[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

OCTOBER 11, 2006

Hubert H. Humphrey Building
Conference Room 705-A
200 Independence Avenue, S.W.
Washington , D.C.

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax , Virginia 22030
(703) 352-0091

PARTICIPANTS:

Subcommittee Members :

  • Jeffrey S. Blair, Co-Chairman
  • Harry Reynolds, Co-Chairman
  • Justine Carr, M.D.
  • Simon P. Cohn, M.D.
  • Stan M. Huff, M.D.
  • J. Michael Fitzmaurice, M.D.
  • Wanda Govan-Jenkins
  • Jorge Ferrer, M.D.
  • Karen Trudel
  • Randy Levine, M.D.
  • Stuart Nelson, M.D.

TABLE OF CONTENTS

P R O C E E D I N G S [9:02 a.m.]

Agenda Item: Call to Order, Welcome and Introductions – Mr. Reynolds

MR. REYNOLDS: Okay, why don’t we go ahead and get started since we’ve got a
full agenda. I’d like to welcome everyone to the meeting of the Standards and
Security Subcommittee of NCVHS. NCVHS is the statutory public advisory body on
health information and policy for the Secretary of Health and Human Services.
We are being recorded and are on the internet this morning.

As we begin our introductions I will ask each of the members of the
committee to note any possible conflicts of interest. We also have a few of our
members and others on the phone today and after I do the introduction around
the table I will ask them to introduce themselves. Is anyone on yet? No one is
on yet so we won’t do that but as they come on we’ll make sure that they
identify themselves.

I am Harry Reynolds, co-chair of the committee along with Jeff Blair. I’m
from Blue Cross and Blue Shield of North Carolina and I have no conflicts.
Everybody around the table, you’ll need to push the on button if you want to
speak and please turn it off when you don’t want to speak or you will be
speaking anyhow.

MR. BLAIR: I’m Jeff Blair, I’m director of health informatics at Lovelace
Clinic Foundation, and co-chair of the Subcommittee on Standards and Security,
I do not have any conflicts that I’m aware of.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality, I’m a liaison to the full committee and staff to the Subcommittee on
Standards and Security.

MR. BECHTEL: I’m Don Bechtel, I’m with Siemens Medical Solutions, I’m
representing today X-12 where I co-chair the Health Care Task Group.

MS. GOSS: I’m Alex Goss representing ASCX-12, I work for Payformance
Corporation and I’m the chair of the Insurance Subcommittee for ASCX-12.

MS. WARD: Maria Ward with Price Waterhouse Coopers here today representing
HL7.

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

MS. WEIKER: Margaret Weiker with EDS representing NCPDP.

MS. GOVAN-JENKINS: Wanda Govan-Jenkins, National Center for Health
Statistics, staff to Standards and Security Subcommittee.

MS. GREENBERG: I’m Marjorie Greenberg from the National Center for Health
Statistics, CDC, and executive secretary to the committee and just truth in
advertising, I’m also a member of the Disability Workgroup for CHI.

DR. COHN: I’m Simon Cohn, I’m associate executive director for Kaiser
Permanente, chair of the committee and a member of the subcommittee, I have no
conflicts of interest.

MS. TRUDEL: Karen Trudel from the Centers for Medicare and Medicaid
Services sitting in for Denise Buenning as chief staff to the subcommittee.

DR. FERRER: Jorge Ferrer, VA, staff to the subcommittee.

MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.

DR. FERGUSON: I’m Jamie Ferguson from Kaiser Permanente. I’m here today in
my capacity as vice chair of WEDI.

DR. WHICKER: Jim Whicker, Intermountain Health Care, I’m here also
chair-elect of WEDI.

MR. SHUPING: Jim Shuping, chief staff executive for WEDI.

MS. KOCHER: Gail Kocher from Highmark, Inc. co-chair NPIOI for WEDI.

MS. SPECTER: Nancy Specter from the American Medical Association.

MS. FRIEDMAN: Maria Friedman, Health Strategies LLC.

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

DR. BICKFORD: Carol Bickford, American Nurses Association.

MR. ALFANO: Bill Alfano, Blue Cross and Blue Shield Association.

MR. FRENCH: Jonathan French, HIMSS.

MR. SHEATH(?): Tony Sheath, Point of Care Partners and NCVHS groupie.

MS. FREDERICK: Anne Frederick, Rx Benefits Coalition.

MR. REYNOLDS: Okay, if we want to get started, it’s good to see some of our
old friends back to talk to us again. So first agenda item is the SDO
recommendations on streamlined standards revisions and procedures. Do you want
to go in order on our agenda or do you already have a prescribed order? And
would that be you starting first, Lynne? This would be the same order that
usually happens, I should have known that. Okay, you have the floor.

Agenda Item: SDO Recommendations – Streamlined Standards
Revisions Procedures – Ms. Gilbertson

MS. GILBERTSON: It is wonderful to be back. Mr. Chairman and members of the
Subcommittee on Standards and Security, the Accredited Standards Committee,
ASC, X12, Health Level 7, HL7, and the National Council for Prescription Drug
Programs thank you for the opportunity to testify today on the subject of the
Standards Development Organization, the SDO process, and how it works within
the regulatory environment. My name is Lynne Gilbertson and I am speaking today
on behalf of the joint SDO initiative to improve the standards adoption process
under HIPAA.

The testimony delivered today on behalf of ASC X12, HL7 and NCPDP is a
continuation of the December 2005 testimony that each individual SDO provided
on this topic. At the conclusion of the December hearings the subcommittee
requested that we, the SDOs, collaborate to present one unified testimony on
this subject.

Our formal remarks to you today are a summary of our comprehensive proposal
document. The recommendations provided to you in the document entitled Proposal
for the Modification of the HIPAA Transaction Standards Adoption Process
represent the SDO unified approach to streamlining the HIPAA standards adoption
process. This joint SDO prepared document examines the current process for
adopting transaction standards, summarizes findings, and proposes ways to
improve the adoption process that will result in increased efficiency. The
joint SDO proposal has been approved by all three SDOs and the approaches we
recommend can and will be implemented by us should HHS elect to adopt this
streamlined approach.

In order to maximize the time for us to engage in a more productive
discussion with the subcommittee on this topic we’ve elected to keep our verbal
testimony brief to allow more time to fully explore your questions to the
identified problems and the proposed solutions that we prepared for your
review, input and support today. In anticipation of this approach we delivered
the document to the subcommittee for your review prior to this session.

To try to understand the process we used Microsoft Project to lay out the
steps, the timeline, the dependencies, the interdependencies, and took that
into a high level version which are shown as the charts that are in this
proposal to understand the current process.

It has become abundantly clear that the Health Insurance Portability and
Accountability Act, HIPAA, has a profound and burdensome impact on health care
transaction implementation specification development and deployment. Several
years of researching the problems resulted in white paper drafts as well as
recommendations to HHS and to NCVHS but it became clear that the Administrative
Procedures Act, or the APA, constrained the process since it has a direct
impact on the federal government’s ability to timely adopt modifications to
HIPAA implementation specifications. The current process for adoption of
transactions adopted under HIPAA is problematic.

Operating in the regulatory environment, the ability of the Standards
Development Organizations to be responsive to industry need is greatly impaired
resulting in stakeholders waiting a minimum of five years to be able to
implement new specifications adopted under HIPAA. Please refer to Section Four,
Problems with the Existing HIPAA Transaction Implementation Specifications
Adoptions Process for further information.

Most concerning are the underlying industry assumptions, and they are
assumptions. One, to wait until the NPRM to review and provide input on the
implementation specifications. Two, based on public comments received through
the NPRM process the approved, published version of the implementation
specification may be opened and updated and republished in order to accommodate
changes requested by the NPRM comments.

Due to the time lag in the APA process these changes may be requested years
after the approved implementation specification has been published and brought
forward. Changes made in this manner either require a new SDO ballot or
approval process to take place, and consequently a new version released, or
cause the SDO to proceed in a manner contrary to their American National
Standards Institute based policies. Refer to Section 4.3, Modifications Being
Made to Approved Implementation Specifications for additional information.

An additional dynamic exists for X12 related to their underlying base
standard. The X12 base standard is used by many industries for EDI exchanges.
X12’s implementation specifications are built from a specific version of this
base standard. A requested change to an X12 imp guide may correlate to a base
standard change. This base standard change needs to be fully vetted through the
consensus based process to prevent a negative impact on other industries.

Therefore the regulatory process is not predictable when it begins or ends,
is potentially very lengthy and compromises the ability of the SDO to be
responsive to industry business requirements.

Now the proposed solution. This proposal retains many of the existing
processes. It also offers a more efficient approach to several of the key areas
where current problems exist. Opportunities for input and participation are not
eliminated. Rather efficiency is achieved by consolidating public participation
and input at the appropriate times. Additionally we propose adding steps that
are critical to the process, such as the development of a benefit analysis
report, requested by the Office of e-Health Standards and Services, OESS.
Finally, this proposal incorporates recommendations that have been made in
House Resolution 4157.

The streamlined process highlights, and this is just a highlight list, the
more detail is in the document. The first is the notification of work. The
Federal Register, the HHS listserves, and the SDO processes alerts the industry
to the development of an implementation specification. The industry is made
aware development is beginning and encouraged to participate. Refer to Section
Five, Changing HIPAA Transaction Implementation Specifications Adoption
Process, the Outline Narrative.

Industry involvement in these steps is critical to the successful
development of consensus based standards that represent the widest most diverse
collection of industry stakeholders. The most effective use of the industry
volunteer input and time is during the development of an implementation
specification, during the development. Individuals not wishing to participate
in the development can participating during the public comment or ballot
timeframe. Valuable input occurs during this timeframe, this involvement
results in the collection of all technical public comments at one time while
the implementation specification is being developed and approved thus
eliminating the need to reopen an already published implementation
specification years later. The collection of comments at one time improves the
timeline for adoption, the industry knows that their comments are discussed
during the development cycle and during the ballot or approval process.

Then there’s the notification of the ballot or approval timeframe. The
Federal Register, the HHS listserves, and the SDO processes alert the industry
to the ballot or approval process steps and the critical dates and timelines.
Once again the industry is made aware and encouraged to participate.

Then there’s the DSMO process that continues to go on, while this process
is underway an industry benefit analysis survey is conducted by WEDI. This is
another opportunity for the industry to be alerted of activity and to provide
valuable feedback. This resulting benefit survey analysis reported is provided
to the SDO, the DSMO Steering Committee, and to NCVHS for their review.

Another step, NCVHS, which now currently receives public testimony, which
would include a recommendation on the change request from the DSMO, as it does
now, a report of the survey findings from WEDI, and the public testimony. Then
the final rule is published in the Federal Register based on recommendations
from the SDO, the DSMO Steering Committee, and the NCVHS, which has been
collecting it. The notice provides the adoption and the implementation
timeframe for the industry.

With these process improvements important benefits are reached. The
timeliness and length of time for adoption are optimized. The volunteer
industry participation is at the beginning of the process yielding more
efficient use of limited volunteer resources. The stakeholders have input
during both the development and the approval of the implementation
specifications and they are notified of the timeline.

Beyond the increased quality perspective timeframe estimates prepared for
both the current and the proposed process indicate potential time savings of up
to three years and we eliminate the possibility of having an endless loop of
NPRM change requests that never move to a final rule. Please refer to Section
5.2, Proposed Improved Process Timeline.

ASC X12, HL7, and NCPDP thank you for the opportunity to offer these
collaborative recommendations on improving this important process. We have
spent considerable time understanding the process, assessing the impacts and
building recommendations. We firmly believe that action needs to be taken at
the federal or Congressional level for changes to occur that will allow us to
be responsive and supportive of industry business needs in a predictable and
timely manner. We look forward to further discussing our recommendations with
the NCVHS and OESS to affect change on this important issue.

Thank you for the opportunity to testify today and we welcome any
questions.

MR. REYNOLDS: Thank you. I would commend you for again getting the industry
together to take a look at this across the board. I’ll open it up to the other
members of the committee and staff and then I’ve got a few of my own questions.
Michael, go ahead.

DR. FITZMAURICE: Once again the industry seems to have stepped forward with
something positive and something fairly complete and I applaud all of the SDOs
for participating in this and coming to a conclusion.

DR. HUFF: Harry, this is Stan, I can’t hardly hear you at all.

DR. FITZMAURICE: I will continue with the praise for the SDOs who’ve come
to an agreement and have put forward a proposal, sometimes it’s difficult and
time consuming in the government to come up with a proposal particularly that
flies in the face of some of the things that we’re used to. So my immediate
impression was gee, I wonder if this is legal, because the APA, American
Procedures Act, requires a certain due process to be followed. And then I
wondered well, this would be helpful to get all the public comments in and if
it were part of the process, I don’t know if it’s part of the APA process, A,
you could change the APA to Congressional action, that’s cumbersome but the
industry can move mountains, its shown in the past that it can.

Secondly, I wondered well, it’s possible that if the Secretary is convinced
that the industry is headed say that all the materially affected parties have
weighed in and there appears to be a consensus it may be possible that the
Secretary could move to a final rule with comment as opposed to going through
the NPRM process.

And then as I listened to Lynne’s testimony reflecting all of your concerns
and solutions I’m wondering, there’s some time in there that isn’t laid out,
that’s the time that the government has to do things, for example the comments
have to be collected, are they collected at the SDO or are they collected
within the federal government, or are they collected at the SDO and shared with
the federal government in such a way we know that 100 percent of the comments
are accounted for as we have to do in due process.

And then secondly as you write a say proposed final rule it has to go
through inside the agency that writes it, then it has to go to all of the
federal agencies within HHS who weigh in on it and if that’s not enough, and it
isn’t enough, it has to go to OMB for OMB comments and OMB decides whether it
goes to other federal departments or not, then it comes back to the Secretary
with requested changes, back to the agencies for their comment on what we hope
would be the final rule.

So the question is does this short circuit some of the time? I think it has
potential to do that, I think it could shorten the time, it does show industry
consensus on what’s proposed, particularly changes in the HIPAA standards
dealing with transactions, I think it’s positive. I don’t know what the
legalities are and so I would have to defer to the Office of General Counsel, I
would even defer to Karen who knows much more about the regulatory process then
I think I do to say what is possible and what is not possible.

But I would like this to be a positive experience with industry stepping up
to the plate and I want us to throw strikes at the industry and let them hit
them out of the park. We all want a faster more efficient process that improves
as technology improves, that improves as agreement improves, and it’s difficult
to move from EDI to object oriented, HL7 Version 3 if we’re talking about
clinical information which we’re not really except for claims attachments here.
It’s hard to have the progress that technology brings without also an efficient
process within the government.

And so I look upon this as a call for the government to weigh in with will
this work and if it needs to be tweaked how can it be tweaked to make it better
and how can the government process dovetail with the industry to reflect what
the industry and consumers want, more efficient claims process handling.

So I’ll conclude by saying I really applaud the industry, you’ve done it
again, you did it before with a short circuited first year changes in the
transaction standards and you’ve done it many times in the DSMO, you’re doing
it again. Thank you.

MR. REYNOLDS: One comment, before you answer that, Stan, would you please
introduce yourself since you are a member of the committee and are on the phone
now?

DR. HUFF: Yes, Stan Huff, Intermountain Health Care and the University of
Utah, member of the committee and a member of the subcommittee. I don’t think I
have any conflict with things that we’re discussing but I have potential
conflict if we talk about HL7 specifically and if we talked about LOINC
specifically at some point.

MR. REYNOLDS: Okay. Responses? I’m not sure if that was testimony or a
question.

MS. WEIKER: Well, Mike, in regard to the collection of the comments,
because I believe that was one of your items, where the SDOs would collect the
comments and obviously those comments would be shared with OESS or NCVHS or
whomever, in fact I know in NCPDP when we receive comments on a ballot, I mean
they’re known throughout, anybody can get that ballot and can see the comments
made by anybody as well as the resolution that we came up with in regard to
that comment.

DR. FITZMAURICE: Margaret, let me just respond to that, we make all the
comments available publicly and I would ask that if you’re considering that
process you might consider doing the same as well so that it dovetails with our
process.

MS. WEIKER: Right, and we could look into using probably maybe some of the
resources you all have, or at least the website maybe to post them, or we could
post them on ours or something. I mean those kind of little details, those can
be worked out, that’s not a problem.

And in regard to timeframe, we do have some of the steps in here, we
probably have cut the time probably too much, we had 90 days for some of the
items to write the final rule and it probably will take more than 90 days to do
that based on history.

MS. GILBERTSON: What we used in the proposed timeline which appears on page
20 was the guidance that’s given in H.R. 4157, the 30 day, 90 day, whatever,
those timeframes, just to see how it would plot out in a new process. So we
didn’t make up these numbers ourselves, they were part of that proposal.

MS. GOSS: In regards to the public comments and building on Margaret’s
remarks from an NCPDP perspective, from an X12, there’s a full reconciliation
of all the comments so if comment A gets submitted there’s a response back to
comment A. And one of the things that I think would be achieved out of this
proposal is a better viewing by the industry of all the comments made and the
resolution of those compared to the consolidation process that now happens in
the NPRM to the final rule preamble. So I think that we actually can elevate
the level of industry awareness and of what’s been commented on and how its
been resolved by the Standards Development Organizations.

DR. FITZMAURICE: Alex, I think you make a very good point and it’s the
industry finding solutions to those comments as opposed to having a longer time
for give and take with the government, I think that could reduce the time.

MS. GOSS: I think it also produces a quality byproduct in that what you
have is everybody working through the issues at one time and everybody can put
their voice into one place, whatever SDO it is, so that you can actually get a
better level of consensus before you develop a final work product that would
then be recommended for adoption.

DR. FITZMAURICE: I think it could add to the process whereby the Secretary
considers all the relevant facts before he or she makes the decisions for
making this change in HIPAA, that could be an improvement.

MS. GOSS: Also in regards to the legal dynamics that you reference, that is
a major hurdle and we do need legal resolution to the policies that are in
place right now.

MR. REYNOLDS: I’ve got three or four questions myself. The first, and again
since not everybody in the room had this ahead of time, the committee did but
as we all, we try to adjudicate this, what do you actually define HIPAA to be?
In other words you’ve got things like NPI out there now, you’ve got other
things, what is the exact definition of what you’re talking about streamlining
right now?

MS. WEIKER: The transactions.

MR. REYNOLDS: Okay, fine, that’s good. The second, as you look at the
summary that Lynne you testified, you come all the way through and you’ve had
the SDOs and everybody look at it and you get to NCVHS and you discuss public
testimony. And our process has always been after we hear public testimony we
make recommendations and those recommendations as we did when we looked at
e-prescribing and other things were for other people to go back and look at it.
But it looks like it moves directly from there into the final rule so it almost
looks perfunctory based on the testimony rather than, I don’t see a loop back
process that says if the public testimony were to be such that the SDOs or
others would need to look at it again, I don’t see the loop back in here. It
kind of says hey we’ve done all this stuff, we’re going to bring it in, but how
you would adjudicate that if that public testimony we heard might be different
than what you had heard or what your process had been, how do we get that back
to you and then come back again? So just if you could comment on that.

MR. BECHTEL: I think it was always our intention that if NCVHS had
considerable concerns that prevented you from making a recommendation to the
Secretary to adopt that those concerns would be brought back to the SDOs and
the SDOs would try to reconcile those. So I don’t think we intended to preempt
that process at all and if we didn’t explicitly say so I do believe it was
intended to be there.

MR. REYNOLDS: Again, I wasn’t alluding that you did, just for completeness
of your recommendation it would have been good to see it and then we would have
had a process that said when it comes to us it’s not a rubberstamp, it’s that
if we have comments then you take it back and bring it back at the next meeting
or something would happen that would show a little more of a process rather
than when we get it it’s kind of that’s it.

MS. GOSS: And this is our optimistic process.

MR. REYNOLDS: The other question I have, and this is going to be the same
question that I’m going to have in a later session. So we talk about
implementation timeframe so we have an industry right now that continues every
time we come up with an implementation timeframe it looks like it’s going to
slip. So now we’re going to go faster setting standards, what have all of you
looked at as SDOs to address the idea that once we say go how we get everybody
to go, and once we say stop how do we get everybody to be done. So there’s this
idea right now it takes a long time but even if it takes a long time people
still aren’t getting it done and we’ll talk about that a lot when we get to
some of the other things on the agenda. So I would love to at least hear your
comments, not necessarily in your structure but how do you see that because if
we’re doing things faster how do we, so for example I would think 5010 would
fall under this, would be a big change again for the industry, so anything that
you can do as far as that concern that would be good, so any comments you have.

MR. BECHTEL: I guess I’ll speak first, I’m sure others will have more to
say. With regard to 5010 this is going to be a much larger change if we adopt
it because its been so long since we had 4010 issued. I think the goal of this
process is to make the standards come out more rapidly so that we have smaller
changes and the changes can be more easily adopted by the industry and not have
to be such a struggle to get completed. So I do agree that 5010 will be harder
to implement but the goal is to improve the process so that we get faster
shorter easier to implement changes.

MS. WARD: In our discussions the group here as we were preparing this
recommendation, one of the decisions we made was that in terms of what is the
appropriate timeframe, is it 18 months, is it two years, how often should we be
turning around new versions of standards, we really think that the SDOs should
not dictate that but the industry, and that’s a very generic term, but wherever
that wider more diverse public industry conversation takes place, we think that
should be driven by that sector of the industry not by the standards
development organizations, we want the standards to be there, to be ready, to
be implementable, but we don’t want the standards organizations to dictate the
timeframes for implementation.

MS. WEIKER: Well, from an NCPDP perspective the changes from version 5.1 to
what we’re calling version D0, they will be a big change much like the X12 4010
to 5010 changes. However with the industry input we have all sectors of the
industry participate within NCPDP that are impacted by our standards so they
are there, they’re requesting the changes, they’re aware of the changes. Our
industry so to speak has met the deadlines, we’ve had Medicare Part D come up
with specific deadlines that we have met, we’ve been very creative in, and I
use that word very loosely, in order to maintain the HIPAA version 5.1 in the
Medicare Part D, we’ve done that. So I think one of the things is by having the
industry participate up front and through the process, one, there are no
surprises so when I open a D0 or I open up an X12 guide or I open up a claim
attachment I’m not going to be surprised by the content, I’ll know what’s
there, I already can start planning, geez, if this goes through like this this
is going to take me six months to make the changes, test it and roll it out. So
I think by having the industry participate sooner versus wait until the end
that will help as well.

MS. GOSS: Margaret makes an excellent point which I want to add one item
too which is not only do we get people more educated as the process of
development is happening so they can forecast the changes they need to make but
we also as SDOs have instituted a number of educational guidance processes
through our 4010 experience to help people with understanding what is really in
those implementation specifications and then also work with our sister
organizations that are not necessarily SDOs but such as WEDI, and we’ve worked
with OESS when they had an Ask HIPAA hotline to give that infrastructure
knowledge that would help the industry move along and adopt the standards more
quickly and more efficiently.

MR. REYNOLDS: Okay, Jeff and then Karen.

MR. BLAIR: First of all let me do full disclosure and indicate that I’m
biased because I strongly support the efforts that you have to try to
streamline the process, I strongly support it. So the questions I have are for
clarification and to try to go back to some of the areas, what was it, December
of last year when you testified to us on this issue? And the last prefaced
remark I want to say is thank you to Marjorie Greenberg for distributing the
document to us so that the committee members could read it over the weekend
before we came so I have read it and it’s very thorough, very comprehensive,
obviously a great deal of thought has gone into this.

As I was going through this and as my reader was reading it to me there
were some times when I felt as if this was targeted towards standards that had
already been approved through the HIPAA process but only involved a new version
or a revision, but there were other times when I just wasn’t sure whether it
was broader than that, so can you clarify that.

MS. GOSS: It is specifically focused on existing adopted standards because
we believe that if a new standard would be proposed that that needs a more,
that has policy implications around it which are not within the existing
processes to cover, that really is a federal process to manage.

MR. BLAIR: Okay, then I would make a small suggestion and that is that if
this document is to be updated slightly that there be either a definition of a
version or a reference, maybe it was in there and I missed it, but something
where I could understand what are the boundaries for a new version or a
revision, the scope that this covers, because if it was there then maybe make
it a little bit more prominent, that’s one piece.

The other pieces that I recall was I remember back in December that we felt
that we could come up with a process to streamline things but as Michael
mentioned some of the HHS legal guidance was winding up saying they couldn’t
change this without Congress agreeing to that. Have you had a chance to explore
a little bit what it would take to either get Congressional or HHS legal
approval for this process, that would help me a little bit because I sort of
don’t know how bit a mountain we’re facing and if you’ve already started to
look into that could you share that with us.

MR. BECHTEL: Yes, I’ve been very much involved in trying to get
Congressional, I’ve been working with a number of Congressional areas on this
issue and in particular the House Bill 4157 is largely the result of work that
I’ve done in cooperation with all these fine people at the table with me. We
have talked to legislative attorneys within the Department, well not the
Department, within the House Ways and Means Committee and within Energy and
Commerce and their opinion was these kinds of changes could be made and
obviously they felt that way because they put forward a bill that was proposing
those kind of changes.

Everything that’s outlined in this paper really is representative of what
we put forward in 4157 but you’re absolutely correct, I do not believe this can
happen without some sort of Congressional action. And what they were perceiving
is that we’re kind of moving the comment period that normally occurs from the
NPRM process into the SDO, almost the delegation if you will, of that process
to the SDOs to conduct and they were constantly looking for well how do you
manage comments, where are the comments placed, exactly the questions Michael
was asking us, and we went through that process with them, what we do as SDOs,
and they were reasonably comfortable that what we were proposing was a solution
that could work.

Now obviously there are different opinions on the Hill with any kind of
legislation and I’m not sure everyone agrees but the ones we were working with
do.

MS. WARD: I have another thing to offer I guess, based on our December
testimony when individually as SDOs we talked about our respective processes
and how we might be able to streamline that, the committee asked us to kind of
put our heads together and come up with the one so we focused, in this group on
this task we focused very much on our processes and how HL7, X12 and NCPDP
could all agree to one process as it relates to standards in a regulatory
environment. But I have no idea the extent to which any part of what I’m about
to say may be true but after the December testimony —

— [Laughter.] —

MS. WARD: I think this is worth putting on the table because after our
December testimony there was one member of the committee, the subcommittee,
that I had subsequent conversations with and then a couple of other folks who
their background in all of this certainly is substantial enough that their
opinion might actually be something we could pursue and that was that it is an
opinion of OGC on how the APA is applied that is restrictive for us in that
indeed the APA might actually be interpreted differently by different
organizations or individuals. So this isn’t so much about the Congressional
approach but more about interpretation of the Administration Procedures Act.
And again I’m not the one to have that debate but I wonder if that can’t also
be something that our friends within the government could possibly explore.

MR. BLAIR: Okay, thank you for that. Is there anybody else that has any
insights on either the legislative issues or what it would take to get legal
approval? If there’s not then I have a few more questions. Is that all right
Harry?

MR. BECHTEL: I realize as you said your question I should clarify something
and I’m not responding to your immediate question but going back to my last
response when I was talking about House Bill 4157, I want to point out that
there’s only one section in that bill that pertains to what we’re discussing
today which is Section 201, not the entire bill, so I don’t want to leave the
opinion that all of 4157 is addressing this. I apologize for the
miscommunication.

MR. BLAIR: I like the way you laid things out and this additional comment
is a little bit of an echo of what Harry has already raised and that is that
when presentations for revision or update for a standard is brought before the
NCVHS in a lot of cases when we’re briefed earlier that it’s coming and we have
our homework done and we’re not hearing the testimony for the first time, just
like in this case where we’ve had a chance to read through the documents, that
usually enables us to kind of come to a conclusion at the end of the testimony
period, however there’s a lot of times when that is raised here and it triggers
responses from other sectors of the industry who want to get heard which means
that we’re into a mode where we’re receiving testimony either from other
private sector organizations and/or federal agencies before we are in a
position to make a recommendation, so maybe if that modification could be noted
in your process, that’s very much consistent with Harry’s, I just phrased it
somewhat differently.

This is my third and last question, one of the things that I remember
hearing as an issue back in December, at least I thought it was in that
session, maybe it was afterwards, was that all of us are kind of part of this
public/private standards development community and we look at what we do, we
understand its impact, and for those folks that attend the SDO sessions they
understand it, and it’s almost as if once it gets here either at an NCVHS forum
or through the NPRM process there’s other aspects of the health care community
that all of a sudden wake up and start to pay attention, and sometimes they
become indicated as a rule by HHS, folks don’t start to react until the
deadline is approaching at which point they wind up objecting and saying oh we
need more time even though its been years while this has been discussed and
preparations could be made. And specifically it was said that well, these other
elements, CEOs, COOs, other executives within the health care community don’t
attend SDO meetings and don’t know what’s going on but that delays us kind of
at the last minute after we think we’ve heard from everybody and then all of a
sudden these objections come in.

What thought had you had or discussions have you had to be able to somehow
educate, include, get awareness during the process that you’ve involved so that
that doesn’t come in after this process is over where we’re thrown right back
into the fact that somebody is demanding an NPRM process at the end?

MS. GOSS: This is Alex, I’m going to take the first stab that because I
suspect that my compatriots will also have remarks on this because its been a
very interesting part of our discussions. Yes, we did testify in December and
we’ve been working on this paper since then so nine months worth of effort. We
really feel that people do need to be educated and that by using the vehicle of
the federal register to get notification out to the industry to say hey folks,
there’s a development going on on a standard that is going to impact you,
please come play here, is going to be the key vehicle for us to make the
industry aware that they need to pay attention at the ballot or public comment
period of the standards development organizations.

There’s always going to be an issue with reaching, getting everyone to pay
attention, we have a little bit of the ostrich syndrome at times, and I think
that our education, if we get a change actually put into play regarding not
having an NPRM for reviewing and proposing adoption of a new HIPAA standard, or
an upgraded HIPAA standard let me say, that there will need to be a series of
educational efforts taken once we get a new process put into place and that’s
something that the SDOs would undertake along with WEDI and I would certainly
hope that our federal friends would also assist with that effort and would look
to OESS to be a leader in that arena.

MR. BLAIR: But essentially the main vehicle for this publicity is the
Federal Register.

MS. GOSS: For the development review period, yes.

MR. BECHTEL: Just to add on to that, my vision of what the Federal Register
announcement might indicate is when a public comment period is taking place
that it be clearly stated in that notice that this is your only opportunity,
there will be no NPRM hopefully and that this is the time to comment so not to
delay. It’s kind of maybe the last moment process just moved up but I think the
Federal Register has to make it clear what the process is.

MS. WARD: Jeff, this is Maria, as Alex pointed out this was a discussion
that really carried on with our group for a long, long time as we prepared this
paper. And I just want to echo what Don said, the Federal Register notice of
the development can’t just say it’s happening, it has to say this is your
opportunity just the way an NPRM says this is your opportunity, you have 60
days. The weight of the message from the federal government really needs to be
conveyed in that Federal Register notice for people to understand the
importance of it. I mean I think we as the SDOs can educate and do awareness
campaigns for years and years and years and it does not get the attention that
a message from the federal government gets.

MR. BLAIR: May I suggest something else for possible consideration? And
that is that if this change does take place there needs to be a major
announcement that the process has changed and that the NPRM process won’t be
there anymore for folks to wait for and that they now need to get involved in
SDOs and if they do get involved in SDOs it may change the complexion of the
SDO process if there’s more business folks and executives and financial folks
now part of that process, the profile of the participants might become altered
a little bit.

MS. GOSS: Jeff, this is Alex, building on your comment, we would expect to
see an increased level of participation in SDO activities although we don’t
believe that our workgroups will suddenly balloon 15 times their current size
but we do expect our public review or ballot periods to balloon in tremendous
size, and being ANSI accredited organizations we have a very transparent
process and a reconciliation as a part of our due process that enables people
to participate in that review and commenting process that really enables the
people that would have paid attention at NPRM to actually have a better level
of participation because they get more intimately involved in the entire
process through the SDOs step by step.

MR. BLAIR: Thank you, I really applaud your efforts.

MR. REYNOLDS: Karen.

MS. TRUDEL: My question has been answered, thank you.

MR. REYNOLDS: Okay, Simon.

DR. COHN: First of all thank you very much for coming and joining us today,
like the other members obviously this is I think an important topic that we all
discuss. I think you know that in HIPAA reports and letters to the Secretary
within the last year as well as in testimony of the House Ways and Means
Committee we’ve obviously been very strongly supportive of a more nimble
process for the HIPAA regulations and modifications to the HIPAA rule so you
know you come to a group that has great understanding I think of the issues
you’re dealing with. Now having said that obviously much of, we’re all aware in
much of what we’re seeing here in the testimony is actually at this point on
Capitol Hill and none of us know how that’s all going to work out. Congress
still will likely start again after the elections, I think none of us know
before the end of the Congress this session exactly what is going to happen.
Obviously one option is is that a bill is passed at which point we have
substantive conversations with you all about exactly how we work in this new
world.

Now the other question and I almost hate to bring it up because it probably
isn’t as happy a world is you’ve done a lot of very good working and thinking
over the last several months, are there parts of what we’re seeing here that
could be implemented, that could help streamline even absent Congressional
activity?

MS. WARD: I think that we were trying to take a two pronged approach here,
we know that there’s activity and potential with bills that are being
considered right now by Congress but we were trying also to say, as you point
out, if that doesn’t result in the kind of changes that we would like to see
could we actually have a regulatory change that supports our approach, so not
just the legislative path but also can we go down a regulatory path. And that I
think leads into my earlier comment about is there wiggle room, is what we’re
dealing with now an interpretation of the APA where possibly there could be
other interpretations of how the APA is applied. So I think we want to, we are
supporting and we think that our recommendations are fully in sync with what’s
proposed in 4157 as it relates to standards but we also coming before you are
trying to take it down the other path which is do we have other options. So
it’s almost like we’re asking the same question of our friends at the federal
level, are there different interpretations that can be offered of the APA.

DR. COHN: Thank you and as you know I think we’ve had attorneys come and
testify to us for, not being an attorney sometimes you can only get so far by
asking questions but have you received any legal opinions from, once again
there are many ways to get legal opinions, one is formal from the government,
another is through people that you’ve retained as a private organization that
may suggest that there’s more flexibility than the government’s current
interpretation of this.

MS. WARD: We as the joint SDOs have not sort of collaborated to engage any
sort of, I’m not talking about the Congressional part, I’m talking about this
document that’s going before the NCVHS in terms of the APA interpretation, the
SDOs as three organizations have not collaborated and engaged attorneys.
AFACT(?) might have supported that and Siemens and private organizations but at
least HL7 has not been involved in engaging an attorney, I know that the
discussions have taken place and they’ve been more related to 4157 and other
organizations, I don’t think X12 paid an attorney did they to have an
interpretation on this?

MR. BECHTEL: I don’t want to get in a dialogue between the people at the
table here but I will disagree with you just a little, we did hire an outside
attorney, the attorney was paid for by AFACT as an organization but the
conversation with the attorney was shared with this group and this group
commented back extensively on what the attorney was providing including HL7,
Chuck provided enormous editorial to some of the work. And this was all
surrounding the APA discussion and I think the attorney that we were working
with would confer that what we’re trying to do could not be done without some
sort of Congressional action to permit the Secretary to delegate this process.
I think that’s what we were trying to do in 4157, so I think probably a better
thing for us to ask of this committee is if you agree with the changes we’re
proposing, any support on that issue would be helpful that you can provide. And
I don’t know what liberties you have in doing that, I know you have some
constraints too, but anything that would support this would be helpful.

MS. GOSS: Much of our work over the last four years in looking at this
issue has been done in concert with OESS and getting, trying to slice this
issue every way to Sunday and what you’re seeing in this 20 some document, the
full testimony, is really the result of we have no more options at this point,
the APA interpretation and the current status that we’re trying to get changed
through Congressional action is the only path that we can take.

MR. REYNOLDS: Okay, I’ve got a couple other questions, and Michael after
me. As you look at the little guys getting involved, little people get involved
in this, when you have a government process they get in free, when you have an
SDO process it’s voted by the members and there is a cost to be a member of an
SDO. How do you envision making the people that would, if you move it from a
government process to a private sector process that has a cost, even though you
have a public hearing it is still voted on by members who have paid dues and
represent a lot bigger players than the standard people, so how do you see that
working so that for example, again looking at the process, they don’t show up,
they might not show up where it costs but obviously some of the other things
that you have in here were free for people to come in and make comment to. So
trying to be inclusive along the way how do you see that playing versus what
the government does? Maria?

MS. WARD: On the ballot for HL7, at least on the ballot side when it comes
to there has been a recommendation and it’s going to be balloted you don’t have
to be a member of HL7 to participate in a ballot, there’s a nominal fee
currently, last I inquired, and this is going back probably to the December
testimony, it was $25 dollars. Now I think we would be perfectly willing to
engage in a conversation if this could be brought forward to reassess that, I
haven’t had that conversation with HL7 but you certainly don’t have to join the
SDO in order to participate in a ballot, and you don’t have to join the SDO in
order to participate in the discussions, the conference calls, sort of
development type things that lead up to the ballot, we in fact encourage domain
expertise and we solicit that to come in and help us as we develop our
standards even if those individuals are not formal members of the organization.
So I don’t see that as a barrier in terms of the development or in terms of the
ultimate balloting.

MS. WEIKER: In regard to NCPDP, in regard to our ballots, you do not have
to be a member in order to vote, we do not charge any type of fee in order to
have a non-member vote on a ballot, the materials would be provided to them,
either electronically or via paper if they don’t have an electronic means, the
adjudication of the comments would be posted. In regard to the development of
the standards most of the detailed work is done at a task group level via a lot
of conference calls, you do not have to be a member in order to participate in
a task group, voting there is just, it’s by consensus, so we don’t believe we
have barriers in regard to having anybody come and participate.

MS. GOSS: From an X12 perspective our public comment period is open to
anyone and everyone, it is done electronically as well as a part of it is in
person, but all comments are posted to a publicly available site and all
answers to those public comments are also posted 15 days before we have an in
person face to face recap of the comment and resolution process. Currently our
ballot is limited to members only however we are currently at X12 taking a stab
at how we can modify that process, we’re trying to balance the needs of the
industry to participate at a reasonable cost with the overhead associated with
individuals either attending a face to face meeting where there would be voting
that would happen, and the process with supporting people who are coming into
an organization that is basically staffed by volunteers.

MR. BECHTEL: Let me just add on to everyone’s comments here, the part we’re
removing that you’re saying is open to the small person, the NPRM process, is
not a vote, it’s only a comment, and so our comments at X12 as Alex has just
suggested is free and open to everyone and is responded to everyone. So we
haven’t eliminated a process that they have, we’ve simply moved that process.
And the balloting part, true, we do have that issue at X12 which —

MR. REYNOLDS: The purpose of the question obviously as we try to look at
this very independently is everybody also has the ability to go up on Capitol
Hill and lobby and everything else so if we’re going to set up a good process
that’s going to work let’s have it work other then the others ways which are
always available, but if you can get more people involved in the beginning and
more people that stay involved and say they’re involved and don’t have barriers
to be involved then that’s the only reason I’m asking the question.

MS. GOSS: And Harry, I would ask you then for guidance and suggestions on
how we can get the attention of those people, the small guys, who are focused
on their clinical practices and providing the safe care for patients. You asked
us about, earlier about the education that has to go on and getting people to
implement these transactions, we still have people that are struggling along
way after our potential train wreck date, we struggle with how to get people to
pay attention and to come play at the table when that’s not their primary
focus.

MR. REYNOLDS: That’s a fact and we sure don’t have that answer either yet,
but that is absolutely a fact. Michael?

DR. FITZMAURICE: I’m wondering, since I’m not an expert in the
administration practices, Administrative Procedures Act, I would bow to people
who are experts in them and that’s probably an OGC if not filtered down from
OGC to the agencies. But I wonder if the Secretary has more discretion than we
understand, to get that we could invite OGC to testify or we could make a
recommendation that the Secretary ask for OGC to consider alternative ways to
speed up the processes in ways that fall under the Secretary’s discretion. That
is we don’t need to leave this as a closed end, it can be an open end,
recognizing that the final choices remain with the Secretary.

MR. REYNOLDS: Jeff, is it a follow-up to that? Karen has another question.

MS. TRUDEL: This definitely does follow-up on that, I would make a
recommendation to the subcommittee, and I have done this on issues in the past
with respect to e-prescribing that the subcommittee make recommendations to the
Secretary that aren’t constrained by what may ultimately be a departmental
interpretation of procedure. I would suggest that if the subcommittee feels
that this particular proposal has merit recommend it to the Secretary, it’s
always easier to get an opinion when you have a specific product for someone to
review, and if there is any external legal opinions that you’d like to pass
along to us that we could share with our counsel’s office we again have
precedent for doing that in some of the e-prescribing discussions on state
preemption where we did assess and consider other perspective from external
attorneys.

With respect to the pending legislation Marjorie may contradict me if I’m
not correct but this is an advisory committee to the Secretary and we don’t
have the ability to provide Congressional recommendations.

MS. GREENBERG: They do not, I would agree with that though, of course the
committee does provide an annual report to Congress on HIPAA and certainly I
would think this would be part of the content of that report that I think we’re
working on as we speak, or it’s going to be brought to the November meeting for
approval so the process for the transactions and some of the issues you’ve
raised actually have probably given us some good content to consider, so in
that sense the committee has specifically been asked by Congress to provide an
annual report on the implementation of HIPAA.

MS. TRUDEL: No, I meant specifically with respect to H.R. 4157 and those
deliberations.

MS. GREENBERG: Right, the committee does not provide lobby for legislation
obviously, although its been known such as in the privacy recommendations
indicate where additional legislation might be needed to address gaps or
problems. And I know Karen realizes this but just for the record the
subcommittee will make recommendations to the full committee and then the full
committee will make recommendations to the Secretary.

MR. REYNOLDS: Okay, Jeff?

MR. BLAIR: As we are going through our discussion this morning and we try
to think of how we can streamline or accelerate this process, because we know
that there are a lot of, there’s a lot of benefit that gets delayed because of
this whole standards development and implementation process which can be
shortened. When I think of the types of issues that seem to come up when we go
through the NPRM process and even after the NPRM process when there’s
promulgation of the rule they tend to not be the technical pieces, the
technical pieces usually are pretty well accommodated by the SDO process and
the implementation pieces are also fairly well thought through. They tend to be
business issues but not the same type of business issues that are used to
identify the requirements for a standard. They tend to be the kind of business
issues of industry, health care industry saying oh my goodness you have wound
up, you being the federal government with an NPRM, saying that this is going to
be implemented in such and such a timeframe and very often the argument is not
with the value of the standards or the technical attributes of the standards,
it’s with the timing and it’s because there’s other relative things going on in
the industry which industry is trying to work through and there’s a conflict.

I think that this, I think it would be maybe helpful if there’s some
thought for us to try to include industry review of the timing of these things
so that that could be included in the process because if it’s not included in
the process then it simply turns out to be a delay where industry goes back to
Congress and says set it back a year, 18 months or two years. And if there’s
some way we could start to build that into the process I think that could help
us.

MS. WEIKER: Jeff, this is Margaret, and WEDI is doing a benefit analysis
survey as part of this process and what we have a vision for them also asking
was about timeframes in their survey because WEDI tends to hit at a more CXO
type of level in a lot of organizations versus the analyst type of people
further down. So we anticipated at least asking WEDI to ask that question as
part of their survey.

MR. BLAIR: And that would be good and if that could be done in parallel, if
there could be some business analysis done in parallel with the technical
standards development so that it’s not serial where we get to the end of this
entire process and then the business community starts to look at it and say I
need two or three years. If it could be done in parallel I think that would be
very helpful.

MS. GOSS: Jeff, this is Alex, the development process, what we’re hoping to
achieve is to have the review of a near final work product done by the industry
which would include a DSMO review and the DSMO bodies provide not only the SDO
voice but also a data content voice. So there’s a way to get input from that
process and typically I know having participated extensively with NUBC and NUCC
as I sit on both of those committees they do talk about these timeline in
business issues and so that comes then into the discussion at the DSMO level
and DSMO and WEDI are working very closely on the benefit analysis report and
that information would then kind of come to a point here at NCVHS for overall
review and also we would expect an opportunity for other industry participants
to testify to you on that topic.

We think that the timing issue is one of concern but we hope by getting
people involved earlier in looking at the technical changes being proposed that
they then will be able to think about what does this mean to me in my current
budgetary environment and systems infrastructure so that as they’re responding
to the WEDI survey or participating here or within the SDOs that that
information is all starting to come together by the time it gets to this point
so that you’re really looking at the big picture at NCVHS to make those
recommendations that go to the Secretary that says okay, we recommend adopting
this new standard and here’s the timing to do it based upon educated
information.

MR. REYNOLDS: Stan, I’ve been remiss not to check and see if you had any
questions.

DR. HUFF: I don’t think I have anything to add, as others have expressed I
thought that this is a very well thought out presentation of how we might
change the process or how the process might be changed, and I don’t, but I
don’t have any additional insights on how we can get there faster or better or
whether we’re going to be successful through a regulatory process or is this a
legislative process. Thanks.

MR. REYNOLDS: Last question.

DR. FITZMAURICE: Margaret mentioned that WEDI is doing a benefit analysis
report of these changes, would this be part of the process that is each time
you had a set of changes there would be a benefit analysis report and do you
see that dovetailing into an economic impact analysis requirement that OMB has
for all regulations that have more than $100 million dollar impact so it helps
streamline the process and that it shortens the development of that impact
analysis.

MS. WARD: I think the inclusion of the benefit analysis report was
something originally that was stemmed from conversations with our friends in
HHS and OESS that that was an important part of moving forward with new
standards. So I suspect that the intent was that they would indeed take the
information on the federal side from that and do whatever they needed to do in
terms of an economic impact section of a final rule.

DR. FITZMAURICE: On the federal side it certainly would help us with how to
frame it in terms of a model and to look at the assumptions about the different
parameters, we might disagree and put different parameters in an economic
impact analysis, but to start with the model and to be able to discuss the
parameters would be very helpful to us.

MR. REYNOLDS: Okay, that concludes our discussion, Jeff jumped out early
and said he was biased, the rest of us recognized good work, so don’t take any
of the questions or any of the things to be any more than adding to what we
thought was an excellent set of work, an excellent paper, a process that’s
needed. I would hope at some point it would even be considered that as all
these things having to do with some of these issues relate that after the first
time maybe it falls into this process for other things also but we should start
small and do the right thing for something that’s already grouped up in that
way.

So thank you very much to all of you, appreciate it, another good job from
those of you we’ve seen over there numerous times and thank you very much and
we’ll get back together at 10:35.

Thank you.

— [Brief break.] —

MR. REYNOLDS: Before we get started are there any other members of NCVHS on
the phone other than Stan? Okay, let’s go ahead and start our next group which
is the Disability Workgroup recommendations and like we said last time we
welcome our friends from CHI who are here on a regular basis to see us also, so
Beth, are you going to lead the discussion and if maybe each person would
introduce themselves, and aren’t you going to have some people on the phone?

MS. HALLEY: Yes, there should be some people on the phone.

MR. REYNOLDS: Okay, so why don’t you go ahead and take care of
introductions so we know who’s who and then please continue with your
testimony.

Agenda Item: Disability Workgroup Recommendations – Ms.
Halley

MS. HALLEY: Thank you, Chairman Reynolds and Chairman Blair for this
opportunity to present the CHI Disability Standard. My name is Beth Halley, I
am with Mitre, and have been the CHI facilitator. I do believe we have several
folks on the phone but if we can take a minute and introduce the people in
person and then we could go to the phone and we can start with Jennie Harvell.

MA. HARVELL: Hello, I’m Jennie Harvell. I work in the Department of Health
and Human Services in the Office of the Assistant Secretary for Planning and
Evaluation.

MR. SHIPLEY: My name is Sam Shipley, I’m also in ASPE.

MR. STRESON(?): My name is Manny Streson, I’m a medical officer with the
Department of State in the Office of Medical Services in the State Department.

MS. HERRING(?): Hello, my name is Irma(?) Herring, I’m also with the U.S.
Department of State, Office of Medical Services.

DR. HUFF: Good morning, I’m John Huff, I’m from the National Center for
Health Statistics in the Classification Section.

MS. HALLEY: If there are any members of the Disability Workgroup that are
on the phone could you please identify yourselves?

DR. DESI: Dr. Desi, Social Security.

MR. CONLEY: Hi, this is Bob Conley, the Centers for Medicare and Medicaid
Services, Office of Clinical Standards and Quality.

MS. CAMPBELL: Hi, this is Kim Campbell with the Office of E-Health
Standards and Services also with CMS.

MS. PRATT: Mary Pratt at CMS.

MR. BOGNER(?): This is John Bogner from the United States Rotary Town Board
in Chicago.

MR. LANG(?): This is Derrick Lang from Social Security Administration.

MR. DANIELSON: Mike Danielson with Indian Health Service.

MS. HALLEY: Thank you and I believe that’s everyone and I think I
interrupted, that was Cheryl Ford who I interrupted. Thank you everyone that is
on the phone, that you were able to join us today.

The purpose of today’s meeting is to give you an update on CHI Standards
Workgroup specifically the work of the Disability Workgroup and they have
presented to you in writing the recommendation. Many of you who have been
around for a while know that the Disability Workgroup, this is phase two of
their work, they did present a report to you during phase one back in 2004,
they have worked to address several of the recommendations that you
recommended. So the work that we are bringing forward today has been about a
year and a half worth of work on top of the original work that the workgroup
has done.

The workgroup has asked that I present an overview and a summary of their
work and the recommendation, and then we could open it up to any questions or
comments from you if that would work. Thank you.

The overview that I’m going to present today is to discuss a little bit
about who our participants are, the scope of our work, a little bit of the
background of the recommendation, the process that we’ve been through and the
dates, the target dates that we’ve been working to get the endorsement to you
from CHI. We’ll talk specifically about what the recommendation is, the actual
standards, and then we’ll talk about some of the conditions that are associated
with the recommendations, some of the benefits that the workgroup has seen and
also some of the considerations of the recommendation that’s in front of you.

In terms of the participants, Dr. Desi who is on the line from the Social
Security Administration and Jennie Harvell from ASPE have led this particular
portion of the effort. We have also had approximately 30 members of our
workgroup and they include ASPE, CMS, the National Library of Medicine, CDC,
Indian Health Service, as I mentioned Social Security Administration, the
Railroad Retirement Board, both the VHA and the VBA, the Department of Defense,
the Department of Labor, and the Department of State.

And I would like to just mention one of our members happened to bring to my
attention that not only has many of the people been working on this but for one
particular member has been their entire career with the government, they
started and their very first project was to work on the Disability Workgroup.
So that gives you a perspective, for some this has been their entire career
effort.

The scope of the workgroup, the scope obviously is disability and
functioning content but based on the recommendations of the first
recommendation that came to you the scope has really expanded a bit to include
disability related assessment forms. And the reason for that was that there was
a distinct need within the content area to look for ways to standardize
disability and functioning content and in that need there was not only the
content but how is the content used. And so as you’ll see as we go through the
recommendation process today that we will expand looking outside of just the
content areas to LOINC which was looked at to actually codify the kinds of
questions that are asked in the disability domain as well as the vocabularies
that support the kinds of answers and the kinds of content that is needed
within the domain. So that is one slight different that you’ll see from the
workgroup initially.

When the workgroup presented during phase one there was not endorsement
because the group really focused on two areas and one had been in the clinical
domain and the other was within the benefits and administrative domains. And
within those two domains none of the standards that were available really
incorporated all of the needs so at that point they were looking at SNOMED in
the clinical areas and ICF in the benefits and administrative kinds of
statistical areas.

Because of this inability to come to consensus on what was really the
appropriate standards you all had recommended taking a look at, maybe looking
at the use cases that were involved with this and potentially LOINC-ifying,
looking at LOINC as I mentioned, LOINC-ifying, the kinds of content questions
that are asked and to look at the semantic terminology that would support that
approach. So in the last couple of years the workgroup has in fact moved
forward with your recommendations and have leveraged and done a lot of analysis
with four different activities.

One is related to an ASPE project that was funded by ASPE and CMS to look
at a specific type of assessment report called the minimum dataset, or the MDS,
which is used for long term care reimbursement and quality measures, nursing
facilities essentially submit these kinds of assessment forms. In addition to
that the Social Security Administration under the direction really of Dr. Desi
and his staff took a look at the RFC form which is the residual functional
capacity form and that is a report that SSA uses to determine benefits for
disability and functioning areas.

And to give you a sense of the scope and why disability is so important,
SSA is looking at about three million applicants or claimants for disability
every year and we heard a presentation by SSA last week who said if they could
save just, they put in hours and hours of trying to collect information from
hospitals and providers and insurance companies, if they could save just a half
hour in that process by automating some of this that would be 1.5 million man
hours a year on a very conservative basis, so I think that gives you a sense of
why this is, in one area why this is an important area to consider for
standardization.

In addition to LOINC-ifying the RFC which I believe Dr. Huff is on the
phone the Clinical LOINC Committee presented, or actually volunteered to pilot
looking at LOINC-ifying the RFC and we’ll talk a little bit about that and that
was in one of the appendix of the report.

In addition to that Dr. Desi also led an analysis of what are all the
concepts across the federal government relating to disability. All of the
participants who you just heard from submitted a survey result and Dr. Desi and
his folks compiled that work and you will see in one of the appendices across
the federal government what are the concepts that are used within disability
between the SSA and the RRB and the Indian Health Service and how are they
similar and how are they different. And then in that process they took that
data and then mapped it to IFC, which is the international classification of
functioning, and then took and mapped it from IFC to SNOMED, and the results of
that work is in the report and we’ll go over that a little bit but they are the
four main pieces of work that compiled the background to the report that has
been presented to you.

In terms of the process, again this work has been done, this phase of the
work in those four areas since about July 2005. The CHI Workgroup as you know,
this report gets vetted and that’s the federal agencies vet this report. We got
a unanimous endorsement of this report at last month’s, or excuse me, last
month we presented it in September and last week we received full endorsement
of this report to bring it to NCVHS, and here we are today.

The actual recommendation, what the workgroup is recommending is that LOINC
be considered for the questions and answer format within the assessment forms,
and CHI endorsed vocabulary be endorsed for the exact or usefully related
content of those answers as related to disability, and then we’ll take you and
show you some information for a broader look at how CHI endorsed vocabulary
support LOINC-ification, the answers of those kinds of questions.

In addition to CHI endorsed vocabularies this workgroup is recommending
that you endorse, and they have endorsed, adding ICF to the UMLS and to develop
mappings between the ICF and SNOMED. And we’ll talk about this a little bit
more but there was a distinct, in the work that this workgroup has done there
was a distinct identification that by adding ICF to the disability domain it
adds a coverage that was not there before so it broadens the ability to
identify standards for the disability and functioning domain and that was a
very strong indication with the analysis that was done by this workgroup.

In addition to the content the workgroup is recommending that HL7 be
considered for the exchange of this information. I know this is similar to how
we presented allergy where we didn’t look at just the terminologies but looked
at really the whole process, and we’ll show you some of the HL7 exchange
recommendations that this workgroup is bringing forward. Another important item
that we want to bring to your attention that all of these recommendations we
are bringing forth as conditional and we will discuss the conditions that the
workgroup has identified associated with these recommendations.

I’m just really at summary level going to take you through these three
pieces of the recommendation to give you an idea of what does this mean, what
does this LOINC-ification of assessment forms mean, what does attaching CHI
endorsed vocabularies for content mean, and what does the HL7 exchange mean.

As I mentioned ASPE and CMS co-funded a study to see the viability of
LOINC-ifying these questions, all of the results, very extensive study, is
available at this HHS/ASPE site noted here and also was noted in the report.
But to date the LOINC-ification of these assessment forms has been done with
our workgroup looking at the MDS, the RFC, and then there are several others
that LOINC is working on including the Oasis form, the IRPI(?) assessment form,
these are all very CMS oriented assessment type forms but the two that our
workgroup really looked at was the MDS and the residual functional capacity.

And essentially what LOINC does, and Dr. Huff, I don’t mean to take any
pride to know more than the clinical workgroup so I will just at a very high
level what they do is they take a look at the manual assessment form, and
there’s lots of questions including demographic information, information to
identify the patient, as well as the disability concept. And they codify these
into LOINC codes so the form has a code and the elements of the form also have
a code. So if we take a look at, here’s a PDF copy of the MDS, this is the
manual form and I know it’s probably hard for you to see here, this is several
pages long, but this is just one of the pages that shows you the patient
information, some of the other types of information they’re going to collect.

And this is what the LOINC form looks like of the MDS, you can see that
there’s a LOINC code that identifies, that 45981-8 identifies this as a
specific form. And then it goes through and it has characteristics of the form
and as you get down into the panel you can see how the codes are assigned to
the patient’s name and as you get further and further into the report LOINC
assigns these codes for all the different kinds of questions that are asked
within this form.

Another example of a manual form that we looked at as we mentioned is the
residential functional capacity form, and the example here shows exertional
limitations and it shows things like occasionally can lift and carry,
frequently lifts and carries, and then there’s qualifiers or scalers associated
to them, can lift ten pounds, less then ten pounds, ten pounds, 20 pounds, etc.
So what the clinical LOINC committee does or did in this example and what LOINC
does is it codifies those kinds of concepts. So here we have exertional
limitations and then you have a code associated to occasionally lift, and then
you have essentially the answers and the physical as we said here it’s pounds,
less than ten pounds, more than ten pounds, etc. So this is the process that
LOINC goes through, it looks at the manual form, looks at the information, and
assigns the LOINC codes to them.

Now that’s the LOINC piece. Then the committee is recommending that we take
a look at CHI endorsed vocabularies to answer those questions. So what the
workgroup, when they took a look at SNOMED, ICF, and several other vocabularies
but for the disability of it what they found in their analysis was that SNOMED
was very good at a very granular level, was able to capture concepts at a very
granular level, was very good at the clinical concepts, but there were gaps
within the disability domain. When they looked at ICF what they found was that
there were numerous higher level concepts within the domains that supported the
needs of people or forms and agencies like SSA that is required by Congress to
categorize their disabilities a certain way and ICF met that need. So where
there were gaps within SNOMED ICF seemed to fill those gaps.

And we also noticed that there were overlaps within these vocabularies as
well, so even though there were still gaps by looking at ICF and SNOMED gave a
much better coverage of the disability domain.

And I think I’ve already talked a little bit about some of the work that
was behind these analyses, in Appendix D of your report was SSA’s survey to all
the federal government agencies that participated and a synopsis of the summary
of those results. And then John Huff who is here did an exceptional job in
creating the mappings between the residual functional capacity concepts, ICF,
and SNOMED. And because of the outcome and the analysis of this this is one of
the really strengths behind this concept of recommending ICF to be included in
the UMLS and to be considered as a CHI endorsed vocabulary, as well as
considering the mappings between ICF and SNOMED.

Here is just one page of hundreds of pages I think of John’s work but it
just gives you an idea, again if you look at that exertional limitations
category of lifting what the ICF code was here, and you can see it’s a d430,
what the explanations within ICF about lifting and carrying, what the concepts
were essentially, and then what the SNOMED code that would be associated with
that. And this is just an example where you can see one ICF code maps to
numerous SNOMED codes and that again is in line with the idea that ICF is kind
of a broader category and SNOMED is a more granular. But I think that within
the report that John and Dr. Desi also participated in and the workgroup
reviewed it was obvious that ICF really did identify a gap in the terminologies
that were needed, that there’s one to one mapping in cases, there’s one to
multiple mappings, and that there are still some gaps within these
terminologies.

This is a review of the other CHI endorsed vocabularies as I mentioned,
these expand beyond disability, you’ll see how lab and SNOMED and HL7 for
demographics, these are the other pieces of the CHI endorsed vocabularies that
could answer those questions that LOINC is LOINC-ifying on our results. So
there you see LOINC, here is how the CHI endorsed vocabularies support the
answering of those questions, and then the HL7 is the third piece of our
recommendation in terms of messaging.

And what we found, and a lot of this information comes from the ASPE and
CMS report but it also was brought up in our workgroup that HL7 has the OBR and
OBX transactions which are for observations and they do support transmitting
both LOINC and SNOMED codes, or CHI endorsed codes, and it was also brought up
within the workgroup, specifically VA and SSA where they would like to start to
transmit this information in a human readable form, even that as a first step
would be a benefit. And that as things become codified through LOINC and CHI if
this recommendation moves forward that there becomes a machine readable version
of the HL7 CDA.

And just to go over those again at a summary level, here’s an example of
the OBR and the OBX transactions and how information is set. Here we see this
is a minimum dataset example, you see the questions, the ability to make
decisions is the question, and then you see impaired and a SNOMED code as an
answer. Again, just an example, an illustration of how HL7 supports this
domain.

Here is an HL7 CDA XML coded version of what the MDS would look like, and
again it just shows you how the XML coding and the coding system and the value
codes support both the LOINC as well as the CHI endorsed standards.

As I mentioned, and that’s a summary of the actual recommendations but as I
mentioned earlier all of these recommendations are bringing forth as
conditional. And one of the reasons the workgroup is bringing these forward as
conditional is a lot of this work has been done in a study environment and
there was a sense that there were three main needs to really bring this
recommendation out and fully endorsed. They include the federal government
creating a web based collaboration tool where these usefully related concepts
from CHI endorsed vocabularies be accessible so that if an agency is creating
an assessment form there would be a place to go to find where these usefully
related matches can be found and that works in conjunction with a knowledge
base that this workgroup is recommending within the UMLS and this would be
essentially a database or a knowledge base of all the LOINC-ified questions. So
again, if you’re creating or if a systems person is needing to automate an
assessment tool they could go to the UMLS, to this knowledge base, and find
what LOINC-ified codes have already been assigned and hopefully create an
environment where there is truly standards used across these assessment tools.

The third condition, and this is a condition that we are looking for NCVHS
to support this recommendation, and that would be that the NLM and the World
Health Organization complete their negotiations on bringing the ICF to be
incorporated into the UMLS. We also recognize that since most of the work has
been done in a pilot and a project environment that pilot testing of these
assessment forms would be necessary. We have this listed as both a recognized
need and you’ll also see it in one of our future considerations.

So some of the benefits that the workgroup has noticed, that by looking at
including ICF in the UMLS and mapping into SNOMED for needed codes that it
really does enhance the coverage of the disability and functioning domain. This
use of blended standards also between LOINC and CHI endorsed standards, and
using HL7 enhances this ability to exchange this information so this workgroup,
similar to allergy but different than some of the other CHI, really took a look
at the whole process so that need of having the exchange messaging standard be
incorporated into our recommendation.

And in addition I think it’s very important this idea of looking at LOINC
as the potential to address assessment questions as well as the content
standards that would be needed to answer, this would be a real benefit in
interoperability, I think the potential to create an interoperable environment
across federal and hopefully private institutions where this information would
be interoperable is one of the goals of this workgroup. And again it enables
the needed analysis of this that would not only address disability but
eventually could expand into other areas of assessments and surveys across the
health domains.

Future considerations, these are also listed in your report and as I
mentioned pilot testing of the implementation programs will be needed for the
assessments and this ability to link them with content standards, so the
workgroup recognizes that this is kind of in the forefront of this process,
that no one really has implemented this, so we are recognizing that pilot
testing will be needed.

There has also been a request that the federal government continue
participation in the clinical LOINC committee, this is obviously an extensive
amount of work, they’ve been extremely generous with our workgroup in looking
and piloting some of the work that is included in the report but there is
recognition of the need to continue participation.

We recognize that federal software will need to be modified to support
these standardizations.

And lastly and perhaps from our workgroup standpoint a more imminent need
is to conduct outreach and to educate people on what the recommendation is here
for disability and functioning domain as well as the assessment form process,
or automating the assessment form process. So the workgroup would also like
your endorsement is to take a use case forward to AHIC and to HITSP and
recognize this as a priority area as HITSP moves forward with its work.

And that’s it from a summary standpoint anyway and we have all of our
subject matter experts here or on the phone and I think would be willing to
answer any questions you may have.

MR. REYNOLDS: Okay, before I look around the room, Stan, since you’ve been
LOINC-ified probably for a lot longer than anybody sitting in this room I’m
going to let you be the first one to ask any questions that you might have.

DR. HUFF: I participated in this process and because of my involvement in
both HL7 and LOINC I think I need to recuse myself especially if there’s a vote
on this. Just allow me to say that I’m very supportive of this process, I
thought there was a very good information exchange and I think this has been a
great presentation of that work. And so I would just say that I’m very
supportive but officially I would have to abstain from a vote both because of
my involvement with HL7 and LOINC as potential conflicts of interest.

MR. REYNOLDS: And I’ve been amazed with the amount of collaboration and
breadth of work that CHI continues, you all continue to bring to us, it’s
pretty amazing, it’s pretty special actually what you’re doing and how you’re
trying to drive this forward. Simon?

DR. COHN: And Stan, maybe you can help answer some of these questions,
we’ll put you in an expert role for the moment though potentially Elizabeth and
Jennie and others can assist with this one.

Now first of all I’m very impressed, I mean what I’m seeing is, I mean
having been, when you came here originally which was disabilities domain and
we’re not exactly sure what it is or how to approach it, being sort of moving
much into the world and recognizing that there’s a reason that there are
questions and forms and all of this in terms of trying to deal with these
areas. So what I’m seeing is obviously a process where you’re taking forms,
identifying the questions on the forms, deconstructing them into various codes
and codification, and then basically reconstructing them as CDA documents via
HL7 that then could be sent out so people can yet fill out more forms or
produce more forms or whatever, so it’s sort of the form circle.

Now I guess some of us had hoped that maybe there’d be less forms in the
future of health care but you may be proving me wrong on that one, but I’ve
made other projections in the future that haven’t worked out either.

Now Stan, maybe you can help me about this one because some of it relates
to exactly how clinical LOINC works and all of this stuff and what we’re going
to get out of all of this. What I’ve seen is sort of rigorous analysis as well
as identification of elements and codification of all of those elements so we
will now have lots and lots of lines on the database of all sorts of questions
with LOINC codes related to forms.

Now the one thing I wasn’t sure about is knowing that, having at times been
someone who’s actually had to fill out forms, is that there’s tremendous
redundancy in the questionnaires typically, typically questions that are almost
alike but not quite alike except for just the small little word here or small
little word there or that the answers are instead of I can only carry ten
pounds it’s 12.5 pounds, or 15 pounds and all of that. And obviously at the end
of the day we would like to see simplification, administrative simplification,
maybe not administrative, maybe clinical simplification.

I guess I’m trying to figure out how this effort moves us in that direction
or doesn’t, I mean you certainly are classifying, you’re computerizing, you’re
codifying, I’m not sure that I’m hearing the simplification part.

DR. HUFF: It’s an excellent question, Simon. LOINC committee has the same
goal as you described, what we’re trying to do is only have one question —

DR. COHN: Stan, I think we lost you with others making comments on the
phone, say it again.

DR. HUFF: We have the same goal in the sense of getting to a single
question, the tricky part really is getting the people who use the questions to
look and see that when they’re making a new questionnaire in fact if there’s a
question that’s already they could reuse. We’re in a bit of a Catch-22, you
have forms that are already in use and either by regulation or by policy can’t
really be changed immediately and so we want to meet the need by creating LOINC
codes that correspond to what’s currently in use. But what we want to have
happen over time is an examination by the various agencies and by the user
groups, or the groups of people who are using these codes, examine it and say
could we in fact use the same question and isn’t it more important, could we
consolidate to a single set of answers that could be used. And so I think this
as an excellent first step in sort of making a category of things and being
able, having a consistent set of codes sort of allows that next level of
discussion, are there some of these that we should now deprecate, are there
some of these that we could consolidate, and I think that’s the next step in
the process.

MS. HARVELL: Can I add an additional comment? In addition to an additional
important first step working towards hopefully consolidation of similar
questions emerging over time as form developers go forward and trying to ask
the questions they need to ask and being able to review questions that have
already been encoded and captures in for example a LOINC repository. I think
another important first step here is this would hopefully enable analyses of
questions and answers that have been coded in LOINC and are captured in a LOINC
hierarchy. And the UMLS database that’s being developed would also support
analyses of codable content, both exact batches and usefully related matches
that haven’t been identified for the questions and the answers in these coded
assessment forms. And being able to analyze the terms that have been, the coded
terms that have been related to the questions and answers would support
analyses of and perhaps including analyses of the similarities of questions and
answers that could lead towards increasing comparability of questions and
answers on these assessment forms over time.

DR. COHN: Thank you for mentioning the word hierarchy because you actually
are bringing up an issue, and Stan I guess I need a little clarification on
this one. Does clinical LOINC have a hierarchy or is that another add-on that
needs to be done after the development of the codes?

DR. HUFF: LOINC does have hierarchies and it has hierarchies now and it has
an improving, we’re working on even more sophisticated representation of
hierarchies. So there are at least kinds of hierarchies that are supported now,
one is basically just the containment hierarchy so that for instance when
you’re creating forms you can represent basically the complete form then show
sections and then questions within sections so it’s just containment that you
would normally have structurally within the form. But then the other kind of
hierarchy that’s supported and actually this came from Steve Steindel and work
in microbiology, there are hierarchies that allow you to collect elements and
know for instance that all of these codes pertain to depression scales or all
these codes pertain to, in the case of what Steve Steindel was doing is that
these are codes that pertain to a particular organism as a causative agent. The
more sophisticated kind of hierarchies we’re working on are ones that would
allow specific use of the hierarchy for a clinical purpose, so for instance if
you wanted to say these set of codes for our purposes all roll up into or could
be used as evidence of existence of a given disease those are hierarchies that
actually are supported now too in the newest version of LOINC.

DR. COHN: Okay, thank you for that clarification.

MR. REYNOLDS: Marjorie, you had some comments, you’d sent some comments out
to the committee on this and some other things, both Jeff and I would love to
hear some comments and statements from you since you also I think enriched, at
least enriched our understanding of this through the emails.

MS. GREENBERG: Thank you. First I really do want to recognize Beth and
Jennie and Dr. Desi and the whole membership of the Disability Workgroup.
Although this has not occupied my entire career it feels like it has but when I
introduced myself and most of you from the Disability Workgroup weren’t here at
that time but when we went around as we do in the morning and introduced
ourselves the members all say whether they have any conflicts of interest and
as Stan said and we’re really pleased that he can put on his expert hat for
this because its invaluable, it’s incredible the amount of collaboration which
I think you’ve recognized that went on in all these CHI groups and this one was
certainly no exception, a lot of volunteer hours.

But when I introduced myself as executive secretary I said just for truth
in advertising I am a member of the Disability Workgroup and have been from its
inception as have Jennie and Sam and Dr. Desi and many others actually, we got
some new people as we went into this phase two but it has been an amazing
process. And I think that in many ways obviously our phase two was very much
enriched by the presentation that was made here on phase one with the
recommendation about LOINC-ification which I still think is an incredible word
but it seems to describe what happens when you take a survey and put it into
LOINC codes. I have that little LOINC pig that Clem gave me and I really should
have brought it to this meeting, either that or give it to my grandson, I’m not
quite sure the best use of it, but it says it all.

But I think I’ve been very proud to be part of this, I think in the first
phase John Huff wasn’t yet on my staff, he filled the position that Paul
Playcheck(?) held for many years as the ICF expert and when Paul retired John
joined us and so he’s been a critical member of phase two and particularly with
the mapping that he’s done with the ICF and the SNOMED. I might also mention
that obviously the national committee has been looking at ICF before the CHI
process with the report that came out of the subcommittee under Lisa Iezzoni on
populations so I think in many ways these recommendations were very responsive
to and the whole process was very responsive to work that’s been done by the
national committee so I want to thank the national committee for your support
in this realm of functioning and disability which I agree with Beth is
extremely important and under recognized I think in our clinical and
administrative standards process.

The communication that I had with you all came after we sent the report, we
had several conference calls preparing ourselves for this presentation. I think
what Beth did not mention is that this is actually the last domain to come
forward under the CHI process, I mean it’s sort of amazing. It was one of the
more difficult ones, I think all the ones in phase two, the multimedia, the
allergies, and now this disability were very complex domains and involved
tremendous collaboration. I really want to recognize Beth whose just been an
incredible facilitator because when you have that kind of collaboration you
need kind of a neutral party to do that, we didn’t have that in phase one as
much, one dedicated, everyone was dedicated but one person, I think its just
been amazing that all of these have come to a fruitful conclusion.

We were talking about the conditions and particularly how you all, if you
are supportive of this report, which we hope you are, how you might help us
address these conditions so that we can move from conditional to full
acceptance. And one of them I think has to do with the use case, the
encouragement of a use case. Right now there is not an AHIC or HITSP use case
that addresses the functioning and disability domains. As you know although the
use cases sound broad like EHR, consumer empowerment, and biosurveillance,
sounds like the whole ball of wax. Then within those topics though there are
very limited, well, limited but critical exchange of information. So even
diagnoses frankly have not been a significant component of those particular use
cases, exchanging information on health conditions, problem lists, etc., but
functioning and disability hasn’t even been on the radar screen or assessment
instruments.

So one thing that we feel would be very useful if this committee through
the recommendations of the subcommittee recommended really the department going
forward with a use case related to this domain, or these domains, disability,
functioning and assessment instruments. And we are in the process right now
within HITSP and AHIC of identifying new domains and new use cases so it’s an
ideal time to put this one, give this one some visibility. And this would of
course then encourage the pilot testing and all that that we’ve recommended.

The other, of course I’m unabashedly pleased that the recommendations
included recognizing the international classification of functioning,
disability of health as a CHI endorsed vocabulary but that as you’ll see the
condition for that is to include the ICF in SNOMED, in the UMLS, and then to do
the mappings with SNOMED CT. And I think Vivian probably also feels like she’s
been working on this her whole career because she has been a critical person in
these, she and Betsy Humphries of course, in these negotiations with WHO. We’ve
made a lot of progress recently in those negotiations but, this is one of my
passions but as you know when we included SNOMED CT in the UMLS, which really
opened up then the opportunity for its use and we included it as a category
four which means that people in the U.S. can access it from the UMLS at no
licensing fee and no cost, that was really to enable the whole use of SNOMED
pilot testing, development of SNOMED and coded electronic health records, all
of that. And it required a substantial financial commitment by the department
as it needed to because the people who maintain SNOMED CT needed to be
supported.

On a much smaller scale this is also true for the ICF, CAP(?) holds the
copyright currently for SNOMED CT, the WHO holds the copyright for ICD and ICF.
We have an agreement on the use of the U.S. use of ICD and there’s no licensing
fee for the use of ICD-10 for U.S. government purposes or U.S. purposes, we
have not yet negotiated such an agreement on ICF and that’s what we’re trying
to do to include ICF in the UMLS as a category four which means it would be
freely available to everybody who would want to use it and then the maps
between SNOMED CT and ICF would also be available and that does require a much
more modest licensing agreement between NLM and the WHO, what’s being discussed
is $50,000 dollars per year.

So we need to raise those funds and that was one of my emails that if you
support the recognition of ICF as a CHI endorsed vocabulary and its inclusion
in the UMLS and its mapping with SNOMED, etc., as part of this whole process
that you also encourage the department to identify funding for NLM to complete
its negotiations with WHO. And we feel that, as I speak as the head of the WHO
Collaborating Center for the Family of International Classification which
includes responsibility for ICD and ICF, that was a mouthful, but anyway I’m
pursuing possible avenues for raising those funds but I think that the support
of this committee would be very helpful in that regard.

Is there anything else, my colleagues, that we’ve discussed that we
particularly wanted the committee to endorse? Does that cover it?

MR. REYNOLDS: Thank you, Marjorie. Jeff, you had a question?

MR. BLAIR: Let me add to the fact that this is very impressive, obviously
very complex, had to integrate a number of different standards to be able to
come up with a useful and meaningful approach. I’m assuming that you probably
have dealt with these two questions but I’d just like to have a better
understanding of it. Number one, I suspect that a lot of patients that come in
that have, that would benefit by this classification have multiple
disabilities, not just one, so question number one is how do you handle
multiple disabilities, and question number two is kind of related to it
although it sounds like it’s a different one is what about conditional
situations with a disability, does that disability get better or worse during
the day, does it get better or worse related to exposure to allergens, does it
get better or worse due to other related conditions, so the second one is
conditional although I think that there may be a relationship between the
conditional situation and the fact that there are multiple disabilities. So
could you help me understand that better.

MS. HALLEY: Thank you, Jeff, I’m actually going to suggest that some of our
experts respond to that, we do have several clinical folks here as well as
Jennie Harvell whose worked very closely with some of that content. So Jennie,
would you like to start and Manny, if you had any thoughts from a clinical
perspective or any of the folks on the phone.

MS. HARVELL: If I’m understanding your question, in terms —

MR. BLAIR: There’s two, multiple disabilities, the second one is how does
it deal with variations in the disability due to different conditions.

MS. HARVELL: So in terms of these recommendations we’re recommending
LOINC-ifying questions and answers, identifying usefully related and exact
semantic matches, that’s part of the recommendations here so in terms of your
question I think in terms of identifying multiple disabilities you’d have to
articulate the question, does the person have a seizure disorder, does the
patient have cerebral palsy, so you would articulate the series of questions
that the user wants to have the disabilities, the disabilities of interest to
the user of the assessment information. And perhaps you’d have some scales
regarding the types of seizures, for example, the response, the answer list
would reflect the types of seizures in this particular example that you would
be, as the user, would be interested in understanding. And you’d represent the
questions and answers in LOINC so your questions would be coded in LOINC and
you’d associate your response set to each of those questions that have been
coded in LOINC. You would identify if there are any exact and usefully related
semantic matches for each of the questions about the disability status of the
patient and the exact and usefully related matches that correspond with the
answer set.

So that’s how I think in terms of our recommendation we’d identify multiple
disability conditions for particular patients. In terms of conditions that
might affect a patient’s disability status I think that is one of the benefits
that could accrue from this type of standardization because I think this type
of standardization would allow analyses across questions and answers in your
assessment form. So if for a particular disability you wanted to know the
impact of time of day or allergens or affective medications you would need to
be able to analyze the patient’s response, across populations perhaps, to
understand the relationship of the environmental or other influences on a
particular disability status.

And so to me the concept of identifying usefully related semantic matches
that are associated with the question and answers that are being asked is one
of the significant value added components of our recommendation. That’s a long
winded answer, I hope it goes towards answering your question at least in part.

MS. GREENBERG: Harry, I have a follow-up and I also wanted to mention, see
I’m trying to closer here, one of the advantages of my having a Blackberry is
that people who are trying to listen in on the internet will sometimes email me
and I just heard that, I mean that could be a negative, they’ll email me with
relevant information, I also get irrelevant information, and what I have heard
here from one of our listeners is that some speakers come in loud and clear and
others are very faint or not audible. My mic is apparently rather low and the
current discussions, this was sent a few minutes again, is inaudible. So I
don’t know that that was you, Jennie, but in any event let’s all, we all need
to really try to speak very loudly and distinctly into these microphones and
I’m also alerting our audio specialist there, if you heard me back there.

In relationship to your excellent questions, Jeff, I think, I agree with
everything that Jennie said and I wanted to make two other comments. One is
that one of the reasons that this functioning domain is so important to get
into the standardization process is that in fact a person can have, of course
they can have a number of functional limitations, but they can have a number of
health conditions diagnoses, but they may or may not have functional
limitations. And actually they may have the same functional limitation across
several diagnoses and you don’t know that when you only have the diagnosis. And
so that’s why it’s so important to be able to also collect information on
functioning which is often what takes a person to the health care environment
or setting is their functional problems rather than whatever their diagnosis or
even their classified disability is.

MR. BLAIR: So when you identify the functional disability that could lead
to a menu of multiple possible diagnoses.

MS. GREENBERG: Absolutely —

MR. BLAIR: Thank you, that’s really what I was, thank you very much.

MS. GREENBERG: And one diagnosis can lead to all sorts of levels of
functioning, higher or lower depending upon various factors and in addition to
co-morbidities one of the big factors as you pointed out is environmental
factors and that is one of the real strengths of the ICF which actually
includes in its classification structure a classification of environmental
factors which is one of the reasons we really want to get it included in the
UMLS because if I’m correct that’s an under covered area right now in the UMLS.
So we didn’t pay you to ask those questions but they were excellent ones.

DR. DESI: This is Dr. Desi, given an example I guess in a use case which
was where my orientation tends to be in Social Security and also in the private
sector as well insurance companies need to know what someone is capable of
doing, you may have seen the forms that say is claim able to do his work or any
other work, and that’s a question that needs to be answered and private
insurers don’t have good ways of collecting that data and being able to analyze
it other then by asking a physician to fill out the form.

If we look at someone who say has arthritis and a heart condition and
neither one of those diagnoses can limit that person’s ambulation to stay 100
feet it really doesn’t matter from the standpoint of assessing capability what
the diagnosis behind it is other than to substantiate the necessity for the
further restriction because if that condition restricts someone to 100 feet of
walking and his arthritis in his knees does the same thing it’s still 100 feet.
At the same time you’re saying that you having a relationship that can be one
to many or many to one, that’s kind of the clinical sense that you can have,
when you asked about multiple impairment, multiple impairment may mean one or
no restrictions or multiple restrictions, or more impairment may have multiple
restrictions, that goes back and forth.

In terms of conditions, things varying throughout the day or something like
that, for work or employability use case we generally look at the lowest common
denominator, taking into account that somebody’s asthma condition may wax and
wane over time, if we could put the restriction in not to expose them to
certain trigger, environmental triggers, but still recognizing that some parts
of the day may be better than others, any medical conditions that have this
diurnal variation, like I said from an employability standpoint we’re looking
at the lowest common denominator, what can this person do throughout that eight
hour day, 40 hour week, even if for 20 hours they can function at a higher
level we need to know what the lowest level of function is going to be. Does
that kind of broaden that area of the question for you?

MR. REYNOLDS: Okay, Jeff is shaking his head, thank you. Mike, you had a
question, then Jeff’s got one and then I’ve got a process question.

DR. FITZMAURICE: Yes, Harry, I too want to compliment Beth and Jennie, Dr.
Desi, and the whole workgroup for pulling together a lot of information and
then deciding more is needed and defining what more is needed truly is an
interoperability specification of standards and standards to be I would guess.
When I ask myself who would be the users Dr. Desi came up with some users as
well as Beth’s presentation, Social Security Administration, Medicare and
Medicaid, I would think workman’s compensation, health plans and many others.
Given the variety of uses I wonder if this is possible to go to AHIC rather
than to HITSP, that might address some concerns over is there government staff
availability to develop a use case, maybe more formal than as presented in this
document, and vet the same standards, is there a willingness to do that.

Is there funding for HITSP to manage this use case? I know that HITSP is
considering, or AHIC is considering giving at least two more use cases to ANSI,
I wonder if there is funding for ANSI to manage yet another use case like this
and I would hope there would be. Is there a matter of timing between the user
need, the Social Security and Medicare and Medicaid and so forth, the user need
and the interoperability specification process, is this good enough to go, but
is it bound too much by the narrowness of users who are basically federal
partners and not private users, is there a more urgent need of the federal
players for having some designation for this set of standards. So I guess does
it, what makes sense, sending it to AHIC, sending it to HITSP, what would get
it vetted and able to be used by the federal agencies more, does the workgroup
have a sense of that?

And I’ll have a second question but it will be shorter.

MS. HARVELL: I think those are really good questions and I think in this,
at least from my perspective this AHIC and HITSP process and the addition of
additional use cases through that process is one that I’m still learning and
trying to understand. And it was my understanding, perhaps incorrectly, that
use cases are advanced via AHIC to HITSP, that’s the only path that I know of,
maybe additional paths will emerge but that’s the only path that I’ve seen to
date.

In terms of the funding question, I think that’s a very good question and I
don’t know the answer to that.

In terms of private users I have a couple of answers about that. Certainly
these recommendations were developed with the federal government, the public
sector’s use cases in mind. But in addition to that, for example on many of the
federally required patient assessment instruments work has been done to
identify that the, because these forms have evolved over many, many years and
predated this big push, oftentimes predated this big push towards health IT
standardizations most of these assessments presently are not standardized. And
in many sectors of the health care industry the IT solutions that have emerged
in the private sector have emerged in response to these federally required
assessment forms. So if the federal government moves forward in standardizing,
deploying more standardized patient assessment instruments I think we’ll have a
positive impact on private sector vendor solutions in that they will become
more standardized.

I also think that this database that hopefully will emerge through the good
work of the National Library of Medicine to represent LOINC coded assessment
questions and answers and the usefully related and exact semantic matches would
be publicly available and could be used not only by the federal government but
also by the private sector as they hopefully go forward in deploying additional
IT applications that could link with these standardized assessment forms.

DR. FITZMAURICE: I guess my question was really as what would you have
NCVHS do, would you have them recommend to the Secretary that the Secretary
adopt the standards? Would you have them recommend that it go to AHIC for an
AHIC judgment about whether the federal government should use them, pilot test
them, and/or a recommendation that AHIC consider this as a use case. I’m trying
to see how not to let all this good work lie dormant for a while while we get
the resources to say yes we can have another use case to be considered through
the process that we have now. One way is to say let’s go and let’s start and
indeed one could go and start without a Secretary’s adoption of these as a CHI
standard but yet there’s a lot of advantage in having a formal blessing, a
blessing from NCVHS, a blessing from the Secretary, a blessing from AHIC, even
a blessing from HITSP.

And it’s the stage at which these are that some of these really do need to
be pilot tested that it might be a different category than say well we need a
use case and then specify the standards, it may be we have a federal set of use
cases and we need to pilot test them to see if this is a really good workable
solution. That’s something that AHIC could say is that we recommend these be
pilot tested for federal use. As we’re learning more and more about the process
and indeed probably giving a recommendation for how this might work, this might
lend itself to something a little bit different then we currently have.

I’m just not sure and I guess what you’re saying is that there are a lot of
different avenues that could be approach to further expand the applicability of
these standards and develop standards.

A second question, who would support the maintenance of LOINC codes as new
questions arise? And would these be category four codes that you could go to
the National Library of Medicine and say I want the disability codes that have
been LOINC-ified and the NLM would make them freely available if you sign a
license for use, or is it envisioned that you go to the LOINC incorporated and
get the LOINC codes directly from LOINC? Where do you go to get them?

Now I would like to see NLM be kind of the, not only the research arm that
looks at these but also the production arm that says if they’re useful, if
they’re adopted, then we make them available to everybody as long as the
resources exist to cover the cost of doing so. Any thoughts about that last
avenue?

MS. AULD: Once they’re LOINC-ified they go into LOINC and they are
automatically available at no charge either from the Regenstrief Institute or
through the UMLS, so there’s no copyright, no royalty charges associated with
that.

DR. FITZMAURICE: Fantastic, thank you, Vivian.

MR. REYNOLDS: Okay, Jeff and then I’ve got one process question.

MR. BLAIR: This another twofer and the central theme is overlapped with
other standards and standards processes. Could you help me understand a little
bit whether anybody has discussed the use of this, I don’t think of it as a
standard, I think of this as a set of capabilities to help define disabilities
and functional limitations. And as such is there an overlap with signs and
symptoms like the standards for signs and symptoms because I tend to think of
either depending on the functional limitations, does that start to flow over
into that area and was there discussion on that.

And the other piece of it which is also kind of related is the way Marjorie
was discussing it where you identify a functional limitation or disability and
then that can be traced back to one or more probable diagnoses, was there any
discussion of how this could enhance and strengthen the use of problem
knowledge couplers being used by DOD, I think that uses Medcin(?) for part of
that. So those areas of overlap, could you help me understand those a little
bit.

MS. HALLEY: Is Nancy Orvis on the line? She’s from DOD and she’s had some
input, she was hoping to attend but I know she’s had another —

MS. ORVIS: No, I’m here.

MS. HALLEY: Great, Nancy, any thoughts on Jeff’s comments?

MS. ORVIS: Repeat your comment, Jeff, sorry.

MR. BLAIR: Okay, the portion was it appears to me as if this whole
structure, this framework for functions and disabilities might be something
that might complement or fit in with the problem knowledge couplers being used
by DOD, did you see that or not?

MS. ORVIS: What we can do is I can make sure that that vendor who provides
the problem knowledge couplers to us, and I would agree that those, because
there’s some decision support trees, that this is what you would come up with I
think is what you’re kind of, yes, I think that’s a very good point and I think
that’s useful for many of the agencies looking at this, that this is really
good work done by everyone in detail and this should certainly help a lot of
vendors or people in decision support figure out how they could use this
information as soon as it gets mature in UMLS and SNOMED CT and the other
places we need to have that work done for this standard.

MR. BLAIR: Thank you. And the other piece was overlap with standards for
signs and symptoms.

MS. ORVIS: Well the signs and symptoms right now are in, we don’t have
symptoms on the CHI list I don’t believe, we have —

MS. HALLEY: Problem lists and diagnosis through SNOMED.

MS. ORVIS: We have SNOMED CT. Now certainly for DOD we use an internal
product that we could talk some about to say that you all do your cross linking
of your whole way internally for your signs and symptoms, we’re using the data
capture technology of Medcin to do a lot of signs and symptoms right now and
yes, this would be an interesting link, I guess we could talk with them about,
but I think that you’re making a good point, this is useful for a lot of us
whose software vendors are saying that what CHI and these kind of workgroups
are proposing is kind of a little, if you want to talk easily across a lot of
venues you can translate it to this stuff and you can use your own proprietary
application in a way, you continue to use your application and map, right now
many have mapped to ICD-9-CM or ICD-10 or anything else like that. But if you
want to talk across a larger higher and travel further if we can develop this
thing for disability, documentation, that will be much more useful in the long
run and saying that your application has to be in all these locations which we
know the market is not going to say that there’s one application everywhere. So
I think this is useful.

MR. REYNOLDS: Okay. The question I have is your recommendations are clear,
your conditions are clear, when I look at future considerations some of them
look like something you might want us to recommend, others look like the second
bullet says participate in a clinical LOINC committee, I’m not sure if that’s a
statement or I’m not sure if that’s a request for us to join or somebody, I
guess what I’d like to hear before I ask for an adjudication of this matter is
which of these do you think are actually part of your recommendation or part of
what you want us to maybe move forward with versus just kind of this is where
you’re going to go.

MS. HALLEY: Thank you, Harry, that’s a good question. We tried to in the
conditional recommendations list the very specific activities that would move
the recommendation from conditional to full. In the future considerations, I
appreciate you bringing that up because as a workgroup and I’d like to hear
from the members but I’ll summarize some of the discussions we had. Certainly
recommending the ICF to move forward with the negotiations with WHO moving into
the UMLS is an important piece and I believe that’s maybe in the future
considerations.

But the other piece of future considerations, as far as the endorsement
goes, the recognition of this standard being endorsed by the Secretary and
moving to AHIC I think is one of the pieces we would like to see endorsement or
recommendation from you and that I do recognize is in the future considerations
and not in the conditional, so we would very much like that. I think the three
conditions we recognize and then the endorsement of this by the Secretary as a
CHI endorsed standard and then having AHIC identify it as a potential
prioritized area for the next use case, they would be the pieces that I think
the workgroup has hoped that you would endorse.

MR. REYNOLDS: Jorge, you had a question?

DR. FERRER: Beth, I also want to comment, it was a tremendous amount of
work that was done here. As you know AHIC and the workgroups and the Secretary,
he’s very time driven and likes very quick wins, he reminds the workgroup every
time that he’s got so much time to do. Let’s say that you did become an AHIC
use case, what would you deliver in a year or in a shorter period of time?
Because it seems that you have a lot of tremendous amount of work that still
needs to happen but you also have to frame that in the political timeframe. So
what would you do?

MS. HALLEY: Well we actually did discuss this and we recognize particularly
a lot of the assessment pieces, there are steps that need to be taken,
including pilot testing, and whether or not that could happen in a HITSP
environment or in a federal project environment is a question. However, one of
the communications that came out from HITSP just this week was asking the
members to identify areas of prioritization to take to AHIC and we recognize
that as part, one of the things is a problem list as well as any expansions to
the current breakthroughs like the EHR, so we would like to see disability and
functioning content be included as a prioritized part of potentially a problem
list or an expansion of the EHR breakthroughs.

So in a short term I think that is doable and in perhaps in a longer term
timeframe, and I know HITSP because we participate in HITSP, may not be in the
next year breakthrough but its certainly with these conditions being met
certainly a lot of advantage of putting that piece, the assessment piece, the
LOINC-ification piece out so that it is broader than just the federal
government, that it is considered at the national level a real opportunity to
interoperate from the three million SSA claimants to the hundreds of thousands
of long term care reimbursements, etc., it’s just a wide area. But in the short
term and I’ll open up to any other comments we would certainly like to see
disability content be included in either the problem list area or an expansion
of the EHR use case.

MR. REYNOLDS: Before anybody else comments what I’d like to do, we’ve run
over quite a bit and I think it was good to do that because obviously this is
the first time you’ve come in with the breadth, kind of some new stuff for us I
think. But I guess to the committee, we’ve got, Stan has recused himself, we
have a quorum with Jeff you and I and Simon, and whether or not we want to take
a vote now or what we want to do and then if we were to recommend that we go
forward with this then the possibility of Marjorie and Stan working with Beth
to put together maybe a draft letter for us because I think this is going, the
reason for my question was a lot of stuff here and exactly which piece you take
forward and exactly what it says. I know personally I would want Stan and
Marjorie to be involved in making sure what that was because obviously the
subcommittee would see it again before we’d take it to the full committee but I
think this is going to take a little bit of crafting, we just can’t, in the
past we’d take your presentation and kind of go on, this one is going to take a
little crafting because there’s a wide breadth of lots of things and now you’re
bringing in AHIC and we’re bringing in some other things so this is a little
different game then we’ve tended to. So Simon —

DR. COHN: I was actually going to agree with you, I mean we certainly
support all this in principle and I think that’s, I think your next steps are
absolutely right —

MR. BLAIR: Did you need a motion? I’d like to move that we go forward with
the preparation of a letter of concurrence.

DR. COHN: Second.

MR. REYNOLDS: Okay, all those in favor? That’s unanimous, thank you, we
appreciate it, we’ll expect a draft from —

DR. HUFF: I abstain but I’m in favor.

MR. REYNOLDS: Yes, we had that point earlier. Okay with that we will
adjourn until 1:00, thank you to all of you that presented, thanks for your
good work and we’ll move forward.

[Whereupon at 12:00 p.m. the meeting was recessed, to reconvene at 1:05
p.m., the same afternoon, October 11, 2006.]

A F T E R N O O N  S E S S I O N [1:05 p.m.]

MR. REYNOLDS: Okay, our next item is an item near and dear to our heart,
the NPI implementation. So we have Jim Whicker and Gail Kocher, we appreciate
you joining us and look forward to your testimony so please begin.

Agenda Item: NPI Implementation – Issues and Concerns Update – Dr. Whicker

DR. WHICKER: All right, thank you. Mr. Chairman and members of the
subcommittee I’m Jim Whicker, chair-elect of the Workgroup for Electronic Data
Interchange. Thank you for the opportunity to speak with you today on behalf
WEDI regarding the National Provider Identifier. By way of information I also
serve as EDI Liaison for AAHAM, an organization of provider patient financial
services professionals and am currently employed as director of EDI with
Intermountain Healthcare in Salt Lake City.

Following my comments, Gail Kocher, who is also here representing WEDI,
will be providing information regarding the results of the WEDI readiness
survey and the NPI forum WEDI conducted in August.

WEDI presented a comprehensive report on NIP at the July NCVHS subcommittee
meeting. We will not attempt to cover all that information again today and have
attached a copy for your review and reference. Today we would like to focus our
comments on a few significant issues related to NPI.

On September 6th 2006 WEDI met with several individuals from CMS
including representatives from OESS. The agenda for the meeting was focused on
the NPI. Discussion was based on feedback received by WEDI during the NIP
hearing. Topics included the overall industry readiness, the NPI dissemination
notice, challenges with the current deadline and dual usage, and coordination
of outreach activities. It was a productive meeting and all topics covered in
that meeting are addressed in detail in the following discussion.

During the CMS meeting WEDI suggested that there be an industry summit for
health plans to discuss the options surrounding adoption and use of the NPI and
gauge from that sector of the industry as to what the state of the industry is.
CMS supported the concept and we will be proceeding with scheduling this summit
as soon as is feasible.

The following are issued WEDI would like to address as key topics to
consider in order to have a successful implement of NPI.

First, there appears to be a lack of understanding of basic NPI tenets.
There is a need to expand NPI outreach to both the payer and provider
community. The frequency and the urgency of messages is critical. WEDI is
committed to providing education to the industry. The support and presence of
CMS payer and regulatory staff provides the draw needed to get those who need
the information to the table. The messages that needs to be sent include,
first, NPI 101, there’s a need for basic information about NPI. For example,
frequent questions heard are can one NPI cross two tax ID numbers, or can a
physician have more than one number. We need to have the ability to push that
information closer to the provider. A CMS conference call was held on September
26th. Thousands of attendees dialed in and many more were unable to
participate as the number of phone lines available was exhausted. This shows
the huge need for that information. This type of format, with that many
participants, cannot deliver the messages that the individual provider office
or hospital appears to need.

What goes out must come in. This message needs to be delivered to help
payers and providers understand the relationship of the billing provider, and
under the 4010 transaction the pay to provider as well, and its relationship to
the payee on the 835. This ensures that the right provider NPI gets the right
payment for the right amount. There are Medicare crossover and coordination of
benefit implications when receivers are not capable of using the identifier,
whether legacy or NPI, that is crossed. The implementation guides were written
long before the NPI rule was written. The guide authors tried to anticipate the
needs and additional education about the intent of the transactions is needed
to head off problems down the road.

Many providers do not fully understand the usage or meaning of health care
provider taxonomy codes. With the recent mandate by Medicare to use them on
institutional claims there is a need for answers to questions about usage of
taxonomy and its relationship to NPI. Providers need to know how payers, mainly
Medicare, will use it to apply payment methodologies to help them determine
their enumeration strategy and other payers need to understand it for crossover
purposes.

It’s critical that more information be presented and supported from CMS in
its role as regulator. Information from CMS as a payer is received as such and
many in the industry question how or if that information can or should be
applied to other segments of the industry. One of the most common requests for
information centers around unresolved issues and questions around subparts.
Medicare has shared a significant amount of information about their data needs
but providers still do not understand the subpart issues well. Information to
help them make intelligent enumeration decisions is needed.

Number two, lack of NPI or NPPES dissemination. As a result of the NPI
hearing WEDI recommended that CMS issue the NPI dissemination notice and have
in operation a dissemination system by June 15, 2006. This date was agreed upon
by the participants in the hearing as the latest date dissemination should be
made available so as to not impact the successful implementation of NPI. As of
today we do not have a dissemination notice.

Access to NPPES data is part of the overall NPI dissemination process
needed to successfully achieve industry compliance. Generally speaking data can
be obtained from two main sources, the providers themselves and in the future
from the NPPES system.

The following are some of the most significant needs for accessing the
NPPES data.

Payers and clearinghouses need the NPI now in order to perform NPI
verification, confirming that an NPI they already received from a provider is
indeed the right NPI that belongs to and identifies that provider. For
population their large internal provider database. To build, establish and test
their internal crosswalks. To begin using the NPI in outgoing claim payment
transactions. And to begin using the NPPI in coordination of benefits with
other payers.

Among other things a health care provider needs the NPI of other providers
now in order to perform NPI validation of other providers such as rendering,
referring, ordering, and so on. To populate their internal databases of
external provider NPIs. To test the use of these external provider NPIs in
electronic transactions with payers.

Billing services and others need the NPI of providers to support their
clients’ needs for appropriately billing payers with those NPIs.

All will need to obtain data from NPPES frequently to make sure new NPI
data is obtained particularly in the coming months when the database will
ramp-up significantly with new applications coming in at a rate of several
thousand a week.

All parties need access to NPPES data to identify which of their trading
partner providers have NPIs and which do not so they can effectively target
their outreach efforts, sharing the NPIs for those who have them, applying for
NPIs for those who do not.

It is critical that the NPI dissemination policy be released immediately.
WEDI urges NCVHS to work with CMS to release the policy as quickly as possible.
Many organizations are considering data use agreements. We are hopeful that
meeting the needs of these requests does not detract from the issuance of the
dissemination policy.

Number three, delays in provider enumeration, both individual providers as
well as organization providers, are of great concern. Statistics from the NPPES
enumeration process show great strides in enrollment of providers. However the
real issue is not the number of providers enrolled but the number who have
shared that NPI with their payers and the payers who have implemented those
numbers into their systems. Gail Kocher will speak on this topic in more
detail.

Anecdotal information indicates that a statistically insignificant number
of transactions between trading partners have actually used NPI. Those
transactions sent with NPI are mostly claims. Few if any payment status or
eligibility transactions have been tested between payer and provider to
validate the implementation of NPI correctly. The critical issue is not who has
an NPI, it is how those that have them are using them.

Concerns have also been expressed about the downtime selected for
maintenance of the NPPES system. Downtimes have usually been during standard
business hours and often for a significant period of time such as entire
business days. In addition industry reports indicate paper applications take
four to six weeks and sometimes as long as nine weeks to process. As we move
closer to the critical May date this will become a much larger issue that may
impede provider enrollment.

NPI testing, successful testing of NPI transactions is at risk for many
reasons. Providers have experienced a significant amount of delay, mostly due
to their lack of understanding of the Type II concept and their being able to
make strategic decisions in how they wanted to enumerate for Type II NPIs.

Providers are still reporting that in many cases vendor supplied billing
systems still need to be modified to handle the NPI.

The industry is still waiting for a dissemination rule in order to finalize
the processes they intend to put into place to collect, validate, create
crosswalks, and so on.

Provider and payer IT resources are involved in other projects such as
changing to the new 1500 claim form and the UB04 claim form.

Payers are requesting proprietary methods of communicating NPI data for
crosswalk building rather than use the recommended methods suggested by WEDI
white papers. These documents had the intent to standardize the sharing of NPI
information from provider to payer until the NPPES system was operational. The
lack of usage of these recommended information exchange processes and the lack
of a functioning dissemination process is creating an administration burden on
both payers and providers. WEDI recommends that CMS, as NPI regulator, assist
in providing education and encouragement to utilize those tools and to expedite
the release of the dissemination policy.

These delays, as well as the number of trading partners that are just not
ready to test, brings the industry to a very short timeframe now to move
transactions back and forth to ensure smooth migration from legacy only
transactions to dual use NPI and legacy transactions and finally to full NPI
usage.

CMS as a large payer organization has had access to the NPPES data via a
data use agreement and seems to be ahead of the industry in its preparation.
They are also able to gather NPIs through enrollment forms providers are
required to complete. Another example is access that Medicare contractors have
to electronic file interchange or EFI organizations and information about NPIs
assigned through that process. These sources of information are not available
to other covered entities. Access to this information has provided an advantage
to CMS that others in the industry who desperately need the information do not
have.

It is important to note however that we have heard the concerns expressed
that Medicare does not have the kinds worked out of their NPI crosswalk. As
such providers face rejections of claims, even though both the NPI and the
legacy number on the claim would be correct.

Concerning covered entity readiness, data and anecdotal information that we
have access to tell us that not all payers and providers will be ready on May
23, 2007. Payers and providers need to consider what plans they need put in
place should a trading partner or vendor fail to be ready in time to test and
validate prior to or after May 23, 2007. They need to consider what post
implementation strategy is needed should they find out that claims and payments
are not being processed as expected. Gail will review the results of the
readiness survey and discuss some statistics that we believe represent actual
usage of NPI in transactions.

The WEDI hearing and subsequent WEDI letter to Secretary Leavitt
recommended the following.

Recommendation, that CMS allows the dual reporting of NPIs and legacy IDs
after the deadline of May 23, 2007, for a minimum of six months. The need for
more than six months should be determined through a status check of the
industry readiness in November 2006. Failure to allow such an extension would
exacerbate and prolong the period of non-compliance.

This recommended six months periods is a transitional period where NPI is
required in all transactions but legacy IDs are allow concurrently as secondary
IDs. This should not be perceived by the industry as a delay in the NPI
implementation by May 23, 2007. Providers must still have completed their NPI
enumeration by the deadline. Systems remediation must have also been completed.
Health plans must still be capable of processing NPI transactions. Extending
the dual use period is only intended to allow trading partners to address NPI
crosswalk, mapping and reimbursement issues.

As of this date the WEDI position on this recommended six month dual usage
transitional period extension has not changed. WEDI is in the process of
conducting a status check of the industry for November to determine if there is
a need to recommend an extension beyond six months. We believe that the signs
in the industry are showing us that many entities have a significant amount of
work to complete to ensure claims and payments continuing flowing
electronically after May 23, 2007. Many state Medicare operations have already
informed providers that they will not make the May 2007 deadline. Any provider
that submits claims to those organizations will need to have the dual
capability long after the May 2007 deadline in order to keep claims and
payments flowing.

I would now like to turn the time over to Gail Kocher. This will conclude
my prepared remarks.

Agenda Item: NPI Implementation – Issues and Concerns
Update – Ms. Kocher

MS. KOCHER: Thank you, Jim. Mr. Chairman and Members of the subcommittee, I
am Gail Kocher testifying on behalf of WEDI. I am a co-chair of WEDI’s National
Provider Identifier Outreach Initiative, NPIOI, and the NPI subject matter
expert liaison from ASC X12 to WEDI. For information purposes I am also a
technical business analyst in the HIPAA Knowledge Center for Highmark, Inc. I
would like to thank you for the opportunity to present testimony regarding the
National Provider Identifier, or NPI.

Industry readiness survey conducted May 2006. WEDI NPIOI conducted an
industry readiness survey in May 2006. I will address the highlights of the
results many of which identified the need for additional data collection this
year.

This survey asked whether respondents had established an overall NPI
project plan. Only a small percentage of providers had established or were in
the process of establishing a plan, nine percent, 80 percent of payers had or
were in the process and 58 percent of providers indicated they had no plan in
place. WEDI NPIOI continues to pursue education and outreach, often in
conjunction with CMS, in an effort to bring full awareness of NPI to the
provider community as well as to other stakeholders.

Survey participants were also asked where they were in their project. At
approximately one year prior to the mandate date a very small percentage of the
industry had implemented. Many providers and payers were still in early phases
of the project process or could not even provide a response to the question.
The state Medicaids met in late September and information coming out of that
meeting indicated that approximately one third of the Medicaids will absolutely
not be ready on May 23, 2007 for NPI only. Another third are planning to be
ready but reports are that many of those will not meet the deadline either. If
the industry reaches a point where some have implemented to NPI only and others
cannot do business without a legacy ID additional impacts will result
especially in the coordination of benefits transaction environment. If
secondary payers receive only NPI on crossover claim files and they cannot
process NPI only the claims process will fail. Providers’ account receivables
will likely suffer. At that point providers are faced with either sending
secondary claims on their own, often resulting in additional costs when using
clearinghouses, or they will bill patients and expect the health care consumer
to pursue reimbursement from the other payer.

The ability to conduct NPI only claims is a significant measure of industry
readiness. Only one quarter of payers and providers will be ready for NPI only
claims prior to the first quarter of 2007. Many of the payers that can receive
NPI only claims late in 2006 are requesting that providers continue to send
legacy IDs even when they are NPI only ready. Both of these occurrences limit
the testing time available to all stakeholders. The available time to react to
any issues identified when entities actually move to NPI only becomes very
limited.

Survey participants were also questioned on the guidance CMS and WEDI have
made available to date. We found that this guidance is not meeting the
expectations of the industry. There are still many unanswered questions in the
minds of the industry. Continued education and outreach needs to be provided
jointly by CMS and WEDI. Key topics that are missing continue to be subparts
and dissemination.

Let me now discuss some questions that are specific to the provider
community. Providers were asked whether they will subpart their organization
and whether they are sending NPIs on claims transactions as of May 2006. The
results clearly show that the industry is still waiting for additional
clarification and information. Many have not decided or do not understand
enough to determine their enumeration schema, which undoubtedly impacts when
they will begin using their NPIs in the transactions. The use of NPIs in
transactions is also a factor of providers having information available from
all their payers as to their payer’s timelines so they can incorporate this
information in their own planning and implementations.

Let me now discuss questions that are specific to payers and
clearinghouses, who are the primary receivers of the HIPAA transactions in
which the NPI will be mandated. Some in the industry are taking a crosswalk
approach that can be attributed to many factors such as atypical providers will
not be issued NPIs or a national ID so legacy enumerations will still need to
be in place. The costs associated with converting legacy systems to NPI only
were significant, estimates were heard of approximately $20 million for large
health plans, due to the complexity and logic behind health plan legacy
enumeration identifying things such as contracting and pricing arrangements.

Many are still working out data collection strategies, especially since the
data dissemination notice is as yet unpublished. The low percentage for NPPES
as a collection method we believe is due to lack of dissemination information
which has forced many to forge ahead and prepare alternatives. Lack of data
dissemination likely plays a role as well with respect to provider enrollment
requirements. Payers and clearinghouses are still undetermined as to the best
approach of obtaining provider NPIs.

Again, the uncertainty of whether entities will be able to access NPPES to
collect NPIs and/or conduct primary source verification has delayed decision
making on the approach to what validation or verification is needed in an
operational environment.

At the time of the survey neither of the paper claims forms that undergo
OMB approval had been approved and we believe that the industry was waiting for
confirmation that the forms would be available with the time allowance that is
required to implement the paper forms with NPI. While OMB approval is not
required for any other payer than Medicare many payers in the industry follow
Medicare’s lead in terms of implementation so as to limit the differences in
requirements placed on the provider community.

Vendors are integral to NPI implementation and there were some questions
specific to vendors. There is still the possibility of over half of the direct
billers having to pay to obtain the needed upgrades for NPI. Payment
requirements may impact when clients obtain their upgrades due to availability
of funds, especially if they did not plan for a cost to their upgrade. Such
costs may cause delays that impact testing by creasing the available time.
Providers that are required to use NPIs on paper claims by a payer may be
impacted if their practice management system is not upgraded by the vendor, or
they do not know until late in the timeframe before May 23, 2007, whether it
will be upgraded or not.

There are several transaction issues that continue to cause concern to the
industry, one of which is the 835 claim payment transaction. Providers need to
understand what they can expect to receive in order to coordinate with their
vendors and clearinghouses when applicable but 61 percent of payers did not
respond to whether or not they will return NPIs or legacy IDs on the 835.

There has been much discussion recently on the 835 and how it is to be
implemented. ASC X12 is currently processing some HIPAA interpretations through
their portal that address this issue. As outlined during a session at the
recent X12 trimester meeting the intent is to return the billing provider NPI
in the payee segment where the tax identification number is returned today. The
TIN then moves to the payee additional identification segment with in the payee
loop and the legacy ID can still be sent in a second iteration of the REF
segment through May 23, 2007. Claims may be bulked to a mutually agreed upon
provider entity NPI but the NPIs submitted on the claims must still be returned
in the 835 in the provider summary information segment.

Adding to the confusion is the Medicare implementation plan as identified
in Change Request 5081 which states that as of October 2, 2006, Medicare will
start sending NPIs on the 835. The NPI will not be sent at the payee level,
however, it will be sent only at the claim or service level which is intended
to identify the rendering provider.

Providers need to understand what to expect due to the many impacts they
face. Medicare’s approach leaves providers and vendors with no ability to test
prior to May 23, 2007, for the claim payment transaction they will receive from
Medicare. For applications that look to the provider ID in the payee segment
for posting or reporting there is not ability to test that the returned 835 can
be matched up to their claims data since the NPI is being returned in a
different location than will occur after the mandated date. Providers depend on
remittance data for claim resolution and/or payment. There are many concerns
over how the data will be returned and bundled. These concerns stem from the
availability of data elements used on an inbound 837 to crosswalk which are not
available on the 835. Provider account receivables changing drastically due to
unexpected claim payment data or last minute changes without testing
capabilities is of significant concern to the industry. The high percentage of
no responses to this question highlights that this is an issue that needs to be
addressed from an educational perspective quickly so that payers will be able
to implement with their trading partners as soon as possible rather than
waiting until May 23, 2007.

Finally let me offer some general summary conclusions and observations. The
survey included strong provider participation with 69 percent of the total
respondents, there were 635. Payers were the next contingent at 21 percent with
clearinghouses and vendors making up the remaining ten percent. The respondents
did not answer many of the questions leading to the conclusion that a lot of
organizations were not far enough along in their processes to even provide an
answer. There were, however, enough responses within each question to conduct
an analysis. Additional surveys are needed to gauge industry readiness going
forward and WEDI NPIOI released a second survey the first week of October. The
survey questions were streamlined for ease of response. Additional content
questions and clarification of content in some existing questions were
undertaken as well.

Now I’ll talk about the WEDI NPIOI August 2006 forum. We held our
4th industry forum in August of this year. Given the attendance of
185 stakeholders it was evident that NPI is still a very significant issue for
the industry. The open forum style sessions brought together providers, payers,
clearinghouses/billing services, and practice management vendors to discuss a
variety of NPI related topics, for example case studies of enumeration
including electronic file interchange or EFI, NPI cross-walking, and the use of
taxonomy codes for subparts. We observed that the industry’s transition is
occurring at a disparate rate. Earlier forums had audience bases that were on a
more equal knowledge level. This forum found some in the audience brand new to
NPI and others at end-stage implementation points. This points to the continued
need for education at the 101 level while also working with those farther along
to educate based on lessons learned.

WEDI NPIOI is continuing to work to educate the diverse audience by
developing a NPI 101 audiocast in advance of the November fall conference,
we’re also working on developing a 101 toolkit. We are also conducting a series
of early adopters audiocasts from various stakeholder perspectives to make
available their lessons learned for others a step or two behind in their
implementations.

There’s also some mismatches between the NPPES enumeration statistics to
actual provider reporting and transactional usage with payers. As of October 4,
2006, a total of 1,234,910 NPIs were issues. The statistics only break down
Type I individual versus Type II organizational. Health plans often track
providers by provider type and specialty so the high level breakout of data is
difficult to compare to health plan data to get a true picture of where the
industry is with respect to enumeration. Industry planning, transition and
implementation would be better served with weekly reports of the number of NPIs
issues. Reports that break out the numbers by NPI type, I and II, and provider
type, for example MD, DO, DMD, and provider taxonomy would facilitate
stakeholder analysis of their status of NPI information exchange and data
collection versus NPIs issued.

CMS estimates were that approximately 2.5 million providers would need NPIs
but there is concern that the estimate did not account for subpart enumeration
or ancillary and allied health care provider types. For example the following
are NPIs issues to Pennsylvania providers, Type I, there was a little over
50,000 and Type II were over 14,000, for a total of 64,737. In contrast as of
October 2, 2006, based on providers on record the following numbers of NPIs
were actually reported to Highmark. For Type I we only had 38 percent reported
and Type II 12 percent for a total of 26 percent of our provider universe on
record. For information Highmark is the largest health insurer in Pennsylvania
based on membership and one of the largest health insurers in the United
States.

The actual usage of NPIs in transaction is significantly less than the
number issued. From August 29, 2006 through September 29, 2006, we received a
little over five million claims electronically, 837 institutional and
professional only, of which 114,000 claims had an NPI in at least one of the
provider loops.

Only two percent, a little over two percent of the NPI claims had NPIs on
them on average. Did have to make note that the graphs did have to be adjusted
to double axes because otherwise the NPIs, claims with NPI numbers would have
been a negligible line across the bottom of the graph.

Providers are still uncertain as to what they need to do with their NPIs
once they have obtained them. Many believe that their health plans will have
access to NPPES as was available for UPINs. Concern over requests to provide
copies of NPPES notification as audit trail documentation that an NPI was
issued by NPPES exist today. Mixed messages from payers about whether or not to
report across the industry is also confusing to providers. Providers are
hearing that carriers and FIs do not need them to report as they have access to
NPPES. Providers extrapolate FI/Carrier NPPES access to their other payers as
well. Other payers continue to request NPIs from providers in a variety of
formats and documentation requirements.

Finally there is an 837 inbound claim transaction concern. As of October 2,
2006, claims are being rejected by Medicare when submitted with NPI only, or
NPI and Medicare legacy ID where the NPI is not found on the Medicare provider
identifier crosswalk. This applies to billing, pay-to, and rendering providers
and secondary provider IDs when a Medicare legacy provider ID is sent. Some
other payers have taken the same approach and other payers have taken the
approach to attempt to translate the NPI to legacy ID but if it does not match
the legacy ID submitted on the claim continue processing with the legacy ID.
These dual strategy differences ultimately impact how and when providers
implement based upon their own system capabilities.

This concludes my prepared remarks. I would like to thank the subcommittee
for the opportunity to present this testimony. Jim and I would be pleased to
respond to any questions or points of clarification that you might have.

MR. REYNOLDS: Thank you very much, very thoughtful industry wide approach
so we’re anxious to ask you some questions. Members of the committee? Nobody’s
hand is up yet, I’ll start.

Tell me a little more about the dissemination rule, you mentioned it a
number of times and what exactly is that, you say it needs to be out, what
exactly is it and what is it going to do to change these numbers that you’ve
already listed here?

DR. WHICKER: From my perspective speaking purely as a provider I see today,
there’s a requirement for example with Medicare B that any time I send in a
professional claim to Medicare I have to identify the referring provider. I
have to identify who it is that sent that patient to our office for services.
Today we have access to the UPIN registry where we can log in, put in the
physician name, city, state, some identifying information and get the UPIN
number so at least I have an identifier to submit on the claim. If I don’t have
access to something like that to get the NPI number the only other option that
I have is their federal tax ID number or their Social Security number, but if I
can’t get an NPI from a physician I’m not going to get their Social Security or
their tax ID, if I get the NPI and have it. So that’s the big concern from a
provider perspective is being able to obtain those NPI numbers from a source
that I can use to submit my claims, otherwise I can’t send a claim in.

MR. REYNOLDS: So this is not just an implementation issue, it’s an ongoing
issue, to have that capability available.

DR. WHICKER: Correct.

MS. KOCHER: And I would add to that that as a payer I want to be able to
verify with the primary source that issued an identifier that that is an indeed
a number that was issued first of all, and it was issued to the person that’s
telling me that it belongs to them, just the same as I would verify DEA
numbers, I would verify a state license, because anyone could create a number
that meets the check digit verification so they could get in through my base
validation but I want to be able to know that NPPES actually issued that number
and to whom it was issued.

MS. TRUDEL: If I could add to that from the HHS perspective, the final NPI
rule in the discussion about data dissemination which is what data are we going
to share out of the NPPES database and how and under what circumstances the
final rule so that that would be addressed in a data dissemination notice to be
published later in the federal register. So what this data dissemination notice
is is the first indicator that both providers, plans, clearinghouses, all
covered entities will have as to how much data we propose to share, under what
circumstances and by what mechanisms. And plans obviously are concerned about
it from the perspective of building their crosswalks, providers are concerned
about it as Jim mentioned from the perspective of being able to identify NPIs
from other providers that they need to submit claims. So the question really is
how much data are people going to get, have access to, and how will they have
access to it over time. The data dissemination notice hasn’t been published,
it’s still in the review process, and believe me we understand how critical it
is to have it out there, we’re moving as quickly as we can to get it published.
And I think that pretty much covers it.

MR. REYNOLDS: My next question, on page six of your testimony you talk
about the recommendation about the six month extension. I was a little
surprised in the first paragraph of that where it says that the decision would
be in November of 2006.

DR. WHICKER: When we held the WEDI hearing I believe it was in May of last
year, it was April of this year, let me get my dates correct here, at that
point we felt like the dissemination notice needed to be out for the purposes
that we discussed so that health plans and clearinghouses and providers could
build methodologies to access that data based on how it was going to be
disseminated and so on and that at that point considering where the industry
was at that point we recommended from the WEDI board that there be at that time
a six month extension to the dual use, and the November date that I’m referring
to here is a status check that we agreed to do to say let’s look in November as
we are further down the line and say where have we gotten to, have we moved
further than we thought, are we closer to implementation, are things moving
quicker than we had anticipated, or is it worse than we thought, are we a lot
further away from being able to have a fully functioning full NPI system in the
industry.

So Gail mentioned a survey that went out the first week of October, it’s
actually out in the industry right now receiving comment, is to find out, do
that gauge right now to say do we need to recommend from at least a WEDI
perspective that we extend beyond that six month recommendation period.

MR. REYNOLDS: So basically in November, right now if left as it is in
November the decision would be made that it would take 13 more months past
November to be done, six months past May but if you start in November when
you’re making the decision it’s still going to take another 13 months for
everybody to implement.

DR. WHICKER: What we’re looking at doing is in November getting the results
back and making a decision as a WEDI board whether we would want to recommend
that we extend beyond six months for the dual use period —

MR. REYNOLDS: Yeah, but what I’m saying is that’s even longer than 13
months, so deciding in November of ’06, you’re supposed to be done in May of
’07, it’s extended to January of ’08 and it may go further, that’s another 13
months. It’s six months above the schedule or more, I’m just, again, everybody
has been at this.

My next question is you have an underlined, you say the NPI is required in
the next paragraph and then you underline some things. So providers must still
have completed their NPI enumeration by the deadline, so what is the governance
of that, what is your recommendation on that, what is, does somebody hurt at
that point or what do we do?

DR. WHICKER: If I were to put in my words what I would interpret that
recommendation is that what we’re saying is that we don’t want anyone to think
they cannot get their NPI and have it ready and up and running by May
23rd of 2007, that in no way are we recommending that we delay
getting your NPI and having it in production on May 23rd. What we’re
recommending is, for example I’m hearing reports that if depending on who the
payer is that I’m working with and the status of their crosswalk capability if
my NPI and my legacy number are not in their crosswalk database even though
both may be valid the transaction could reject and my claim could come back. Or
I could have the NPI in there but the payer may not have all of their back end
systems for applying contractual arrangements, they may not be applying the
appropriate contract payment of that claim and so on May 24th I
start getting payments in under NPI that may not be correct. Or the claim will
hit the payer system and because they don’t recognize the NPI but they’re going
to have to pend the claim and start doing some manual processing and working of
the claim.

So our recommendation is to say let’s go six months beyond May
23rd and allow the provider to continue sending both legacy and NPI
so that if a payer has an issue with processing the claim they’ve at least got
that legacy number as a fallback to go back and look at their crosswalk and
make sure that they’re processing the claim appropriately so the provider is
not hurt by having a claim reject or pend and not be able to be processed.

MR. REYNOLDS: Okay, but looking at your words in May, I agree with what you
just said, but in May if the NPI is not, if somebody hasn’t gotten an NPI what
would you expect to happen?

DR. WHICKER: Right now what WEDI’s position has been if they don’t have
their NPI May 23rd the claim should be rejected because it’s a
requirement by law that have an NPI on their claim on May 23rd.

MR. REYNOLDS: Rejected and turned to paper? Which is what would happen.

DR. WHICKER: That’s potentially —

MR. REYNOLDS: I’m asking, is that WEDI’s recommendation that it be rejected
and turned to paper?

DR. WHICKER: I wouldn’t say that that’s the recommendation that we’ve made,
the recommendation is that the provider has to have an NPI and an electronic
transaction on May 23rd.

MR. REYNOLDS: And you would expect who to enforce that?

DR. WHICKER: I would believe that follows OESS to enforce.

MR. REYNOLDS: Again, I’m trying to completely understand your
recommendation.

DR. WHICKER: What we’re really trying to do, I mean to be honest with you
we’re trying not to have provides default to paper and trying to get the word
out, get your NPI, get it in your transaction, and if you’re concerned that
your trading partner isn’t ready to go they’ll at least have the same number
that they were able to process claims on the 22nd.

MR. REYNOLDS: Now you mentioned providers, what parameters do you put on
payers and vendors, May is May and so all the providers in the world can be
ready, if a vendor is not ready, if a payer is not ready, you got the same
situation but you don’t mention anything in here on any kind of a jurisdiction
over any of them.

DR. WHICKER: I don’t think that we necessarily addressed, those are
separate entities. What we were saying is that for the industry there’s a May
23rd deadline to have NPI and that payers, providers and
clearinghouses have to be ready to have the NPI and it would be required to be
in their transactions on May 23rd, 2007, and that all three
entities, providers, clearinghouses and payers, based on the recommendation
would be allowed to continue sending the dual use strategy types of
transactions for six months beyond that May 23rd date so that I mean
as we discussed in our last paragraph I mentioned there’s already several state
Medicaids who have told me as a provider sorry, we’re not going to meet the May
23rd date so I’ve got to be able to send those and my clearinghouse
is going to have to be able to process those without rejecting my claims or I
will be forced to paper.

MS. KOCHER: Can I just add to that, to your question, the way the final
rule is structured right now the providers have until May 22nd to
get their NPI and everybody has until May 22nd to implement NPI only
and so both of those things, if a provider waits until May 22nd they
have no ability to do any dual testing. We can educate and educate and educate
and encourage them but there are going to be those that don’t do that until May
22nd and so if they would have the ability to do dual for a little
longer timeframe we feel that will be a better implementation and transition
for the industry. So there’s no intent to hold anything else up, just allow
dual capability.

MR. REYNOLDS: The reason we had asked this question earlier this morning a
little bit on the SDOs as far as us speeding it up, you get to an end date and
then we say everybody has to be at a certain point and what kind of
jurisdictions over that and you look at 5010 we’ll be talking the same thing
and then ICD-10 we’ll be talking the same thing, so trying to get a sense as
you as obviously a significant entity in grouping people up for these kinds of
things, that’s why I was pushing on this a little harder to really get a sense
of what does that mean May 23rd and if somebody says I’m not is that
really a big deal.

DR. WHICKER: I’m not sure if this will answer your question per se but one
of the things that as a provider that I’m concerned as I am testing with my NPI
and working through this whole process is it takes me back to the 2001/2002
timeframe when we were in the middle of remediating our systems and developing
the X12 transactions and starting to send 837s and receive 835s and the testing
that had to happen at that period of time. And in some ways that was easier for
me because I was validating a new format of claim that had the same data
content from a billing data content point of view, maybe it was a little
different format and a few qualifiers were different and so on.

But today with the NPI change it’s actually going to potentially affect my
reimbursement, that if there’s an issue with the provider number that the payer
is going to be looking at and reimbursing me as a provider and it’s incorrect
the consequences are substantially greater. Whereas under the original
implementation of these transactions I wasn’t changing provider numbers,
Medicare knew me as who I was and Blue Cross knew me with the same numbers and
now I’m doing a wholesale change of all those identifiers that for years and
years and years every payer has been able to use to identify me.

One of the fundamental issues about the NPI if I understand it correctly
it’s a national provider identifier so that anyone who looks at data that’s
passing through the health care industry they will know who the provider was
that performed that service and traditionally provider numbers have been payer
specific, payer based identifiers that do identify the provider but also
identify the provider in the contract. And so one of my facilities could have
multiple different provider numbers with a payer depending on the type of
service that provider was billing. And one thing that hasn’t I think filtered
down to a lot of people is to understand that this NPI is not a contract
number, it doesn’t identify the contract that the provider has with the payer,
it identifies the provider, and that’s where some of the rub that I’m seeing,
some of the testing and the delay in how providers and payers are trying to
work through these issues.

MR. REYNOLDS: Michael?

DR. FITZMAURICE: Thank you for the testimony, we haven’t heard it laid out
this precisely and with what the specific issues are so I really appreciate you
coming on board and letting us know.

I think you just answered my first question which was in the past health
plans have used the provider number to denote which payment schedule to use for
the provider for payment, the hospital ED or physician’s office, other clinic,
here’s the provider number that ties them on the contract and here’s a payment
schedule. So I would ask you has that problem been solved but I think you just
told me it hasn’t been solved and they don’t seem to be aware that they’re
going to have to make that change, that is very scary.

And also you’re talking about one third of the Medicaid programs aren’t
going to be ready, I think they use it as much as anybody to denote how much to
pay, that’s double scary, and it’s not yet Halloween. What’s the way out of it,
more education? Scare everybody so that they realize this is a read deadline?
And any leeway that might been provided hasn’t been decided upon yet, there’s
going to be a horrendous cash shortage on the providers, they may get the float
but the providers are going to be very unhappy.

DR. WHICKER: I would agree with that and I’m not sure exactly what’s going
to wake everyone up, I think it’s going to be May 24th, 2007, when
providers start to see claims that haven’t taken the time to do their testing,
to work with their payers and communicate.

Just speaking from personal experience within Intermountain Healthcare it
took us quite a while to sit back and determine what our enumeration strategy
was going to be and we took information that we received at some of the WEDI
conference where Pat Payton for example did a presentation last May and she was
very clear and I wished every payer and provider in the country could see it
but it basically said payers need to look at more than just the NPI on the
claim to determine their payment methodologies, there’s other data out there
that they’re going to need to look at to figure out how to pay and process the
claim.

And so as we’ve sat back and met with payers sometimes we have some ah ha’s
on our and the payers are having the same ah ha’s where they’re figuring out
wait a minute, I’m not going to get the data that I thought I was going to get
in the past and I’m going to have to remediate my system to be able to process
and pay claims for this provider.

DR. FITZMAURICE: Let me ask another question that based upon the experience
that we’ve had with the HIPAA claims transactions and the getting everybody on
board, my question really was can you tell me now who is further along,
providers or payers or clearinghouses or vendors? Everybody has to be there in
order for the system to work but in the past the health plans were ready and
the providers, providers were ready and the health plans seemed to be ready, we
heard both sides of that. This may be a little bit early to give any judgments
but can you give us a shadow of who needs to be prodded maybe a little bit more
and are the vendors serving the providers and the payers well in this?

MS. KOCHER: I think from the data that we received back in the May
readiness survey the payers were farthest, were overall farthest along in their
plan and their project phases and actually vendors were sort of, vendors were
farther along, providers were split, there were a significant number of
providers that 35 percent just couldn’t even answer the question. I talked to
vendors, I deal directly with some of the vendors, I also deal with providers,
and it really gets down to how in tune they are, how important they think it is
to their system. There’s so many smaller vendors out there that I think to some
extent that is an impediment because they’re all doing it on their own and it’s
the vendors that are participating and following the national education and
trying to work collectively in some of the organizations like AFACT and others
and HIMSS that I think they’re the ones that are farther along, it’s those mom
and pop shops that ultimately are impacting the single or like office
providers, rural community providers. And they’re the ones that we’re
struggling to figure out how can we get to them because they are the ones that
may not have internet connection or don’t get the notice until a week after the
presentation was given. And I think that’s where the target audience needs to
be is those individual vendors, providers, who aren’t getting the message, or
aren’t acting.

DR. WHICKER: And I would probably echo that as well. I’ve done
presentations and spoke about NPI to several provider groups over the last few
months and every time I ask how many of you have actually sent a transaction
with an NPI on it and I think I probably had in the hundreds of people that
I’ve spoken with maybe three or four that have actually raised their hand and
said yes, we’ve sent a claim transaction with an NPI. But if I ask them how
many have their NPI almost every hand in the room goes up. So they’ve got their
NPIs, they haven’t sent them, and so I say why have you not submitted them,
they generally blame it on their vendors.

Now in the defense of the vendors, I had a provider approach me at a
meeting a couple of weeks ago who said our vendor is not able to handle the NPI
yet and they haven’t released it. And I said who’s your vendor and without
mentioning who they are it’s someone that I’m quite familiar with because we
happen to use them as well and I know they’re ready because we’re actually
starting to create our transactions and be ready to test. So there’s even been
vendor and provider there’s some miscommunications in some instances so I don’t
know how pervasive that is.

But I would agree with Gail payers tend to be more ready, I think the
larger providers and larger health care organizations that have the resources
to have someone who’s keeping on top of NPI, who’s attending the WEDI and the
X12 meetings, they know what’s going on, they know what questions, it’s the one
who are dialing in, and I don’t in any way mean that the conference call that
we had with CMS the other day was not of any value but just the sheer number of
providers who are getting on and asking questions that, they’re looking for
somebody to validate the decisions that they’re making and it’s just hard to do
that in a one and a half hour conference call when there’s several thousand
people wanting to ask their own question.

DR. FITZMAURICE: One last question, a short question, that is
clearinghouses perform the function of translating stuff that comes in into the
right standards and sending it out, sometimes billing services do that too. If
the provider already has his or her provider number, national provider number,
is this a function of the clearinghouse is to verify that number when a claim
comes through and that’s why the NPPES, one of the reason why the NPPES is so
important is that you need to get access to a master inventory to let the
electronics flow as fast as possible?

DR. WHICKER: You’re correct and without having access to the NPPES all you
can do is validate that the number matches the structure with the check digit
at the end of the ID. When we started our testing we didn’t have our NPIs and
so we were creating dummy numbers and we found out that the software, the
company that we used to validate our claims and transactions recognizes a good
NPI, doesn’t tell it’s the right NPI for that person but it does validate it. I
think in the ideal world you would want a clearinghouse that could not only
check the validation of the number but also ensure that it’s a number that has
been assigned and that it belongs to Hospital XYZ or Dr. Jones.

DR. FITZMAURICE: Thank you for great testimony.

MR. REYNOLDS: Simon?

DR. COHN: I think this is sort of a brief question, I somehow feel I asked
it the last time you were all here. The recommendation I see from you is
certainly well thought out and I’m certainly very sympathetic to it but I’m
having a little disconnect between this solution and the problem you’re laying
out. And maybe I’m misreading all of your graphs and material but I’m hearing
yeah there’s a problem with everybody mapping and letting everybody else know
their number but there’s seemingly a very big problem that not all the
providers may have their numbers by May 23rd, at least that’s, and
maybe I’m missing something here but I didn’t, you mention in every room you go
in all the providers are raising their hands and they have their NPIs, that
appears to be you’re in different rooms than the survey was. And so I’m
obviously sitting here going geez, we could recommend a proposal such as you
have, it seems to solve part of the problem but as one who doesn’t like to send
out multiple letters suggesting different tactics on a three month level what
about the other problem, about getting, what happens to the providers who
aren’t going to have it on the due date?

DR. WHICKER: I guess the way that I would answer that is as you’re correct,
it only talks to the one problem of the mapping, the crosswalk, creating the
reimbursement issues and so on. What that does is it doesn’t penalize the
provider who has got his NPI, who has done his testing and is ready to send
transactions. By not delaying the May 23rd date for the providers
who haven’t enrolled it basically puts the carrot out there, maybe the stick
that’s going to beat them, that if they don’t enroll then they’re the ones that
are going to be panelized. And I’ll guarantee you as a provider who has a
different reimbursement window with Medicare if I don’t have my, well, A, I
can’t submit a paper claim so I have no choice, I would just stop processing
claims to Medicare and I would probably be unemployed with my employer if our
system stopped sending Medicare claims on May 24th, 2007. And so I
think there’s a significant incentive on the provider side to get their NPI and
have their system up and running to send it. My concern though still is that as
I have that number now I’ve got to test with every payer that I’m under
contract with, those are the ones that I’m most concerned about because those
are the ones that generally have the more complex payment arrangements with me
and that’s what scares me and that’s why I would like to be able to have that
little extension.

DR. COHN: Sure, and I don’t mean to give the answer, I’m just sort of
trying to think of whether there’s, thinking of this in a comprehensive
fashion, and I don’t know what to do about that other piece either but Gail,
maybe you have a thought.

MS. KOCHER: Well I think that since the final rule didn’t stagger the
enumeration to the transition to the implementation by proposing that the
enumeration stay solid but that dual transition and the final implementation
date moves out that gives us a staggered approach that on the hindsight may
have facilitated the industry, gotten providers to move faster. If we would
consider moving everything we would be at the same point whether it’s six
months, whether it’s May or it’s December, because the providers that would say
oh, now I have another six months, so I think the intent was to let’s get one
piece of the puzzle done and now we give ourselves time to work on the next
piece and that transition because that’s the piece that impacts the provider’s
payment.

MS. TRUDEL: I’d just like to provide just a little bit of background in
terms of some of the things that CMS is looking at and I think they dovetail
very nicely with some of what Jim talked about. Obviously one of the main
things that we need to do and we realize this is to publish the data
dissemination notice as soon as we can.

Another thing that we need to do is as we did for the initial
implementation we do need to continue to do assessments and we’re doing our own
assessments based on the NPPES data that we have available to us, Medicare
data, and also working with WEDI and other industry organizations to gather
some of that information.

Outreach clearly is a crucial thing and Jim mentioned that we actually did
have a HIPAA roundtable a few weeks ago devoted strictly to the NPI where we
maxed out on 5,000 phone lines. So it’s very clear that people are starving for
this kind of information and we need to make sure that we continue to give it
to them.

The other thing that we need to do and that we’ve talked to WEDI about in
the context of this plan summit is to make sure that the plans are all sending
messages to providers that are similar. And we have already started to say to
providers don’t just get your NPI, start to use it as soon as you can, so it’s
get it, share it, use it. And the more we can target those messages to make
sure that providers understand how much lead time they really need in order to
be safe I think that message is very critical too.

Not to say that these are going to solve all the problems and we’re all
going to be fine but these are some of the things that we’re looking at to try
to make sure for instance that the very basic idea of the providers at least
having their NPIs in time is addressed.

MR. REYNOLDS: Any other questions? We had some discussions earlier, if we
have a hearing in December we may want to definitely have you back because as
you mentioned your timeframe here, that’s why I was pushing on that to see
because obviously the full committee meets in November and then we meet in
February again so anything we would want to produce to support anything you’re
doing is key, our timing, as Marjorie mentioned in the earlier segment you can
meet with the subcommittee all we want, we got to get it through the full
committee before we have this group really pushing something.

So I think it’s key that we stay closely aligned with you as to what’s
going on because this is a big issue and this happens to be part of my day job
and we’ve put on 20 seminars in North Carolina for all the providers, we’re at
19 percent enumeration, and we’re ready to receive them. So this is a 50 state
look at the reality of the world and our RHIO is pushing it too, so it’s a
different game out there on the street for everybody that’s on the street and
for the next session I think we’ll want to hear a little more from CMS on the
may 23rd because the reason I think that’s key is, and I won’t make
Gail shake her head but I promise you Highmark is not going to drop claims to
paper and not going to stop processing claims because Jim back to your point in
the end if the claim gets held up it’s the individual J.Q. Public who ends up
with an accounts receivable sitting out there with somebody that did a service
for them.

So I think in the end we can talk here as industry people, in the end
there’s a real person with a real bill for a real service and we got to be
careful we don’t play ping pong with it and leave them out of center —

DR. FITZMAURICE: Harry, could I ask a quick question? You’re not testifying
but you’ve mentioned that 19 percent of the providers in North Carolina had
been enumerated, you mean that 19 percent had gotten their NPIs and the others
didn’t report that they had, or 19 percent had gotten their NPIs and given them
to their health plan?

MR. REYNOLDS: I’ll say it this way, a lot more than 19 percent have their
number, with 20 seminars we’ve only gotten 19 percent to turn them over to us,
and a lot of the people that do have numbers are not necessarily providers that
submit claims, we’re finding that out also. So be careful, the numbers are a
little skewed, a lot of people who don’t actually do claims but are, they have
their numbers so good, you can get real excited about the numbers, let’s talk
about the people that are doing business. So that’s the big issue that as it
gets parsed that’s a big issue, so the numbers to me are a little fluffy —

DR. FITZMAURICE: 19 percent of the people that you pay have given you their
numbers.

MR. REYNOLDS: Have given us the number to work on the crosswalks, even
though we’re ready to do it, and those are real numbers and those are as of
yesterday. We need to change the message that’s for darn sure because we’ve
been out there and talked to a whole lot of people and it isn’t getting
through.

Any other comments from anyone? Okay, thanks everybody, really appreciate
it.

Okay, is there anyone on the phone? Are any of the other NCVHS members on
the phone please? Okay, good.

All right, the next session is hearing about the pilots on e-prescribing
which is a subject near and dear to our hearts, so John please proceed.

Agenda Item: AHRQ – Update on E-Prescribing Pilots – Dr.
White

DR. WHITE: Thank you very much. All I’m going to say is I know how to clear
out a room apparently since about half the folks here have left.

Hello, my name is Jon White as the nametag says, I work with the excellent
Dr. Fitzmaurice at the Agency for Healthcare Research and Quality, and for
about the last year and a half I’ve been kept pleasantly busy working on the
e-prescribing pilot projects as mandated by the Medicare Modernization Act. I
want to say that I’m really grateful to be able to come here today, all of this
work rests on the work that NCVHS did prior to the initiation of these projects
and I’ve taken the time to read everybody that you’ve written so I’m really
grateful for the amount of work that you all went through to get here to this
point and I’m hoping we can do you proud by the time we’re done with this.

So I’ll start with just a brief reminder, like you all need it, about the
Medicare Modernization Act, and that specifically among the many things that
MMA requested, directed, was that it directed the Secretary of HHS to conduct a
pilot project to test the initial standards in order to provide for efficient
implementation of the information requirements for an electronic prescription
drug program set out in section 1860D-4(e)(2) as you all know, specifically
information on the drug being prescribed, possible interactions and warning
with respect to other drugs and patient medication history, as well as
information on eligibility and benefits such as drugs included in a formulary
or tiered formulary structure.

So that’s the direction, you all may remember these, these are the
foundation standards as adopted by CMS through regulation again after
significant work on the part of NCVHS, NCPDP SCRIPT Version 5.0, NCPDP Telecom
and ASC X12N 270/271.

Now I have a list of the initial standards here as we put them in the RFA,
I will back up a little bit, there’s a little history, we were contacted in May
2005 by CMS who was directed by the Secretary to undertake this work, CMS
engaged with us at the agency knowing that we have a health IT program and we
have wonderful people like Mike Fitzmaurice who work with us and so we do a lot
of work in this area and we think about these subjects a bit. And after a phone
call and a half the folks at CMS said so why don’t we send you the money and
let you do this work and our then director Scott Young said that sounds great,
looked at me and said Jon, this will be you, so here I am. My background is a
family physician and I do the work that I do because I’m really interested in
the ability of information technology to improve care that we deliver and
although at first blush doing standards work on electronic prescribing may not
seem like that fits that need it really does and we’ll talk about that as we
get a little bit further into it.

After review of the Medicare Modernization Act HHS determined that these
could not be contracts, these could not be contracted, these had to be
cooperative agreements, couldn’t be grants, couldn’t be contracts, had to be
cooperative agreements. AHRQ has in place a fairly robust peer review process
not until that of NIH so for a lot of reasons it was felt that AHRQ was a good
place for these projects to go through.

So we developed a request for applications, which was released I think in,
I want to say October, it was October, and we had a fairly quick turnaround
time, we gave folks about five weeks to put together applications to respond to
this request for applications. So my hat is off to the e-prescribing industry,
came together in a very nice way, we had a review panel, Jeff Blair was part of
that review panel and we’re really grateful for his participation, which I am
really grateful to say really understood the issues and did a fantastic job of
reviewing the applications that came in and were able to give us really sound
advice about which projects to select.

So from a release date in August, October, I can’t remember, it all blends
together, in late 2005 we made awards before December 31st, 2005,
which any of you who have been involved in the grant making process can
probably appreciate that was a fairly rapid turnaround time but again because
there were a lot of folks who understood this work well and were prepared for
it to come we have really consequently had a number of excellent projects that
have been running and I’m going to talk a little bit about those today and kind
of tell you where we are and then lay out for you the path forward.

The reason why for all that exposition is to understand that since these
are not contracts these are grants, they’re cooperative agreements which means
the government has some influence but the important thing to know is that the
ultimate about what comes out of the project lies on the grantee as long as
they adhere to the original application, as long as they address the issues in
the RFA. The point of that is that what’s in the RFA is really, really, really
important so I’m going to go real explicitly through some of the stuff that was
in the RFA because that’s what you’re going to get out of the pilot projects,
there’s a reason for me to kind of belabor this, which I will.

So in the RFA we specified initial standards. Many of those standards were
existing, some of those were not at the time that we released the RFA, always a
challenge to ask people to test things which don’t exist yet, it’s okay, DARPA
does it, why can’t we do it. But here’s a list of them, specifically we asked
folks to look at formulary and benefit information, NCPDP was developing a
standard which was on its way out and has been out using the RxHub protocols
and pilots should determine if it should be adopted as a standard.

Exchange of medication history, determine the readiness of NCPDP’s standard
medication history message.

NCPCP SCRIPT, fill status notification function, the pilots need to assess
the business value and clinical utility of this.

NCPDP SCRIPT cancellation and change functions.

The structured and codified sig, we said, and again this is all language
from the RFA, pilots should test structured and codified SIGs, patient
instructions, developed through standards development organization efforts,
nice nebulous language.

Clinical drug terminology, specifically pilots should determine whether
RxNorm terminology translates to NDC for new prescriptions, renewals and
changes.

And prior authorization messages, the pilot should determine functionality
of new version of the ASC X12N 278 and evaluate the economic impact of
automation and impact on quality of care, and to support standards development
organizations development of work flow scenarios.

So those are the initial standard, not foundation standards, that we asked
folks to take a look at.

We laid out research objectives in the RFA as most of our RFAs do. We said
that folks should determine whether vocabularies and code sets are unequivocal
and can communicate needed information.

To determine how initial standards to be tested interoperate with the
foundation standards.

Consider how the information is transported.

Consider the suitability and the impact of particular e-prescribing
standards with respect to the workflow of the participants, in other words, and
this is Dr. Fitzmaurice verbatim, are the right data being sent the right way
and are they usable and useful to recipients, please translate into English,
thank you, Mike.

Also public/private partnerships that will result, we looked for
public/private partnerships that will result in interoperable standards based
data sharing across multiple care sites and lead to measurable, generalizable
and sustainable improvements in patient and quality of care.

Again, standards are important but they’re important for a reason and
that’s what we hope they lead to.

The core evaluation questions we asked all the grantees to answer:

Are the right data being sent?

Are the data usable and accurate?

Are the data well understood at all points of the transactions?

Are all of the above listed initial e-prescribing data communication
standards included in the pilot working? For example, can they effectively and
unequivocally communicate the necessary information from sender to receiver to
support the electronic prescribing functions? Are the data for the patient an
the prescription transmitted accurately among all participants in the
transaction, such as the pharmacy, pharmacy benefits manager, router, plan and
prescriber?

Do the initial standards work well together and with the foundation
standards? If not, why, and what workarounds were used?

And unspoken there is the next part, how can the initial standards be
improved to address workarounds?

How long does it take to conduct each transaction using the initial
standards?

Can all appropriate drugs and other therapies be ordered via electronic
prescribing?

So a good chunk of questions that we expect them to answer, that they’re
going to bring back to us.

Beyond just the standards we also asked the pilots to look at outcomes and
specifically things that would be, in health care that would be impacted if we
brought these standards into existence and kind of pushed electronic
prescribing as we’re supposed to in the Medicare Modernization Act.

Specifically we wanted them to report on use of on-formulary medications
and generics.

Changes in the rate of potential inappropriate prescribing, for example the
Beers criteria.

Change in the rate of hospital and emergency department use overall.

Report on medication errors.

Adverse drug events.

Rates of hospitalizations and emergency department visits associated with
adverse drug events, for example bleeding while anti-coagulated, ACE inhibitor
caused acute renal failure, anaphylaxis, rash, etc.

Workflow changes in prescriber offices, whether this means fewer
interactions with pharmacies, freeing up support staff time for other
functions, more time available for patient interaction.

Workflow changes relating to verbal orders.

Prescriber uptake and dropout rates.

Changes in prescription renewal rates.

Changes in new prescription rates.

Changes in fill status rates.

Patient satisfaction.

All things that people probably want to know about when they say so am I
going to pick up a PDA, a Tablet, whatever, and electronically prescribe.

So we went through the process and I fondly call our collaborators in this
project my piloteers, it gives it the feel of the Mickey Mouse Club, and
there’s a reason for the separation here. The top four are grantees, CMS ponied
up $6 million dollars for this and $6 million dollars went to the four grantees
that you see listed there, the grantee institutions are Achieve Healthcare,
Brigham and Women’s Hospital in collaboration with MA-SHARE, RAND in
collaboration with Blue Cross Blue Shield of New Jersey, and SureScripts in
collaboration with Brown University. Just below that is a contract that CMS
elected to execute and put in with the pilot projects, they are held to the
same constraints as the pilot projects but they are a contract. They also got
started a couple months later because of the contracting process but basically
CMS brought forward an extra million dollars and took a look across the work
that the grantees proposed to do felt like each one of the different
characteristics that these projects brought was important enough to look at
that they managed to find an extra one million dollars.

The standards that these folks are looking at are listed here, NCPDP
formulary benefit 1.0, SCRIPT 8.1, prescription history request and
prescription history response, prescription fill, cancellation requests and
cancellation response, prescription change request and response, and refill
request and response, as well as NCPDP structured and codified SIG, RXNORM,
which is clinical drug terminology, both the ASC 12N 278 health care services
review standard which is the prior authorization request and response as well
as the ASC 12N 275 claims attachment standard for prior authorization request
and response and those are both initial standards.

Beyond those standards each one of the projects takes a unique look at an
aspect or a characteristic of electronic prescribing. I’m going to flip back
one slide for a second and talk about the piloteers. I put them in this order
because it’s alphabetical order, not because I have a favor for any one over
the other. I love all my children differently.

Achieve Healthcare is a health care technology company based in Dallas but
they are working in Minnesota and specifically they’re working in four long
term care institutions in Minnesota. Two of them are controls and two of them
are receiving electronic prescribing. This is the only project which is looking
at the long term care setting and one can probably appreciate that as this will
impact CMS and the regulations they felt that long term care was an important
setting to look at.

The Brigham and Women’s Hospital and MA-SHARE is a unique environment,
Brigham and Women’s has a long history of excellent research in adverse drug
events as you all probably appreciate. They bring that experience which is
largely based in their hospital setting and they’re extending it to their
ambulatory setting so in addition to testing the standards they are really
robustly looking at adverse drug events and how that can be impact by
electronic prescribing. In addition they are connecting with MA-SHARE which is
a fairly good sized project connecting many of the health care providers in
Massachusetts and CSE(?) is a tight partner with Brigham and Women’s and has
been running a lot of the gear head work I’ll affectionately say, I mean that
in a good sense, at testing the standards and implementing the electronic
prescribing utility in their care settings.

Also worth mentioning that the application through which this is being done
in Brigham and Women’s is called the electronic gateway is going to be made
available at the finish of the project as in an open source application, it
will be made available to folks who want to pick it up and use it which is
attractive.

RAND and Blue Cross Blue Shield of New Jersey, Tony Sheath is here in the
room with us today, and I’m grateful for his presence as with many of the other
folks here because I’m hoping that when my memory fails they can contribute.
RAND is doing really in the estimation of the reviewers did the best job of any
of the applications purely at looking at the standards and the process through
which they were going to evaluate the standards and how well they worked and
specifically probably gave the most robust look of anyone at RxNorm. They are
working fairly extensively in New Jersey with a number of provider sites and in
addition I know Tony’s special project is prior authorization which Tony led
for NCPDP, the workgroup that created the prior authorization standard, so I’m
really looking forward to good things from them on that.

SureScripts you’re all familiar with, the scope of this project is quite
significant, six states, all these other folks are located in a particular
state. This project crosses six states, I think they were looking at about 270
providers was the last I had heard which again, you’re not talking about
thousands and thousands of prescribers but you are talking about a number of
different regulatory settings which is really critical both for SureScripts as
a business but also for us in our regulatory process and how we estimate
success or failure of these projects.

I have been delighted with the work that Kate Lapan(?) who is from Brown
University and the rest of the project has contributed to the academic rigor
that they have brought to this, this has been a really, all of these represent
a really heartwarming, if I can say that, collaboration between industry and
academia and the public sector, SureScripts is a great example of that and I’ve
been really pleased to have that.

NEO, Ohio KePRO is the QIO in Ohio and this was the contracting mechanism
that CMS elected to go through. The strength that this project particularly
brings is that they look at a number of small offices and the workflow that
happens in these small offices, which is everybody is looking at workflow to
one extent or another but again the reviewers felt like this particular
project, that was a real strength of this.

So you can probably appreciate that in addition to the standards work
there’s some significant variation across the projects as far as the settings
that they’re looking at, the types of resources and experience that they bring
to the table.

So having said that I will also reflect to you that as you look across
these standards that the projects are looking at not all of them are looking at
them in the same way, many of these settings, many of these standards are being
tested live in doctor’s offices with patients and with computer in hand. A
number of these are not being tested in that way, either they’re being tested
in a laboratory setting, a non-live setting but still a fairly robust
laboratory setting, or they are not being directly tested with prescriptions
but instead folks are looking at them with regard to their business utility or
their clinical value and evaluating them in that respect.

I will harken back again to the fact that these are grants and these are
contracts, we cannot hammer these square pegs into round holes. These folks all
made excellent proposals and applications but as a consequence they had to
stick to what they proposed which is again why that information in the RFA was
so important to have laid out as clearly as we could but also will reflect that
what you get out on the back end is going to be what I consider, and the folks
who are taking a look at this to consider, a robust look at these standards but
do not expect the same data from each individual grantee, this is not going to
be a meta analysis kind of in that respect. So I just wanted to kind of flog
that dead horse for a little bit and just point that out to everybody.

In addition to a quarterly report, well hang on, let me back up for a
little bit. So in January we awarded these and the grantees have been furiously
working, I think that is probably fair to say, these folks have been working
harder than just about any other grantee or contractor I’ve had the pleasure to
work with, with the possible exception of our evaluation contractor who I will
get to shortly. There was a lot of infrastructure to spin up here in a very
short period of time, we’ve all had the pleasure of working with health care
providers and know how grouchy they can be, so getting systems in provider
offices, operational, in a fairly short period of time and then kind of
robustly gathering data and pulling this out, they are coming near to
completion with this phase of the project with kind of gathering their data.
There are a few folks who will need a little bit of extra time towards the end
which not for some of the core work, for some of the standards work, but I’ll
get to that in a minute.

But by and large all these folks are getting this work done in one years
period of time, MMA is very clear that the stop date for this work is December
31, 2006, so within one years period of time there has been a lot of work that
has gone into this and they have been working, I was tickled, we had a
conference call, we have monthly conference calls and we had a conference call
the other day and Drew Morgan from CMS was going through some information, I
was going through some information, and it was just silence on the other end
and I said are you guys still there, yes, yes, we’re still here, why aren’t you
asking questions, they said we’re all doing four different things at the same
time, we’re here for you but we are really going with our hair on fire so they
really have been working fairly furiously.

In addition to submitting us quarterly reports telling us how they’ve been
doing there is specified in both the RFA and in their notice of grant awards a
final report and I want to go very clearly again through with you what has to
be in all the final reports.

There has to be discussion, so there’s a standards and an impact side to
the final report, for the standards side discussion of implementation by
standard.

Answer the question do all of the standards, initial standards included in
the pilot work?

Do the standards work well together?

How can the initial standards be improved? Again reflecting of what you
heard from the research objectives.

How do you the initial standards work with the foundation standards?

Are the right data being sent?

Are the data usable?

What is missing?

What should be changed to improve functionality?

Barriers to the adoption of initial standards.

Critical success factors for adoption of initial standards.

List of techniques for making the standards work.

And other suggestions for improvement of standards in the future pilots.

Now there’s a couple things there that I want to call out. The top half is
fairly self explanatory, what should be changed to improve functionality is
going to be different from pilot to pilot depending on the environment in which
they put this in as you can probably appreciate so that is going to have to be
pulled together on our end.

Barriers to the adoption of initial standards, this is going to be probably
some of the more interesting work for me because you do have so many folks from
the electronic prescribing industry involved with these projects. Their
assessment of barriers and success factors and next steps to take are really
going to be interesting to me because they both have to be practical about what
we put in and how we put it in or what the recommendations are about that as
well as guardedly optimistic cheerleaders about moving this forward. So I’m
very curious to see what will come out of this as probably we all are.

MR. REYNOLDS: Jon, before you change slides, in the second sentence what
word is missing?

DR. WHITE: Do all of the initial standards included in the pilot work?

MR. REYNOLDS: Do they work, thank you, it’s fine.

DR. WHITE: Again reflecting the homespun wisdom of Mike Fitzmaurice because
I think those are your words as well. That’s the standards side.

The impact side read something like this.

Effect on functionality, integration with practice management and
electronic health record and decision support systems. Again, variable from
pilot to pilot, some of them will be a lot more robust than others.

Standards effect on quality and patient safety, maybe a little hard to
tease out but I’m from AHRQ, I had to put it in there.

Does the use of initial standards increase efficiency of prescribing? Very
interesting question, may not have been the right question upon further
reflection but it’s the question and we can talk about that later.

How the use of an electronic prescribing system improved care from
prescriber perspective.

Effect on adverse drug events, changes to medication error rates.

Participants by type by month for the duration of the pilot, and these were
who’s using the system, did they drop in, did they drop out, why did they drop
out.

Reasons for changes, plus/minus participation and retention rates.

Patient experience with health care, as an example, not to push our AHRQ
horn but the CAHPS instrument.

Impact on beneficiaries.

And the ubiquitous other information as specified by the project officer,
whatever else I ask for.

And that’s what we’re expecting to come out from the final report. Again, a
number of these projects are looking at things other than this or things in
much more depth and detail than we’re requesting here so you will see
additional information coming out but these were the things that we really
asked them to focus on and report out to us in addition to the other work that
they’re doing.

All right, so I’ve given you an initial appreciation for the timeline up
until now, let me give you an appreciation for the timeline from here on out.
You thought we had our hair on fire, I have very little hair left but what hair
I have left will be on fire and perhaps incendiary. The evaluation contractor
work was awarded to AHRQ’s National Resource Center for Health IT which is
primarily led, the primary contractor is the National Research Center at the
University of Chicago. These folks are the primaries but they have brought in a
number of folks from the world of electronic prescribing and the pharmacy world
to assist us with looking at these projects.

The next quarterly report was due yesterday, I have a template that I
haven’t sent to them yet so they have a week to get that done and that’s mea
culpa.

The pilot work ends on December 31st, 2006, the report to
Congress is due April 1st, 2007, four months later, no, three months
later, I want to say four months later, three months later. Secretary to adopt
standards by April 2008 and standard in effect by 2009, this is the MMA
timeline. So let me back up and talk to you about some of this.

These folks have in the past several months put in infrastructure, set up
research teams, have been generating data, have been gathering data and are
reporting to us on this. The evaluation group is getting up to speed, have been
and are pretty much well up to speed on where all the projects are. Their final
report is due to us two months before the report is due to Congress as such we
have pleased with projects and they have graciously assented to really work
collaboratively with us over the next several months to get as much of this
done ahead of time, meaning now, as is possible.

You can imagine that the report to Congress is going to encompass a number
of elements, CMS needs information for an impact analysis for a draft
regulation that will come out of these projects, we will be quite busy. The
evaluation contractor and actually a lot of folks from CMS too will be actually
visiting a number of the pilot sites over the next couple months to kind of,
nothing like going there and touching it, as well as having frequent phone
calls, we’ve already had a number of phone calls with them, we are having
weekly meetings to kind of keep everybody up to speed on where we’re going with
these projects. And we are really hoping to get something done and into
clearance relatively quickly after these projects end.

And you all can appreciate that that’s a really tight timeline, I’m not
without a little bit of anxiety about it as Karen knows, I’ve sent her late
night emails, but we will get there and we will get there because they really
are excellent projects and excellent people working on this.

So that’s a summary of where we are and I am really looking forward to
talking with you, answering questions and getting feedback and things like
that, thank you for having me come talk to you.

MR. REYNOLDS: Okay, Jon, well done, and after your compliments to Mike and
Jeff you’ve tainted your conversation quite a bit —

DR. WHITE: The first part of any good political speech is bond with the
audience —

MR. REYNOLDS: Well done and this is a subject we really care about so
that’s great. Mike, you have a comment?

DR. FITZMAURICE: I hate to be asking questions of myself —

— [Laughter.] —

DR. FITZMAURICE: One question and that is what methods will these grantees
and contractor be using to determine how well the standards work? I can think
of before and after, I can see looking over time and are things going up or are
they going down, I can see comparing those that have them with those that
don’t, and you said that each one is kind of different, can you give us a
flavor for what methods they’re going to be using to determine how well the
standards work.

DR. WHITE: Sure, the first thing to appreciate is that it’s going to vary a
little bit by standard, there are some standards that when we asked for
applications were out there and were, although there wasn’t extensive industry
experience with them was enough experience that it was out there and they could
actually make concrete plans at the time of the application around what they
were going to do with that standard. A number of those have been in production,
being used for transactions in provider offices, and for those standards you
will see back, and these are things like NCPDP SCRIPT 8.1, a number of the
elements contained under that, you will see data on the standard was used for
this many transactions.

On a very basic level they’ll initially look at did the right data go to
the right place for the right purpose and that information will be reflected
back. On a next higher level and on a less specific level the projects will
look at because this information was available this effect was present on
safety or perhaps because this standard did not work as anticipated this
information was not available at the point of care and we saw this range of
adverse drug events during this time that could potentially have been impacted
by having that information available in the same place and the same time.
That’s for the production level.

The next level of testing that you’re going to see kind of generically
across the pilots is lab testing, which is where they’ve set up a virtual
environment, there is not live doctors with live patients but they have an
application, Brigham and Women’s for an example has what they call a harness
which is a test EMR that has patient data, fake patient data in it. They’ve
taken a set of actual prescriptions which contain elements which they have
recognized as important to verifying that certain things work and they’re
looking at certain standards within that lab environment. So they will be able
to reflect back to you when standard X was put through its paces in the lab
environment, all the data went to the right place as anticipated or it did not
go to the right place and here’s where it actually went.

The third level is evaluation of the elements of a standard and looking at
things like the business utility, the safety utility, the clinical utility. One
important one to call out I think is probably the structured and codified SIG
standard which became available in I think April of 2006, all of the pilots are
looking at that in a lab setting, they are not looking in a live setting,
because from the end of April to December 31st is just not enough
time to actually get that out there.

So I will also say that there is a little bit of variation between pilot
projects as far as the way that they’re looking at some of these standards.
Some folks may be looking at prior authorization for example in a non-live
setting whereas others are looking at it in a live setting, and the challenge
is going to be to bring that data together in a useful and meaningful way.

Does that answer your own question?

DR. FITZMAURICE: Except for telling us what the final report is going to
say which you can’t, that was good, thank you, Jon.

MR. REYNOLDS: Jeff?

MR. BLAIR: Of course our real interest is in the final report, I will
refrain from asking you for a preview, I’ll just have to wait. But since we
can’t ask about the meat at the end what about feedback to NCVHS, what could we
have done better that could have helped the process?

DR. WHITE: That’s a very thoughtful question. I’ll answer and then I may
actually ask other folks around the table to feedback, other folks who have
been also involved in the projects who may be able to answer that better.

I think NCVHS did an excellent job of sifting through the landscape of what
was out there and what, both what was out there and what you thought needed to
be looked at in order to have electronic prescribing be useful and workable. As
we can all appreciate it seems like a very simple thing to whip out a
prescription pad and write Lisinopril 10, POBID, PTAW, no refills, that simple
act belies a very complex set of circumstances leading up to and stemming out
from the act of prescribing.

The only way to have been more helpful which I’m not really sure how you
would have done this would have been to have given us a little more structure
at the outset as far as specific things that were in existence that needed to
be tested. And here’s why I say that, because at the time that we wrote, and
again, all this is on a fairly compressed timeframe, you know what you could
have done, you could have talked to Congress and given us a better timeframe
for MMA, that’s what you could have done. But you will wind up seeing
variability about what comes out of the pilots because we weren’t able to be
specific enough when we asked for folks to send us applications and I think
that’s just a function of temporality, I don’t think there’s anything that
necessarily could have been done other than to see these standards exist now,
test these, these standards either are on their way very shortly or not so
shortly but at least take a look at those, and then here are things that don’t
exist, nobody has got plans to but really do need to be in place in order to
have a quality prescribing process.

So that’s my two cents worth, do other folks around the table want to say
anything about that? Let me dangle, okay.

MR. REYNOLDS: Jon, you made a comment earlier about the clinical and
business value, tell me a little more about that.

DR. WHITE: Sure. Although we may not appreciate it as providers medicine is
a business, health care is a business. What we also don’t appreciate about the
health care, well, that’s not true, we are increasingly appreciating this, is
that we do have such a fractured health care system to the point where we
really do have to look at clinical and business value separately.

I wind up spending a lot of time thinking about health IT and the whole
reason I do my job is not because I was really looking for a job in the federal
government, two and a half years ago I was delivering babies, but the reason
I’m here is because I really believe that in order to deliver quality health
care as a clinician I need better information about my patients and my patients
need better information about my patients and the care that I deliver, which is
why I do what I do.

That conversation is divorced largely right now from how much it costs to
install an electronic medical record or an electronic prescribing system, or
how much does it cost to order a lab test or to write a drug, I can’t tell you
how many times patients called me back and say remember that drug you wrote me
for, I couldn’t get it because it’s not on the formulary, or did you know that
it cost me $160 dollars to get this, and I go no, that was just the best drug
for you as far as I knew.

Those conversations need to come together, I am not going to talk on the
bully pulpit, what I will say to you is that because these projects do really
reflect a great collaboration of industry and academia and the public sector is
that you will get a robust discussion, if somewhat separate, about clinical and
business utility of a lot of these things, it probably won’t be quite to the
extent that any of us want it to be but both of those things are really
important to look at because even though it may be really great for me as a
clinician to have the medication history every time I write a prescription for
a patient if it takes me twice as long to write a prescription and you add that
up over a 100 prescriptions over a day that’s not insignificant to my business
although I may know it’s the right thing to do for my patient. Both critical,
not clear how they come together yet but both being looked at by the pilots.

Is that what you were asking? That may not be —

MR. REYNOLDS: That’s good, yeah. One other comment I’d like to make is,
maybe offline, talk to you and Michael, out of these same standards, we just
rolled this out in North Carolina, I made a presentation at one of Marjorie’s
seminars, we started in March, have 544 doctors using it already, will have
1,000 by the end of the year, our tracking these clinical and business results
like 33 percent of the time we give them a drug/drug interaction message they
change the drug, what percent are generic substitutes, average time to deploy,
so these are real prescriptions, 109,000 prescriptions so far. So if there’s
any way you would want to look at any of that data and add it to your report or
what you’re considering, and better yet talk to the actual doctors and/or
vendors and/or others that are rolling it out, to add to your statistics be
more than happy to offer that, not because of the company because of the fact
that it’s real people doing the exact same standards rolled out everybody that
was in this room that agreed to do it.

DR. WHITE: I will say back to that both Karen and myself would, and the
evaluation team, many of whom are here today, would actually really value any
data you or anybody else can provide to us. Part of the report is going to be a
background review of not just the current environment but what’s out there.

I would reflect back to you also the recent Institute of Medicine report
Preventing Medication Errors, yesterday I was at a CERTs steering committee
meeting at AHRQ, CERTs are the Centers for Excellence in Research and
Therapeutics. And we had one of the folks who was on the IOM’s panel get up and
it struck me there are two recommendations, two sets of recommendations, and
the first one says everybody should be electronically prescribing by 2010 and
everybody should have plans in place to electronic prescribe by 2008, which is
a noble sentiment. And then about two or three recommendations later it says we
don’t know a whole lot about using health information technology to prevent
medication errors, we do some but we need to do more work on things like work
flow and other things.

And I called that out to him, I said on the one hand you’re aggressively
pushing electronic prescribing as a tool, and on the other hand you’re saying
we really don’t know whether this works or not. And he said well, the
handwriting thing is important, even if we just get to keeping people from
having bad handwriting that’s important.

We talked about a little bit more and there’s more to it than that but it’s
a fact that there’s not as much data out there as we need to really be
convincing so the more data we can garner the better. And again, we’ll do what
we can in the period of time that we’ve got.

MR. REYNOLDS: Any other questions from anybody on the committee? As we were
talking at lunch about formulating a December subcommittee meeting, and we’ll
have that discussion again this afternoon or tomorrow morning, we may —

DR. WHITE: I may be back, the pleasure of my company —

MR. BLAIR: I guess I refrained from a whole bunch of questions because I
have the idea that it would be difficult for you to comment on the things that
have worked well, the things that there may be difficulty, areas where you’re
getting, you expect to get a good deal of data and areas where it may be thin
or areas where mapping of terminology is going well or it’s not, so is that
true that you’d really like to refrain from commenting on those at this point?

DR. WHITE: Yes is the short answer. The longer answer is all of those
things are there and all of those things have been in our heads as we’ve gone
along but the final chapter is not yet writ is what I would say and until it is
writ I’d just be shooting myself in the foot, which I’m very good at doing but
will decline the opportunity for right now. But I’m happy to come back and tell
you more specifics when they’re available.

MR. BLAIR: Is there some arrangement that we could make so that shortly
after you provide the report to Congress April 1st that we might be
able to get a copy shortly after that?

DR. WHITE: I would actually hope and expect that that report will be
disseminated widely and in particular I am happy probably through Karen to
expedite that, yes, the short answer is yes, happy to.

DR. FITZMAURICE: What I want to say is in kind of summary of what Jon has
done and what Karen has done and the partnership of CMS and AHRQ, it’s
virtually an impossible task to evaluate what a standard or maybe even a set of
standards can do for a given process because when you put it in the system
changes and you’ve got something different. And if you haven’t looked at it for
a while before and looked at it for a while after you can’t do it. If you
haven’t measured these things and tell me anybody who knows all the errors in a
particular facility over even a short period of time, nobody does. And yet this
is the state of the art that couldn’t be done without full industry
cooperation, without the standards development organization cooperation,
everybody wants to have the health care more efficient, not just for their own
businesses and their own incomes and their own profits, but for their own
selves, their parents and their kids.

And you’re seeing the partnership result in what the state of the art is in
evaluating something that has probably never been evaluated before and its been
guided and led by the National Committee on Vital and Health Statistics, by
experts who advised us before we wrote the RFA, by people who evaluated what
came in, it’s a widespread partnership that doesn’t stop in this room. And I
think the NCVHS recognizes that in a lot of different things that we do, it’s
never more focused than right here because we’re looking at something that is
very, very difficult to do and it will be done and we’ll have the best report
that we can in April.

MR. REYNOLDS: Anything else? Jon, thank you, we look forward to seeing you
again and again and again. Okay, we’re running a little bit ahead of schedule,
we’ll take our break now and if you come back at 3:25, we’ll give everybody 20
minutes this time so see you at 3:25.

— [Brief break.] —

MR. REYNOLDS: Okay, the next portion of our agenda is Karen Trudel going to
cover our electronic prescribing of controlled substances, another subject that
we remain very interested in. Karen?

Agenda Item: Electronic Prescribing of Controlled
Substances – Ms. Trudel

MS. TRUDEL: Well to an extent I think this presentation is going to share
some characteristics of the last one in that the things you probably most want
to know are probably things that I can’t tell you. So I’m going to make up for
that by providing some background in case people have forgotten when we had the
last installment of this story.

The Controlled Substances Act which is administered by DEA does currently
require pen and ink signatures and paper prescriptions for controlled
substances. By law pharmacists are required to be responsible for assessing the
legitimacy of prescriptions including both the signature and possible
alterations prior to their dispensing medications for controlled substances.
And the DEA has additional concerns in terms of how pharmacists can continue to
do this in an e-prescribing environment, how the DEA can audit compliance and
investigate and prosecute diversion which is criminal violation in an
e-prescribing environment.

The DEA over a year ago put into place an ordering system, electronic
ordering system for controlled substances, this is on the supply side, not on
the dispensing side, and they rolled that out with a PKI solution. At the time
that the original e-prescribing hearings were going on the DEA had been
considering a similar PKI solution for the dispensing side.

The concerns that were raised in the NCVHS hearings and that HHS also
adheres to are that having two different solutions for controlled and
non-controlled substances would cause potential slow down in e-prescribing
adoption since there would be two different solutions and that current
e-prescribing even though it is not widespread the applications do not
currently use PKI.

At the time that the hearings took place there was only one e-prescribing
pilot that was testing PKI for controlled substances, that was at a VA hospital
which as we know is a closed environment, and while it was working well there
were some concerns about how that could be scaled.

A meeting was held in July, a public meeting, to allow both DEA and HHS to
understand each other’s requirements and issues and to understand the current
e-prescribing environment and hear industry input on a potential future
direction for e-prescribing of controlled substances.

Generally the industry testifiers took two quite different positions. One
suggested that we should move immediately to the ultimate solution, we should
look for a very robust technology with PKI, potentially smart cards, and
essentially build this infrastructure up from the ground. Another group
suggested that we use existing framework, the existing e-prescribing framework
that’s in place and fill whatever gaps are needed to provide the kinds of
assurances that DEA requires for controlled substances.

Some of the discussions were that e-prescribing could provide better
monitoring of scheduled drugs. There were concerns that we not have a solution
that was so robust that the cost involved would hamper adoption. And as I said
there was some consensus that at least in the beginning a solution should be
based on existing standards and fill in gaps.

There was a thought that we should incorporate existing technologies,
change should be incremental, that there were already HIPAA standards on the
books for covered entities with respect to authentication. And with respect to
PKI there were concerns about a lack of extensive health care experience, the
costs involved in supporting PKI, and the potential for scalability to a level
that would be required for e-prescribing industry wide.

Some of the discussions resulted in identification of alternative
safeguards that could be used by DEA in place of actually having the paper and
pen prescription for controlled substances that’s available now. The fact that
there are electronic audit trails built into many of these software products
that are in use. That there is already authentication in use throughout the
e-prescribing chain starting from the provider going through the clearinghouse
or aggregator to the pharmacy. That there was data integrity throughout that
chain. That there were already HIPAA security rules in places that addresses
many of the authentication requirements. And people also mentioned the fact
that the fill status notification which is one of the transactions in the NCPDP
SCRIPT suite that is being tested in the pilots because it provides the real
time input back to the prescribing physician that a prescription has been
filled that this provides an additional business closing of the loop with
respect to controlled substances because this gives the physician a notice that
something has been filled and if he didn’t prescribe it that obviously provides
a little bit of a safeguard where the prescriber, the alleged prescriber can
begin to look into what actually happened there.

After the conference DEA and HHS have assessed the testimony, both agencies
have been reviewing it in great detail. We have had coordination meetings
subsequent and DEA because they are the lead agency is in the process of
assessing a number of legal and technical issues. Currently as I said the
regulations and requirements on the books have a requirement for paper and pen
and ink signature for controlled substances, to make a change regulations would
be required. DEA as the lead agency would be, is in charge of determining what
changes they may want to make and we are going to be discussing issues in that
respect with them collegially.

We will be having ongoing discussions and I can’t say again because we’re
in a pre-decisional period what decision will occur, don’t know what a specific
timetable is, do know that both agencies are committed to completing an
analysis and trying to arrive at a solution and that both agencies found the
public meeting to be extraordinarily useful and provided a really wide range of
information that was very helpful in our helping to both understand our
somewhat different sets of requirements and perspectives and to get a sense of
what is out there in the industry today that we could bring to bear to solve
some of these problems.

Any questions?

MR. REYNOLDS: Questions from the group?

MR. BLAIR: All my questions you’re not allowed to answer.

MS. TRUDEL: I’m glad I made that point clear at the beginning.

MR. REYNOLDS: Michael?

DR. FITZMAURICE: Hypothetically speaking if DEA found merit and HHS found
merit in an electronic prescribing method that could also include controlled
substances would the action taken be to write regulations to permit this on
DEA’s end and is there any action that HHS would take of a corresponding
regulatory nature? It would seem to me that DEA would have to write regulations
—

MS. TRUDEL: I’m speculating here but yeah, the point I was trying to make
was that DEA is the agency that’s responsible for administering the Controlled
Substances Act and the DEA regulations that are on the books today don’t
facilitate electronic prescribing so in order to move in that direction
regulations would be required, they would definitely be required from DEA based
on the Controlled Substances Act. Whether HHS would need to publish regulations
to make sure that we are consistent with that I think would probably be
something that we’d have to look at in terms of is anything we’re doing now
contrary to what a new regulation would require.

DR. FITZMAURICE: I’m not sure that prescribing is a HIPAA transaction,
paying the claim for a drug is a HIPAA transaction, so we may not need to have
a HIPAA transaction on there.

A second question, hypothetically would DEA be interested in giving
temporary relief to a region or an area of the country that wanted to
participate in a pilot whereby they put cost controls and you look at
controlled substances prescribed electronically and see if there is more or
less egregious behavior under electronic prescribing than they might find in
some other place. Is that the kind of a pilot kind of a research project that
DEA would find merit in?

MS. TRUDEL: I really can’t answer that question, I don’t know the answer.
To go back to your original question since I actually can answer that one, I’ll
cling to it, the prescription itself is not a HIPAA transaction and my off the
top of my head analysis would be that if the solution were consistent with
HIPAA and the solution could wrap itself around the existing e-prescribing
transactions, it would seem that everything would be pretty seamless without
HHS doing any more regulation.

MR. BLAIR: Karen, is there any desire on the part of the two entities, HHS
and DEA, to attempt to come to some kind of a understanding on how controlled
substances could be included within e-prescribing for the report to Congress
which is due by April the 1st?

MS. TRUDEL: I don’t think the timing is good for that.

MR. REYNOLDS: I have a comment and a question. I don’t think that the
payment under e-prescribing is a HIPAA transaction either because most of them
go from the pharmacy benefit manager to the pharmacy —

MS. TRUDEL: It’s a retail pharmacy drug claim, that is a HIPAA transaction,
the prescription is not —

MR. REYNOLDS: Is it paid by an 835?

MS. TRUDEL: No, it’s by NCPDP —

MR. REYNOLDS: That’s fine, okay. The pharmacies take care of that, we take
care of other people. So if HHS and DEA agreed on whatever they agree on and
decided to move forward with something, are there any state laws relating to
these controlled substances that would then have to also be dealt with in any
way so to make it a multi-step process or is it the DEA owns the deal and once
they make the decision then the decision is done?

MS. TRUDEL: There are state laws particularly with as I understand it, and
we’re reaching the ends of my knowledge here, particularly with the controlled
substances in Schedules III through V. But again the state regulatory agencies
do tend to take a lot of their direction from the Controlled Substances Act and
the DEA regulations. So I think there would be some state law that would have
to be harmonized.

DR. FITZMAURICE: If I could follow up on that, if I could remember what I
was going to follow up on, oh, I wonder if the Controlled Substance Act has
anything in there that would allow DEA regulations to supercede state law, that
might be one way to assist the states in making a quick change.

MS. TRUDEL: I know there are already state regulations in place so the best
I can do is to say that the next time we have a discussion with DEA we’ll be
sure to bring that up and have that be a topic for discussion.

MR. REYNOLDS: Any other questions on this or issues with this? Well, Karen,
thanks for keeping the ball going and it’s obviously a subject that makes
related to this more robust if we can make it happen. Okay, with that that ends
the prepared comments, what I can take since we’re running a little bit ahead
of time is whether anybody in the audience has any public comments or anything
they want to make based on anything they’ve heard today, and if not then we’ll
move into our committee discussion. I see some people moving but nobody heading
towards the mics, heading out.

Agenda Item: Subcommittee Discussion

MR. REYNOLDS: A couple things have come up today I guess that we need to
talk about, the first, I heard it mentioned today and Marjorie you’re still
here, I heard it mentioned today that the HIPAA report is coming out in
November, I know that the department is working on it but will we, will this
subcommittee, the full committee or somebody see it?

MS. GREENBERG: Definitely. I’m not sure what the status of the first draft
is, I think Simon may be able to report on that but it would, after it’s
drafted it would got to the subcommittee for review and then only after the
subcommittee, and probably to the Privacy and Confidentiality Subcommittee, it
would go to at least those two and then after the subcommittee commented then
it would go to the Executive Subcommittee and eventually to the full committee,
but I think you’re concerned about the timeframe —

MR. REYNOLDS: Well again, the next subject will be our next hearings and
discussions and so I’m just trying to decide if —

DR. COHN: Let’s talk about this one for a second because first of all,
Harry, like Karen just to keep things going here, I can’t tell you anything, I
can’t answer of your questions —

— [Multiple speakers.] —

DR. COHN: What we are doing is creating a first draft of a report, this
will include obviously a review of what’s happened this year and probably for a
couple months before on HIPAA. I think I’ve also asked the work to take
particular pains to include for example references to the work that the
subcommittee did earlier about the HIPAA lessons learned and things like that
so hopefully that will be a slightly more thoughtful framing of the discussion
a little bit.

I think that certainly we need to get a draft that will certainly include
this, that relates at least to the transactions for the subcommittee to review
and certainly anything related to privacy and security also needs to be handled
by them, and clearly, I mean you’re right, it would be nice if we had it today
to discuss, as it is I’m sure we’re going to have to have a conference call to
sort of review it and provide additional input.

MR. REYNOLDS: When do we want to send it, when is the desire to send it to
Congress?

DR. COHN: I think our plan was to have it, I mean and once again we’ll
obviously make sure, we’ll see how this plays out but I think we waned to take
it to the full committee which is at the end of November, so we have a little
while, I mean this isn’t like you have to have it written up tomorrow but also
observe that this is the last full meeting of the Standards and Security
Subcommittee before that next committee meeting.

MR. REYNOLDS: That’s why I was bring it up, I was bringing it up as process
more than anything else —

DR. COHN: Exactly, so clearly that will have to be a conference call at the
very least to discuss that but I think you already identified that there were
things that we needed to have a conference call on.

MS. GREENBERG: Well the committee is meeting at the very end of November,
the 28th and the 29th, but it should go to the full
committee, the version that you’re taking approval should go to the full
committee certainly a week before, before Thanksgiving obviously, early that
week of Thanksgiving at the latest I would think, which means it has to go to
the Executive Subcommittee before that so we’re already getting into, sort of
backing up here to about a month from now that it needs to go to the Executive
Subcommittee.

MR. REYNOLDS: That’s fine, I’m just making sure as we set our plans.

As we look at, we have a tentative subcommittee meeting in December, we
heard from WEDI today that they talked about that in November they will make
their next look at whether or not they will want to continue to look at this
extension, I think also CMS continues to look at this and obviously any
recommendation coming from WEDI that’s gone to the Secretary or gone anywhere
else and been discussed with us obviously we would want to know what CMS is
doing so that as we would write anything coming out of that December hearing to
the Secretary we would at least have good input. Because then if we did it in
December it would have to be February before it went to the full committee
which would be where we would take a stance, I’m trying to remember, I don’t
think we’ve set any committee meetings for next year —

DR. COHN: No, I was going to bring that issue up.

MR. REYNOLDS: So that’s another thought as to whether, there’s a February
meeting of the full committee which is the next time, if anything we did letter
wise other than maybe CHI is going to be, that’s when it’s going to be heard
because we’re not going to do anything else, I don’t see anything else we can
pull off between now and November that makes any sense especially if we’re
going to be focused on the HIPAA report so I think that kind of, I’m just
trying to look at our collateral that we’re trying to put together to move
forward.

And then obviously as I think we heard today e-prescribing we had talked
about, Karen has got, excuse me, CMS is going to put out, start working on the
final NPRM or whatever is going to come out of it in January so whether or not
a hearing from us in December to look at that to hear any issues related to
that is again timing again because that would mean that if we had a hearing and
put some input then I think you have to have it, well, you’re talking about
trying to have it out in April, Karen, what were you saying on the NPRM
possible?

MS. TRUDEL: Yeah.

MR. REYNOLDS: So again, looking at our timeframe anything we would want to
say we got to say early enough so that it gets into their process and it can be
considered. But then tying it these pilots we heard today as to whether
anything that would come out of there would be helpful and we can’t hear
anything out of there until after the end of the year so I’m trying to balance
all this and at least have a discussion, we’ve got something to say on all
these but the timing of how we do it and the timing of where it is and the
timing of what it means is really probably one of the more critical. Simon?

DR. COHN: I actually also look at Karen but I think we’re probably talking
about a subcommittee meeting either in December which is what’s currently
scheduled or very early in January and I think that it really is a question of
figuring out how we can best help HHS and CMS with the work that they’re doing
which I think becomes the deciding factor on that.

MR. REYNOLDS: On both NPI and e-prescribing, the two things that are kind
of sitting out there right now.

DR. COHN: Exactly. And I suspect that NPI may be a little more flexible in
terms of timeframe, actually both of them are pretty, I take back what I said,
both of them are tight on timeframes.

MR. REYNOLDS: Yeah, because I think if anything is going, I mean obviously
any kind of a, if we were to adopt WEDI’s recommendation and pass that one
that’s a big deal to a lot of people.

DR. COHN: I guess I would sort of comment that I know we’ve heard now from
WEDI twice and I think the world of WEDI, I’ve previously been on their board,
but I do think if we’re going to get to the point of actually writing a letter
on NPI it would also be good to hear from those also in the community and
potentially hold a slightly wider set of hearings to get wider input to see if
there really is an issue there or not. But once again I know they’re doing
work, they’re asking people also but I think we need to also make a bit of an
assessment on that.

MR. REYNOLDS: Okay, other comments around the table on agenda items? On the
timing of these? That’s what we have this time for to try to get ourselves
together on what we want to do next. Marjorie?

MS. GREENBERG: So at this point it’s not clear whether you need to have
that or will have that meeting in December? Might want to have it in January?

MR. REYNOLDS: In other words I want to continue the conversation on the
timing of when these key things would align and whether or not anybody has got
something else that needs to be considered and then I think that tells us which
one it will be. Do you have any input as to which one would be better or worse
from your standpoint at least as a piece of input, not necessarily —

MS. GREENBERG: I think you’re right, either one would allow if you wanted
to have some letter of recommendation that would allow you to get it done for
the February meeting but you’d have to do it, have the meeting, if it were
January it would probably be relatively early in January because the February
meeting is mid-February. So I think if you’re thinking, right now people have
that date in December locked in to the extent that they do and so certainly if
you’re thinking about changing it to January we would need right after this
meeting to poll the members very quickly because January is not that far away.

MR. REYNOLDS: I totally agree. Karen, why don’t you give us a little input
on especially e-prescribing, what the schedule you see based on, we heard from
Michael’s group a little bit ago, we heard some others, kind of what the flow
is for you so that will help us and what would it be that you would think would
be most helpful from us, and that would also then start formulating what our
hearing might look like.

MS. TRUDEL: Obviously the longer we wait into December or early January the
more information we’ll have from the evaluation contractor but that said as
John indicated we have no choice but to multitask on the evaluation so the
question in my mind is how much information could we draw off the evaluation at
a point in time to come in and present it in the December meeting. That is
unfortunately a question that I have not thought to ask Jon while he was still
in the room so I can take that back as a quick turnaround action item to find
out at the point in time when the December meeting will occur how much
meaningful data would we have from the evaluator and would it make sense to
wait a few more weeks into early January and try to have that discussion then.

MR. REYNOLDS: Do you have any comment on that Michael?

DR. FITZMAURICE: How soon would we need to know something in order to make
some recommendations, I’m not sure what recommendations we would make for the
electronic prescribing that wouldn’t be in the report but yet I’d want us all
to be fully aware of what’s happening, it would be nice if we could provide
input on a draft and maybe I will talk with Karen and Jon to see if that’s
possible, I know that we’ve done that before on some things like the National
Quality Report, National Disparities Report, might be useful to have some
comment like that. But as far as electronic prescribing I don’t see what
additional recommendations we would make other than in the report but maybe we
need to wait until December or January to decide that ourselves.

MR. REYNOLDS: Karen, what would you want from us that would be helpful?
Back to Simon’s earlier point, what would be helpful from us as far as
e-prescribing right prior to you doing an NPRM?

MS. TRUDEL: I think the notion was to, because a lot of these
recommendations came from the NCVHS in the first place in that some of these
were things that NCVHS recommended be pilot tested, that this was our
opportunity to close the loop and that because we’re drafting documents in a
very quick turnaround mode we are developing, will be developing document
shelves and starting to populate recommendations before a lot of this work is
finished. So we thought it would be helpful to provide an opportunity for input
from NCVHS fairly early in the process whereas if we wait until February for a
report to Congress that’s due on April 1st and that report has to go
through an internal clearance process we then run into some problems of how
could we actually implement your comments.

DR. FITZMAURICE: I see that as being an impossible job, NCVHS to say we
said test these standards and we see from your tests that we don’t have the
results yet but we think they’re going to be good and so we, we can’t make a
recommendation like that, it’s kind of an impossible job for us to make a
recommendation based upon what we recommended before to say yes, the test was
successful without having the report, or without having at least the data that
goes into the report.

MS. GREENBERG: Well yes but I guess if the report, the report from the
evaluator is due the end of December, right?

DR. FITZMAURICE: January 15th.

MS. GREENBERG: What was due the end of December?

MS. TRUDEL: The pilots end —

MS. GREENBERG: The pilots end the end of December so it’s January
15th. So if the subcommittee met in December, and this is something
that Karen says she obviously has to talk with Jon about, and they were able to
provide the outline for the report, some content, etc., etc., that would give
the subcommittee an opportunity not to make recommendations about the standards
or e-prescribing but maybe just say well if you could include A, B, or C, or X
and Y also in the report it might make it more useful or that type of thing.
Obviously in January then the report is essentially written or submitted.

If that were to be helpful to have the committee or subcommittee kind of
provide some input into what the final, what would be good content for the
final report beyond what’s being planned then that would have to be in
December, there would be no value to that in January, December might even be
too late, I don’t know, it may be that, I mean you now have the slides from the
presentation that Jon made and you might want to look those over and have a
conference call and say is there anything here that concerns us, is there
anything that we would like to kind of flag that the evaluators should be
looking at based on the concerns that we’ve had and the recommendations we’ve
made, the sooner you could do that the better probably. It just depends on
where you think you might have input. I would think as for actually making
recommendations about, related to these standards, etc., you really couldn’t do
that until after the April 1st report was completed probably but I
don’t know.

MR. REYNOLDS: Michael, were you going to make a comment?

DR. FITZMAURICE: It’s not on this exactly but what we’re looking at is do
we have a December meeting or a January meeting and what can we do about each
one of the issues, we’ve got electronic prescribing, we’ve got the HIPAA
standards streamlining, do we want to make recommendations on that. We have the
national provider issues and I heard that, I think it was Simon say that he
thought we would like broader input into those issues and are they still real
after several months and I’m sure they will be real but to what extent are
people getting interested in it, Blue Cross, American Medical Association,
might be called upon to testify. Time is short for making recommendations if
we’re going to get them out in June or even before June in case of the National
Provider Identifier. I guess I always like to have it sooner rather than later,
give us more time, put the time pressure on maybe the testifiers and give us an
extra couple of weeks to write up recommendations. That would argue for
December although I’ve got so much leave I’m going to be taking some of it in
December but these things are important so maybe I’ll not take that much leave.

MR. REYNOLDS: Jeff, you had a comment?

MR. BLAIR: The MMA directed NCVHS to evaluate, select, and recommend
e-prescribing standards and we executed that responsibility. It then indicated
that there would be pilot tests and it then indicated there would be a report
to Congress. And when I looked at that it didn’t say that the pilot tests would
then come back to NCVHS and that NCVHS would report to Congress and I think
that unless CMS and AHRQ ask us to be part of the process between December and
April that we could be more disruptive than helpful. And the other piece is the
limitation of our timeframe here because for us to be helpful if they were to
ask us we would probably have to have all of those members that conducted the
pilot tests, that actually were the five entities, testify to us for us to get
enough information to be helpful to contribute to that report in a meaningful
way. So it just doesn’t seem like we could make it fit in a way where we really
could be constructive and that’s not that I’m not interested in e-prescribing,
I’m very much interested in e-prescribing, it’s just doesn’t seem like we could
contribute without being disruptive in that timeframe.

I do think in terms of the NPI that we might be constructive but I think we
would have to have hearings probably in December from other groups, other than
WEDI, I kind of am echoing Simon’s comments that I have tremendous respect for
WEDI and I think it probably gives us a pretty good picture of the industry but
we need more diverse input to be able to come up with meaningful conclusions.
And in reality if we did that it would be the full committee meeting in
February before we could wind up passing NPI recommendations and I almost
wonder whether that’s too late, I’m not sure.

And then on the other piece which is the streamlining, I’m sort of back to,
I’m certainly supportive of the streamlining, I think all of us are, but I
almost feel as if that’s either going directly to Congress as an idea or it
would go into an area where maybe we would have to hear from a panel of
Congressional and HHS attorneys to wind up saying what is the best process to
recommend to Congress. That’s something we might consider doing although I
don’t know if that goes beyond the jurisdiction of NCVHS for us to get into
that kind of policy assessment area.

MR. REYNOLDS: Okay, one other thing, let me throw it on the table while
we’re trying to figure out where we’re going next. Simon, is there any reason
that the December hearing dates, since you have incorporated almost all the
Standards and Security group into NHIN, that there are any agenda items on NHIN
that could go along with that at the same time?

DR. COHN: You’re asking a very good question, I think my intent had been
actually to, I mean if indeed the work of the NHIN Ad Hoc Workgroup is complete
with the delivery of the report then we dissolve the workgroup and at this
point the question will be is whether there’s follow-on work that needs to
occur so I think it’d be a little waffling on that one but that would certainly
be a key piece.

I hear everybody sort of struggling about exactly how to, I mean sort of
what to do when in the next several months and I don’t think that, I mean it
may not be something we can resolve in open session —

MR. REYNOLDS: And we have some time again tomorrow morning.

DR. COHN: Exactly, so we can sort of reflect on it a little bit. Certainly
if there are urgencies to letters, as we’ve discovered later on this month
there’s ways to deal with urgencies to letters if indeed there is an urgency to
a letter we better brief everybody real well in November at the full committee
meeting about the reason for the urgency.

Now having said that of course that a lot of times the act of holding a
hearing on an issue like NPI and getting to the point where you’re actually
making committee recommendations, subcommittee recommendations, does a lot to
help inform and move the federal government and its associated agencies in an
appropriate direction because it isn’t just our recommendations, it’s the
actual process of all that we hear and the conclusions we all reach together.
So there are many ways we could deal with that if mid-February is too late for
a letter on NPI or not, there are things that we can do to handle that so I
don’t think that that’s an impossible situation.

But I do think we need to think about it, I mean I think the other issue
which we’re obviously, we’ve all been wrapped up in the NHIN work but I do
think that there’s something called with committee meeting and coming up with
its agenda for 2007 and it probably needs to be more than just finishing up a
lot of other pieces that have been sort of dragging on, I’m really looking for
more of a proactive agenda dealing with sort of the next issues.

MR. REYNOLDS: I plan to pull that, we had that chart that we were using for
a long time and then we got pulled into hand to hand combat, a whole lot of
things that were —

DR. COHN: But what I’m saying is between now and then or at that meeting
would be an occasion for that sort of discussion also.

MR. REYNOLDS: Let me just summarize then. We know that this committee has
to work on the HIPAA report, doesn’t have to be a hearing but we’ve got to work
on the HIPAA report. We commissioned the CHI letter out of today’s discussions
so we have two pieces of collateral that obviously will need to be dealt with
over the next full committee meeting, we got that.

The NPI obviously is an outstanding national issue that I would think we
will probably weigh into one way or the other because any time you start
talking about a transition period or delaying something that was agreed on, and
we’ve heard enough testimony we probably should have something to say on it,
one way or the other, otherwise back to the idea of people are talking to us
about being part of the process that would streamline something and then we
take something that’s this big affecting the whole industry and don’t engage,
and engage all the way to the Secretary, then I think we’re probably almost
disenfranchising ourselves from a key process.

Others may disagree but that’s the way I see, I mean you got some big games
going on, those are not the ones to turn our heads on and be afraid to engage
in. But on the other hand I don’t want, the December meeting was initially put
on there as a tentative session, we had done the business that we had actually
executed for ’06 so I’m not interested in just spending money to come up here
and say we did what we did, so that’s why I’m trying to adjudicate this a
little more aggressively than I would on our normal process.

So if everybody agrees with what I’m said and I’m going to let you make
your comments on, we have tomorrow to talk about it and we have other times to
talk about it but I’d just like to make sure that we make sure we keep our
portfolio clear. And then we need to set up ’07 and I think we’ll bring the
chart back whenever we meet next and really get into what we’re doing and work
that with others because I think that’s going to be key.

DR. COHN: I’m actually going to make a comment just to follow-up with
Jeff’s statements about e-prescribing and once again this sort of goes along
with my general view of us being proactive and involved. Obviously I think it
would be very useful to hear more from CMS about the results of their
evaluation but we may just want to take some time and hear from the actual
people that have been involved in the projects to just get a sense of was it
successful, did the standards work, I mean standards are a key piece here but
it’s also, I mean the standards are really supporting an important business
process and clinical process that is providing increased quality, safety, value
to society, and really I think what we’re interested in at the end of the day
is making sure that that expands more widely —

MR. REYNOLDS: Adoption being a key point.

DR. COHN: Adopting being a key piece and so talking with them to sort of
see how this went, the goods and the bads and whatever, supplement whatever
evaluation information we’ll get from CMS I think would help obviously, it
would help certainly round out whatever advice we might want to give to HHS on
next steps.

MR. REYNOLDS: Because I think when you use adoption it probably goes beyond
your studies but that was one of the charges that we continue to keep an eye on
was how does it really work in the individual office, not just is the standard
okay and does that look like it’s going to be okay. Marjorie?

MS. GREENBERG: I agree with Simon, I was thinking of the, it’s somewhat
different but the analogy of actually bringing in the contractors on the NHIN
and hearing from them and that I think was certainly valuable to the committee,
I think there would be real benefit. So if you say that then I mean probably
the middle of December is not a great time for them since they’re finishing up,
their reports are due the end of December, but I did just want to, but I think
I would still just say we’ll keep that December date until you hear otherwise
because I do recall when we have tried to hold meetings early in January it
really is difficult because a lot of people are on leave, certainly you have
the whole use or lose with the government as Mike alluded to but a lot of
people are on leave at not only the last two weeks in December but even the
first week in January, it’s a hard time to contact people, it’s a hard time to
reach people, you don’t have your full complement of staff to do the work. So
if it’s got to be done we’ll figure out a way to do it but it is not an ideal
time to meet.

MR. REYNOLDS: And if we had an NPI hearing, I just mention North Carolina,
we’re using three national vendors to roll this out to 1,000 doctors in ten
months, so having them come in and testify as well as these other people that
are doing this other study talks about those, they’re on the ground, they’re
doing it, forget what state it is, forget what the situation, they put it in a
1,000 doctor’s hands in ten months. So when you talk about adoption that’s a
pretty significant focus, it doesn’t matter where they did it, and obviously
that’s the kind of input that gets back to the adoption because it’s small
docs, it’s larger docs, it’s all kind of docs as we try to make it happen.

We got some time tomorrow to just touch base for a few more minutes but I
wanted to make sure we at least got all these things on the table today so we
could kind of paint a picture of who we are, what we are and what we’re going
to try to do between now and the end of the year and then how does that match
up to the full committee and how does that match up with what we’re trying to
help with and so on.

Are there any other items anybody wanted to discuss this afternoon? Okay,
with that the meeting is adjourned.

[Whereupon at 4:16 p.m. the meeting was adjourned.]