[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

January 29, 2008

Hubert Humphrey Building
200 Independence Avenue, SW
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
www.caset.net

TABLE OF CONTENTS

P R O C E E D I N G S [9:05 a.m.]

Agenda Item: Call to Order, Welcome and Introductions

MR. REYNOLDS: I’d like to go ahead and get started. I’d like to welcome
everyone to the Standards and Security Subcommittee of the NCVHS. NCVHS serves
as a statutory public advisory body to the Secretary of Health and Human
Services. In that capacity, the Committee provides advice and assistance to the
Department and serves as a forum for interaction with interested private sector
groups on a variety of key health issues.

Over the next day and a half, for today we’re mainly going to be getting a
number of updates to the panel relating to things like NPI, E-Prescribing, long
term care. We’re going to have a long term panel, DSMO presentation. And then
towards the end of today, we’re going to be reviewing as a subcommittee the
list of things that we sent out as far as our inventory so we can get ready for
next week’s Executive Subcommittee meeting.

I’d like to – we’ll go around the room in just a minute here and let
everybody introduce themselves, and I’ll ask members of the Committee as to
whether or not they have any conflicts. I’d like to first introduce my
Co-Chair, Jeff Blair.

MR. BLAIR: I’m Jeff Blair. I’m Director of Health Informatics at Lovelace
Clinic Foundation, and obviously Co-Chair of the Subcommittee on Standards and
Security. I’m not aware that I have any conflicts of interest.

DR. STEINDEL: I’m Steve Steindel, Centers for Disease Control and
Prevention, staff to the Subcommittee and liaison to the Full Committee.

DR. FERRER: Jorge Ferrer, Health Informatics Specialist, staff to the
Subcommittee, no conflicts.

DR. WARREN: Judy Warren, member of the Committee, no conflicts.

DR. COHN: Simon Cohn, Chair of the Committee and member of the Subcommittee.
No conflicts.

MS. BUENNING: Denise Buenning, lead staff to the Subcommittee, CMS.

MS. ESQUIRE: Mary Esquire, CDC, NCHS and staff to the Subcommittee.

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

MS. SPIRO: Shelly Spiro from Spiro Consulting, Inc. representing the
American Society of Consultant Pharmacists and Long Term Care Pharmacy
Alliance.

MR. MCKINNEY: Frank McKinney, MDI Chief.

MS. MITCHELL: Sue Mitchell, Omnicare Information Solutions.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and Executive Secretary to the Committee.

MR. REYNOLDS: And I failed to note as the Co-Chair that I do not have any
conflicts of interest that I presume. We don’t have Karen Trudel here quite
with us yet, but we’re going to move on to our next agenda item which is an
update on E-Prescribing by Denise Buenning.

Agenda Item: Update on E-Prescribing NPRM/Final
Rule

MS. BUENNING: Thank you, Harry. I just want to give everyone a very brief
update as to the progress we are making towards a final rule on E-Prescribing
standards. Just as a little bit of background for everyone, back in 2003 the
Medicare Modernization Act gave us the responsibility of establishing a
voluntary e-prescribing program for Medicare Part D.

And as a result of the MMA, we conducted pilot testing in the calendar year
2006 of some initial standards, some six standards that the Secretary deemed
that we needed more experience with and more information on in order to adopt
them as final e-prescribing standards.

In 2006, we conducted the year long pilot, and at the end of that time we
evaluated the results of the pilot and reported to the Secretary that of the
six standards that we tested, two were ready for implementation in Medicare
Part D, one standard was technically correct, RXL was technically correct, but
that we needed to have some additional industry feedback as to whether its
implementation would constitute a burden to the industry.

And then there were three standards, Codified SIG, RX Norm and Prior
Authorization that were not yet ready for implementation for Medicare Part D.

As a result of the pilots, we issued a report to Congress in April of last
year and then followed that up with a Notice of Proposed Rulemaking on November
16, 2007 that proposed to adopt the standards for formulary and benefit and for
medication history, asked for additional information on RX Fill, asked that the
industry consider the adoption retirement of NCPDP Script 5.0 and the adoption
of the updated version NCPDP Script 8.1, and we also asked about the compliance
date which as mandated by MMA is one year after the issuance of the final rule
in April 2008.

The closing period, the comment period closed on January 15th of
this year. And as you can imagine, we are very, very earnestly pursuing getting
those comments read, categorized and preparing our responses to it. We are
still looking at having out the final rule as of April 1st which
puts us around two and a half months away. So, as you can imagine, it is a very
hectic time for us, and we did receive a wide variety of comments from
different segments of the industry, from pharmaceutical manufacturers, from
SDOs, from healthcare systems, health plans, individual physicians and
pharmacists. We were very pleased to see the wide range and the gambit of
responses that we received.

Generally, I don’t think there were any surprises. We did get a lot of very
good insights that we are considering in our responses. So I can tell you at
this point we are still on target to have this out in April of this year. And
that’s pretty much my update.

MR. REYNOLDS: Denise, did you, which two – you mentioned this three
nos, one – what were the two that actually made it through.

MS. BUENNING: Okay, the two standards that we proposed for adoption in the
NCRM were NCPDP Script 8.1 which had the medication history standard included
in it, and also NCPDP Formulary and Benefit 1.0. Those are the two that we are
proposing for adoption.

We asked for comments on RX Fill because even though it technically works,
we heard feedback from the industry that if they were to receive feedback every
time a patient picked up a prescription that this could be a burden to them,
and they didn’t know that it would affect their workflows in a negative way. So
we asked for comments on that.

The three other standards that were not ready for adoption were Codified Sig
which is an NCPDP standard, the prior authorization which is a combination of
four standards, and the RX Norm which is the National Library of Medicine
standard.

MR. REYNOLDS: Any questions from the Committee? I’ve got some, but I’ll
defer to someone else first. Judy?

DR. WARREN: I want just clarification. The second standard of NCPDP was 4.0.

MS. BUENNING: It was formulary and benefit 1.0.

MR. REYNOLDS: Jeff?

MR. BLAIR: Denise, what is the next step? What would we expect in terms of
those that didn’t make it here. Thank you. In particular, how long will it be
then for things like RX Norm, for the Codified Sig, for Prior Auth and for the
Fill Status Notification because I imagine each one is a separate case.

MS. BUENNING: Fill status is technically ready to go. RX Fill was proven in
the pilot testing in the calendar year 2006 to technically work. The question
was whether its adoption would be burdensome on the industry on prescribers who
would get all of this feedback about prescriptions being filled, not filled,
partially dispensed, et cetera. So that is the question we had imposed in the
NPR and to the industry if we were to adopt it, what would its use be, how
would you feel about it.

MR. BLAIR: Well, let me just stick with that one for the moment. That was
potentially one of the standards that might have made it possible for us to
come to an accommodation with the Drug Enforcement Agency for us to be able to
cover controlled substances.

So if that is held up, then where do we stand with controlled substances? I
would hate to see – and by the way, the comments that were made back were
in terms of clarifying how it might be used and a lot of those clarification
with respect to how a pharmacy and physician or an integrated health plan might
use the pill status notification. So it wasn’t something wrong with the
notification itself. It’s a matter of the usage after it’s in place.

So in short, does this have a ripple effect where this then delays the
agreement of DEA to have us use E-Prescribing for controlled substances.

MR. REYNOLDS: Karen, I think you wanted to comment.

MS. TRUDEL: Yes, Jeff, you’re putting us in a really kind of a difficult
place because the proposed rule did make it clear that Fill Status was ready to
go. We received a number of comments pro and con. We’re still looking at them,
and it’s possible that we may adopt Fill Status as part of the final rule.

But the decision process is still ongoing, and we can’t really speak for
where we’re going until the Secretary approves it.

MR. REYNOLDS: Okay.

MS. BUENNING: I want to answer the other part of Jeff’s question. Where are
we in terms of the other standards. The one that is, I think, closest to being
ready, I know that the industry is working on this and we are as well in some
work groups and some discussions that we’re having with NLM is RX Norm.

The other two standards, Codified Sig and Prior Authorization, are going to
take some more work. And from the feedback we’ve gotten actually through the
NPRM process we’re getting indications that the industry is already coming
together to work on this. So I can’t give you any timelines at this point. But
it is a priority to get those standards ready to go just as quickly as we can.

MR. REYNOLDS: Simon?

DR. COHN: Denise, thank you for the update. I guess I’m reminded, of course,
of the regulatory requirements related to MMA and the time frame that you’re
describing. I guess the question I have as we move into the later years of the
legislative piece is what are the expectations of further updating change,
additions to these standards post-2009? Are we in a situation where either it
makes the cut for this final rule, and then that’s it? Or is updating and
further modification contemplated?

MS. BUENNING: The standards, by their very nature, are always modified and
updated, and you know, we do have to follow the process that’s in place for
open discussion, public comment, notice of proposed rulemaking. We also have a
streamlined process that allows the Secretary to adopt updated versions of
existing standards if they meet certain criteria. So that’s the backwards
compatibility issue I think we’ve discussed before.

So we do have some mechanisms in place that would allow us to as
expeditiously as possible adopt standards as we get feedback, you know, through
forms like NCVHS and other mechanisms to take those forward.

MR. REYNOLDS: Steve?

DR. STEINDEL: Thank you. Denise. In the many groups that I work with, there
has been a lot of discussion going on around medication standards, and I’m
using that term as an umbrella. We have a AHIC proposing medication use cases,
and we’re going to have some discussion later on an area where they’re sort of
merging this with the E-Prescribing.

We have HITSP who has pronounced medication management standards for
transfer of that information within the guise of the personal health record and
also the EHR. And finally, we have the E-Prescribing standards –
regulations, not standards but regulations. And where I constantly face the
problem on many of these discussion groups is what trumps, and it really is a
very controversial question because some of these, while they’re using the same
standard, the same – I won’t say standard. That’s a wrong word. They’re
using the same methods and the same ideas of how to do things. There are twists
and turns that are differences in them.

And is there any advice that I can have that I can sort of share on these
phone calls? And yes, Karen, I am putting you on the spot.

MS. TRUDEL: Yes, I think you raised a very good question because the venue
of medications goes way beyond the Medicare Part D ambulatory prescribing
stage. But our legislative authority under MMA is limited. And so what we’re
basically trying to do is to adopt standards that work in our area and that
theoretically are well accepted industry standards that are going to be used in
E-Prescribing with the understanding that as HITSP moves on and some of these
standards and terminology become more sophisticated, we may have to step back
and see how those two environments cross each other.

That’s, I think, the only advice I have. And it’s inherent in the fact that
we’re operating under a very specific limited statutory authority.

DR. STEINDEL: And thank you, Karen. Actually, that was helpful.

DR. FERRER: Denise, can you elaborate a little bit on the RX Norm? Can you
elaborate on the RX Norm NLM problems that you’ve had?

MS. BUENNING: From my understanding, there were some problems with the quote
unquote crossover translation between the languages as I call them. I’m not an
RX Norm expert, and I can probably get you some more detail as to exactly the
nature of the issue.

But it was what they call a syntax problem, a synchronization problem. A
synonymy, I’m sorry, a synonymy problem. And I know that we have been working
with the National Library of Medicine and some other folks to try and resolve
those. And from what I’m seeing in the comments that we’ve gotten back, most of
the issues have already been resolved.

MR. REYNOLDS: Karen?

MS. TRUDEL: One of the other things is, is that because the pilot programs
went into place so quickly, none of them actually had a chance to really field
test RX Norm. They more like bench tested it. And so even if the synonymy
issues that Denise referenced are actually fixed, we don’t really have a clear
feeling of how it really works in real life transactions in E-Prescribing. So
that’s one of the things that we’re looking to remedy.

The other thing is that until there’s a complete NDC database and FDA is
working on those regulations, there’s a shortage potentially of NDCs to map RX
Norm concepts to. So we’ll have to see how that impacts real life.

MR. REYNOLDS: Yes, Mike, why don’t you introduce yourself and then Donna for
the record.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality. Then are you going to Donna or to me?

MR. REYNOLDS: Let her introduce herself.

MS. PICKETT: Donna Pickett, National Center for Health Statistics.

DR. FITZMAURICE: Denise, about synonymy, is it that you don’t know if the RX
Norm code is equivalent to what the doctor prescribed or equivalent to the NDC
code that the pharmacy filled, or both.

DR. BUENNING: I believe in some instances it was both.

DR. FITZMAURICE: Okay.

MR. REYNOLDS: Denise, as we have looked at all these standards, one of the
things that we always deal with is the adoption. So as you’ve seen the comments
come in, if you’re able to, can you discuss what are the types of concerns that
providers and others are expressing as to the implementation, you know, the
actual adoption of it now. Tomorrow, we’ll have another discussion on what
adoption could take as a form. But I’m talking about just what are the things,
what are the barriers that appear to be coming in through comments.

MS. BUENNING: I’m not really seeing anything unusual in the discussion of
barriers. The industry is indicating that they have experience with 8.1, that
they’re familiar with the formulary and benefit, that they understand that the
three standards that were not ready for adoption, are not ready for adoption
and obviously are not pushing towards that. I think we had one commenter who
said in their opinion we could adopt all six standards by 2009 with no problem,
and I kind of questioned their rationale on that.

But I think we’re getting some information that in some cases we under
estimated provider costs, and we’ve had that pointed out to us. In some
instances, I think actually one instance where a health plan came to us and
said we could use more time.

But I’m not seeing anything that jumps up as a barrier that we haven’t heard
before and addressed.

MR. REYNOLDS: Any other questions from anyone? Okay, Denise, thank you.
Karen has arrived. So we’ll go back to her slot, and we’re going to get an NPI
update from Karren Trudel.

Agenda Item: NPI Update

MS. TRUDEL: Good morning. This is Karen Trudel from CMS. I’m going to talk
primarily about the Medicare status on NPI implementation, and then I’ll talk a
little bit about some anecdotes that we have from industry and again mention
the compliance date upcoming on May 23rd, 2007.

In Medicare Fee for Service, we’re receiving about 91 percent of all claims
containing an NPI, and that includes an NPI or a NPI and legacy pair for the
billing provider or the pay to provider. On January 1st, we
implemented a reject policy on our Part A side that claims that do not have an
NPI we’re rejecting, and our reject rate stays pretty much around ten percent.

We have been sending out a number of messages and alerts before that. What
we’re really looking at as the key indicator of how things are going to go for
the next few months is that on March 1st we will begin to reject
professional claims if they do not have an NPI or an NPI and legacy identifier.

Claims with only legacy identifiers will be rejected. And, again, we have
been sending alerts out, and we’ll really be looking to see what that does to
the claim rejection rate on the primary professional claim side.

We will continue to allow legacy numbers for secondary provider fields that
referring, operating, attending, et cetera. And of course, on May
23rd of this year, we will only accept transactions with NPIs in
both the primary and secondary provider fields. So if a claim contains a legacy
identifier at that time, it will be rejected and we will also require NPIs on
the other electronic and paper transactions.

CMS will be hosting a national NPI Roundtable call on Wednesday, February 6
from 2:30 to 4:00 p.m. Eastern Standard Time. This will focus on the status of
the Medicare implementation, and there will be a related question and answer
session. Registration details will be available on the CMS website.

So really I think what we’re seeing is that the percentage of claims with an
NPI is creeping up. We have a key date of March 1st for the
professional claim, and we expect about two weeks later we’ll begin to have a
sense of what the reject rates look like for that and what the impact of that
action will be, and we will have a roundtable call on February 6th
which I think is pretty timely to talk about the status of implementation.

We continue to see confusion on the part of professional providers in terms
of which NPI to use and which place on the claim, whether they use the
individual NPI or the organization’s NPI. We’ve done an enormous amount of
outreach and have been doing outreach in partnership with WEDI and a number of
other industry organizations.

We continue to hear that there are some providers who, for one reason or
another, don’t believe that they need to have an NPI and were a little bit at
odds to know what to do about that. We’ve done pretty much everything we can
think of in terms of providing the input and outreach and education. So we’ll
see how that goes.

In terms of other industry input, anecdotally we’ve gotten reports from
other plans that between 75 and 88 percent of their claims are coming in with
NPIs. I’d be interested to hear anything that the members are hearing, and that
definitely may not be representative of industry. They’re from a small group of
responders who are giving us voluntary input.

And, again, the contingency ends on May 23rd, although covered
entities aren’t prohibited from listing their contingency plans prior to that
time. I’d be happy to take questions.

MR. REYNOLDS: Okay, first, Karen, I will make a comment. I thought you might
have some statistics. In North Carolina, we’re at 94 percent inpatient
institutional claims, and right at 90 percent professional. But I think your
point and as we look at the things the Subcommittee needs to go forward on,
this whole idea of adoption, because, again, that’s with the year extension and
that’s with about – I think I would agree with you. We have done so much
outreach I’m not sure we can reach any further, and I’m not sure we can come up
with any new ways to say it. But as we go forward with all these standards and
we think of 5010 and we think of ICD 10 for this Committee, this ability to
really communicate with the providers and make it somehow happen continues to
be a pull. It’s not a – if we push, we pull the whole industry, and you
could hear from CMS and I can say the same thing is doing everything possible
trying to find ways to do it. But we just can’t quite get there.

And I personally commend CMS for the cut offs because that does say that
there is a date that they tree on and you’ve got to step up. And as the rest of
the industry starts moving there, then it will be – but thank you, Karen.
I think you guys are doing a great job. Mike, you had a question.

DR. FITZMAURICE: I want to join with you, Harry, in complimenting CMS that I
think they’ve done it very much the right way establishing a boundary, giving a
year’s extension for compliance and for outreach, and then fixing a hard date.
It really sends a good message to industry that this is real, and that there’s
a little bit of compassion and you may have problems. Let’s give you a year to
fix those problems. But they’ve got to be fixed.

The question I have for Karen is when you say the professional claims, is
that all the Part B claims, or is it the professionals like the physicians,
practitioners, and does that include things like durable medical equipment.

MS. TRUDEL: Professional means all Part B and durable medical equipment,
anything handled by a carrier or a DMAC.

DR. FITZMAURICE: Thank you, Karen.

MR. REYNOLDS: Same thing in our case. So as of May, we’ll be able to check
NPI off and move on to the next case, right or somewhere close to that.

Okay, we’re running ahead of schedule. But since Lynne’s up there, why don’t
we keep moving. Let’s keep it going. So, Lynne, if you would – Lynne
Gilbertson’s going to give us an update on NCPDP Script, and thanks for joining
us again.

MS. GILBERTSON: Good morning. I’m Lynne Gilbertson from the National Council
for Prescription Drug Programs. I’m going to provide a standards review of the
enhancements that have come forward for the NCPDP SCRIPT standard which was
used in E-Prescribing. As the SCRIPT standard relates to the long term care
environment, you’ll hear from the panel later today, and I’ll let them speak as
the standards support the industry and it’s their voice that’s much more
important than what the standards have move forward for. But this will provide
you with an overview.

Included in the packet was a recommendation letter that was sent in December
and a overview of the SCRIPT enhancement for a summary level. But I’m just
going to touch very high level so that if you have any specifics, you can refer
to the – it’s not very fun to sit and listen to techie talk for an hour.

So we’ve had an interesting timeline. In May 2007, the long term care
industry participants brought forward a request to the national committee for
the removal of the exemption from E-Prescribing for long term care. You
remember in the original long term care was exempted from the electronic
prescribing. They could participate, but they were not required to.

And so this recommendation came forward for the use of SCRIPT Version 10.1
or higher. Meanwhile, the industry was discussing it’s time to move forward off
of the point one of SCRIPT and plan for the next versions going forward.

So during the August and during the November NCPDP workgroup meetings, the
industry talked about what the plan of attack should be, and this is for long
term care and ambulatory. So all of the folks who are participating in
electronic prescribing today.

On November 16th, one week later, CMS released the NCRM on
electronic prescribing as it relates to SCRIPT in particular Version 5.0 and
then 8.1. Well, by then in December, the NCPDP submitted a recommendation
letter to NCVHS and CMS related to the next phases of moving forward.

It’s really cool to be in this industry because people meet, have a problem,
get it solved, get it moving and then ask for moving it forward. So it is
really an interesting environment that is quite fast pace at the industry’s
needs, not at what a standard could bring forward. We only support that.

The recommendations that were submitted in the December letter is
recommending the use of SCRIPT Version 10.5 with an implementation date of
January, 2010. This is for ambulatory and long term care use. It gives the
industry time to complete the standard development process, to complete the
requirements for their implementation time frame to get their business plans
together, and for CMS to proceed through the NPRM process.

The recommendation also included the continued support of Version 8.1 of
SCRIPT. Currently, there are dual versions supported, Version 5 and Version
8.1. But the industry is predominantly using 8.1. So in the recommendation, the
use of 8.1 as the industry moves toward 10.5 continues to support that dual use
for some time.

MR. REYNOLDS: Lynne, we don’t usually ask questions here. I need a
clarification.

MS. GILBERTSON: Okay.

MR. REYNOLDS: When you say you’re going to continue the support of 8.1, is
that after 2010?

MS. GILBERTSON: Yes, yes.

MR. REYNOLDS: Okay, thank you.

MS. GILBERTSON: And then the sunset of Version 5.0. These recommendations
were included in the comments to the NPRM so that CMS was aware that this was
coming forward and not surprised as well as the National Committee.

To give you a little information on SCRIPT 10.5, it is currently under
ballot. This is its timeline. Right now in January, it’s under ballot. We will
adjudicate the first round of comments in February, so it’s in a couple of
weeks. We expect ballot comments because the industry does read the standards
and provide information back to us of whether there are other enhancements,
something we missed, and typos, things like that.

We’ll adjudicate those comments in February, and an anticipated ballot
recirculation which will have any updates from the comments received will take
place in April. And then during the May NCPDP workgroup meetings, we will
discuss any recirculation comments that might come in. There’s a mandatory
30-day appeal time frame which will take place in June. The NCPDP Board of
Trustees will be asked to approve the standards and the process that it’s gone
through in July of 2008 with the publication to come right after that in July.
So that’s the time frame of 10.5.

In every implementation guide NCPDP creates, we have an appendix that lists
the version changes so that the implementer is aware of what has changed from
specific versions. As I mentioned, I included a summary of the version changes
from post 8.1 which the first version after that was 9.0 through 10.5 in your
packet so that you have, if you wanted to see a more detailed level. That is a
summary level. There is much more detail in the NPI Guide. But I really didn’t
figure you’d like to read those pages.

Just a very brief discussion of the changes that have come forward with
SCRIPT since the 8.1 was approved. The version 9.0 was approved in October
2005, so quite a while ago, and it only had one minor change which was removing
a unit qualifier in a field that was causing confusion amongst implementers. So
we did what the industry requested and removed that.

Version 10.0 was the next version. It was approved back in October 2006, and
this is the first version that identified some very specific long term care
needs that came forward based on the MMA pilot. There were additional
qualifiers that were added to different fields, a very other fields that were
actually added. SCRIPT, instead of trying to build everything for everybody in
Version 1, the industry brings forward the changes they need at the time they
need them.

So as it was not – some of the things for long term care might have
been anticipated mainly by accident as the industry tried to develop SCRIPT
back in the old days. But now we had some very specific pilot results that have
come forward with very specific needs for long term care that we could add into
the standard and have it approved.

SCRIPT 10.1 was approved in July 2007. It had long term care needs that had
come up as well. Once we got through the pilot, we have a very active Workgroup
14 of long term care in NCPDP that meets regularly and tackles problems the
industry receives, brings forward those changes and once the changes are
approved, they go to ballot. So you’ll see a recurring theme that our long term
care folks have brought forward for updates to the standard.

We added a transaction called the census update, and this is a transaction
where the facility can notify the pharmacy with new resident information,
changes about that resident or discharges about the resident so that the
pharmacy and the facility are in sync with information related so that the
pharmacy obviously has the most up to date information for dispensing
information.

We also added a resupply request transaction which is nothing more than a
refill request, but it’s based on the long term care needs. There is no
requirement for a refill request and response as there is in the ambulatory
setting. Can the patient have more, yes or no, that kind of thing. In a long
term care setting, that’s not the workflow. So we added a tweak to the refill
request transaction.

And then there was another need brought forward by the industry for some
medication history of an order number to use as a trace back number when the
medication history goes back and forth to the prescriber.

In Version 10.2 which was approved in July 2007, we added a needed no longer
than date and time which is used for special delivery needs in the long term
care environment.

SCRIPT 10.3 is anticipated approval of April 2008. It added two factors for
the medication history environment which is the source of where the medication
history was obtained and a phone number if it came from a dispenser. This is
used in what they call de-duplicate processing. You can have medication history
information coming from multiple sources, and you want to make sure you have it
de-duplicated so that you can filter out whether or not you received this
medication history information from another source that also had it.

SCRIPT 10.4, the anticipated approval is April 2008. It supports the ability
to send multiple pharmacy routing indicators which we call the bin and the
processor control number. That’s how claims are identified for which payer they
go to, and it allows the pharmacy and the facility, for example, to send this
information back and forth to help somebody if you know which routing to use
for a claim. Because you know the patient’s health plan, you can send that
information as assistance for the demographic profile of the patient.

We also added the support of the Sig statement which came from the
structured and codified Sig format. It is a conditional segment. The Committee
will remember you heard testimony during the pilot about the use of this Sig
format, and it has been incorporated into SCRIPT so that if future piloters
wish to use it, they’ll have a standard method for exchanging this information.
We don’t expect it’s done. But it gives everybody a framework for a common
ground to be able to send back and forth and then when the changes come in,
we’ll adjust the Sig standard environment, the segment into what the industry
requests.

One of the things that we were discussing a little earlier is related to
ARC’s Norm Sig and the prior authorization function. AHRQ and CMS are
sponsoring a one-day expert panel for electronic prescribing. Those are the
three topics. We will be having web casts about those and a one-day session to
say what do we do to move these forward. How do we, for example, continue using
the industry expertise to make RX Norm a workable solution in the industry.
What is the barriers. Let’s get over them and get going.

On Sig, the same thing, and then prior authorization’s a little different
animal because it still is needing some industry joining of meeting of minds, I
guess. So they will be tackling that. But it’s a great opportunity flowing from
the pilot to really discuss what do we do next. Let’s really get some
deliverables out of this session.

And then SCRIPT 10.5 I mentioned earlier. It’s approval is anticipated for
July 2008. It includes support of XML which is then incorporated into the M
Guide. In SCRIPT 8.1, XML was a companion document, and now it’s incorporated
in so it just keeps everything together.

We also added support of a HITSP recommendation that came forward for the
management use case. And so the medication management, some of the
recommendations were the use of the federal medication terminology code sets
for describing drug items. And so NCPDP is balloting that support.

And then there were some constraints that were identified by HITSP in the
medication management use case, and so we added those as well, and those are
all under ballot. So that’s it.

MR. REYNOLDS: Okay, Lynne, thank you. I’d like to open it for discussion.
We’ve got Steve, Mike, Judy.

DR. STEINDEL: Lynne, thank you very much for that enlightening presentation,
and I use that word deliberately. What – I’m not going to comment
specifically on the changes to the various versions. They’re obviously because
of the consensus process that exists in NCPDP, there are obviously changes that
were required by the profession to represent what’s going on in their
environment today.

And there’s also since the period of time we last looked at these which was
SCRIPT 5. something in the initial standards which wasn’t that many years ago,
roughly five versions, not counting the point versions that have come into play
here.

And so just as a very rapid summary, it appears that the clients who use
NCPDP standards are willing to accept the idea that the standards should evolve
rapidly and meet today’s needs. The problem is that what we’ve been doing both
in the private sector with regard to HITSP and in the public sector with our
regulations is we tend to freeze standards. And evolving them to meet current
needs sometimes gets to be, shall we say, difficult.

Do you have any advice on the rest of the process on how we should think
about this? You’ve obviously been successful in your world with your
environment in having an evolving process.

MS. GILBERTSON: The wisdom of Solomon and the patience of Job.

DR. STEINDEL: And don’t go into DSMO talk later.

MS. GILBERTSON: Yes, right. Let me fill the acronyms, no. Fundamentally, the
standards can move forward quickly. We can on a quarterly basis adjudicate
changes the industry has brought forward.

Part of that answer, I guess is that the standards should continue to move
forward as quickly as they can so that they are ready when the industry wants
to adopt. Now we’ve recognize under HIPAA and under MMA that we’re moving
versions that probably will never be implemented because right now we’re using
8.1. Some folks might be using Version 10 in their environment, for example,
some of the long-term care has moved to that even though they’re exempt. But
there might be SCRIPT 9 and 10.1 and 10.2 and 10.3 that never see the light of
day. But they’re there, they’re available so that when the industry decides
what do they want to go to, it’s going to be ready before the time frame of any
regulatory requirement.

So 10.5’s gone under ballot, and the shot gets fired to say please let’s
move forward. That’s one of the tensions. Now there’s always a struggle for me
to try to address the needs of the future. I am personally very wowed with
folks who can see further out. I tend to be able to see what is the need, how
do we solve it, let’s get it done, let’s move forward.

So there is a not maybe a tension, a consideration that I’m not quite sure
how you marry those together because I tend to see what do we need to solve
now, and let’s not try to make it perfect. Let’s just try to do the good and
make it go forward.

I am an active participant of HITSP in the medication management use case,
and it has been a struggle of what could be versus what is, and whether
implementers can buy into what could be versus what they’re offering their
clients today. And all I can suggest is that we are trying to work within the
regulatory process we have. The DSMO has brought forward some suggested
changes, things like that. But it’s the backing of the industry. What do you
want, when do you want it, and there shouldn’t be any real disagreement because
the industry should be in one voice of what they want, and the standards just
need to be there for them when they’re ready. Probably not a very good answer,
but —

DR. STEINDEL: Actually, that was a very interesting answer, and I thought it
was a good answer and if the Chair would let me digress for a second. I –

MR. REYNOLDS: The word second would be the key word.

DR. STEINDEL: Yes, I will be brief, Harry. This is somewhat what we were
discussing in the ride over. I was actually asked to give a talk to the CDC on
the use standards, et cetera, and the person putting together the talk cites
the question; when do we use standards? And I never really, you know, we think
about that all the time, but we never were asked the question bluntly to answer
it.

And so I just said, you know, really we use standards to freeze time. When
we’re ready to freeze the industry at that point in time and actually your
answer sort of crystallized that thought a little bit because what NCPDP is
doing is producing intermediary pictures of where the industry is, but it
doesn’t really pull the trigger until industry agrees it’s ready to freeze
time.

So I thought that was a very interesting approach. So you were very helpful
from my point of view. Thank you.

MS. GILBERTSON: I like that. That’s an interesting thought.

MR. REYNOLDS: Jorge, do you have a follow up to that? See this is still your
time.

DR. FERRER: I’m on TSTAT, so I’ll make it very quickly. Lynne, based on your
experience when competing standards co-exist, what would you say is a
reasonable time frame for the industry to reconcile those differences because
you’ve had a lot of experience doing this. I mean, clearly you have a time
frame within those work group that you say you know, enough is enough, and
let’s move this forward. What would you say historically has been your
experience on that?

MS. GILBERTSON: Within NCPDP, we don’t tend to have too much competing
standards going on. Usually, the industry –

DR. FERRER: Yes, but in long term care as an industry globally speaking, not
just in the E-Prescribing state. You might – there might be situations
where it actually occurs.

MS. GILBERTSON: I might defer that question to the panel because the
industry needs to give input on how long they need to get ready. If there is a
chasm meaning there isn’t a standard and it’s proprietary versions, I would say
that is really our standards. So you wouldn’t want to, you know, you have to
bring those together.

As far as a time frame to move, we tend to hear a lot of a year to 18 months
as a time frame. But I really think it’s the problem we’re solving and how long
is it going to take for that. So when the industry has some request to bring
forward, in NCPDP we tend to – it may take, for example, up to a year to
resolve as far as getting it through the ballot processing and things like
that. But that usually gives somebody a frame work of what they’re shooting
holes at. It’s not trying to bring competing things together. So I’m not sure I
answered the question, though.

MR. REYNOLDS: We can also ask it. Jorge can ask the same question of the
panel later. So we’ll see if we can get through this. Mike?

DR. FITZMAURICE: I would like to disagree with my esteemed colleague from
the great state of Georgia that standards are about freezing time. That comes
from the State of the Union message last night. We’re starting to get into the
election mode.

I think the pharmacy industry has shown it’s been very vibrant and very
flexible. When nobody else was connected, they had four, five or six connectors
on their desk. And when everybody else wanted some, they moved to get one
connector on their desk.

I see that they keep moving along. And so I’m wondering if it leads to a
better model of standards, and Steve may like this better than my attacking his
freezing time, that maybe there’s a way that you have a standard, it’s
regulation, it’s law. But you keep moving forward, and as long as it’s
backwards compatible, and it’s something Harry would like, too, that you can
keep moving forward, let the industry adopt it. And so then the regulations
start lopping off the tail end, and at some point we’ll stop supporting this,
we’ll stop supporting this, and we keep moving ahead with progress, letting the
industry adopt those thing that it wants to adopt until we’ve lopped off the
tail end. So that that gets us a way to move forward in time with these
snapshots, but it lets the industry guide where it’s going in the development
of the standards.

MS. GILBERTSON: It can be a real shame if you have to be mandated to move
forward. It really is a shame, and I think you have enough percentage of market
pressures, whatever you want to call it in electronic prescribing to move
people forward. But when the HIPAA surveys were done earlier this year, you
know, and one of the degrees for moving to a new version was I mandate it. It
really is a sad state of affairs that there’s not business opportunities for —

DR. FITZMAURICE: I would respond to that by saying that I don’t think it’s a
shame so much as I welcome the industry saying we want to do this altogether,
and so we want HIPAA. It’s been difficult to move beyond HIPAA or through
HIPAA. But I think it was a great awareness from the state of the industry that
we needed something like this. Now maybe we can get to something better.

MR. REYNOLDS: Karen, was your comment on that? Okay, and then Simon has a
comment on that, and then, Judy, you’re still on. I promise you’re on the list.

MS. TRUDEL: From my perspective, this backwards compatibility is a really
critical factor because we were able almost as soon as we adopted 5.0 to
respond to industry’s request that we go ahead and make available the voluntary
adoption of 8.1 which we did in a period of probably about three months from
start to finish in the Federal Register.

And since we have done that, from what I’m hearing, much of the industry has
voluntarily evolved to 8.1. There’s been no pain to speak of. We haven’t heard
any complaints and that ability to move forward at a voluntary pace, I think,
really is critical, and the backwards compatibility is what let us do that.

MR. REYNOLDS: Simon.

DR. COHN: Lynne, just leading in with a very basic question that sort of
follows along with the backwards compatibility assumptions from Mike and Karen,
do all of these versions of SCRIPT, do they all meet in your view the concept
of backward compatibility.

MS. GILBERTSON: Yes.

DR. COHN: Okay. When do you see as clinical staff will be broken, or do you
sort of see that as going on into the future?

MS. GILBERTSION: I don’t know examples of – I don’t know if you would
not reach backwards compatibility. I mean, one of the things that enters into
the picture to obviously help the compatibility is switches/clearing
houses/intermediaries who can do miracles with transaction routings and
translations. I don’t know. Marc, do you see any? I don’t know what it would
take to make something not backwards compatible. You usually always give a
route.

DR. COHN: Okay, thank you.

MR. REYNOLDS: Judy.

DR. WARREN: I think my questions are much easier. Curiosity on my part.
Saturday, you talked about in Version 10.1 the prescriber order number. Could
you just explain why that’s needed a little bit and why there are other needs.
I didn’t understand exactly why you needed a prescriber order number for
medication history.

MS. GILBERTSON: I figured you’d ask me that one now.

DR. WARREN: Sorry.

MS. GILBERTSON: I brought my more detailed with me to see if – the
crowd is saying the reconciliation of –

MR. REYNOLDS: Someone needs to come to the mike so we can hear, please.
Could you introduce yourself.

MR. GINGRICH: Mark Gingrich from ARCO. I think that was introduced to
provide additional reconciliation. It was added to the source code so if the
medication was prescribed electronically, the ID coming back in from the
prescriber went back to the initial prescription so you would have a round
trip.

MS. GILBERTSON: Thank you. Yes, the prescriber getting the medication
history back. They say, oh, yes, that’s my tie back number electronically.
Thank you.

DR. WARREN: And then I had a second question. You were talking about working
on codified Sig format, and I know at one point you were getting together with
HL-7 and SNOMED and others to come up with the terminology that needs to be
used there. How is that effort going?

MS. GILBERTSON: The recommendation that was approved was for the use of
SNOMED in all the code sets needed within the structure and codified SIG except
for – I don’t remember if it was two or three fields that are using FMT
terminology, the Federal Medication Terminology.

DR. WARREN: Okay. And then just the last question, and this one, Simon
nudged me to see if I was going to ask another terminology question. In 5.12,
you talk about you supporting HITSP, and you’ve got Federal Medication
Terminology code sets. Now is that what you just mentioned as being in the SIG.
What are the Federal Medication Terminology code sets?

MS. GILBERTSON: They are for drug form, drug strength, a potency unit and a
measurement unit, and they name –- all I can think of is it’s a long URL
to the NCIT, Federal Medication Terminology, what is it called, I don’t know.
There’s a potency. Well, if you go down the tree structure for the potency
unit, there’s a drug strength.

DR. WARREN: Just to clarify, this is used in conjunction with SNOMED and Net
Sig. That’s what you’re referring to here?

MS. GILBERTSON: No, these are for actually describing the medication itself.

DR. WARREN: Got it, okay, thanks.

MS. GILBERTSON: Here’s the drug strength you’re talking about, and then
here’s the instructions that Sig, and they’re all in line with the HIPAA
recommendations for using FMT for these things and SNOMED for these things.

DR. WARREN: Okay. Thank you.

MR. REYNOLDS: Jeff?

MR. BLAIR: And Lynne, I don’t know if you can answer this, maybe somebody
else in the room is able to. I’m also not familiar with FMT, and I have
somebody with RX Norm and what it’s offering, and then the VA developed, I
think the name of it, in short, I understand the National Cancer Institute has
been developing some work in here. But maybe my question is what does the FMT
provide that other federal code sets are not providing, specifically RX Norm?

MS. GILBERTSON: Let’s see, I’m not an FMT expert, and if I had my laptop up,
I could at least refer to slides they’ve put on their website to help explain
to NCPDP folks how this all works because this was all brand new information.
There is the Internet –

MR. REYNOLDS: I think Steve can be a big hand. Steve?

DR. STEINDEL: And Jeff, actually we approved the FMT as part of our
medication standards both with going through CHI and the NCVHS Report on
terminology standards. What we did was we approved several big ones. There was
MBFRT. There was RX Norm. I think those were the two big ones.

And then what we did was we approved a set of existing FDA terminologies
that was embedded in their guide books to use to further describe medications,
one of which was the Union Code, and then there was a set of much smaller
terminologies that really didn’t exist at that time as truly free standing
terminologies but were part of the literature the FDA used for regulatory
purposes when providing documentation from the pharmaceutical manufacturers.
And this gets into the areas that Lynne was just trying to touch on like
dosage, potency, et cetera. And so they were pulled out of the FDA regulatory
literature and made part of the distribution system. So it’s still under FDA
control that existed in the NCI which is where NCI comes in.

But these are just a set of very small specific terms for description of
drugs and drug dosage that FDA was using.

MR. BLAIR: So let me see if I under – one thing that’s good on this
that apparently it fits in with work that’s been done, and CHI apparently
evaluated it and approved it within its portfolio of medication standards.
That’s terminologies, and that’s good.

But I think what you’re also saying, Steve, is that at the time FMT was not
used at the time when we read through and approved that.

DR. STEINDEL: Actually, that’s only partially correct. It was not used in
the clinical domain, but it was widely used by FDA clients which includes
people who were doing clinical trials for FDA.

MR. BLAIR: Okay. You know, I don’t ever remember seeing that. Was it
actually in the documents –

DR. STEINDEL: Yes.

MR. BLAIR: Okay.

DR. WARREN: It’s the power of the Internet. I actually pulled up a slide set
by Randy Levin who gave a testimony to the Subcommittee. In October 2006,, they
have a whole slide about the Federal Medication Terminology because I didn’t
file it in my head that way.

MR. REYNOLDS: No, either did I.

MS. GILBERTSON: And try and explain that to the pharmacy industry, the what,
the who.

MR. REYNOLDS: Okay. I’ve got a couple questions. I’ll stop after each one,
and if anybody else on the Committee has one, feel free to jump in. If not,
I’ll ask them.

One tactical question. You mentioned the patient identifier qualifier in one
of your earlier slides. As we continue to hear, all of us continue to hear
about matching patients to their records and everything, what is the kind of
thing that’s a patient identifier qualifier?

And with what you’re doing in your standards, are you trying to align to
anything else as it comes to how you identify your patients.

MS. GILBERTSON: That was a global term. Nothing’s in caps except the word
patient. It refers to ways to identify the patient to the system. So that would
be a medical record identifier number, a facility ID number or a patient’s
account number depending on what kind of system was assigning it.

So it’s not necessarily tip of the nose identify a patient, but how do I
call this patient so I can get at the records in my system.

MR. REYNOLDS: Okay.

MS. GILBERTSON: Now I will limit questions.

MR. REYNOLDS: Mike, you had a question, and then I’ll take my next one.

DR. FITZMAURICE: I think what HITSP did in its recommendations for
medication terminology, and I think Lynne was there. So she can say I’m right
or I’m wrong, is they adopted SNOMED wherever they could, and where they didn’t
have the terms in SNOMED, they adopted the Federal Medication Terminology.

MR. REYNOLDS: Okay, Lynne, my question or kind of a statement, too. As I
study your implementation versus the rest of the industry’s implementations, I
see two significant differences. The vendors in the pharmacy world appear to be
at the table and to be making these changes much more rapidly than what we’re
seeing in the other sites for the people that deliver these capabilities out to
the world. I know we’ve seen it in our environment.

Second, and see if you agree with this, much of the industry struggles with
the level of person to put on a lot of these committees. And as I see the
people that come in in your group, they seem to be people that are much more
horizontal in their authority in a company or in the industry or in other
things rather than many of the other industries or the other things we try to
do, whether it’s HIPAA or anything else. You’ve got somebody that may be very
technical or another piece and doesn’t necessarily see the full picture.

So as we struggle with adoption and we look at NCPDP and it’s going what you
want it to be, and then you look at the rest of this, and so adoption’s key.
So, for example, when we did E-Prescribing, we used vendors. Well, the funny
part is I was heavily involved in that. I don’t have a clue what level they
implemented. I’ve got a few questions now.

But it’s insulated whereas everything we’ve done with HIPAA and everything
else for everybody that does it, every single entity that touches it has to
know all the details. And so I’m struggling to understand because, again, this
Committee is going to be looking at this next set of wave of standards and
implementing them and so on. And so this is a real fun discussion because
you’re the poster child. No, congratulations.

MS. GILBERTSON: Okay.

MR. REYNOLDS: You know, and we’ve got to make sure that whatever we try to
learn from that, and we talk about return on investment. I mean, you guys stood
up there and you talked and it moves and it happens. And we should even go
yeah, that’s good. Everybody agrees, yes, that’s good, and we kind of have the
discussion. But everything else is hand-to-hand combat, you know, from segments
and google like people up and trying to make a difference.

MS. GILBERTSON: Okay, well, I thank you for the compliment. We do bring
together competitors and people who probably think that DSMO’s from the dark
side meaning completely opposite end of the world. So, yes, that is a
fundamental need. You’ve got to have the people who are going to be
implementing the stuff back there. I mean, it really is so very important.

Perhaps NCPDP because we have as often as a quarterly ballot cycle that the
changes can come forward faster. We tend to have a different viewpoint of
what’s the problem, let’s get it solved, let’s move forward where other
organizations tend to take more of a future goal in mind. I mean, or they have
different sectors. I mean we are really focused on the pharmacy industry
perspective and ambulatory long term care, paired processors, vendors, all in
that sector where if you are trying to move standards forward that have to deal
with finance and transportation and commerce all in the same umbrella, perhaps
that causes a difference.

If you’re modeling from a more theoretical down to the practical levels or
the practical up to the theoretical, you have a different time frame, too. So
it probably has its pros and cons depending on who’s sitting on what side of
the fence.

MR. REYNOLDS: How much of the stuff that you do, though, actually forces
individual doctor’s offices or institutions to have to change? First there’s
the vendor and the conduits and the pharmacies and the others.

MS. GILBERTSON: I think that’s a great question to ask the panel.

MR. REYNOLDS: Good. I’ll write it down.

MS. GILBERTSON: Yes, because we’re slow and the standards just say here’s
the data. You can throw now across the wire. But there’s always discussion of
how does the best work flow.

MR. REYNOLDS: Okay, any other questions from anyone? Talk a little bit about
an agenda adjustment. So let’s take a twenty-minute break. It’s 10:35. And if
you wouldn’t mind doing your two o’clock at that point, you’re presenting that
right? The DSMO?

MS. GILBERTSON: Yes. Only because it has nothing to do with electronic
prescribing.

MR. REYNOLDS: Well, I guess what we’re trying to do is – I don’t want
to try to rush the panel, okay, because, again, I think it was scheduled at
one, we may not have either – the crowd might be here, but the people that
want to listen may not. We need to be fair.

MS. GILBERTSON: The only concern is we have the DSMO representatives coming
in on the telephone.

MR. REYNOLDS: Okay, well, that’s fine. We’ll get a second break, no problem.
But we come back from break at 10:35.

MS. GILBERTSON: I’ll be glad to do it, but I don’t know if they’re
available.

MR. REYNOLDS: We have stacks of four or five ideas. But 10:35 when we come
back, we will begin looking at the planning of what we want to do going forward
as a committee. We sent that out. Let’s spend between lunchtime going ahead and
starting on that. We’ll do our afternoon at 1:00 p.m., and then the two
o’clock, and then we’ll finish up our discussion after that however long that
session will take, okay, so that that way we keep ourselves moving.

Okay, with that, Lynne, thank you. Thanks, everybody else who passed the
time, and we’ll see you back in 20 minutes.

[Break]

MR. REYNOLDS: Okay, welcome back. I gave you a few extra minutes, and we’ve
still got some stragglers. But we’re going to go ahead and get going.

What we’re planning to do as a schedule now is we’ll probably discuss this
from 10:45 to 11:45, stick with the lunch period that we have, give people a
chance to do their other stuff, be back and one, and this afternoon’s schedule
will be as identified here. But we give us an hour to kind of kick this off.

And let me just kind of level set this. As some of you may or may not be
aware, this is a transition time for the Full Committee, and a number of people
in this current Committee, you know, are basically running out of tenure. And
so one of the things I think that we owe this ongoing Committee and the Full
Committee is the knowledge of what we’ve done over this last period of time,
the key elements that we have as far as what we have listed, and t make sure
that we put a plan in place that can be moved forward as we do it.

Because remember there’s an awful lot of knowledge and substance around this
room on these subjects, and most of these subjects that we have listed, and
Jeff will make some comments in a minute, too, are not subjects that are going
to go away. They are subjects that are going to continue to move forward, and
they are subjects that if some of them can be dealt with now, it will maybe
make more things like the poster of NCPDP that we heard of today so that as we
continue moving forward, we can do it.

But so I ask you to seriously engage. I know Karen Trudel had to leave for
the rest of the day, and Margaret, she’s supposed to get me back comments by
the end of today. But we really need to go through these. We need to make sure
that whatever list we send forward to the Executive Subcommittee or the Full
Committee gives a good picture of what we feel should happen and how this
Committee can make a difference going forward in what I think are going to be
important and challenging times, but exciting times because we continue to
change the industry.

If you look at where HIPAA is now, you look at where E-Prescribing is, you
look at some of the things that are going to continue to move forward, the
train has left the station. Let’s make sure that we give it a good destination.

So with that, Jeff, why don’t you make a few comments, and then we’ll get
into the substance. Your’s is on.

MR. BLAIR: As Harry said, we really would like to have your critical look at
this document because this is reflecting the thinking that we have on the
Subcommittee and that we would really use to try to move forward during this
next year and the year after because it’s always obviously updated.

One of the things that I’d like to draw your attention to in terms of maybe
focusing your constructive criticism here is in the lower lefthand side around
seven o’clock on the picture, you can tell this is how a blind person thinks,
okay, like a clock here. In that section, there are four subgroups. One is
issues around current standards. The second one is issues related to the
evolution of standards, whether that’s from version to version or from ICD-9 to
ICD-10 to ICD-11, or whether it’s the movement towards clinically specific
terminologies. So that’s the second piece is evolution issues.

The third one is issues with respect to process, either process in terms of
the standards development process, adoption process, implementation process,
and regulatory process. In short, it’s taking longer than we would like for all
these processes to play through. Are we holding up the industry with some of
these activities. So that’s the third area.

The fourth one is to see if we could look at standards more broadly where we
could look at coordination, and the NCVHS offers us some opportunities for that
because the full NCVHS Committee is not just Subcommittee on Standards and
Security, although, of course, Harry and I always think that the world revolves
around that. But we have a Population Subcommittee. We have a Quality
Subcommittee. We have from time to time we pull in a workgroup related to the
National Health Information Infrastructure, and we have a Privacy Subcommittee
as well.

So it just so happens that when you look at coordination, these
subcommittees offer fertile ground for opportunities for coordination. So if I
could maybe direct your thoughts and comments and critiques to these four areas
and to try to prime the pumps slightly. Do these four areas, are these the
useful four areas to represent our work. We’ll look at other parts of the page,
you know, as well. But for right now, are these the four areas that are useful?
Did we leave out something? Are the sub-items underneath that representative of
these? Did we leave out something there? Anything that might help us understand
our role and perform our role better and contribute to helping the industry
move forward.

MR. REYNOLDS: Let me make one other comment before I start looking for
hands.

The key part to this is this Committee in particular, especially as some of
the next few standards come up and as we see the regular updates we get, can
get, the undertow can be the just do the hot stuff and just do the current
stuff.

And so we really want to make sure we take a hard look at that left side and
decide what we can really, really – we should be looking at to help move
people forward, not just sitting where we are. So with that, I will open it
first. Michael, do you have a comment?

DR. FITZMAURICE: I don’t have any quarrel whatsoever with the subjects to
develop. I think you’ve done a good job in laying these things out. I would add
to it maybe a cross-cutting deal, and that is in the coming year we’re going to
be moving to a new administration, new president, possibly a new head of HHS.
And so we’re part of a committee that advises the HHS Secretary on health
information policy. And we may need to think in terms f a product that briefs
the Secretary on what NCVHS does. That’s why this page is so good. What NCVHS
does, what we consider the hot issues and one things on the subject to develop.
I would leave a space for what does the oncoming Secretary want us to do.

Now we still have plenty of work to do before a new Secretary comes on
board. But we want to be aware and be sensitive and be cooperative with the new
Secretary coming in, be a tool, be a useful right hand to the incoming
Secretary, particularly in view of the fact that AHIC has moved out to the
private sector. Is there something that we should be picking up to help advise
the Secretary given that fact. So it’s a cross-cutting deal, something to be
considered when we look at the current subjects.

MR. REYNOLDS: Thank you. And for this afternoon, later when we do this,
we’ll get everybody’s feelings now and have a full discussion. But I want to
actually go through them one at a time later on to make sure we get a sense
because, again, the words that this Committee can click forward will help the
next group looking at these to get what we want, not just, oh, that’s a nice
three words there, oh, by the way, I wonder what they were talking about. And
since we don’t know that, we’ll back off and go on to the next one.

Okay, so we also have to put a little light around this so when we prepare
this – so if we were turning this over to another committee, what are the
words we might want to put under these as we think about it to make sure that
then they get it. So Marjorie’s next, and then Michael back to you.

MS. GREENBERG: Well, I commend you for having developed this, and I know
it’s been under development for a while now. And so knowing you two gentlemen,
I’m sure it keeps getting improved, and I think some of the other subcommittees
have actually looked enviously at this attractive diagram and said they should
do the same thing.

And, of course, next week, as you point out, the Executive Subcommittee is
going to be meeting. And since the theme of 2008 seems to be change, there is a
lot of change going on in the Committee. And as Mike points out inevitably in
the Department at the end of this Administration, and it’s sort of like the
NCVHS members, you can’t have more than two terms, so usually.

But a few things, and when we get into the details later, I may have some
comments. But just a few things that come to my mind, and that is particularly
the issue of cross fertilization between subcommittees and workgroups that you
referred to. I actually do think the Committee has – the overall committee
has improved in that area. It has made progress, let’s put it that way, in that
area.

This has always from the time that this Subcommittee has always been a
strong subcommittee from the time it was established because it really had a
mission with the legislation, with HIPAA and everything. It just had a very
clear mission which I think often when you have more general missions, it’s
harder to grab a hold of. But this group has been very hard working. It’s had
its mission, and it has, I think, actually done an admirable job in meeting it.

But when you mention, of course, privacy, there’s synergy there. And I think
one of the issues for the next iteration of the Committee and its subcommittees
is whether security should stay with the Standards Subcommittee. I don’t know
if you have that on here or not. I’m not sure I saw it.

MR. REYNOLDS: No, that’s a great idea.

MS. GREENBERG: Or should go with privacy. We had that discussion before. But
the way the Privacy Subcommittee, the way it was organized and led, et cetera
was certainly, you know, also had its plate full and was doing a very excellent
job, too, and was not prepared to take on security except for one member didn’t
really have that expertise in any event.

But I think most of the rest of the world does include security with
privacy. And so I think this would be the time to revisit that, I mean, at the
time that we have the turnover of the chairs and certainly the chair of the
Privacy Subcommittee will serve two terms.

So that’s, I think, one issue to really think about. Another one is the
relation – I don’t think anyone mentioned populations, and you know,
sometimes we’ve talked about it. I think John Lumpkin used to talk about right
brain, left brain or whatever. But the – and Justine was not able to be
here, I guess, today. But certainly I think she brought over her populations
hat to work with you all in the standards area, and I think that has been good.

But right now at NCHS, we are really working on integrating with the
standards agenda for the biostatistics system which is sort of the bedrock of
population health data. And so the synergy with the kind of standards,
certainly the clinical standards that this Subcommittee has dealt with as well
as the more administrative standards is going to increase. And, on the other
hand, vitals are very interesting because they’re an administrative system, you
know, just get people registered and all of that, and we know what those
administrative purposes are. But they also are, as I said, the bedrock of
population health and public health data.

So I didn’t see anywhere down here under regular updates, and you’ve already
got a slew of them. But you didn’t mention any of the public health agencies
other than potentially, I guess, NLM which is there more in its terminology
framework.

But I would like to see more synergy between the populations activities and
the standards because I think as we really, if we really realize the vision for
the NHIN and electronic health records, et cetera, clearly there will need to
be much more synergy.

MR. REYNOLDS: I’m in total agreement. I’ve got three things listed over here
that weren’t on the chart, and you’re exactly right because I think one of the
things that we’re missing an opportunity to do is if we don’t make it part of
some of these standards and it’s data that’s going to be helpful to quality,
populations or any of the other downstreams, then there’s going to have to be
another process set up. And if that process is not part of the normal
administration and some of the other things, it’s going to be much harder to
get it.

MR. GREENBERG: I mean, talk about things being frozen in time, some of these
systems are frozen in the 18th Century almost or the 19th
Century. They need to, you know.

MR. REYNOLDS: Right. Okay, well, good, no, great comments. Now you mentioned
on the regular updates. Can you –

MS. GREENBERG: Well, I was thinking, you know, I don’t know if every month
or even quarterly. But do you want to hear from CDC. Of course, CDC is
responsible for some of the terminology standards. But also there’s the Public
Health Information Network which is using many of the standards that the
clinical data systems are using. So I would put CDC down there, you know. I
would say that would be the main one. You already have NLM. But there could be
activities related to clinical trials, NIH.

DR. WARREN: Well, specifically NIH right now is putting out grant efforts
calls centers for CTSA, Centers for Translational Science Award. And in that
one, one of the things that the Centers who apply, they must have a strong
clinical informatics background.

And it’s part of the NIH roadmap to start looking at supporting the adoption
of various data standards also within the research community. And so they are
also looking at what we’ve done with high standards, what NCVHS has looked at.
NCI has kind of led the way, and so they’re looking at that.

I know that some of the early discussions of the first awardees, they got
– part of being an awardee is that they have these national councils. So
there’s a council on informatics that all the awardees attend. And so they’re
trying to figure out where do their deliberations and work go. So that might be
another group that would be important for us to get regular updates from.

MR. REYNOLDS: Steve?

DR. STEINDEL: Ed needs the list whoever it is.

MR. REYNOLDS: What’s that?

DR. STEINDEL: Ed needs the list, and here it is.

MR. REYNOLDS: You are the list.

DR. STEINDEL: I am the list. Wow.

MR. REYNOLDS: That’s right.

DR. STEINDEL: This is to pick up on some of the comments that I’ve just
heard. You know, I am concerned and also pleased to hear Marjorie’s comment
that we should add CDC to the list of regular updates.

MS. GREENBERG: You provide updates.

DR. STEINDEL: Well, and let me continue on that because I’ve had some
thoughts, and we’ve had some discussions in part within CDC. This is CDC
Atlanta, not CDC NCHS. CDC NCHS, there’s an obvious total connection between
that group and NCVHS for many, many reasons, right, and I’m not going to delve
there.

So when I say CDC, please read it as CDC Atlanta. We’ve had some
discussions, and CDC back in around 1997 when the role of NCVHS was expanded,
decided to deliberately commit resources to the expanded NCVHS because it hit
us in three specific areas. One was privacy, and that is an area that we will
continue our involvement.

The second was claims attachments, and the third was as referred to then the
PMRI standards which have now evolved into the galaxy of ONC, HITSP use cases,
et cetera. And what’s happened in our mind is a lot of NCVHS’ work in the area
of obviously claims attachments is right now dormant. And even if it does
accelerate, our plans for what we’re using the claims attachments for which is
to get easier access to clinical data we’re now going to do from the HIE stream
that’s going to flow with the NHIN.

So claims attachments to us have really ceased to be of major importance,
which leaves us with the PMRI standards. And in recent years, we’ve actually
seen a decrease in the agenda and useful part of the agenda in the type of work
we did before in the PMRI standards where we were actually centers of a lot of
the thoughts, the philosophies, the directions in that area, and we’re looking
at what really is our continued need to be involved at the level that we are
with NCVHS outside of the privacy arena.

And so what I’m speaking to, and this is somewhat what Judy has spoken to
and what you, Marjorie, have spoken to about rejuvenating our interest, and
that is to bring back some of the forward thinking that we gave in the past to
the use of information in clinical systems for population health derived
benefit.

You know, Judy mentioned clinical trials which is one area that we actually
are interested in. And you know, if we start expanding our thinking and our use
and our development and touching on some of Jeff’s issues, let’s start looking
at the implementability of the standards of the pronouncements of groups like
HITSP in the real world and focus more in the area of the future and what we
can do to move things instead of the nitty gritty of how a standard is
constructed. You know, that would rejuvenate our interests.

Maybe it’s appropriate for me to raise this as an issue to sort of help
encouraging the constructive additions to this thought effort. I have been in
the mode during the past four to five months of looking at the AHIC use cases
and the HITSP standards from an implementation standpoint for our health
information exchange and the nationwide health information network. And, of
course, that’s a different role for me because all of you know that I’ve been
involved here in the NCVHS focused on trying to have the federal government
adopt forward moving standards.

So now we have a situation where NCVHS and CHI and HITSP have all wound up
saying we have this – Steve’s word was a galaxy of standards with improved
clinical specificity, SNOMED, LOINC, RX Norm. And yet, here I am on the other
side, and I’m as an implementer.

And where we want – there’s a very great motivation. But we’re looking
at trying to implement these standards, and it’s not quite so easy. And the
other pieces are that there’s disconnects. Because up until now, I think and I
don’t know, this may be my failing, maybe some of you had a broader view. But I
was looking at this as a one step process where it was going to be the
healthcare providers that would be implementing this, whether it would be a
pharmacy, whether it would be a hospital, whether it would be a medical
practice, and I was looking at it that way.

But now we have a health information infrastructure which almost has three
different levels, and where we’re finding the difficulty sometimes is that
where we looked at this as one issue, one implementation, we’d still have the
providers, the original one, the providers and the medical practices and long
term care and the pharmacies needing to implement these standards.

But then you have whether or not the health information exchange implements
them – health information exchange networks. Some people call them REOs.
And then the third element is the communication between health information
exchanges which is the NHIN. And when we start to look at it in those modes, we
find additional challenges.

Now I’ve said all this as a background, and the background is that one of
the major missing elements on the chart possibly – and I’d like to have
your feedback on this, is what do we need to spend more understanding the
impediments to implementing the standards and getting adoption.

One of them we have touched on a little bit which is, is there a return on
investment, for example, okay. But we haven’t looked at the other issues. I
just gave an example of another set of issues because in a sense we’ve spent
ten years encouraging development and adoption of the standards and made
tremendous progress. And you look at the HITSP documents, and they are rich
with thought.

So this is my open question. Is it the role of NCVHS to now begin to examine
how to address the impediments to implementation of the standards.

MR. REYNOLDS: One thing I think is – to play off your comments, Jeff.
One thing I think is different, a lot of the standards that have been
implemented to date have been looked at as transactions which is a piece of a
process.

As you move to health information exchanges, as you move to the NHIN, it’s
more of how people do business between each other where the person gets
involved, where the person’s data might be, what are the business models that
they do to succeed, how does it affect quality.

Because if those – if all those things don’t come out of that, the
passing of data just to pass data in a standard format is not necessarily a end
game for anyone. I mean, we can do that. We can all do that. So I think your
points are well made that this whole idea. We’re on the trend line which went
from transactions to implementation of that and then to health information
exchanges which is grouping up locally and using those transactions and others.
And then you move to the NHIN and then you wrap all the things around it. And
is there a stream other than just pieces and parts, other than going out and
saying I need piece three and I need piece four and I need piece eight, and now
I’m okay.

Is there really a stream of consciousness because, as you say and you read a
lot of the documents, somebody says there’s thousands and thousands of
standards out there. So if I’m one of these small providers or I’m a HIE or I’m
a NHIN, which ones do I pick up.

Let’s say they approve 150. Which ones do I pick up to make a difference.
And then once I pick them up, do all the other people that want to group up
with me pick them up also because if they don’t, we don’t do the business. If
they don’t, we don’t have an agreement. If they don’t, we don’t have
information flowing the same way, and we don’t make a difference whether it’s
on quality or anything else.

And so some of the – and the other thing is some of the players that
have been involved in a lot of these standards may not be the same players
going forward. So if you took the HIPAA transactions, you have payers heavily
involved. You take the HIEs, you may not have payers much involved at all.

You take the NHIN. I’m not sure. So you’re going to have segments that were
important in one. So it’s going to ebb and flow. The person wasn’t necessarily,
you know, we had HIPAA privacy. So I’m not saying this that they’re not
important. But the individual person in the HIPAA transaction because of the
privacy rule was taken care of. But as you move the HIE and the NHIN, they may
be more in control. It’s not somebody that’s protected.

And as we write the most recent privacy letter that’s going to be coming
forward and we talk about what kind of a say does the person have. So this
whole idea of standards and what they mean and where this is going is now part
of a much bigger quilt, and everybody’s got patches. But we’ve got to figure
out the design of how they, you know, because otherwise it’s going to look like
– may grandmother used to do this. So I am familiar with – I used to
deliver the pieces, and she made magic.

No, but I think the fun part is that that’s what we’ve got to think about
now. And so – and I think as we, Justine and I are preparing something for
the Executive Subcommittee for discussion because as we look at all of our
committees, and we did the Ad Hoc on NHIN and we did the Ad Hoc on Secondary
Uses because it was a trend of thinking. It was a horizontal flow of issues,
not a vertical through standards or vertical through privacy, a vertical
through something else.

So as we deal with this as an Executive Subcommittee, we’ve got to have the
same discussion to make sure that whatever – and so the reason it’s really
important for us to put these down, some of these might not end up being ours.
But they sure are issues that since we see it, we’ve seen it in many cases
because of what we’ve done. We need to make sure that we have a good list here
that can be pulled by the Executive Subcommittee, pulled by the Full Committee
and then decided by the next iteration of this Committee as to how we make a
difference, not just because that righthand side, as I said earlier, that
righthand side is like an undertow. The current hot issues, we could have
hearings. We could two, three, four hearings a year and just be moving along.
But the lefthand side is where we, I think NCVHS can differentiate itself
because everybody else is thinking use cases for a standard, for selecting
standards that are already there and some of the others. We’re kind of building
the forward thinking.

So that’s what’s exciting to me about we approach this lefthand list is
where we make a difference. Judy, and then Michael.

DR. WARREN: I think one of the things that just kind of struck me as Jeff
was talking about his own, you know, personal shift to either the light side or
the dark side, I’m not sure which you think —

MR. REYNOLDS: It’s my side, and now he understands, yes.

DR. WARREN: Because the gray side that I live in – well, we’re going to
run out of colors real fast here. I think that the issue has become is that the
whole standards world we have become successful. And because of that, more
people are beginning to understand what standards can do for them.

So as you said, we first started doing this for transactions. And so the
business people got all hot about it. And then, Harry, as you start talking,
you kept using the word business. Well, I live in the clinical world, and the
clinicians are figuring out what standards can do for them to not only get to
quality metrics and to start giving best practices and identify that. But now
the researchers are coming in and realizing they can actually collect research
data if the EHRs are set up appropriately. And so they’re wanting in on that.

The CDC is wanting in not only to do some of the transaction modeling, but
actually taking a look at what rashes are showing up, what other kinds of
clinical symptomatology is showing up in different clinics.

And now you add in some of the work that’s happening on the implementation
side as hospitals are implementing EHRs. They don’t always have the right
knowledge at hand about things they should think about as they’re implementing
those EHRs. And because of that, we still see an awful lot of failures. And
depending on what articles you read, it’s failures anywhere between 60 and 90
percent of implementations fail which is far too high for the costs.

So I think what’s happening is we’re seeing this progression of starting
out. We wanted to simplify business and now we’re beginning to see that that
really is working towards that. Now it’s coming up to clinical, and it’s making
it much more complex for us to start addressing these.

And so as we start looking at barriers to implementation, it’s a lot more
places that we have to look. So back to your comment, Harry, of who needs to be
at the table, I think they’re evolving new players. As they find out about what
health IT can do for them, they’re beginning to come up to the table that we’ve
never seen before. And so how do we handle them as we’re trying to make
recommendations about standards and how the world works from health IT.

MR. BLAIR: Harry, could we just swing back to one piece that I sort of like
in answer to Judy with your comments. Are you winding up saying that you feel
it would be appropriate for NCVHS to include in its role implementation issues
or not.

DR. WARREN: Yes, I think it is. I think that’s kind of our next step. I
mean, first we had to worry about what to implement, and we’ve become
successful at putting together some strategies. Now with that, I don’t want us
to back away from figuring out how to develop the standards or support them or
what we’ve been doing in the past. It’s almost like we’re now adding another
nuance to what we currently are doing.

MR. REYNOLDS: One thing that I’m adding, Jeff, we did have facilitating
standards adoption by smaller providers recommending that we put comma HIEs’,
comma NHIN and comma, playing off Judy’s comments, new players.

MR. BLAIR: Harry, we have the word adoption. Now this is when I think of
adoption, I think of whether HHS declares that it is either mandated for
adoption or they’re providing incentives for adoption.

But I’m thinking of the actual implementation maybe as the next step beyond
quote adoption.

MR. REYNOLDS: I think that’s what when I wrote this, that’s what I meant. In
other words, that there are standards. For example, right now there are
standards, a lot of standards view our adopting them as an HIE, and you are
making them real. That’s what I meant. We can change a word if we want to.
Michael, you’ve got a comment. So think of it if you’ve got another. Michael,
then Julie.

DR. FITZMAURICE: I have three points similar to make, and the first one was
and probably the most important was that encourage a focus on implementation
and return on investment. Jeff did a very good job of articulating that. I
don’t think there’s anything more to be said on it. But we’ll say it anyway,
right.

Secondly, look for exchange of other subcommittees in NCVHS like we’ve done
with quality. We’ve had good exchanges there. Here’s what informatics and what
standards can bring to quality, and what quality can bring a reason for being
to standards.

Marjorie articulated the cross-cutting, and so I don’t have anything more to
add to what Marjorie said. I guess I did add a little bit.

But the third point is – well, let me start with a little story. I
couldn’t figure out where my money was going. And so I went through and said
let me take all my checks. Let me take all my credit card transactions. And
over time, checks had gone down, credit card transactions have really gone up
and kind of code each one of them, food, housing, communication and then break
out telephone as a separate category, and I had a category called ten which was
everything else, and that got to be a big category and I kept trying to break
that down so I could understand where’s our money going. No blame, just I’d
like to know where it’s going.

And so I’ve done that for a couple of years. And the parallel to it is that
as we start accumulating our own clinical information, as hospitals build their
own clinical repositories and data repositories, we’re not talking about a
transaction exchange. Here’s a current lab test. We’re talking about let’s go
and pull the information from a database for the whole year and develop a
performance measure for administration, a performance measure for quality.

And with each hospital having its own separate coding systems, their own
separate places they put this information in their databases, it becomes hard
to aggregate that information without paying somebody to go back into the
database and say pull out all the quality information pertaining to the heart
and then pull it together.

Well, what this is leading to, and in my story about the checks, if I wanted
to exchange why I spend money, where Steve spends money, where Harry spends
money, it may be hard because we’ll have different categories. Some people use
managing your money, Quicken, and they’ll make different categories than I do.
So it’s hard to exchange that information. It takes somebody to go out and pull
it out wherever it was stored.

If we would look a little bit in the coming year at is there a need for an
information model for the United States for database storage of health
information, clinical and administrative so that if people wanted to, they
could take particular tags and say, all right, this is a heart measure and put
it on each one of them so if you have to do quality measure, you just start
pulling that with these strings attached.

So we all have the same strings attached to our data even if we have our own
strings, our own separate strings. Just like each hospital has its own code
list for a laboratory, a code list for this, a code list for that. But when you
exchange information that’s pulled out of a database, it’s hard to aggregate
it. It’s hard to understand.

I spent some of my life on information models. It’s a black hole. You can
sit around and talk about information models and never get anything. On the
other hand, Australia has an information model. We have a RIM model that could
serve as a basis for a national information model.

So do we need to think about one. Do we need to call people in and ask them
is there an advantage in having strings attached to the same kinds of data for
particular purposes like quality, like measuring return on investment, like
whatever kinds of performance measures there are with providers’ offices, with
hospitals, with nursing homes.

And maybe the answer is no. It would be too painful and too hard to go back
and retag everything and too cumbersome to develop a set of tags. But we’re
kind of swimming in separate databases without it.

MR. REYNOLDS: Judy?

DR. WARREN: Yes, I just wanted to wrap up. I was looking at the graphic. A
lot of the stuff that we’re talking about and looking for new players that are
coming into this, I think, are going to be coming from some of our discussion
about secondary uses of data and decision support. And so we need to keep that
open.

So we’ve got bits and pieces of what we’ve been talking about. It’s just
we’re getting to look at them in a different formulation than what we have in
the past. And so maybe that shows some of the evolution of the thinking of our
Subcommittee as well.

MR. REYNOLDS: Yes, because we needed to have secondary uses on here.

DR. WARREN: Right.

MR. REYNOLDS: And what was the other one you just said?

DR. WARREN: Decision support.

MR. REYNOLDS: Right.

MR. BLAIR: Actually, they’re over in the hot topics. But nevertheless,
that’s okay.

DR. WARREN: Well, but what I’m saying is that if you look at them at the hot
topics and you look over at our subjects to develop, there are almost one to
one relationships on some of that. But I think we need to keep that the
subjects to develop can really inform the work we’re doing there, but they can
also help us to evolve to the next step.

MR. REYNOLDS: Right. The other thing I wanted to add to that is what we’re
realizing is that standards are actually the adoption of standards and how you
use them is actually moving many of us into a new business that we weren’t
necessarily in before. So let’s take a personal health record as a great
example.

There are standards. There are information. You can find a lot of ways to do
a personal health record to use the HIPAA privacy. You can use everything
that’s out there. The problem is when you’re done in the end, what did you just
become. No, I’m serious. No, I mean, this is – and so I think everything
that we’re saying here, is standards now is to me, I did some woodworking this
weekend, and you’ve just got a bunch of tools, and then you go do what you do,
and you look at it and go, yes, that’s pretty bad. But I think we’re finding
that adoption up until now, back to our earlier discussion, implementation has
been a particular thing. But now we’re going to be doing business. You
mentioned clinicians. You mentioned the people getting involved. You mentioned
all this other stuff happening.

A good example is as soon as CMS comes out with pay for performance, the
other thing we don’t have, they have just defined performance, okay. Not a
coined status, not a performance. They’ve defined the subject. Once they define
a subject, what are the standards that make up the ability to execute that
subject.

And so whether you take pay for performance, the other thing that CMS is
using a lot right now which is Medical Home. Okay, you’re starting to hear
that. Okay, so the point is one of the things we can also step back and look
at, and this may be a full – I want us to really get after this from my
viewpoint because this is all going to go to the Full, you know, for the plans.

But you think of these things, and so you use what we learned in quality,
and you use what we learned in population, you use what we did in privacy.
Security, I agree with Marjorie, is probably from an audit standpoint for all
entities that are involved in healthcare, I would say security and access to
data are probably the number one things that outside auditors are looking for.
So it is now actually to me, I would say, the number one hot button that’s out
there. And right now, as you say, we’ve kind of looked at privacy and looked at
standards, and somebody bumps into security, we deal with it, but we haven’t
necessarily grabbed it and embraced it.

So I think all of these things, so all these things that we’re listing here,
the information model, Mike, is great because a lot of people don’t have that
horizontal view of how it’s going to work. And so they do a piece, and then
they do another piece, and they go whoops, spent money, whoops, did it, didn’t
happen. That’s part of the issue with HIPAA. We sometimes implemented it as an
individual transaction. We didn’t necessarily make it part of business for
anybody. I mean, when I say business, I mean the business of adopter, the
business of an individual office, the business of a payer, the business of a
clearinghouse. We made it the next transaction, the next withdrawal of money
versus where’s your money going, you know. Those ATMs, all those – when
you used your credit card and everthing, then you gathered information from it.
But you actually got – your transaction was worthwhile because you bought
something. But what you can do with that information now is far more
worthwhile. Well, we’ll leave you and your family to figure that out. Marjorie?

MS. GREENBERG: I’m curious. Lynne thought she had a break now til after
lunch. Because we –- before the break, there was discussion around –
it almost reminded me of how free form people often look lovingly up to or with
great desire up to Canada because – and so the standards group here is
kind of looking at NCPDP and saying, well, how come you guys have your act
together and nobody else seems to, or what makes it work.

And I’m just wondering, playing off of what Mike was talking about, the
extent to which the pharmacy industry and NCPDP and the whole standards
process, to the extent that you have an information model and you’ve really
used that as a tool to kind of look at all the functions or maybe you use the
RIM, I don’t know.

But I mean in the very beginning I remember when HIPAA got started talking
to Bill Braithwaite about how, well, you know, before we just launch into all
of this and dive into it and start developing all these standards and
everything, do we need to do some modeling? Do we need some kind of information
model.

Well, nobody – I mean, he thought it was a good idea, too. But nobody
had time to really look at what the functions are, you know, what the flow is,
all of that so that maybe what you’re implementing isn’t so much you’re just
sort of glaming it on to a system, but it’s more organic which seems to be the
case in the privacy world. It seems more organic that you have needs, you
identify them, you solve them and you go on to the next thing, and it doesn’t
throw your whole information flow and your whole business process out the
window. That’s my impression that it doesn’t. So that’s why you implement them.
You know, that should maybe make things better like those of us who are
standards junkies dream about.

So to what extent is there that kind of a vision, or are you just lucky or
something.

MS. GILBERTSON: This is Lynne Gilbertson of NCPDP. If I understand the
question related to an information model, we do not have one that, if I believe
the way a true technie, the only information model I’m really familiar with is
the HL-7 RIM which to me is pink and yellow and green and whatever other color
box is and arrows and things like that.

So if that’s what you mean by information model, I do not have a picture
like that that I am or a URL diagram or whatever those kind of things are.
NCPDP doesn’t have that kind of function.

We are participating in the HITSP Foundations Committee which that’s one of
the things they’re looking at. But once again, I think there’s a difference of
those that are very comfortable in the information modeling environment and
those that are probably more familiar and comfortable in the messaging
environment. And if that’s the difference in how you look at how you do things,
then we are – NCPDP is much more on the messaging.

I’ve got a need to exchange data. This is what I want to exchange, and
here’s how I do it.

MR. REYNOLDS: Let me make one comment, and then I’ll jump to you next and
then Steve. I want to make a comment to Lynne because I’m real familiar with
what they did because, as you know, we implemented what they did, and I
presented it on Capitol Hill about a month and a half ago.

And the fun part is our charts showed a business model, not a ROI model. A
business model that played off of everything that they built. So they built the
standards. They put everything in place, and we just took it and packaged it
into a business capability.

MS. GILBERTSON: By they, you mean NCPDP?

MR. REYNOLDS: Yes, yes, right, yes. So everybody was heard. So I think if I
were to add one word, Marjorie, to your recommendation, it would be –

MS. GREENBERG: Well, it wasn’t a recommendation. I was just –

MR. REYNOLDS: Well, no, no, no, I think it’s a good one. No, what I’m saying
is because what we’re talking about, we’re talking about a picture of people.
We’re talking about a roadmap to people. And the problem is an HIE still in
many people’s minds is a bunch of things connected together. They’re not buying
into – you can’t find more than – we had a good discussion at dinner
last night. You can’t find 15 people in the country that can really tell you
what will make a jump. E-Prescribing, we finally got a hold of what will make
it. So, for example, on the first million prescriptions, 50,000 were changed
because the doctor and the patient had information at the point of care. Now
that’s a business model that’s then you can think your information and what did
that do and your standards and what can that do and so on. So I think you can
build off of those.

So what I’m saying is both of those together, which is a vision of where
this goes, not a happy chat, but a real discussion about where the success of
this could take us, not just the next standard or the next piece or the next
data element. But where we can really get for real, that’s the energy that they
then generate, you know, because as I’ve said, I took everything they did. We
didn’t actually use any of our own internal people to do anything, and we
instantly changed North Carolina. That’s pretty fun. I mean, so they handed it
to us.

So I think if we can also add that to it and spend some time having those
discussions, not just somebody come in and say let me tell you about our next
two standards. Tell me about where it’s going to make a difference not in our
lives. You know, we get into that, then you start getting into much more
technical. Where is it going to make a difference. So we have Jeff and then
Steve.

MR. BLAIR: We’ve gotten, I think, really helpful feedback in terms of
expanding on what’s on this sheet. Let me continue to prime the pump a little
bit in terms of encouraging your reactions to these ideas because if you almost
look right through this page, you wind up saying this page is winding up saying
what’s the role of NCVHS, and the world has changed in the last several years.

And we now have AHIC which creates use cases. We now have HITSP which winds
up identifying the staters to enable those use cases. We wind up having other
initiatives and projects that are coming into play. And so if you looked at
this page from the standpoint of what is NCVHS’s role relative to these other
institutions’ initiatives that have created, then that may also be helpful for
you to wind up saying, aha, well here’s what NCVHS does. Here’s the role that
NCVHS does uniquely. Here’s the value add that NCVHS contributes that AHIC or
HITSP is not doing.

MR. REYNOLDS: Steve.

DR. STEINDEL: I’d like to make somewhat of an observation. And one term that
we’ve been using a lot is information model – not plural, not models, an
information model. And it was a very good question to ask of Lynne Gilbertson
and do they actually operate with an information model.

And I’d like to point out that what we’re dealing with in that world is an
extremely circumscribed use case. Very tightly confined, it’s a group of people
that understand their business, and they don’t really, as was pointed out, need
a formal information model because they’re all working in the same world.

If you take a look at BDI in the business world, you’ll find in most cases
they actually don’t operate with formal business models. An invoice is an
invoice. There may be certain twists and turns that they’re dealing with in
terms of their particular business and what they want in an invoice. But it’s
basically the same.

We have an interesting thing coming up in the new AHIC use cases on
immunization on that scene stopping in case of emergencies, and we had a
discussion on this in HITSP last week. And the basic comment was isn’t that
just supply chain management. Do we have to be looking at something else.

And we’ll be fleshing out those discussions in the future. But I think we
need to start looking at things in the area of are they circumscribed. Do we
have good answers that can fit into the business model. As Harry pointed out,
he could just take what they did in E-Prescribing and move it into his business
model and show success.

But then when we go on to the bigger world, this is one circumscribed piece
of the clinical data world. And as Mike was talking about, as we move into the
larger world, is there really an information model, or is there a series of
circumscribed models that somehow we can describe together using some type of
bridging or adjudicating concepts.

And we really haven’t looked at things in this particular way, and this is
the type of discussions I think we need to facilitate here because at HL-7
they’re not going to do it. They’re focused on the RIM. Everything has to go
into that one model, and we need to start thinking about not that one model but
how are we going to make HIEs work.

Right now, Harry very correctly pointed out data is going into them. Data is
not really coming out of them, you know, because we don’t have a good way of
figuring out how this data adjudicates with each other. And you know, this is
even in the grand master at Reagan Street. You know, they haven’t been able to
do things across. We’re talking about these decision support model. When we
talk about decision support, we’re talking at these massive rules that are
looking at trying to adjudicate this.

So people are thinking about it, but we should think about this being a
focal point of moving the industry in a new way of thinking. We did that in the
past when we did the initial NHII report, and we should start thinking that way
in the future, and I think that would be very helpful to us.

But stop thinking about an information model, but a description of the way
this industry really connects with each other which is discrete pieces that
have to talk, and that doesn’t mean silos.

MR. REYNOLDS: Comment, Mike?

DR. FITZMAURICE: Once again, my colleague from Atlanta shows that he is
indeed esteemed. I buy into what Steve says. There may not be one information
model. In fact, an information model is an answer to a question. Rather than
ask Lynne, I would have asked her colleague from RX Hub about an information
model because you needed one for Katrina. You might call it a data dictionary
to solve a particular problem. But you needed to know where everybody’s
information was and that it was the same in order to build this drug database
that doctors could access to find out what medications a patient in front of
him or her were on.

So I’ll just say amen to what Steve said. There may not be one national
information model. There may be one simple national information model and then
you build your own information models from it.

MR. REYNOLDS: I’m going to let Marjorie comment. Let me make one comment in
the middle.

Information model, though, is many times in the eye of the beholder. There
are many of us who, you know, I work in the technical area, but I also work in
a business area. An information model to me isn’t just like most people that
would be working with a database think an information model is. It’s also how
do we really do business, and what does it mean.

So I believe that the subject or the idea of that model, and I’m going to,
for example, if you look at the underwriter laboratories, they don’t make lamps
and they don’t consulting on lighting. And more and more, what we’re doing with
standards is the next underwriters’ laboratory. It says you can plug it in, it
will be fine. You’ll get this or you’ll get that data. This will happen, and
you put it in any standard plug. The problem is somebody needs to spend some
more time talking about how to light the room, what kind of light you ought to
use, whether or not you’ve got a big enough bulb in there. No, I’m serious. I
mean, that’s what it’s becoming.

So I think it just struck me as we’re hearing this, this is a good
transition. Marjorie.

MS. GREENBERG: I was just going to make an observation. It’s perhaps a
little glib. But just like the NHIN is a network of networks, they were talking
about how network of models or something, a model or models or a network of
models.

But as Steve said, that sort of integrates them. So it’s not just one big
information model in the sky. But it’s bringing to it something other than it’s
this standard to do this thing, you know, and to kind of piecemeal approach
that we still seem to be suffering from.

MR. REYNOLDS: Let me, yes, because to play off of that, as I said on
E-Prescribing, we have the individual who is a patient, a member and an
employee. And then you have the provider, and then you have the payer, and then
you have the provider and the payer. When all that works, which is what they
did with E-Prescribing. So everybody got their piece in there. The benefits got
to the right place. The process was right. The doctor/patient relationship was
okay. The decision support let them make a decision, and you went on. That’s a
model. That’s a model that works which is exactly right. So they do work even
though – I’m siding with you on this one.

MR. BLAIR: Can I weigh in?

MR. REYNOLDS: Yes, Jeff, and then we’re going to break for lunch.

MR. BLAIR: Well, then that kills – it doesn’t make any point for me to
say anything then because I’m still trying to pull this together.

MR. REYNOLDS: Well, let me do it this way.

MR. BLAIR: In terms of what does all this mean in terms of what the role of
NCVHS.

MR. REYNOLDS: Let me help you. Let me help you.

MR. BLAIR: Allow me to get it out, and then you can help me.

MR. REYNOLDS: You don’t need to – you don’t need to. I don’t want you
to get it out. We’re going to break right now. Let me tell you why I say that
because you’re going to have ample time, if you remember the agenda –

MR. BLAIR: Okay.

MR. REYNOLDS: You are going to have ample time. We grabbed an extra hour.

MR. BLAIR: Very good.

MR. REYNOLDS: To start the conversation. We did not agree to finish the
conversation in an hour. We did agree to break at 11:45 for lunch and have
everybody back at one. So from a protocol standpoint, we will continue after
the group this afternoon. Thanks, everybody. See you at one.

[Luncheon recess]

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

Agenda Item: Long Term Panel

MR. REYNOLDS: I like this panel already. They came right up to the table. We
got a few people that will join us. But I want to make sure we go ahead and get
going so that we appreciate you coming in on time. We’ll honor your time.

So our discussion starting this afternoon is our long term care panel
scheduled for an hour. So I’m not sure that’s a long term, but we’ll go from
there. And I’d like to go in the order of the presenters. So Frank McKinney and
then Eileen, William and Shelly. Is everybody okay with that? Right, okay, so
if we’re okay with that, then that will be great, okay. So with that, Frank,
you go ahead and start, please. If everybody could introduce themselves before
they speak, that would be great.

MR. MCKINNEY: Actually, Anetha has a few words to introduce us and the group
of folks that are talking today. A little closer to the mike, okay.

MS. KIRBY: My name is Anetha Kirby. I’m the Director of Membership Services
and the staff lead to the NASL Health IT Committee. It’s the National
Association for the Support of Long Term Care, and we represent the providers
of ancillary services and products to the long term care facilities themselves.

To my right, we have Frank McKinney who is the E-Prescribing Product
Specialist at MDI Achieve also representing NASL this afternoon. Next, we have
Eileen who’s representing the American Healthcare Association and the American
Association of Homes and Services for the Aging.

And then we have Dr. Russell who’s representing the American Medical
Directors Association, and then Shelly Spiro who is representing the pharmacy
and pharmacist perspective with Spiro Consulting. What we hope to hear is offer
you four different perspectives to kind of give you the full picture of what
E-Prescribing is like in the long term care environment.

All of the associations that are represented here this afternoon are also
part of a collaborative effort that began with the organization of a long term
care health IT summit, and this has been held for the past three years. It’s
planned again for this June in Baltimore.

And with the first summit, we created an initial roadmap to advance health
IT adoption in long term care facilities. What you have in front of you is a
draft version of an updated roadmap. It is for two years in 2008 to 2010 plan.

We began with six co-sponsors, many of which are in this room, and have
grown to now 22 co-sponsors, and that reaches from government agencies,
consumer advocacy groups and also long term care associations.

We’ve also worked together on building a nursing home electronic health
records system to be delivered to the Certification Commission for health IT.
We’ve also worked with HITSP on medication management beginning with the use
case, the prototype detailed use case and then now with interoperability sets.

And we have a launching care representative on the AHIC Chronic Care
Workgroup and look forward to submitting comments on the consultations and
transfers of care use case that is now under the management of the Chronic Care
Workgroup.

Today, we are offering you four specific recommendations, the first of which
is that the NCPDP SCRIPT 10.2 or higher be the standard, that we left
E-Prescribing exemption on long term care facility, that the implementation of
E-Prescribing standards coincide with the certification of EHRs, and that the
elimination of the exemption for computer generated passes be postponed under
January 2010.

These provisions in place, long term care facilities can adopt E-Prescribing
solutions safely and quickly. And with that, I will pass the baton the Frank
McKinney.

MR. MCKINNEY: Thanks, Anetha. Again, I’m Frank McKinney. I work for MDI
Achieve. We’re a supplier of long term care financial and clinical systems to
long term care facilities and continuing care communities.

I also chaired the Long Term Care E-Prescribing Task Group at NCPDP. So
we’re a forum through which pharmacists, pharmacy vendors, long term care
vendors, and stakeholders put together thoughts and needs for additions to the
NCPDP standard for long term care, and that was started a few years ago.

In the last couple years, we’ve been very active in responding to
experiences we’ve had in the pilots and ongoing needs as well, expanding the
standards for the long term care. MDI Achieve at that point Achieve
Technologies, was one of the 2006 EMS pilot sites in the E-Prescribing pilots.
During that pilot, we learned quite a few things that were pertinent to the
conversation today regarding the use of the SCRIPT standard in this setting.

Also, we learned some things about the work flow of long term care
facilities as it applies to E-Prescribing and opportunities for today and, I
think, some opportunities moving forward.

During the pilot, we basically applied the prescribing standards that were
in place and used in the ambulatory setting at that time in the setting of long
term care skilled nursing facility. We found in adapting those standards to
long term care that certain of those worked well as is without any changes.
Specifically, the X-12 and formulary and benefits standards for communicating
pharmacy benefits so they can be displayed during the prescribing process.

Some of the other messaging, especially around basic prescription flows of
the new prescription could be used with some additions. So Lynne alluded to
some of those changes, and I won’t go into them in detail. But things like just
reflecting that in a nursing setting the patient is a resident at a facility.
So including a location of the facility, room and bed, some other facility
information, and other information that’s pertinent to their care and also to
the coverage of their care. So the responsible party for financial matters, for
instance.

Those messages worked fairly well as is, but they did require some changes
that we put through afterwards. Further, we found that there were some work
flows in the long term care prescription process that just were not there that
are present in the ambulatory process. So the key aspects of that in the long
term care setting, orders tend to be open ended for the most part. So you have
somebody on a maintenance medication. It’s a chart order that gets put into the
person’s chart, and medication is refilled until a change to that order is
made.

And because in an ambulatory setting a prescription is for one or two
refills at most, we had to put in place some conventions, some using existing
messaging and some expanding the messaging to support that process so the
handling of open ended orders is a key deficiency in the 8.1 standard with
respect to long term care that didn’t exist or that made it not suitable for
long term care.

And lastly, regarding the standards, we found that there’s some messages
that, while present and possible to be used in the ambulatory setting, weren’t
being but were really critical in the long term care work flow. And so the fill
status is one of those that we made use of and the cancel. So the cancel works
in conjunction with other sort of administrative messages around an open ended
order canceling one. The fill status really created the ability to have a round
trip communication flow between the facility and the pharmacy.

And so, you know, in terms of characteristics of long term care that are
pertinent to this, it’s really the fact that in long term care the pharmacy is
a co-partner really in the management of medication for the resident. An order
gets created at the facility. But then from then on, the pharmacy is
responsible for reviewing the medication load in the form of a consultant
pharmacist and also maintaining inventory levels at the facility.

So having the pharmacy have the opportunity to communicate back what was
dispensed specifically for that resident, whether it was the ordered medication
or generic alternative, for instance, is really important so that they’re in
sync throughout the course of that medication’s life.

So based on these findings, we made adjustments to the standards. Lynne
talked to many of those. We worked through our long term care task group at
NCPDP. We made adjustments over the course of 2006, 2007, and that really
resulted in sort of the critical mass for supportive long term care with
Versions 10.1 and 10.2.

We at MDI Achieve feel that that level supports long term care work flows
adequately, and others do as well. We’re in the course of implementations with
pharmacy vendors and transaction loading hubs also are supporting 10.2. We’re
just at the point of initial implementations, but the die is cast with respect
to that.

Also, we’ve in working with this collaborative and the folks at NCPDP have
determined that the industry can support 10.2 as a long term care standard and
currently with a different standard for the retail ambulatory setting of 8.1.
And also folks on this group participating in the HL-7 long term care
functional profile effort that Anetha referred to, and that too is identifying
SCRIPT 10.2 as the standard that would support long term care.

Just very briefly, the Long Term Care Task Group has since turned to move on
to start addressing sort of the next level in these of long term care in the
standards. Currently, we’ve got proposals going forward to the ability to
provide the consultant pharmacist and the dispensing pharmacist with more
information about the resident, diagnoses, allergies, also results of
prescribing time, DR checks or safety checks with which the physician can
provide comments as to the acknowledgement of conditions that could potentially
cause a contraindication, but in this case may be acceptable, really creating
that shared information database so that the pharmacy as well as the facility
can help manage the medication therapy for the resident.

With respect to work flows, a couple plans stringer pilot, we really did
focus on adapting the standards for communication centers for long term care.
We did get some experience with the work flow in the facility and how that
reacted to the electronic messaging. We did not depend in our pilot on changing
the physician’s role in the facilities that we piloted in. Instead, we for the
most part continued that certain “nurse as agent” model where the
physician would convey their orders to a nurse of the facility. The nurse would
enter those and get into the person’s electronic record, and that would then go
electronically to the pharmacy.

Even in that sort of limited adoption of the technology, we did find some
efficiency gains at the facility in terms of reduced communication time, fewer
call backs from the pharmacy regarding orders, and some indications of safety
benefits, although we didn’t study that in a statistical manner.

We did recognize a reduction in the number of meds on average per patients
suggesting maybe there was less drug duplication as a result. We did find in
our report that greater adoption by physicians would release greater benefits
with respect to making use of safety messages during the prescribing process
and also coverage information.

Subsequent experience supports those conclusions, and we believe that with
full standards adoption and participation from the physician and the nursing
home, we’ve got evidence that this can work quite well. It can be implemented
and integrated smoothly into the processes of the nursing home.

With respect to the vendors’ perspective and standards, today system vendors
in this space are moving forward with SCRIPT standards. But we do also have
demands for other non-standard proprietary interface projects. So especially
when it comes to electronic communication administration, we have to split our
time. And I personally believe and I think others in the industry believe that
if there was an indication of a standard for long term care, it would provide
that sort of tipping energy to allow us to focus on standards based projects
giving them the upper hand over the proprietary projects that we still need to
pursue.

So based on that, we believe that lifting the exemption to long term care in
E-Prescribing rules is critical. We also, thinking of our customers, believe
that it’s important that while we move forward shoring up support for a
standards based electronic prescribing in long term care that we do provide an
allowance for existing prescribing methods until the point at which
alternatives are in place across the board. We’re lagging behind retail to some
extent and availability.

And so that would include allowance for fax generated or computer generated
faxing until a point where we hit that critical mass which we think will come
along in both the same time as the start of long term care EHR certification
expected in 2009.

So that pretty much ends my comments. I’ve included some details regarding
the standards and the pilot findings with respect to those.

MR. REYNOLDS: Good. We need a microphone

MS. DOLL: Hi, I’m Eileen Doll. I’m a registered nurse as well as a nursing
home administrator, and I’m here representing the American Healthcare
Association and the American Association of Homes and Services for the Aging.

We are the groups that provide the care to most of the people in the nation
who are in long term care facilities whether they have developmental
disabilities, they’re there for a short period of time for rehab, they’re there
for a long period of time for hospice, or whether they’re there for end of life
in a facility.

And, of course, our people do tasks in and out of the healthcare system all
the time in acute care, ambulatory care, and whatever. And I have had 30 years
experience in this field as an administrator and as a nurse and working also
with implementing clinical systems. And this opportunity in front of this
hearing is very important to the long term care industry because we have seen
sometimes that long term care’s been passed by in discussions about moving
forward with HIT. And we do really appreciate the opportunity to talk with you
about this.

We do have, as I said, an important role in all this, and our facilities are
not always really capable right now and not all of them could tell you the
difference between SCRIPT 1, SCRIPT 2.4, SCRIPT 10.2. They do know the NVS 2
versus NVS 3.

But we need a standard in the nation that our facilities can move forward.
The quality of care of our residents depends upon it. The life of our staff
depends upon it. We know that it’s important, and we all want the same
outcomes, that is, this good care for our residents.

And as Frank said, we have been working as a collaborative toward some of
these goals for years now. Frank is on the Committee. So am I developing the
EHRS profile for our electronic medical records. We feel very strongly this is
important, and we know that these standards can be the catalyst for forming a
solid base for E-Prescribing and letting everyone move forward in the same
direction.

Just so we have a common perspective, Frank alluded to the work flow issues.
This is just actually the Getty diagram. This is the most famous picture I’ve
ever seen. I love it, and it kind of shows how everybody intertwines. You don’t
have to memorize this or really understand what’s on it. But the whole point is
like the Lady and the Tramp, hopefully everybody gets the middle eventually and
the communication takes place.

But in the long term care facility, the order, as Frank said, may be
“nurse as agent.” The physician says order this for me, and the nurse
codifies the order or tries to read the handwriting, and then the pharmacy says
it’s not on formulary, and it’s back and forth and around and around. And
finally, 24 hours later, when there’s a new nurse on, the doctor’s not on call
any more, the order might get clarified for an emergency order.

Now that’s a little bit exaggerated just a little bit, but it is almost that
bad in facilities where you have no easy way to communicate and get the answers
quickly.

MR. BLAIR: Let me understand this. So you’re asking us to standardize this
process?

MS. DOLL: Well, no, we have standardized this process a little bit. And
through some of these standards, we’re messaging it’s quickly changed. It won’t
take – it’s not that complicated. But this is the kind of thing that
Frank’s group had to work the way through how these messages could work in our
environment and the other needs that were different between ambulatory and our
inpatient setting.

So we do feel that SCRIPT 2 is a standard that should be used because it
allows for this type of messaging. It has a flexibility, and it is an evolving
standard. But we need something, as we said, that can really tie everybody
together, and this adoption won’t change anything that actually happens. It
will just make it happen easier.

The staff now has to fax orders back and forth which can be fraught with
error, and we really need to get rid of that as soon as the standard is adopted
so we can move with the rest of the nation. And we really know that using
electronic systems will reach high utilization and make the highest efficiency
if we can get it done as quickly as possible.

Physicians are going to have a better job. They won’t have to memorize
allergies, memorize formularies, memorize this, memorize that, no allergies, no
current medications because the system will do that for us. And they don’t have
to worry about did the therapy because the system will let us know that.

Nurses won’t be chasing down physicians. They won’t be communicating back
and forth because right now they are the nurse in the middle agent. They have
to see what the written order says. They have to make sure that that
formulary’s been checked. They communicate everything back and forth, and it
just is – it will save so much time for the care and provide more care to
the residents in the facilities.

And, of course, hopefully medication will be administered more safely once
we get all this taken care of. That’s the bottom line, too. Safe administration
by safe prescribing practices.

And the work flow when we get done will look a little bit better. It should
look something like this. This just shows how communication can flow smoothly
and securely between and amongst the people in the chain.

Now as I said before, there are slow movers in our sector, and some of them
only do use an MDS computer. But once a standard is made and accredited and is
– the EHR products are accepted, our field will move forward. This is not
a hearing on funding, but of course there are many barriers here and there.

But getting a standard for E-Prescribing for our industry is one barrier
that you all can help us overcome. I did share with you what Frank had
mentioned. This is in your – on page five, you see. This is what we did
put in our profile for our standard, the SCRIPT 10.2, and we really hope that
all of this can harmonize and make our road smoother on our roadmap to CCHIT
accreditation and having our facilities participate with everyone else in the
electronic health exchange.

We have information we need to exchange about our residents that’s very
important. So we do advocate for all of the, for this SCRIPT, and we ask that
it be made into effect hopefully January 1st, and that we can then
get rid of the faxing problem.

Now there is one little part that I’m not going to really address, but it’s
still up in the air about controlled substances, and that still is a barrier
for everyone. And we know that that may have to have a different way to be
handled as we go forward.

So we really need E-Prescribing that fits our needs, and we do feel that
SCRIPT 10.2 does that. So thank you very much for listening, and we look
forward to any questions you may have.

MR. REYNOLDS: In my four years on the Committee, you’re the first one that’s
had divine music intervention at exactly the right time when you were asking
for something. I’m not sure – that’s a little scary. I thought this was
our room.

DR. RUSSELL: I’m not sure about aiming here. Can you hear me? Thanks. I’m
Bill Russell. I’m a physician, practicing clinician as well as the Corporate
Medical Director for ten facilities in the area. It’s a retirement community.
We also have about 21,000 independent living residents and operate in a
continuum of care setting.

My comments are written and submitted. I won’t read from them. I’m here to
represent the American Medical Directors Association today of which I’m a
member. AMDA represents about 7,000 medical directors and long term care
physicians as well as directors or nursing, consulting pharmacists and others
who are intimately involved in the delivery of long term care medical services.

And as has been sort of suggested by the comments so far, medical care in
the nursing home is an intensely collaborative process, and any adoption of
standards has to sort of accommodate the reality of the work flows which we’re
also well, how shall we say, illustrated if not lampooned.

The E-Prescribing should, capital S, should reduce errors and increase
patient safety and improve the quality of care, and we all know the upside
there. We also know the costs and risks associated with medication errors, and
I think that’s kind of why we’re all here today.

So my comments are going to be really pretty much focused on fleshing out
the reality from the physician’s perspective. And yes, you know, SCRIPT 10.2 is
a good thing, and AMDA certainly supports the adoption of standards for the
reasons which were already mentioned.

Clearly, as a stimulus to adoption of electronic health records and let’s
just say electronic health records in the nursing home, it’s really vital that
E-Prescribing be put in the context of the overall health information strategy,
and that the lifting of any waiver for E-Prescribing in long term care has to
be coupled with some understanding of the adoption matrix and important
benchmarks for electronic health functionality in the nursing home.

The successful implementation certainly could improve work flow and
productivity and safety, although the comments about the imposition of
electronic solutions on a work flow that’s as bizarre as order entry in the
nursing home were germane.

We found in our experience that when you automate in efficient workloads,
what you get are more errors and more dissatisfaction and more inefficiency and
less quality. So, again, lifting of the waiver has to be tied to further
maturation of the basic infrastructure and technology that allow the
prescribing to happen in the first place.

Physician order entry is usually delegated to a support staff person or
nurse who may transcribe a written, verbal or telephonic order. This indirect
order, what was described as the agent entry process, creates opportunities for
transcription eligibility errors, and many of those errors won’t go away
because, again, you have issues of language, communication. But most
importantly, people have to understand that many times physicians are
prescribing when they are not in the building, when they don’t have direct
access to the health records nor access to the patient to validate
observations.

I was struck by the comments about the need to cancel orders. And what we
see many times is that many orders are initiated and stopped before they’re
even filled, and the reason is that the data that moves, for example, from
hospital to nursing home is often acted upon. And then when a physician comes
in and actually does an assessment, the medication which are truly required
based on geriatric principles, long term care goals are different than what a
hospitalist might prescribe or what a patient or family may be advocating for,
and the nurses are not in a position to understand this information.

So really the best E-Prescribing, the value proposition for E-Prescribing in
a long term care setting will come when a physician has access to greater
information independent of the nurse as agent. Regional health information
networks with perhaps delegated privileges into hospital medical records, full
documentation systems in the nursing home which include nursing assessments,
other kinds of biometric parameters and other things which will allow us to
say, okay, I can look at those blood pressures, I can look at those weights, I
can look at those nursing notes, I can see the social work notes, I can look in
the hospital records as opposed to relying on sometimes a transcription of a
single document and some of the quality people who are familiar with this, the
quality of the transferred documents are not always adequate for the
prescribing.

So, again, E-Prescribing has to be put in the context of the opportunity for
excellence in prescribing. It was mentioned that there’s other data in the
prescription in the nursing home that correspond to regulatory requirements
which have to be embedded in the order to be effectively managed.

It was mentioned that diagnoses are important. There’s also fairly
significant amount of off label use that goes on in the nursing home. So a
prescription not only might need to or should include the disease state. But
when used in an off label, for example, for behavior management, the target
behavior, the course of therapy and beginnings of what we look at from the
physician’s perspective is how do we know this is working, and when can we stop
it because nobody likes off label prescribing.

Schedules for dose reductions are especially important for psychoactive
medications. There are also numerous opportunities for E-Prescribing in a long
term care facility for things like anti-microbials which can be linked to lab
data, to sensitivity profiles for community based information. So, again, these
values will begin to be realized when we move to standards, and, again, we
support the use of standards for the reasons mentioned, but also to make sure
that people fully understand that in the early phases there’ll be a lot of what
I would call pain and suffering.

So E-Prescribing creates additional time and technical requirements for
physicians. And again, this isn’t about reimbursement or incentives. But
E-Prescribing adoption will be very difficult until the incentives are properly
aligned.

The value proposition is clear for the pharmacy which no longer would have
to data enter fax prescriptions, for nurses who would now presumably have an
easier job of getting the right medicine.

Physicians, on the other hand, may have additional time requirements and
certainly additional communication requirements associated with E-Prescribing.
These are all things that physicians want to do because they – continuity
of care will help, clinical training for nurses will help. And I can also tell
you from personal experience and from communication within the industry that
the skill set for nurses as agent is fairly high and will be higher in the
E-Prescribing environment, and we would hope that the additional training
costs, that the additional turnover that’s associated with the implementation
of E-Prescribing would be factored into an implementation plan and timeline.

So AMDA fully supports the movement toward automation of clinical records.
But E-Prescribing without a robust strategy for clinical data propagation to
physicians offsite and after hours will create more hardship. Additional pilots
and fully automated electronic health environments would be very useful, and we
need to define what the critical mass of automation required for successful
implementation is.

It will take many years to implement E-Prescribing. However, the benefits
are totally worthwhile, and we’re very supportive. There’s some sections on
barriers which you sort of mentioned many of the barriers already.

Basic clinical systems are quite heterogeneous within the industry. Some are
simply using MDS submission software. Some people are using MDS in care plans.
Some are using clinical notes. Again, the more clinical information that’s
available, the better the E-Prescribing value proposition.

We won’t talk about incentives for providers, although hopefully somebody
will factor that in. And, of course, I don’t think you guys are the ones who
would do that. So the other thing is, as was mentioned with the schedule two to
five drugs, you know the state boards of pharmacy are still very proprietary on
these requirements. And when you talk about special paper forms, wet signature
requirements and other kinds of things, it can create a lot of complexity for
any prescribing environment and frustration for everyone.

And we’ve seen this where our patients have been in significant pain, unable
to be medicated because of the inability to communicate in a fashion acceptable
to local pharmacy board in a timely way. And most of the time, the
institutional pharmacy vendors are willing to go the extra mile and support a
patient care. But clearly there’s some risk involved there.

So in looking at the NCPDP SCRIPT 2 standard, glad to know that there’s more
development to be done there. But certainly the diagnosis or rationale for
every medication order, target symptom for psychoactive medications, for
off-label use.

The payer status is so important because of the user experience there. You
want to coordinate the Medicare D benefit. You have facility billing under the
skilled benefits so patients – the facility’s the payer. Sometimes the D
Plan is the payer. Sometimes it’s a out of pocket, non-covered benefit. So
payer status should be included in the message.

There’s also a lot of movement in the long term care facility. People stay
in a facility but move from skilled to non-skilled status. People become
hospice. Hospice designation becomes challenging because you have certain drugs
which are related to the hospice diagnosis, others which are not and therefore
coverage, I’m seeing that familiar nod to the head. So I’m thinking you’ve
already figured that part out.

And so that sort of concludes my comments. I appreciate the opportunity to
weigh in. We are huge supporters of and a fairly innovative provider of
electronic health information and data exchange in long term care. But we see
long term care as a fairly unique setting which is a collaborative process with
at large physicians not always on site and a somewhat loose network of
hospitals, other service providers, physicians and pharmacies creating the
product in the long term care facility, all of whose needs have to be met by
any prescribing initiative. Thank you.

MR. REYNOLDS: Okay.

MS. SPIRO: Well, I’d really like to thank the Committee for listening to
especially the long term care industry. Some of you know me. I’ve been around.
My name is Shelly Spiro. I am here representing both the pharmacists and the
pharmacy perspective as it relates to electronic prescribing.

I have submitted personally myself a couple of statements to the Committee
concerning the SCRIPT standard and removing the exemption. Actually here I am
representing the American Society of Consulting Pharmacists from the
pharmacist’s perspective, the long term care pharmacist’s perspective and also
the long term care pharmacy alliance from the pharmacy perspective.

I’m also a work group for team chair, co-chair for the Long Term Care
Workgroup as it relates to NCPDP, and we have formed several task groups within
the NCPDP Workgroup. I know that you’ve heard Lynne Gilbertson talk about the
long term care workgroup, and Frank McKinney is the lead for the Electronic
Health Record Task Group.

From the pharmacist’s perspective, from the American Society of Consultant
Pharmacists that actually represents about 8,000 plus pharmacists dealing in
the long term care setting which includes many different environments dealing
with the quality of life of the geriatric patient, the senior care patient, and
this includes nursing facilities and dispensing and consulting services for
pharmacists.

From the pharmacist’s perspective, reducing medication errors is a very high
priority for the consultant pharmacist. This is done mainly through drug
regiment review of what we call medication regiment review on a monthly basis,
and we really believe that instilling an E-Prescribing system within the long
term care environment will really help reduce medication errors.

I was also a consultant on the Long Term Care E-Prescribing Pilot and have
been involved in this project for many years. And we really believe that an
E-Prescribing solution will help prevent medication-related problems. The
pharmacists who work in long term care and with the geriatric patient are
really focused on medication related problems because you see in the long term
care and especially with geriatric patients multiple co-morbidities, many, many
diagnosis issues and many medicative related issues, and our pharmacists are
trained to actually help identify those problems and work with the prescribers
and the nursing facility staff, the nurses to make sure that the patients are
getting the appropriate medication needs.

We really believe that by instilling an E-Prescribing solution married with
the electronic health record will really help alleviate the duplicate therapies
that might take place and also help bring that information to the consultant
pharmacist more readily than what we’re seeing today.

It’s really important that we look at E-Prescribing in the final solution as
a marriage between the electronic health record and the certification process
with the electronic health record in long term care. And within the Workgroup
Team within the NCPDP process with SCRIPT, we’ve actually been working with the
certification process for the functional S Model for the electronic health
record in making sure that the SCRIPT standard was incorporated into that
process so that when the nursing facilities buy time that they actually are
going to incorporate and begin to certify the electronic health record in this
environment that the electronic prescribing portion’s already built into the
system.

And we’ve done this through the pilot testing. The pilot testing was not
just a pharmacy sitting there working with a facility. It was really working
together as a team to make sure that the process worked as one unit. And we’ve
done this also with the work that we’ve done within NCPDP but also with the
work that we’ve done with defining the EHR functional model moving towards the
certification process.

From the standpoint of the pharmacies, the Long Term Care Pharmacy Alliance
actually represents the majority of the long term care – the pharmacy
providers actually service the long term care patients. Over a million –
there’s probably about 1.6 million patients residing in traditional skilled
nursing facilities, and the members of the Long Term Care Pharmacy Alliance
represents definitely more than that on the provider side, probably about 70-75
percent of those.

What we’ve found from the pharmacy side is the solution for electronic
prescribing, and we have the vendors and many of the pharmacy providers
involved in the process with E-Prescribing. And what we’ve found in the pilot,
as Frank had talked about previously, we definitely found time efficiencies. It
took one minute per prescription order saving time on the nurse’s side when
actually a medication order was transmitted to the pharmacy. So we do see some
time saving efficiencies from nursing facility time.

We didn’t find as many time saving directly from the communication between
the pharmacy and the facility for E-Prescribing. But what we did find was the
pharmacy’s work flow was a lot better from faxing and sorting. It eliminated a
lot of those manual processes that the pharmacy found.

So we do need some more pilots to go into really find out what the true time
saving factors are within long term care. The pharmacies themselves are on
board with electronic prescribing and want to move towards an electronic
prescribing solution. Some of the barriers that we’re finding are that the
facilities, as Frank had alluded to, are asking for proprietary solutions
because there aren’t standards in place, or the standards weren’t ready for
prime time, so to speak.

But what we are finding is that if we don’t put together some type of
mandate to move forward with E-Prescribing, I look at it as two things will
happen. We will start to see more proprietary solutions, and we’re sort of at
this level right now where with the need for technology and the efficiencies
that technology can bring in the long term care setting, we’re finding that
proprietary solutions are beginning to grow much more readily.

I believe – personally believe that with standard implementation, we
might help move towards the standards especially as we move toward CCHIT
certification for long term care and electronic health record. And I think that
system vendors would appreciate – I do have system vendors that I do work
with and find that writing proprietary solutions are one of their biggest
issues right now and are very costly, and those costs eventually pass along to
the providers.

And if we can move those vendors to work toward a standard solution that it
would really help. So eliminating the long term care exemption will definitely
promote the standard.

One thing that I would like to mention also is something that Lynne had
alluded to which is the controlled substances and the issues with controlled
substances. Probably more over in long term care than any other industry,
because of the hospice issues that we see in taking care of the geriatric
patient and the special needs of the geriatric patient, that dispensing
controlled substance does become an issue.

And we saw this within the pilot actually working with E-Prescribing. We had
to come up with an entirely different way of handling controlled substances
than we do with handling the regular electronic prescription. So it really
hindered the work flow.

And what encouraged – I know that you’ve heard from many others,
encouraging to resolve the issue on controlled substances, and I thank you very
much.

MR. REYNOLDS: Okay, very informative panel. Thank you. I’ll open up to
questions. Jorge?

DR. FERRER: Dr. Russell, I have a question for you. It appears that based on
your testimony, you would not recommend that electronic prescribing stand alone
software packages be sort of built outside of the clinical information system
EHRs. My question to you is, based on the Association you’re representing, can
you share with us where some are more one way, some the other because it used
to be that we used to think that E-Prescribing was a precursor to where it
would kind of pave the road, if you will, and I’m not so sure that that’s
actually correct.

DR. RUSSELL: In long term care, you’re not going to – you may build a
bridge, but you may not have enough roadway to go between the two statutes. The
order, the traditional paradigm of the order and E-Prescribing really only
takes you from the order entry person down to the pharmacy and back. But you
still have a huge gap between the provider and the nurse as agent piece, and
there is great movement now to close that gap.

A number of things are happening because then for many years advances in
provider models, nurse practitioner credentialing and privileging through
regulatory changes in ability for nurse practitioners to be there and their
availability is greater.

But more importantly, the data people need to write great orders, has
historically not been in the nursing home. And we are finally breaking through
in a number of way, whether it’s the continuity of care document that’s coming
out of CCHIT so that the information coming out of the hospitals is better. But
more importantly, I really do believe that access, physician access to the
record from offsite is really critical, and I also think that there’s been a
great improvement in the industry in terms of the physician, especially the
AMDA membership participation in the care process so that although the
regulations may say you can take 30 days, the physicians are there on the first
day.

Physicians may be much more willing to go the extra mile now to write the
right order as opposed to get off the phone and write any order because that
has historically been what’s happened. People have mentioned that we’ve relied
on consultant pharmacists to come behind us and say you’ve created a medical
regiment here that’s not appropriate for that person’s medical diagnosis. Well,
that’s kind of embarrassing from the physician’s perspective, to be honest with
you.

So we want to get to a better paradigm, and I think we’re making great
progress there. So, again, for all the reasons mentioned, we need to get to
standards, and I think we need to put the nursing home toes in the fire a bit.
But I think we also have to be mindful of what the true value proposition is,
and it’s not going to be realized in 2010. We’re not going to be there yet.

So whatever matrix, adoption matrix we choose to link to E-Prescribing and
whatever value propositions and incentives we put in place, I think they have
to be fairly sober.

E-Faxing, by the way, doesn’t solve any of this. It doesn’t really matter if
you’re faxing a prescription or if you’ve got a nurse sitting there typing it
off the keyboard. What this will get to is fully automated clinical
documentation systems which link hospital, nursing home, physician’s office
accessible 24/7 where doctors can actually get in and make good choices for
patients whether they’re onsite or not.

MR. REYNOLDS: Denise?

MS. BUENNING: I actually have two questions, and I think the first one I
might direct towards Shelly. But anybody can chime in. In getting responses to
our NPRM on the final E-Prescribing standards, we did receive a lot of comments
about the potential lifting of the exemption for long term care.

We also had a widely diverse set of opinions as to which version of the
SCRIPT standard should be adopted for this. And from what I’m hearing today, it
looks like the consensus is pretty much 10.2. But we’ve also heard from
representatives that say anything 10.0 and above, it’s got to be 10.1. The WI
folks go to 10.5. So can you give me some feeling as to whether 10.2 is the
prescriptive standard that the industry would support, and if so, why.

And then the other question I had is with regard to the readiness of the
industry to embrace E-Prescribing in long term care, I know the Erickson
facilities achieve – you are on the cutting edge always applying health IT
to the long term care industry, and we obviously hear from you very frequently
because you are on that cutting edge.

But to Eileen’s point, there are a lot of long term care facilities out
there that just barely know MDS. So given that chasm, can you give me some
ideas as to where we are industry wide with regard to their readiness to adopt
E-Prescribing.

MS. SPIRO: I certainly can address the diversity of our request for an NCPDP
version. When the Long Term Care Workgroup, the NCPDP Long Term Care Workgroup
was formed, we worked really hard to work with the current SCRIPT standard
which was 8.1 at the time that the MMA went into effect for E-Prescribing and
worked with that standard to modify that standard for the long term care.

There is a definite gap between 8.1 and 10.0. 10.0 is probably the minimum
that we could adopt in the long term care industry. Just as an example would be
the need to route and have information for the facility, the unit, the room,
the bed and identifying that patient which is very different than the
ambulatory setting.

What we’ve done because we were – I mean, at points we were meeting
twice a week to get some of the requests into NCPDP and get this validated. We
have been consistently moving forward to make sure that we shorten the gap
between the ambulatory and the long term care setting.

We believe that the most current version that is ANSI accredited which is
10.2 because we know that you would want to adopt something that was ANSI
accredited is 10.2. As we move forward with the industry, anything above
actually 10.0 will work in the long term care setting.

The majority of the modifications that took place are probably 10.3 for long
term care. So probably most of that information is in there. Now as we agree
with the rest of the industry that 10.5 would be the best version for all of us
to go to and are willing to go to it. But we don’t want to wait until 2010 to
implement long term care.

So we need something before that 10.5 which I believe Lynne had said in her
presentation today that the industry would like to go to 10.5 and by the year
2010. With CCHIT certification for the electronic health record which should
begin sometime in 2009, we would need to have an E-Prescribing standard name
for long term care.

So we need to have at least something that is named, and we took the latest
ANSI accredited version which is 10.2 to be the standard name for long term
care. Now as far as intermediaries who help us transmit the information between
the facility and the pharmacy, it has been a personal struggle to get them to
adopt a higher version above 8.1. And I can tell you I’ve spent and I know some
folks in the audience can attest to my diligence in asking them to go ahead
with the higher version to make sure we can implement E-Prescribing in the long
term care setting. So that has been one of our barriers is getting the industry
as a whole and especially intermediaries to adopt a higher version for long
term care when everybody else is on 8.1, and 8.1 will not work in the long term
care setting.

I will let one of my other colleagues address your other issue.

MS. DOLL: Go ahead, Eileen. Of course, we were not going to discuss this
unless asked. There are so many barriers to adoption of anything new, and
certainly to 8.2 patient technology and long term care.

You have rural areas. You have areas where they don’t want to move forward
unless they’re forced to for any reason, and then they might want to move
forward, and they want to make sure that they’re moving forward the right way.
There’s capital expenditures. There’s training expenditures. There’s time
expenditures. And people want to do it the right way the first time.

So this is why we weren’t going to attack this. But we want this part to be
right so we can move forward, and this is a part of the standard for getting
records set. You know, our staff can go on EBay and buy their goods whatever
they want, but they can’t do a computer screen to find a medication order, no.

I think some of our training needs won’t be as great as we expect, but there
will be training needs. There’ll be so many barriers to overcome from their
work being looked at for once. Do they actually do it or not do it. What are we
going to do with the information. Who’s going to know it in this room and not
know?

But you know, this is all – we depend on our bank accounts to be
accurate now, and we would expect our medical records to be accurate, safe and
transmitted safely. And certainly prescribing medications in long term care is
very important to the total care and quality care of the patient and so is the
record because what the doctor was saying. The doctor wants to be sure that
when a nurse said the blood pressure was 200 over 90 that it wasn’t 120 over 64
before he changes the medication or she changed the medication.

Knowing what’s really in the record is so important, and that communication
between the record, the physician, the nurse, the pharmacy create the quality
of care for the patients which we’re all looking forward to. And I know
physicians, too. They might not want to use the PDA for prescribing, but they
know how to get their email. So we all use technology in a way we like it
sometimes. But this technology we’re going to be using for the benefit of our
people we take care of. Does that answer it?

MR. REYNOLDS: Do you have another question? Next is Judy. Judy, then Jeff.

DR. WARREN: Yes, my question was one of just maybe a little bit more
information. One of your recommendations was to lift the long term care
exemption from MMA. And I just wanted more of your thinking about why you’re
making that recommendation.

MS. SPIRO: In the E-Prescribing regulations for MMA, long term care was
exempted, and because the SCRIPT 8.1 was not ready for the long term care
industry. That was one of the reasons why we were hopefully why one of the
reasons we were awarded the pilot was to try to test this to see if the
standards actually did work in the long term care setting.

So what we did, we took the 8.1 and actually modified the fields to send
what we now see in 10.1 in order for it to work in the long term care setting.

DR. WARREN: So why do you want to be exempt? Can’t you get what you need
–

MS. SPIRO: Well, we want to lift the exemption. We want to lift the
exemption so that the industry would then have a standard and begin to use the
standard. Right now, we don’t have a standard. Anybody is just doing whatever
they want.

DR. WARREN: So it’s really helping you set the standard and trying to push
the industry to meet it.

MS. SPIRO: Yes.

DR. WARREN: Got it.

MR. REYNOLDS: Okay, we’ve got Jeff, Michael and then me.

MR. BLAIR: One of you indicated that you felt there should be a mandate for
E-Prescribing. Could you tell me who that is?

MS. SPIRO: Jeff, it was probably me. This is Shell.

MR. BLAIR: Thank you, Shelly. It’s helpful to the degree that you’re able to
do so, and anybody else can comment as well. NCVHS has been through a history
where in some cases at the direction of Congress the use of standards has been
mandated. And when they are mandated, we’re forced to consider all of the
different possibilities anyone that might suffer because of a mandate who,
what, when, where and why just like a newspaper article so that we don’t do
damage when we mandate.

So I’m not asking this question to be reluctant to mandate. It’s just that
if we do recommend that it be mandated, we have to be as complete, thorough and
specific as possible so that we mandate it properly and correctly. So what
guidance can you give us when you’re recommending that we recommend mandating,
and maybe to make it simple, why don’t you think of the who, what, when, where
and why. We’re going to mandate the use by who. When would this be effective,
under what circumstances. Any guidance you can give us to clarify what that
mandate should be.

MS. SPIRO: Yes, thank you, Jeff, and that’s an excellent question. Mandates
for long term care are probably help the industry move faster than they
normally would. It’s just unique to the long term care setting just from the
first standpoint.

But I think the biggest issue has to do with the Medicare Part D Program. In
the Medicare Part D Program, long term care was not exempt. We have the same
requirements as the ambulatory setting for Medicare Part D Plus. Many other,
many, many other issues.

E-Prescribing was one of the areas that they did not mandate and exempted
because the standard was not ready for the long term care industry, and we
believe that we’ve moved up with the rest of the industry which will help us
with some of the Part D compliance issues.

There are many pieces that we built into the E-Prescribing process.
Especially one example would be formulatory and benefits standard that will
help in the Medicare Part D process.

So that is definitely one of the benefits to the mandate. The mandate is
more related to the MMA and Medicare Part D issues which is a large majority of
the patients who are being the actual – the benefit is a Medicare Part D
benefit for a lot of our patients, and we believe that we’ve built in a lot of
pieces into the E-Prescribing portion to take care of that.

To answer your question on timing, I think the most important piece is
because to have the most efficient E-Prescribing process would be –-
although E-Prescribing can be a stand alone and we’ve built it to be a stand
alone process between the communication and long term care facility and the
pharmacy, once we meet that electronic health record that’s certified
electronic health record at the facility, that is where E-Prescribing will
really shine, and some of the things that Dr. Russell talked about would be we
would be able to incorporate that. Some of the things that the consultant
pharmacist is doing, that kind of communication that we’ve built into the
electronic health record really helped.

So the timing issue deals with the certification process of the EHR which
should take place sometime in 2009. Does that answer your question? And I don’t
know if any of my other colleagues care to respond.

MR. BLAIR: Is there any part of the long term care industry that you would
exempt? Would you exempt long term care facilities in rural areas? Would you
exempt other long term care facilities that might have special needs or
difficulty complying?

You know, anything where you could help us avoid imposing a mandate where
someone can’t actually step up and comply.

DR. RUSSELL: I think you do run the risk of having a tremendous amount of
non-compliance with lifting the exemption too quickly. Again, I think the
purpose of what everyone’s saying is that we need to agree on standards so that
the development process and the adoption process can move quickly to a
readiness to implement, and that’s the window of time that I don’t think any of
us can say specifically how long that would be.

And I don’t know that it’s a rural issue either because some urban
facilities will have tremendous challenges meeting E-Prescribing standards for
different reasons, and it really, again, I’m a pretty big believer that the
border entry process is really the issue to be solved here.

E-Prescribing without a solution to order entry is going to be simply, I
think, wallpaper over bad plastic. I think you have to get the order entry
piece worked out.

MR. BLAIR: Well then if I’m hearing both of you correctly, you’re saying
that it isn’t that we specify the time, although there might be an end time.
But it’s that E-Prescribing standards must be used at the time when a long term
care institution either implements an electronic health record system with
E-Prescribing or a stand alone E-Prescribing system, that those E-Prescribing
systems must comply with the standards. Is that what I’m hearing?

DR. RUSSELL: That would be my take on it. I think all of us struggle with
what an appropriate timeline is because we know what a heterogeneous industry
we’re dealing with, and it’s not even one industry. It’s a collaboration of
multiple industries.

MR. MCKINNEY: My understanding is that lifting the exemption really would
mean that for those providers, those vendors that want to pursue E-Prescribing
that there is a defined set of communication standards that they should follow
in doing so. I imagine that helps pave that road. It helps get us more
experience so that we can really address this as part of the whole care
process.

And so I don’t think there is an issue with setting that standard for those
that are in a position to pursue it. So I think that’s the differentiation.
Setting standards, I think, can be quick. Mandating use across care setting
sets what would depend on readiness. So I think we would all urge to lift the
exemption from the standards for those that are prepared to do it quickly, but
then leave the mandate to the point at which there’s industry readiness for
that.

MR. BLAIR: Thank you.

MR. REYNOLDS: Michael.

DR. FITZMAURICE: I hear a good message coming from the nursing home and the
pharmacy industry about this. As I see it, I’ve heard that this will save
nurses time. It may cost physicians some more time, reduce errors. It may save
money on refills. It would help manage the medication order, delivery and
administration process more efficiently.

Will it have an effect on net income that’s not considered in these factors.
I’m thinking if I were a nursing home, I would say, well, here’s another
capital expenditure. I’m going to have to pay for software maintenance. Why
would I get involved in this when I have a system that’s already working.

So maybe I’m asking Frank –

MR. MCKINNEY: I could take a swing at it and others probably have comments.
One aspect of this in our experience or experiences we go, and here we’ve had
subsequent pilot and production experience with the standards, and we’re
finding that different settings, different organizational goals will really
impact what they pursue and the benefits they get out of it.

And we’ve found that where you have a facility that is cost conscious,
that’s one of their key goals in implementing E-Prescribing along with safety
is also to help them manage their prescription spend on behalf of the residents
and for the portion that they’re responsible for as well, that there can be a
pretty material reduction or at least management ability of that prescription
spend by having the benefit information available at the time of prescribing.

So if a physician, especially with Part D, it’s harder and harder for the
physician to just remember that this med, this is the covered drug. I think
that used to be the case with Medicaid. But today, it’s a flip of the coin, I
think.

And so the physician or even in a less perfect world, a person that’s at the
point of entering or communicating that order can see that this is not covered
by this resident’s plan, but this other, you know, there’s a generic equivalent
or there’s another alternative that we could ask the prescriber about that’s
really an impact on the spend for the resident and for the facility. And so
that I don’t have firm numbers on it, but I believe that that’s definitely
something that materially should be factored into it.

DR. FITZMAURICE: I must say that having all of you together and speaking
with one voice makes a strong impression on us.

MS. DOLL: I want to say something, too. You said that they have a system in
place. We have a system in place, and it’s working. It’s not working. In other
words, so many errors occur on what they call turnover where every month the
nurses check the old orders against the new and update the old with the new,
and darn if they forgot an order, and darn it, the patient doesn’t get that
medication for a few days or it should have been discontinued, and they
continued a few more days.

So E-Prescribing and use of electronic record, it’s all part of the same
solution. But it isn’t always working, and we still can’t read physicians’
handwriting, and we still don’t get the pharmacist’s needs met. So it’s all
part of a package that we see as being important because it isn’t always
working right now.

MR. REYNOLDS: Okay, I got a couple questions. I’m not sure what you want us
to recommend. No, let me tell you why I say that. I’m not saying that in any
derogatory way. I hear E-Prescribing. We’re well aware of. I hear – but
then I hear maybe it has to be part of the EHR before anybody wants to use it.

And then I hear 10.2, and then I hear it’s going to take a while, and 10.5
is really the one that’s got what you want. And so I’m not saying I don’t have
the answers, but I’m listening to the words. And so I just want to understand
because – and then the next question I’m going to ask is there are other
people representing the industry in the room, and we kind of did this the last
time we did 8.1. If there’s anybody in the room that’s from this industry that
would have a dissenting feeling to this approach, this would be a wonderful
time to move to the microphone because as we look at doing our due diligence,
if we’re going to use a single panel which is a wonderful cross section, but I
think we would be remiss in doing our process not to invite anybody else that
was in the audience who would not want this to happen, have a significant
concern or if we said 10.2 and 10.5 had something to say, that we would remiss
in not welcoming them at this particular moment if this is going to be our
process.

So with that, if you could help me kind of get a sense because I think there
probably ought to be some kind of a letter probably coming forth. But I’d sure
like to have a wonderful discussion. I’d sure like to have one more time for
the dumb guy real clear what we’re trying to get done.

MS. SPIRO: This is Shelly. Probably the – I hope I’m speaking for
everybody. But please –

MR. REYNOLDS: Well, I’m going to make them nod their heads.

MS. SPIRO: We would like this Committee to recommend to lift the exemption
for long term care to Version 10.1 or higher or any ANSI-accredited version at
the time you write the letter. And we are willing and do support NCPDP’s
request to move to 10.1 with the rest of the ambulatory setting on
E-Prescribing when 10.5 becomes ANSI accredited which would be probably in
– the industry would request to move to that in 2010. So we would be on
board with it from a long term care standpoint.

So we are asking to lift the exemption for long term care is probably our
biggest request.

MR. REYNOLDS: Microphone, microphone.

DR. RUSSELL: I want to make sure I’m clear on what lifting the exemption
truly means. What I feel we’re advocating for is a standard to allow the
development process to be focused on a functional electronic data exchange that
will make E-Prescribing a value proposition for the industry.

The way it’s currently configured, work flows, heterogeneity, et cetera, if
we were to implement E-Prescribing tomorrow and mandate it everywhere, there
would be a huge cost and very little quality gained or no quality gained.

So – and let me say why I’ve seen it because I’ve seen places that have
gone to order entry processes that have had to pull back. Erickson, which was
mentioned, on the cutting edge from electronic documentation perspective, has
not been able to fully implement E-Prescribing in a long term care setting
because of the lack of readiness by all the necessary participants.

So I think a few years to ramp that up, and when you say lift the exemption,
I’m assuming that means with a target point somewhere down the road, and I
think that’s the real issue is what that target point and what are the metrics
that allow you to know that the industry is ready to move forward.

I don’t think you want to just open the gate and say, you know, let’s go.
So, again, get to standards, focus the development process, put the target out
there for the industry, work toward that. That’s all necessary. But I do think
you’re going to have to accommodate a lot of preparation by the industry to be
able to be in compliance with E-Prescribing even by 2010.

MR. REYNOLDS: Yes, the Committee’s been through HIPAA implementation. We
understand that. Jeff has a clarifying assignment. So let me get Jeff to
clarify his answer.

MR. BLAIR: Frank, is it Frank?

MR. REYNOLDS: No, it’s Bill. Who was speaking?

MR. BLAIR: The last person.

MR. REYNOLDS: It was Bill.

MR. BLAIR: My understanding is that NCVHS has within its domain the ability
to recommend – we could recommend that standards be mandated for
E-Prescribing or electronic health records. But we don’t have the breadth to
mandate or recommend mandating the use of E-Prescribing. There’s a very big
difference between the two because the latter is saying that everyone has to
implement E-Prescribing by a certain date. I think that’s at maybe possibly a
Congressional level.

On the other hand, if E-Prescribing is installed in a healthcare facility,
we could recommend that the standards they use for interoperability and for
semantics comply with the national standards already recognized for
E-Prescribing. Is that distinction helpful?

DR. RUSSELL: That’s helpful, yes. And again, speaking from the physician’s
perspective, understanding that someone’s ass is going to be gored here, and
there’s no question about it. There will be a lot of training necessary for
physicians on how to make best use of these standards and processes.

MR. REYNOLDS: Simon?

DR. COHN: I actually wanted to follow up also just to since you’ve dived
into this issue of E-Prescribing as a mandate versus standards themselves. I
just wanted to make sure that I understood based on your own experience and
organizational experience.

It sounds like at this point you actually have E-Prescribing in some of your
environments, but not in everywhere.

DR. RUSSELL: We have. We have fully electronic medication administration
records and order entry. What we don’t have for lack of standards is a full
data exchange with the institutional pharmacy to get the coordination of the
benefit, Medicare D, formulatory information, therapeutic interchange, those
kinds of things that — but I can also tell you that an admission assessment
went from being about a two-hour job for a nurse to being about a five-hour job
for a nurse.

So it has a big, there’s still a development cycle that has to happen both
on the training and human side and also on the software and technology side.

DR. COHN: Okay. Well, then maybe just let me ask maybe you and two of the
others just to make sure I’m understanding. You know, obviously the issue of
standardizing on these standards or whatever is not an issue if you haven’t
implemented anything yet. It is an issue if you have systems that are already
doing E-Prescribing but are using sort of old standards or no standards in
which case you need to update your systems.

Now so my question is given that fact base, does that change any of the
opinions, change any of the timing around going to those standards, or are we
dealing with a nescient enough industry that’s really not an issue.

MR. MCKINNEY: I think that’s my sense. Previous to working at MDI Achieve, I
worked in ambulatory prescribing. And there was an environment where pharmacies
and you had the claims process had been in place for quite a while. You had
many things that were already in place. And so making changes to those
standards was much more difficult from a practical perspective. There were more
folks impacted. It was greater pain, and it slows the enhancements to that
model.

In long term care, it really is at – and so the cost of standardizing
won’t get less. It will get more over time. So I think summarizing the group, I
think there is full consensus that setting that standard now when it’s cheap
relatively speaking is the right thing to do, and there will be some impacted.
But it’s a much smaller number of folks, and it will be six months down the
road or 12 months down the road, I believe. And I think that also helps create
that sense of direction, that sense of reality that enables vendors to put
resources against development of these systems as well.

And so many of the aspects of providing the physician with enough
information to do their work to be able to see the chart in various settings
not only at facilities but when they’re at dinner and they get a phone call, et
cetera, that’s not really so much standards directly standards based. It’s
application development based.

And so I think setting the standards means that vendors see this as
something that’s in place, something that’s moving forward that encourages them
to put in the development time to improve the system, to improve usability by
physicians, make it a more viable full process sort of thing. Delaying that
allows vendors to say this isn’t quite time yet, so we’re not going to go ahead
with it.

DR. COHN: That’s helpful.

MR. REYNOLDS: Okay, we’ve fleshed the guests out of the bowels. Would you
introduce yourself, please.

MS. MITCHELL: Good afternoon. My name is Sue Mitchell. I’m with Omnicare
Information Solutions, one of the vendors that is also being represented at the
group here. We’re also a large institutional pharmacy provider. So and our
group was very much involved in trying – with the crafting of the comments
coming in.

The first reason it came up originally was during the whole scooping of
discussion, again just making sure that our understanding was the fact that as
we talked about the removal of long term care from the exemption, it truly was
only going to affect those facilities that had opted to go and pursue
electronic exchange prescription information. So again we’re looking with a
body of facilities that have already made the commitment to health information
technology.

I totally concur with what Frank is saying in that by establishing at this
point a compliance with SCRIPT 10.2. I think that what that does for industry
is truly help the physicians so that we are working towards interoperability
not only within our facility but our pharmacy, but then hopefully also out to
the physician office setting that we know is using SCRIPT information to begin
with. So truly it’s a matter of trying to help us play better in our healthcare
community.

MR. REYNOLDS: Thank you. Jeff’s going to ask a question.

MR. BLAIR: When you say 10.2, are you saying 10.2 but no further, or are you
saying 10.2 or higher?

MS. MITCHELL: Thank you for asking the clarification. 10.2 or higher with
the understanding that everything is backwards compatible.

MR. BLAIR: Thank you.

MR. REYNOLDS: Clarification. But I heard, Shelly, you said 10.1.

MS. SPIRO: And I know there’s a lot of – we originally had said 10.1
because 10.1 actually has the minimum that will work in a long term care
setting. But we as an industry have agreed that anything higher will work. But
you can’t go below that.

The industry itself, we don’t have anyone other than what we did in the
original pilot actually using the standard because it hasn’t been adopted. So
whichever answer – a time and frame. Whichever one gets approved, the
industry has agreed that that’s the standard that we would go with.

We know that you would like to go with – that it makes sense,
especially with CMS, to go with an ANSI accredited standard, and that’s the
last name ANSI accredited standard is 10.2.

MR. REYNOLDS: The rest of the panel. So is it 10.1 or higher or —

MR. MCKINNEY: This recalls a conversation this morning about the point in
time and freeze in time, and how do you accommodate the fact that the industry
is very energized and is moving forward quickly. And so it sort of depends on
when you ask us, I guess, to an extent.

So when 10.1 was the latest ANSI approved version, that was the best one at
the time. But I think that the idea that as long as subsequent versions are
backwards compatible, we would recommend at this point the most recent version,
and that’s 10.2.

Our groups are all moving forward to make further enhancements to the
standards which will undoubtedly implement. So ideally if there were the
ability to state sort of the current level of support 10.2 or higher standards,
that would really be the best case scenario because it would not prevent
vendors from implementing greater functionality or better improvements without
having to go through a process of getting that approved.

MR. REYNOLDS: Okay. All right, we got it, too. Okay now the next question is
so – but also I think we’re hearing that once this would be lifted that
there would obviously before any standards would be required, there would need
to be the appropriate implementation plan for anybody that would use it just
like anything else, whether that was HIPAA or whether that was NPI or whether
that was E-Prescribing or whether it’s anything else. Is that correct also? I
mean, you don’t want to have it listed and be required immediately.

MR. MCKINNEY: Well, I don’t see it personally any risk. I’m looking at my
cohorts of naming a standard and having that with that condition that if you
are a party that is pursuing electronic prescribing that you use that version
that’s been named.

I don’t see any prerequisites to that. The prerequisite would be to
mandating its use which I think is outside the realm of the use. But as far as
the definition of how the standard is implemented there being sufficient
industry conventions surrounding implementing the standard, I don’t think there
are any additional needs that would prevent vendors from implementing it in a
way that makes sense and it’s consistent with the expected use of it.

MR. REYNOLDS: No, just process wise, any time you put a standard – any
time a standard gets out there, anybody could pick it up and use it or
recommend using it or recommend that it should be required to be used or
anything else.

For example, one of our issues tomorrow that we’re going to discuss at
length is, oh, well, for a while is the possibility that public discussion of
AHIC possibly recommending the requirement of E-Prescribing. That’s one of our
agenda items for tomorrow.

So we would – you wouldn’t necessarily want this, so you lift it, and
then it’s required. So this is a new industry. This is a new group, we were
told. So there’s got to be some kind of implementation time, I would think, to
protect you because I keep hearing everybody saying, well, we’re not there.
We’ve got to move to there. Yes, you set a standard so people can start moving.
But that’s a whole industry to move forward.

I’ve heard enough of your testimony to realize we’re starting brand new for
a lot of people. I mean, this isn’t something brand new for E-Prescribing and
brand new for EHRs and brand new for the whole process. So remember, there are
a lot of things in play in this world of standards right now, and I’m just
trying to understand it.

MS. MITCHELL: And Harry, I’m sorry because I may have missed some of Frank’s
comments. But again, I don’t think they were in here asking that you place a
requirement on the long term care facilities that they have to use
E-Prescribing.

MR. REYNOLDS: We are not – I was not alluding to that. I’m alluding to
the processes that could occur after standards exist at any one time. I’m not
recommending anything new.

MS. MITCHELL: Right. So and I guess my other question would be that with the
E-Prescribing rule, my understanding was that the current NPI and medical mouth
said that if we establish a standard of 8.1 or whatever, there would be one
year to become compliant with that standard.

So if we were to set it for 10.2 for the long term care facilities, those
pharmacies that currently may be using HL-7 messaging standards would have a
one year time period to switch over and be compliant with the new requirement.
So is that your understanding?

MS. BUENNING: Right. There normally is a time period between when the final
rule comes out and a compliance date, and that can be up to a year. It can be
at the Secretary’s discretion depending on whether it’s a modification of a
standard that’s being adopted, a new standard, et cetera. So it really depends.
So you do have a little bit of flexibility.

But I just want to be clear that in the NPRM that we put out on November
16th, we asked for comments regarding the lifting of the exemption.
We did not propose it.

MR. BLAIR: Could I have –

MR. REYNOLDS: Yes, you have one last one, and then we’ll share.

MR. BLAIR: The time frame might especially impact vendors because the vendor
may need time to upgrade their systems to support 10.2 or higher. So we’ve
heard 12 months, and I haven’t heard anybody say be uncomfortable with 12
months. Are there any E-Prescribing or EHR system vendors in the room that want
to make a comment as to whether they would feel comfortable with 12 months?

MS. SPIRO: This is Shelly. I can speak on behalf of the pharmacy system
vendors. The majority of the pharmacy system vendors who deal in the long term
care arena are prepared to move to a 10.1 SCRIPT standard from the pharmacy
standpoint – I’m sorry, 10.2. Didn’t I say 10.2?

MR. BLAIR: Okay, okay, and 12 months is adequate or –

MS. SPIRO: They’re ready to go now with that standard from the pharmacy
system vendor standpoint.

MR. MCKINNEY: I can speak on behalf of NASL who has as members pharmacy
system vendors and long term care facility vendors, and a year I believe is
adequate from our perspective as well.

MR. REYNOLDS: Okay. Our process, thank you very much. Our process is that we
would begin to draft a letter and obviously everything we do is in public. You
have a chance. Now we think we understand. You’ve had more than ample chance to
help us understand further, and then other things may be occurring as we go
along. But thank you very much.

The other thing that’s real exciting to us, any time a group comes together,
that represents a significant industry and all the constituency of an industry.
Just like we talked about NCPDP, it makes it a pleasure to try to move forward
and make a difference. So thank you very much for all of you being willing to
get together even if you agree or disagree on the tiny pieces. Thank you very
much, and we really appreciate that. Thanks.

From an agenda standpoint, let’s go ahead and take the break now since it’s
been about an hour and a half from lunch. At a quarter to three, we’ll start
and then move on from there. So thank you.

[Break]

MR. REYNOLDS: Okay, let’s go ahead and get started again. Back by popular
demand for the multiple time today, as I said the poster child. So we’re going
to go with Lynne, the poster child, Gilbertson. That’s what we’ll start naming
her.

Agenda Item: DSMO Presentation

MS. GILBERTSON: Margaret and Don, are you still on?

MR. BECHTEL: Yes, we are.

MR. REYNOLDS: Yes, could you go ahead and introduce yourself, those that are
on the phone, please.

MS. WEIKER: This is Margaret Weiker with EDS. I am the current Chair of the
DSMO NCPDP Standardization Co-Chair and Board of Trustee member as well as ASC
X12N Vice Chair.

MR. REYNOLDS: Hi, Margaret.

MS. WEIKER: Hello, Harry.

MR. REYNOLDS: Who else, please.

MR. BECHTEL: Don Bechtel.

MR. REYNOLDS: Hey, Don.

MR. BECHTEL: I am the Co-Chair of the X12 Healthcare Task Group and the X12
primary representative to the Designated Standards Maintenance Organization
known as DSMO.

MR. REYNOLDS: Okay, Lynne.

MS. GILBERSTON: Okay. We will tag team between the in person and on the
phone. This is the DSMO Report to the National Committee on Vital and Health
Statistics. The DSMO is the Designated Standards Maintenance Organizations.

The DSMO brought forward recommendations for existing or new standards to be
named in the next round of HIPAA back in May 2007, and then NCVHS put forth a
recommendation letter to HHS in September 2007.

So the industry moves again. Since May 2007, six new recommendations came
forward under the DSMO process, and we wanted to make sure the Committee was
aware of them as soon as they had finished the process. Hence, the December
letter to the Subcommittee and this testimony to provide any additional updates
we can for you.

There were three DSMO change requests that were related to errata which will
be discussed in the future in this presentation. Two are for new versions to be
named to existing standards, and one is for a new standard to be named under
HIPAA. And these have been brought forward to alert the Committee of the fact
that these change requests have been through the DSMO process and to begin the
regulatory processes as were required under HIPAA.

Just very briefly – going to go through the change requests. More
information was included in the December letter, and Don will be talking a
little bit further about the specific changes in his presentation.

The first change request is 1064 which is an errata for the X12 278 Health
Care Services Review, and this is correcting several typographical errors found
in the original publication.

Change Request 1065 is errata for the X12 837 Health Care Claim, the
institutional claims, once again for typographical errors found. Ten sixty-six
is the change request for errata for the X12 837 Health Care Claim –
Dental, and this is once again some typographical errors.

Change request 1060 is for the X12 820 Premium Payment Transaction, and this
is a version upgrade from the Version 4010(a)(1) to a 5010 version. So way back
in testimony for the first set of changes coming forward, not all the standards
were ready at all the same time. So this is just to bring you up to date with
the 820.

Change Request 1067, there’s a minor typo. I’ve 820 in there which is not
correct. It’s the X12 270/271 which is the eligibility benefit request and
response. This is a formal request to bring forward this standard transaction
from the 4010(a)(1) to the 5010.

And Change Request 1063, this is a new standard coming forward. It’s the
NCPDP Post-Adjudication Standard Implementation Guide, and this is the
reporting of after the fact, after claims have been adjudicated reporting that
is done between payers and their clients in the healthcare industry. I’ll
discuss that in a little bit. This is for a new standard to be named in HIPAA.

We’re now going to switch hats and give a little bit of detail from X12 and
NCPDP about the given change requests that have come forward to give you a
little bit more detail.

The post-adjudication standard, as I mentioned a minute ago, is for use by
client groups, pharmacy benefit managers, payers, vendors, administrative
oversight organizations, anybody who has interest in the exchange of
information of after the fact reporting about claims, pharmacy claims data.

And one of the reasons this standard’s being brought forward is it works in
harmony with the telecommunications standard Version D.0 which is also going to
be put forward in the recommendation for HIPAA, and obviously its claims are
being sent in Version D.0. You would want to report post-adjudication
information using that same basis of version.

Currently in use in the industry we have the post-adjudication standard
Version 1.0. More use of proprietary or custom formats, and there have been
some creative uses of the NCPDP batch standard which was not intended. But
since the batch standard holds claims data, some folks used that standard as a
way to report the post-adjudication information.

The recommendation that was brought forward is that there’s a little bit of
a disconnect with the naming of HIPAA standards for version update versus new
standard that are brought forward. So the HIPAA legislation requires a two year
implementation period for new transactions, but 180 days or more for new
versions.

So we’ve got a little bit of a disconnect with implementing the telecom D.0
for the claims processing, for example, and the post-adjudication coming
forward as a new standard having a two year implementation cycle. So there’s a
recommendation that the industry should be able to begin using Version 2.0
prior to a compliance state because once the claims start flowing in Version
D.0, you want the post-adjudication information to follow along with it. So
therefore there should not be any hindrance to the industry to use the
post-adjudication standard ahead of time.

The types of information this standard is used to report is auditing of
services, retrospective drug utilization review, evaluating with healthcare
reporting statistics, capitation rates, all sorts of information that you could
use that data between payers, PBMs and their clients.

And now I’m going to switch it over to Don to discuss the changes that have
occurred with the errata of the change requests that have come forward.

MR. BECHTEL: Thank you. I think we’re on slide 16, and what we wanted to
clarify is when we were – under 4010, we had addenda that was recommended
for implementation with the 4010, and that addenda was referenced as
4010(a)(1), (a)(1) being the designation that we were making addendums to this
original 4010 standards.

Now this was sort of to allow us to accommodate Section §161.04
Modifications as a transaction and code set final rule and was also a
modification to implementation guides that X12N was publishing as X12N as
opposed to just the 12. By that, I mean N being Insurance Subcommittee was
working directly with the publishers to publish documents for this purpose,
implementation guide documents in particular.

That had led to several problems with the X12N community, and we have been
told that going forward we really need to utilize only X12 documents for
anything that we’re publishing out of X12N. And therefore, we’re now referring
to our implementation guides as technical reports Type 3 or TR3. It’s still an
implementation guide, and it still looks very similar to what you saw before in
Version 4010 in terms of format. But technically these are now X12 documents,
and we made this distinction between X12 does not recognize addenda per se. It
only recognizes errata when we make modifications to published documents.

So if we go to slide 17, there are two types of errata that we can have in
X12, and neither these type one or type two can actually change the base
standard or the associated internal code sets related to that base standard.

And just as a clarifying point of reference, an implementation guide or a
TR3 would constrain the base standard to specific use and purpose and provide
guidance on when to use transaction loops, segments, data elements, et cetera
for that particular purpose.

So within the X12 standard, we have many code values or in some cases
elements associated with data segments, and segments associated with
transactions that we don’t necessarily always use. In fact, many times we’ll
mark them as not used. And so by marking them not used, we’re constraining the
standard to conform to how we want to use it in healthcare.

So errata is a way for us to make modifications to our implementation guide
to change the constraints, but not change the standard. So if we look at a Type
1 errata on slide 18, a Type 1 errata would modify a published implementation
guide with changes that require trading partners to exchange transmitted code
sets or transaction sets that have actually been modified.

So if we were to use the implementation guide before the errata, we would
have transaction sets that might look different if we were using the errata. So
a Type 1 errata changes the constraints of the implementation guide, changes
the constrains or the use of the transaction sets such that it would appear to
be different on the receiving side, and both sender and receiver have to work
or operate with that errata to be able to successfully exchange those
transactions.

A Type 2 errata only modifies the implementation guide in terms of the
information that’s being described. It does not change the constraints. So
these are typically typographical errors or modifications to some of the
explanatory text of the implementation guide. It is not changing the way the
transaction status is structure or constrained.

So with that in mind, there are differences in the way we approve errata,
looking at slide 20. A Type 1 errata, because it does change the constraint and
does require trading partners to identify that there’s something a transaction
set with the errata and the receiver has to use the errata still to interpret
that transaction. We require a much more extensive review and approval process
to those changes, and it’s basically a 29-step process for us to go through to
change these which includes opportunities for public review and comment. It
includes an opportunity for an open forum at X12 to explain the changes we’ve
made and the response we’ve made to any public comments.

It includes an opportunity for all affected work groups to approve the
changes including task groups of healthcare, the task group two is the
Healthcare Task Group. Task Group Four is our implementation guide task group
that reviews and makes sure we haven’t done something that would be against the
rules of the implementation guides.

X12N, the Full Insurance Subcommittee, has to approve, and we also have a
requirement for the X12 Technical Assessment Subcommittee to review and make
sure that we haven’t violated any design rules for X12 itself.

This is a fairly extensive change and is pretty much very similar to writing
a new guide for all intensive purposes. It had the same number of steps
associated with the approval process.

A Type 2 errata which is, again, mostly typographical errors or
clarification to the text only has 13 steps that we are required to follow to
make such change, and it only requires approvals from the work group and
healthcare task group for the implementation guides. It does not require Full
Insurance Subcommittee reviews. It does not require Technical Assessment
reviews. So these type of Type 2 changes go through pretty quickly.

Going to the next slide 21, to put in context the changes that we’ve put
forward, the change request to the 837 institutional claim is a Type 1 errata
in that we have changed one of the looping structures in the implementation
constraints from what was originally published with this errata such that two
trading partners exchanged the documents, they have to know that this
constraint exists. So a fairly minor change, and it really was a typo, it does
significantly change the outcome potentially of what the transaction sets might
look like.

If we go to the next slide, the 837 dental claims, this was also a Type 1
errata. But this was much more significant than a typo. This change
specifically was addressing requirements from the dental community where we’ve
taken one of the segments and one of the data fields within the segment of the
tooth status segment, particularly the DN2, and activated it. Where in the
original release of 5010 we had it as not active, we’re now requiring this data
field to be used, and it would be valued with a JT code which indicates that
it’s utilizing universal national tooth designation system for identifying
tooth numbers.

We’ve also modified semantic notes associated with the dental service
segment and the line adjudication segment to eliminate the use of HCPCS
Procedure Modifiers and only use the ADA code sets.

So these are rather significant changes, and again would require that both
trading partners are aware of the errata, that the errata’s being used in the
exchange of the transaction, and that’s a fairly significant change.

The next slide talks about the healthcare services, and this is a Type 2
errata, very much a correction to some typographical information that was made
and specifically it was referencing in one of the explanatory notes the use of
service level loop rather than the use of the patient event loop. It doesn’t
change the way the transaction’s structured. It changes the way we’ve described
it. It was described in error. So we did want to make the modification, and we
want to publish the errata to this TR3 that it’s clear to readers of the guide
what’s actually being done.

On the 270/271 new transaction as we had noted in our testimony on July
30th of this past year, we were having some concerns from the
industry with the versions that we intended to or had ready to publish for
those transactions. The concern was centered around some privacy issues because
we were trying to create some search options that would allow us to identify
patients within or members within the health plan with significantly less
information than we’ve used in the past.

There was raised concerns that people might do more fishing or acquire
information for people that they shouldn’t have information for. And so we
needed to go back and review what we were doing and get consensus around what
the best way would be to do these searches.

And we did come back with a significant modification of that which has been
addressed in this implementation guide. And so rather than doing an errata, we
simply went to a whole another version of the implementation guide itself, and
we are now bringing forward this new version of 5010.

The impacts of these changes, going on slide 25, for the errata, anyone who
has already purchased the 837D or the 837I implementation guide for TR3, they
will be notified that there is errata available, and they can download that
errata for free. There’s no additional charge for that.

Anyone who has not yet purchased those guides, when they do at this point,
they will automatically get the errata at no charge. And for the 270/271
transactions, since we have never put the original version of 5010 out for
publication for people to pull, there should be no impact on this at all.

And I guess my slides continue. Going to slide 28, X12 activity, we wanted
to take an opportunity to let the Committee know that since our July
30th testimony we wanted to let you know that we took to heart much
of what was discussed that day in terms of what the industry knew about version
5010, and that there was not a clear understanding in the industry as to what
the benefit of 5010 would be to them, particularly the justifications, if you
will, the business justifications for making this change.

So we’ve been spending a great deal of time at X12 since that time providing
and developing educational material on Version 5010, and we’ve conducted
actually several presentations to date. One is the last WEDI Conference in
November. I did a audio presentation at AHIC on Version 5010, and we are
planning to do many more presentations either by audio task or face-to-face
sessions. We have a WEDI pre-conference session scheduled for the upcoming May
conference this year, and we will spend an entire day in their pre-conference
going through al the transactions in much more detail than we did in our
testimony to the Committee.

And we’re also planning to make audiocasts available to other organizations
if they’re interested and also to do face-to-face sessions for those
organizations that would be interested in having us make such presentations.

Finally, next slide 29, the business justification of X12 has basically been
focusing our educational effort on the business justifications. We went back
and tried to identify specifically what those justifications are and have put
that into our informational material. Much of that material is still in
development. But we plan to have it ready within the next two months.

I would also point out that we’re working collaboratively with WEDI to
identify some of the business benefits of these changes as well, and that WEDI
will be looking at these transactions more carefully and trying to identify
operationally the benefits to their organization in a way that X12 would not be
able to do effectively.

And we’re also working with NCHICA and WEDI on a timeline project to try to
prepare the industry for what steps need to be taken to do the implementation.
You’ve probably seen some of this on the press. We have an implementation date
that we’re not very proud of at this point, 2014. But what we’re trying to
identify is that the work to be done, if we continue to do the work the way
we’ve done in the past, it would take us until 2014 to get the implementations
completed.

We’re hoping that through industry work that NCHICA and WEDI can make some
significant improvements to those timelines and find a way to implement these
in a much more expedient process. And I think that’s the end of my comment.

MS. GILBERTSON: Thank you, Don. We’re going to now switch to NCPDP
activities as related to the next round of HIPAA or HIPAA II as I lovingly
refer to it.

NCPDP has a strategic national implementation process, a SNIP Committee.
It’s a sister committee to WEDI SNIP specifically for privacy industry items.
And in January and February of 2007, we held webcasts explaining the
telecommunication standard D.0 as an educational series. Those webcasts are
still available archival for folks who are now interested as they start gearing
up.

We performed surveys for the telecommunication standard D.0 batch 1.2 and
Medicaid Subrogation 3.0, and these findings were presented to the National
Committee in July. And the SNIP Committee also prepared and executed a survey
for the post-adjudication standard 2.0 which I’ll be presenting today.

The SNIP Committee has been very active working on HIPAA implementation
white paper, offering timelines and guidance for the industry being prepared
for 2010 date, and fine tuning the information that is going into that. Now we
are also working with a WEDI representative on making sure things are
dovetailing where appropriate.

The SNIP Committee is also actively working on what we’re calling an
implementation guide for payer sheet. When Telecom 5.1 was named in HIPAA
originally, we prepared what the pharmacy industry calls payer sheets or cheat
sheets which may be in a medical environment more of a companion guide or a
couple paged to a couple 100 page document that explains how a payer implements
the particular standard.

The payer sheets were well used in the 5.1 world. So SNIP is actively
working on a full implementation guide for payer sheets for the D.0
environment. For a consistent approach to how payers share information with
clearinghouses, vendors, pharmacy systems in what kind of requirements they
need for their business in the telecom D.0 world.

And we’re also planning future educational sessions that either NCPDP will
host or items that might be collaborative with WEDI and X12N, and we have
presented to anyone who wants to hear information about the standards coming
forward in the next round of HIPAA in different venues.

I mentioned the post-adjudication survey. This was as part of the
information bringing forward new standards to the National Committee and to
CMS. Either WEDI or NCPDP performs these surveys to give you some guidelines on
what the industry is thinking related to the standard coming forward.

This survey was run December 24th through January
11th, and based on the information received, it appears from the
information which the detail is included in your packet that the industry will
benefit by bringing forward Version 2.0 as a HIPAA mandated standard.

Some of the findings, these are high level which are included in your
packet. Of those who responded to this survey, 12.5 percent currently used the
post-adjudication standard Version 1.0. Forty-three point eight percent are
using one of the other NCPDP standards probably the batch standard as I
mentioned earlier which was not its intended purpose but can be set to the
work. It’s not the best solution. But we understand why people might have done
it.

And then of the folks who responded 81 percent said they also are utilizing
a proprietary reporting standard, and I actually should have put an
“S” at the end of that because some are with many client groups that
they support, representing different standards. Actually not even standards.
They’re proprietary formats that they share between them.

One payer, I think, mentioned about 100 different formats they have to
support. Obviously, there’s a base behind it. But it’s tweaked 100 different
times. So there’s quite a lack of standardization when it comes to moving this
data back and forth.

A majority of the responders indicated it would take between 181 to 365 days
to implement the standard 2.0. So that gives you and CMS some information on
guidance of implementation.

And the benefits of moving to this standards, some of them that were cited
in this survey is obviously the data was compatible with the telecommunications
standard pharmacy claims files, et cetera when groups move from one pharmacy
benefit manager to another.

There’s expanded inconsistent data content. It standardizes the format
across all their clients and ease of a client implementation and administrative
and maintenance simplification. Those are some of the things that were cited in
the findings from the survey. And that is all to report. We’ll take questions
now.

MR. REYNOLDS: Okay. First, what I’d like to do is maybe Denise or somebody.
It’s been a while since we’ve had, I think, a new standard come in. What’s our
process? Update us on the process if somebody could do that. What’s our process
for receiving these and moving forward.

MS. GILBERTSON: The same process. Send the area, final rule, final adoption.

MS. BUENNING: Well, I think it’s pretty much the same process. The
recommendations are brought forward. We input them. The committee than makes
their recommendation, and then we take into consideration as we move forward
we’ll make in process.

MR. REYNOLDS: Right, but new standard, do we need to hold a hearing?

MS. BUENNING: If it’s a new standard.

MR. REYNOLDS: Well, that’s what – we’ve got one coming forward as a new
standard. So –

MS. GREENBERG: Now I know we have –- we always here get an annual
report, and that was what, the May one?

MS. BUENNING: You’re referring to the DSMO Annual Report?

MS. GREENBERG: Right.

MS. BUENNING: Yes, that was in May for the previous year.

MS. GREENBERG: Right. So is this the next annual? No.

MR. REYNOLDS: No, this is a number of changes.

MS. WEIKER: Right. Marjorie, this is Margaret. There will be another annual
report that will be forthcoming.

MS. GREENBERG: Okay. I’m just wondering if there are other things – if
this is already the end of January, and if there’s going to be some other
things coming in March or something like that, if we were going to group them
as opposed to – that’s why I was asking.

MR. REYNOLDS: What’s your feeling?

MS. BUENNING: The DSMO have not received any change requests past these. So
it’s been very quiet after this bunch came in.

MR. REYNOLDS: So that’s all three of them? I mean, that’s –

MS. WEIKER: Yes.

MR. REYNOLDS: Yes, okay.

MS. GREENBERG: So you’re not working on any additional ones at this point?

MS. BUENNING: No. None have come forward that I’m aware of. And also
recognize in the recommendation from the Committee in September, you had, I
believe, it was two new. I know Medicaid Subrogation was brought forward as
new, and was there a new X12 brought forward.

MS. WEIKER: No. What happened then was you have the NCPDP Medicaid
Subrogation is new. But in the letter, the 820 and the 270/271 were included.
However, what actually happened was there was a little bit of a timing issue,
and those were not actually finalized through the DSMO process at that time.

MR. BECHTEL: Right, but those are also not new standards. Those are
replacement standards.

MS. WEIKER: Correct.

MR. BECHTEL: Where the subrogation standard, I think, is brand new.

MS. GILBERTSON: So in this whole HIPAA II package, I guess, we’ve got a
bunch of new versions to existing and then two new standards coming forward,
Medicaid Subrogation which is already recommended and then the
post-adjudication now.

MR. BECHTEL: Right, and I would also just want to answer that there may be
other new standards that X12 would be bringing forward sometime in the future.
But at this time, I can’t tell you when and I think they would go through the
process on their own. In other words, we wouldn’t expect you to bundle them in
what we’ve put forward so far.

MR. REYNOLDS: So the categories that I saw as I was listening, there was
some typos. So that’s –

MR. BECHTEL: Basically, typos. The dental claim transaction is a little more
significant than just a typo.

MR. REYNOLDS: Right.

MR. BECHTEL: We did eliminate the HCPCS code from it, and we did reference
only the ADA code set and we’re referencing a new code set for the tooth
designation which had not been part of the standard before.

MR. REYNOLDS: Yes, I’m trying to group them. Obviously, the things that
would be most important to us are where we’re changing functionality.

MR. BECHTEL: Right.

MR. REYNOLDS: Which forces some kind of discussion on what that is, what’s
it mean, what’s it do, what’s it act like. The second, the other question I
have is some of them change 4010. Some of them change 5010.

MR. BECHTEL: Yes, the errata is not –

MR. REYNOLDS: But I’m saying since there is no final rule on 5010 –

MR. BECHTEL: No, what we’re doing is we put forward 5010 claims for
institutional and dental. But we since putting them forward had modification to
what we had done because we found either corrections were required or industry
had asked us to make modification in the case of the dental side.

So we’re bringing forward corrections to the version 5010 that we brought to
you back in May.

MR. REYNOLDS: But since CMS is at some level working on a final rule, where
does that fit?

MS. GILBERTSON: They’d be working on an NPRM.

MR. REYNOLDS: I’m sorry. Excuse me. The proposal. I’m moving right along. I
saw the implementation.

MS. GREENBERG: This would be one way to speed up the process.

MR. REYNOLDS: Marjorie, I’m streamlining it. Let’s go take that along, and
let’s go. Let’s move this baby. Okay, so that –

MS. GILBERTSON: But the recommendation was for the 5010 of different X12
transactions. They just want to make sure we’re referencing the correct errata
change to go forward.

MR. REYNOLDS: Right. I guess the thing I’m struggling with and everybody,
any time we’re changing functionality, any time you’re adding a new standard,
we got to have the public process, the public discussion. We can’t just say we
had this given to us and we’re going to do something with it.

So I’m trying to get a sense here of packaging this in a way so that if we
put together a hearing and we put together the discussion to get input from
others, that we understand exactly what we need to get done, how we get it
done, you know, that kind, who would be the right testifiers.

MS. GILBERTSON: Well, back in July, the Subcommittee heard testimony on the
5010 transactions and the NCPDP transactions. So that was the public testimony
that then spurred the recommendation letter. Now we’ve got the errata coming
forward which is really just to make sure it’s the most recent information, and
then you’ve got the post-adjudication standard coming. So whether or not
there’s a public hearing on post-adjudication or –

MR. REYNOLDS: I don’t think there’s any question there has to be one on
post-adjudication. Any new standard coming forward, I think, we would be
significantly remiss in our process not to have some kind of hearing on that.
Simon, you look like you have a question.

DR. COHN: Well, yes, I was just trying to figure out the – and I
apologize. I don’t have the letter that we wrote previously on this in front of
me. I was trying to remember whether the 820 premium FEMA transaction was
included.

MS. GILBERTSON: It was the 834 health plan enrollment, 820 premium payment,
270/271 which was the timeline, 278, the 837, the 276/277 and the 835.

DR. COHN: Okay. So literally we are to have a rider then in the new NCPDP
transaction.

MR. REYNOLDS: What I’d like to recommend today is why don’t we, if anybody
has any questions on anything we’ve presented, then what I’d like to do is make
sure that we get another look at the letter. And then tomorrow we’ve got some
time to figure out how we move forward.

I’d like to make sure we answer any questions, that we get any questions
answered today and then you said you’re going to be here tomorrow, too, right?
Okay, good. Opportunity. We wouldn’t want a day to go by that we didn’t get to
see you.

Okay, were there any questions? So on these – I’ve got a couple on the
new post-adjudication, you know, I’ve implemented HIPAA, and
post-adjudication’s just not hit me as exactly – and you said that’s part
of, Lynne, mainly NCPDP?

MS. GILBERTSON: It’s an NCPDP standard, yes.

MR. REYNOLDS: Okay. And used again for what?

MS. GILBERTSON: For reporting information about claims after they have
occurred. We have ghosts in the room.

MR. REYNOLDS: From who to who?

MS. GILBERTSON: Between PBMs, pharmacy benefit managers and their clients
which would be the health plans, the groups, the employer groups, things like
that.

MS. WEIKER: It could also be carried for retrospective DURs where the
healthplan or PBM would have the claim data for a quarter, and then a lot of
times they send that to an outside entity like a university that actually runs
those type of reports and reporting back to the state board, et cetera. So it
would be used to exchange data with those types of entities as well.

But primarily, it would be used as Lynne said, payer to payer, payer to PBM,
PBM to their clients.

MR. REYNOLDS: And was this PBM driven? Their client driven, or who drove
this?

MS. GILBERTSON: More of the PBMs who are having to support many different
versions.

MS. WEIKER: Yes and other payers besides peer pay, PBMs. I’ll just take a
little step back and become from the an EDF point of view, we use this to date
for some of our state Medicaid’s as well where there are managed care
organizations that provide a policy benefit as part of that Medicaid recipient
being in that managed care organization. We exchange data back and forth with
those types of entities. So it’s not just a peer pay PBM. It’s also used by
other entities as well. And in fact, we’re one of the entities that implemented
Version 1 of the post-adjudicated family.

MR. REYNOLDS: Jeff.

MR. BLAIR: If this is communications between PBMs and the payer, it’s not
clear to me that this falls within the traditional demands that we have been
making judgments on between the three public domains. Admittedly, this is a
public domain which is a payer, but it’s a payer to a payer. So it’s not
between a provider and a payer or a clearinghouse and a payer.

And I’m almost wondering whether there’s a requirement that HHS or actually
anoint this as a HIPAA transaction. Maybe you could just use it without having
– is there a reason why you would want HHS to do a ruling on this? Is
there some value in that for you?

MS. GILBERTSON: Well, one of the covered entities is our health plans. So if
they are the client of the PBMs or the payers, they would be a covered entity
under HIPAA.

MR. BLAIR: Yes, but I guess my question is if this is a useful transaction
and you can use it now, why go through this whole process.

MS. GILBERTSON: Now obviously an industry panel would be more adept at
answering the questions. But what I have heard is that it is very difficult to
move the health plan, the covered entity, the client groups from propriety or
custom format to an industry standard using the industry standard data that
comes in the claim.

Margaret, do you have anything to add?

MS. WEIKER: Yes, that’s what the saying – if you look at – the
majority of the survey are using some type of proprietary custom format. And to
move people off of that on to a standard while some entities couldn’t do some
mandating depending upon whom they are, to move off is very difficult. And with
the movement to Version D.0 and the additional value deal, et cetera, to go in
and retrofit or to have to say, okay, now I’m going to update proprietary
standards to retrofit D.0 when there’s a standard out there, yes, you may get
some movement. But typically, believe it or not, what the members of NCPDP that
would use this standard as sub is we’d like to move it forward through the
HIPAA process. That way, it mandates it. We’re all on the same versioning. It
puts D.0 with those associated fields. Ultimately, it reduces cost,
administrative simplification, more accurate reporting because now I’m getting
the same type of information to everyone versus all the constant type of
reporting. And ultimately, when you start passing dollars down the line with
how much it costs to do this versus another and who ultimately pays for it,
ultimately it does save the patient money because costs gets – they sort
of flow downhill, sort of speak.

MR. REYNOLDS: Simon.

MS. WEIKER: Well, you know, if you look at it and you say, well, geez, it’s
kind of payer to payer, plan to plan or PBM to payer or whatever, if you think
about some of the coordination, a bit of this point of view you could also be
payer to payer, a vendor of HIPAA as well. So there are some question, you
know, was it not necessary to have it to be done from a provider.

MR. REYNOLDS: Simon and then Steve.

DR. COHN: Yes, well, this actually is an interesting one. At least to my
understanding, PBMs are actually business associates of payers is my
understanding of the technical relationship which is different than COB where
they’re actually free standing independent payers without necessarily
contractual relationships of business associate relationships anyway.

MS. WEIKER: Sadly, there are some of those. A lot of the PBMs do have those
business associate agreements with COB.

DR. COHN: Okay. You know, I do think we sort of need in some ways to seek
guidance from CMS in terms of their perspective on scope of actually what’s the
intent of the legislation and where exactly this fits. I am certainly
sympathetic to NCPDP in the sense that this is in the spirit of an
administration simplification which is obviously what we’re all trying to move
forward on. But I do think it is an interesting question about whether –
regardless of whether we got into this or not, whether CMS would look at this
one and say, gee, this is out of scope because of our legislative mandate.

MR. REYNOLDS: So, again, like I said, let’s – I don’t see any more
hands to ask questions. So we’ll have the hours between now and tomorrow to
figure out exactly what we’re going to do with all of this.

We really appreciate – obviously, you guys have done a lot of work, and
it’s a lot of work. And we will come back tomorrow with a point. So any other
questions? Okay, thank you. Thanks to all of you and Margaret and Don, thank
you.

MS. WEIKER: Thank you, Harry. Thank you, Lynne.

MR. REYNOLDS: Okay, the next part of our agenda before we close out is
Marianne would you mind getting that slide back for us from this morning.

DR. COHN: And actually, Harry, just to sort of complete the thought, we were
focusing on that. But certainly it appears to be based on the errata and
current pieces that we shouldn’t forget. It looked to me like the dental
colleagues are probably a group that we need to hear from at least with respect
to the errata.

Agenda Item: Subcommittee Discussion

MR. REYNOLDS: Okay. Where we were this morning, and I know some of you had
to step in and out at different times. So let me kind of catch everybody up.
We’ve put the chart up this morning which we had sent out to everyone. It came
up with a number of different discussions.

One of the things we added at least consideration under the subjects to
develop was the new Secretary issue because obviously we’ll be getting a new
Secretary. Another one is populations and how can standards help populations.
In other words, are there any kind of standards discussions that we need to
have to make sure that we capture the right data, do the right thing from any
of the things that exist.

We also talked about things like business models and information models for
some of the standards. So, for example, we’ve had a lot of individual standards
that we worked with. But how does it all group up. As we’ve talked to Jeff
about – as Jeff has talked to all of us about a health information
exchange, how do you group these standards up to make something real rather
than just individual pieces.

We talked about more and more subjects like pay for performance and medical
home are coming up which start, you know, are really starting to go
horizontally across our committees, and this is part of our discussion. And
Simon, as we get into the Executive Subcommittee, is as you get quality and you
get the things that came out secondary uses, you know, the things that came out
of there we need to do and then you start taking things like Medical Home and
pay for performance, because as we were saying, as soon as Medicare or CMS or
anybody does pay for performance now, performance is a subject. And now how
does all the data flow about performance, and does it come in through
standards, does it go out through standards, and what does it do. So those are
again subjects that start to really affect us.

Under regular updates, we added NIH in there under current hot issues. One
of the – I put it under current hot issues for the Executive Subcommittee
and us to recommend is where should security reside because I think we were all
discussing – well, I brought up that as more and more you look at all this
data and everything that’s going on, security appears to be, at least where I
live daily, is the number one thing in the eye of the auditors, the number one
thing in the eyes of a lot of others.

And so security’s going to need to be a subject unto itself whether it’s
part of this Committee or privacy or whatever. But it’s going to be a subject
that will have to traverse every subject, everything that we talk about going
forward because you can’t really have privacy without security and so on. So
that’s going to be an issue for us.

One other thing we added where we all kind of focused on, and I know Karen
told me it was her probably one of her main hot buttons was this idea of
facilitating standards adoption/implemention. And we had for smaller providers
HIEs, NHIN and new players in the field as we deal with it.

So this whole idea of – we’re continuing to roll these things out. How
do we get them adopted, how do we get them implemented in a much better
timeframe than we are right now. You heard the discussion on NPI and then a
good example is the recommendation coming out on 5010 that says it would take
between now and 2014 just to put 5010 in. That is the WEDI recommendation, the
timeline that’s out on the street right now. That is not – whereas NCVHS,
we put out a target kind of roll out of two years, one year roll out, two
years, one year roll out, and you staggered it. That’s talking about up to six
years for one, you know, after industry which – I mean, those two are
direct dichotomy from each other. You know, realistic glide path of any kind of
something moving.

So Steve.

DR. STEINDEL: Harry, my general question on the statement and I don’t
disagree with either of the two comments I just heard about, security and
implementing standards. But are you mostly confining and focusing your world on
HIPAA?

MR. REYNOLDS: I’m not focusing it anywhere. I think that standards and
standards and not just HIPAA.

DR. STEINDEL: And I want us to think about it that way because, you know, we
do have a legislative responsibility to look at the implementation of the HIPAA
process, et cetera. But I also think that we have a responsibility to look at
what’s going on in the implementation of standards outside of the HIPAA
process.

MR. REYNOLDS: And I think one of the things we have on here under process
issues was remember we’ve had this subject for quite a while on harmonizing
standards between IHE, HITSP, use case specifications, the whole thing. So
that’s definitely one.

And again, for those of you who weren’t here this morning, one of our spots
was how do we really identify where we make a difference, not that we just get
caught in the undertow of the next piece. And then I think we had a lot of
discussion today that as we have here under our process issues promote smoother
flow between all of our committees, you know, because who has what. So when you
say standards and you talk about some of these things, Steve, that you’re
talking about, that also affects some of the other things that are going on in
the other committees.

So that’s kind of a quick summary of where we were this morning. Jeff, we
talked a little bit ago, and I think you had some thoughts on maybe how to take
a next step forward to discuss this. So why don’t you go ahead and share that.

MR. BLAIR: Thank you. The discussion we had this morning was really very
good for us to take a look at whether we have the right topics, and whether we
have anything missing. And so now I think the next step would be for us to sort
of pull this all together and then sort of look at the Subcommittee on
Standards and Security role in this context that over the last several years we
have had a couple of new players in the healthcare informatics standards
community added.

AHIC is developing use cases. HITSP had ramped up to playing a much, much
bigger role in terms of identifying the standards that would support those use
cases and in so being pulling together standard specification documents that
cut across many of the standards for implementation and harmonization.

So given the fact that there’s AHIC, there’s HITSP, and there’s CCHIT, now
let’s look at this particular sheet and let’s see if we can clarify how the
role of the NCVHS/HHS could be most effective, most constructive in the new
context of these other players. What is our role.

MR. REYNOLDS: Okay, Simon and then Steve.

DR. COHN: Well, thank you. You know, I think I want to make a couple of just
sort of high level comments here, and see there it goes, and I think the work
done so far has been very good and very thoughtful.

Now first of all, I do want to also frame an additional responsibility of
the Subcommittee, and that’s that it isn’t – the role of the Subcommittee
is not just to figure out what it itself should be doing around standards and,
I guess, security, but also to advise the overall committee and overall what as
a committee we should be doing around standards and security. And so I think it
is – it may not be that anything gets done here. But I see this as an
important think tank to hopefully help inform what we’re doing as a full
committee in this area.

Now from my view, I do think that part of the question I always ask in all
this stuff because there are, one of the wonderful things about standards is
that there’s so many of them. And as, I think, Jeff was beginning to comment,
there are so many levels, and we can get into the weeds and we can get into the
blades of grass and we can pull out the microscope and look at the blade of
grass. We can even pull out our electronic retro microscope and begin to go
further, and we can actually also do DNA analysis on the grass if we choose to.

I guess, and we have actually done that in the ten or 12 years that I’ve
been around here. I guess I wonder, and it’s one thing that we need to think
about is what level we want to play. I certainly think that from my view, I
mean, we can choose to get down into that level. But I think if there’s
actually at this point maybe as an important responsibility that we had either
subcommittee or full committee level which is this sort – and I hate to
use this term, develop grand strategy for standard, but really begin to look
and try to figure out how all this stuff fits together, be it HIPAA, be it
non-HIPAA and how is this all fitting together, and is it in the interest of
the country and are we moving forward as opposed to proprietary HIPAA versus
non-HIPAA standards versus whatever.

And I think it may be beginning to be the time for that sort of a thoughtful
analysis. Similarly, I’m actually and I want to just bring this up because it’s
probably there somewhere, but I don’t – I mean, my glasses are good, but
they’re not that good. I’m sure they do. I’m sure they help me. But you were
talking about a grand strategy for standards. But I would also suggest that
there’s probably also this sort of developing grand strategy for terminology,
and I think that’s there somewhere, but I’m not sure I see it. It’s implied.
It’s implied. Well, that’s where I was going to go is that I think that there’s
actually and once again this is just sort of helping, you know, one of our jobs
is obviously to coach forward things that are going in the right direction and
all of this.

Certainly, I don’t know everything that there is to know about how those
ICB-10 to SNOMED connection between terminology and classifications is going or
occurring. But I do think that that’s, I mean, to my view that’s potentially if
it works out as planned an important part of the grand strategy.

And then the question is, well, what more do we need. What about all of the
other things that are going on. And so we need to at least provide some space
in what we’re thinking about over the next while as to how we need to either
promote that or identify what else needs to be done, identify barriers to if
indeed we think that’s the right direction.

So anyway I was just – I’m sorry, I just sort of taking my BB gun and
shooting in all directions at once here. But I just wanted to get a couple
things on the table.

MR. BLAIR: Can I just make sure that I’m with you on this because I think
you’re responding to the question that I was asking, what is our role, and you
zeroed in on the grand strategy. And then I think what you did is you took it
to the next level to say that what you meant by the grand strategy is that this
grand strategy include standards which I think you may have meant transaction
standards as well as terminology standards. And then you wound up thinking of
it in terms of the evolution between standards as all part of the grand
strategy.

So am I with you that that, you feel, is where our role could be most
helpful?

DR. COHN: Jeff, in your reframing, I’m not sure I completely understood what
you said. So I’m not sure whether I’m in agreement or not. I think what you’re
doing is, I think, taking your framing. But I’m not sure. I mean, this may be a
conversation we need to have to figure out whether we’re both saying the same
thing or not.

I’ve asked others if it sounded the same or not.

MR. REYNOLDS: Steve’s got a comment, and then –

DR. STEINDEL: Yes, I’m going to pick up first in part of my original
comment. But before I do, Simon, I’m going to steal your wonderful analogy
about going down into the weeds, into the dirt and into the DNA in the future.
I thought it was wonderful. Thank you.

But you know, the original reason I raised my hand and since I do have the
mike, I’m going to comment somewhat on Jeff and your comments as well, was when
Jeff was talking about what groups we need to look at going into the future and
he mentioned CCHIT, the one group that he didn’t mention that is becoming more
and more prominent is IHE because if you actually take a look at what HITSP is
doing in general is they are finding the IHE standard to anoint. Yes.

DR. WARREN: I need to comment. IHE does not develop standards because I was
part of the last IHE process on developing a profile for assessments.

DR. STEINDEL: Okay.

DR. WARREN: And what they do is they apply the standards that are out there
and see if they will work within the current vendor environment.

DR. STEINDEL: Environment, and it’s those IHE profiles that are being
adopted HITSP. That’s true.

DR. WARREN: How can –

MR. REYNOLDS: Well, some of those are work arounds.

DR. STEINDEL: Yes, and they –

DR. WARREN: Yes, and I’m not sure IHE knows that.

DR. STEINDEL: No, IHE knows it very well, and they are promoting it to go
that way. The only difference between the two is that HITSP is basically
pulling wherever they can IHE portfolios of standards to see if they fit the
use cases and then tweaking it to try to make the use cases, to support the use
cases. It’s a very complex interplay that’s going on right now that we need to
be aware of and we need to look at and understand.

DR. WARREN: Yes, and about a year and a half ago, we had IHE come and give
testimony when it was becoming obvious that they were doing more of these
profiles and it was going to connect, et cetera. So maybe it’s time for us to
really come back and see what they’re doing again because I know that they’re
evolving rapidly.

DR. STEINDEL: Come back and also to see how it’s fitting in with this
process and the influence that they are exerting on the HITSP process.

MR. BLAIR: Steve, would you fold that into what Simon is saying in terms of
our role and that we look at that, and we wind up seeing how does that fit into
the grand strategy at hand.

DR. STEINDEL: And I was going to do that. But also I’d like to comment that
actually in this harmonization role that we’re looking at across the standards
process, CCHIT is not a major player in the sense that what they do is certify
systems to use HITSP anointed processes. So they are very important in having
those standards rolled out. If you want to roll them, EHR vendors want to be
certified. So they’re an extremely important cob in the mechanism.

But actually in the development of the standards themselves, they are not
that much of an important cog. Now in the CCHIT process where they’re trying to
figure out if they can certify systems, they may come back to HITSP and say we
are not ready to certify at that stage because it’s not complete. But they do
not go and develop it. So I want to be careful of their role.

Now going forward –

MR. REYNOLDS: Marjorie’s next –

MR. BLAIR: A clarification on that observation that you said is that what
CCHIT is doing is coming up with criteria for their certification. When they
come up with the criteria, they’re picking the standards that are necessary for
adoption, and they’re doing it from the standpoint of certification.

So in a sense, they are a very influential player in terms of what standards
get adopted. So I’m not saying that what you said was wrong. But I am saying
that I think that when we look at a grand strategy for standards that they
become a player.

DR. STEINDEL: Yes, but the charge to them is to pick whatever possible HITSP
standards.

MR. REYNOLDS: Marjorie.

MS. GREENBERG: Well, it’s sort of like this morning as we were saying
there’s the network of networks, it’s the network of models. There’s also
– this may be less a grand strategy than a strategy of strategies because
I don’t think it’s not necessarily one grand strategy for either HIT or for the
NCVHS. But it may be a series of interlocking strategies, and I think, well,
Simon can certainly speak for himself. But I think where Simon maybe was going
or where I would go from what he said is that clearly on a regular basis this
Committee does not have the capacity as currently structured to go into the
weeds too many times and too often.

It could if it used the mechanism that is potentially available to set up
other technical groups and et cetera which in its history it’s done and is
actually allowable. But that would require a lot of resources, and probably I
mean it isn’t necessary because of all these other groups that are out there.

But there is an occasional time. So I don’t think we can always say we
should always be at 20, you should always be at 20,000 feet or 10,000 or down
in the grass or never in the grass. It kind of depends on where the gaps are.

And if there is nobody else working in an area or addressing an area then
the Committee, I think, over its history and even in its more recent history
might get into trying to identify very specific types – not developing
standards, but at least identify very specific recommendations.

In another area where there’s a lot of activity, it’s more trying to
harmonize or get other people at the table. I think Justine recently in some
calls of the – conference calls of the Quality group have gone back and
looked at kind of some of the history of the Committee and identified –
actually I think I have it here in my blackberry, but some roles that the
committee plays. So shining a light on things, bringing different view points
together, trying to get the different partners or players or stakeholders to
work something out on their own, maybe facilitating it.

So there are a lot of different roles, and there are occasional times where
really getting down and dirty really serves a purpose because nobody else is
doing or because the Department’s actually asked the committee to do it. So I
would hesitate to have some sort of grand strategies as we always fit in here
because sometimes it’s one way and sometime another.

But I think the problem is when there’s no strategy, and often there isn’t
or there’s conflicting strategies or there’s no coordination. And I think the
Committee definitely can play a role there by identifying that and either
helping the stakeholders to coordinate better and develop a strategy or shining
a light on this.

So those are just some thoughts I have about not being too rigid as to where
the Committee fits, but it can play a role in different areas and just making
sure that you have enough information to know that you’re not needed here, but
you might maybe could add value there.

MR. REYNOLDS: Playing off of – I think a lot of the words that we have
up there and a lot of the ways we talk about it almost limits us as to how we
thought about it. But I think your most recent comments, so if you really took
it and put it into the three categories, what other strategic and looking
forward things do we want to think about.

So I listed here the grand strategy, and this is not complete, just a
thought process.

MS. GREENBERG: Sure. I wasn’t being critical.

MR. REYNOLDS: No, no, no, I’m not saying you are. No, I’m agreeing. I
already had this written down before you even started talking. So grand
strategy and standards.

MS. GREENBERG: I’ll go home.

MR. REYNOLDS: No, no, what I meant was you didn’t, you added to what I was
thinking, okay. Grand strategy for standards, grand strategy for coming into
harmonization of standards, those are the kinds of subjects that would be more
in a – then the next level could be things like implementations,
evaluations and learning. That’s kind of a shining the light, you know. We know
we’ve implemented these things in the past. It’s taken too long. What’s real
adoption. The new standards 5010, ICD-10, you know, things we’ve got to really
grab them, move them forward and keep it going.

And then you get down to what I call tactical requirements. No, because we
do have some tactical requirements. I would say that part of what Lynne just
had us go through with what we did was a tactical requirement. What the DSMO
said, we need to move it forward. We need to go through a process.

So some of that fit down at the bottom in the tactical. Others fit up here
in a new standard which is kind of in the middle range, and we’ve got to build
it. We’ve got to get it to change, and we’ve got to do it. So just some thought
so that we make sure, again, I use the word somewhere else the other day, under
tow. No, I mean, under tow’s a great word if you think about it.

MS. GREENBERG: When you’re from North Carolina, yes.

MR. REYNOLDS: No, we have so many – there’s so many standards, there’s
so many things we can get through that you can get mesmerized, and all of a
sudden you’re so far away you didn’t do strategy, and you don’t have time to
swim back there. No, I mean, it really is. It’s an interesting concept. But I
think if we can do that and then as we go forward back to Simon, I think your
point’s well made is we go to the Full Committee and say, you know, as we look
at this from a standards standpoint, we think we play at three levels. We have
to play it at the lower one and the second one. We haven’t necessarily taken
that lead that we could take in the top which is the strategy.

With so many standards and so many things going on, who’s stopping and
talking about putting it together because, for example, philosophically now,
philosophically use cases become tactical, but they help you think about a
strategy, okay. We need to help think about the strategy so that then when
somebody does a use case, it may be in a different context. I mean, that’s just
a thought because right now there’s a lot of point solutions. To what end?
Where’s the light shining, as we’re using Marjorie’s term. Where’s the light
shining that we want to go to and tactically we can get there in lots of
different ways with lots of different styles because just taking the HIEs
again, as somebody says, if you’ve seen one HIE, you’ve seen one HIE. But if
there’s a strategy for what it’s supposed to get to, it doesn’t matter what
they each individually look like as long as we’re trying to come up with at
least a discussion.

So that we would make sure that as we put hearings together, we try as much
as possible to have pieces of these in each one because, again, the under tow
– because, again, as soon as 5010 hits and some of these other things hit,
the under tow to do our tactical stuff and to do that starts to suck up
everything we have, and then we keep listing it and we keep trying to move
towards there. But we didn’t necessarily set a plan to get there. So if we
could maybe do that. Marjorie, yes.

MS. GREENBERG: And I’m assuming we’re going to hear at the February Full
Committee meeting, as Simon was alluding to, we’re going to have two
presentations that fit together regarding terminologies and classifications.
And one is the international plans for ICD and its relationship to SNOMED, et
cetera.

And then the other is the white paper that’s been done by AHMIA and AMIA on
this need for a roadmap and for more of a grand strategy in that area. So then
this could then see what people think after they hear it. But it’s an example
of could be the Full Committee would want to keep it on its radar screen or in
some way could go to a subcommittee. Certainly, Standards is going to be a
player there.

And so there is an example of other people have developed things, but –
and part of the Subcommittee’s role is say, well, how does this fit in with
everything else that we have been doing here. So you know, another case may see
a need for such a strategy or roadmap and nobody’s developed it.

MR. REYNOLDS: Right.

MS. GREENBERG: So that’s an issue.

MR. BLAIR: Clarification of the roadmap. I’ve heard roadmap used two
different ways. Now when I relate it to the grand strategy, I tend to think of
a roadmap that would be similar to a roadmap for the evolution between ICD-9,
ICD-10, ICD-11 and LOINC and RX Norm. I think of that type of a roadmap related
to grand strategy for standards.

Other people are winding up using the term roadmap just simply for ICD-10,
for example. So which one were you referring to?

MS. GREENBERG: I was thinking more broadly. Certainly, I know of the –

MR. BLAIR: Good. That makes sense to me.

MS. GREENBERG: We will be –

DR. STEINDEL: Full Committee?

MS. GREENBERG: I hope so.

DR. STEINDEL: I mean that – no, that’s what they’re aimed for.

MR. REYNOLDS: Marjorie, don’t answer that.

DR. STEINDEL: No, that’s what it’s aimed as informative presentations
because the reason why I was asking was obviously the NLM and IHTSD was missing
from the set of presenters, and I know they have thoughts in this area as well.
And I would have no objection to these two groups presenting as long as it’s
informative and it’s not being presented as any type of decision making
information.

MS. GREENBERG: No, no, yes. Well, I mean if the groups ask the Committee to
do something, that’s their prerogative. But the idea is information and then we
only have so much time in one meeting, and there’s some other things going on
also. So it would fit in with that.

DR. COHN: And this informational session may just be the beginning of an
effort which is something that we’ll have to sort of figure out. I guess I
should comment publicly that I’m the alternative U.S. Delegate to the IHTSDO,
though I’ve never yet attended one of their meetings, but I keep meaning to.

DR. STEINDEL: What is IHT?

MS. GREENBERG: That’s the International Health Terminology, the SNOMED SDL.

DR. STEINDEL: Oh, the SNOMED, okay.

MS. GREENBERG: But its name is officially the International Health
Terminology DSL.

DR. STEINDEL: That’s right. Thank you.

MR. REYNOLDS: Okay, one other category I’d like us to spend a minute on that
especially I think we can help the Full Committee and the Executive
Subcommittee are what other subjects that standards participates in, has to
participate in but not necessarily lead. So I’ll give you a great example
– NHIN.

Anything that comes up on NHIN and standards are involved, and we need to
have some standards representation on whatever the Committee, secondary uses of
data, maybe, maybe not. I think it would be good if we could just put together
some health information exchanges obviously.

So if we could come up with a list because, again, as we meet next week with
the Executive Subcommittee, this idea where we’re being handed more and more
subjects. So secondary uses was a subject. The NHIN functional requirements was
a bit of a subject. And so but it’s broader than just standards, and it’s
broader than anything we’re doing.

So what are the other types of things that are out there now that might be
helpful for us to make sure that the Full Committee and the Executive
Subcommittee specifically next week are aware that are things we think are
cross-cutting, not just one current standing committee. Steve and then Michael.

DR. STEINDEL: Harry, one of the biggest things that we have not looked at
that’s rising its head as an extreme importance and is a big standards issue is
decision support/knowledge representation systems, and especially making them
transportable and computable.

MR. REYNOLDS: Decision support slash what?

DR. STEINDEL: Knowledge representation.

[General discussion.]

MR. BLAIR: Can I again ask for clarification –

MR. REYNOLDS: You can ask for clarification and then Michael’s turn.

MR. BLAIR: Decision support is something everybody, I think, wants to move
forward to. When we do, we tend to wind up saying, well, we go to the NCP
medication history or we – in other words, we employ existing transaction
and terminology standards to enable it. So what are you saying that’s different
than the standards that are being developed and the terminologies that are
being developed.

DR. STEINDEL: The terminologies and the messaging standards that exist in
this area have nothing to do with decision support algorithms.

MR. BLAIR: You’re talking about the algorithms?

DR. STEINDEL: Right, the decision support systems.

MR. BLAIR: And now are you saying that we should standardize the algorithms?

DR. STEINDEL: To make a lot of what we’re talking about in this system work,
we need transportable and computable decision support systems that we can move
between healthcare networks.

DR. FITZMAURICE: Could I qualify what Steve is saying. Basically, I think we
need knowledge representations if we know something, how do we represent that
knowledge so that it can be used in a decision making format.

DR. WARREN: But what we’re talking about here, too, are just the formats.
Like there’s the medical logic models that was out there for a while, Ardent
Syntax. We’re now coming out with GLIF. There are a couple of others that I’ve
heard about that I don’t remember them well enough to think –

DR. STEINDEL: And actually this has become such an important issue within a
lot of the HITSP use cases that we will be – HITSP will be holding in
March as part of the population health TC a day long session looking at
recommendations in this area.

MR. REYNOLDS: So do you say we lead that subject or do we participate in it.
What should our role be in that?

DR. WARREN: Well, I just want to clarify one other thing. When you’re
talking about knowledge representation, are you talking about some of the
ontology work and also conceptual graphs and some of that, or is it trying to
clarify what we mean by knowledge representation.

DR. STEINDEL: Actually, from my point of view, Judy, I am more in the second
realm because I do not know what people mean when they say knowledge
representation, and I would prefer a clarification, and I would like us to
drive towards the computable part in decision support area.

DR. WARREN: Okay.

DR. FITZMAURICE: I’d like to come in on that, too, and I agree with Steve.
I’m in the second category as well because I think the work that –
knowledge representation is like the information model. I think it’s useful. I
think we need one. I think it’s a black hole if you don’t have the problem
you’re going to face staring you in the face.

But I think that having a format to move knowledge from one place to
another. How do you represent the knowledge. What do you know, how do you
represent it and move it into a decision making format like in Ardent Syntax,
if this, then that.

MR. REYNOLDS: You had a question?

MR. BLAIR: This is an area that I’ve been interested in it for a long time.
But now that you bring it up, I’m wondering what should be the role of SSS in
enabling – are we solving a problem that’s out there that other people
can’t solve? What should be our role to add value?

DR. FITMAURICE: Go ahead, Steve. I’ll follow you.

DR. STEINDEL: Yes, and I hope we’re going to say somewhat the same thing,
Mike. Nobody has really stepped up to the plate to be the body in which people
can present alternative ideas and have an expert group comment on those ideas.
And that is the role I think NCVHS has served very well in the past and can
serve specifically in this area going forward.

And if Harry, you know, you asked should we be leaders. If you consider that
to be a leader role, yes.

MR. REYNOLDS: No, no, no. I’m saying should this Subcommittee be a leader in
that subject, or should it be another committee or –

MS. GREENBERG: That’s probably for the Executive Subcommittee to assess.

DR. STEINDEL: Yes, but nobody within the community, and that includes not
just NCVHS but even outside has stepped up to take the focal point role on
this.

MR. REYNOLDS: Well, and that may be one of our things that moves up to
–

DR. STEINDEL: Is that what you were going to say, Michael?

DR. FITZMAURICE: Yes, but I would phase it in terms of sometimes you do
leadership by posing the problem you’re trying to solve, and then you call
people together in a hearing and ask them what would you use to represent this
medical knowledge.

Would you use Ardent Syntax. Could you use GLIF, GEM, et cetera? What are
the pros and cons so that by understanding the problem doesn’t mean that we
have to find a solution. Maybe the solution doesn’t exist. But we synthesize
what we know about it and what others know about it. We find out how does the
industry feel about the current stage of development and then decide to move on
to something else or to make a report or make a letter of recommendation saying
here’s what we find, here’s what we think you should do, Mr. Secretary. And
sometimes there’s nothing the Secretary should do.

DR. WARREN: And I would just add to that because there’s going to be some
important interaction between that effort with standards development and
terminology development that there may be some things that are coming up in
decision support that may change the way we want to go on with standards and
terminology development or influence the way we’re currently going on both
ways.

DR. FITZMAURICE: Harry, is it my turn now?

MR. REYNOLDS: Yes sir, it is.

DR. FITZMAURICE: I didn’t know if I was using up my turn or infringing on
Steve’s.

MR. REYNOLDS: No, you’re doing fine. No, that was another one.

DR. FITZMAURICE: All right. I like to infringe on Steve.

DR. STEINDEL: You’re infringing on mine, Mike.

MR. REYNOLDS: You’re starting new again.

DR. FITZMAURICE: You asked what are some of the things going on we should be
aware about. ONC has funded nine contracts to groups called the NHIN
Cooperative. They’re to take the HITSP use cases, apply architecture to it and
make it work in a laboratory-type setting using synthetic or made up data.

The federal government wants to be a tenth component of that and have a
federal consortium that becomes the tenth member of the cooperative. There are
four government agencies, DOD, VA, VADOD and Inhealth Service and Social
Security Administration who have their own use cases that they want to put into
these.

So there may be 13 gateways into the NHIN. There are nine cooperative
members plus a federal consortium, and that’s going on now. And so we should
probably keep up on what they’re finding out about the HITSP standards because
they intend to find gaps and will prevail on ONC to go back and do a fast track
with HITSP to say change your interoperability specifications to address this
gap, and that’s going to be happening during 2008 at the same time HITSP is
more than flooded with additional use cases.

MR. REYNOLDS: Other comments? Okay, questions. So as we go through if we
play around a little more getting ready for at least discussions with the
Executive Subcommittee next week and then obviously on to the Full Committee
when we talk about it, decide to give us time to looking at it from a strategic
and implementation and evaluation and we’ll work the words and then the
tactical requirements.

And then what other kinds of subjects that we see coming up that, without us
being proscriptive as to what the Committee’s and the requirements that the
Executive Committee and others come out with, we feel that there is some kind
of a standards presence that needs to be — as we set up the Ad Hoc, we’ve kind
of looked around at what the subject is and made sure that we did it.

So obviously, I mean, just the two, and I listed some others. But obviously
the NHIN and HIE, any time you’re talking about those things, standards is in
the game. I mean, there’s no way to – it’s got to be at the table. Some of
the stuff that, things like pay for performance, medical home, all this kind of
stuff where data is going to be required in some kind of a standard way, we
would want to be in the game.

So all we’re doing, and again, we’re putting this forward as indications.
This is not proscriptive that, oh, by the way if there’s an ad hoc committee
set up and you don’t pull somebody in that understands standards, have a nice
day. You know, we’re not saying that. Again, it’s to try to influence as we try
to figure out what we’re all going to be moving forward and where we can play.

So Simon, I mean, Steve and Mike and then Jim.

DR. COHN: Well, I’m just generally going to comment that I think you have a
list, and I think that’s a good list. But I would actually suggest that
virtually everything we do in the NCVHS needs standards input, and it’s
actually probably something we need to once again re-evaluate as we get
together with the Executive Committee and as the Committee proceeds in the
future.

And I actually don’t know, I’ve got to say that I have – we have a
couple of standards committee, but I don’t know, maybe we get hamstrung by our
own title because I think of this as somehow a committee that understands the
technical infrastructure, real world, how things work, and also understands
standards. But we do get somewhat limited by the way we describe ourselves.

MR. REYNOLDS: Right. But I was also trying to be also in deference to the
other committees to start the discussion, try to be politically correct. The
reason I’ve listed all these things is obviously I’ve got quality data down
here, I’ve got a number of populations. So the point is it’s to say, oh, by the
way, standards is going to permeate the flow of – we’re about the business
flow, we’re about interoperability, we’re about the standards, we’re about
those kind of things, and that plays into about every subject that’s coming up
now. That’s where I was going. But I didn’t want to just blatantly say, oh, by
the way, every subject you might ever think about if we’re not in, you’re not
getting it.

So Steve, and then Michael. So that’s where I was going.

DR. COHN: My final comment is, of course, that they would say quite rightly
that their perspectives also need to be reflected in –

MR. REYNOLDS: Well, and I think – no, that’s exactly the point.
Hopefully, that’s a discussion that will go on because hopefully if they think
of these same things as they think about it. So, for example, if we come up
with something like as the NHIN proceeds and populations is not really playing
in that game, then there’s going to be a whole lot of data available about a
whole lot of things that they may not have been able to take into
consideration. And so Steve and then Michael.

DR. STEINDEL: And I think I’m going to, you know, as I hear more and more of
the discussion, I think I’m actually going to just reinforce what’s being said
because what I really felt uncomfortable with was in your original statement,
Harry, and I forget exactly how you phrased it now. It was a long time ago like
a minute. You know, about it sounded like on something that was using standards
like the medical home or something like that because, as was pointed out as we
discussed later, virtually everything uses standards at one point.

And I got the sense that you were talking about interjecting ourselves into
that process, and I don’t think we are. And it was clarified now what we’re
really talking about is taking a lot at those processes and making comments and
understanding how it fits into what we refer to earlier as the grand strategy
of standards.

MR. REYNOLDS: Correct.

DR. STEINDEL: And that is what I see as our role, and I think as I see heads
shaking, I think we’re seeing that people are coalescing on that idea.

MR. REYNOLDS: More and more subjects are going to stress the grand strategy
of standards, not tactical implementation of a standard, and I think that’s
where we’re headed. Yes?

MR. BLAIR: I almost think of it slightly differently in the sense that I
think that with the discussion we’ve had today, many of the pieces that we’ve
referred to as our list start to fit together to comprise the grand strategy.
They are subsets of the grand strategy that will fit together.

I think we just need to take this page and sort of make a new page that
takes it the next step with the grand strategy and showing the relationship
between all those elements as they fall together into a cohesive grand
strategy.

MR. REYNOLDS: Okay. Michael.

MR. FITZMAURICE: A way of thinking, and that is we’re all keeping our eyes
on the newspaper and the elections and Clinton and Obama and McCain and others,
Romney.

DR. STEINDEL: What is their position on standards?

DR. FITZMAURICE: I’ll refrain from making any comment. They’ll come up with
health plans. There’s no meat on the bones at this point. In fact, there’s
almost no bones. But as they move into November, they’ll have more meat on the
bones. They’ll have to come up with something. It’s probably going to be one of
our goals is to look at what they’re proposing and see can the data system
support this because one of them is going to get elected, we hope, and they’ll
appoint somebody as Secretary of HHS, and they’ll start moving on the health
plan. It’s going to be one of the big things, the economy, the war, social
security, health can’t be ignored.

We’ll have to think of what advice we want to give them in terms of what
data system will be supported for their plan, things like pay for performance,
consumer empowerment may lead to comparing providers. It may lead to
establishing value which means where we do find the economic data to go along
with the clinical data and the quality measure data.

So these are the things we’d want to think about. And what I bemoan
particularly at this time is that we’re losing a lot of good people off of
NCVHS, and we may want to think of having a panel sometimes next fall or maybe
next December to ask them what they think and have them give us advice on how
to address the new administration and their plans.

DR. STEINDEL: That goes along with Marjorie’s statement. They’re never
really gone.

[Laughter]

MS. GREENBERG: You’re not supposed to let them know that. Well, actually,
can I say something here?

MR. REYNOLDS: Yes, you can.

MS. GREENBERG: This morning I was going to comment, make a similar comment
to Mike’s actually, oh, you never know, but I mean it does seem that some type
of health care reform is likely to be on the platform of whoever is elected.

And I was going to suggest that we should go back to the testimony we took
in the early ‘90s, 1993 or so when we did, we had some people come in from
the Administration and I think outside, but what did they wish they knew or
what information did they need to do this forward planning, and of course they
didn’t have a lot of the information they needed, and that doesn’t stop people
from coming up with plans.

But it would be interesting to go back and look at that and then also just
informally or even more less informally to find out whether any of those gaps
have been filled in the intervening really 15 years we’re talking about because
I think it’s going to become relevant again. So that was just a thought I had
this morning and it follows up with – I mean, we could find the minutes of
the – I don’t know about the transcript. But –

MR. REYNOLDS: So you have taken that assignment, is that correct?

MS. GREENBERG: I will give it to somebody, yes.

MR. REYNOLDS: That is not a committee assignment. Make sure that’s on there.

MS. GREENBERG: No, I will give that assignment, ask someone to do that

MR. REYNOLDS: Okay, any other comments from anyone?

MS. GREENBERG: Well, not the part about do we now have that, but at least to
find out what was it that people said.

MR. REYNOLDS: No, what were the key things discussed, yes.

DR. STEINDEL: If the people are still around, can we invite them back for
the 60th anniversary to do another hearing?

MS. GREENBERG: Sure.

MR. REYNOLDS: Okay, any other comments from anyone? Thank you for all the
input. We’ll work this and get something out there, and then we’ll get
something good as we go forward. I think we’re in a much better place as far as
our discussion next week with the Executive Subcommittee on what we’re thinking
and what we need to come forward with.

With that, if there’s no other business, we will adjourn two minutes early.
Thank you very much. Have a nice day.

[Whereupon at 4:27 p.m. the meeting adjourned.]