[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

January 25, 2007

National Center for Health Statistics
3311 Toledo Road
Hyattsville, Maryland

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
(703)352-0091

TABLE OF CONTENTS

P R O C E E D I N G S [9:00 a.m.]

Agenda Item: Introductions and Opening Remarks

MR. REYNOLDS: Good morning, everyone. I would like to welcome you to the
Standards and Security Subcommittee of the National Committee on Vital and
Health Statistics. NCVHS is the statutory public advisory body to the Secretary
of Health and Human Services.

I would like to remind everybody to turn your cell phones off and if you
would, realize that this is being recorded and it is on the Internet. So, if
you will keep that in mind as we go through today.

I will ask members of the committee and everyone in the room to introduce
themselves and I would like members of the committee to bring forth whether or
not they have any conflicts of interest that they are aware of.

So, I am Harry Reynolds, co-chair, from Blue Cross and Blue Shield of North
Carolina and I have no conflicts.

MR. BLAIR: This is Jeff Blair. I am co-chair with Harry and I am director
of health informatics for Lovelace Medical Foundation and I am not aware of any
conflicts.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
staff to the subcommittee and liaison to the full committee.

DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the
committee and the subcommittee. No conflicts.

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

MS. WEIKER: Margaret Weiker, EDS.

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

MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health
Statistics, CDC, and executive secretary to the committee.

DR. WARREN: Judy Warren from the University of Kansas School of Nursing,
member of the committee. No conflicts.

DR. COHN: Simon Cohn with Kaiser Permanente, member of the committee and
chair of the committee and member of the subcommittee. No conflicts.

MS. BUENNING: Denise Buenning, Centers for Medicare and Medicaid Services,
lead staff to the subcommittee.

MS. KUHN: Kathryn Kuhn, National Community Pharmacists Association.

MR. KYLE: Frank Kyle, American Dental Association.

MS. SPECTOR: Nancy Spector, American Medical Association.

MR. ESHRIC: Mark Eshric(?), Siemens Medical.

MS. SPIRO: Shelly Spiro, representing the American Society of Consultant
Pharmacists.

MS. VILARET: Michelle Vilaret, representing the National Association Chain
Drug Stores.

MR. ARGES: George Arges with the American Hospital Association.

MR. OFANO: Bill Ofano, Blue Cross/Blue Shield Association.

MR. WILDER: Tom Wilder with America’s Health Insurance Plans.

MR. REYNOLDS: Okay. This morning our agenda is that we are going to start
off talking about the DO Proposal Review that they have on streamlining
standards. So, we look forward to that.

Then we will have a panel that will — we call it a reactor panel to what
is recommended, to hear what they have to say. Then we will have some
discussion after that, basically on what we have heard this morning and we will
have some further discussion before we adjourn, on yesterday, which seems like
it had to be three days ago — yesterday’s discussion that we had on NPI.

So, with that, I would like to — I will just go down the order. Margaret,
so if you would go ahead and start, please.

Agenda Item: SDO Proposal Review

MS. WEIKER: As I mentioned earlier, I am Margaret Weiker with EDS, but I am
representing ASC X12 this morning. I am the vice chair of the Insurance
Subcommittee. I am also a board of trustee member for NCPDP and serve as the
lead standardization co-chair for the Standardization Committee. I am also a
member of HL7. They are unable to attend today.

I think they sent a letter to the subcommittee in regard to their absence.
They are fully supportive of the process that we have outlined before. So, if
there are questions in regard to HL7 procedures, et cetera, I may be able to
answer them. Otherwise, we just may have to go back and ask them if there is
something very specific that I may not know.

So, Lynne will actually read. So, I will turn this over to Lynne.

MS. GILBERTSON: Good morning.

The testimony delivered today on behalf of ASC X12, HL7 and NCPDP is a
continuation of the December 2005 testimony, where each SDO provided
information on this topic. In November 2006, the SDOs came back with a final
unified testimony on this subject.

In that October session, we provided you with a document entitled
“Proposal for the Modification of the HIPAA Transaction Standards Adoption
Process.” The document represents the SDO unified approach to streamlining
the HIPAA standards adoption process. This joint SDO prepared document examines
the current process, summarizes findings and proposes ways to improve the
adoption process for increased efficiency.

The joint SDO proposal was approved by all three SDOs and the approaches we
recommend can and will be implemented by each organization should HHS elect to
adopt this streamlined approach. Minor modifications during the testimony were
requested by the committee. We made those changes and submitted the final
document back to the committee soon after the October meeting.

The current process right now, 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 4.

Most concerning with the current process are some underlying assumptions;
that it is okay to wait until the NPRM process to review and provide input on
these final implementation specifications, which could be years after the
actual approval of the implementation specs. Based on public comments received
through this NPRM process, the approved published version of the implementation
guide is expected to be reopened and modified, republished, reballoted, the
whole process gone through over again, which could be years later than the work
that was done originally.

The regulatory process is not predictable, when it starts or when it ends.
It is potentially very lengthy and it compromises the ability of the SDO to be
responsive to the industry’s business requirements.

The proposed is included in this document as well. It retains many of the
existing processes. It 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 appropriate times. Additionally, we propose adding
steps that are critical to the process, such as the development of a benefit
analysis report, which has been requested by OESS.

Some of the highlights, the Federal Register, the HHS list serves, the SDO
processes, industry notifications, they alert the industry to the development
of an implementation specification. The industry is made aware and encouraged
to participate. Refer to Section 5.

The 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 industry
volunteer time is during the development of these specs. Individuals that don’t
wish to participate at the development level, can participate during the public
comment or ballot timeframe, however the approval process works.

The valuable input occurs during this public comment or ballot timeframe as
well. This involvement results in the collection of all technical public
comments at one time, while it is being developed, while it is being approved
and thus eliminates the need to reopen a published standard years later.

The collection of comments at one time improves the timeline for adoption.
The industry knows that their comments are discussed during this development
and during the ballot or approval process. Then another process involvement is
the Federal Register, the HHS list serves, the SDO processes, the industry
notifications. Alert the industry that there is a ballot approval process and
the critical dates and timelines so the industry is made aware and urged to
participate.

Then while the DSMO process that we currently have is underway, the benefit
analysis survey is conducted by WEDI. This is another opportunity for the
industry to be aware of the activities going on and to provide much needed
valuable feedback. The resulting report is provided to the SDO, the DSMO
Steering Committee and to NCVHS for their review. NCVHS receives public
testimony, which includes the recommendation of a change request from the DSMO,
a report of the survey findings from WEDI and public testimony.

Finally, the final rule is published in the Federal Register, based on
recommendations from the SDO, the DSMO Steering Committee and NCVHS. This
includes the adoption and implementation timeframe from the industry.

With these process improvements, important benefits are reached. The
timeliness and the 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 all the timelines.
Beyond the increased quality perspectives, timeframe estimates prepared for
both the current and the proposed process indicate potential time savings of up
to three years. We eliminate the possibility of an endless loop of NPRM change
requests that never move to a final rule. Please refer to Section 5.2.

ASC X12, HL7 and NCPDP thank you for the opportunity to discuss this again.
We have spent considerable time understanding the process, assessing 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.

Thank you very much.

MR. REYNOLDS: Before I open it for questions, just let me — what would you
like this committee to do? I will let you finish your letter.

MS. WEIKER: Well, Lynne and I discussed that this morning because we knew
you were going to ask that question, Harry. I didn’t know if you wanted —
basically, what we would like is for this committee to write a recommendation
to the Secretary to make any necessary changes, legislation, rules, whatever,
in order to allow us to implement the process that we have outlined in our
paper.

MR. REYNOLDS: I am writing that down with your names under it.

A couple other quick questions. The last three days — this is Simon’s and
my third full day of hearings here — I have heard the word, the term of art,
“the industry,” used many times. I think what yesterday pointed out
was that through everything that is going on, a portion of the industry or
portions of the industry are continually being missed through the communication
processes we use now. So, you used it a number of times. So, how with this new
process, which obviously if people — if there are a number of people who don’t
know they should have an NPI, then the fact that there would be an SDO, that
they are working on a standard or that that would be their point of input or
they should get involved is a gap that I think we are all struggling with, just
period, you know, is how does everybody talk to the industry, if we are going
to talk to the industry, you know, if we are going to use that term, you know,
magically.

So, speeding up this process a little bit, you know, because anything the
government says people tend to listen to a little more than maybe something
that is outside of that. So, help me construct how — you know, what else is
going to happen with what you are talking about doing that is going to raise
that level of involvement because, you know, it — sometimes the actual
standards development is not as visible as some other things.

MS. GILBERTSON: Okay. Quite a few things in that wisdom of Solomon and
patience of Job.

The concern is that we need to become predictable and timely with NPI, for
example. Everyone that — you can’t say everyone, but those who wish to
implement and keeping up with events knew the May 23rd, 2007 date and worked
steps to accomplish that.

One of those major steps was having a database to bank up against, to
support accurate information that would have to be shared. When you miss a
major step like that, you throw off all timeliness and predictability because
now you are building a project plan based on secondary or tertiary events that
you are going to try to buffer yourself. How can we get along with this when we
miss this step.

I think it is very important that if you are going to have milestones and
deadlines, you make them. Now, you know, the industry as a whole are — human
beings as a whole want change, but they don’t want to change. So, how do you
balance that? I want something because I want it, but I don’t necessarily want
to implement because you want it or I don’t want to implement what you asked
for.

So, we don’t use the term “the industry” lightly when we are
talking about it because there is a misconception that someone, perhaps, like
someone in an SDO determines what we are going to do moving forward with
standards, just to make everybody’s lives miserable and the SDOs do not
determine their schedules.

The SDOs consist of volunteer members from the industry, who say we want,
we need, we want to move forward and when they agree as a consensus body they
want to move forward, we come forward with the next specs and we bring them
forward. So, in that regard, the industry is who we are speaking on behalf of
because they have said we want to file a DSMO change request. We want to move
forward. But guess what? Our patience runs out when we will see you in seven
years before we can start implementing.

How do I build a project plan when I have no idea when an NPRM would be
issued or no idea when there would be an implementation timeframe I have to be
ready for? So, we are kind of giving mixed signals. You need to be moving, you
need to go forward, but we are our own worst enemies sometimes with why are we
still waiting.

Things that we have asked for in previous years, recommendations from the
committee, still have not seen the light of day. Now, there are various
reasons. We are human, whatever. But we keep giving the message of, well,
sometime it will happen. Meanwhile, how can I build a project plan when I can’t
implement that? If I do, I will be out of compliance. Now what?

MS. WEIKER: In regard to outreach, we all probably get 20 e-mails from list
serves or associations or organizations that we belong to in regard to
education. This is happening or this meeting is happening. We also realize that
a single doc sitting across the street is not going to come to an X12 meeting
or to an NCPDP meeting. They are just not going to do that.

I know in instances where we have actually practicing pharmacies, our
pharmacists come to the meeting, but yet he had to hire somebody to go behind
the counter so he could attend the meeting. You know, he is like what is my
cost benefit of doing this? So, more and more, our providers are relying on the
associations they belong to represent them in these arenas. I know at X12, we
have several that come in and represent and are very active and I think those
that were missing, as we heard yesterday, there were providers that didn’t
realize they even had to get an NPI, et cetera. Are there groups, associations
that these providers belong to or, you know, how do you reach those that are
not in the main stream.

I think we do have to look at where do they belong. What do they read?
Those kind of things, put an article in a magazine. So, I think the industry as
a whole needs to look at how do we encompass everybody and how can we figure
out to get the few that are sitting out here that aren’t in the know. But I
know from an organization, an SDO point of view, more and more relying on those
organizations and associations to represent them in that arena and we welcome
that.

MR. REYNOLDS: I am going to continue along a train of thought now and then
I will turn it over to everybody else.

So, the word “hurry,” “hurry this up,” not hurry
unreasonably — make it more expeditious, make it — okay. I am good with that.
But we continue to see that the other things that are getting implemented are
taking longer than we all wish.

So, using your term, you said it is volunteers. So, at a time where you are
going to take a process and make it tighter, in an environment where even when
we make it long, we miss people, are there are any — do you have any plans —
I didn’t see them in the record — do you have any plans, back to this idea —
there is a difference between volunteers because, obviously, you tend to get
the volunteers from the big people that can group up and take staff and send
them somewhere.

But maybe — you know, at least I would like to hear your words on the fact
that, you know — and everybody, you know, pays to be part of these and so on,
some dues or something — is whether or not there should be some standing
people making sure that some of these other things get recommended because if
we are going to shorten the timeframe, then if we are missing them in the long
term, we are going to miss them in the short term and then when it comes here
or any of the reviews that you are having, it puts a dramatic burden, a more
increased burden — not dramatic, I will be careful — an increased burden on
us and anybody else that you have set up as the public forum, to make sure that
those people are included, having those types of people that were discussed
yesterday, the smaller providers, the this, the this, the this or this in your
process in some way, to make sure that there is a complete look is a thought.

I am not recommending it. It is a thought. It is a question that I have
because as soon as you shorten it, you know you may run right by a whole lot of
people and that is going to then — somebody at some point is going to have to
go time out, we have got to talk and we have to make sure we get everybody.
Because the volunteer thing is still, you know — well, all of us struggle with
that at times as to who could volunteer for what.

If you could help me with that.

MS. GILBERTSON: One of the recommendations we did put in the paper was that
we use some of the existing processes to be more informational, the Federal
Register, the HHS list serves, to notify that work is even starting. Now,
granted, an SDO continues to constantly work on the new requests from the
industry, but here is a banner message. I think it would be very helpful to
also see how far reaching those list serves might be within organizations.
NCPDP notices are shared with X12, HL7, our organization and association
contacts, things like that.

So, I think we have a lot of far reaching. How far down we get I can only
guess. But we seem to have a lot of information going out, but adding all those
different features of the actual steps, here you were doing this now. Here you
were doing this now will help. I think if we are trying to get to the actual
provider level, we are probably fooling ourselves because what we need is
association organizational assistance. They perhaps don’t want to worry about
is this a data field or 6 bytes or 25 codes or whatever. They want to know what
is the practical implementation. How is this going to affect me?

So whether we notch up the EMP(?) guides a bit so there is more business
examples in there, that might be helpful, whether there is more expansion on —
NCPDP is doing web casts right now on Version D.0 to say here are the business
cases we are bringing into this new version, please join us. We will talk about
what your questions are, things like that. But once again, that is more of a
technical perspective because we are not going to tell people how to do their
business. We are just going to say here is what the specifications mean based
on your business needs.

So, perhaps some more joint WEDI sessions, association sessions, things
like that, where people can pop in, listen if they want. At that level, we
might get a percentage of less than the null.

DR. FITZMAURICE: As I listened to this, I am really in favor of speeding up
the process, but I also read something in the paper yesterday or the day before
about habeas corpus, which relates to due process and applied to us it means
getting public comment and public influence and doing our own due diligence
consideration. So, as I see the process, you would have a federal registered
notice of the process of the development of the standard or modification of the
standard. Everybody come and join in and bring your considerations.

You then have the SDO development of the modification or of the standard
and an SDO ballot. Let’s say a Federal Register notice of the ballot and the
way to get every member of the public into that ballot may be paying a small
postage fee for having the ballots mailed if they are mailed in. That is up to
the SDO.

So, we are getting notices out there. We are trying to alert the public
about this. Then it goes to the DSMO. The DSMO does its thing and says, all
right, we are ready to go. We agree with it and we got good public comment. We
send it to NCVHS. NCVHS looks at it and says, yes, a little tweaking here or
there after the tweaking. We say, yes, it really looks good and where do we
send it.

We can’t send it for a final rule. So, we have to send it to the Secretary.
The Secretary receives it, says who is responsible for this, sends it to CMS
and it goes through the regulatory process that will lead to HHS approval and
OMB clearance and then to Federal Register publication, assuming it all goes
through smoothly, publication of final rule with comments and a compliance
date.

Now the public can then write in and comment but if the comments aren’t
substantial, then it holds. I don’t know that it speeds up what goes on with
our due diligence, with what goes on within the agencies, within the
Department, even within OMB. If we could pinpoint more closely where the
holdups are and the reasons for the holdups, then we might be able to attack
those.

I am for this process. I am for making it work with the Administrative
Procedures Act, but once it gets inside of HHS, I don’t know how we can do our
job faster. I think maybe we can do our job faster. I think having the public
looking at this and saying we did it in this time period, the clock is ticking
for you, not that something is going to go off, but the public will be watching
more closely. I would hope that that would also speak up the process and get
more cogent comments in more quickly.

MS. GILBERTSON: One of the things to consider, I don’t want to use the term
“speed” because that is not what this is about. If the industry wants
six years to implement a standard, the industry will recommend that and that
should be what goes forward. If the industry wants 18 months for something
else, that is the industry recommendation. So, we are not talking about speed
of how fast we are shoving things out to the industry. It is when the industry
asks and gives a timeframe that we try our best to adhere to those kind of time
frames.

You know, I am accused of living on Planet Utopia a little bit and I know
there have been extensions and things like that, but I also think that if you
have a plan and you know what you are expecting and things fall within that
project plan, you are not going to deviate that much. What I am more afraid of
is if the industry asks for it, they are still waiting for it six years later.
To begin the process of the NPRM, they are still waiting for it years later.
Nobody believes it.

MS. WEIKER: A perfect example of that, putting on my NCPDP hat, is a
recommendation this committee made in regard to the billing of supplies. That
is basically just fallen into a black hole and contingency rules, plans, are
still in place and will be in place until we have some final resolutions.

So, you know, as Mike said, you get to a point and then it just kind of
sits there and it falls into this nebulous, you know, worm hole, as Lynne might
say, that says, okay, now what? Now we sit and wait. We have all done our due
diligence. We have all done our work, but now it sits and what do I do?

DR. COHN: I am really not going to ask a question. I am just going to give
a very brief comment and I will apologize if my facial look sort of telegraphs
my thoughts. I just want to way I am very sympathetic to the issue of
identifying — you know, having the process be predictable and I think that is
really what we are all seeking.

Obviously, from my perspective, having heard — I mean, this presentation
you are giving today is not all that different than what we saw three or four
months ago or was reflected in one point proposed federal legislation, which
obviously, didn’t go far last year or didn’t make it completely through the
process last year.

Obviously, I think our intent today was to not just hear from you but also
hear from others in the industry to get wider thoughts on all of this stuff.
But regardless of exactly how everything looks, I think we are all very
committed to the increased predictability of the process. I guess I should also
comment that — this is obviously maybe not as brief as I had thought — I had
the opportunity to give a presentation recently about HIPAA after ten years.

Certainly, one of the things I observed in the — at least from my view is
that the industry doesn’t appear to be able to tolerate lots of change and,
indeed, we are at this point from my view only really moving from
implementation to optimization. I am only really now beginning to hear from
people in the industry about the desire to sort of move to new standards, at
least in a couple of the areas. I mean, NCPDP may be different. We need to
somehow have a conversation about why you are different, but I certainly am
just observing at this point that people as we are beginning to optimize CAQH,
WEDI and all this, that there is suddenly beginning to bubble up actual genuine
needs for now modifications to the standards. So, that is just another
reflection that obviously the conversation is timely but that the industry
really wasn’t ready for it, seemingly, up until very recently, in my
observation.

So, anyway, it is not a question. It is just a comment. I am looking
forward to the other industry comments on the proposal.

MS. GREENBERG: Two things. One, on the issue of outreach. I think those of
us who were here yesterday, the first speaker was from the National Minority
Quality Forum and it struck me that one — I thank Denise for bringing them in,
for bringing that organization in. I am not sure we have heard from them
before, but — they may be a group that you are well aware of. But given your
comment and I think it is true, that associations, consortia, you have it, are
really the ones who have to do the heavy lifting of trying to find out what
their constituencies want and then representing them in the standards
environment, which is getting increasingly busy.

I mean, as we meet here today, I don’t know there are about three other
meetings that each of us could probably easily be at and another ten we don’t
know about. So, I think that is a realistic approach. But I am thinking that
the associations also — and maybe you already do this, but need to partner
with groups like this and other groups, who are — who represent members of the
profession, but who are not as commonly seen certainly in these meetings and
probably in your meetings as well.

So, I just wanted to mention that because I know you weren’t able to be
here yesterday. It strikes me that that would be a useful collaboration.

The other thing is I was really taken — not that I am sure it is the first
time it was said, but what Lynne was saying about being predictable and timely
and, of course, being the opposite of predictable and timely, which is the
process seems to be now. As you said, this is partly the real world and we
don’t really live in a predictable and timely world, it seems, but we can
strive for it.

I was thinking the original report by WEDI about the potential for savings,
administrative savings, with administrative simplification, which I know we
haven’t realized yet, but I think there are still — we all kind of still
ascribe to that potential — was very effective because it really focused on
the business case and the real savings potentially in dollars, as well as
improvement hopefully in quality and somebody yesterday referred to quality
driven efficiency or something, which was something I thought was nice also.

I wonder if it would be helpful to make this case to try to do something
like that again about the actual business case for predictability and
timeliness in light of what, as you were describing, what members of the
industry can do in that kind of environment and what all the costs are of
unpredictability and lack of timeliness. I mean, I think we all agree that
these are good goals, but if you could actually do some of that kind of benefit
analysis, like was done in those original WEDI reports that might get some
attention, from policy makers. Maybe you have already done this, but I don’t
know that I have seen it because there are real specific costs here, staff
costs, research costs, planning costs, false implementation costs, all of that.

MS. WEIKER: I agree and I know there have been organizations that have
looked at other transaction because everybody talks about claims, claims,
claims. Well, there is a whole bunch of other HIPAA mandated transactions.
Eligibility, and that is getting some traction now with the CAQH initiative and
the cost savings, they are trying to, you know, put dollars to some of that.
Then you start looking at like prior authorizations and what has happened is
once people start opening some of these guides and these guides we have to
remember are ten years old now and they are like, oh, wait a minute, the
business is now this and how do I do it in this guide that was written long ago
that maybe I didn’t pay a lot of attention to because I was looking at claims,
which does affect your cash flow, but in the long term to truly get those
savings and to move away from the paper based environment is you have to
implement those other transactions.

As an example, I saw recently where it cost like $4.70 to do one prior
authorization and if you could automate that to where I don’t send in all this
paper, then, obviously, anytime you start doing that, you start reducing your
costs. You reduce your clerical, mailing, posting, et cetera.

So, I agree, some of those studies are kind of just now being done, but
they are being done very silo-ish, so to speak. Maybe that is something WEDI
should do is go back and say, okay, we wrote these papers X years ago. Let’s go
update them. We know so much more now than we did then and add the process and
the timeliness and the challenges we all have and had.

MR. BLAIR: I want to sincerely commend the work effort that the DMSOs have
made in trying to see if you could come up with a useful way to streamline the
process. I mean, this is not your first draft. You wound up doing a first
attempt, listening to the response you got when you came to us before,
improving it, there are certain things that to be honest with you, you probably
would have liked to have streamlined further. On the other hand, there is the
balance because you still have to have a diversity of constituency groups that
are heard. It still has to be a deliberative process.

So, within the constraints of a consensus-based process and diversity, I
think you have made a major step forward. I strongly support the
recommendations that you have given us. I think you have given us the
recommendations within the context that history has played out so far, which
has been HIPAA. HIPAA is still going to be with us, but we are trying real hard
to move beyond HIPAA. There is the Consolidated Health Informatics Initiative
Standards, which I would like to be considered as part of this streamlining
process.

I don’t know if that means that we have to revisit these. I hope not. I
would really like for the thoughtfulness, the benefits of this process to be
examined by an array of other SDOs that have been beyond the scope of the
DSMOs.

My wish is that a lot of them would look at this process and say this is a
helpful process. They will sign on. Maybe you have other ways of looking at
that. But clearly where we have national goals to try to implement electronic
health record systems as quickly as possible, e-prescribing as quickly as
possible, to try to move towards a nationwide health information network as
quickly as possible. RIOs are struggling against areas that haven’t been
defined.

I think the issue of trying to streamline the process has gotten even more
urgent and at the same time, the diversity has gotten broader. The challenge
has gotten greater. So, anyway, I will summarize my comments by saying — by
maybe asking you both a question is have you thought about saying that the
streamlining process would be broader than HIPAA, would include the
Consolidated Health Informatics Initiative, maybe HISPE(?) and whether you have
reached out to those entities to see if they would also concur. Maybe that
would broaden and strengthen the constituencies to support the acceptance of
these recommendations and if you haven’t, if you have some good approaches to
try to do that so that there is not further delays and we could take advantage
of the streamlining process as soon as possible.

So, that is my question to you.

MS. GREENBERG: I cheered when you mentioned CHI, by the way.

MR. BLAIR: You cheered or —

MS. GREENBERG: Marjorie cheered.

DR. STEINDEL: Marjorie, Steve turned in chagrin when it was mentioned.

MS. WEIKER: Yes, we were watching the different faces.

MR. BLAIR: All right. Then, obviously, I don’t get to see all of the faces.
So, I welcome all comments and views.

MS. WEIKER: Jeff, what the three SDOs looked at was we looked at the
process, was the HIPAA process that we are bound by into through legislation,
through regulation and he said here is the HIPAA process here at the APA. This
is what we are tasked to do, so to speak. That is the process we looked at and
involved people with.

We did not go into CIH, HISPE, the SDOs are involved in the HISPE effort
because they are looking at their use cases and saying what standard fits this
particular use case, what data set, et cetera — did go to the SDO, but that is
outside of a different process versus what we have been mandated and regulated
to do in regard to HIPAA. So, we just looked at the HIPAA process because right
now that is what is legislated and regulated for the SDOs at this point.

MS. GILBERTSON: And I would not recommend other SDOs having to be under
HIPAA if they were to ask.

MR. BLAIR: I never would have thought of it as being under HIPAA. I was
thinking of it as good work that you have recommended as a process to try to
streamline building consensus among SDOs and having it go through the
regulatory process, to federal adoption of standards. That is the way I was
viewing it.

So, do you still feel as if — that we have to look at this as, quote,
under a HIPAA process?

MS. GILBERTSON: Well, one of the things that is going to happen since we
are all very involved in HISPE, for example, is if the use cases ask for
modification, we are stuck. They have to wait until the next version of HIPAA
is adopted because we can’t change the standards we are being asked to enhance
because of the use cases.

So, as part of the standards readiness that we worked on in HISPE, we
recognized that one of the criteria that have to be looked at when they are
evaluating standards, code sets — “standards” is a very broad term
under HISPE — we have to pay attention to whether or not there are federal
regulatory legislative constraints that a particular standard might be under or
need to be used because of.

Now, another Tier 2 criteria is that it is represented in NCVHS
recommendations and HHS recommendations, in CHI recommendations. So, we do use
that as Tier 2 criteria under HISPE. So, there is very definite collaboration
going on in that respect, but what we have a concern with is, okay, let’s move
the industry forward, based on what the business need or what the use case is
or whatever, but you can’t use it. That is not a very favorable environment.
So, I am not sure if we completely answered all your questions, Jeff, because
we are collaborating. We are trying to move things forward. But the regulatory
process as it exists for the HIPAA transactions right now because I can’t
address everybody else’s regulations, tie your hands instead of moving you
forward.

Did we miss any other points, questions?

MR. BLAIR: Maybe what you are saying is that — and this is not clear to me
and maybe this is why Steve winced. I don’t know. Maybe he could explain. Are
you saying that other standards, for example, I am just throwing some out as
examples, not from an advocacy standpoint, all right? We have ANSI accredited
standards like SNOMED International. We have other entities that are promoting
standards like IHE, where the STM standards that have created CCR, that is ANSI
accredited. We have — and you can start to go down the list in terms of other
ANSI accredited and ISO standards, a whole bunch that are a part of CHI, that
we would love to be able to move forward as quickly as possible.

I don’t know whether or not we move them forward by leaving them out of
this process or having them join the process. Maybe if somebody could answer
that question, that would also help.

MS. GILBERTSON: Could you explain what you mean by move them forward?

MR. BLAIR: Let’s take RX-Norm. I will just throw in another one. All right.
We are going to wind up wanting RX-Norm to be available for e-prescribing. Is
it going to have to go through the NPRM process analogous, the HIPAA process
and then the next time we have a version upgrade of RX-Norm, we are going to
have to wait four to six years for a version upgrade? Or is the fact that it is
not a HIPAA standard, does that mean it could move faster?

MS. GILBERTSON: Yes.

MS. WEIKER: Yes. The industry wishes.

DR. COHN: I just want to clarify, Jeff. I sort of hear where you are going,
though. Under HIPAA code sets can be updated at least yearly and more often
than that once they are identified as a standard. You may have other examples
you want to give, but, remember, ICD-9, CPT, NDC, et cetera, all are named as
code sets through any of these methodologies, don’t require the process you are
describing. So, this is an issue of clarification. You may have other examples.

MR. BLAIR: So, SNOMED, RX-Norm and LOINC, for example, they could move
faster. They are not limited is what you are saying? We can have version
upgrades in those more quickly.

MS. WEIKER: Well, there are two kinds of things when you talk about a code
set. You have I am implementing ICD-9 and that is in HIPAA and that is what
must be done. But let’s say I want to move to ICD-10, for example. First,
because you want that code set used in your claim, in your eligibility, in your
whatever, whatever, that now has to go through the DSMO process because the
DSMO is responsible for those code sets that are part of HIPAA.

So, if I want to go from 9 to 10, you have to submit a DSMO change request
and it goes through this process. Also, the SDOs would have to make sure that
the qualifiers are in the transactions and those type of things as well before
you could use it. But let’s say once I named ICD-10 or I have named ICD-9 it is
currently named, I can add codes to that code set monthly, yearly, daily,
whatever, the process of who maintains that code set has, like for NDCs, you
could do that weekly and it is done weekly.

MR. BLAIR: It sounds like the thesis of what I was proposing was wrong. I
just heard an “uh huh” from Steve. In other words, the — it sounds
like the HIPAA transactions and code sets are constrained by federal laws. The
CHIs are not. They could move forward more quickly and we ought to leave the
CHI standards out of this and just do what we can to move the HIPAA standards
process forward with what you have proposed and keep them separate.

MR. REYNOLDS: What I would like to do now is thank you very much for
presenting because I think I agree with Simon. We are going to have a
discussion after our break on this. First, we are going to have the reactor
panel. So, you guys, as you know, we think you have done a great job the couple
times you have been here. So, we are anxious to now hear from others as to what
they think about it, other than just us. So, if we could go ahead and get that
panel up and get started right away.

Then after they are done, we will take a break and then we will discuss it.
Thank you.

[Pause.]

MR. REYNOLDS: Let’s get started. Our next panel called the reactor panel —
that is an interesting headline — so we look forward to it and I will just go
down the order of the presenters here. So, Tom, we will have you go first,
please.

Agenda Item: SDO Reactor Panel

MR. WILDER: Thank you very much. Good morning.

My name is Tom Wilder and I am the senior regulatory counsel for America’s
Health Insurance Plans. I want to thank the committee for the opportunity to
join you today to talk about the process that is used to adopt, modify and
implement HIPAA standards.

AHIP is a trade association. We represent about 1,300 health insurers and
our members literally on any given day process millions of HIPAA transactions
for a variety of business operations. I think the paper that is presented to
you and the recommendations from the three SDOs does a very good job of
outlining some of the concerns and frustrations with the current HIPAA process.
I think there is pretty widespread agreement among the industry if you will
that the process that is used now not only to modify existing standards, but to
adopt standards at the front end and to implement them at the back end is
dysfunctional.

Again, the paper, I think, provides yu with a good sense of what some of
those concerns are. I think that the paper is good as well in that it really
kind of forces us to have a discussion that the industry has needed to have for
some time about how to get that process fixed and I have some suggestions and
recommendations in my testimony. It is by no means I think all of the things
that I think need to be considered but they are just some things that I would
lay out for you.

First of all, I think that for most of the industry, the process that is
used to adopt and modify standards is a black box. Most of our members really
don’t understand who the SDOs are, what they do, why they do it and why it is
important to them. So, I think it would be very helpful for the SDOs to
actually sit down and perhaps in cooperation with CMS to actually put down in
paper, in a white paper or other documents a clear outline of who they are,
what they do, how they do it and most importantly why the industry should care.

The SDOs are correct. There is industry involvement. There obviously needs
to be more industry involvement, but typically those are the folks who are
really kind of standards experts. They get really excited about what a loop
segment is. There is not a broader understanding amongst — and I am not saying
that to be pejorative. There is just not a broader understanding amongst the
CIOs and the CFOs and the others about, you know, why this process is
important.

Secondly, I think it would be very helpful for the SDOs to reach some kind
of common agreement on a standard process that they can all use together in
conjunction so that there is a — and, again, I would put this in this paper, a
clear explanation of here is how you submit a change request. Here is how it is
considered. Here is the deadlines for those considerations. Here is the
balloting process that we are going to use for that balloting process.

As you know in any business organization, you have got to have
predictability. So, if the deadlines were sinked up amongst the three
organizations, at least there would be some common process at the front end
that everybody follows to get change requests considered.

Thirdly, I think it is important for everybody to have a better
understanding of pilot testing. I know pilot testing has been very valuable in
some of the recent HIPAA standards considerations but there is not a very good
understanding of what pilot testing is and when it is needed and when it is not
needed and how best to incorporate it into the process.

Right now, it is done typically after the NPRM comes out. Maybe it should
be done earlier. I don’t really have a clear answer to that, but I think if the
standards organizations and CMS, again, could sit down and kind of talk through
with the industry the value of pilot testing, who needs to be involved in pilot
testing and when it could be plugged into the process, I think that would be
very helpful.

Finally, in terms of at least the recommendations I have in my testimony, I
think the opportunity for public comment at the agency level must be preserved.
That is comments after the NPRM comes out. I would agree with the
recommendations in the white paper that earlier public notice would be very
helpful, earlier opportunity for the industry to comment at the standards level
is critical and I think that will resolve most of the issues.

But first of all from a strict legal perspective because this is a
regulatory process, from the standpoint of the Administrative Procedures Act, I
don’t think you can actually do away with public input at the rulemaking
process. I think it is very important to preserve that public input because
again when a standard is being considered, those folks who are intimately
involved in the process, they are members of the standards organizations. In
some cases they have paid a fee to below to that organization and when you get
to the rulemaking, it is then when the wider public at large, if they choose
to, can actually write into the agency and say, you know, yes or no, this
concerns me because of X, Y and Z.

In the earlier panel, they actually talked about the billing for supplies
issue, without going into the detail of that. I was involved in some of those
discussions and recommendations to the NCVHS and it wasn’t until the rule was
actually published and some of the folks actually started to look at it, that
is when the red lights went off.

So, sometimes, regrettably it is not until the very end that people
actually start to kind of recognize where there are problems.

Finally, I would like to just take a step back and just make a general
comment about, again, the process from beginning to end. This is something
actually that Blue Cross and Blue Shield Association, I think, made in some
earlier testimony, either to this group or to another forum. But they actually
suggested that there be what they called a critical path analysis of the HIPAA
process.

I think that is a great idea. I think in some forum, either here at NCVHS
or perhaps WEDI or another group someone needs to actually sit down with
everybody in a room and just think about the process that is used from
beginning to end and how we can do a better job of improving that process.

To Jeff’s point, I think some of the other standards organizations need to
be involved in this discussion. I would not want to bring everything under
HIPAA. HIPAA is good because it actually sets some firm deadlines and has an
enforcement so everybody knows they need to follow those standards. But because
it is embedded in the regulatory process, that is where I think a lot of the
delay and slow down comes. So, I think the industry through some form really
needs to kind of take a step back and say, okay, we know we need these
standards. We know we need to have predictability. We know that we need to have
a deadline upon which everybody can rely.

We know that we need to have some kind of mechanism that forces everybody
to follow that deadline. How can we do it in a way that is a lot more rational
than what we have now?

I thank you again for the opportunity and at the end, I would be glad to
answer questions.

MR. REYNOLDS: Tom, thank you.

George, we will go with you next.

MR. ARGES: All right. Chairman and members of the subcommittee, I want to
thank you for the opportunity to be here today and talk about the proposed
modification to the HIPAA transaction process.

We know that the SDOs follow the American National Standards Institute
process, which unfortunately does not always have the benefit of full provider
participation. I have often heard that providers need to become more involved
and engaged, but the realities are that it is difficult for providers to
basically send someone to these meetings and will likely remain so in the
future.

In many respects, the purpose for the creation of the Designated Standards
Maintenance Organizations was to give providers a voice in the review and
approval of changes to the implementation specifications as outlined in the
HIPAA standards. As you know, the DSMOs include each of the ANSI SDOs, as well
as the three data content committees, the Dental Content, the National Uniform
Billing Committee and the National Uniform Claim committee.

Each of these content committees really strives to bring forward the
provider viewpoint on important decisions that can influence the HIPAA
transactions. The content committees look at the policy implications of a
change and how it would affect the operations of the provider and the health
plan.

The DSMO focus is not so much on the technical side of how a segment within
the electronic transaction carries information, but rather on the policy and
implication that a change will have on the day to day business routines of each
constituency represented on these committees. This includes instructional
narrative to help users better understand when and how a particular data
element should be used.

The DSMO was created after the final rule on the HIPAA transaction
standards was published. One of their first tasks, obviously, was to conduct a
fast track review of how these transactions would apply and that in essence led
to the Addenda versions of the current standards. Once the initial effort was
complete, the DSMOs turned their attention to reviewing suggested changes for
future transactions.

A number of these changes have been incorporated in subsequent versions of
the standards. Generally, all of the DSMO have worked hard and worked well
together to basically include some of these change requests. The volume,
however, of the DSMO review has decreased substantially in the last several
years, but in examining the 005010 version of the claim standard, we also noted
that 85 percent of the changes were not brought before the DSMO for review.
Fortunately most of these changes are not substantive and include many
improvements in the structure and the instructional material that make up the
standard.

We want to emphasize we want to commend the X12 group for a lot of these
improvements. The question of whether the AHA is prepared to support the next
version of the existing standard can be answered as a simple and strong
“yes.” The 005010 version includes many changes that the NUBC brought
forward such as diagnosis indicator reporting and future changes to support
ICD-10 coding.

In addition the NUBC and X12 have worked closely to make improvements to
the claim transaction, for instance, in the interpretation of the inpatient and
outpatient applications of the transaction standard. This version contains
significant improvements that should be adopted as a replacement to the
existing standards and we wholeheartedly support moving that as quickly as
possible.

But there are more questions that remain unanswered and require attention,
questions as to whether the current process is working at its best and whether
there are opportunities or areas where the process could be made better. These
are some of the issues hat I believe require immediate attention.

We know that the current process takes too long and presents us with a take
it or leave it dilemma. As a whole we need to establish a process that relies
on incremental stages for earlier input and review. The process must include
all affected parties and must involve DSMO input throughout the development
process.

Over the years X12 has made improvements in how they manage requests for
changes, but the establishment of a more rigorous outreach program is
imperative. This includes adopting a public mechanism that logs and posts all
change requests. In addition, it should actively seek the review from the other
DSMO members as they are looking at changes that are brought to their SDO work
activity.

Additionally, it would be beneficial to publish an advance notice of change
items up for review in advance of the trimester meetings. This would help alert
affected organizations of upcoming issues and provide them with an opportunity
to comment. We realize that X12 is composed of volunteers and that this would
impose an even more burdensome work activity on this individuals. But initially
this may be difficult to apply, but in the long run, I believe, it will make
their job easier.

We would expect that minutes to the workgroup meetings and discussions be
made available and accessible through a single central portal that would first
serve as a central point of reference and provide a better understanding of the
issues before the SDOs.

Formalizing this process would improve the outcome and increase the
awareness of the upcoming changes under consideration. While many of the X12
workgroup leaders strive to apply these goals informally, communication
vehicles are often not formalized and vary from workgroup to workgroup. Some
workgroups utilize list serves and different web boards. Others rely on
periodic conference calls. This makes it difficult for individuals, especially
those who are unable to attend the trimester meetings, to find, review and
provide input on various workgroup activities.

As I noted earlier, 85 percent of the changes in the implementation guide
were made without prior DSMO review. Greater communication and involvement
earlier on is the key. Last year, Congress worked on a bill, HR4157. It
included provisions to expedite the change process for the HIPAA transactions.
It relied on notice and publication during three distinct points in the
standard setting process. The first would be a notice that ANSI will begin work
on the development of the new version of the implementation guide. The second
notice would occur when a draft of the guide was available for review and
comment and then third a notice would be posted to indicate that a final
implementation guide was available for review.

By the way, I believe it included a final opportunity for input through the
NCVHS hearings on whether appropriate outreach and input had occurred and to
entertain any other final comments from any interested individuals or
organizations. We would expect that the DSMO organizations would be engaged
throughout this process, particularly during the first two phases. This will
allow us to help correct any areas where there may be some egregious element
that may have been added or changed, that would adversely affect health care,
but fundamentally the AHA is supportive of the stages that have been outlined
in that proposed piece of legislation. We do believe that improvements and
better communication throughout the development process is essential and that
the DSMOs must play a more active role throughout that development cycle within
the X12, as well as other SDOs.

In conclusion, we want to reiterate our support for the adoption of the
next version of the X12 standards and we would urge NCVHS to encourage change
to the existing process, hopefully, one were X12 and the DSMOs can increase
their communication and review of future changes under consideration.

Again, thank you for this opportunity to present today.

MR. REYNOLDS: Nancy.

MS. SPECTOR: Good morning. I am Nancy Spector, director of Electronic
Medical Systems of the American Medical Association.

As some of you may be aware, I am also chair of the National Uniform Claim
Committee, which is a member of the Designated Standards Maintenance
Organization and I also served as the 2006 chair of the DSMO Steering
Committee.

The AMA would like to thank the National Committee on Vital and Health
Statistics, Subcommittee on Standards and Security for inviting our input on
the proposal for modification of the HIPAA Transaction Implementation
Specifications Adoption Process as put forward by the Standards Development
Organizations of the DSMO.

The AMA’s comments on the modification proposal that I am presenting here
today are based on policies that have been developed by our House of Delegates
at various times over the last several years. They are part of larger policies
that do not necessarily speak just to HIPAA modification, but they provide an
overview of the physicians’ view on this topic.

To begin, the AMA supports the ongoing development and use of standards for
electronic data interchange. Policy adopted in 2000 asks in part that our AMA
continues to facilitate the rapid development of uniform, industry-wide,
easy-to-use, low cost means for physicians to exchange electronically claims
and eligibility information and remittance advice with payers and others in a
manner that protects confidentiality of medical information and to assist
physicians in a transition to electronic data interchange.

A second policy reaffirmed in 2004 calls in part for our AMA to advocate
the use of standards that are continually modified and uniformly implemented.
The business needs of health care are continually evolving and, therefore, the
standards through which data exchange occurs need to continually be modified
and updated. Without ongoing modifications, the standards and implementation
guides become outdated and may no longer support the administrative needs of
the physicians or the industry as a whole.

Technical changes to match new health care needs are not the only reason
for modifying the standards and implementation guides. Clarifications in the
instructions of the guides themselves are needed to improve the processes the
guides support. For example, since widespread usage of the X12 version 4010
implementation guides began after they were named in 2000, the industry has
learned much about the instructions of the transactions.

In some cases, instructions were found to be unclear and ambiguous or
business needs changed since the original writing of the guides, which led to
various interpretations. This created an added layer of burden to physicians
and the industry when various interpretations were implemented.

The AMA is aware that the X12 5010 Technical Report 3s are being brought
forward through the DSMO process for consideration for adoption. We understand
that many of the overall improvements in these guides are clarifications to
instructions, which make the requirements for the transactions clear and less
burdensome for physicians. Specifically, the situational notes in the
transactions have been restructured and rewritten. The Situational notes are
used to clarify the business content, clarify the format of the data content or
indicate relationships in data content between different transaction sets. The
improved situational notes provide very clear rules as to when each element is
to be sent and when it is not to be sent with a focus on data requirements when
they are known to impact adjudication. This will result in improved
standardization and clarity among the guides and in the industry’s use of the
guides.

The many improvements that have been made in the newer versions of the X12
TR3s emphasize the need to continually modify and update adopted standards.
Improved standards and implementation guides will assist the industry in
continuing to move forward with better business processes and may also entice
those in the industry that have not yet implemented electronic systems to do
so.

Next, the AMA supports the proposal’s call for industry input at the
development stage of the standards and implementation guides. AMA policy
reaffirmed in 2002 asks in part that our AMA encourages physician participation
in the appropriate national organizations involved in the implementation of
HIPAA regulations.

The SDO’s proposal is for more industry involvement to occur at the
standards development stage and calls for notification through the Federal
Register of SDO work beginning on new versions of standards. The intention
would be to reach the widest range of interested parties and encouraging them
to participate in the work. In addition, the proposal calls for the Department
to announce the approval process for a new version through their far-reaching
federal list serves, again, encouraging participation at this stage in the
development of the standards.

The AMA supports the proposal for early notification of the SDO work and
encouragement of more participation at this level. Currently, the AMA
participates and contributes in X12’s work developing standards and
implementation guides and will continue to do so.

Overall, the AMA does have concerns about the current level of
participation by providers in standards development compared to other segments
of the industry. For standards and implementation guides to be well-received
and widely adopted by the industry, there must be equal participation in their
development. The AMA will be happy to work with X12 to further explore possible
ways to improve not just physician involvement but provider involvement as a
whole.

I just want to address Margaret’s comment from earlier that there are many
associations that are involved with X12 specifically and, yes, they do
represent a wider range or broader number of providers, their members, but when
it comes to business matters, the associations have one vote as a member of X12
and even though they represent hundreds of thousands of providers, they still
have one vote compared with the other members that are there participating.

Finally, the AMA would like to voice our concerns about the frequency of
the adoption of modified standards and implementation guides. AMA policy
adopted in 2000 calls in part for our AMA to study strategies on implementation
of the HIPAA regulations, such a limit on the frequency of modifications, which
will lessen the financial impact on physicians. A second policy adopted in 2001
calls in part for our AMA to continue to aggressively advocate to Congress and
the Administration, physician’s concerns with the administrative simplification
provision of HIPAA and that the AMA seek changes, including legislative relief
if necessary to reduce the administrative and cost burdens on physicians.

The AMA recognizes there is a balance between too few updates, resulting in
outdated standards and guides and too frequent updates, resulting in
administrative and financial burdens for physicians. Clearly, there are costs
and benefits of upgrading to newer version of a standard. The benefits are in
having better transactions that more closely meet the physician’s business
needs, which I spoke of earlier. The costs are literally the financial costs
for the physicians for the necessary system upgrades or costs that are passed
onto them by their vendors. In addition, there are other administrative costs,
including staff training, possible interruptions in the processing of
transactions and the general overall time spent on the implementation.

The question of how often to upgrade to newer versions of standards and
guides is really a double-edged sword. If modifications are not made often
enough, the work necessary to complete the modification will presumably be more
extensive and costly, which we are currently facing with the X12 4010 version
to the 5010 version. One could argue that more frequent modifications involving
a smaller number of changes would be easier to implement and cause less
widespread disruption and upheaval in the industry. Unfortunately, there is no
evidence at this time as to which is more costly, the smaller, more frequent
modifications versus the more extensive, fewer modifications.

The SDO’s proposal addresses the lack of predictability in the current
process and a lack of agreement on how often the industry wants to move to a
new version of a standard. The AMA agrees with their comments that knowing the
process and associated timelines will enable physicians to manage and allocate
resources for competing initiatives. Also, the industry needs to reach
consensus on when to proceed to the next version and this is an industry
decision, not an SDO decision.

Perhaps these are questions that could be answered separate from the
proposal in terms of the step-by-step modification process and the AMA would be
willing to work with NCVHS and other interested organizations in addressing
these questions.

In summary, the AMA supports the use of continually modified and uniformly
implemented standards and early involvement by physicians and the industry in
the standards development work but has concerns about the frequency of
modifications because of the potential financial impact and administrative
burden that will be placed on the physicians.

The SDO’s proposal raises many good questions about not just the steps for
modifying the standards, but about the overall process of which it is a part.
Now that the transactions and code set regulation has been in place for several
years, it seems appropriate that we as an industry review the process and take
necessary steps to improve it so that we can achieve the administrative
simplification we are all looking for and the AMA would be more than willing to
participate in this work.

The AMA hopes that you have found this information to be helpful and we
look forward to working further with the subcommittee, the full committee and
the Department as this proposal continues to be evaluated. Thank you again for
the opportunity to testify today.

MR. REYNOLDS: Thank you, Nancy.

Kathryn.

MS. KUHN: Hello. My name is Kathryn Kuhn and I am representing the National
Community Pharmacists Association. Thank you for allowing us to testify on
behalf of this important topic. I would like to point out that NCPA does
represent independent pharmacy marketplace. I did share these specifics with
you yesterday. So, I won’t review them again with you today.

What we would like to do is point out a couple of things that we see as
problems with the current HIPAA standard modifications process and then point
out a few recommendations for how we would like to see that process change
moving forward.

First of all, the one major problem that we see with the current process is
the DSMO process. In our experience when a change request enters the change
request system, the SDOs collectively evaluate and ultimately vote on the
change request. But typically the SDOs in general don’t lack the expertise to
evaluate a change request if it is outside of their domain. So, they must defer
to the SDO with the relevant expertise.

So, what results is you have all these SDOs that can’t deal with a topic or
change request because of their lack of expertise outside their domain. So,
they end up abstaining in the voting process. So, we feel like this aspect of
the HIPAA modification process is very ineffective and needs to be reevaluated.

Secondly, we would agree that there needs to be more timely adoption of new
implementation specification standards. For example, if you look at the
regional pharmacy transaction standards today that we are using, which is the
NCPDP version 5.1, NCPDP actually since that version has been implemented has
developed another version that currently exists and it is more than 20 versions
advanced from 5.1, which is currently in draft form and that would be version
D.0.

Some recommendations that we would like to see incorporated moving forward
as part of the HIPAA modifications adoptions process is support for an
abbreviated process and we would encourage this so that more timely adoption of
standards could occur. We also support what was being proposed by the SDOs,
continued use of the WEDI cost benefit analysis surveys to study the impact on
materially affected parties, particularly including the provider community. In
developing the WEDI surveys, we think that substantive quality survey questions
should also be developed by a broad cross section of the industry and not just
limited to the SDOs.

The survey questions should address impact on technology, implementation
costs and requisition of additional patient data. They should also address
impact on provider work flow and potential diversion from patient care and also
should include an assessment of the administrative burden on the industry.

We would like to further comment about the WEDI surveys. We feel that these
surveys should also include samples that represent a broad cross section of the
industry and it must include providers in the survey pools. For pharmacy
providers we recommend working with the Pharmacists Services Technical Advisory
Coalition, which is called PSTAC. This is comprised of seven national pharmacy
organizations and they all represent provider communities.

Just to give you a rundown of who belongs — which provider or pharmacy
provider organizations belong to PSTAC, they include the Academy of Managed
Care Pharmacy, the American College of Clinical Pharmacists, the American
Pharmaceutical Association, the American Society of Consultant Pharmacists, the
American Society of Health System Pharmacists, the National Association of
Chain Drug Stores and the National Community Pharmacists Association.

These are all provider groups belonging to this one organization that are
focusing on improving the EDI Health Care Claims Infrastructure specifically as
it relates to pharmacy providers and just as an FYI, PSTAC is also a member of
the AMA CPT Editorial Panel. So, it is a credible group. I do serve as
executive secretary of that group.

Another recommendation that is part of the HIPAA modifications process
moving forward is that we would like to see a creation of what we refer to as a
holistic process that allows for systematic review by the health care industry
and one that establishes a scheduled review process and includes associated
timetables. So, for example, a review of the need to change to a new HIPAA
transaction standard might occur every two years or five years, but there
should be some sort of timetable or schedule where that would occur.

Also, this process would be one that utilizes the federal rulemaking
process that provides for public comment regarding the industry readiness for
change. With this process we feel it is still very important to maintain as
opposed to limiting such a process to an SDO process only because the SDO
processes lack broad dissemination that is characteristic of a federal
rulemaking process and typically the SDO processes involve decision making at
the workgroup levels and they also could have limited representation of the
materially affected parties.

So, for example, in the case of the NCPDP SDO, that retail pharmacy is
affected by in terms of our claim transactions, pharmacy providers are exceeded
three to one by payers, processors and vendors in the NCPDP organizations. So,
they are underrepresented and I think we have heard some of that from the other
SDO membership organizations.

As part of the federal rulemaking process, we think it should also include
specific timeframes or milestones for decision making to alleviate this
protracted adoption process and we would agree with that aspect of the SDO
proposal, but we feel like the process should only focus on industry readiness
in terms of readiness to move to — a transition to a new version of an
implementation specification and not focus any further on changes to the
implementation specification because we feel that that — at that point it
would have been through a vetted process. We would just like to focus on a
transition to industry readiness.

What we don’t to see occur again is — as part of any sort of standards
modification process — is a repeat of retail pharmacies experience when HIPAA
was first implemented. At the time prior to HIPAA implementation, retail
pharmacy was already using an electronic health care claim transaction, which
was NCPDP version 3.2 and it was widely accepted by the — 3 at that time.
However, with HIPAA, implementation of HIPAA, it mandated a higher version,
which was movement to 5.1 and at the time it had not been fully vetted by the
pharmacy industry. So, many considered it an unnecessary transition at that
time and it cost a major expense for the industry to implement. We don’t want
to see that occurring again.

We would agree that there are benefits that have been proposed by the SDOs
and with the inclusion of our recommendations we feel that they would establish
a schedule for upgrading the HIPAA adopted implementation specifications that
lagged behind existing implementation standards and they would also establish a
reasonable predictable maintenance cycle for HIPAA adopted standards that have
not been feasible to date. However, it would provide for the necessary checks
and balances via a federal rulemaking process.

That concludes our comments and I thank the committee again for the
opportunity to provide this testimony and our feedback.

MR. REYNOLDS: Thank you, Kathryn.

What I would like to do is, Lynne, would you and Margaret mind joining us
at the table since we heard from you and now we have a reactor panel. Let’s
discuss it. If we could do that, I think it would be good and I will now open
it to the committee for questions.

Judy.

DR. WARREN: This was a question that came out of Nancy’s testimony. You
were talking about — it is on page 2 — the business needs are continually
updating and may actually outstrip some of the standards. How would you suggest
we go about this keeping up with the business needs because you were saying
that some of the old specification guidelines were concerned about business
practices that are in the past. So, this is causing problems.

MS. SPECTOR: I don’t know if I have the answer for that in terms of keeping
up with the business needs. I think that that is something that the SDOs in
their work in looking to are we ready to move to a new standard, a new start,
writing a new guide, I think that is part of what their work is and, again,
that is representative — you have got participants from the various sectors of
the industry there, who are recognizing what are the newer business needs and
do the current — does the current transaction guide accommodate that work or
do we need, you know, new loop segments, elements that will accommodate that?

The one issue — and I am not well-versed, I admit, in the transaction
guides, but you have got the health savings accounts that are becoming more and
more popular and do the 4010 guides accommodate all of the needs in terms of
the data that needs to be, you know, exchanged for those transactions. So, that
was one of the new developments that I was thinking about that may need to be
met. I am sure there are other examples that others could give.

DR. WARREN: To follow up on that, I think everyone of you has made the
comment that your particular sector is not well represented in the SDOs. It is
like the SDOs are over here and the work you want done is over here and you are
not participating.

From my own discipline, you know, I go around trying to get everybody in
nursing involved in the SDOs and my involvement, I mean, there is a big need
and the SDOs are trying to get the providers there so they can do that and they
are not able to bring them there. So, do you have any suggestions about how to
encourage your own particular sector and this is for everybody to participate
in the SDO process so that we can be more appreciative of business.

MR. ARGES: I think one of the things I had commented on was if the SDOs
themselves could lay out the issues that they are discussing ahead of time in a
way that is easy to find, the time slot that it will be available and making
certain that they can communicate it. I mean, I think the associations would be
happy to be able to go to the web site, identify the particular item up for
discussion, tag that item and contact our members to say this is coming up. We
believe this is important. You need to be there as part of that discussion.

I think that is one way around it, but right now, I think it is very much a
byzantine process. It is a lot of who you know, going behind the scenes and
kind of figuring out after the fact about what is going on. Again, there are
different levels of workgroup documentation. Some do a better job than others.
It would be nice if there could be some pushback really on the workgroup to
focus more on formalizing their actions and their work activity in a way that
lays out more of a here is the agenda. We are logging it in. We are making it
available for the public to see.

This will be up for the next trimester meeting as part of a discussion
item. This is what we have considered today. Here are the minutes from that and
this is the type of outreach that we have had.

MR. REYNOLDS: Before I recognize anyone else, Jeff has a comment for you,
George.

MR. BLAIR: I am a little surprised by — I think the comments, the things
that you are asking for are all appropriate and I am a little confused by them
because the standard development organizations that we have been working with
in health care that are part of the HIPAA process and almost all of them that
are part of the other standards that will be CHI are accredited by the American
National Standards Institute, ANSI. The criteria to be accredited is that the
agendas need to be posted in advance, typically on web sites and that they have
to be open meetings, consensus meetings and virtually everything that you just
articulated are required processes to be accredited by a standard development
organization that is recognized by the American National Standards Institute.
Am I missing something or were you just not aware that these requirements were
in place?

MR. ARGES: No, I am aware of the ANSI requirements and it is an open
process and it is consensus driven. The question is are you getting people to
attend as the process develops, where the discussion takes place, where the
workgroup issues take place. All too often a lot of that discussion is really
who you know, rather than laying it out formally in a way that can get people
to go to a particular meeting.

I would wager if you were to go to the X12 web site today and say, okay,
there is a trimester meeting coming up in a week, what are the top three issues
for discussion on each of the workgroup activities and my guess is you will not
be able to find it easily or find the top issues that will be up for
discussion.

MS. TRUDEL: I am recalling my first foray into an X12 trimester meeting and
it is very daunting, the structure, the number of workers that are meeting
concurrently, the fact that the issues tend to be couched in technical terms so
that you don’t get the business notion of what is behind a change to a loop or
a segment.

I think there is always room for improvement there. But I would follow up
on Kathryn’s point also and say that the regulatory process isn’t perfect
either. In the proposed rule for the first HIPAA regulation, we specifically
proposed 5.1 and we got no comments saying that 3.2 would be better.

So, there are always ways to, you know, improve either one of those
processes.

MS. KUHN: I would like to point out, recognize that this SDOs have to
adhere to the ANSI standard. However, if you look at each one of their
structures, they all operate differently. Some may encourage or discourage more
provider involvement based on say their membership fees, for example. I think
if you look at their balloting process, each one of them operates a little
differently, too, may also affect provider involvement and provider input into
the decision making process. So, those are our concerns.

MR. REYNOLDS: Judy had a question and then Marjorie and, Lynne, did I see
your hand? Is this on the same — what I want to do is I want to finish any
comments on this because we have got another list going on with other people’s
questions.

DR. WARREN: My comment is — and now I am speaking from my own experience
of working in an SDO, specifically in HL7 and one of the biggest challenges we
had was trying to get providers to attend the meetings. I realize it is
daunting because people are looking at specifications but without the providers
there to help us with the use cases, it was very difficult to do those things.

When we made outreach, we got no response back and I think that is very
frustrating when the SDO knows that they need the providers there. They contact
the various organizations or people they know and there is no response. So, I
guess I am suggesting back since everybody here feels that they are kind of
outside, that maybe somebody within your organization needs to reach out to the
SDOs to their formal central offices and say I am here. I am your main contact
with AMA or AHA or, you know, whoever. When you need help in these areas, we
will provide somebody.

All the meetings are open. You don’t need to be a member to attend any of
them and you can show up. Although I will tell you I agree with Karen. My first
meeting at HL7 was daunting. You know, it is kind of like — I don’t even know
what room to go to. You need to find someone that is willing to go at least to
a second meeting because the first one is just figuring out, you know, what is
happening and how the agendas work. But think most of the SDOs have people that
if you say, you know, I need some help in figuring out how to attend, they will
assign someone to you and connect you up and make sure that you could
participate.

So, I am just arguing for it. This needs to be a bi-directional street
between the providers and the SDOs so that they can inform each other.

MR. WILDER: If I could respond real quickly. I think the industry first of
all is becoming more aware of the importance of the process. I think early on
we just were clueless and so we are getting smarter about it. We have all
talked about some things that can be done in terms of better transparency,
better uniformity among the organizations.

Again, my cautionary note is the SDO process is not always the place where
the right decisions need to be made. Again, they focus on more of the technical
aspects of a standard and sometimes there are policy issues that need to be
dealt with elsewhere. So, we need more inclusion in the SDO process. We need
more participation but we also need to recognize that that is unfortunately not
the end all or be all of all of these changes.

MS. WEIKER: When we talk about the SDO and the industry and I look around
the table, we are the SDO and we are the industry. So, when comments are made
about, oh, the SDO needs to do this and the SDO needs to do that, we are the
SDO. We are the change agents that need to take charge and propose those
changes.

I agree, communication in some of the SDOs could be better, more
uniformity. I don’t disagree with that at all, George, and we are trying to do
that. These are volunteers that co-chair these groups, that write these guides.
They have got another full time job. So, we need to be careful. We agree we
need more outreach and how to do that. We are very open to that and, yes, we
know it can be very daunting to go to an HL7 meeting and to go to an X12
meeting. I mean, I have been there where it was my first meeting, too. We are
trying to put together more of an educational, like how to get around kind of
thing.

As mentioned, the SDOs are now saying, you know, we need to assign somebody
to the new members or the new attendees to help them through the process
because we want to keep those people coming and get them there, to keep them
coming versus they come once and like, oh, my heavens, what the heck is all of
this about and never come back because then we have lost and we have lost as an
industry.

So, I guess my comment is we are them and we need to be the ones to make
these changes.

And in regard to the ANSI accreditation, each organization is ANSI
accredited and ANSI says you have to have — you must follow an open process.
It doesn’t say how you do that process. It just says you must do, you know, X,
Y, Z. Having agendas is not part of any of the accreditation.

But each SDO through the years developed their processes based upon their
membership and the rules at that time and how they operated, some prior to ANSI
accreditation and made changes. So, yes, we all do it a little bit differently,
but yet we all still follow those same principles.

MR. ARGES: Just a comment. I agree with Margaret. In essence the entire
community is part of the SDO and what I was trying to convey is can we do
better and the answer is yes. We should be able to do better. If we are looking
to basically adopt an expedited process that really puts different faces of
look and see and touch and feel and review, we want one that can basically do
the type of communication a lot earlier and is inclusive so that we don’t have
to necessarily go through a PA process that waits after the fact to get public
opinion. You are really reaching out to try and get that as soon as you can and
try to be inclusive as early on as possible. That is my point.

If we can formalize it in a way that everybody feels comfortable with, then
I think it really bodes well for the industry. I mean, I think a lot of the
SDOs have done a terrific job. I am not trying to say that they haven’t. What I
am trying to say is we can do a better job.

MS. GREENBERG: Tom was, I think, quite explicit that — in his caution
against eliminating the notice of proposed rulemaking that allows the public
broadly to comment on a regulation. But I didn’t hear and maybe I missed it,
but an explicit position from the other three presenters on that. Maybe that is
because the organizations, you know, don’t have one or I missed it. I wondered
from each of you, Nancy and George and Kathryn, whether your organizations are
supportive of that aspect of the WEDI proposal or feel that you still need the
opportunity for public comment to a proposed rule issued by the Department.

DR. STEINDEL: Excuse me. I want to add to Marjorie’s comment because I was
going to ask something very similar. What I would like to hear from each one of
you is where your proposal differs or how you would augment what was proposed
in the opening session, the six bullet items. That goes along with what
Marjorie is asking because one change I heard was keeping the NPRM process.

So, Marjorie, do you forgive me for adding on?

MS. GREENBERG: That is okay.

MR. ARGES: My viewpoint is the initial phase for significant NPRM process
really is when a standard has not been identified in name as a standard prior
to that time period. When you are going from one version to another version and
you are looking at this expedited process and you are trying to engage people
early on, in essence you are modifying what has been an NPRM process at the
back end and the way it is now, it is take it or leave it. You basically
designed the standard and here it is, you accept it or you reject it. That, to
me, doesn’t seem acceptable. What you want is public input at the earliest
stages so that everybody has no surprises, that when the final product is
there, you can pretty much embrace it and move on with it.

The idea of having it predictable is one that is important and we need to
be, I think, on a regular cycle in terms of new versioning only because you are
probably not going to get it right to begin with anyway. What you want is the
opportunity to change it. The problems that we have is that you don’t have that
opportunity to change it. You want to process that says it is not necessarily
perfect, but here is what we have done. Here is what we have reviewed. This is
how it will look and feel. It will be in place for, I don’t know, two years,
three years after it has been laid out, but if it doesn’t work well, then we
need to then change it.

The problem we have today is it is out there and good, bad or whatever, it
is out there for a long period of time and people are just out of compliance or
it is not working for them.

MR. REYNOLDS: I would like to take a break now. Come back and hear the
other two responses. We will take a 15 minute break.

[Brief recess.]

MR. REYNOLDS: Point of order. We are going to spend the next 15 minutes on
this because we obviously have a — we need to have a little discussion of our
own, based on other than the questions and then we need to make sure that we
get two or three other items we have to take a quick look at.

So, George, you had commented. Steve had asked for — and Marjorie had
asked for a couple more comments.

MS. SPECTOR: I can go ahead and comment for the AMA. In terms of Marjorie’s
question about elimination of the NPRM specifically. As I read through the
proposal the pieces I picked up on are the call for early involvement of the
development stage and I do think there is an opportunity within that
development stage to expand it beyond just the technical writing of the guide,
but also try and pull in those conversations about, you know, what is this
impact going to mean in the settings. Is this — you know, just talk more about
this policy kind of issues as the development takes place.

Then the other piece I focused in on was still the call for NCVHS testimony
before, you know, a letter would go forward to the Secretary, supporting or
making a recommendation about the change request and so I look at that NCVHS
testimony as the opportunity to hear from people in the industry,
representatives of the industry on is the industry ready for this. Is this the
right time to do this? Hear about that cost benefit analysis work that WEDI is
going to be doing and then also to have discussions about the implementation
timeframe, how best can this be rolled out, looking at what other competing
initiatives and priority are going on and trying to coordinate among those so
that everybody is not trying to do everything at one particular time.

So, I think that if those concerns can be addressed through that NCVHS
testimony and then maybe shift some policy questions into the development
stage, I believe the AMA would be fine with removing the NPRM process.

MR. REYNOLDS: I forget which one of the other two of you were supposed to
comment.

MS. KUHN: Well, I think I addressed this in my comments that that was part
of our recommendations is that we do retain the NPRM part of the process as a
way to allow for public comment of the need to transition to a new transaction
standard.

MR. REYNOLDS: Mike, you had a question and then Simon, you have got the
last one.

DR. FITZMAURICE: We have heard a lot of good features about the proposal
and some things that you would like, one of them being a chance for public
comment and following the Administrative Procedures Act. So, I ask you if the
SDO proposal as we have heard it today were consistent or modified slightly to
be consistent with the APA, would your organization support it. If not, where
would you go to modify it to make it acceptable?

MR. ARGES: Can I ask a question? I am not quite sure I understand what you
would modify to be as part of the APA. There are like three distinct phases
that have been proposed. Each of those has a notice for the public. So, what
modification would you make there?

DR. FITZMAURICE: The modification might be when it reaches the Department
is there — that the APA require an NPRM, a notice of proposed rule making with
public comment or can it be put out as a final rule with comment and if
comments aren’t great, then it becomes the final rule. It may be that the —
knows much more than I do about the APA and I think probably Karen knows more
than I do about the APA — would say you have got to insert something, insert
more than just public hearings, maybe NCVHS has to take all written comment,
take the written comments, too.

I am not sure, but those are things that I had in mind when I said some
slight modifications to be consistent with APA. So, what I say is if the SDO
were consistent or modified to be consistent with the APA, would your
organization support it, the SDO proposal and if you wouldn’t, if you still
have problems with it, where would you go to modify it to make it acceptable.

MR. WILDER: I think what I would look at in terms of modifying what they
have put forth is some process to designate what is a what I would call a minor
modification, which I think 99 percent of them are versus the 1 percent, where
— while you are modifying existing standards, it actually has a major impact
on a business process and you need to have more and lengthier input.

For those minor modifications, because of the requirements of the APA, HHS
may decide we are going to fast track this and we are going to issue it as an
interim final rule with opportunity for comment, with a short 30 day comment
period. For those modifications that are significant, you might want to have a
more robust process with a longer comment period or have pilot testing or what
have you. But, again, I think most of the modifications actually are not a big
deal. They get fully vetted at the SDO level. I just again caution you. There
are some things where you actually need to have more in depth discussion.

DR. FITZMAURICE: So, basically for minor modification you would support the
SDO process. For something more than minor, you would like to see more
industry, maybe public comment.

DR. WILLIAMS: Yes, again, with one caveat. I am by no means an APA expert.
I think you are going to have to have some opportunity for public comment at
the rule making level. I don’t know where that dividing line falls. I would
defer to others, but you may need to actually — maybe it is a shortened period
or what have you, but you may need to actually publish it in the Federal
Register or have comments of some kind.

MR. ARGES: I think I would agree with Tom. There should still be an
opportunity for public comment as a final analysis but I would hope that
earlier on, there could be really no surprises. I mean, hopefully the
communication is occurring the way it is supposed to occur and if perhaps a
change law could be developed early on to kind of summarize the type — nature
of changes and who all might have been involved in the approval, there really
should be no surprises. I think you can kind of cut down on the time at a later
date, for one final opportunity or comment to basically approve up or down the
rule.

MS. SPECTOR: I agree, again, with the idea that there needs to be public
comment in the process and I guess the question is what — how do you define
public comment? Does it have to be an NPRM, an interim, final rule, final rule
with comments or — and I am by no means an expert with APA, could NCVHS
hearings and maybe — and an opening for written testimony to be submitted,
does that constitute public comment?

I guess the other question I would raise is in that public comment, is
there going to be any definition as to what those comments are about because
what we currently are facing is if those are technical comments and it is
deemed that a change needs to be made in the guide, it can’t be made in that
version of the guide. It has to be made in the next version of the guide, which
is not the guide that is named in the NPRM. So, you have to issue another NPRM.
So, I mean, that is that loop that you get caught in. So, are those public
comments going to be limited to only policy type questions? Are they going to
allow for technical changes? Because that gets you back into that same loop
that we are in right now.

DR. FITZMAURICE: So, but if that were handled then, then you would support
the SDO proposal?

MS. SPECTOR: Yes, because I think without it, we have got what we have now.

DR. FITZMAURICE: Yes. Exactly right.

MS. KUHN: I don’t have anything to add.

MR. REYNOLDS: Simon, you have got the last one.

DR. COHN: First of all, I want to thank this panel. I think it has been —
especially the last couple of minutes have been tremendously interesting. I
wasn’t sure we would actually get to a place of substance as opposed to, you
know, just sort of talking about issues. So, some of these last few comments
have been very helpful.

Now, let me drill down even maybe a little further into substance. I expect
that probably sometime in this coming year, we will probably start talking
about modifications to standards. One could imagine even though we haven’t
talked about priorities, that my understanding is is that there is an NCPDP
modification coming forward, D.0, and X12 is I think — 5010 coming forward.
Exactly.

My question is with all of this discussion, what advice would you give to
all of us as we think about embarking on this one. How does all of this
conversation affect how the NCVHS should approach this, how all of you should
approach this? And you can certainly follow up with written comments if you
would like to afterwards, but it is just — we are drilling down from a hundred
thousand feet to 50 to 5 and now we are down to about a hundred feet in terms
of — what do you think? You know how we function. You know the current
processes. What are your recommendations for this — for these modifications
that are upcoming?

MR. ARGES: To me, the process that has just been outlined in terms of the
SDOs, No. 1, I think, would be an improvement because the way — what we are
confronted with today is either you take the 5010 or you reject the 5010. So,
you are then faced with having to look at another four or five years of
development time to get a modification of an existing standard out there.

So, to me, it is important to keep that in mind, but I think what we have
learned as part of the DSMO discussions is I think the DSMOs can work together
fairly well. We have a change law. Can we make improvements? Sure. And I think
we would like to see that. I would like to see an X12 log that is created as
they look at changes so that we can move them forward. It would be easy to kind
of have them piggy back what I think Steve Bass in Washington Publishing ably
provided to the DSMOs as part of their process.

Maybe there might be some issues of funding within the X12 process or the
other SDOs in terms of trying to apply some of those communication rules is
what I view them as.

MS. GILBERTSON: It is a pretty concerning environment right now, Simon,
because I think there was a lot of industry activity working toward HR4157 in
the timeframes that were suggested there, along with the modification process.
The status of where any of that stands — I mean, there was a lot of activity
getting to that point. So, to consider the X12 versions moving forward or the
5010, the NCPDP standards coming forward is extremely concerning in the current
environment because people are being asked to review the implementation guide,
to make comments, to go through the formal ballot process in 2007 and we have
no guidance for them as to how to build their project plans or when they can
even consider this.

From the pharmacy industry perspective, we have made over — an amazing
amount of modifications that are nasty for the industry to support Medicare
Part B and the industry has said we know D.0 is going to be a lot of work, but
we are tired of shoving things in and what is our project plan for D.0 and we
can’t give them any kind of guidance. The NCPDP standard guidance is after
adoption, trading partners should not — or after approval of a standard,
trading partners should not consider implementation before 180 days, but now
they have regulatory processes that say you cannot implement this without being
out of compliance, asking for some kind of waiver, something like that to move
forward.

So, that is extremely concerning unless there are bills coming forward or
modifications coming forward somewhere from the industry. As an SDO, we cannot
lobby. So, we just — we say here is the standard. The industry wants us to
move forward, but as for implementation timeframe, it is anyone’s guess.

MR. REYNOLDS: Very quickly —

MS. GREENBERG: I know we are talking about 5010, but my understanding that
X12 is working on 5050 now?

MS. WEIKER: 5040.

MS. GREENBERG: 5040. So, let’s say we go through a two year process here to
adopt 5010, do we even want 5010? I mean, and I guess that is what you are
saying, just getting 5010, without changing the process kind of puts us where
— instead of ten years behind, maybe four years behind or something.

MS. SPECTOR: I was just going to say one question we could ask, though, is
do we want to keep 4010 because that is what we are faced with, keeping 4010
indefinitely for something that maybe better —

MS. GREENBERG: 4010, I realize, but I wondered if 5010 is really what you
are talking about or 5040.

DR. COHN: Once again, I am going back to the HIPAA law, which I am going to
have to look at Karen to make sure I have got this one right. I don’t believe
that the modification provisions are the same as the actual new standards for
adoption. Can you remind me on this one?

MS. TRUDEL: Very different —

DR. COHN: The two year —

MS. TRUDEL: They are very different in terms of the Secretary’s discretion
to — that the compliance date. Within initial standards the Secretary is
constrained by the legislation to have it be two years after adoption for
everybody except small plans. Whereas, for modification, he has a great deal of
discretion, as long as the implementation date is more than 180 days after
adoption.

DR. COHN: Okay. Thank you.

MS. TRUDEL: There is no limit on how long it could be either.

DR. COHN: So that would be obviously something else that one would want to
ask the industry. I just wanted to — since that comment about two years had
been brought up, I did want to set the testimony straight on that.

MS. GREENBERG: — the rule making process.

MR. REYNOLDS: Jeff, you wanted the last comment on this one?

MR. BLAIR: Yes. And Karen, are you saying that we are not even in a
position to accept the proposal from the DSMOs because of what you just said?

MS. TRUDEL: No. The only initial standard that is in play at this point is
claims attachment. We have adopted standards for all of the other transactions.
So, theoretically, 5010 over 4010 is a modification. It is not new.

MR. BLAIR: I am going to make a motion and I want to preface the motion by
indicating that it asks for an accommodation on the parts of those folks, who
had said that they especially want the opportunity to make public comment
during notice of proposed rule makings and while this doesn’t totally shut this
off, the standards development process does involve a certain amount of
investment on the part of those folks that want to have more business issues
and business practices represented in that and I think it should be. It should
be as diverse as possible, as inclusive as possible.

So, the fact that an investment needs to be made in greater participation
in the standards development process doesn’t — I did not find that a
compelling argument to wind up saying that we should keep things the way they
are, and, therefore, it is something I respect, but I feel as if we make that
investment in getting business practices and business requirements into the
standards development process, that we could streamline the process and frankly
I think we might even have better ideas included in the final standards if the
business practices are integrated with the rest of the standard development
process at that time, than if it is included separately in an NPRM process.

So, my motion is to accept the recommendation from the DSMOs for the
streamlined process.

MR. REYNOLDS: Is there a second?

[There was no response.]

Motion dies for lack of second, Jeff.

Thank you, all of you, very much. We really appreciate you coming forward
and your testimony was very, very helpful. Thank you.

Agenda Item: Subcommittee Discussion

Okay. We have got three things to touch base on and I am going to move
quickly through two and then we will spend some time on the letter and what we
need to —

DR. COHN: Can I make a comment?

MR. REYNOLDS: Yes.

DR. COHN: That last motion, I think from my view, the lack of a second does
not prejudice for the conversation about that issue.

MR. REYNOLDS: That is correct.

DR. COHN: About that issue, which I think is probably a very germane issue
for writing of a letter.

MR. REYNOLDS: No. And I would say personally the reason I did not move to
second it was that I think we need further discussion and I think we heard
differing views. For example, if I were to say something — I would like to
hear a little more from Michael. He was talking about the APA and other things,
which I am not as astute in as he is. So, accepting that motion and then adding
some of the things he said may make a letter.

That is why I didn’t move.

DR. COHN: I just wanted to make sure that those who had testified are
brought forward —

MR. REYNOLDS: That is correct. It is not about the motion. It is about all
the discussion that went on and we haven’t put that together to agree or
disagree.

MR. BLAIR: Would the motion be more appropriate and more likely to be
accepted if the motion was for us to craft a letter with appropriate exceptions
to —

DR. COHN: Jeff, I think this is a process question. I think we need to talk
about it first and then let’s figure out the next steps and then we will see if
a motion is appropriate.

MR. REYNOLDS: Proper procedure says you can submit any motion that you
want. So, I am not in any way keeping you from doing that.

MR. BLAIR: Okay.

MR. REYNOLDS: So, do you want to or not, submit another motion?

MR. BLAIR: It is fine. I think we can just simply go through the process.

MR. REYNOLDS: That is fine. I am just making sure we go through appropriate
process. Okay.

The first thing is the future agenda items and I passed it out to everybody
yesterday and you saw what it is. I have spent some time with Marjorie this
morning. We are usually budgeted for two hearings a year and I think with the
number of things that we have listed there, we are probably going to plan to do
— we are going to do three. What we are looking at right now and I am not
going to go through that chart because I think this letter is far more
important against the full committee soon.

So, I am asking each of you, you have seen what we have put together as a
structure. You have seen what we have put together as possibilities. I would
love to hear from each of you if you have problems with what those subjects
are, problems with what we are thinking going forward, that you get those to me
by next Wednesday.

Hearing none, then Jeff and I will make a proposal to Simon as to what we
— what our next hearing would be. Now, I am looking at some timeframes and
probably if we are only going to have two others maybe the end of April and
early May because one of the things we have in our next hearing is hearing from
the e-prescribing and then in early April they are giving their update to
Congress. So, that would be a good reason to move that further into April and
May. So, we could pick that up in our next sweep through.

Then, obviously, you are looking at September or October and the reason you
are looking there is we have to do the HIPAA annual report and we have got to
do some other things like that that we are required to do, plus it would be a
good time to maybe check back on the NPI after our letter that would go out, if
we do one now. So, those two hearings might fall into a good spot to be able to
do that.

Plus the other subjects, but I am just kind of laying it against things we
know are going to have to probably be involved in. So, I would like your
comments by Wednesday.

Yes, Marjorie.

MS. GREENBERG: You could think in terms of a half day after a national
committee meeting. In this case we — the Privacy and the Standards and
Security met sequentially and there was quite a lot of overlap. So, there are
ways that —

MR. REYNOLDS: I agree and I think — but I think the important thing and as
you see on there, remember, we had some a consideration column because there
are some synergies that we may have with others. So, I am just talking about
the business that we know this committee has to do as its charge. Then there
may be other things that will come up from others that add to our charge and
then whether those need to be separate hearings or we would do the kind of
things you are talking about is what we are — that is where I think we are
going.

So, right now, we could really know what we need to do and that is probably
going to be two more sessions and then anything else that comes up from anyone
else, we will do that.

Yes, Simon.

DR. COHN: I appreciate you bringing up all the issues but based on our
previous conversation, I do think we need to put exclamation on the 5010 and
the D.0, which I recognize is in there and you will need to work closely with
the —

MR. REYNOLDS: Absolutely. No question. One of our subjects in there is
standards and I just paraphrased why never on time. All this plays together.
So, how do we work the whole process. 5010 would be a great example of the next
one. What do we do for the next one that makes us do it as an industry than we
did this last one.

Any issues with that, approaching it that way? I please ask you to take a
look at it. As a matter of fact, I — go ahead.

DR. WARREN: You are going to send out a notice for us for dates for these?

MR. REYNOLDS: Yes.

DR. WARREN: So, we don’t need to give you dates.

MR. REYNOLDS: We will work with Marietta and go ahead and start pulling for
dates. I was trying to give

you —

MS. GREENBERG: Remember that the Executive Subcommittee is meeting on May
3rd with a dinner on May 2nd.

MR. REYNOLDS: That is what I am saying. We will work through with — I will
work with Marietta on the other schedules that are out there and then we will
look at what we are doing.

The next thing is the NCVHS annual report and we covered this the other day
in the privacy session. I have already submitted all my comments.

MS. GREENBERG: You are talking about the HIPAA report.

MR. REYNOLDS: Yes, the HIPAA report. What I would like to do and I have
talked to Denise, if any of you have specific changes that you want to submit,
if you would please submit them directly to Denise and again by the middle of
next week because remember we have all been asked to kind of look at this by
December anyhow, last December.

MS. GREENBERG: Right. Well, I am assuming that Jim Scanlon and staff are
working on the revision as we speak.

MR. REYNOLDS: That is correct. So, I am just saying to you if you have
comments — in other words we were supposed to have done it earlier. If you
haven’t done it, you might want to get involved. Some of us have and so I don’t
need — see a reason to take the whole committee’s time to go through something
that everybody can read and can comment on.

All right. So, having covered the two of those, let’s talk about
yesterday’s letter or yesterday’s hearing and possibility of where we stand and
we obviously spent a little time talking about it last night and trying to get
our thoughts together as to what we thought. So, I would like to paraphrase
what we said and then what is going to happen is that Denise and I and Jeff
will work together on a draft. We will probably have to schedule, obviously,
conference call or something else, because we need to have this to the full
committee, which is February 12th. So, this is not a —

MS. GREENBERG: The process is that the subcommittee has to agree on the
letter and then it is supposed to go to the Executive Subcommittee before it
goes to the full committee.

MR. REYNOLDS: I understand, yes. I agree and that is what I am saying. So,
the time frame is short and we need to move.

Here is what we had kind of — trying to talk about and pick apart the
structure not the words because, again, I haven’t rewritten anything and don’t
plan to. I am paraphrasing what we heard last night. So, by May 23rd, we feel
that the covered entity should be able to individually have themselves ready,
which means providers ought to be able to get their numbers and we will spell
these out as sub-bullets under their providers, should be able to get their
numbers. Payers should be able to process. Clearinghouses should be able to
process NPIs. So, that is what we would say would happen.

MS. GREENBERG: Can I ask a question?

MR. REYNOLDS: And that outreach would continue.

Yes, you may.

MS. GREENBERG: Is that assuming that the dissemination notice —

MR. REYNOLDS: That will be the next thing.

MS. GREENBERG: That is what was unclear to me yesterday, though, whether
payers can be ready without that.

MR. REYNOLDS: They can be ready to process. They may not have all the
numbers and they may not have all the cross walks but they could be ready
internally to process. Remember, because we are not saying implement. We are
saying ready to process because, obviously, if we are going to recommend
anything after May 23rd, it is called working together to make it production
ready.

DR. COHN: Harry, can I just ask a question?

MR. REYNOLDS: Please do.

DR. COHN: Maybe it is the very first sentence. I am presuming that what you
are discussing is recommendations that involve a contingency. Is that correct?

MR. REYNOLDS: That is correct.

DR. COHN: I just wanted to clarify that he was talking about
recommendations that involved the contingency, you know, implementation.

MR. REYNOLDS: The next is as we said in our letter in November, the NPPES
and the data dissemination must come out to allow full implementation. Now,
further our discussion last night and again as a framework was that the
industry be given once the NPPES and the data dissemination are put out and
available, that the industry be given six months after that to complete its
readiness.

Now, during that six months we had numerous discussions about what should
occur. You know, we heard all the way from WEDI, where you got every claim has
to have things or it could be that we basically are — just say that they are
six months and that the industry needs to work together and do whatever they
need to do and do their cross walks and do everything else and I think we
settled on the fact that by stating that there should be six months, that we
basically — that is as far as we go. We don’t — we are not prescriptive on
what people should or shouldn’t be doing with each other or how they should or
shouldn’t do it or who they are or aren’t during that six months time frame.
But basically we are saying we are saying by May they should have what they
need. They should be able to do it themselves and then when they get this data
dissemination and the NPPES, they ought to be able to begin processing.

The one thing that we still haven’t completely settled on, which we will do
some more looking at is whether or not because of the fact with drug claims, as
we heard from that discussion yesterday, whether or not since they pretty much
don’t have a relationship with the people, with the prescribers necessarily,
don’t have a — whether or not that would take anymore time to make sure that
they were able to get those numbers so the prescriptions could start

— could work.

So, that is the only question that was still on our mind.

Yes, Karen.

MS. TRUDEL: I don’t think that is an issue that is limited to pharmacy. I
would say that is a — there is a similar construct in terms of laboratory and
diagnostic services where the referring physician very often does not have any
business relationship with the lab at all.

MR. REYNOLDS: I think that is a great addition and that is why we are
talking about it in open forum today. I didn’t say we had all the answers last
night. No, but I think that is perfect. That is the kind of thing we got to
make sure. So, basically then what you are saying is there are — we were
wondering whether there were two distinct legs and I think you are making it
clear there is one leg.

Yes, please.

MS. TRUDEL: I think there would have been two distinct legs if there had
been more prescriptive discussion about whether you are talking about dual
processing or not. If you take that off the table, then I think they become
very much more similar.

MS. GREENBERG: [Comment off microphone.]

MR. REYNOLDS: Yes. That is where we decided to go, again, not necessarily
to define for anybody what they need to do because you are basically saying
that that is where it is. Now, that is the structure of what we heard.
Obviously, yesterday we had a lot of information. We had a lot of approaches.
We have a situation that we are dealing with and so that is the construct.

Yes, Simon, please.

DR. COHN: I guess I would make a couple of maybe just clarifications to
what you are describing. I guess I just wanted to bring them up just to make
sure that we are sort of in agreement.

First of all, I think when you talk about six months, you are talking about
six months from the May implementation date or the date of the — not the date
of the release, the date of dissemination — data is available, whichever is
later.

MR. REYNOLDS: That is correct.

DR. COHN: So, I just want to make sure that we understand that.

MR. REYNOLDS: That is correct.

DR. COHN: I also want to make clear — and once again this is just looking
around to see if there is an understanding that the NCVHS intends to have
ongoing hearings to monitor this and will provide further advice to CMS and the
industry as it is perceived about whether there needs to be any additional
adjustments made to any of the —

MR. REYNOLDS: That is why as I looked at the end of April and the
September/October, those would be two possible good times to basically have
those check-ins also.

MR. BLAIR: The second point that you made was that the payers would be
ready by May 23rd to begin processing. Is that what you said? Or to begin
testing? What was the statement you said about the payers being ready by May
23rd?

MR. REYNOLDS: What we are saying and I want — whether it is payers —
well, we use payers and clearinghouses, will have their systems modified to
handle NPI. I did not say in production.

MR. BLAIR: Then the question I have for clarification is for clearinghouses
and payers to be ready, are you including the fact that they would have had to
have received NPI numbers from providers in order to do that?

MR. REYNOLDS: No, they would not. They can test. Anybody can test prior to
that with made up numbers and other things. That is why — that is the only
reason for the transition that we are talking about is since everybody has it,
you can’t do it. I would say that enough of these people have relationships
that they should be able to get some validated to be able to test prior to May.

DR. FITZMAURICE: I am looking at the incentives for working hard, spending
money and being able on May 23rd, not only to have your system tested, but to
begin real time processing of actual claims for those providers who can give
them sufficient number of NPIs. Should there be an incentive to do this as fast
as possible or maybe the mirror image, a disincentive for those people who
don’t make it possible for this to be done?

MR. REYNOLDS: I think the whole reason that we have said need to be in the
position that we said, which is providers having a number. Payers being ready
to process and clearinghouses being ready to process, which are the only
covered entities we really can chat about. I mean, I could go on with another
whole list, but it doesn’t make any difference, is that we can enforce it and
we enforcing it but it is still a May date for them to do certain things. If
you aren’t by then, we are not even alluding to what kind of jurisdiction
anybody would have over that, what kind of follow-up anybody would have on that
or what kind of anything else would happen. We are saying that people should be
able to be ready.

Now, obviously, when that gets to the Department, they can read that anyway
they choose to as to what they would want to do at that point.

DR. FITZMAURICE: Yes. You hit it right on the button. Do we want to make
any references to — in a contingency plan that we might recommend that they
consider in centers to reward those who make it happen even faster?

MR. REYNOLDS: Well, remember, and I will play off a number of Karen’s
comments and a number of other people’s comments yesterday. The date is May
23rd. I mean, we can’t change that. We cannot change that. Nobody can change
that. So, all we are saying is that there is a certain place, hearing the
testimony we heard, there is a certain place we feel everybody should be and we
haven’t seen any road blocks for them to get to that point. Remember, we heard
what we heard. We discussed what we discussed and we are giving a status of the
industry. We are not necessarily — and we don’t have the jurisdiction over
this. So that is kind of where we are.

DR. FITZMAURICE: But we can make recommendations. We don’t have the
jurisdiction and if we want to be silent on it, that is fine, too.

MR. REYNOLDS: I guess I would say it differently. As part of this process
of preparing a letter, if anyone has recommendations, like yours, that could
clearly be articulated and discussed in a draft, I mean, that is part of this
whole process that we go through. But as a group last night, we did not discuss
or go into any further —

MS. GREENBERG: [Comment off microphone.]

MR. REYNOLDS: Everything we heard yesterday, which includes that we have no
jurisdiction over the dates. They are in law. So, we are just making a point as
to what we think the industry should be able to do by May 23rd not what should
happen in a case that somebody does or doesn’t. You are asking whether we
should go further and we — I haven’t heard anything from the committee
different than that or positive than that.

MS. TRUDEL: Just again kind of to remind people what the regulations give
us the ability to do and not do, the compliance date is what it is. We don’t
have any ability to reward people for making it. We have the enforcement
ability to penalize people for not making it and the contingency process allows
us to give covered entities, who are making a good faith effort to not be
immediately subject to enforcement. So, essentially that is kind of our
construct that we are operating inside.

MR. REYNOLDS: Wouldn’t you also agree that this really is a complaint
driven process?

MS. TRUDEL: All of HIPAA is a complaint driven process.

MR. REYNOLDS: I understand. So, what I am saying is we recommended where we
think people could and should and would be on May 23rd. If a complaint were to
come in, then that — you know, it is a complaint. It is going to be a
complaint whether or not there is any transition period. It is going to be
anything else and the status of that particular entity that was complained
against at that point would come under discussion, whether we ever write a
letter or not.

DR. COHN: Obviously this brings up the issue of compliance versus
enforcement. So, I think that is potentially a piece that needs to be reflected
in the letter. I think we also generally need to be — err on the side of being
less prescriptive rather than more prescriptive in terms of the details,
knowing that the industry is diverse and I think we heard that — because
anybody can complain at any point. That is clearly in the process.

Marjorie.

MS. GREENBERG: Is the committee suggesting or recommending that CMS should
implement a contingency plan here or — I guess what I don’t understand is can
someone be out — even if CMS — does CMS have the ability to implement a
contingency plan without any change in the regulations?

MS. TRUDEL: It is the Secretary’s authority to publish contingency guidance
and that was done in 2003. I would say we have the same authority now or the
Secretary does —

MS. GREENBERG: So, if someone then complains that some business partner
wasn’t in production, would they have grounds? I mean –

MR. REYNOLDS: If you were to read —

MS. TRUDEL: Can I explain how the process would work? The complaint would
come in and because it would be an NPI complaint, it would come to CMS and in
the course of looking into the complaint and doing our fact finding, if we had
contingency guidance in place for the industry, we would look to see whether
the complained against entity was otherwise compliant in making a good faith
effort to work with their trading partners. If that were the case, then we may
make decisions not to impose penalties.

MR. REYNOLDS: The reason we have been very focused on that date is that if
somebody hasn’t spent any effort, we have heard that there aren’t any major
road blocks as to why they shouldn’t be able to spend the effort to get to a
certain point by May 23rd. If they don’t and a complaint comes in, that may be
looked on a lot — that has got a whole different flavor whereas the last time
there was a contingency, it really didn’t have — it wasn’t requiring anybody
to be anywhere.

MS. GREENBERG: I thought there was a plan.

MR. REYNOLDS: Yes, but this is a little further along than that.

That is the thought. That is the structure. I mean, it is going to take
some work to get it to a point that it sounds like something good.

Steve.

DR. STEINDEL: This last part of this discussion has confused me because in
the first part of the discussion what I was hearing was, okay, there is a
certain set of things that can be done by May 23rd and we have outlined those.
Then I thought we were going to note, too, HHS that there are going to be
difficulty in complying with the NPI regulation due to the lack of the NPPES
and that we were going to recommend some contingency response because of the
lack of NPPES and that would be the contingency guidance that we would
recommend that CMS uses when they are looking at a complaint.

MR. REYNOLDS: Correct.

DR. STEINDEL: So, we are in sync. It was just a matter of a little bit of
phrasing.

MR. REYNOLDS: Yes.

Okay. Any other comments on structure, the thought that we need to do?

We will begin to put out a draft. We will obviously post the calls because
I am sure industry people know we will be very interesting in what this says,
especially we had so much interest yesterday and I think very helpful. I think
that it was absolutely outstanding input. People were incredibly professional
in presenting it. The emotion was limited. It was really good. I really
appreciated it.

MS. GREENBERG: You are considering an open conference call?

MR. REYNOLDS: Well, we may. I don’t know. I mean, that is what we have to
decide what we are going to do.

Any other issues — well, questions? Jeff, back to your earlier — is it
the desire of the committee that some type of a letter or recommendation or
something start being put together on the SDO proposal, any other discussion
that we heard earlier? If so, then we will need to decide on a time frame. It
may or may not need to be ready for February, but it may be for the next full
committee, whenever that is, but I am just throwing that out on the table so
that we make sure when we walk out of here we understand clearly our
assignments and the timeframes of those assignments.

So, Jeff, you might want to jump in on that since you had previously made a
motion on it as to what you would like to see happen.

MR. BLAIR: I guess I would submit for consideration to the subcommittee the
drafting of a letter that would support possibly with amendments or, you know,
contingencies or wordsmithing, but would support the basic concept of a
streamlining of the process, I mean, the SDO and the NPRM process.

DR. COHN: I presume we can discuss this without having to second it?

MR. REYNOLDS: This is a chat.

DR. COHN: Thank you. Because I would like to chat about it.

I thought the discussion today was very, very helpful and I think we, at
least from my view, it felt to me that the fundamental elements of the SDO
proposal appeared to be very sound. I did hear, I think, what I thought were
some very welcome additions from other panelists. Then I think the other piece
was the issue of public comment, which I think we need to think about. I was
particularly intrigued with some comments made by one of our lead staff in
relationship to the variety of options that the Secretary might have in terms
of the actual rule making, which might help expedite the process.

I personally don’t know enough about that and I don’t know whether we can
get information in written form to help educate us and allow us to make a
determination or whether we need testimony. I mean, I am a little concerned. I
think the last time we had testimony from a lawyer on this issue. I don’t think
we came away any smarter — that is a bad — let me reframe that.

I thought that the many issues were brought up of value by the attorney,
but I didn’t come away with a conclusion or a way of really being able to put
it together. So, I think whatever we come forward with potentially needs to
consider that because I was — it would seem to me that there maybe some ways
that there may be some ways that we can incorporate public comment into all of
this stuff in a way that doesn’t necessarily slow the process. I think that —
whether we need to explore that in open hearings, get written information, I
don’t know.

But that was the part that I am — in terms of trying to put it together.

DR. STEINDEL: Simon, I think we need a little clarification on from the
process that they put together was in the last two steps because it seemed to
occur after the SDOs had finalized their process and is there a feedback loop
because what happens if NCVHS holds public hearings in this area. We uncover
some new information. Is the intent to actually use that as a feedback loop and
then it also occurs at the next step at the final regulation stage. You know,
do we anticipate the Secretary having any discretion at that final regulation
stage on what can be done, final reg with comments. As was pointed out, what is
the nature of those comments.

I think those two areas need to be clarified.

MR. REYNOLDS: Michael.

DR. FITZMAURICE: We may need a lawyer to comment authoritatively on it. One
of the things that we could do is recommend to the Secretary that there is
merit in this proposal and the industry has by and large looked upon it
favorably in our hearings and that we recommended the Secretary consider it and
also consider obtaining legal advice as to how it could work within the
construct of the Administrative Procedures Act.

MS. TRUDEL: I actually absolutely agree with that and actually have
suggested that before. I think there would be very long protracted dialogues
and discussions to assess how a proposal would fit with the APA. I don’t think
you could get someone to come in here and provide testimony that would say,
yes, no. But I do think that it would be easier to get that kind of assessment
done with care if there is a specific proposal on the table for people to look
at as opposed to looking at something theoretical.

I would suggest sending it forward with that caveat.

DR. STEINDEL: I think we just got our letter.

MR. REYNOLDS: Is everybody comfortable that that type of a letter, taking
what we have heard and what we want to add that way would be the appropriate
thing to begin? I see heads nodding. Anybody disagree with that?

MR. BLAIR: You don’t need a motion for that either?

DR. WARREN: We are going to write a letter and then we are going to send it
to have one of the lawyers look at it to see if it is within —

MR. REYNOLDS: No. Asking the Secretary to have lawyers look at it.

DR. WARREN: Got it.

MR. REYNOLDS: Now, the thing is now let’s talk about timeframes. Is this in
— does this come before us in the late April, early May timeframe or is this
something we are trying to get in position to give to the full committee in
February?

MR. BLAIR: If it is possible for us to get it to the full committee in
February, I would like to see that happen. If it turns out that it is not
possible, then, you know, we have to accept reality, but, you know, this is a
process of trying to streamline the — we have tried the streamline process for
more than a year and I certainly would like to have it move forward as quickly
as possible.

MR. REYNOLDS: I am sure everybody would agree that you have just designated
yourself as a drafter, along with whoever else you might want to help you.

MR. BLAIR: How did that happen?

MR. REYNOLDS: And you know the timeframe between now and the meeting. I
took the other one. You got this one. Would you like to adjust your thinking on
the timeframe?

MR. BLAIR: I will do my best.

MR. REYNOLDS: Okay. Are there any other items that need to come before the
committee?

MS. GREENBERG: In other words there is a possibility you will have a second
letter?

MR. REYNOLDS: There is a possibility.

MR. BLAIR: And, Michael, maybe you could assist me since you offered some
wording that I think —

DR. FITZMAURICE: Yes, I will, Jeff.

MR. REYNOLDS: My letter has priority. So, if I need Michael, he is in line
—

DR. FITZMAURICE: And maybe have Denise pulled in to help do the boilerplate
of here is why we are involved in this.

MR. REYNOLDS: Denise is helping me first.

MS. GREENBERG: But at a minimum you would have something maybe to review
among yourselves in February.

MR. REYNOLDS: We might have, yes, in our breakout session.

Any other — yes, Simon?

DR. COHN: Before you adjourn, I was obviously just trying to figure out
what exactly are the next steps of the subcommittee between now and our full
committee meeting in the middle of February?

MR. REYNOLDS: Denise and I will draft a letter. I will try to have it out
by the middle of next week, which is about what we need to do, get it to the
full committee and make sure we get calls scheduled or whatever.

We will expect involvement. We will expect help because this is going to be
–obviously, the last two days have been complicated set of hearings. So, this
isn’t one that is going to dash off — dash quickly off your pen.

We are about to recommend a significant thing. So, I ask that all of you
please engage. Okay?

Hearing no other business, consider us adjourned. Thanks for everybody’s
attention. Everybody stayed really focused.

[Whereupon, at 12:10 p.m., the meeting was concluded.]