t do it. Now as part of the public data,
the accessibility we have the ability to incorporate that. I think that is a
deliberate cross-cutting issue that we should take up. That is two and perhaps
that could — I love lumping, but that could even be brought together.

DR. CARR: I think that is right. What I am hearing is going to be spending a
lot of time together. It has been a tremendous opportunity —

DR. TANG: — time apart.

DR. CARR: Exactly right. We talked about this yesterday that the synergy and
the collective wisdom really flourishes when we have face to face time,
breakfast, lunch, and dinner and it has been in the last few days.

DR. GREEN: Again, just on to repair this. But I think the action step here
is for a February 8 hearing that we should decide that we should delegate to
the privacy and population subcommittee the responsibility to prepare the
hearing and that we should understand that it would be really terrific if we
just basically started the NCVHS committee meeting one day early and everybody
attend.

DR. CARR: I agree. I think this would be very rich. What Judy and Walter did
this summer was ensure that there was representation from each of the
subcommittees at the July hearing and I think that is what we need to do now —
that everybody can be here, but we would do that.

DR. FRANCIS: We have Walter from standards and we have Paul from quality. We
have a co-chair of quality and a co-chair of standards represented on privacy.

DR. TANG: Why don’t we just be explicit and just have the executive
committee which has the built in representation for all instead of saying let’s
delegate it to another silo.

DR. GREEN: I would speak against that. We are talking about February 8. We
are talking about a call Monday, Tuesday or Wednesday to executive this. We are
talking about having the questions refined and done by December 17. The
invitation is going out before Christmas. The functionality of the executive
committee means that we have eight people plus the staff to do that and you
know what. That is not executable given the fact that this is December. I
believe that we should take as a habit of the NCVHS heart that we actually do
delegate through our subcommittee structures’ responsibility for different
parts of the —

DR. CARR: I am good with that. I think that what we are looking for is
cross-cutting representation and that is part of the responsibility.

DR. GREEN: I think we already have it for the February 8 meeting.

MS. GREENBERG: I agree with you on that. But I think that the other two
subcommittees’ standards and probably should have an opportunity to contribute
to the question set.

DR. SUAREZ: This is actually true for every single hearing we should have
from now on.

MS. GREENBERG: Everyone won’t get all of their questions in as you can only
ask people so many things at one time, but make sure we have those
perspectives. It will put a little strain on the budget, but if the whole
committee wants to come to those 2 days prior to the full committee meeting I
think we can do it.

DR. CARR: Remember we didn’t meet last year in February.

MS. GREENBERG: Yes, pay for it afterwards. If anyone has an in with the
weather man, we do not want a snowstorm that week. And then if standards decide
to take that Friday — I think that is fine.

DR. CARR: Blackford and then Larry.

DR. MIDDLETON: One very quick just sort of process note. I think we have
this problem almost every time it seems. There is a hearing and we have to
marshal all the forces and kind of jump through hoops and what not. I would
like to suggest to the chair I think with staff support that we develop a
3-year roadmap for each committee defining the integrative projects and always
know what is coming up 36 months in advance and plan appropriately. If you are
building small projects having a roadmap like that is critical. I can’t imagine
sitting different here in reality for us to be effective.

MS. GREENBERG: I think at least 2 years. The membership turns over and all
that, but 2 years would be nice.

DR. GREEN: Don went by this but I want to go over it again and make it very
explicit. We need for all the people here and our liaisons to propose the
questions that they want us to address and we need proposals for the
communities to present and we need them now. We need them in the next few days.
And I think it is okay to send them to Susan. Susan is going to be the
collector of those.

And the second thing is do we leave a decision on how long this hearing is
until we understand the hearing just a little bit better because it is not a
certainty that we all need to be here for 2 more full days.

DR. SUAREZ: Just a very quick question or a comment because I think the
reality from an operational perspective is we should have still the lead
responsibility of a hearing to one or two committees of that, but no more than
that. And they develop an overall structure. The other committees can
contribute with perspectives and questions and comments, but from an
operational perspective it makes sense for just us to designate a — committee
—

DR. CARR: What I am seeing is sort of a template that whenever we have a
hearing we say are there questions to ask from privacy, from a standards, from
a quality, or a performance perspective and that maybe that begins to shape how
we ask this. I like the idea that Susan would do some of the interviewing ahead
of time to bring these issues out then we are starting from a more
knowledgeable base.

MS. KANAAN: I already have many of you on a list, your names on a list to
take the initiative to contact you. About seven of this group is already on my
list, but please do feel free to send me your suggestions either of questions
or of specific communities that we should look at. Larry suggested the term
nominator that some of the preliminary conversations are about asking people to
nominate candidates for people who would testify.

DR. WARREN: It just seems to me as we start talking about our processes that
before this as a committee was developing their hearings and stuff, they were
the only ones that got to see the agenda or the timing or anything like that.
There has never been any way to get out the word more broadly. What I am
wondering if it would be very easy to put the other committee chairs a CC on
all of that communication so that as the means are being planned we are aware
of what is there so if we do have information or concerns, we can channel it to
whoever is coordinating the committee or the meeting.

MS. GREENBERG: — copy of the executive subcommittee which includes all the
—

DR. CARR: Or send it to the whole committee. It is only three other people.
Let’s be serious here. We may get to a real economy by having take one group of
people and then applying all of our questions to that group. Paul, thanks for
putting it in that way and then we are not all fighting over I want the next
day and the day after. We allocate the amount of time we need to have all the
questions addressed. I think it would be really cool.

DR. FERRER: I think tomorrow we are prototyping virtual meeting, is that
correct?

DR. CARR: Yes.

DR. FERRER: Okay because sometimes — I know we love each other, but it is
really hard to be here 5 days in a row especially some of us that are
clinically active. I mean impossible to do that because you have to get
coverage for your service and it is really hard.

DR. CARR: Exactly. But the answer is going to be somewhere in between that
we have cross-sectional representation as we talked about with some of our
other ad hoc committees. There are some people that can foresee this is a time
I could give extra time. There are others that can’t. But that we will have
representation from the various subcommittees.

DR. FERRER: But the ability — not to physically be here, but because for
example, Paul and his committees, these guys — they have the same problem. You
can’t fly everybody to DC.

MS. GREENBERG: Let me say and I didn’t get a chance to talk about the NCVHS
webcast pilot for the December 13 standards meeting, but you know we are having
it tomorrow. And if it is successful, we could certainly do that for this
meeting that we are talking about. Some people — obviously I would suspect
most of the people of these two subcommittees who are organizing this to be
there, but others could be on the web and watch portions of it and participate
as allowed by your schedule. We are going to try to do more of that.

DR. CARR: Perfect segue then onto standards.

DR. SUAREZ: Our headline and I think we have a very rich discussion this
morning around we are about to deliver to Congress next year the
10th annual report to Congress on HIPAA and so we thought it would
be a great opportunity to create a true analysis and assessment of where we are
with HIPAA in this country and how much this standardization and these
standards adopted and implemented as we have heard not so much in terms of
penetration across the industry necessarily, but it will be great to understand
where we are. That will be what our biggest headline will be next year for us.
We will be looking at convening a hearing and we were talking about starting
with a hearing that will allow us to understand where the industry is in terms
of 5010 and ICD-10 because every year we want to do that assessment and
understand.

But then also understand and do a gap analysis, do a more deliberate and
refine pretty much scientific I guess surveying of the industry categorizing
and broken into different segments by transaction of HIPAA, by payor and
provider, by other standards like MTI, how things are going. That is our
biggest part of it.

And certainly the expectation is with delivery draft letter. It will be a
letter, not a draft. We will deliver a letter instead of the report to Congress
next year in February. Every February we usually deliver that to Congress.
Instead of a report in February we will deliver a letter advising Congress that
we are in this 10th anniversary. We are going to be doing a much
more in-depth analysis and reporting back what we expect to be by quarter three
of next year with a full HIPAA report to Congress. That will give us time to do
during the first three orders the sort of gathering of feedback. We will
probably need to look at resources to do a much more in-depth environmental
scan and that kind of analysis and evaluation.

We are looking at not just HIPAA in terms of the transactions, but also the
code sets and adoption of ICD-10 and terminology and identifiers as well. It is
going to be a very comprehensive view of HIPAA. That is our first group of
activities next year.

The second one of course is going to be continuing to do our currently
mandated requirements. Next year by February we have to deliver the letter of
recommendations based on the input and the hearing tomorrow on EFT and
operating rules. That will be one of the things early next year. We will come
to this committee to present and issue basically a letter of recommendation.
Any amendments or any changes to the first letter that we just delivered a
couple months ago on the operating rules and the plan ID will also come in
February based on the feedback that we will hear tomorrow. That is the first
part of the year.

Under AHQA basically the next round of priorities come later on in January
of 2014 when the federal regulations on claim attachments and on the next set
of operating rules will be issued. In 2011 we see a couple of other possible
hearings that we will fill in through the later part of the year. One would be
on claim attachments as an early portion and that will be probably later in the
year; hearing and understanding where are things with claim attachments in
preparation of the development of these final rules that will come in 2014.

Also we talked about a couple of other topics and priority areas. We talked
about all payor claims database and we talked about public health standards in
terms of the standards applied to public health. That is another area where we
think will be an opportunity for a hearing. And, again, in this true — the all
payor claims database and the public health standards there is again this
opportunity to connect with privacy, to connect with quality, to connect with
population health. That is the progress in 2011.

Starting in 2012 we are going to see a recurrent set of activities.
Basically every other year we are going to have to convene hearings in April
roughly to understand where the industry is and where things are with respect
to transactions and operating rules and what are the next types of standards
and areas for standardization. And that is actually set in the AHQA statute to
begin to do that and do that every other year and even provide a report in July
of every other year separate from our HIPAA report, a report that will be
identified in this next round of standards and areas for standardizations.

That will basically set us up our ongoing activities sort of every other
year. We expect to see probably two or three hearings a year on the foreseeable
next 2 or 3 years based on this requirement of keeping sort of an eye on the
industry plus the implementation of the new standards on AHQA.

DR. WARREN: I think one of the things that came to life for us this morning
as we were looking at our plate, most of which we cannot determine, Congress
has done that for us on the timeline, is to use this next HIPAA report and I
have to credit Justine for having the right words that kind of twisted
everything of we need to totally reformat the way we have been making our
report on HIPAA so that it is not only what has been accomplished, but also
going in to what are the barriers, why aren’t we implementing these standards,
do we have the right standards, the wrong standards, really kind of opening it
up for that kind of view and to come in with that.

I think one of our challenges is going to be are there alternative ways that
we can do this task without the three to four extra meetings a year on top of
the full committee meetings. That will take us a while to figure out. A lot of
the dates that Walter mentions realize that those are the dates that the
regulations have to be written. It is like when he talks about 2014, it means
our work for that has to be done by the end of 2011/2012 so it can be passed on
to the secretary and to CMS so that they can meet all those target deadlines.
We are still on a pretty fast track with that.

MS. GREENBERG: It is December. I hear a scrooge. I just want to support what
Blackford and of course Justine has been saying and that is that we need to
develop a calendar with your must list and your wish list. Of course we don’t
really have — the government is on a continuing resolution and I don’t know
whether we will have a budget for fiscal year 2011. Our current thoughts — our
thinking is that we have the same budget as last year. It could be less
depending upon what happens and that we will get the reimbursable funds from
Jim since he is sitting there committing himself to that, but even that in the
past has only allowed I think for four full committee meetings and each
subcommittee to have maximum one stand-alone hearing and one in conjunction
with one of those full committee meetings. I am hearing more than that, but I
think — I am not going to say you can’t do any of this.

What we need to do is develop this schedule certainly for this year. Let’s
say calendar year 2011 which goes over the two fiscal years: FY 2011 and FY
2012 because we are now in fiscal year 2011. And then we will assess what we
can do and how we can do all of this. And one way maybe is to have some webinar
meetings so the way other FACA’s are using it. We are obviously pursuing this
now. I think we all agree there is no substitute for in person, but we also
heard not just finances as Jorge said. He is not prepared to move back to
Washington. The sooner we can get this down and then understand what the
requirements are the sooner we can start coming up with —

DR. SUAREZ: Being the standards committee we talked about that, Judy and I.
Being the standards committee we are certainly willing to offer the idea
because we thought about that concept of we want to play this into a schedule
over the next 2 or 3 years. We can create the standard template the other
committees. That actually in my mind would be the way to — at the end of every
year every committee or subcommittee has to turn in this template that shows in
a very standardized way what the workload is going to be for the next year. And
then all of those can be put together.

DR. CARR: I think I have heard from everybody that they are thinking in
those terms. We would like to get those back from you by the end of December.

MS. GREENBERG: Can I ask since you have volunteered here to work with — is
Katherine here? Katherine Jones? She is behind the post. To work with Katherine
on this. I think rather than everyone sending their own thing having one
template and you guys are willing to kick it off and work with Katherine then
we will make sure we know what questions we need to ask and then we will send
it to the rest of you.

DR. CARR: I want to underscore. I think this report on HIPAA will be
excellent. It will pull together all the work that you are doing and it will
tell the story that doesn’t always get out when we focus on the individual
pieces because the goal will be to say what was our goal, where are we on that
journey, and what is preventing us from getting there so it then becomes quite
actionable in terms of next steps. My only request is you know that slide
presentation, could we put all of HIPAA on that so that we can point to if we
had this. Seriously. I thought that was just an incredibly elucidating
presentation, because you can begin to understand what are the pieces that need
to work to make this all come together.

DR. SUAREZ: There is only one question I come to think about because of
course HIPAA is not just standards and codes(?)and identifiers, it is also
privacy and security. I don’t know, Leslie, if there is — and here again as an
opportunity to bring the work of other committees and the work that we do in
HIPAA. Is there an interest?

DR. CARR: We tried to do that with a HIPAA report in the past. Your piece
lends itself to measurement. And as we said you will need some resources, and
we have already heard from folks who can help you with that. But we want to get
some pie charts of 50 percent is done, 50 percent is one paper. We have a plan
for that.

MS. GREENBERG: And your template should include not just hearings that you
need to hold and how to estimate one day, two day, whatever, but the kind of
support you would need. If you need someone to do an environmental scan.

DR. SUAREZ: Also the ultimate outcome of course which is the letter, the
timing of that letter of recommendation, that has to align with the
subcommittee meeting.

MS. GREENBERG: Not everyone maybe able to be as structured as you all
because they don’t have these congressional requirements.

DR. CARR: Final 30 seconds, Paul.

DR. TANG: Just a logistic. Just as you were asking for the schedule, could
Susan maybe prepare a template for our questions? Here the cross-cutting
hearing, what is the explicit objective, what are some of the questions. Just
suggesting a template for you to get input about the cross-cutting hearings.
What is the topic of the hearing? What are some questions to explore and what
are some suggested panelists? To the extent that we can — and maybe they are
linked to the question, but to the extent that we can have some kind of format
that we can operate on.

MS. KANAAN: I actually drafted a query which I gave to Don. It is sort of
along those lines. We will send that to everyone.

DR. CARR: Send it out and if we modify it or expand it. All right. We are
right on time and I thank everyone for your excellent participation and I wish
you safe travels on your way home for those who are going home.

(Whereupon, at 1:00 pm, the meeting adjourned.)