[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Meeting of Subcommittee on Standards and Security

July 28, 2004

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, DC  20201

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

TABLE OF CONTENTS

P R O C E E D I N G S  [9:18 a.m.]

Agenda Item:  Call to Order – Welcome and Introductions – Dr. Cohn

DR. COHN:  Well good morning, I want to call this meeting to
order.  This is the first of three days of hearings of the Subcommittee on
Standards and Security of the National Committee on Vital and Health
Statistics.  The committee as you all know is the main public advisory
committee to the U.S. Department of Health and Human Services on national
health information policy.  I am Simon Cohn, chairman of the subcommittee,
and the national director for health information policy for Kaiser Permanente.

I want to welcome fellow subcommittee members, HHS staff, and others here
in person.  I do want to inform everyone that normally we are on the
internet but I believe that currently our internet connection is down, I think
we ll try to notify everyone when we get on the internet, for the moment the
testimony and discussions will just be recorded and transcribed.

Obviously there s a lot to cover over the next three days and I think those
in the audience and those around the table need to realize that the agenda has
changed since yesterday and there s been some reshuffling of presenters and
times.  This morning we start out with a presentation on formulary issues
from Steve Avey from the Foundation for Managed Care Pharmacy and we ll start
onto that after introductions and introductory comments.  That will be
followed by a discussion hearing from those representing consumer
perspectives.  After the break we hear from the state boards of medicine,
then after lunch we move to the state boards of pharmacy, payer perspectives,
then talking about pharmacist perspectives and finishing with physician
perspectives.

As we always do we do have an open mic that will be at the end of the day,
right now it s scheduled for likely somewhere starting between 4:00 and 4:15
and that will be followed by subcommittee discussion.  We re hoping to
adjourn no later then 5:45 today but if we re lucky maybe a couple of minutes
earlier, we ll see what we can do on that one.

Just to remind everyone in the audience and around the table sessions for
Thursday and Friday start at 8:30, not 9:00, and the final adjournment on
Friday is scheduled for 12:30.

Now as always I want to emphasize that this is an open session, those who
are in attendance are welcome to make brief remarks if you have information
pertinent to the subject being discussed.  We are obviously as I mentioned
also have time at the end for an open microphone session for those who want to
make comments about the activities or discussion items of the day.

Obviously in all of this I want to thank Jeff Blair, our vice chair, for
his leadership in moving this agenda forward.  Maria Friedman isn t here
right at this moment, we obviously want to thank her for tremendous efforts to
put these meetings together, and it s really been a remarkable effort in terms
of us moving forward.

With that let s have introductions around the table and then around the
room.  For those on the subcommittee, and this is only in reference to
those on the subcommittee, if there are, if you have any conflicts of interest
related to any of the issues coming before us today would you please so
publicly note during your introductions.  With that, Jeff, would you like
to introduce yourself?

MR. BLAIR:  I m Jeff Blair, Medical Records Institute, vice chair of
the subcommittee, and I m not aware of any conflicts of interest, however if
discussion on the CCR comes up I will need to recuse myself.  I ve been
asked to clarify this, I m not participating in CCR activities however my
employer has been.

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

DR. FITZMAURICE:  Michael Fitzmaurice, Agency for Healthcare Research
and Quality, liaison to the full committee and staff to the subcommittee.

MS. AMATOYABUL(?):  Margaret Amatoyabul, independent consultant and
contractor to the subcommittee.

MS. GRAHAM:  Gail Graham, staff to the subcommittee, Department of
Veterans Affairs.

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

MR. REYNOLDS:  Harry Reynolds, Blue Cross and Blue Shield of North
Carolina, member of the committee.

DR. WARREN:  Judy Warren, University of Kansas School of Nursing,
member of the subcommittee, and I m not aware of any conflicts that I have.

MS. TRUDEL:  Karen Trudel, Centers for Medicare and Medicaid Services,
staff to the subcommittee.

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

MR. MILLEK(?):  Ed Millek, a company called Prescription Informatics.

MR. THINK(?):  Carl Think, also with Prescription Informatics, we re
an e-prescribing technology company.

MR. AVEY:  Steve Avey with the Foundation for Managed Care Pharmacy.

MS. SCHLAY(?):  Marissa Schlay for the Academy of Managed Care
Pharmacy.

MR. SHEETH(?):  I m Tony Sheeth with Point of Care Partners, I m a
consultant and I do a lot of work in electronic prescribing.

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

MR. SIMPCO(?):  Mike Simpco, Wal-Greens Health Services.

MS. ZIGMAN-LUKE:  Marilyn Zigman-Luke, America s Health Insurance
Plans.

MR. HAUSNER(?):  Tony Hausner, CMS.

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

MS. TOWNSEND:  Jessica Townsend from HRSA.

MR. WEINARD(?):  Ron Weinard from Wal-Greens.

MS. DROWL(?):  Jill Drowl from Wal-Greens.

MS. REIN:  Allison Rein from the National Consumers League.

MR. BUSOWITZ(?):  Roy Busowitz, National Association of Chain Drug
Stores.

MR. SANICK(?):  Dan Sanick from Caremark(?), a pharmacy benefit
management company.

MR. BIZZARO:  Tom Bizzaro, FirstDataBank.

MS. MACARTHUR:  Kit MacArthur with Wellpoint.

MR. ROTHERMICH:  Phil Rothermich, Express Scripts.

MS. SWANSON:  Terri Swanson, CIGNA Pharmacy Management.

MS. BURN(?):  Terri Burn, Rx Hub.

MS. WOOLY(?):  Shelly Wooly, Rx Hub.

MS. HAMBY(?):  Pat Hamby with McKesson.

MR. MARTIN:  Ross Martin with Pfizer.

MR. ROBERTSON:  Scott Robertson with HL7.

MS. COKLEY(?):  Emily Cokley, Community Health Funding Report.

MR. MELLIKAN(?):  Mark Mellikan, MediSpan.

MS. ECKERD:  Karen Eckerd from MediSpan.

MR. SCOTT:  Phillip Scott with the National Council for Prescription
Drug Programs.

MS. STEMBER(?):  Leanne Stember with the National Council for
Prescription Drug Programs.

MR. SILKE(?):  David Silke, Health Strategies Consultancy.

DR. COHN:  Okay, well I thank everyone for joining us.  I first
of all should mention that the internet is now on, so I want to welcome those
who are listening in on the internet.  This is a meeting of the National
Committee on Vital and Health Statistics, the Subcommittee on Standards and
Security.  I should also comment that I know many of you got in a little
late last night, we want to thank you obviously for showing up and obviously
thunderstorms and weather are sometimes difficult in Washington during the
summer.

With that Stan would you like to introduce yourself and identify if there
are any issues that you need to recuse yourself of.

DR. HUFF:  I apologize for being late.  Stan Huff with
Intermountain Health Care and the University of Utah in Salt Lake City, and I
would need to recuse myself on issues related to HL7, I m a vocabulary co-chair
with HL7.

DR. COHN:  And before I ask Jeff to make any introductory remarks for
the day I actually also just want to publicly note that I m a member of the CPT
editorial panel, therefore if the issues around CPT come up today, which I
doubt but you never know, I will obviously be recusing myself from those
discussions.

Jeff, do you want to make some introductory comments before we move into
the testimony for the day?

MR. BLAIR:  You betcha.  We are here because of the directive
from the Medicare Prescription Drug Improvement Modernization Act to the NCVHS
to evaluate and make recommendations on e-prescribing standards.  For
those of you who are not aware of the fact that the work plan that we are
following, right now it s work plan version nine, it may go up to 21 or 30 or
something, who knows, but as of know it s version nine, is available on the
NCVHS website and that would help you to wind up putting in perspective the
thinking of the committee as we go forward to try to give our first set of
e-prescribing recommendations to the Secretary in September, and then the
second set in March.  The main thing that will be deferred until after
that first set will be electronic signatures and other issues that we can t
cover between now and September.

Other then that let me just acknowledge the assistance of Margaret
Amatoyabul, who is a consultant who is assisting the subcommittee in being able
to capture all of the information about standards, their limitations, their
gaps, the related issues, because she has done a tremendous job for us.

Simon, let me turn it back to you.

DR. COHN:  Okay, well Jeff, thank you.  I think with this we ll
ask our first testifier, I think Steve Avey, come to the front and talk to us a
little about your perspectives on formulary management.  Thank you for
joining us.

You re going to need to get near a microphone and I believe we have a
computer, you actually may want to, okay, great.

Agenda Item:  Formulary Issues – Mr. Avey

MR. AVEY:  If I could first very quickly introduce the organization
that I represent, first of all there s the Academy of Managed Care Pharmacy
which is a professional organization of about 5,000 pharmacists who work in a
variety of managed care settings, be it health plan or PBMs.  I am the
executive director for the Foundation for Managed Care Pharmacy, which is the
research and education arm for the Academy.  I was asked this morning to
present some testimony regarding some formulary issues so what I would like to
do is first of all talk about the basics of a sound formulary management
program and we had distributed to you this document, and then I d like to talk
about the environment that we have lived in and are living in today in terms of
formulary evaluations.  We re going to introduce you to a guideline that
the Academy has established for formulary evaluation of medication and the
impact that that guidelines has had.

In terms of sound formulary management I think this committee is familiar
with what a formulary is, it has evolved over time.  In the old days a
formulary was something that it was a list specifically of drugs that were
covered for benefit and those drugs that were not on that list obviously were
not covered.  But in today s environment it isn t so much is a drug
covered or is it not covered, it s at what level is it covered, so we have a
variety of tiers that a medication may fall into.  But a sound formulary
management system is vitally important for many reasons.  First of all
when it s properly designed and implemented it really can establish drug
therapy that is rational, clinically appropriate, safe, and cost effective, and
each of those is vitally important to us.

It also supports not only an affordable but a sustainable benefit, and as we
have dealt for the past 15 to 20 years with employers and a variety of other
payers it s not only critical to have a benefit design that is affordable today
but that you can sustain into the future as we think about the Medicare
Modernization Act and you think about sustaining that over the long term, it s
vitally important that we have a sound formulary management process.  It
balances high quality care with the cost associated with that care and in a few
minutes I m going to describe how exactly we re able to do that.

In order for us to have a sound formulary management system we have to have
something called a P&T Committee, a Pharmacy and Therapeutics Committee,
which is made up typically of physicians, pharmacists, and other health care
professionals.  They have some very important responsibilities if they re
going to have a sound formulary process and first of all it s their
responsibility to evaluate medications for inclusion on the formulary.
And in some cases even to describe at what tier a medication might be
covered.  Communications are vitally important specifically as medications
are added to a formulary or medications are taken off of a formulary, of
communicating to prescribers those changes.  They have to periodically
assess therapeutic categories because what is true today may be different two
years from now so occasionally P&T Committees will go back and reexamine a
therapeutic category that previously they had done to see what influence new
medications might have in that therapeutic class.  And then they have to
develop a strategy for medications that are not covered in terms of making
those medications accessible by patients in some format.

Now the system itself should also be involved in informing physicians and
pharmacists who have a difficult time as formularies change understanding what
the coverage is for a specific medication in a specific program.  They
have to also educate plan members of what a formulary is, how it works, how
medications are added to that process.  And then when asked I think they
also should be responsible for explaining what the rationale is for decisions
that are made for inclusion on a formulary.

So let me tell you just a little about the environment that we live in and
this slide shows you, on the green line what we re showing you is the
expenditures for pharmaceuticals, the red line is hospital expenditures, and
the blue line is physician cost.  And as you can see the expenditures for
pharmaceuticals has been in the double digit rate for a considerable period of
time and if you re a payer you would look at that and say why are my
expenditures on pharmaceuticals so much higher then they are for hospital and
physicians.

And there s actually a good reason for that, there really are three areas
that that expenditure increase really falls into and unfortunately if you
listen to the trade press they would have you believe that it s all cost.
But in reality the cost piece is only about a quarter of the increase, the
biggest piece of it has to do with utilization and as you re well aware as we
find out how medications work and what impact they have on us we have tended to
add more medication to our regimens.  If you just look at cholesterol for
example in 1990 the acceptable cholesterol rate in the United States was 240
and today it is below 200 so you can see that millions of Americans now are
taking medications to reduce cholesterol because we have found that there are
positive benefits from doing that.

The area that I want to focus on today though is that one of the reasons
that we have increases in pharmacy expenditures is changes in prescribing
habits, that physicians are using newer medications as opposed to older
ones.  Clearly from employers and payers what we have heard is that they
want better control over pharmacy expenditures and what we have seen in the
past four or five years is a shift in payment to the recipient, to the member,
who now is paying a higher co-pay for that benefit.  They also want to
ensure appropriate utilization, if we get a great new drug out on the market
payers will want to pay for it but they want to make sure that the utilization
is appropriate.

And then the payer is also demanding that they understand what the value is
from these new medications, there obviously is a higher price tag associated
with it and they want to understand what value they re actually getting
back.  And then they also want to understand what the rationale is when
formulary decisions are made.

Well the Academy about five years ago looked at the decision making
environment for formularies and found that there were a number of issues
there.  The first one is that there was no consistent way in which managed
care organizations evaluated medications, and some were doing an outstanding
job and others we felt needed to improve.  The information needed to do a
good quality evaluation was really lacking and in just a minute I ll show you
why.  We also felt that there needed to be more emphasis on the value that
the medication brought as opposed to just what it simple acquisition cost
was.

We really see that for the past five years there has truly been a changing
environment.  In the old days, in the early 90s when I actually sat on
some P&T Committees I can tell you that we clearly were in the top half
there.  Unfortunately without proper information decisions would fall to
anecdote and bias, we clearly did not have complete information, and we clearly
focused on drug impact only.  And what we re trying to do is shift things
down to the bottom where we make decisions based on evidence, where we look at
the total medical costs that are associated, and that we really look at total
health impact.  But if we re to do that how do we do that?

Well, the Academy came out with a new set of guidelines that I d like to
talk to you about.  We looked at the decision making environment and we
thought you know what, there really is a need for improvement.  And when
we looked at the diversity out there we felt like there had to be a more
standardized approach to evaluating medications.  And so we came up with a
new guideline that is called AMCP s Format for Formulary Submissions, it is
also known in the briefest context as the AMCP Format, or you ll also hear it
called the Dossier Process.  And the idea behind this was to reduce this
variation that I just described, we wanted to see a much more standardized
approach to making formulary decisions, we wanted to make sure that we were
truly focusing on value and not just specific costs.

And so what we did is develop a standardized template that could be sent to
a manufacturer and say this is the information that we need in order to make a
good decision.  The manufacturer then develops what s called a dossier
that has that information in it and submits it back to the P&T Committee.

Now the additional information primarily that we re talking about is off
label use, outcomes information, unpublished studies, database studies, quality
of life, functional status, and then a health economics and modeling
studies.  All of those are pieces of information that we believe are vital
to a P&T Committee as they make a decision.  Well of course that
information is not the kind of information that a pharmaceutical company could
just provide as say a marketing brochure, and so we had to talk to the FDA and
say we re interested in obtaining this information and so what we d like to do
is develop a process where we can request that information and that a
pharmaceutical company can submit it to us.  And so the FDA accepted the
fact that if we were to ask for a dossier that that would come under the
guidelines of an unsolicited request and the pharmaceutical company could
provide that information.

The FDA was supportive of the overall concept, they liked our goals and
objectives, and they were interested in what pharma s response to that
was.  And as we explained to them that most pharmaceutical companies were
building dossiers at the corporate office level they were comfortable with that
analysis.

So the objectives of the Academy and my foundation for the last three years
have been first of all to refine the format document itself, the guidelines,
and second of all to provide training at all levels so that people could
understand how to use this new tool.  And that s exactly what we have been
doing.  Now to understand the process, when we say dossier we mean data,
we mean that this is a scientific document.  We have told pharmaceutical
companies we don t even care if it s on glossy paper, we don t care if you
provide us graphs that are in color, all we care about is the science behind
it.  And one of the things that s clear is just because you build a
dossier does not mean that you re necessarily going to make it on formulary,
it s dependent upon what science that document has.

Communication is obviously vital in this and it s going to require as it has
the last three years new thinking.  And what we ve actually asked
pharmaceutical companies to do is include in their clinical trials thinking
about outcomes because no longer is it enough for a drug to just be safe and
efficacious, now we have to understand how does that drug fit in with other
therapies that currently exist and that truly is a new way of thinking and
clearly patient outcomes is what we re really focusing on.

So to date, three years after the guidelines were instituted, we have over
150 million Americans who have coverage from a health plan or a PBM that are
using the AMCP Format process.  We have had wide acceptance from the
pharmaceutical companies, I think in the beginning they were somewhat reticent
about this new process, it truly is a new way of thinking, it s a different way
of marketing clearly with evidence as the basis and clearly focusing on patient
outcomes.  The thing is the United States is late in the game, actually
when you look around the world Great Britain, Australia, and Canada have been
requiring this same kind of analysis for some period of time and we re just
late coming to the table.

Well I wanted to show you this because in a second you re going to see where
we put the format in terms of formulary decisions.  When you look at a
formulary decision there are a lot of elements that are there, the elements of
the format really talk about evaluation based on the factors that I discussed
previously.  There are a lot of other factors that a P&T Committee
have to take into consideration besides that.

Well, in terms of a reality check the format does identify the evidence
that s needed and that s much different evidence then what we used to use in
the old days of prior to five years ago.  What it doesn t do is it does
not provide a precise answer, we do not give an answer there, we just tell you
what information you should be requiring.  It does define how the
information should be provided but we do not define what the decision making
process should necessarily be.  It provides really great data to a P&T
and we believe that it s the basis for a sound decision, but it doesn t
necessarily guarantee that we re going to lower health care expenditures.

Final thought, when you consider managed care s responsibility to make
valuable medications to patient populations at the right co-pay level and I
cannot stress that enough.  We have concerns about co-pay level and how
high can they go and what impact does that have on compliance.  When you
consider a patient s right to have access to the medications that have the
highest chance of succeeding, and when you consider the cost consequences of
some of the new therapies available, sound formulary management is absolutely
critical and we believe that an evaluation process similar to what the AMCP
Format offers is something that really makes a lot of sense.

So those are my prepared remarks, I d like to open it up and have you ask
whatever questions you would like.

DR. COHN:  Okay, questions from the subcommittee.  Steve?

DR. STEINDEL:  Thank you, that was a very interesting talk, it gave me
some thoughts on some ideas about formulary standards which I hadn t considered
before, I appreciate it.  One question that I do have is how often does a
formulary change decision have to be made?  Is that a periodic thing or if
a hot new drug comes out on the market tomorrow the formulary is going to make
a decision to put it on the next day?

MR. AVEY:  That would rarely be the case, normally P&T Committees
have scheduled meetings and a typical P&T Committee may meet four times a
year, it may meet monthly, that depends widely by the health plan and the
PBM.  But it s all thought out in advance and you heard me say that
communication is critical, if there s a new blockbuster drug coming down the
pike a pharmaceutical company knows about it and actually most of the folks in
managed care probably know about it well in advance.  It s important that
that entity have a discussion with that pharmaceutical company months in
advance of the launch of that product so that they can get that scheduled on
their P&T Committee process and have the best information available at the
time that meeting comes up.

DR. COHN:  Harry, Stan, and then Jeff.

MR. REYNOLDS:  You presented the relationship between PBM and the drug
manufacturers as far as the formulary information going back and forth.
One of the issues that we face as you look at e-prescribing is once that
formulary is decided and in place and gone through your whole process, now it
has to be delivered to the care giver in some kind of a structured standard way
so that one is the only way, they can understand it, it s clear, it takes that
entire template you had, breaks it down into actual practical capabilities for
them to use.  Could you give us any thoughts on how you see that as the
next step because that s the step that we re pretty much having to face as far
as establishing our process —

MR. AVEY:  It s an absolute critical step because if you can appreciate
the pharmacist in the field who has met with prescriptions that a physician has
not known whether it was covered or not and the patient arrives at a pharmacy
counter, they re then told that it s not covered and then a phone call needs to
be made back to the physician who then needs to be gotten a hold of first of
all and then explained what medications are available for them to select, a
very inefficient process.  E-prescribing is the answer and I will be
honest with you that we within managed care have been frustrated with the lack
of progress that we ve actually made on e-prescribing because in that modality
a physician can tell at the moment of prescribing what medications are on
formulary and off.  It is the answer for us and we ve been very slow at
adoption.  The ultimate response to e-prescribing where we can arrive at a
prescription that gets submitted to a pharmacy that s already gone through the
formulary editing process is one that will make our system far more effective
and efficient then it currently is, it s absolutely critical to the process.

DR. COHN:  Did that answer your question?

MR. REYNOLDS:  Not completely.

MR. AVEY:  Okay, so one of the things, let me go back to the process
situation.  Today the e-prescriber community has developed formularies
that a physician with a Palm can go to a specific health plan, let s say that
it s Blue Cross/Blue Shield of California.  They can actually click onto
that health plan and it will bring up by disease state or by therapeutic
category what medications are on formulary.  It s fairly sophisticated and
so it answers the question for the physician right up front what drugs are
covered and which ones are not.

MR. REYNOLDS:  But I mean, obviously you have a handle on the whole
industry, are there formats out there that you think really are delivering the
right things to the physician versus that you think we ought to consider
looking at or hear about or do to consider endorsing as we try to develop some
standards because in the end we re supposed, actually where it happens we re
supposed to try and do something about it.

MR. AVEY:  I think there s some organizations that are sitting in this
room right now that have products that you would certainly want to
consider.  Quite frankly the frustration that we have isn t that the
systems aren t there and that they don t work, it s been adoption by the
physician community to utilize that technology.  And the problem is I
think we haven t yet convinced the physician community of the real value of
that and how that can save them administratively.  It has not been done in
such a way that the physician community has bought into it because there
clearly is a financial obligation established with that.

DR. COHN:  Okay, Stan?

DR. HUFF:  So just to make sure, you develop content and formulary
content, how is that communicated, I mean are you using, is it a human readable
format or do you actually have a data format in which you communicate the
formulary information to —

MR. AVEY:  The means by which managed care organizations and PBMs
present that information to their members varies by the organization.
Lately the best technology available is that it s available on websites and so
a patient could actually go to a health plan or PBM s website and determine
whether the medication they re on is covered.  The beauty of that kind of
system is that it can be updated very regularly and so any changes that occur
can be presented to that member.  Previously we literally had hard copy
formularies available, they get outdated very quickly and it becomes a very
frustrating situation in trying to make the best information available to
members.

DR. HUFF:  The scenario I m most familiar with or maybe I m
conjecturing, there are really two ways at the time or ordering that formulary
information could be made available.  One is that I could have in some
batch way transferred the formulary once a week or once a day or once a month
into the pharmacy ordering software.  Or at the time of order I could
actually go query some other database that was external to myself on a real
time transaction basis and just ask about the particular circumstance that I m
in.  Are you familiar, or do you have any recommendation for the committee
in terms of the format that would be used to move formulary information in a
batch form from some content source to the actual environment of the ordering,
or a transactional format for doing that same kind of transfer of information?

MR. BLAIR:  To the prescriber.

DR. HUFF:  To the prescriber.

MR. AVEY:  Yeah, I was going to say we need to talk about which
provider you re talking about.  Obviously it s critical that the provider
have that information at the moment that they re actually prescribing the
medication.  The systems that I have seen that are available, the database
is updated actually in I think most cases at least on a weekly basis if not on
a daily basis and actually the database that s being queried in a variety of
ways can be downloaded overnight into the physician s personal server, or it
might be that they re actually querying a database that s remote that can be
updated again on nightly basis, or would be available to a physician in real
time.  I think the vast majority of organizations download that
information onto the physician s server.

DR. HUFF:  And do you have any recommendation for the committee on the
format that would be used for downloading that formulary information?

MR. AVEY:  No, I don t think I m the right person to ask that question,
I think you ll have to talk with other folks that have greater understanding of
that process.

DR. COHN:  Thanks.  Jeff, you re next and then Marjorie —

MR. BLAIR:  Before I ask my questions I want to make sure that my
understanding is correct, otherwise my questions are irrelevant.  You do
not gather, my understanding is that you do not gather formulary information,
what you gather is the information from the pharmaceutical manufacturers that
enable the PBMs and the payers to decide what will be in the formularies they
create.  Is that a correct statement?

MR. AVEY:  It s a correct statement but I need to make sure that you
understand one thing, the only way that a pharmaceutical company can
disseminate that information is if it is specific to the requester, so our
foundation doesn t touch it, we don t actually ourselves request that
information, it has to be requested by the specific organization that s
evaluating the mediation.  The FDA is very clear on that, they don t want
these dossiers just out in the public, they want it sent directly to the
individuals who are evaluating that drug.

MR. BLAIR:  Right, so what you have done with AMCP is you ve set up
criteria so that the information that will be provided to the PBMs and the
payers will be more scientific then they have been before —

MR. AVEY:  That is absolutely correct.

MR. BLAIR:  So that the decision that the PMBs and the payers make
about what goes into their formularies should become more consistent and
defensible, is that correct?

MR. AVEY:  That is absolutely correct.

MR. BLAIR:  Okay, now here s my question then.  In the three years
that you have been providing this very constructive helpful service has there
been any observation or measurement that in fact the PBMs and the payers have
moved towards either greater uniformity or consistency in terms of their
formularies they create?

MR. AVEY:  That is an outstanding question, and the answer to it is we
don t know.  It s very difficult for us number one to gather information
on who exactly is using it.  As I gave you some data, those are the
organizations that actually have let us know that they re indeed utilizing the
guidelines.  But here s the rub, the problem is just because somebody says
they re requesting dossiers doesn t really tell us exactly how they re
utilizing them.  It doesn t tell us what rigor they re going through in
that evaluation process.  We actually are in the process of doing a formal
evaluation that does exactly what you just described and that is to help us
understand at the end of the day have we really improved the process or did we
just improve the information passing phase of it, and that s a very good
question.

MR. BLAIR:  One thing that I think might be helpful to the committee,
or Health and Human Services, is when you get the results of that and it does
show the areas where there s greater consistency in the formularies or in the
structures of the formularies or in the decision making criteria that the PBMs
and health plans use to create the formularies, that would be helpful
information because that might then provide a foundation for some future
development of standards for communicating in the formulary information to the
prescribers, it would be input, it would be background base information, so
that I think would be helpful.  Do you have any idea when that information
might be available?

MR. AVEY:  I think that we could have some preliminary information
available within a year.  The kind of evaluation we re talking about will
be extended over probably the next two years but we ll have some preliminary
information within 12 months.  So we re happy to share that information
back with this committee, and quite frankly we d love to see a more formalized
process and adoption take place.

MR. BLAIR:  And I wasn t implying in my question, for those folks that
are here from PBMs and health plans, I was not implying that all health plans
and PBMs select the same drugs for their formularies, I think all I m looking
for is if we can standardize either the communication of the formularies or the
structure of the formularies to prescribers so that they can more readily
understand what drugs they can prescribe and if they want to ask for
preauthorizations that we could expedite in a balanced way, in a balanced way,
how and when exceptions to the formularies could be process, then that would
improve the e-prescribing process.

MR. AVEY:  Mr. Blair, you actually have encapsulated what our concept
was all along, we did not intend to dictate to anybody what their formulary
decisions were, what our attempt was was to standardize at least the evaluation
and to standardize the information that an organization should look at in order
to make that decision.  And our attempt was to make sure that we were
doing the best job of evaluating the medications, the decision making process
is left up to the individual organization.

DR. COHN:  Steve, thank you.  Marjorie and then Judy.

MS. GREENBERG:  Thank you.  Actually my question I think follows
nicely on this discussion of standardization of the evaluation process.  I
noticed in the list of elements that you re recommending in this sort of
evidence based review that you included outcomes broadly and specifically
functional status information.  And I wondered if you are recommending
standards or some kind of methodology or information systems or whatever to
collect that information, this is an issue that we ve discussed in the national
committee and is quite, and in the Quality Workgroup, etc.

MR. AVEY:  There are many areas of the evaluation where we re breaking
new territory and actually quality of life studies are relatively new.
And probably not as accepted as some of the other areas of science because
they re far more subjective.  It doesn t mean that they aren t important
but we need to have those folks who serve on P&T Committees to understand
what a good quality of life study is and what a poor one is.  We have the
same problem with pharmacoeconomics, that s an area that is relatively new as
well and not well understood by the average pharmacist or physician, which is
why we ve been doing these training programs for the last three years to bring
the expertise level up.  We re always interested in pursuing guidelines or
standards that help make any of these studies more plausible and more
acceptable.  I don t think we re into it far enough for me to state yeah
there s a standard here that will help us in that process, but clearly that s
the direction that we d like to see thing go because as we train professionals
to look at the information the more standardized approach there is to those
studies the easier it is to evaluate.

DR. COHN:  Okay, thank you.  Judy?

DR. WARREN:  Stan asked my question.

DR. COHN:  What?

DR. WARREN:  Stan asked my question.

DR. COHN:  Okay, that s fine.  Any other questions from the
subcommittee?  Well, Steve, I actually want to thank you, I think it s
been a very useful conversation.  Obviously I think we need to be all
aware just in the subcommittee that this is sort of one level above how this
information gets to the physician and clearly there s a piece here that
everyone needs to recognize which is that it s one thing to have that dossier,
it s another thing to figure out how that connects in with benefits and the
type of programs you re offering and obviously that s a critical issue, all
PBMs and all health plans do not get the same costs and contract negotiations
with pharmaceutical companies, etc., and all this does impact final decisions
about what s going to be in a formulary.

MR. AVEY:  Right.

DR. COHN:  Anyway, thank you very much.

MR. AVEY:  Thank you, I appreciate it.

DR. COHN:  Okay, now our next set of testifiers is consumer perspective
and I guess I would ask David Chess and Allison Rein to come up and join us if
you could, in front.  While you work technically on getting the
presentation up on the screen I obviously want to thank both of you for joining
us.  As I understand David you re from Project Patient Care, thank you for
joining us, and Allison Rein you re from the National Consumers League, so
thank you both for joining us.  And David I think you re going to start
out as soon as we can find the presentation.

Agenda Item:  Consumer Perspectives – Dr.
Chess

DR. CHESS:  First I d like to thank you for inviting me to speak before
the subcommittee and let me give you a little background on myself.  I am
an internist, geriatrician, a devoted caregiver, have been practicing for 20
years, and founder and executive director for an organization called Project
Patient Care.  And it is from those seats that I want to give you a
patient perspective and a physician caregiver perspective.

I have personally used e-prescribing for approximately four years so I don t
know if there s anyone else out there in this audience who has but I have
actual, it s been between myself and my patients for some time now.  And
clearly I believe it is an important technology and an important innovation for
improving patient care.  As you already know e-prescribing has the
potential to make our prescribing system safer, more efficient, and may
ultimately save money.  E-prescribing can markedly decrease errors
inherent in physician s handwriting and pharmacy interpretation and
transcription of prescriptions.  It can immediately alert physicians to
drug interactions, allergies, can tell us when patients have filled and
refilled their prescriptions to improve compliance.  E-prescribing will be
an important part of our EMR, our information, our health record for the
individual patient, and it will be an important tool for quality assessment and
improvement.

Like most tools with great promise there s also a significant opportunity
for abuse.  When a physician is applying an e-prescribing tool he or she
is not alone in the room with their patient, there is now a third party.
This third party can potentially influence the physician s prescribing.
E-prescribing is in fact, at least potentially, the most effective way for
affecting physician prescribing behavior out of any tool yet far implemented.

It is an efficient avenue for government, pharmacy benefit managers, and
managed care organizations to markedly influence what is being prescribed for
their members.  One can easily envision a physician with a patient in an
exam room prescribing what he or she decides is the best remedy for that
individual, putting the prescription of choice in the Palm Pilot, and a screen
that pops up notifying the physician that the medication needs to be
pre-approved by the managed care organization, and on the same screen some
alternative medications that are preferred by the managed care organization
popping.

Alternately the screen may automatically steer the physician to an approved
medication limiting choices that the physician may make through this
device.  And alternately again the screen may just flash preauthorization
required, call 1-800-preauthorization.  These barriers, these levels, will
significantly impact what physicians prescribe and I m sure that everyone here
will understand that.  Doctors will not pick up the phone on a routine
type of basis to get a preauthorization.

Pharmaceuticals represent about 17 percent of the health care budget.
The ability to influence how a physician prescribes has massive financial
consequences for companies with a vested interest.  Currently there are
many ongoing efforts to influence physician prescribing behavior.  What
distinguishes e-prescribing is a remarkable efficiency by which this
application can effect physician prescribing behavior real time.  This
again may be good or bad.  There are surely physicians who could use the
help.  The concern is based on the motives that drive the development of
formularies.  Most medication formularies are economically driven and do
not take into account individual patient needs.  Our concern is that we
are creating further barriers to individual patient care and in fact making it
more difficult for physicians to care for patients and for patients to receive
the treatment that is in their own best interest.

This is particularly important for chronic conditions and for people with
multiple active conditions.  As our society continues to age chronic
disease and co-morbidities become the rule, not the exception.
Individualized prescribing will be increasingly important.  Our concerns
have been reinforced by a recent study sponsored by Project Patient Care, the
potential cost and burden of restrictive formularies, which looked at the
impact of restricted prescribing on people 50 years and older, all with
insurance, and we also queried the physicians who cared for this subset of
people, all of who had a chronic disease.

What we found was that in this study of over 1,000 participants, the study
was performed by Harris Interactive, we found that over 12 percent of adults 50
and older with chronic disease undergo a medication switch per year, that s
approximately 8.9 million people when extrapolated.  Of these people who
underwent medication switches, I m not going into the details of this slide
only because it s not particularly relevant to this conversation, but of the
people who did undergo a switch we found that 30 percent had some adverse
reaction, either 13 percent the medication didn t work, or 22 percent that was
an untoward side effect.

We then dug deeper and we asked what happened to these 30 percent of
people.  And we found that 58 percent reported that the incident, that the
switch resulted in either a moderate to severe event and it was the premise
that it was going to be mainly minor side effects but that s not what was
reported.  When we then dug deeper and looked to see what happened to the
58 percent of people who had moderate to severe interactions we found that of
those 30 percent, 33 percent of them required an additional medication to treat
the side effect, 18 percent required an urgent physician visit, 14 percent
found themselves in the emergency room, and 11 percent reported
hospitalizations.  The N on this becomes insignificant and it may be off
by a factor of four but even at a factor of four you re talking about hundreds
of thousands of people being impacted by formularies who have chronic disease.

Now the striking thing here frankly, and I just completed a review of the
literature with David Nash(?) over at Thomas Jefferson, is that the amount of
study that has been given to the impact of formulary in people with chronic
disease, people who are seniors, as we roll out a prescription plan for our
nation, is microscopic.  And that s why this is of concern to me in that
—

MR. BLAIR:  Could you repeat that sentence?  I didn t quite hear
that, what is microscopic?

DR. CHESS:  The amount of study that has been done of the effect of
formularies, in switching people from medication to medication in people with
chronic disease has not been studied as a system change.

Our health care system is a study in contrast, we expend enormous sums of
money trying to prove the efficacy of a given treatment yet we rarely study how
changes in the system impact on the product, patient care.  Other
industries study the processes before full implementation so it fully
understands its value proposition, the quality versus cost equation.  An
automaker knows that a small shift in the assembly line can have important
consequences.

With e-prescribing we are about to markedly impact patient care.  I am
an advocate for this innovation, I am also worried about its abuse and how it
will effect my ability to best serve my patients and ultimately our
community.  I ask this committee to put patient safety first, patient
safety demands that we study the impact of e-prescribing on patient care
outcomes, that we establish guidelines to ensure that this new technology will
not be yet another barrier to care.

I ask this committee to be wary of not creating another fissure between
physician and patient as a third entity enters the examining room.

DR. COHN:  Thank you very much.  We ll have questions and
discussions after we ve had the other testimony.  Allison?

Agenda Item:  Consumer Perspectives – Ms.
Rein

MS. REIN:  I will apologize in advance, while the National Consumers
League is highly supportive of efforts to become electronic it is usually our
approach to communicate to people at a very basic level so I don t have
anything for you to look at, I should have brought a picture of my dog but
you ll just have to bear with the blank screen.

My name is Allison Rein and I m the assistant director of food and health
policy at the National Consumers League.  I m here today to share with you
some of the ongoing efforts underway at NCL and to provide a patient oriented
perspective on electronic prescribing.  I ll begin my comments with an
overview of NCL and the SOS-Rx Coalition and its current activities in the
electronic health domain.

The National Consumers League is a private non-profit advocacy group that
uses education, research, advocacy, investigation, publications, and
public/private collaboration to accomplish its mission of representing consumer
interests on marketplace and workplace issues.  Formed in 1899 we are the
nations oldest consumer organization committed to protecting, representing, and
advancing the economic, social, and health interests of consumers.  For
over 100 years NCL has provided government, business, and other organizations
with the consumer perspective on social concerns including child labor,
privacy, food safety, and health care.  A natural extension of this
mission is our recent initiation of the SOS-Rx Coalition.

The Coalition is a collaborative one that s dedicated to promoting
outpatient medication safety initially among seniors.  Convened in 2003 by
NCL with support from Express Scripts as founding sponsor the purpose of the
Coalition is to make the outpatient use of medications safer.  To ensure
that the work of the Coalition drives real change in the health care system our
voice is national and our actions evidence based.  The Coalition
represents more then 60 organizations from a broad perspective from the health
care field including patients, consumer groups, academic research institutions,
government, payers, providers, pharmacists, pharmacy benefits managers,
employees, or employers rather, and pharmaceutical companies.

SOS-Rx has chosen to focus on initiatives aimed at promoting consumer
actions and system changes that enhance the safe outpatient use of
medications.  From the outset the Coalition considered how best its
members could contribute to the dialogue without replicating efforts already
underway.  Furthermore, the Coalition did not wish to serve as, or be
perceived as, a standards setting organization.  Rather Coalition members
expressed a strong desire to educate patients and then harness the force of an
empowered consumer to advance broader health system change.

I know that this audience is acutely aware of the current limitations in our
health care system, it is economically inefficiency, administratively
burdensome and complicated, and too often yields unwanted clinical
outcomes.  We have many data points to suggest that some action must be
taken to improve upon the status quo.  Adverse drug events occur in five
to 18 percent of ambulatory patients each year and preventable medication
errors cost an estimated $2 billion a year in the U.S.  And while
electronic prescribing initiatives have demonstrated significant gains in
patient safety, communications, and overall efficiency, only ten to 16 percent
of U.S. physicians use some form of electronic prescribing.

Recognizing the need to consider the patient perspective in any solution the
SOS-Rx Coalition has embarked upon four projects that either directly or
indirectly empower patients to effect change.  Of the four projects
currently underway two warrant specific mention in this forum given their
relevance to the issue of electronic prescribing and the potential it has as
part of a broader health care paradigm shift to improve patient safety.

One ongoing effort of the Coalition is the development and promotion of a
standard personal medication record template that could be used by patients to
record and track all medication use.  This would include prescription
drugs, over the counter drugs, vitamins and herbal supplements taken regularly
or sporadically.  The guiding principle behind this effort is summarized
as follows.  Consumers should have a role in ensuring that a complete
accurate and updated list of medications and supplements is available to all of
their medical care providers so as to maximize therapeutic benefit and minimize
the risk of adverse events.

The specific technologies required to make this happen are not the subject
of this Coalition effort.  We realize that technology ranges from paper
forms to cards, electronic records, web portals, and beyond.  These are
merely the enablers.  Our focus is on the role of the patient in making
sure the specific outcome of an accurate medication list is achieved on a broad
scale and in the near term.

Although the personal medication list would ideally be implemented as part
of a broader personal health record the Coalition recognizes that incremental
steps are needed.  The fact that many patients interact with numerous
prescribing physicians and receive medications from a variety of sources speaks
to the urgent need to establish a hub for this information.  To this end
the Coalition has developed a paper based template that will be reviewed and
tested on patients and eventually disseminated widely as part of an aggressive
campaign.

The other relevant project that s been undertaken by the Coalition involves
a two tiered effort to accelerate the adoption of e-prescribing, an initial
phase of research and discussion has yielded a definition and an accompanying
set of guiding principles that can be used to establish a baseline standard for
e-prescribing that is patient oriented.  As has been suggested in the
report of the eHealth Initiative electronic prescribing is broadly defined as
any system that uses a computer to assist in creating a prescription.
This definition can encompass several options ranging from basic clinical
decision support to a vastly preferred fully integrated electronic health
record.  The initiative further specified, and the Coalition supports this
notion, that any definition must meet additional requirements and some of these
include rapid adoption of implementable and usable computerized prescribing
technologies, the ability to work in a variety of practice settings with a
variety of existing IT infrastructures, encouragement of rapid development and
adoption of standards to allow choice of systems and use of common services,
encouragement in the creation and application of appropriate incentives and
education, and preservation of the patient/physician relationship and choice in
the delivery of health care.

As this project develops further the Coalition will consider additional
patient focused criteria that must be met by any normative definition of
electronic prescribing.  An initial but not yet comprehensive list
includes support of safe care, use of nationally adopted technology standards,
compliance with best practices, patient access to educational and reference
materials, patient access to a complete medication regimen, enhanced
communications, for example renewal requests and compliance reminders,
portability across all systems regardless of provider, pharmacist, or insurer,
and maintenance of patient privacy and trust.

MR. BLAIR:  Excuse me.  For my benefit could you please reread
that list slowly.

MS. REIN:  Sure, sorry.  Support of safe care, use of nationally
adopted technology standards, compliance with best practices, patient access to
educational and reference materials, patient access to a complete medication
regimen, enhanced communications, such as renewal requests and compliance
reminders, portability across all systems regardless of provider, pharmacist,
or insurer, and maintenance of patient privacy and trust.

Given the task of this committee we ask that you also acknowledge the
critical nature of workflow standards as well as technology and data standards
in determining the uptake and successful use of any electronic prescribing
system.  If we truly want to empower consumers then we will need to create
a system that is highly attuned to their needs and that does not create tension
between patients and providers.  For example, if patients are going to be
encouraged to promote e-prescribing then we will want to ensure that some of
the following needs are addressed.

First, the patient must be able to instruct their provider to transmit a
prescription to any pharmacy they choose regardless of which vendor created the
system.  Anything less will result in more work for the physician and less
satisfaction for the patient.  Second, any e-prescribing capability must
make it possible for the interested patient to review his or her medication
list and update it before any electronic prescription transaction occurs.
This ensures that patient efforts to maintain an accurate list are not
undermined by implementation of the e-prescribing system.  The same
information should be available to the physician and in both cases should be
accessible by PDA, cell phone, PC, and/or some other medium.

Third, any e-prescribing system must enable patients to self report minor
and major adverse drug reactions as defined by standards.  Physicians also
should be able to incorporate this information into the patient s medication
record.  And finally, and decision support rules must be able to
distinguish between information submitted by patients and information submitted
by a provider.

These suggestions do not represent a comprehensive list but rather highlight
the need for any workable system to incorporate patient needs and preferences
into its design.  Many of these needs and preferences may be revealed in
the second phase of the effort which involves a collaboration with eHealth
Initiative.  Working together the Coalition and the Initiative plan to
identify patient touch points in the continuum of care that are effected by the
prescribing process and chronicle the benefits that can accrue to patients
through use of e-prescribing.  Having gone through this exercise the group
will recommend strategies for communicating these benefits to patients as part
of a broad campaign.  However, before embarking on a patient education
campaign that sells patients on benefits of electronic prescribing  the
SOS-Rx Coalition believes that it is critical to take a step back and consider
a broader spectrum.

That is, we need to address the current consumer demand problem that stems
from the public misperception that there is no problem with the status
quo.  Many Americans may be generally aware that there are flaws in the
current health care system, and some even have personal encounters that
undermine their faith in that system.  But most do not fully appreciate
how frequently medication errors seriously effect patient health.

One proxy for consumer awareness is the extent to which an issue is covered
in the popular print media.  Those in this room likely have read numerous
reports in peer review publications outlining the potential benefits of
e-prescribing but how many patients have even heard the term let alone have a
knowledge base to provide rudimentary definition or describe how it might
actually benefit them.  To demonstrate this the Coalition commissioned a
content analysis of e-prescribing media coverage in consumer publications
between October 1st 2003 and July 20th 2004.  In
total fewer then 20 stories covered the topic and most of these were business
journals oriented to industry analysts and not general consumers.

Obviously much needs to be done to educate patients about this issue.
In implementing its campaign the Coalition plans to develop messages that will
help patients understand both the risks inherent in the current system and the
potential safety benefits that could accrue with adoption of electronic
prescribing.  Of critical importance however is the notion that we do not
want to do this in such a way that scares patients into inaction.  Rather,
we hope to provide support to patients by integrating use of a tool, the
personal medication record.  If patients feel educated and empowered with
a tool that is immediately at their disposal to improve their safety then it is
more likely that they will have a positive response to the campaign.

In addition it is the Coalition s hope that through adoption of this tool
patients will not only have to take, have taken steps to improve their own
safety, but will have compelled their providers of care to recognize at the
personal patient level the benefits of e-prescribing.  In taking this
approach the Coalition has redirected lobbying tactics for achieving electronic
prescribing.  Instead of focusing efforts solely on the physician through
incentives and education the focus is turned to the patient.  As more and
more patients learn about the flaws of the current system and the incredible
benefits of e-prescribing more and more physicians will be compelled to
consider such options.

Despite the promise of improved patient safety that this campaign may yield
the Coalition acknowledges that several issues will need to be considered as it
moves forward.  To maximize the success of the campaign we will need to
identify and segment approach via patient targets, conduct further research to
gain a better understanding of patient perspectives, perhaps conducting an
evaluation of current understanding as well as the wants and needs for an
e-prescribing system.  We will need to convert the e-prescribing concept
and information into a language that people can actually understand.  And
we will want to partner with other private and public entities to broaden
dissemination of the campaign messages.

Ultimately the National Consumers League and the SOS-Rx Coalition believe
that through a dual process of educating patients and providing them with
useful and appropriate tools it is the patients who will have the greatest
influence in promoting the rapid adoption of electronic prescribing.  It
is with this consumer focus that we hope to drive electronic prescribing
standards development.

Thank you.

DR. COHN:  Well, thank you both for very interesting and hopefully
useful testimony.  I know the subcommittee has a number of questions, I
think Jeff had already indicated to me that he wanted to lead with the
questions.  Are there others that have questions?  Okay, Jeff you re
on first.

MR. BLAIR:  Thank you both, it is really helpful that we have this
important perspective included among all of the testifiers that we ve been
receiving.  Allison, you have mentioned that it s important to have
workflow standards —

MS. REIN:  Yes.

MR. BLAIR:  You re not the only one that has suggested that to us but
I m not aware of a workflow standard.  Do you know of one that could be
made available to us?

MS. REIN:  I don t know of a particular standard, what I m suggesting
by some of the points is that we need to establish them —

MR. BLAIR:  Okay, so it needs to be developed.

MS. REIN:  Yes.

MR. BLAIR:  Okay, and I gather that NCL SOS-Rx intends to participate
in that or contribute to it or support it, is that correct?

MS. REIN:  Yes, I mean as I mentioned at the outset we re not a
standards setting organization in a technical sense but we do hope to in our
collaboration hit upon all of the touch points for patients in the continuum of
care and ultimately figure out where the process needs to go and then we would
provide recommendations along those lines.

MR. BLAIR:  Normally I m not in the mode of being a cheerleader but let
me go ahead and wind up indicating that I think your initiative is extremely
important and one of the things that has been absent in standards, accredited
standards development organizations that create standards for information
technology in health care is there s little or no representation of the
consumer viewpoint.  So I would like to encourage NCL SOS-Rx to make it an
objective to send representatives and participate in the standards development
of accredited standards development organization for health care information
technology.  It would be a wonderful contribution if you could make sure
that the consumer view is represented.

MS. REIN:  Thank you, I m sure we would be very, very happy to do that.

MR. BLAIR:  And if you need any guidance on that there s a number of
people on the committee and other people in this room that could help identify
the different accredited standards organizations that are working in this area
that could benefit by your participation.

MS. REIN:  Thank you.

MR. BLAIR:  Dr. Chess?  I think you made a very appropriate case
for concern that there might be abuse by payers in terms of the criteria that
they use for establishing formularies.  And I felt perfectly comfortable
with the points that you made about the possibility of abuse from that
sector.  I think that when we hear from the payer viewpoint they re
concerned about abuse or if not abuse maybe neglect or lack of concern by
health care providers in prescribing drugs that may not be in a thoughtful
manner where there are appropriate lower cost regimens available or that there
might be in some cases fraud.  So I get the impression that your concerns
are valid and their concerns are valid, so what I m going to get to is I m
giving you the premise of my observation here and then I ll ask my
question.  Given that the concern of abuse is valid in both areas have you
given some thought to the standards that might be appropriate for the display
of a formulary that could at least make the motivations of both sides
transparent a la how should the formulary from the PBM or payer be
displayed?  What is the structure, what is the content, that is shared
between the two entities?  Have you done any work on this or considered
this or is there someone we could refer to that might help us to look at
standardizing the format communication and/or display of formularies to
prescribers?

DR. CHESS:  Thank you for your question.  There are actually two
parts to the answer as I see it.  Number one the concept of abuse is
interesting, I don t think that the vast majority of physicians out there will
consider their prescribing methods to have anything to do with abuse.
They may have preferences, they may be influenced in different ways, but the
vast majority of physicians that I know, and I ve put together a 70 doctor
group in Connecticut so I know a lot of doctors and I ve had tons of
interactions, don t work on that level.  However, like managed care in the
early 80s where there was massive promise for doing better for our consumers,
for our patients, for ourselves, it has fallen far short of that dream and it
is mainly motivated by dollars at this point.  It has become another
company.  And so we can have our dreams and our wish list about what
e-prescribing can do but I think we re going to be enormously naïve to
think that the dollar will not massively influence how you are taken care of by
your physician.  And a lot of this will be transparent to the patient
because the doctor is going to be looking at this here and the patient is not
going to see that there.  So I think that there s an important backdrop
here and it s not about good guy or bad guy, it s not about that at all, it s
about human beings, organizations, everyone wanting to survive and do the best
they can for themselves.

As I see it the responsibility that we all have here is to create guidelines
to help guide the system and I would be delighted to, there are many specific
ideas in terms of since I ve used the technology of how to make that interface
both informative and not a barrier to care, and there are ways to do it that
are relatively simple.  And there are Sure Scripts and others who are
doing it in a very thoughtful way at this point and it may not be the way we re
doing it today, it s what happens as the dollars get turned and the
opportunities for more profits are there.

So I ll be glad to speak with whoever wants to hear me about specifics of
how that can be done but that s not a problem.  The biggest underlying
problem frankly is that we continue to make changes in the health care system
without appropriately studying its impact.  I ll give you a wonderful
example of this, the gatekeeper, in order for you to go see your specialist for
how many years did you have to get approval from your primary care
physician.  Do primary care doctors ask for this anointed position?
We did not, this was something that was brought on by health care companies
saying that we need to control specialist utilization.  17 years after
implementation, after many of us added personnel to our staff to be able to
make those referrals and live within the system, all those gatekeepers have
disappeared, there s hardly a health care company out here who uses it and
guess what they found, it wasn t cost effective.  It is not fair and it is
not right and it s not right for patients to implement policy without studying
its impact.  All these things effect the ability of patients to get
care.  And with chronic care it gets amplified.  When a person is on
multiple medications that formulary may not work and we just need to make it
that it works for individuals, that there are easy ways to document exceptions.

I m not saying that we don t need guidelines, I m not saying that I
personally believe that this whole piece can be a wonderful way of improving
care, monitoring and feeding back to physicians in terms of standards of care,
but again it needs to be framed in a way that is not driven just by the dollar
and we need to do these studies up front before we implement a massive change
in our system.  And if we re not going to do that we at least need to set
up simultaneously significant studies so that three years down the line we have
some data so we know what to do.  Formulary itself is not a bad thing but
I ll make you a bet for certain subsets of medications it is bad, but the
studies have not been done.

So again, I m not for or against anything except I want the best for my
patients.

MR. BLAIR:  We need better information, the studies need to be done,
yes —

DR. CHESS:  We need to study things just like General Motors does, just
like Proctor and Gamble does for their toothbrushes before they put out a new
toothbrush, they know when they change the system of development what its
impact is going to be.  We re making a substantive change here, and I
believe a very potentially wonderful change, but we need to do it with real
study —

MR. BLAIR:  Sensitivity to the fact that if we don t do it carefully
and in a transparent manner there could be abuse by one side or the
other.  Is that fair?

DR. CHESS:  Correct.

DR. COHN:  Okay, Jeff, thank you.  Judy and then Harry and then I
have a couple questions and Michael.

DR. WARREN:  This is for Dr. Chess.  It really kind of follows up
on Jeff s thing, when you were giving testimony I was really struck by the
passionate way you described with e-prescribing being the third party in the
room, in the exam room, and how that would effect your relationship with the
patient.  My understanding is is before e-prescribing you still had a
third party in the room but it was a piece of paper, which was the formulary
that you had to prescribe to.  So now I m trying to understand the caution
you want the committee to take in looking at standards.

DR. CHESS:  The reality, and we did a survey of physicians, is that it
is unusual for a physician to go look for a piece of paper to find out what s
on that patient s formulary, there are too many out there.  In my
community there are a dozen different HMOs each with their own formulary.
We don t know them, we don t go looking for them, I prescribe what I believe is
in the best interest of my patient.  I may then get a phone call from the,
in fact this slide here looks at how people get switched from the medication
that they re on to an alternative medication and there are three different
methods.  One is they have been stable on a medication and there s a call
from Medco, or they ve changed health plans or the health plan has changed
formulary and they come to you and say this is going to cost me $30 dollars, if
I get this it will cost me $10 dollars.  And so they re already stable on
something and you switch them, that s the majority, that s the ten percent bar.

The next is when I write the prescription and then the person takes it to
their pharmacy and the pharmacist tells them that this is going to cost them
$100 dollars, if you get this it will cost $30 dollars, and then the pharmacist
calls me, or the patient calls me and a discussion ensues.  And then the
third way is while I m writing the prescription a conversation about economics
occurs.  Those are the three ways that we identified that those changes
occur.  But we don t sit there with a piece of paper looking, we don t
focus on what s best for the pharmacy, for the pharmaceutical company or for
the HMO or for the PBM, we re considering the side effects and the benefits for
that individual patient and I believe that s the way the majority of
physicians, and the data that we have speaks to that, that is how most doctors
work.

This will markedly change that, in fact there was a study, I don t remember
exactly where I saw it but approximately 40 percent of prescriptions, the
efficacy of switching from the PBM point of view is about 40 percent and the
main driver for it is the fax machine as of today.  With this device it
will markedly change and they expect compliance with formulary to go up into
the mid 90s, so it s the efficacy of this intervention that is going, that has
the potential to markedly impact patient care.

DR. WARREN:  I m still not really clear what your issue is in us
recommending standards because we re looking at providing more information to
the physician at the point that they re writing the prescription.

DR. CHESS:  The issue is not standards, the issue is what the interface
is, it s how it s done and how and if it creates barriers for the physician to
prescribe what he or she believes is in the best interest of their
patient.  It is not having a window that says this is the preferred and
these are the different dollars involved if a person has that.  It s the
easy override of that because I know that s what s in the best interest of my
patient.  And in fact that may be a good thing because it cuts out a phone
call from the pharmacist because I m writing the more expensive thing for you
and this is why, so that conversation ensues.

DR. WARREN:  Then what you re speaking more about is some of the
workflow standards that Ms. Rein was talking about.

DR. CHESS:  Right, but those are guidelines, those are going to be
guidelines in terms of what a PBM or what government or what a health care
company is allowed to put on that face.  Are you allowed to put required
to call this number?  You do that you are markedly impacting patient care.

DR. WARREN:  My last question is for Ms. Rein, you had talked about
having the patients accessing their own medication record and being able to
update that and things like that.  How would you see that happening, would
that be like a web based tool or have you not —

MS. REIN:  I think that eventually that s the direction we would like
to see and it would be part of a broader health record that s accessed.
But I think we re a long way of seeing the vast majority of consumers having
access to those types of tools.  So the way we re approaching it initially
is I see the trajectory for our two projects, the personal medication record
and the electronic prescribing as moving in tandem.  So I think initially
we re thinking of a paper based system for that personal medication record but
eventually the electronic prescribing system should be able to incorporate in
those elements for patient access and it could be through the same media that
are used by the physicians as by the patients.

DR. WARREN:  You kind of see that as an add-on to e-prescribing
sometime in the future?  That that would be part of the process of the
patient participation?

MS. REIN:  It s something we feel very strongly that patients need to
be able to access, they need to, we need to start somewhere so we re starting
with paper saying they need to keep track of it.  But in terms of moving
forward with electronic prescribing they need to be able to access that
information otherwise the decisions that are being made by the clinician may be
done without full information and I think what we re trying to do is mitigate
the likelihood that you have adverse events and that you have fully informed
patients and fully informed physicians.  I have a couple of colleagues in
the back of the room who might have something to add on this.  Andy or
Will, do you have anything to —

MS. GREENBERG:  Come to the microphone please.

DR. COHN:  And Andy, please introduce yourself.

DR. BARBASH(?):  I m Andy Barbash, I m a neurologist, I actually work
with the SOS-Rx initiative while still practicing and doing other things.
A basic premise I think is to understand that the project to engage consumers
in their role in the management of their medication list in many ways were that
to be accelerated and become part of our standard operating culture, it would
potentially have a big impact actually on things that happen within the
e-prescribing world.  So we re envisioning that as a process in
educational outreach and beginning to develop a much more standard assumption
on the part of the larger fraction of consumers in this country that they have
an active role and responsibility in ensuring, just like all the doctors in the
room know, people walk in with a piece of paper, that that becomes more of a
standard operating behavior.  So realistically the way to start that is to
work with the kinds of tools and technologies and methods that people have
available today, for some people that s a web portal, for some others it s
cards, and others it s paper.  The important thing is developing a
standard understanding of what is the nature of the information that the
consumer has the greatest knowledge about and what role did they play in that
process.  Were that to become more of a standard part of our culture that
can come well in advance of the broad adoption of electronic prescribing but it
would end up actually having an impact on some elements of electronics
prescribing.  Is that helpful?  And relatively brief for me.

DR. COHN:  Thank you Dr. Barbash.  Are you done Judy?  Okay,
Harry.

MR. REYNOLDS:  Kind of controlling the care for two senior adults I m
well, your testimony brings back many fears from this year where we had two
drug incidents and almost lost somebody.

The issue that I see that s our job is most of the standards that have been
set forward or most of the things that have been done in the health industry
have been back office.  We are now moving the back office in the front
room together very closely in the patient care and as health care gets more
complicated education is key.  So if both of you can step back, which I m
having to do right now from the personal situation of having seen some of these
things occur so I agree with much of what you have to say, and help us take a
look at e-prescribing can be a way of sharing information, it should not be a
way necessarily telling people how to, consumers how to do what they do or
doctors how to do what they do or payers or anyone else.  So our job is to
have to step back from that both personally our own environments or anything we
do to try to create these standards.

So if each of you, and especially to Dr. Chess, the idea of things like the
prior approval or the things that since you ve done e-prescribing, I ve got 150
questions for you and I m going to ask one, but I think the key thing is since
you have used e-prescribing, when you mention things like prior approval and
you mention other things, what are the things that you have used in
e-prescribing that are pluses, and on things like prior approval which probably
going forward there will still be limitations whether on what is or isn t
covered in the industry period for a while until things sort out and until more
information is available and so on.

Now Ms. Rein from your standpoint you mentioned incentives and you mentioned
access to education material, if you could go a little further on what you re
thinking about on both of those as we do this.  So, Dr. Chess?

DR. CHESS:  The e-prescribing tool that I used, actually the company
recently went out of business, so I ve been without my toy.  But number
one the first thing that had to be done to make it workable was they had to
electronically download all my patient data into it and they did that.
They loaded it with all the pharmacies in Connecticut that I might be using so
that was already loaded on there.  And it was, I mean I actually don t
have a copy of it here but I have it on my Palm and it s just very, very
simple, you need a preauthorization to get into it so there s security
there.  And then it was a very rapid easy to find, all the meds were there
and you just scroll down, you hit what you want, and once it had the patient s
information it would, if there was an allergy it would pop out allergy, it was
there was a potential drug interaction, if the person was on Cumadon(?) and on
something else it would pop that out for you right up front before you send
it.  It also had formularies in there but it had no barriers, it was all
informative so at this early stage there was no push, it was just
education.  So I mean I loved the tool.

And then what happened is we did all of our refilling on my medical
assistants computer, that was also on the same web channel, and so I
downloaded all my stuff on that machine so the background stuff, information on
the patient is there.  When the patient s meds are refilled we know it s
been refilled, when it hasn t been we get a report every month of who hasn t
filled their medication, so we can then follow-up with a phone call and say are
you okay, what s going on.  Or pull the chart and say oh yeah, we DC d
that medication.  So as a patient quality tool it s a great tool.
And you have to understand, I m not here to stop progress, I m here because I m
an advocate for it, I just know like every tool out there it can be abused and
this is our opportunity to frame it in a way that it can be used quickly,
easily, and improve office efficiency and improve care.

MR. REYNOLDS:  So what did the formulary have on it that made it come
across to you as helpful, not a push?

DR. CHESS:  Once I chose the medication, and let s say the person was
on a Blue Cross plan, it would flash that person s Blue Cross plan, it would
say formulary, within formulary, or if it s not it would say not in formulary
and give me choices of what was formulary.  So if it was a medication that
it didn t really matter to me I would just pick something that was on
formulary.  If it did matter to me I would then talk to the patient and
say listen, this is what your insurance company pays for, this is what I d like
to do.  So there aren t any surprises when the person gets to the
pharmacy.  But again, it wasn t going through a lot of different screen,
it wasn t advertising, it gave me the data to have an intelligent informed
conversation and that s what I would like to see built in as our standards.

MR. BLAIR:  Could I ask for a little more elaboration on this?
Harry, could I share your question a little bit?  So here was information
from PBM or health plan providing a formulary to you that you felt comfortable
with and what would happen for example if you wanted to prescribe something
that was not in the formulary and you had to ask for a preauthorization, what
mechanism did they have there?

DR. CHESS:  There was no preauthorization in the system.

MR. BLAIR:  There was no, was that a frustration to you?

DR. CHESS:  No, it was wonderful because then I just prescribed what I
wanted to prescribe.  And then again it becomes an issue, the economics
here is that we all can pay out of pocket any time we want, it s our health and
it is not, sometimes we choose to get what we believe is in our best interest
and not what is the cheapest or what the PBM thinks is.  So what it allows
me to do is have that conversation with the patient up front that this is what
they want me to prescribe, this is what I want to prescribe, this is what my
concerns are, and it s the person s individual health, they get to make that
choice.  But that machine doesn t restrict me from sending in that
prescription.

PARTICIPANT:  I have a quick follow-on question, when you did receive
information of whether or not a drug was on or off formulary did it specify the
degree of cost sharing if it were?

DR. CHESS:  Yes, it usually had dollars signs, if it was three dollar
signs it was a lot, if it was two it was, so that was kind of how they broke it
down.

PARTICIPANT:  So it wouldn t differentiate between say a $20 dollar or
a $50 dollar co-pay?

DR. CHESS:  It didn t give that degree of detail but I would welcome if
it did, that would be fine.

DR. COHN:  I think I m up next unless Harry you have a final, I m
sorry, Allison.

MS. REIN:  Sure, your question was about incentives and education and I
think that what we plan on doing will address those.  I don t have
unfortunately answers because we need to do research with consumers and we need
to figure out that workflow spectrum on the continuum of care where consumers
are going to be interfacing with electronic prescribing.  And they re
currently engaging in some kind of behavior and we want them to exchange that
behavior for something that is going to benefit their health, so we need to
figure out what the compelling arguments are going to be to convince them to do
that and so whatever messages we come up with that communicate incentives are
going to hopefully capture those elements and then we would provide the
educational materials in support of that.  I could envision there being a
lot certainly with the personal medication record, encouraging use of that and
providing them with the support materials needed to do that.

DR. COHN:  Let me just ask one or two quick questions here and I just
want to warn everybody we have five more minutes before we adjourn for this
session so we ll try to keep it brief.  David I was actually going to ask
you, I mean we already had about five questions about this, you talked about
sort of principles of formulary but if you have any further thoughts we d
obviously welcome a communication, a letter from you about any other thoughts
you had though I think based on what I m hearing, principally what you re
describing is a level of transparency and I think if you had your rather you
wouldn t have pharmacy plans constructed in a way where they required
preauthorization but I m not sure I m hearing a whole lot more then that.
Am I about right?  Am I close to it?

DR. CHESS:  That s correct in the other piece and I know it s not the
purview of this committee but we have accepted formulary as a carte blanche
being acceptable and we need to go back and question that premise and say that
yes, we need to do the studies to know it s good for this group of medicines
but it may not be good for this group of medicines.  Is it good for
antidepressants, is it good for cholesterol medicine, is it good for high blood
pressure medicines, and the answer is not the same for all of them, we ve data
that really raises red flags.  We need a whole lot more study out there to
look at that because again, this is a tool that s going to push everyone into
formularies.

DR. COHN:  Okay, well David I guess I live in a  world where as
far as I know most everybody does have a formulary of one sort or another, at
least in the managed care world, and I guess the data you showed me didn t tell
me that one shouldn t have formularies, it s more that they should be
intelligently constructed.  Now let me just ask a very quick question
about your research because I notice it all labeled as unpublished data.
Obviously this is stuff that I mean I think is interesting, obviously I would
tend to believe it more if it had been refereed and published, is this going to
be coming out and will others —

DR. CHESS:  We have an economic analysis of the data that I ve done
with Marilyn Moon, that should be coming out, we re sending it into JAMA,
whether they ll accept it or not I don t know but we are working on getting
that published.  And then the data itself has only been delayed by my own
laziness, I confess.

DR. COHN:  Under those circumstances I would have a hard time faulting
you just because I think we all have that problem.  I guess in all of this
as I look at this there s quality issues, there s economic issues, and I think
that recognizing the economics is just not a health plan issue, it s really a
consumer issue, because it s how much the consumers have to pay in terms of
cost shifting and new products, it s how much really comes out of their monthly
dues and all of this.  But I guess I was sort of seeing underneath all of
this that there may be an economic argument the health plans and PBMs should
consider.

DR. CHESS:  That s exactly right, what a lot of this is just taking it
from this pocket and putting it in that pocket, it s all silo medicine here,
silo economics, and that s really the point of the work that I ve done with
Marilyn, Marilyn Moon, and that will be coming out shortly.

DR. COHN:  And we would certainly welcome quick publication of that so
we could sort of further review it.  Michael and then Steve and then
hopefully we ll take a break.

DR. FITZMAURICE:  Thank you, I enjoyed the testimony, it s always good
to hear from consumers and I think you ve registered well your concerns for
patient choice and patient safety and your advocacy for more research on health
system changes on policies.  But Judy s question and Harry s questions got
me thinking about which is better, to have a formulary that guides, restricts
physician choice, or to have the drugs tagged with their out of pocket cost to
the patient so the patient and the physician can reach a mutually informed
choice of benefits and costs.  Obviously the goal is to increase the
effectiveness of the drug decision making process and improving patient
outcomes while as Simon said constrained by the out of pocket cost to the
patient.  So the question is should the national committee advocate a
standard that permits transmitting, or permits access, to the effectiveness,
the side effect, and the patient cost information to this prescriber at the
point of the time from the prescribers making that drug decision making
choice?  And then secondly, should we be looking at a standard that allows
the prescriber to communicate to the pharmacy why that drug was chosen for that
patient?  Either one or both.

DR. CHESS:  It would be wonderful to have a real data repository that
had head to head comparisons of the medications that we use.  Those
studies are extremely rare, the only one that s come out was the recent one,
Lipitor versus Provocal(?) and they will never do that again, that is just not
research that s done.  So if you re going to have something that is
reliable and not just opinion we re going to have to, we have a lot of catch up
work to do.  So in terms of really having a comparative efficacy chart
that doesn t exist to date so that s the problem there.  And again, that s
why there needs to be really substantive research.  As we get older and
we re setting up the system for all of us here, we re all patients, we re all
on stuff and we re going to be on more stuff, so I m not sure I answered your
question but if it was available then I certainly would think that that should
be a part of it.

MS. REIN:  I would 100 percent echo that but just add that that seems
like an awful lot of information to be conveyed both to a physician and a
patient and the medium would have to be, it would have to be conducive to
understanding at both levels and I think that would be a real challenge.

DR. COHN:  Okay, Steve?

DR. STEINDEL:  First I have a comment and then my question, when you
mentioned there was only one study, I m aware of another study which was the
diuretics study versus the other forms of hypertensive medication.

DR. CHESS:  That study is different because it s not, it s generic
versus other generics in other types of medications.  What usually the
question becomes is it between a Vasotec or Lycinopril(?) or Prinivil or all
these in the same class and there s no head to head between them.  That
was comparing a separate class of medication with other classes —

DR. STEINDEL:  Which actually leads me into the question that I was
planning to ask because I got a little confused on your responses to several of
the questions looking in a broader case.  And we had a very large
conference here in Washington last week that introduced the stakeholder
framework for health IT over the next ten years and one of the key drivers for
that system is the widespread introduction of electronic health records broadly
to all providers.  And also implicit is that is decision support systems
that would come up and talk to the providers.  And information on
formulary and formulary content can be viewed as one part of a decision support
system and I was confused on at times I heard that you were in favor of these
types of systems and at other times I felt that you were not.  And if I
can summarize what I m hearing is that when they provide the proper information
based on proper studies you re very supportive of them.  Is that a fair
assumption?

DR. CHESS:  That s 100 percent correct.

MR. BLAIR:  When Steve was referring to your decision support, that is
drug to drug interactions, drug to allergy, drug to lab, that s —

DR. CHESS:  It s algorithms, I mean EMR is not foreign to me and this
is part of my world frankly.  And I have, I welcome that type of, we re
all human beings, we all forget things, we all need triggers and reminders and
if it helps me do my job better I m all for it.  At the end of the day
though I need to make a decision about the care of my patient and it may mean
taking risks that are not what the textbook say is the best channel but that s
what I need to do and I don t need barriers to do it.

DR. STEINDEL:  Thank you for that clarification.

DR. COHN:  Well with this I want to thank both of you for really what s
been a fascinating panel, we are despite my —

MR. ROTHERMICH:  May I make a comment?

DR. COHN:  Sure, if you make it brief because we re going to take a
break.

MR. ROTHERMICH:  We have our turn tomorrow so I ll keep it brief.
Phil Rothermich with Express Scripts.  I wanted to just take issue with a
couple of points that were made about formularies being driven by economics
because they re not.  As AMCP pointed out these formularies are developed
by P&T Committees which are composed of pharmacists and physicians who take
their obligations very seriously.  Economics are used to break the ties,
when research that s out there suggests that two drugs are equivalent the lower
cost alternative may be on formulary and the less efficient medication may be
considered non-formulary.  But this process is about providing information
at the point of care, it s not about changing the allegation of the physician
to make the correct decision and as Dr. Chess pointed out the conversation
between the patient and the physician can be about making those economic
choices and about making them in an informed manner.  So this shouldn t be
considered a referendum on cost management tools because I think we all
understand there isn t enough money in the system to give everybody everything
and there s often the case where there are equivalent choices, things go
generic and utilization drops dramatically because samples are no longer
available and physicians needs to be reminded that what was once a wonder drug
is still a good drug and a good choice to begin with when you have no
information about what the patient will or won t tolerate.  And so I just
want to make sure that we stay clear to the mission that no one is suggesting
that e-prescribing be used to make incorrect decisions, it s all about making
informed decisions.

DR. COHN:  Thank you.

DR. CHESS:  Can I comment?

DR. COHN:  Sure, David, go with your final comment.

DR. CHESS:  I agree with everything you said but there s, first of all
there are thousands of formularies out there and one company may be doing it in
a way that has more integrity then others.  And again it s a free market
economy so that s one point, that there s tremendous variability in how these
formularies are formed.  Number two is that you can t show me data that
says that formularies save money because the data is not out there.  When
you look at the whole continuum of care, the whole, that you re just not
increasing hospital costs, that you re just not increasing long term care
admissions, and that s the type of studies that have not been done.  So
you don t know whether or not formularies help our health care system contain
costs.  I think that they can if they re done intelligently but I don t
think we have that information.

DR. COHN:  And thankfully I guess I would observe that under the MMA
actually there are formulary discussions going on a separate track literally as
we are probably meeting here to sort of figure out how the Part D formulary is
going to be structured and what the categories are going to be.  So
obviously we have a piece of it but there s obviously, we are not ourselves
responsible for actually the formulary, we are responsible for trying to
identify ways to get that information in the most useful way possible to the
clinician.

Anyway with that I want to give everybody a ten minute break, we re running
a little bit over but not badly.  And I want to thank the people for
really a wonderful session.

[Brief break.]

DR. COHN:  Okay, would everyone please be seated?  Okay, our next
presentation is really from the Federation of State Medical Boards and I want
to thank Lisa Robin for coming and joining us.  I don t know if you d like
to introduce, yourself further or just start your testimony, your choice but we
obviously look forward to your testimony.

Agenda Item:  State Boards of Medicine – Ms.
Robin

MS. ROBIN:  Alright, thank you.  Well good morning Mr. Chairman
and members of the committee, I m Lisa Robin, vice president of leadership,
government relations, and policy for the Federation of State Medical
Boards.  The Federation is a national non-profit organization comprised of
the 70 state medical licensing and disciplinary boards of the United States and
territories.  As such the Federation is positioned as a leader in medical
regulation and an authoritative source of research, policy development,
education, and information.  The Federation s primary mission is to
improve the quality, safety, and integrity of health care by developing and
promoting high standards for medical licensure and practice.  We also
assist state medical boards in achieving their statutory mandate to protect the
public.  As a collective voice for state medical boards the Federation
monitors state and federal legislative initiatives, works collaboratively with
federal and state regulatory agencies, and offers legislative assistance to and
on behalf of our member medical boards.

Regarding the subject of interest today the internet has had a profound
impact on society including the practice of medicine and pharmacy, and offers
opportunities for improving the delivery of health care.  The appropriate
application of this technology can enhance medical care by facilitating
communications with physicians and other health care providers, refilling
prescriptions, obtaining laboratory results, scheduling appointments,
monitoring chronic conditions, providing health care information and clarifying
medicine advice.  However, the practice of medicine, including prescribing
and dispensing medications via the internet, has created complex regulatory
challenges for state medical boards in protecting the public.

The Federation of State Medical Boards has actively been involved as a
national leader on the use of telecommunications and the internet in the
practice of medicine for a number of years.  In 1996 the Federation
published a model act to regulate the practice of medicine across state
lines.  In 2000 it published guidelines for internet prescribing.  In
2002 it published model guidelines for the appropriate use of the internet in
medical practice, one of the first national standards established for internet
medical practice.

Those guidelines, which the Federation recommends be adopted by state
medical boards, emphasize the key interest of the Federation with respect to
internet pharmacies and the use of the internet in the practice of medicine as
follows.  An appropriate relationship between the patient and the
physician must exist before a prescription is written and medication
dispensed.  Failure to have an appropriate physician/patient relationship
poses serious health risk including adverse drug reactions and/or interactions,
misdiagnosis or delay in diagnosis, failure to identify complicating
conditions, and the misuse, abuse, and diversion of prescription drugs
including controlled substances.  In addition to issuing model guidelines
the Federation has aggressively sought to identify internet pharmacies that are
dispensing drugs on the basis of prescriptions written by health care providers
whose relationship with the patient does not appear to meet minimal standards.

In 2000 the Federation established the National Clearinghouse on Internet
Prescribing to collect and disseminate information on rogue internet sites,
those sites that offer both prescribing and dispensing services for
prescription drugs to consumers based on an online questionnaire.  The
Clearinghouse is unique qualified to coordinate information between regulatory
and enforcement entities because of its formal relationship with all state
medical boards and its well established lines of communication with state and
federal regulatory agencies, including the Department of Justice, the Drug
Enforcement Agency, Food and Drug Administration, and the Federal Trade
Commission, as well as the National Association of Boards of Pharmacy, the
National Association of Drug Diversion Investigators, and the National
Association of Attorneys General.

To date the Clearinghouse has supplied information for more then 150 cases
on the federal level and more then 300 cases on the state level.  The
Federation strongly supports state based regulation of the practice of
medicine.  With regard to internet prescribing state medical boards have
the authority to discipline licensed physicians prescribing and dispensing
medications inappropriately.  39 state medical boards have already taken
actions against licensees.  26 have adopted rules and policies, and 14
states have introduced legislation to clarify this authority.  In addition
state medical boards are communicating among themselves regarding physicians
licensed in more then one state.  These cooperative efforts have been
effective in closing several internet sites and causing a number of physicians
to cease their affiliation with questionable operations.

The Federation has also supported the development of federal legislation to
protect patients ordering prescriptions over the internet.  H.R. 3880, the
Internet Pharmacy Consumer Protection Act, and its companion bill S. 2464,
which are currently before Congress, would provide significant protection for
consumers who use the internet to obtain pharmaceuticals.  H.R. 3880
addresses three issues crucial to the protection of patients ordering
prescriptions over the internet.

First, patients should know with whom they are dealing, the bill requires an
internet pharmacy to disclose the name and location of the pharmacy that is
dispensing the drug as well as the name and licensing information of the
physician providing the medical consultation on which the prescription is
based.  If a physician wrote a prescription on the basis of an online
questionnaire without having any preexisting relationship with the patient then
almost without exception a state would find that such physician had violated
practice standards.  Therefore disclosure will not only be beneficial to
patients but will allow state medical boards to identify individuals against
whom they can take a disciplinary action.

Second, state attorneys general are not able to enjoin the operations of an
internet pharmacy that effects citizens in their particular state if that
pharmacy is operated out of another state.  Many of our member boards
believe that a number of internet sites that dispense drugs in an inappropriate
manner could be shut down if the attorneys general had nationwide injunctive
powers as well as the ability to pursue other civil remedies, including
damages, restitution, or other compensation across state lines.  The bill
authorizes those injunctive powers.

Third, while state boards have the authority to discipline physicians who
are prescribing and dispensing drugs over the internet inappropriately the
boards cannot take action against operators of internet sites that dispense
drugs.  While state medical boards believe that the law and regulations
governing the physicians in their state are clear as to what constitutes an
appropriate physician/patient relationship for purposes of writing a
prescriptions some courts and prosecutors believe that certain state laws and
regulations were ambiguous in this regard and thus failed to pursue certain
legal actions.  H.R. 3880 addresses this ambiguity with language which
strikes a reasonable balance in requiring and defining an appropriate
physician/patient relationship for the narrow purpose of regulating internet
pharmacies while recognizing the exclusive role of state medical boards in
defining that relationship under other circumstances.

In its model guidelines for the appropriate use of the internet in medical
practice the Federation addresses physician use of electronic communications
and the internet in the delivery of patient care.  Pertinent portions of
the guidelines are as follows.  Treatment and consultation recommendations
made in an online setting, including issuing a prescription via electronic
means, will be held to the same standards of appropriate practice as those in
traditional or face to face settings.  Treatment including issuing a
prescription based solely on an online questionnaire or consultation does not
constitute an acceptable standard of care.  A documented patient
evaluation including history and physical evaluation adequate to establish
diagnosis and identify underlying conditions must be obtained prior to
providing treatment, including issuing prescriptions electronically or
otherwise.  Physician offices should have written policies and procedures
that address privacy, health care personnel who will process electronic
messages, hours of operation, types of transactions that will be permitted
electronically, required patient information that should be included in the
communications, archival and retrieval, and quality oversight mechanisms.
Sufficient security measures must be in place and documented to assure
confidentiality and integrity of patient identifiable information.  All
patient related electronic communications, including patient/physician email,
prescriptions, lab results, evaluation, and consultations should be stored and
filed in the patient s medical record.

In conclusion the internet offers tremendous opportunities for improving the
delivery of health care and can be convenient for patients and cost
effective.  However, it is the position of the Federation that use of the
internet in providing medical services, including prescribing and dispensing
medications, should supplement and enhance but not replace the crucial
interpersonal interactions that create the very basis of the physician/patient
relationship.

Thank you for the opportunity to testify today and I ll be happy to answer
any questions.

DR. COHN:  Lisa, thank you.  Do you want to introduce the person
—

MS. ROBIN:  Yes, this is Eddie Allen and he s the Federation s
Washington representative.

DR. COHN:  Okay, thank you for joining us.  Jeff, I know you have
a question and I think I have, okay, Jeff.

MR. BLAIR:  Thank you, Lisa, I think what the Federation is doing with
respect to internet pharmacies is very important and very helpful.  Has
the Federation looked at all at issues related to e-prescribing between
prescribers and retail and commercial pharmacies?

MS. ROBIN:  No, we have not, actually the scope of the Federation is
limited to the physician s practice and protecting the patients in this area.

DR. COHN:  Jeff I think you sort of asked the question that I was
asking which is whether they had any comments related to the Medicare
Modernization Act and it looks like that s not something that either has been
discussed by the Federation or at this point isn t within the scope of your
discussions.

MS. ROBIN:  Right, we just wanted to raise our concerns that there
would be adequate standards in place that would protect patient information and
ensure that there s an appropriate relationship between the physician and
patient.

DR. COHN:  Let me just ask about that one because I m actually looking
at your areas and concerns, it s actually sort of a novel, it s an area that I
haven t really thought about.  Actually that s not quite true, it s an
area that I ve thought about in a different context but it seems to me that
really probably somewhere in our document should be a comment about a need for
all of this coming out of an appropriate interaction and relationship between a
physician and provider, which I think is really the basis of your concern here.

MS. ROBIN:  Yes, and that there be appropriate licensure, that the
physician would be licensed in the jurisdiction that the patient is located.

DR. COHN:  I think that s very helpful.  Steve?

DR. STEINDEL:  Just a quick clarification on the comment that you just
made, do you mean the prescriber?  Because in many cases in many states it
can be somebody other then the physician.

MS. ROBIN:  Correct, my comments would be limited to usually the
physician because that s who state medical boards, but also in some states they
have jurisdiction over other prescribers but it would be the prescriber, yeah.

DR. STEINDEL:  Thank you.

DR. FITZMAURICE:  I notice in your testimony that you re concerned
about the physician/patient relationship and the internet pharmacies and the
lack of relationship between a physician and a patient, or at least the
prescriber and the patient.  A lot of what you talk about though since a
pharmacy could be one place, a prescriber could be another place, seems to be
interstate commerce with these internet pharmacies and usually we re getting
into states versus federal authorities.  And your response seems to be
well lets give the state attorneys general national authority.  Is there
some point at which it crosses and you would say well maybe this is a role for
some place in the federal government and I m not sure where that would be?

Secondly, you want the patient information to be put into the patient s
record, but some people have an idea of the electronic health record as being a
website located wherever and physicians and hospitals and caregivers from all
over feed information into that record even across state lines.  So I m
sensing a starting of the blurring of state lines and a discussion perhaps
somewhere else of state s responsibilities versus federal
responsibilities.  Has any of that been part of your thinking as well?

MS. ROBIN:  Yes, as we have, and Eddie may be able to address this
better then I.

MR. ALLEN:  With respect to the jurisdiction of states attorney
generals, our support of giving them those types of abilities really stems from
the fact that the main tool to go after internet pharmacies in terms of statute
now is the Food Drug and Cosmetic Act, which is a federal law but we are aware
of the fact that the prosecutorial resources at the federal level may be
limited particularly in certain areas.  And so this would be a situation
where the state attorney generals essentially would be able to supplement the
activities of the local U.S. attorneys.

DR. FITZMAURICE:  Let me follow-up with a second question and that is
the role I see of all this is really to protect the public from this, and you
talk about, you ve identified rogue pharmacies and 14 physicians have been the
subject of disciplinary actions, more then 150 cases and so forth.  Is
this information about how the rogue pharmacies are, which physicians have been
disciplined, is that available to the public that we re trying to protect?

MS. ROBIN:  Yes, any disciplinary actions against physicians is public
information.  We ve worked with the Department of Justice and oftentimes
that is not public information until after the cases have been closed.

DR. COHN:  Other questions, comments?  I m not sure that I have
any questions either based on, I mean I think you had a very succinct
testimony.  I guess the only other piece I would ask from the
subcommittee s perspective is recognizing that we are obviously talking
specifically about e-prescribing under Part D and this more general issue
assuming obviously there is the appropriate physician/patient
relationship.  Obviously we would invite any written communication if you
have further discussions with your state bodies just because some of them may
have opinions on this that are not immediately obvious to us but as such I
think we ll obviously take your testimony under consideration in terms of our
report to the Secretary and CMS.

Is there anything else that we have at this point?  I mean what this
mean is likely we can actually adjourn early for lunch.  Judy, I take back
what I just said.

DR. WARREN:  Well, no, it s what you said made me think of something a
little bit different.  When you re talking about this relationship between
the physician and the patient, and most of your testimony was about the
internet pharmacies, is there any distinction between what happens in a
telemedicine interaction with this and do you have any comments on that on
where e-prescribing would fit within that kind of interaction?

MS. ROBIN:  Well certainly and I think it does fit within the
telemedicine arena and we certainly are supportive of mechanisms that would
facilitate legitimate telemedicine practice.  The difference between the
internet pharmacies and the telemedicine is that patient records are available
in a telemedicine consultation, those physicians would have access to
information about the patient that he would be treating, prescribing, or
providing medical services for.

DR. WARREN:  So your main concern is in using the internet pharmacies
that there can be prescriptions written without any access to patient
information whatsoever?

MS. ROBIN:  Yes —

MR. ALLEN:  I mean the classic rogue pharmacy that we re talking about
is the one where the person has never had any contact with the pharmacy at all
or with a provider regarding this particular prescription, he or she fills out
an online questionnaire and on the basis of that a drug is put into the mail to
that person and sent to that person, that s what we consider the kind of
classic rogue pharmacy.

DR. HUFF:  I don t know if this applies or not but do you have any, or
have you had discussions about digital signatures or electronic signatures or
any issues related to that that need to be in place for instance if somebody
was prescribing inappropriately that would allow you then to uniquely identify
and be able to prosecute somebody who was inappropriately prescribing?
Has that been an issue of discussion?

MS. ROBIN:  It was discussed among the committee that came up with
these model policies and any system of unique identifiers would be helpful to
the system and be helpful to medical boards or other regulators in identifying
those individuals.

DR. COHN:  Steve and Michael.

DR. STEINDEL:  Your statement about the rogue pharmacies and your
issue about them not having access to the patient s medical records and just
basing on a questionnaire, if we move on to what was envisioned last week here
in Washington to the National Health Information Infrastructure where that
information could be made accessible would your objections go away?

MS. ROBIN:  The language in our policy, if the information about the
patient was evaluated, available and evaluated, yes, I don t believe that our
policy would make any distinction that there be a separate paper record, just
so the information would be available and evaluated before treatment was given.

DR. FITZMAURICE:  I guess your comments about the appropriate
physician/patient relationship gives me a little pause and I guess my question
would be does FSMB have a national definition of what the appropriate physician
relationship might be because it seems that you have guidelines for a
telemedicine relationship so that s video, you might have guidelines for a
phone relationship, and then guidelines for an email relationship, at some
point the relationship becomes so stretched or so not much of a relationship
you say now there shouldn t be a prescription filled on the basis of this
relationship.  Do you have such a definition?

MS. ROBIN:  We did not define the physician/ patient relationship and
very states have defined it because it s a fluid relationship, it s basically,
it is an offer and agreement for treatment between the physician and the
patient.  It doesn t have to be in person according to our policies, it
could be a distance relationship, but there has to be some offer for treatment
and acceptance for that treatment.

MR. ALLEN:  But Lisa s answer points up one of the problems which is
that when you re in a situation involving a rogue pharmacy in the absence of
there being a very hard and fast definition of what a patient relationship with
a physician is prosecutors are reluctant to proceed for fear of not being able
to prevail in court, which is why we signed on to a definition in this
legislation that Lisa talked about for the limited purpose of pursuing people
who operate these rogue internet pharmacy sites with a specific proviso in the
legislation that for all other purposes the definition of what an adequate
patient/physician relationship resided in the individual states.

DR. COHN:  Jeff, I think you have a question?

MR. BLAIR:  Yes, whenever Stan asks a question I always try to
piggyback on it, it s just a policy that I have.  His question just
brought up a thought, because he asked about e-prescribing, actually electronic
signatures, and what occurred to me was you re concerned about whether or not
there s either appropriate information or an authenticated prescriber involved
in the process that evaluates that information.  And e-signatures kind of
gets to that in the sense that do you have a position, or have you examined the
idea of using electronic signatures to authenticate that there is a board
certified prescriber of some type that actually assumes the responsibility for
reviewing the patient information, might be done electronically, where are you
or what guidance or what thoughts can you share with us on those lines?

MR. ALLEN:  I think a number of the individual states are looking at
how to use electronic signatures and how those fit into the practice of
medicine.  The Federation has not provided guidance to the states on that.

DR. COHN:  And I guess just maybe to paraphrase what I think I m
hearing from you, I don t hear that you re having an issue identifying who s
dispensing the medication or who s writing the prescription here, it s really
more a question that you have that it s not a legitimate physician/patient
relationship.

MS. ROBIN:  Well, that they are a licensed physician and as far as —

MR. ALLEN:  We eventually identify them but the fact is that if they re
hiding without any identifying information on a website that doesn t identify
whose actually writing the prescription it takes us a whole to find out who
actually, I mean it mean, it s not until we get B. Smith on the package of
pills that arrives in the patient s home that we have any hint as to who this
person is.

MS. ROBIN:  We believe it s critical that the patient have information
as to where the physician or the other, or the prescriber is licensed, so in
the event of an adverse outcome they do have a remedy, they know what state
board, who has jurisdiction for that prescriber and where they may go to file a
complaint.

MR. BLAIR:  Let me clarify my question a little bit here.  Remove
the issue of whether electronic signatures is a mechanism here, what you re
focused on is that the prescriber be identified, be licensed, and there s some
authentication process that that prescriber is the one that reviewed the
specific information for that prescription.  Is that correct?

MS. ROBIN:  Yes.

MR. ALLEN:  Exactly right.

MR. BLAIR:  Okay, then that probably becomes a set of criteria that s
applicable whether it is an internet pharmacy or whether it s e-prescribing.

MS. ROBIN:  Yes.

MR. BLAIR:  Thank you.

DR. COHN:  Karen has a question?

MS. TRUDEL:  I just want to clarify and I don t mean to put you on the
spot but in the list of stakeholders that the Congress wanted the committee to
consult was state boards of medicine.  And what I think I m hearing as the
bottom line here in terms of your general position on electronic prescribing is
that electronic prescribing in and of itself when done as part of a physician s
normal office practice does not generate any additional conduct requirements
then if the prescription were being written on paper.  And so I guess what
I m kind of saying is it sounds like you re saying this is not a particularly
critical factor from the perspective of state boards and I just want to clarify
that.

MS. ROBIN:  I would just make the point that e-prescribing should be
held to the same standards as any other area of practice.

MS. TRUDEL:  Okay, thanks.

DR. COHN:  Any other questions?  Okay, well I think we re actually
going to adjourn a couple minutes early, we will reconvene at 1:00, I want to
thank our presenters for a very helpful session and we ll come back, give
everybody a couple minutes over an hour and we ll see everybody back at 1:00.

[Whereupon at 11:56 a.m. the meeting was recessed, to reconvene at 1:00 p.m.
the same afternoon, July 28, 2004.]

A F T E R N O
O N  S E S S I O
N     [1:10 p.m.]

DR. COHN:  We re going to get started here for our afternoon
session.  Our first panel this afternoon is from the State Boards of
Pharmacy and we re happy to have, well, —

MS. ANAGNOSTIADIS:  I ll help you out —

DR. COHN:  Thank you, we were trying to practice and I think I would
butcher it.

MS. ANAGNOSTIADIS:  Eleni Anagnostiadis, I m the patient safety senior
manager with NABP.

DR. COHN:  Okay, thanks.  And our other panelist is Carmen
Catizone, 50 percent that s not too bad.  I believe Eleni you re going to
lead off.  Oh, Carmen is going to lead off, okay, please.

Agenda Item:  State Boards of Pharmacy – Mr. Catizone
and Ms. Anagnostiadis

MR. CATIZONE:  Thank you Mr. Chairman and thank you to the committee
members for the opportunity to appear today and share some information with all
of you.  We represent the National Association of Boards of Pharmacy which
is very similar to the Federation of State Medical Boards and our members are
the jurisdictions that regulate the practice of pharmacy, the pharmacist and
pharmacies throughout the United States.  Our membership also includes New
Zealand, Australia, South Africa, and eight provinces in Canada, so we have an
international perspective as well.

We ve been involved in electronic transmission of prescriptions since 1996,
we ve convened various task forces, participated in various conferences, and in
fact contacted CMS in 2001 after a task force convened and presented some
information to CMS in regard to electronic transmission and the efforts of the
State Boards of Pharmacy.  At that time CMS responded back to us in
February of 2003 and indicated that they were sensitive to the issues of the
state boards and were anxious to work with us.

The primary document that we use in communicating or working with electronic
transmission is a model state pharmacy practice act and regulations, which is a
roadmap or guideline for the states.  And early on the activities on the
model act and what the states focuses on facsimile transmissions, although
electronic transmission was a new concept the computer to computer processes
and programs weren t actually in effect and it was primarily facsimile
transmissions of prescriptions, and even at that time it was limited to
transmission of prescriptions.

We ve defined key terms that are relevant to electronic transmission,
digital signature, electronic signature, and if computer systems which the
states utilize have to have security systems for access and authenticating the
prescriber, authenticating the pharmacist, and authenticating the patient
information.  So state regulations are very much involved in this area and
have been very interested in what s happening federally and the new standards
that may be developed.

I d like to turn it over to Eleni now who will talk with you about a recent
survey she conducted of the States Boards of Pharmacy.

MS. ANAGNOSTIADIS:  Regulatory activity regarding the electronic
transmission has significantly increased in the past year closely associated
with anticipated changes in the Medicare requirements and the expected
initiative of the federal government to encourage that adaptation.  In
order to determine the extent of this activity and the similarity or variations
among the states NABP recently conducted a survey of the State Boards of
Pharmacy to determine which states actually allow for electronic transmission
of prescriptions and to determine and identify challenges and/or barriers the
states face in either developing regulations and/or implementing electronic
transmission of prescriptions in their state.

We did learn that nearly every state does allow for electronic transmission
of prescriptions in some form, as Carmen alluded to this also includes
facsimile prescriptions.

A couple of the major challenges and barriers that came out of the survey
results had to do with security and technology and I ll just list a couple,
they re bulleted in your handout, these are some of the things that the states
responded to specifically.  The lack of uniformity of security and
safeguards used by companies.  The actual security of the prescriptions
verifying the authenticity.  Electronic signatures versus digital
signatures.  Intervention by a third party, that is a software company
perhaps having access to patient specific information.  Forgery.  And
incorporating biometrics to assure irrefutability.

In the technology area the things that they mentioned had to do with the
ever changing technology and sometimes the regulations, they can t change the
regulations as frequently as the evolving technology so that was one of the
barriers that they faced.  One of the states also mentioned that the
government process required to approve new regulations can be timely and
sometimes it is an impediment in getting something like this passed.

In discussions that I had with Maria from CMS, who by the way did a
phenomenal job in setting this up and we appreciate her efforts here, I asked
her what might be of benefit to this committee and she asked if we could maybe
do a side by side comparison of the various state regulations that had to do
with electronic transmission of prescriptions.  It was very difficult to
do because it s like comparing apples and oranges but I did attempt and in the
back of the handout, and I m going to highlight some of these points here, but
there is a comparison chart at the back of the handout and I m just going to
preface it by saying it is not all inclusive nor is it comprehensive, it s just
to give you an idea of the different regulations that might, that you might
find in the different states.

First I m going to point out some of the similarities among the regulations
in the various states.  Electronic signature and/or other secure method of
validation is very high on the priority list of many of the states and they
include them in their regulations.  Nearly half of the states require some
form of electronic signature and/or other secure method of validation.  A
few states, I believe it s two or three, require digital signatures, however I
will tell you I ve been in contact with one of those states who have said that
they re trying now to change the regulations to allow for electronic
signatures, so they re moving backwards and saying I think this is a cost of
the technology that s available, they actually are going to address it in their
next legislative session to alter that language to include electronic
signatures.  And roughly one third of the states do not specifically
address this issue of electronic transmission or signature.

I m going to leave a copy of this with you, Carmen alluded to it earlier,
this is actually the roadmap and model rules and regulations that the National
Association of Boards of Pharmacy puts together that has to do with the
practice act and regulations.  This actually, we do define electronic
signature and digital signatures in here and our recommendation to the state
boards is to if a prescription is transmitted electronically that either an
electronic or a digital signature accompany the prescription from the
prescriber to the pharmacy.  I will mention one thing, the Drug
Enforcement Agency is the agency that is responsible for controlled substances
and the allowance of prescriptions to be transposed electronically, however
they have not come out yet with their regulations regarding what type of
signature will be necessary in order to transmit controlled substances.
So I would urge the committee to maybe have a conversation or dialogue with the
Drug Enforcement Administration to see where they stand.

Some of the other similarities regarding what must be included on the
electronic order, for example the transmitter s phone number must be there for
verbal confirmation, the time and date of the transmission, the identity of the
pharmacy intended to receive the transmission, and also the authorizing
agent.  We must be able to track back who the authorizing agent is who
allowed that prescription to go through.

And finally another commonality is the pharmacist s ability to exercise
professional judgment regarding authenticity and validity of the
prescription.  And those three commonalities are incorporated in the model
rules and I do have, appendix A actually has some of that information there for
you as well.

I m going to switch gears real quick and just talk about five core
principles that we at NABP would like to see incorporated into a standard, or
core elements.  These principles were designed to assure that electronic
transmission standards safeguard patient health, safety, and welfare.  The
objectives in the Medicare law are very similar to the objectives that we have,
one, improving patient care and two, improving the quality of the care that the
patient receives.

The first element is ensuring against unauthorized access, it s really
important that the integrity of the prescription not be compromised in
electronic transmission of a prescription.  The prescription shall be
transmitted directly to a pharmacist in a licensed pharmacy of the patient s
choice with no intervening person having access to the prescription drug
order.  Any altering by an intermediary would adversely effect patient
safety and is in direct conflict with state laws that were established to
ensure the integrity of the prescribing process.

The second core element is the authenticity and security of prescriptions
which I alluded to earlier, it s important that either an electronic or digital
signature or some method of validation to authenticate that prescription be
part of the national standard.  Privacy and patient confidentiality,
everybody that was at the meeting last week I know understands that this is an
issue, it s greater then just electronic prescribing and it s going to be even
more important as we move towards the electronic health record.  But the
national standard should require that all entities that have access to any of
the patient specific information comply with the HIPAA regulations.

Patient choice, the patient shall have the freedom of choice regarding the
pharmacy at which their prescriptions are filled regardless of whether or not
the technological capabilities are there.  And finally the
prescriber/pharmacist collaboration must remain intact.  It s very
important that the communication between the prescriber and the pharmacist is
not hindered at all with the adoption of electronic prescribing.  We see
it as an opportunity to increase the communication between the prescriber and
the pharmacy but it s just important that the pharmacy have the opportunity to
contact the doctor for questions about drug interactions or perhaps there may
be allergies noted on the pharmacy prescription, the software system in the
pharmacy, or there might be over the counter medications that the patient takes
the doctor might not be aware of.  So maintaining that interaction between
the prescriber and the pharmacist is also key.

Now I m going to turn it back over to Carmen.

MR. CATIZONE:  And to summarize and close I think what we tried to
illustrate in our verbal presentation today which is presented more in depth in
our written testimony was that the State Boards of Pharmacy have been involved
in this issue since 1996 beginning with the use of facsimile transmissions and
our perspective has been the public health and safety, so we ve looked at
issues like access to that prescription order, who should have access, who
shouldn t, and the standards for the prescription format, standards for the
quality of care that the provider should be delivering to their patients, as
well as defining any entity that s involved in accessing those records and
making decisions about that patient s medication as being involved in the
practice of pharmacy and therefore being required to be licensed as a pharmacy
or as a pharmacy benefit manager, or as an entity that s practicing pharmacy in
those states.

We ve not been as much involved in the technical standard portion of
electronic transmission, we ve deferred to the other standards setting
organizations but we ve worked very closely with them to make sure those
standards are recognized by state regulation in some degree, and also that
those standards don t conflict with state regulation or state security
requirements for processing systems.

And finally we re concerned about preemption, we understand the need for
preemption of state pharmacy acts and regulations to avoid a disparity among
the states and to provide some uniformity and to ease the interstate
transmission and conduct of business, but at the same time we think there are
some very good safeguards in the state laws that should not be preempted by any
federal standards or any federal legislation.  We ve been involved in the
internet like the Federation, we have an accreditation program for internet
pharmacies, we look at the transmission of data and prescriptions, and we also
have a service where we notify states of pharmacies and pharmacists that have
been disciplined, as well as collect consumer complaints in regard to internet
transactions, internet adverse reactions.

And again in closing we would be glad to work very closely with the
committee and provide you with any additional information or answer any
questions you may have as you move through your process.  Thank you.

DR. COHN:  Thank you both very much, I m sure that we have a number of
questions from the subcommittee.  I guess I want to lead off with one or
two here and one of them just to get some additional clarification from not
your last sentence but probably two or three sentences back where you made a
comment that sounded very good at a high level but I don t know exactly what it
means about that there are certain things in the state regs that ought not to
be preempted, and maybe you can explain that a little further especially in
light I think of Eleni s sort of comment that she believed that she reviewed
the various state regs, that they were described as apples and oranges.
So either give us some examples or give us some —

MR. CATIZONE:  The principles which Eleni touched upon are the areas
that we think shouldn t be preempted, the access to the medication record, the
security, the confidentiality —

MR. BLAIR:  Could you go a little slower and when you say these items
could you, like access, access by who, please explain it fully, each of these.

MR. CATIZONE:  The position which NABP has taken and which many of the
state boards have taken in regard to access is that when that medication order
or that prescription is transmitted from the prescriber to the pharmacy there
should not be an intervening third party that would alter that medication or
alter that prescription.  If there is access to that medication to
determine whether or not the patient is eligible for that health plan or
whether or not that actually is the person within that plan or within a certain
formulary, that s a lot different then changing the medication to some other
product, that s the access that we re talking about.

In terms of security some states do not even allow passwords to be used for
computer systems for processing prescriptions because they re concerned that
the passwords don t provide the level of security that they feel necessary for
some of those systems.  That s probably the extreme and not the position
that NABP would take but certainly we would ask that you look at certain
security provisions for accessing systems that are being used by prescribers
and pharmacies for sending and receiving prescriptions.

And then the HIPAA privacy requirements and confidentiality laws, we ve
worked with the states to make sure that the state laws complement HIPAA and
provide the extra assurances that may be needed that weren t part of the
federal act.  So those are just some of the areas that we would have
concern with.

DR. COHN:  I think Jeff has a question and then Steve.

MR. BLAIR:  Eleni, I believe you had the observation that there s some
of the states that have backed off of digital signatures and are now finding
electronic signatures acceptable.  And are you able to give us a little
bit more of a description as to how you or they define digital signatures
versus electronic signatures?

MS. ANAGNOSTIADIS:  I ll be happy to share what our definition is of
digital and electronic signature.  I don t know that they re utilizing the
same definition that we are but —

MR. CATIZONE:  And as Eleni is looking that up, the problem that we re
facing at the state level with these definitions is we re awaiting the federal
definitions to make sure there s not a conflict.  So we ve looked at the
FDA s definition of electronic signature which they accept as part of the drug
approval process in those applications and we re awaiting with the DEA is going
to say in terms of their digital signatures.  So the states have been on
hold saying how do we define this, not knowing what the federal definitions may
be and as Eleni reads our definitions they ve served as just a starting point
for the states, maybe a holding pattern, to reserve a place in their definition
sections for what may be forthcoming we hope soon from the federal government.

MS. ANAGNOSTIADIS:  And before I share those definitions with you I am
happy to supply the subcommittee with the results of the survey and one thing
that I didn t mention just because of the time limitation was that a lot of the
states did talk about the Drug Enforcement Agency and the importance of them
getting out what their regulations are going to be for controlled
substances.  Because again, they don t want to go in and put electronic,
change the regulations and the DEA say you need a digital signature, so there
are some states that are on hold.

For Mr. Blair, electronic signature is an electronic sound, symbol, or
process attached to or logically associated with a record, an executed or
adopted by a person with the intent to sign the record.  A digital
signature on the other hand means an electronic signature based upon
cryptographic methods of originator authentication and computed by using a set
of rules and a set of parameters so that the identity of the signer and the
integrity of the data can be verified.

MR. BLAIR:  So in both cases, I may be reading something in here, maybe
your thought on this, is it your opinion that in both cases whether it s an
electronic signature which from your definition, that s consistent with my
perceptions of what they are too in that electronic signatures are broader and
a digital signature is an electronic signature but not all electronic
signatures are digital, that s one piece.  But the other piece is it
sounds to me as if they require, or they enable the identification of the
individual signing it, authentication and non-repudiation.  Are those the
three elements that seem to be retained no matter whether they call it digital
or electronic?

MS. ANAGNOSTIADIS:  Yes, that is my understanding.

DR. COHN:  Steve?

DR. STEINDEL:  Yes, thank you, I have two unrelated questions,
originally it was just to one of you but you both picked up on this.  When
you said that an electronic prescription should, the way it flows, the original
words were used was it should not be touched by another person in the
process.  And then Carmen the way I interpreted some of your expansion of
it, it might be we could have intervening computer systems involved with it,
which aren t persons, that could potentially change it and what really I was,
the question I was getting to was are you really looking for some type of
non-repudiation on an electronic signature and it really doesn t matter when
intervening bodies come in the way.  Because the person thing I would see
fine because I can see the flow of electronic prescriptions going through
various computer systems, so I was originally just going to ask a clarifying
question on that but when you made the statement about potential changes, etc.,
which really could occur by a computer system.  Is what you re looking for
is non-repudiation?

MR. CATIZONE:  Exactly, and in our model act we define person as any
entity, including both an individual, a corporation or pharmacy, so that term
is much broader and in the sense of touching we re saying one doesn t
manipulate that prescription to be involved in the practice of pharmacy and
secondly repudiation must occur.

DR. STEINDEL:  Thank you for the clarification.  My second
question concerns this very nice list you ve put together about state standards
in this area.  I notice a lot of them have some type of requirement for
written retention, do you have any comments on that?

MS. ANAGNOSTIADIS:  I think a lot of these, I can t tell you how
recently these regulations were updated, I think a lot of these regulations
were put into place years back before we had the every evolving technology and
moving towards that, that s a concern or a light bulb that went off in my head
as well if you have, for example, one state, and I apologize, I think I skipped
over some of the variances, one state requires a pharmacist to verify and
manually initial every electronic prescription.  Well we know that if
everything goes electronic at some point in time they re going to have to
change the regulation, it s going to be almost impossible for the pharmacist to
initial each and every one of those.

MR. CATIZONE:  Many of those regulations were written as Eleni said
when fax paper still came on rolls and it would disappear over time, so they
haven t been updated by the states.

DR. STEINDEL:  I was confused, I live in Georgia and I was confused
whether a prescription could actually flow electronically because it seemed to
require a written prescription as well.

MR. CATIZONE:  We re talking George, we re talking a lot different,
Georgia even licenses PBMs so that s a whole different state.

DR. COHN:  Okay, Michael?

DR. FITZMAURICE:  Earlier this morning we heard from the Federation of
State Medical Boards what a physician has to do to get disciplined for internet
prescribing, essentially not have patient information or have only a
questionnaire without ever seeing the patient.  What does a pharmacy have
to do to get disciplined for internet dispensing?

MR. CATIZONE:  The basis for taking action against the pharmacies and
pharmacists has been that there s not been a valid prescription as the basis
for the dispensing of that medication to the patient, or that they ve engaged
in the trafficking of diverted products by dispensing medications to patients
without any prescriptions whatsoever, or that they ve dispensed unapproved
products, particularly those that have been imported from Canada.  And
like the Federation the states are following that but the lynchpin is how you
define what is a valid prescription which goes back to the Federation of the
Medical Boards as to whether or not that involves a person to person
interaction between the prescriber and the patient, or whether a medical
questionnaire or cyberspace consultation will suffice.  Our members in the
state medical boards have said online questionnaires and cyberspace
consultations do not constitute an acceptable standard of medical practice and
our state boards have used that as a basis for taking action against
pharmacists.

DR. COHN:  Other questions from the subcommittee?  Karen?

MS. TRUDEL:  I m mindful of your statement of apples and oranges but
I m also harking back to your statement about Georgia, are there any state laws
where there are significant enough restrictions that we would be hard put to be
able to implement e-prescribing in those states or that the restrictions would
be so significant that it would be very difficult to get adequate uptake of
electronic prescribing?  And if the answer to that is yes then what would
you propose would be a course of action in those states?

MS. ANAGNOSTIADIS:  Without going back and actually looking at each
state individually I d say there might be two or three states that would have
difficulty in implementing electronic prescribing.  I don t think it s not
something that we can overcome, we re more then happy to talk with the
individual state boards of pharmacy and a lot of times it doesn t reside with
the board of pharmacy because they may agree with it but trying to get it
passed within their legislatures, so it s sometimes bigger then the board of
pharmacy piece.  But I don t think that any of these issues, challenges,
or barriers are things that we can t work with the boards to help them overcome
and if we say that this is something that s going to be done at a federal
level, if you want to participate in providing these services for Medicare
patients, then you re going to have to adapt to some of these changes.

DR. COHN:  Margaret?

MS. AMATOYABUL:  Can you address the variability of content in the sig
by state?  How variable it is?

MR. CATIZONE:  I m sorry I didn t hear that.

MS. AMATOYABUL:  Can you address the variability in the content of the
sig?

DR. COHN:  And you mean in the prescription right?

MR. CATIZONE:  You mean what is required on the prescription?
Again I would say the bulk of what is required is fairly uniform across the
states and it mirrors the federal requirements.  But as you move beyond
the core requirements you re going to find variations that may require
expiration dates in some states, that may require the pharmacist s full name in
some states, different ways to present the product, whether it s the generic
version or whether it s the brand name product with the following
substitutions.  So those are probably a lot more numerous then we would
like them to be and could be problematic if there s a standard format for
e-prescribing that doesn t meet some of those state requirements.

DR. COHN:  Any follow-up, Margaret?

MS. AMATOYABUL:  Does your model include that or did the survey include
that, the extent of variability?

MS. ANAGNOSTIADIS:  No.

MS. AMATOYABUL:  So we couldn t do anything, I mean we can t get at
that information.

MR. CATIZONE:  Sure you can, we ve done surveys, we also have within
our offices that we make available as a program that has all of the state laws
and regulations on a computer program that you can access and we ve run surveys
on what the prescription formats are in the various states, we d be glad to run
that and turn that over to the subcommittee for additional information.

DR. COHN:  That would actually be very useful and probably sooner
rather then later.

DR. HUFF:  And just to clarify, I mean she s specifically talking about
the signature line where you say two tabs four times a day, the directions to
the patient line —

DR. COHN:  Actually I think that she was referring to the entire, well,
that s both, that s why I was asking her for correction because I didn t think
it was the sig line, I thought it was the overall content that needs to be in
the sig, well, in the prescription.

MR. CATIZONE:  In our written testimony Eleni has outlined what the
basic requirements are that we ve advocated in our model act but if you re
talking about the signature you re crossing over into a whole other area and
it s outside the scope because of the drug product selection laws and the
medically necessary, those sometimes are outside the scope.

DR. COHN:  I think the sig as we re describe it is like QID, take twice
after meals, whatever, but I think that what we re really talking about is the
overall data content that is required from state to state for a legitimate
prescription.  Margaret, do I have that right?  Stan, are you okay
with that?

DR. HUFF:  Yeah, I would like the sig data but it sounds like it s hard
to get.

DR. COHN:  Well, maybe that s part of it, is that if there is, but I m
not sure anybody requires any particular content on sig level, I mean how they
write it is all free text isn t it?

DR. CATIZONE:  Well it s based upon medical and pharmacy practice
standards and what the accepted terminologies may or may not be, we now see
that the Joint Commission, JCAHO, is saying that they re trying to eliminate
the abbreviations and the use of some of those Latin or other
terminologies.  So as that standard takes effect in the hospitals it will
probably be developed or adopted by the states and those variations, those
abbreviations will be eliminated and incorporated in the state regs also.

DR. COHN:  Okay.  Jeff, question?

MR. BLAIR:  Karen Trudel asked a question about whether there s
anything that you re aware of varying by state in terms that would limit
e-prescribing.  I sort of want to pin that down a little bit more,
specifically do different states have regulations that effect either what can
be done, what can be included in the formulary or anything about formulary
information, preauthorization, or drug utilization review, those three things,
are there issues in those three areas that have to be considered if there s
federal adoption of standards for e-prescribing?

MR. CATIZONE:  As Elena mentioned earlier electronic transmission of
prescribing is probably allowed to some extent in all states.  There are
probably existing laws and regulations in the states now that are going to slow
that process down or make it more burdensome in one state compared to another
state.  Ohio is an example of a state that I think is very highly
regulated and has some very specific requirements for authentication,
signatures, passwords, those areas that may impact electronic
prescribing.  If the federal preemption is broad and ignores some of the
state requirements or the state laws that are in effect you ll probably see a
backlash from the states to try and gain some of that ground.  But if a
preemption looks at what are the good components of state laws, retains that
but tries to help, tries to work with the state to eliminate those burdens, the
more restrictive requirements, I think that approach will be much better.
There s nothing that we can think of that effects formulary or requires
formulary decisions or prior authorization in the pharmacy practice act, they
may be part of the Medicaid program requirements or some of the drug product
selection laws within the states that are outside of the boards of pharmacy
authority.  The drug utilization review would fall within the state boards
of pharmacy and states do have regulations that address that issue and what
should be done and some of the record keeping that may be necessary for that
activity.

DR. COHN:  Other questions?  Comments?  I actually have one
question, I just want to explore this just a little further, I think the full
committee or one of its associate committees may very well have a hearing
looking at privacy issues at some point in the future but having said that you
did obviously bring up the issue of privacy.  And it looks to me like you
have principles that are certainly very appropriate privacy principles in terms
of alignment with HIPAA, coverage by HIPAA in terms of this entire
process.  Are there any other concerns you have in relationship to privacy
and e-prescribing that we should be aware of or take into account?

MR. CATIZONE:  I think the other concerns or the other issues of
privacy and confidentiality are already addressed in the state practice acts
and would pertain to any medical record or patient record, whether it was
transmitted electronically or via paper or via telephone, so those requirements
are already in the state laws and acts, it s just a matter of making sure that
we complement what e-prescribing would ask for or what safeguards they would
put in place rather then conflict with existing state laws.

DR. COHN:  Okay, so I think this, make sure I understand you, I think
what you re saying is is that you re at this point not concerned about privacy
as it is right now, you just want to make sure that anything that goes forward
doesn t inadvertently decrease the privacy safeguards currently intact.

MR. CATIZONE:  Right, or decrease them to a point where the states
wouldn t be comfortable with that lessoning of restrictions.

DR. COHN:  Okay, great, thank you.  Other questions from the
subcommittee?  Well, I actually want to thank you, both the amount of
information and I m sorry I didn t have a chance to review your appendix in
advance to look at the state variability but I suspect that we will have some
additional questions for you as we begin to look through that and analyze it
and certainly any additional information that you can provide us about any of
this over the next several weeks would be certainly well appreciated,
especially the relationship to the differences in content requirements from
state to state on these prescriptions would also be very helpful as we sort of
move forward to our first set of recommendations.  Obviously I want to
thank you both very much for really a wonderful bit of information.

MS. ANAGNOSTIADIS:  I just have one parting comment, I had the
privilege of attending the meetings last week which most of you were a part of
and I just want to comment the committee for their enthusiasm and dedication to
this cause.  When I heard Secretary Thompson get up there the first day
and said his expectations of a recommendation from this committee is the end of
this year instead of next June I know how hard each and every one of you are
working and we are more then happy to support you in any way that we can.
Like I said I ll leave a copy of the model rules, forthcoming will be our
survey results, and we will be happy to do that search for you regarding the
prescription drug order.  So if we can be of further assistance don t
hesitate to ask.

DR. COHN:  Thank you so much.  Now our next panel is the payer
perspective and we can ask Joseph and Charles Kennedy, Charles I can say his
last name, Joseph maybe you can help me —

DR. RADUAZZO:  It would be my pleasure, first of all it s spelled
incorrectly, R a d u a z z o, Raduazzo —

DR. COHN:  Well, I m actually delighted that I didn t try to pronounce
your name since I would have butchered it by definition under the
circumstances.

DR. RADUAZZO:  You most certainly would not have been the first nor the
last.

I would like to thank the committee for allowing me to come and speak to you
today, electronic prescribing is something that we feel very strongly about, as
Tufts Health Plan and I do personally —

DR. COHN:  You need to get closer to the microphone.

DR. RADUAZZO:  Electronic prescribing is something that we feel is very
much needed, this comes at a level of a health plan, as a provider, and also as
the son of a pharmacist.  And also when I came in this morning, or this
afternoon and looked at the name on the outside of the building I had to
chuckle because I don t know if all of you are aware but Hubert Humphrey s
chosen profession was pharmacy, he only later went into politics and had some
success there as I recall.

What we d like to talk about today are the standards but I think more
specifically in my case I d like to tell you about our experience at Tufts
Health Plan with a pilot we did up in Massachusetts.  This little
background here, America s Health Insurance Plans is a national trade
organization for health insurance companies, there are 1300 member companies
and those companies insure approximately 200 million Americans.  Tufts
Health Plan is an AHIP member, we are a health maintenance organization, we
also offer a wide array of products to individuals through employer
groups.

We undertook a pilot for electronic prescribing along with PocketScript,
which is a company that has since been purchased by the Zicks(?) Corporation,
and AdvancePCS which has since merged with CareMark(?), we however have kept
our name over that time.  The purpose of the pilot was to demonstrate that
electronic prescribing technology could improve both the safety and efficiency
of our process of prescribing.

I don t think I d have to try to hard to convince all of you that electronic
prescribing is a necessary thing, a couple of things that you may need to know
because as we move forward with standards and try to implement electronic
prescribing we want to make sure that we re accomplishing what needs to be
done.  First of all physicians need a great deal of help keeping track of
all the medications on the market.  It s been estimated there s 17,000
brand and generic medications on the market.  There are approximately 1500
medications or new indications for existing medications that have been released
in the past three years.  The average physician deals with 16 insurance
plans, that s at least 16 different formularies and multiple benefit designs
for each plan.  This is something that we can t realistically expect
physicians to keep track of, they re going to need some help.  And rather
then send them something in the mail or have them find out after they ve made a
prescribing decision that it is not a formulary drug or there s a prior
authorization, we feel it s necessary to give that information at the exact
time that the prescription is being written and that s what makes e-prescribing
a very effective tool.

Now putting that aside there are a few other issues that the Institute of
Medicine has raised, such as the 7,000 deaths a year from medication
errors.  Ocean Leap was recently quoted as saying that that is significant
under estimation of the number of deaths from medication errors.  An
interesting statistics, you are ten times more likely to be admitted to an
emergency room due to a medication issue then a car accident, so it puts some
perspective on the issue that we have.  And the American Society of Health
Plan Pharmacists actually did a telephone survey and found that 61 percent of
patients were concerned that they might get the wrong medication so we have a
significant credibility issue with the system as it stands.

Now our pilot included 200 providers, we provided to them electronic
prescribing software and hardware, the original pilot was set up with
individual hand held computers that were connected through a wireless network
within the office, much the way your wireless phone works at home, to a server
that was in the office and was updated each night through the internet.
That included information on formulary choices on prior authorization needs, on
preferred drugs, also had some medication drug reference involved, and finally
patient history.  Now this is an important piece because the patient
history allows physicians to see what other physicians have prescribed,
unfortunately despite the technology that s available most physician s offices
are working on 19th century technology and do not communicate very
well, thus a specialist could write a prescription that the primary care
physician would be unaware of.  This is not a good situation.

The ability to get prescribed or adjudicated patient history allows a
physician at the time of prescribing to review those drugs that the patient is
actually taking and avoid potential drug/drug interactions.  Using this
technology physicians were allowed to send an electronic fax directly to the
pharmacy, an electronic fax because at that time the rules from the Board of
Pharmacy in Massachusetts did not allow for electronic signature, so that s I
think apropos to the discussion you just had.  That has since been changed
due to the Mass Medical Society and several health plans working with the Board
of Pharmacy, we ve been able to now legalize electronic signature within the
state of Massachusetts and that has made the process much easier.

Now when we look at the functionality, I d like to run through that briefly
because it mirrors what has been suggested in the Medicare Modernization Act,
patient eligibility, benefit design including prior authorization requirements,
formulary information, medication history, drug/drug interactions were added at
a later stage in the pilot, and allergy screenings are scheduled to be added at
this time I think within the next month, physician alerts about drugs that have
been discontinued, formulary changes, etc., has also been added.  And also
reporting functionality, this allows a physician to see whether or not members
fill in a prescription as intended.

And when we move to the next slide you ll see that we were able to by the
use of this technology reduce prescription rejections because physicians and
patients knew what the formulary was at the time the prescribing was taking
place.  We improved patient safety, as a matter of fact we decreased the
number of errors that occurred because they were caught before the prescription
was written due to drug/drug interaction or patient history information.
We also were able to identify issues of non-compliance and you ll three see
examples up here, one of a diabetic patient that was not filling insulin, and
not being up front with the physician about that.  Another patient that
was taking an incorrect dosage of a medication, doubling up on a pill that was
potentially dangerous.  And a third was identification of a patient that
was in fact abusing a narcotic medication and not being truthful with the
physician about filling this.

But additionally we noticed that there was a savings of at least one hour
per physician per day in the office.  This savings came mostly from the
time involved with refilling prescriptions, which now is at the click of a
button as opposed to calling the pharmacy with each individual prescription.

We also were able to poll pharmacists involved with this and found that it
saved them about an hour a day of phone calls, and that s important when you
consider that there are 150,000 phone calls a year to clarify prescriptions at
this point.  I cannot begin to estimate the number of phone calls involved
with refills on prescriptions, I know that the 150,000 that was estimated
probably is about twice as much as my office experienced a year for refills.

What about lessons learned?  Well, we did find that we needed to keep
it simple for physicians.  Actually, let me skip ahead one slide and talk
about that and then I ll move back to this first slide.  Implementing an
e-prescribing technology in an office is a bit labor intensive, there s
training that needs to go on, it needs to be integrated with a practice
management system that exists, so there is some up front work to be done.
There are also workflow changes that must take place and that takes time.
Physicians have traditionally been reluctant to change, or resistant to change,
and I think it s important to understand why that is.  Most physicians are
very busy, their offices are working to capacity, they do not have time to
change what they re doing unless it s going to save them time.

Please no one quote this in the media but a very wise managed care executive
in Massachusetts once said that free is not cheap enough for physicians, and he
was not trying to suggest that physicians are cheap, he was trying to
underscore the fact that time is at least as important to a physician as
money.  And that we need to make sure that these solutions are easy to
use, easy to understand, and we need to be able to address their concerns about
moving things into the workflow.

There are also security concerns for physician funding, the implementation
of the HIPAA legislation, physicians are very concerned about what information
they send or receive and how it happens.  It is very important as you put
together standards that the standards are compliant with the HIPAA legislation
which I believe is in the Medicare Modernization Act, but also that it is very
clear to physicians that this is the case, they are using an appropriate
e-prescribing solution that they do not need to worry that they could
potentially violate HIPAA.

State laws or regulations, I can tell you that in Massachusetts there are
two issues, one was the electronic signature which has been resolved, another
is the privacy act which does not allow physicians to see without the expressed
approval of a patient, and this is a separate approval from the HIPAA approval
that s required, to see any drug history on substance abuse, mental health, or
HIV.  Now that has caused us to limit what physicians can see in the
patient history when they use our e-prescribing devices and I will tell you
that their response has been quite negative to this.  They feel it
compromises their ability to safely prescribe and I would agree, many of those
drugs have significant drug/drug interactions.

And as far as expense physicians as far as we can tell are not willing to
foot the bill for implementing electronic prescribing, most physician offices
do not have an IT budget, they are small business for the most part and do not
have the money to invest in electronic prescribing.  As a matter of fact
our focus groups have told us that they feel they should be reimbursed to use
an electronic prescribing device.  Now I don t know whether the government
has any plans to do that, I can tell you that at the present time health plans
are considering it but we ve made no move in that direction.

Let me move back for one minute, other potential barriers to adoption.
It s our opinion that you should stick as close as possible to the standards
that were put out in the MMA.  The reason is that some of the other
suggested standards such as laboratory data and drug interaction screening will
require a merging of databases that currently do not merge, there s no
opportunity at this point except in a practice that has a very sophisticated
electronic medical record and has a very close relationship with either the lab
that they use or the hospital which they work to integrate that level of
data.

Given the fact that it s difficult to get physicians to warm up to this
technology because it represents a change I think the simpler the standards are
the better.  We d like to make sure that the standards are straightforward
enough that they could be applied evenly throughout the country.  I would
also like to suggest that the ability to change the standards be a streamlined
process.

Technology is developing at such a pace right now very similar to say cell
phones or any other electronic equipment, we are about to see RxHub come up
online, SureScripts is up online, at this point in time if it takes a year to
amend the standard as it does for the HIPAA legislation we re going to have a
problem keeping up with technologies that move slower.  So I would implore
you to find a way to create a very streamlined process so that we can keep pace
with the changes that are coming.

As far as America s Health Insurance Plan s recommendations, and I will tell
you that these are certainly in line with the feeling of payers, formulary
benefit information should be available at the point of care, I think that s a
given.  I mentioned the streamlined process so that the standards can grow
as the technology expands.  I strongly suggest, and we strongly suggest,
that a pilot be undertaken with these standards.  We learned a tremendous
amount from the pilot that we did working with only 200 physicians and I think
as you approach mandating electronic prescribing it would be very helpful to do
a pilot and I m sure that there would be ample opportunity to perform such a
pilot.

The standards as we mentioned earlier should definitely be in compliance
with HIPAA and not create additional administrative burden, and I believe
that s specifically listed in the MMA, that there shouldn t be any specific or
increased administrative burden on pharmacists or physicians.  I think by
allowing the standards to be in compliance with HIPAA and consistent with HIPAA
then physicians who have just spent a great deal of time and effort in
complying with HIPAA will find it much easier to use.

And also I think it s important to understand what eHealth Initiatives are
out there, I know that you ve had representatives from the Mass Medical Society
speak to you earlier, I believe Tom Sullivan came down, and he must have
informed you about the interoperable medical record which is what they re
moving toward, the ability to take a medical record with you as a thumb drive
or a smart card so that the patient is carrying his or her own record.
It s important that as the standards evolve they allow that to happen, they
also are consistent with electronic medical records which are being instituted
in many of the large physician practices across the country, in particularly in
academic medical centers.

That ends my part of the discussion, I ll be very happy to entertain any
questions you may have.

DR. COHN:  Okay, we ll have a conversation after both of you have
presented.

Agenda Item:  Payer Perspective – Dr.
Kennedy

DR. KENNEDY:  Good afternoon everyone and thanks for the opportunity to
share with you what Wellpoint Health Networks has done in the area of
e-prescribing.  To give you a little introduction on Wellpoint, we are a
health plan, we own multiple Blues plans, Blue Cross of California, Georgia,
Missouri, Wisconsin.  We also have another health plan called
Unicare.  We have a PBM with over 40 million members associated with
it.  And we have quite a bit of experience with the internet, we have
multiple internet initiatives underway, we also reward our physicians for
quality, in fact we ve paid out over $50 million dollars for pay for
performance quality awards to physicians who meet our quality standards.

I d like to spend some time with you today talking about our technology
effort around a program we call our Physician Quality and Technology Program,
which is our name for our e-prescribing program.  We have a couple of
other initiatives underway I d like to touch on, we ve bought an outcomes
research company and with that company we are launching a variety of studies to
look at the effectiveness of clinical care within our network and I ll describe
one of those initiatives to you and describe how it relates back to
e-prescribing.

There s three key messages I would like to leave with you however.  One
is that we feel that health plans should play a central role in the deployment
of e-prescribing and electronic health records and I think through this
presentation some of that rationale will become clear.  Secondly, that the
barriers to electronic health records and e-prescribing from our perspective
are as much business model and business oriented as they are technical or
standards based.  And thirdly, that meaningful progress in deploying
e-prescribing and electronic health record solutions will require a respect for
and a focus on the payment methodologies that are currently in place and may
develop over time, as well as a focus on recent advances in biotech and
clinical research, as well as the leverage and use of the data that you capture
through this new infrastructure and how we can actually use that data to either
feed information back to physicians or come up with other business process or
business structures that actually allow you to get the value out of the
e-prescribing investment.

Our strategy in e-commerce as a health plan has generally revolved around
administrative transactions and so on the left you see I think what is quite
common for most health plans to have, which is basic functionality over their
internet for their physicians to use.  You could think of this almost as a
front office function.  We have now moved into a financial function, or
perhaps a back office function, where we are beginning to allow our physicians
to process claims over the internet via a web based link rather then
traditional EDI mechanisms.

We then plan on getting involved with what I would call clinical
administrative functions, these are things that a health plan does, they aren t
pure clinical e-commerce per se but they are administrative transactions that
are more clinically oriented, things like ER notifications, if a patient that
belongs to a particular physician goes to the emergency room that generates a
claim that comes to us.  We can deliver that message back to that
physician so he is aware of it so those types of clinical administrative
functions.

And then finally we plan to get into clinical support, i.e., actual
e-prescribing services, actual outcomes research services, that help us, that
allow us to help our physicians in our network deliver the highest quality care
that they can to our members.

With an eye towards executing this strategy we have launched a rather
significant program for us.  We call it the Physician Quality and
Technology Program and its intent was to in a very strong and meaningful way
say to the physician community that we believe e-prescribing is important and
we re willing to put significant financial resources behind it.  We
launched a program that gave physicians two choices, they could either choose a
handheld e-prescribing unit with software loaded on it for e-prescribing
capabilities, it had a wireless hub and it had a subscription to an
e-prescribing service for a one year time period.  With this
infrastructure physicians were able to get decision support at the point of
care when they were making their prescribing decisions and all prescriptions
were faxed to the pharmacy of choice.  We believe that this was the
package that we hoped that most physicians would get behind because this
offered real opportunity to improve both the quality of care and reduce the
costs.

However, we were well aware that if you look at the level of infrastructure
in the clinical environment that many of these physicians would not be ready
for such a package.  And so we also deployed an alternative package, we
called id the paperwork reduction package.  And the idea here was to give
physicians the option of getting a rather beefy desktop computer that they
could use and access our websites, and really if they didn t already have high
speed internet access, weren t already sophisticated when it came to the
internet, this was at least a first step in getting them more involved with the
internet.

Our hope was that the majority of physicians would choose the prescription
improvement package and that the minority would choose the paperwork reduction
package.  In fact it was just the opposite, almost 80 percent, greater
then 80 percent of the physicians who were offered this package chose the
desktop computer, about 15 percent or so actually chose the e-prescribing
option and that was quite disappointing to us.  I ll talk a little bit
more about that later.

As we looked this was a very significant investment for the company and we
had to come up with a variety of rationales to make an investment of this
magnitude.  And when we looked at the various vendors that were in the
space, when we looked at the level of technical sophistication of PDAs, we
believe that the technical infrastructure was not deployed but existed to be
able to do this.  When we looked at for instance the Tufts experience,
deploying something like this for 200, 300 physicians is one thing, trying to
roll it out to 19,000 physicians over five states is quite another.  And
so we were looking at it from the perspective of yes we believe that the
technical and business and clinical case is there, that it adds value, but then
when you think about how to scale this up so that a large health plan could
actually take advantage of it, what are the types of steps you would need to
take to be able to make that happen and that s where we focused a lot of our
activity.

One of the things we did feel we were on fairly solid ground was that there
were sufficient pilot successes to justify the $42 million dollar investment
and I won t go through all of these but I will mention the CAQH study that
indicated the 100 physicians that they studied for one year, about one out of
73 prescriptions were cancelled or changed due to either warnings of a
drug/drug interaction or an allergic reaction.  And when we saw that
statistic and looked at the tens of millions of prescriptions that are written
every year within our PBM and our health plan we saw a significant, we saw a
significant foundation to make this investment.

There were a variety of places we could enter into the e-prescribing space,
we could do something relatively simple like an electronic drug reference
similar to what Hippocrates offered, no connectivity but simply had drug
reference information on a handheld PDA.  We chose to do something more
complicated and yet have the potential for greater return then that and that
was what I m identifying at step four, which is a solution that offered
wireless connectivity via the internet to an ASP vendor, that ASP vendor is
then hooked up to our PBM and also has an interface to the practice management
system within the physician s practice.  What this offers is sufficient
functionality so that we think over time as we look for the results we should
be able to see meaningful improvement.

So the points that Joseph made about being able to track a patient s
medication history, we are able to do that with our solution.  We are able
to get demographic data out of our claim systems as well as to the degree it
exists from the practice management system.

This did add a certain level of complexity however, this wasn t something
that we could just contract with Dell and have them deliver thousands of PCs to
physicians across this nation.  What this required was an engineer to
actually go out to the physician site and work with them to look at what
version of their practice management system they were running and whether they
actually had an interface that was already built that they could then use to
interface to these practice management systems.

What we found was that we required that all of our vendors be HL7 compliant,
unfortunately what we found was that most of the practice management systems
out there were not.  Even if the current version is many of the physicians
were running on older versions that were not HL7 compliant.  What we ve
generally done to get around that is a batch download process where we get
information on a periodic basis and we are requiring our vendors to write a
fair number of custom interfaces so that we can support the volume of the
physician delivery system that we would like.  But this is definitely a
problem, this has definitely slowed us down and definitely speaks to the need
for standards.

Our approach around seeding the market, as we looked at our primary value
proposition, which is helping our members have financial security when it comes
to their health care needs, we are certainly well aware of the ongoing increase
in medical cost trend.  And we felt that a bold and alternative approach
to trying to control those costs other then what a health plan traditionally
does was required and it was that rationale that drove this rather significant
investment.  The primary problem we chose to address was the lack of
infrastructure so our focus was get the infrastructure out in the delivery
system so that we at least have a basis to do other things from.

We also anticipated several market impacts, one of them would be that
competitive parody would force other health plans on board or launch similar
efforts and in fact we are already cooperating with several of our competitors
to get additional physicians and additional health plan data on board with our
initial initiative.  The other thing we found was that when you try to do
something at this scale you need vendors who can actually delivery and the vast
majority of the vendors we found in this space, we put them through a variety
of tests.  One was a financial wherewithal test, another was a level of
technical sophistication, and what we found was that there was a very small
number of vendors who could meet those two requirements.  And even those
vendors who could meet those requirements were accustomed to deploying tens to
hundreds of physicians at a time, not the thousands of physicians that we were
looking to deploy.  And so by making an investment of this size we were
hoping to have some additional market impacts around attracting additional
capital to the marketplace as well as making a statement that we think that
this is a market that s going to grow and worthy of further investment.

We also used Microsoft as our technology partner so that they could provide
a level of sophistication and support.  One of the concerns that we heard
from physicians all the time was I get involved with one of these little
companies and then they go belly up and I m stuck without a solution.  And
so by having Microsoft there to validate the technology as well as having our
own business people go through the company s financials we felt we could reduce
the concern that physicians would have about making a commitment to
e-prescribing.

Let me just say that the opportunity to impact the vast majority of our
member visits, I mean we re a rather large health plan, but what we found was
that because the use of our network is relatively concentrated with an
investment of this magnitude we can actually impact about 19,000 physicians
within our network.  And when you look at the number of office visits that
that represented, that represented almost 75 percent of the office visits that
our members had.  So 19,000, although a large number, is not an unwieldy
number and is a target we feel can shoot for to getting our physician community
fully engaged with e-prescribing.

This project was launched without any specific ROI per se and what I mean by
that was it was a strategic investment because we did feel that something bold
and something different on a large scale needed to be done.  That doesn t
mean we re not tracking measures of success, however, and there are some very
concrete and low level measures of success that we think we will be able to
measure and show value.  One of them is formulary compliance and another
is generic utilization.  We know from our data very well that a one
percent increase in generic utilization equals about a half percent decrease in
total drug utilization costs.  So we feel there will be some very clear
financial measures that we ll be able to track that will show the appropriate
ROI on this investment.

We will also track measures around quality of care and we will be looking at
some of the standard utilization metrics, admissions to the ER due to adverse
drug events, or hospitalizations, as we roll out this solution to our physician
community.

I would like to mention one other thing we re doing which is we ve acquired
a company called Health Core which is an outcomes research entity.  And I
mention this in association with e-prescribe because we look at e-prescribing
not as an ends to itself but as a foundation upon which we can build additional
value for our members.  One of the things we re making a very significant
push towards is outcomes research, and let me give you a very concrete real
world example of why we think this has value.  If you have a deep
unistrombosis(?) and a blood clot in your leg and you look at the clinical
trial literature, what it will say is that the appropriate therapy which is
heparin and cumadon blood thinning , if you can keep the bleeding time in the
appropriate range the clot dissolves and you have 100 percent recovery.

If you look at the clinical trial literature it will say that about 80
percent of the time physicians are able to keep the bleeding time in the
appropriate range.  And that about 15 percent of the time it s too low,
and five percent it s too high.  Well, we delve into our data, this is
real world data that gives us information on how the physicians and patients
within our network, what s the level and quality of care that they re getting,
and what we found was that only 38 percent of the time were physicians able to
keep the bleeding time in the appropriate range.  15 percent of the time
it was too low, and worst of all 47 percent it was too high.  And the
question we asked ourselves is are the outcomes equal, and the answer is no, we
know that when it comes to bleeds from having your blood too thin the odds
increase by ten percent for every ten percent of the time the bleeding time is
too high, and for strokes because you didn t get rid of a clot, in this case in
an HO fibrillation example, the odds increase by four percent for every ten
percent of the time the bleeding time is too low.  And there s clear cost
implications to this, retreatment doubles the cost and complications increase
the cost times three.

So by using our e-prescribing infrastructure that we are deploying and a
variety of other efforts we have underway including capturing lab data from our
lab vendors, linking that to the administrative claim data that we already
have, what we are beginning to build is a comprehensive view of the clinical
practices within our network.  And what we would like to do is be able to
feed that information back to physicians so that we can help them deliver the
highest quality care that they possibly can.

I ll wrap up with just a couple of lessons learned.  The biggest
question we got from the physician community when we approached them was how
big a commitment is this if I implement e-prescribing, and they were very
concerned about disruptions to their office workflow, to having to close down
their practice for this, there was a wide variety of business relationships, be
they IPAs, medical groups, how could e-prescribing be integrated when we were
perhaps only giving four physicians out of a group of ten the e-prescribing
capability, how would that impact my office workflow.  And we spent a fair
amount of time delivering good answers to that.  We also pushed our
vendors very hard to make sure that the vast majority of these deployments
could be done remotely without a lot of onsite handholding.

There was a lot of concern about the quality of the information within the
system.  How could I ever be sure that this information is correct?
You say you have information on what drugs my patient is taking regardless of
which physician prescribed it, how can I be sure of that?  So there was a
lot of concerns about the quality of the health care history as well as you say
you re going to give me alerts and advice about drug/drug interactions, how can
I be sure that the alerts that you re giving me are quality alerts and are
actually clinically valid?  So those were the types of questions we
received from, those were the top questions we received from the physician
community.

And finally as a summary we looked at the literature out there that said
physicians are very interested in e-prescribing and that they are very focused
on it, that was not our experience.  Our experience was that e-prescribing
was not high on most physician s radar screens and that there s a significant
gulf between what the literature says physicians want and what our actual
experience was.  That wasn t a total surprise to us but the magnitude of
the gulf was a bit of a surprise.

Secondly, as we knew, there are a variety of screens between people who are
trying to influence what a physician does and the physician himself, and one of
the biggest ones is the office manager.  And the problem we faced there is
despite our best efforts to communicate the value of e-prescribing to the
office manager they did not understand nor value that.  And so if you
don t reach the physician and get their buy off you won t have as successful a
deployment as you otherwise might.

To steal Joe s words, free is not cheap enough, and that is certainly the
case.  A major hurdle was the number of physicians who were concerned
about the ongoing price after one year.  Our statement to them simply was
you know e-prescribing is coming, this is a risk free, free way to get involved
with e-prescribing and again, even that was not enough for many physicians.

And finally there was significant concerns with a health plan delivering
clinical IT solutions and the thought was are we putting cookies inside these
computers that somehow enable us to understand additional information about how
the physicians are practicing and will we somehow use this information to
extract additional financial concessions from them.  That was actually a
significant concern for many physicians and several medical societies and so
there is a very big perception issue that we still have to deal with to this
day.

Deployment of a mobile solution is complicated and time consuming, you
really are going into something that is already a high performance environment
where patients are being seen very rapidly.  When you introduce this
technology you re interrupting the fundamental DNA of a practice, patient
visits and patient revenue, and that is something that physicians are very
sensitive about as they should be.

I made the point about all vendors not being ready for this large scale
implementation, and finally PDAs did not seem to be sufficiently robust for
physician interest and objectives.  We heard quite a bit that they d
rather have a tablet PC then a PDA, we heard quite a bit that they were
concerned about only being able to prescribe within their particular practice
environment as we set up the wireless environment there.  What they really
wanted was geographic independence, wherever I am, cell phone, 802.11
environment, wherever I am I want to be able to prescribe and our solution
didn t quite enable that.

So with that I won t go through any recommendations around standards, let me
just stop there by saying Wellpoint has taken a very significant and very large
first step into e-prescribing, we ve learned a lot and we look forward to
taking these learnings and applying them more broadly within our provider
delivery system.

Thank you.

DR. COHN:  Well, thank you both for some very good testimony.  I
actually want to start out with a couple of questions and I m sure other on the
subcommittee have questions also.  Charles I was actually intrigued
because this is actually the first, I mean I ve received literature about the
Wellpoint implementation, actually I wanted to make sure that I truly
understood all the nuances of sort of what you were doing.  I guess first
of all make sure that your comment about the fact that this has been obviously
promoted primarily as an e-prescribing promotion or initiative whereas you ve
described that 80 percent of the providers actually went for regular PCs, and
just to make sure the PCs did not have the capability on them to support
e-prescribing.

DR. KENNEDY:  That s correct although we are revisiting that decision,
but the initial thought was if you aren t on the internet today we ll give you
a basic PC and internet access and you can begin to get accustomed to the
internet.  If you are already on the internet relatively technology savvy
here s a way to begin using technology in your clinical practice and that was
the e-prescribing solution.

DR. COHN:  Okay, then let me ask a follow-up question on this one which
was you had actually brought up something that I realized that we maybe not
have looked at quite as hard as we should, we ve obviously in the world of
e-prescribing have talked a lot about integration, interoperability with the
NHII, basically the clinical NHII.  But I was actually struck in your
conversation about the trouble you seem to be having with pieces of integration
with the administrative world, sort of the world of X-12 and practice office
management systems, whereas I guess I understand that what you re trying to do
is to create connectivity around the demographic data primarily and get that
information in and you sounded like you were unable to do that.

DR. KENNEDY:  Well what we wanted to do was we knew that the top, I
don t know the exact statistics but there s a relatively small number of
practice management systems that have the predominance of the market and those
tend to be the larger group practices that have the more sophisticated
solutions.  But as we looked at the 19,000 physicians in our network the
majority of them were actually practicing in environments of about five or
less.  And in those environments you find all kinds of things, all kinds
of practice management systems that haven t been updated in years, that no one
really thought how do you pull data out of these systems, and so we did run
into significant difficulties with very, very old systems that just weren t
designed for these kinds of interfaces.  We re working through those but
the point around standards and interoperability is an absolute key one.

DR. COHN:  Just to finish off this piece because I m really obviously,
obviously we want to have clinical interoperability but we also need to have
administrative clinical interoperability —

DR. KENNEDY:  Absolutely.

DR. COHN:  And is your perspective at this point based on the work
you ve done that with a current or relatively current practice office
management system that you would not have this problem?

DR. KENNEDY:  With a relatively current system we re okay, and again,
all of our vendors had interfaces that could support a HL7 interface, that were
HL7 compliance, so if the practice management system was HL7 compliant we were
fine.

DR. COHN:  That s what I meant, is you seem to be indicating issues
with the practice office management information systems.

DR. KENNEDY:  I would say about, I don t know the statistics offhand
but my guess would be just based off the volume of noise we had around this
issue that it s somewhere between a third and a half of the systems could not
interface easily with the e-prescribing solution.

DR. COHN:  Okay, I guess the final question, I know Jeff has questions
and others, but you obviously are, I mean one can take your results many
different ways and 20 percent is obviously disappointing.  On the other
hand as I was reflecting if I were being given the choice of a PDA or versus a
real computer, I hate to use those terms, I ll probably get email about that, I
might choose to get something that s big and can sit on my desktop or sit on my
desk.  How much do you think that that sort of choice impacted sort of
what happened here?

DR. KENNEDY:  Oh, quite a bit, I mean if you looked at some of our
marketing materials, I mean if you just put up a PC versus a little handheld
PDA there is kind of a value issue there.  But we went to fairly extremely
lengths to talk about the value of the underlying software, the functionality
that you got, and how that could improve the quality of your practice.
And we did let them know that the packages were equal in value in terms of
commercial value, so in fact the PDA solution actually ended up costing
more.  I really think a lot of it was deployment challenges, reaching the
physician rather then the office manager, despite our best efforts we were
effectively screened by many of the office managers, and I think that in
retrospect it probably would have been better to come up with a pure
e-prescribing solution but we knew that many of the physicians weren t ready
for it.  So we wanted to bring along all of our network so we felt we
needed at least to offer some base level of solution.

DR. COHN:  Okay, thank you, I ve obviously taken much of the time
here.  Jeff, you have questions, Steve, and Harry.

MR. BLAIR:  Are you able to tell us which of the HL7 standards you were
looking at?

DR. KENNEDY:  Not off the cuff but I could provide you that
information.

MR. BLAIR:  Or which in terms of the functions, I mean you said it was
to practice management systems —

DR. KENNEDY:  Some of them had lab data in it, some of them had patient
demographic data, some of them had ICD and PCT data, and so if we had either an
ANSI standard or an HL7 standard to be able to work with we could then talk to
that practice management system.

MR. BLAIR:  Okay, you didn t mention NCPDP as a standard at all, so
that was not involved.

DR. KENNEDY:  That s correct.

MR. BLAIR:  Okay, thank you.  And I had a question of our other
testifiers, forgive me for forgetting your name, I apologize.  You had one
statement that RxHub was beginning deployment, I don t remember your exact
words but something to that effect, could you elaborate on that a little bit?

DR. RADUAZZO:  Well, as many of you know RxHub is essentially an
enormous junction box through which health plans, pharmacies, physicians can
all communicate, and PBMs as well.  It offers significant promise when it
comes to easy transmission of electronic data in a safe secure
environment.  To date I know that they have tested and I believe they ve
made it through the eligibility portion of the system but I would have to defer
to Jim Bradley, who is the CEO of RxHub, to tell you exactly where they
are.  But as that approaches functionality it will completely change the
situation that we have.  The pilot that we did, and I would dare say that
the pilot that Wellpoint did was relying upon the ability to directly connect
with a PBM, not through an external junction box but actual direct
connection.  That s what happened with us and currently we have the
ability to do that with our health plan and with Blue Cross/Blue Shield of
Massachusetts through the e-prescribing functionality that we have
deployed.  But none of the other health plans in the area or national
health plans or Medicaid in the state of Massachusetts can send information in
that way because there s no single conduit to do that.  So once RxHub is
functioning to that level we will have the ability to allow that level of
functionality, interactive formulary information and eligibility information,
on virtually any patient that comes in to see a physician.

DR. KENNEDY:  And Joe is absolutely right, we have a custom direct
interface with Zicks and Allscripts but we ve required in our contract that
they link to RxHub so that as additional PBMs come on board that functionality
will be available to the physicians.

MR. BLAIR:  Okay, so from what you re telling me the work at Tufts and
with RxHub, it was a pilot, it wasn t an actual working implementation.

DR. RADUAZZO:  No, the pilot that Tufts Health Plan undertook involved
direct connection between the Zicks Corporation, which at that time was called
PocketScripts and Advanced PCS.

MR. BLAIR:  And how long ago did that pilot complete?

DR. RADUAZZO:  That was two years ago that that was completed.

MR. BLAIR:  Two years ago and it s not been implemented since?

DR. RADUAZZO:  RxHub is not at this point transmitting that form of
information, no.

DR. COHN:  I think somebody wants to make a comment on this one, can
you introduce yourself?

MS. BURN:  I m Terri Burn with Rx-Hub, I m not usually this
quiet.  Actually we did do a pilot with Zicks Corporation, and I know
Tufts is part of that, a couple of years ago but we are in production with
Zicks Corporation and multiple other vendors as well as three PBMs, a hospital,
etc., so I m confused by your statements about that you re not working, or
RxHub is not up and running, we are up and running and we are providing that
data to Zicks Corporation from Advanced PCS, or CareMark, sorry.

DR. KENNEDY:  I think the question is in any specific geographic market
you may have varying levels of penetration and participation by PBMs but you do
have some of the large ones on board don t you?

MS. BURNS:  We have ExpressScripts, Medco Health, and the Advance
portion of CareMark, and it is a significant portion but you re right, we
aren t connected to Wellpoint, however we re open to connecting to any payer
who d like to work with RxHub and we have been using these standards for three
years, so just a clarification.

DR. COHN:  Jeff, any additional questions or can we go on?  Steve.

DR. STEINDEL:  Yes, Dr. Kennedy I probably have about a thousand
questions and a thousand comments about your presentation, mostly with respect
to what happened last week when the strategic plan was presented, a lot of it
has to do with incentives, etc., and what you re doing.  But getting down
to the specifics of what we re focusing on today in the e-prescribing area, one
thing I was impressed by was there seemed to be a presumption that every office
you went into had a practice management system and you were linking into
that.  Do you have any idea of how many offices you went into had
electronic health records?

DR. KENNEDY:  This is a guess but about less then five percent.

DR. STEINDEL:  Less then five percent, so it s in line with what we re
hearing nationally, that s what I suspected.  The other sense that I got
from probably a very early slide where you showed the various stages of
connectivity that Wellpoint is going through, it seemed to be that a lot of
those solutions were proprietary solutions and that is the case, I can see by
your nodding your head and I wanted to confirm that.

DR. KENNEDY:  Yes they are.

DR. STEINDEL:  Okay, if a set of e-prescribing standards came out would
you still maintain those proprietary connections and provide access to the
standards or would you go to the standard base solutions?

DR. KENNEDY:  We would encourage our vendors to go to the standards.

DR. STEINDEL:  Okay, thank you.

DR. COHN:  Harry?

MR. REYNOLDS:  I have three questions that each of you could answer if
you would please.  The first was the mention that standards should only be
focused on MMA, so that s the charge of the committee but any time you look at
standards you wonder why that was specifically the recommendation when you have
two private sector groups sitting in front of you.

DR. RADUAZZO:  I would say that the reason that we are suggesting you
stick with what is in the original MMA document is that that is a reasonable
expectation of what can be delivered at this point in time by most
vendors.  Going beyond that may require connectivity in areas where it s
currently not available, so in an attempt to keep it as simple as possible for
physicians, because I believe as Charles pointed out there are many, many
issues well beyond the standards that deal with workflow, that deal with
getting used to technology, etc., that we will have to deal with in getting the
physician community on board with this.  Keeping the standards relatively
simple will be useful in moving things along.

DR. KENNEDY:  I think what we have tried to do as we have deployed this
program was to insulate ourselves from many of these issues by putting the
requirement on the vendors we work with to be consistent with nationally
adopted standards, so our approach is more, we re to some degree standards
agnostic but pick a standard.

MR. REYNOLDS:  Incentives for adoption, what do each of you see.

DR. KENNEDY:  Well there s no commitment nor formal plan in place at
this time at Wellpoint but the things that are being discussed are in a time of
medicine that is as complicated as where we find ourselves today, can we really
be paying quality bonuses at the level we re paying them without e-prescribing
and electronic health records, so that argument is being made internally, how
that gets implemented, if it gets implemented how it gets implemented in a
timeframe is all unknown at this point but that is certainly on our radar
screen.

The other thing we were very interested in was when Dr. Brailer made his
presentation it wasn t specific to e-prescribing and electronic health records,
he talked about clinical research and outcomes research.  We see the
opportunity to enable select physicians in our network the opportunity to
participate in outcomes research and clinical research in a much more
administratively simple way then what has occurred to date as a potential
financial opportunity for them.  So we see the potential to diversity
their revenue stream and we will take a close look as to how we can play a
constructive role.  So I think there s some pay for performance
opportunities, there s some research opportunities, and finally we will, we ve
made a public commitment to help physicians with the financial risk and the
technical risk in doing this and I think you ll see us continue to do that.

DR. RADUAZZO:  Our approach will likely take a pay for performance type
of view.  Currently we re involved with a product called Bridges to
Excellence that some of you may be aware of, Bridges to Excellence rewards
implementation of processes into a physician office that are known to improve
quality of care.  We would view e-prescribing as one of those processes
and as we move forward with products that do pay for performance, creating a
differential in payment for physicians, e-prescribing will certainly be
prominent as one of the metrics.

In addition you may have read about tiered network products that are out
there, these are found throughout the country, many of them are tiered based on
economics, we have introduced a product that is tiered based on a mixture of
quality and efficiency and certainly e-prescribing will be one of the
physician, outpatient physician metrics to determine quality.  Our feeling
is that by creating a financial business case it makes better sense, simply
paying a dollar or two may not really do it, tiering a network makes a big
difference.  And we would also like to be able to pay physicians
differently if they not only implement a process that demonstrates that they re
using the process and that s where our rationale is right now.

MR. REYNOLDS:  And the last Simon is more I guess a comment, both of
you mentioned Microsoft, Microsoft was mentioned earlier today, and as you
think of the Sasser(?) virus and the other things that went rapidly through the
country Microsoft seems to be a target so as we think about these and then you
start communicating and then it starts getting into practice management
systems, one of the things we keep hearing is protection of systems and
security and other things.

DR. RADUAZZO:  Actually the product that we re using can be used with
multiple systems, Palm, pocket PC, obviously Microsoft products and
Blackberry.  We ve tried to be operating system agnostic because it s
important to be able to connect to many different platforms, use what the
physicians are comfortable using, that s another big implementation issue when
you have to take a new device with a new operating system and introduce that
along with e-prescribing software.

MR. REYNOLDS:  Part of my point was we re trying to be somewhat
unsophisticated to reach everyone but that also brings in some risks that can
proliferate through everybody s environment much faster so we ll need to
consider that as we go on.

DR. COHN:  We probably ought to ask Charles that question also since he
was the one who obviously explicitly mentioned Microsoft as a partner.
Concerns, comments?

DR. KENNEDY:  I guess when I look at the level of concerns we have in
trying to do this at scale security was certainly at the top of the list but
part of the rationale around choosing Microsoft is they have the resources to
bear to bring security patches and solutions to the equation as fast as
possible, and it just so happened that we had a particularly strong
relationship with them.  It certainly wasn t anything magical to Microsoft
per se it s just they ve been a good technical partner of ours.  Are we
concerned about security?  Absolutely and we have within our functional
specs a lot of requirements that the user ID and password but we wanted to make
sure that none of the data was stored on the little handheld device so if
someone stole the handheld device they could get access to PHI so we made sure
all the data was stored centrally.  We went through a variety of steps to
try and be as careful as we could be about security but there was no specific
magic to Microsoft and we hope to get to platform independence, just at the
time we were deploying it they stepped to the table in a big way.

DR. COHN:  Michael, maybe the last question and then we ll take a
break.

DR. FITZMAURICE:  As you were talking maybe you answered the question
but I m not sure, for Wellpoint what is the business model for
e-prescribing?  For example there are revenue streams, does the physician
pay, does the pharmacy pay, the health plan pay, is it per transaction, is it
subscription based and to whom?  And then do national standards improve
the business case for Wellpoint?

DR. KENNEDY:  Those are good question.  The business model is a
subscriber based business mode, so we paid for all of the infrastructure to go
out there and seed the market, we also paid for a one year subscription to
the ASP vendor who was providing the service, but then after that the physician
is required to pay for the service on an ongoing basis.  We ve pushed very
hard with our vendors to get a significant discount because we brought them all
of this business so it will be a preferential fee but the physician will still
ultimately pay.

Currently there is no role for the pharmacy to play because all of the
prescriptions are being e-faxed or faxed to the pharmacy and so I know there s
been a lot of discussion about who should pay around that link and we really
tried to bypass all of that because we didn t really see, I mean there is
significant value in having the pharmacy connected but on the list of value
adding functions we felt that was toward the bottom and not toward the top so
we were okay with eliminating that piece of the peer end to end electronic
connectivity.

For Wellpoint there s several important value adds, I think one is we have a
commitment to make sure that our members get the best quality that they
possibly can get and we believe this is a vehicle to do that.  That helps
us both with our primary mission but it also helps us commercially because now
I m seeing with all this activity when a request for proposals come from the
consultants they re now asking what are you doing in the area of e-prescribing
and certainly we can describe a leadership position there.  So there s
certainly a commercial value proposition to us.  There s also a
relationship value proposition to the physician community, certainly the
relationship between health plans and physicians has had its challenges over
the year but this is an area where we feel we can collaborate and truly bring
some value that a typical physician in a small practice probably couldn t get
it.  So it has a lot of value propositions.

DR. FITZMAURICE:  And do national standards improve the business case
for you?

DR. KENNEDY:  National standards improve the business case primarily
around reducing time to deploying, improving ease of deployment, as well as
probably enabling more vendors to come into the space and not get locked into
proprietary solutions.  We would certainly like to avoid that and national
standards would certainly help.

DR. COHN:  Okay, I want to thank our presenters, it s been a very
useful conversation and I m sure we ll be talking more as we move forward on
this.  I m going to suggest we take a break for 15 minutes and we ll come
back at 3:00.

[Brief break.]

DR. COHN:  Okay, let s get seated and we ll start with our last
session.  We re obviously running a couple of minutes early which is all
to the good.  This section is really on a pharmacist perspective and we
want to thank Kevin Marvin and Sandi Mitchell for joining us.  Kevin
you re with the American Society of Health System Pharmacists —

MR. MARVIN:  Yes, I m a member of ASHP and representing them.

DR. COHN:  Okay, and Sandi, you re from Johns Hopkins, so I want to
thank you both very much for joining us.  Kevin are you going to be
starting out?

MR. MARVIN:  Yes, in fact I will give the presentation and Sandi here
is to help support with examples and so forth as questions come up.

Agenda Item:  Pharmacist Perspective – Mr. Marvin and
Ms. Mitchell

MR. MARVIN:  Well, thank you committee for inviting me and giving me
the opportunity to present the pharmacist perspective here.  I also thank
ASHP for supporting this opportunity as well.

I m a pharmacist and I m currently employed as a senior project manager of
information systems at Fletcher Allen Health Care in Burlington, Vermont.
Fletcher Allen is a health system in alliance with Vermont College of Medicine
and is the only academic medical center in Vermont.  We cover both Vermont
and northeastern New York, we have 500 licensed beds in the hospital, 23 sites
and 50 outreach clinics with a medical staff of more then 600 physicians.

I m also the chairperson of the American Society of Health System
Pharmacists, which is ASHPs pharmacy practice section advisory group on
physician order entry and informatics.  ASHP is a 30,000 member national
professional association that represents pharmacist practice in hospital,
health maintenance organizations, long term care facilities, home care
agencies, and other components of health care systems.  The mission of
ASHP is to advance and support the professional practice of pharmacists in
hospitals and health systems, and serve as their collective voice on issues
related to medication use and public health.

The American Society of Health System Pharmacists has a long history of
advocating Congress and federal agencies about the importance of safe and
efficient medication use process.  I m please to provide you with ASHP s
views on developing e-prescribing standards.

Studies have shown that approximately two percent of all new prescriptions
contain one or more problems requiring pharmacist intervention prior to
dispensing.  Approximately 0.5 percent of all new prescriptions contain an
error with the potential for harm if it reaches the patient.  Based on
these numbers and prescription volumes it equates to approximately 9.8 million
prescription errors with potential to cause patient harm entered community
pharmacies in the year 2003.  And not including hospital errors, $177
billion dollars is spent annually on outpatient medication related problems in
the United States.  Medication orders in hospitals have even a greater
rate as studies have shown.

Pharmacists serve a unique role in patient care as being responsible for the
medication use and drug distribution systems.  This responsibility
includes complying with the requirements of the FDA, the DEA, state boards of
pharmacy, Joint Commission of Accreditation of Health Care Organization, or
JCAHO, pharmacy benefit plans as well as state practice standards.  In
addition to dispensing and distribution responsibilities a large component of
pharmacist s responsibility is in the transcription, verification, translation
and communication of medication information between the components of the
medication use process.  ASHP supports efforts to standardize the
information pathways in the medication use process that are developed in an
open forum with the involvement of all stakeholders, which you re doing a great
job here in accomplishing that, to not hinder the ability to safely and
efficiently meet the patient s medication therapy needs, and are developed in
an iterative process with appropriate measures to support continuous process
improvements and improvements to the standards.  Also we believe that the
standards should be developed in consideration of the need to evolve existing
systems to meet the standards.

So in identifying potential standards there s been discussion of
identifiers, and there s a need to support universal identifiers of patients as
well as prescribers as multiple people have mentioned here.  The need for
universal patient identifiers is especially apparent when maintaining allergy
histories and immunization histories which carry throughout the life of the
patient and you certainly do not want to lose.  Standard methods are also
needed to positively verify prescribers identifiers in order to meet the DEA
and state board of pharmacy requirements which was mentioned earlier today.

In order to support the efficient use of dosing and allergy checking it is
necessary to include other patient information and to try to standardize the
communication of that information, which includes birth date, patient height
and weight, and certain laboratory results.  Minimally allergy coding
should be standardized and stored with the medication profile for retrieval in
order to reduce the potential for missed allergy errors.

Messaging standards of HL7 and NCPDP script have simplified the transmission
of medication order and prescription information between components of the
medication use process.  AHSP supports the continued expansion of these
standards to meet the e-prescribing and medication use process needs.  It
is important that the field level details of these standards match in order to
maximize the interconnectivity of these standards, as well as the cross
functionality between the systems that use these standards.

So with regards to coding standards drug names are very important.
AHSP supports the standardization on use of the generic medication name.
We support the continued development of the Rx-Norm standards which focus on
generic naming structure.  Current drug databases store multiple drug
names and this does cause a fair amount of difficulty for pharmacy.  In
testimony I ve provided some examples, artificial tears are oftentimes
described many different ways within drug databases.  Some drugs have
modifiers on them that makes significant differences from one drug to the next,
even drugs within the same name, Buproprion XL and SR are some examples
there.  And the combination products of multiple ingredients create some
difficulties as well when they re oftentimes ordered and used in multiple trade
names.

Besides drug names there are other elements that should also be
standardized, and that includes dosage forms, and the dosage form is very
important to supporting the clinical checking to make sure that you re not
comparing apples and oranges, even though the drug component is the same the
dosage may, or the form of the dosage may have significant differences in terms
of dose level checking and accurate dose level checking.  The unit of
measure is also important, there are standards are needed which allow automated
conversion of these units of measure for dose checking, one example is Digoxin
which oftentimes is ordered as 125 micrograms, or 0.125 milligrams, and many
systems do not have the ability to convert those and we need to have standards
around that.  The other standard is of course units is sometimes difficult
to convert, dealing in units, not units but international units and other
somewhat non-standard methods of measuring some medications.

Modifiers are also extremely important and many times these modifiers are
used by pharmacy to identify which generic or trade product to fill a
prescription with.  And the modifiers can include such things as whether
the item contains latex, the flavor of a liquid preparation, whether
preservatives are in the item and what type of dyes are in the items.
Oftentimes these are not supported in a standardized fashion to support the
automated checking of allergies and to support pharmacy in selecting of the
correct items.

The instructions or sigs are also a strong potential for
standardization.  The components of the sig include the frequency, the
route, the site of administration, the indication for the medication, certain
modifiers with the medication which oftentimes now are handled via slap on
labels on prescription vials and are missed by patients, those are such
modifiers take with food or milk or take without food or milk, as well as
certain things like conditional frequencies, which create a lot of complexity
when you need to administer something one hour before a procedure or after a
procedure, and when you get to more complex therapies rates of infusion.

The historic Latin standard for sig coding has been identified as unsafe in
many cases.  Some codes are no longer allowed but standard alternatives
have not been universally accepted.  Some examples are such as QD dosing,
QOD for every other day, and left and right eye and ear such as OSOD.
There s currently a great need and opportunity to standardize a new sig coding
structure.

Order routes of administration need to be standardize to support the rule
based clinical checking to reduce false positive warnings for drugs that have
multiple routes of administration.  An example there is Gentamicin which
is given both topically as well as orally and you do not want to have
interaction warnings for the topical item if it isn t administered orally.

When the above sig information I mentioned is not coded in a standard
fashion it is very difficult to accomplish such items as automated dose
checking as I mentioned, the medication administration reminders and
verification to support patient therapies, and the automated translation of
patient instructions to more understandable format.  And I think this is
an important issue, patients oftentimes have a hard time understanding medical
terms and it s often stated that medication terminology for patients should be
at a fifth or a sixth grade reading level and we need to make it take advantage
of what tools we have to support that need.  Also this information if not
coded in a standard fashion makes it difficult to do historical reporting and
DUR against dosing and dosing instructions.

At the same time it s important to recognize that free text items reduce the
potential to automate downstream components of medication use process as I
mentioned so therefore coding supports that.  And then those components
include the administration, the monitoring, the retrospective reporting, and
clinical checking.  Free text is still needed though, you don t want to
close the gate to be able to support special instructions that many drugs
require free text for.

E-prescribing standards need to be structured to support medication process
workflow and handoffs.  Communication between physicians, nurses, and
pharmacists need to be supported.  Significant telephone time is spent by
pharmacists handling refill and third party issues, third party payer
issues.  Technologies are in place to allow patients to electronically
request prescriptions refills from their pharmacy but no standard processes are
available to support the request of pharmacies to the prescribers for that
refill request.  As a result there s significant effort and telephone work
occurring between pharmacies and the prescribers and there s significant
opportunity to enhance those workflows.

We also can t forget the medication administration component of the
ambulatory medication process.  In the hospital environment there have
been a lot of studies that have showed that significant errors occur in this
medication administration process and this is the case when trained
professionals are doing it.  Yet in the ambulatory environment patients
are administering medications themselves and you can imagine the type of errors
and I m sure you re well aware of the types of errors that can occur.
Standardization of the coding of medication information and instructions will
allow for a good translation of these instructions into the language that is
better understood by the patient.  Consistent labeling and language will
support better understanding of patient medication use.  Confusing
terminologies, such as indications and dosing, can be translated in a standard
fashion into a language the patient understands and then the patient can also
be then involved in the validation of the prescription that s in front of them
because they ll better understand the indication.

E-prescribing standards should also support the ability of a physician to
order additional consultive or educational services for the patient at the time
of prescription entry.  Busy physician oftentimes don t have time to
provide that level of education to patients and it would be very helpful to
provide a mechanism of them communicating that need to the pharmacy.
These cognitive services provided by pharmacy provide significant support for
the patient s better understanding of their medication therapies and increase
compliance as a result.  Many states and benefit providers will reimburse
pharmacies for these services.

E-prescribing provides opportunities to automate the monitoring of the
medication administration side of ambulatory medication use process.  As
has been mentioned you can monitor refill activity, monitor whether new written
prescriptions are filled, and provide prescription fill and refill information
to prescribers so they re well aware of how the patients are using their
medications.

The conversion of a prescription in e-prescribing to a pharmacy product is a
complex process.  It is common in the current hospital world for a
computerized prescription order entry system, or prescriber order entry system,
to be implemented that results in an electronic order being printed to paper in
pharmacy and transcribed back into the pharmacy computer system for
dispensing.  And as we just heard that s oftentimes also done in the
ambulatory environment.  Hospitals with proprietary integrated physician
order entry and pharmacy systems are the only ones that have implemented CPOE
systems without some type of manual process of converting the physician order
to a pharmacy product.

This cannot occur with ambulatory e-prescribing in an open ambulatory
environment where product selection is determined by a combination of the
patient s pharmacy insurance benefit, the patient s choice, and the inventory
of the pharmacy filling the prescription.  A typical inpatient pharmacy
carries approximately 2500 to 3,000 products in stock, the total number of NDC
products available has been mentioned by other prescribers to be approximately
80,000, and this number is significantly greater if you include the OTC items.

Some examples of complexity of this matching process are shown here with
Warfarin, if an order is prescribed for 12 and a half milligrams of warfren a
decision needs to be made based on the products available how to fill that and
what I ve shown here are four different examples of how that could be filled by
combining a ten milligram and a two and a half milligram tablet, or using other
combinations of five, ten and two and a half milligram tablets to meet the
need.  And this can be complex, in some cases it results in two
prescriptions and two co-pays for the patients, in one example here it results
in one co-pay for the patient but the requirement for the patient, actually two
examples show that, but the requirement to the patient either to split tablets
or to take five tablets to meet their dose.

If e-prescribing standards don t consider the translation of medication
entity to product detail we will still have an error prone transcription
process.  We need to develop standards that avoid this unacceptable
solution.

Standards need to support the integrity of the original written
prescription, the systems sure assure that pharmacists are not modifying the
intent of the prescription and are selecting the appropriate product to match
the medication entity prescribed.  Therefore the data elements carried in
the original e-prescription should carry forward the final prescription
fill.  Additional data elements will be coded, or need to be coded, based
on the product selected and these should be the same data elements that the
pharmacist uses in selecting the product to meet the original prescription.

This coding is necessary to support rule based clinical checks that work the
same for physicians and pharmacists.  It also supports rule based product
selection which may be possible if we standardize these data elements.  It
may support better physician, pharmacist, and patient communication because
they will all be talking the same language looking at the same data elements
and the same descriptions.  It will also reduce transcription and
translation errors by allowing the patient to be part of the verification chain
by seeing the prescription as it was originally written by the physician and
not just a translation of the prescription that the physician wrote.
Standards need to provide a hierarchical framework for medication coding from
the drug entity level down to the product level, which would be the NDC.
It is likely that manual transcription will continue until this hierarchical
structure is developed.

As prescription information moves through the medication use process it
should be added but not modified or deleted as can be implied by what I said
earlier.  It s supported best via hierarchical data structures.
Standards are needed to clearly define the source and owners of each of these
data elements in an order or prescription.  This is necessary to control
the data integrity of that prescription.  In some cases the ownership of
that information can be shared between the physician and the pharmacist but the
rules need to be clearly defined on how that information is shared.

One example of that would be the selection of the flavor of a liquid
ingredient for a pediatric preparation, in many cases the physician will be
very involved in making that selection, in other cases it s left up to the
pharmacy.  And there may be other cases such as tablet selection, select
the combination of tablets based on the ability of the patient to swallow
certain size tablets or the quantity of tablets, or even the patient s ability
to break a tablet.

Standardized methods are needed to support enhanced communication
processes.  The systems need to support the communication of decision
rationale downstream into the medication use process.  For example, when a
physician overrides a clinical warning the reason for that override and the
knowledge of that warning having occurred needs to pass on to the pharmacist so
the pharmacist doesn t call the physician back and bother them with the same
warning.

Some expansion of the messaging standard will be needed to better support
the handoff of prescription from the physician office to the pharmacy.  In
addition to the prescription information the passing of medication or medical
benefit plan information to the pharmacy will support faster processing of the
prescription by the pharmacy.  In addition to this the patients HIPAA
release for the pharmacy would be best if received prior to during this
handoff.  Without proper patient approvals pharmacy will not be able to
access the patient s global medication history and fill the prescription until
the patient arrives at the pharmacy.  This will create unneeded delays for
the patients.

In addition the e-prescription system should support upstream communication
in the medication use process.  Such upstream communication would include
the request for refill authorization as I mentioned, or pharmacist
interventions to clarify dosing, routes of administration, and other
information on that prescription.  This is all to avoid the interruptions
and the use of the telephone to accomplish this need.

E-prescribing standards also need to support patient empowerment, patients
need to be able to select the pharmacy, payment method, and influence proper
selection or product selection within the prescriber s intent.  Patients
also need the ability to review the consolidated medication history information
as was mentioned earlier today.  Standards need to support this as well as
provide a mechanism for the patient to verify that the medication received
matches the medication ordered.

The development of e-prescribing standards is a continuous improvement
process that will occur through iterations of design change and
measurement.  Methodologies are needed to assess the safety and efficiency
of the system and to provide the evidence to support continuous improvement of
the processes and the standards.  Such measurement standards should
include such items as time stamps to be able to measure delays within the
process and also needs to support methods to document and measure interventions
that occur throughout the medication process.  And these interventions may
occur by pharmacists or may even occur by patients as was mentioned, it would
be nice for patients to document adverse drug reactions.  Methodologies
are needed to monitor the measures and as appropriate to adjust systems
processes and standards to improve them.

Last week the Joint Commission announced their 2005 patient safety goals and
one of their patient safety goals is very relevant to e-prescribing, and that
is the goal to accurately and completely reconcile medications across the
continuum of care.  According to this goal they want the development of
this type of process and documentation to occur in 2005 with full
implementation by January of 2006.  This will include a complete list of
patient s medications, also communicated to the next provider of service when
it refers or transfers a patient to another setting.  So it covers the
verification of prescriptions at the time a patient presents as well as passing
that information forward to the next provider of service.

This direction from JCAHO will significant increase the interest in the
e-prescribing effort within health systems.  It will also include the need
to support profile lists of OTC medications, dietary supplements, drug samples,
take home medications, and possibly medications administered within the clinics
and the hospitals.  It is important to recognize that the e-prescribing
standards, though starting as the electronic prescribing will evolve to include
all medications.  Since these medications will eventually be all included
in the same medication profile they should ultimately share the same standard.

JCAHO and the state boards of pharmacy require that pharmacists review
medication orders prior to the medication being dispensed to the patient except
in the case of emergencies.  In order to support this order verification
pharmacists need complete access to a patient s medication profile, allergy
information, problems or diagnosis lists, height and weight information, and
other applicable laboratory results and other clinical data.  This
requirement for pharmacist verification recognizes that the electronic rule
based clinical checks are not complete and don t support other pharmacist
functions.  These other functions include the direct monitoring of
patients, the education of patients, the local and regional practice
differences that the pharmacists have to deal with, and the identification of
programming or system set up errors.

In conclusion I would like to emphasize that the development of
e-prescribing standards will be an ongoing effort with iterations and
improvement.  Pharmacists are important members of the health care team to
assure that the components of medication use process meet the requirements of
the legal, regulatory compliance, payers and most importantly the patient
because the patient does deserve it.

Again, I thank the committee for providing this opportunity to present the
health system pharmacist perspective with regards to development of these
e-prescribing standards and ASHP remains available to provide input as these
recommendations are developed.

Thank you.

DR. COHN:  Okay, well we have time for a couple of questions.
Jeff, I think you wanted to start?

MR. BLAIR:  Kevin, your testimony was outstanding, it was very, very
helpful for you to delineate the areas where standardization is needed and
appropriate.  Now you are I believe familiar with both the HL7 and the
NCPDP script standards is that correct?

MR. MARVIN:  Not to great detail but to a higher level I am.

MR. BLAIR:  Which ones have you worked with?

MR. MARVIN:  Mostly with HL7, HL7 is primarily used within health
system environments and inpatient environments.

MR. BLAIR:  Now many of the areas of standardization that you
articulated here I thought that the pharmacy TC of HL7 had addressed at least
to some degree.

MR. MARVIN:  They have developed and identified the named fields and
identified field links but data element content standardization has not been
done in many of the components of the HL7 standards.

MS. MITCHELL:  Additionally the HL7 standard has for example in dose
routes or dose forms a list which does not suffice for clinical practice within
a hospital, it s a shorter list, not a clear definition as you ll need to see
on a practicing for nursing, so that it has not, we ve found that we have to
expand the list and then pass this additional expanded list system to system.

MS. BLAIR:  I would find it very helpful to get a clarification of
which of these areas are included with NCPDP script and which are included
within the HL7 pharmacy orders and which ones are standards gaps, are not
addressed by either.  And I don t know, if there anyone, Stan, do you, or
even Ross is working on the harmonization —

DR. HUFF:  There are people here who met yesterday looking at
standardizing crosswalk between NCPDP and HL7.

MR. BLAIR:  Are they able to sort of map that to the things that Kevin
articulated to us?

DR. COHN:  Jeff, I think somebody wants to comment.  Would you
please introduce yourself?

MR. ROBERTSON:  My name is Scott Robertson, I m one of the co-chairs of
the medication information sig at HL7, actually yesterday we had a meeting
between HL7 and NCPDP specifically looking at mapping function and content
specifically in the area of the e-prescribing standard.  There will be a
more complete report in your next session but we, it was a very productive
meeting yesterday and we think we can address a good crosswalk between the two
to support at least the first phase of the implementations that will be
needed.  There are issues with specific content and vocabularies, those
are issues that we have to deal with but we haven t run into anything that
appears insurmountable at this time, it s a matter of we actually have to sit
down and get the work done and we ve started that process.

MR. BLAIR:  One last thing, Scott, thank you so much for being here,
Kevin indicated all the areas of standardization from the perspective of a
pharmacist.  And many of the members of HL7 in particular and who may be
prescribers might have a slightly different view.  It would be really
helpful if when you pull together the testimony for us for August whether
there s some of those areas where for one reason or another the prescriber view
may not coincide with the pharmacist view and if there s an accommodation or
explanation of that.  Is that something that you think you can add?

MR. ROBERTSON:  Yes, I neglected to mention that I am a pharmacist —

MR. BLAIR:  But you do have other folks on your team that are also
doctors.

MR. ROBERTSON:  There are physicians, systems vendors, people
representing other international organizations, so we believe that between HL7
and NCPDP we can provide a very broad range of views, bring a broad range of
views to the discussion and the ultimate harmonization of these two standards.

MR. MARVIN:  I would suggest you also make sure you look at the
workflows, especially what I pointed out in terms of the product selection, the
conversion of that physician order, what does pharmacy need in terms of data
elements to support the product selection.  There are efforts to map
products back to the higher level order entry entity but there needs to be some
discussion around what is needed to support the product selection.

MR. ROBERTSON:  There is a considerable effort going on in the HL7
medication information and vocabulary committees to address issues relating to
drug nomenclature and this includes input with Rx-Norm standards, NLM s work
and work from a number of other terminology systems that, from England and the
Netherlands and a couple other countries, so we ve got, again, we ve got a
broad basis of people working on it, bringing a number of different
perspectives, whether that s practice based or the more information based, or
regulatory based, the FDA is involved in these discussions also.

MR. BLAIR:  One of the other things since Stan typically has to recuse
himself from things on HL7, however he can answer questions.  So Stan, do
you have anything else that could help the subcommittee understand?

DR. HUFF:  Well, I thought again, I would second what you said that
Kevin did a very nice job and brought out some of the important issues in
translation of a prescription into the set of tablets or things that a patient
should take and those are issues that in fact HL7 has addressed, I think we
need to review and make sure they re sufficient but there are places to
represent essentially what was written and what was dispensed or what was in a
sense what was filled, which is really that sort of translation from what was
written to a set of pills that somebody can take.  And so I mean those are
issues that are at the heart of a lot of these standards, not just HL7 but
NCPDP and Scott and these other guys are a lot smarter about it then I am.

MR. BLAIR:  My last part of this series of questions would be since I
think Lynn Gilbertson is here too, one of the areas that Kevin pointed out is
that many of the messages, especially NCPDP script are in text format and I
know that the ideal is that everything be codified so it can be measured and
specific and everything like that, on the other hand there s an area of
pragmatism and ease of use and Lynn, do you have any thoughts or comments to
just put that in perspective before we go on?

MS. GILBERTSON:  This is Lynn Gilbertson, NCPDP.  That s a loaded
question, Jeff —

MR. BLAIR:  Oh, I m sorry, I didn t mean to make a loaded one, I just
wanted to give you an opportunity to add your thoughts and perspectives on it.

MS. GILBERTSON:  Well, it s one of the things we were discussing during
lunch, codifying the sig is, I think we can all agree it s a wonderful thing to
accomplish and it would be good for health care in general and all the typical
good things that can come from that but you also have to weight the prescriber
and the pharmacist needing just what did the prescriber intend.  And it s
the one offs and the two offs that care, can I codify it, can I use it for
research, can I use it for outcomes, and so the direct users who would have to
implement the modifications would not necessarily see the immediate
benefit.  So I think in some, we just have to bear in mind reasonableness
as we go through this, we can codify everything but if anything of the intent
on any of these data elements is somehow modified we are in serious trouble and
we will make sure that kind of thing doesn t happen.  I mean there have
been enough exercises of codifying sigs that if you don t do it quite right you
end up with something in the left ear instead of the left eye and things like
that.  And as in the NCPDP environment when it comes to the telecom
standard for billing of claims we have standard billing units and standard ways
of expressing items so we re going to bring that to the table and with for
example with HL7 s experience and with the industry experience hopefully we ll
come up with something that does not hurt the users of these systems by making
it so techie that it s really cool but the immediate users don t see any of the
benefits, it s the one offs and two offs that really like it.  I didn t
answer your question but it s a perspective.

MR. BLAIR:  No, thank you.

DR. FITZMAURICE:  I wonder if I could ask a question of Lynn, about her
response, it seems to me that it s a pretty important patient safety concern if
it goes in my left eye versus my left ear and in looking through the importance
of the sig the automated dose checking, somebody has to enter that into a
computer if it s not already entered in a computer.  If the physician at
the time of prescribing is able to enter that information into the computer
virtually once and for all and it doesn t get changed that would seem to me to
enable the automated dose checking and alleviate some of the left eye left ear
problems.  And so it seemed to be more important to do the sig then
not.  Am I off base here?

MS. GILBERTSON:  I turn to the crowd, some of the pharmacists who are
deeply involved in this are Scott, you can answer that a whole lot better then
I can.

MR. ROBERTSON:  The automated dose checking in a majority of cases
comes down to things like maximum daily doses and dose versus weight, dose
versus body surface area, and those tend to be able to be done without complete
codifying of the sig because you can indicate what the daily dose is and then
based on other parameters do the appropriate calculations.  Yes, making
sure that something that s made for the left eye goes in the left eye rather
then the left ear might be important but there are times that products that are
made for ocular use are used in your ear.  Hopefully not the other way
around but there are times when the, and something that we ve had to deal with
in HL7 terminology, there are times when the dosage form implies a route of
administration but that s not the route of administration that s being used.

DR. COHN:  I guess Michael the answer to this one is that it would be
helpful if the prescriber was very good at making sure that the medication went
to the right place.

DR. HUFF:  Yeah, well just a comment, this is a comment from IHC and
our experience, we have both inpatient and outpatient prescribing systems and
its as Scott described, I mean the ideal workflow is one where the clinician is
in fact choosing from a structured set of codes what they want to say in the
sig so there s not this idea that they write it in freehand and then a
pharmacist or somebody else transcribes it and tries to figure out what they
meant, and part of that is actually just for speed because it s much faster to
pick from a common set of things then it is for them to freehand type in what
would normally be in the sig.  At the same time I agree with Lynn, the
common things are common, you can handle huge volumes with things where you can
say you really need to take this three times a day.  There are other
situations that are very specific and you want to always allow the opportunity
for the clinician to say in free text exactly what they meant and that goes
along with the testimony that we ve heard on a couple of occasions here as
well.

DR. FITZMAURICE:  So Stan are you saying it s more important to have
this standardization at the level for the physician doing the prescribing
rather then having it at the point of the pharmacy?

DR. HUFF:  Well, you want to allow both.  Ideally you want to
capture it directly from the clinician so it s unambiguous what they intended.

DR. COHN:  Okay, hopefully we re done with this piece.  Do you
have a comment that you wanted to make?

MR. SIMPCO(?):  Hi, I m Mike Simpco from Wal-Greens and also a
pharmacist, and you made a great point that the intended directions a physician
may give may not necessarily match the product being dispensed and the
standardization of sig codes could present a great danger when you re trying to
look for a solution to actually promote patient safety, could actually result
in a more dangerous situation because of the interpretation of those sig
codes.  Right now in the NCPDP format the sigs do come as free form text
and surely something could be done at the physician s office in a
standardization sig and then a translation of that in some manner.  But
then again in this whole HL7/NCPDP combined workgroup that s exactly what will
need to be addressed.

DR. COHN:  Okay, I think we ve talked about this one, thank you.
Steve, do you have another topic?

DR. STEINDEL:  Yes, well I have a comment on this topic, a very quick
one, and then I have a couple of questions for Kevin and thank you for your
very nice presentation.  The comment that I have to make on this
discussion that we just had, this very useful discussion about the mapping of
NCPDP script to HL7 and the development of sig codes, etc., I just would like
to point out that last week we got a very clear message and that clear message
was doing this work tomorrow is too late, doing it today, we re going to have
to live with that, it s not really adequate.  So we re moving in a very
fast world so I think my message to the people who were just commenting, we ve
been discussing this for a long time, we have to find the paths that we can
start moving down, and that s my comment.  My questions Kevin, this is
mostly in the workflow area, we ve had numerous comments on standards for
workflow and we ve have numerous discussions internally about what does that
mean.  And the way you actually put it was standards to support workflow,
not necessarily workflow standards, is that really what we should be looking
at?  At various points in the workflow where there should be some
standardization we should make sure we have recommendations that standards, we
either note that standards exist or we note that standards are needed.

MR. MARVIN:  Well, I look at it as a conundrum with technology, you
either try to implement technology to support your way of doing things or you
adjust your way of doing things to best use the technology and I think there s
some balances that need to be played with workflow and there are some cases
where it does make sense that we need to change our potential way of practicing
to be more efficient now that we have a new technology, there are other cases,
we certainly don t want the technology to drive us in a direction we don t want
to go.  So I think it s a balance, I think you have to approach it both
ways.

DR. STEINDEL:  Thank you, and this is probably my naiveté and
Karen walked out of the room as probably the expert, but what is the patient s
HIPAA release for pharmacy?

MR. MARVIN:  It s the same release that the patient signs when they
come into any clinic, the first time they present at the pharmacy they need to
sign a release of their information so the pharmacy can then communicate with a
third party and adjudicate the claim.  So there s a signature process
going on with regards to that.

DR. COHN:  I think that s an over statement, I think that the health
care provider or entity has the option and obviously a responsibility to try to
inform the person of privacy and they can I think elect to have them sign, but
I think what you re describing is I think an earlier version of the privacy
rule and the specifics and I think things have been levelized a little bit —

DR. STEINDEL:  I think things have been changed, I don t think —

MR. MARVIN:  Good, certainly the pharmacy I m aware of is still
following that practice.

DR. STEINDEL:  We are aware that there are people who are reading
between the lines.

DR. COHN:  Harry I think last question and then we ll move to our next
discussion.

MR. REYNOLDS:  I also would echo that this is well put together and
just about the time I thought I was getting it together you loosened some of my
thoughts up.  I wrote wow on one of them actually and that s your
example.  Support communication of warning override rationale by the
physician to avoid follow-up communication by the pharmacist.  That
statement adds a significant degree of complication to the systems that have to
be in place, to the doctor s time, to everything else that goes on.  So
back I guess to where Steve was, so supporting workflow versus dramatically
changing the way people work now from a standpoint, especially at the point of
care, is a challenge and you have, you kind of put the gauntlet down on that
challenge with actually using this example —

MR. MARVIN:  Because if you don t go through that effort you re going
to get the call, or oftentimes you hopefully will get the call if the
pharmacist is doing their job of following up on potential problems.

DR. COHN:  I guess we can t throw away our phone tomorrow in all
circumstances.  Any last questions or comments?  Kevin I really want
to thank you for some very interesting testimony and thank you for having
written it so comprehensively, and Sandi thank you for joining —

MR. MARVIN:  Thank you for having us.

DR. COHN:  Okay, with that, our next presenter is Clem McDonald,
obviously thank you for joining us, it s very odd having you on that side
rather then with us, I think as everyone in the audience knows Clem was a
member of the subcommittee for many, many years and obviously it s great to see
you back.

DR. MCDONALD:  Well, I m not up yet by the schedule, you must be ahead
of time.

DR. STEINDEL:  No, you re 11 seconds late.

Agenda Item:  Physician Perspective – Dr.
McDonald

DR. MCDONALD:  Well, this is fun to be back in this room, I think I
went off in January and you wouldn t think that you d miss it after seven and a
half years of all these meetings so I appreciate your giving me this chance and
I m going to try to present some of the issues from the point of the view of
the practitioners for e-prescribing and with the goal of defining things that
could make it better and more attractive.  And I may get into some of the
pharmacy parts a little bit because I think there s some things aren t as good
for them as they could be either, and I m going to tend to read this but since
most of you don t have it I guess that won t be so painful but I won t be as
detailed as I am here.

So I mean bottom line I think, I personally have few doubts and from what I
can even understand that a community pharmacy and pharmacy benefit managers
could benefit a lot from e-prescribing as we ve heard figures that it costs $25
dollars on average to handle that call back to physicians, to solve some
problem with the prescription.  But I certainly hope that the threshold
wouldn t drop so that we get calls on every darn interaction of the 5,000,
every interaction, everything, to your point.

And there s good things, patients would certainly prefer to have the
prescription filling process go smoothly and to have the prescription filled
and waiting for them when they reach the pharmacy and any system that would
help physicians quickly traverse the jungle of different formularies that
constrain prescribing from the various payers would be, I think would be
nirvana to them.  Methods for approving refills that use less telephone
time would also be welcome, for many physicians the ability to see what
medication the patient was taking based on what they really had filled would
also be kind of like a new kind of heaven and so that these all are at least in
principal are possible with these systems.  So in principal all these and
more could be delivered by e-prescribing systems and I ve got two references
that kind of describe in detail what all, there s just plenty of evidence about
that.

But the uptake as I understand it by physician s offices have been slow, I
don t have really detailed figures but I think it s quite small, I hardly know
anyone who s actually using it.  And some explain this lack of uptake on
some intrinsic perversity of physicians as though they re sort of a flawed
human subspecies in that they re the ones who won t use technology because
they re sort of basically something is wrong with them.  But the real
reason may have to do with the barriers to capturing the alluring benefits of
e-prescribing, we like to point out some of these issues with the hopes NCVHS
could suggest incentives and policies that would make these go away.

And first I want to emphasize that what you have to do to do a good
e-prescription is you ve got to identify up to six things, somehow it s got to
get transmitted, six entities, and I want to go over some of the issues with
each of these entities.  So the patient, so most e-prescribing systems, I
reviewed a couple of them, use the patient s name as the primary identifier,
and that actually is how a lot of the office practices work and they type in
the name or part of the name and they resolve ambiguities if there s multiple
patients with the same name.  Some of them actually require to click on
things just to see the external information to help you resolve it which is not
so good.  But the name is not a great identifier because of misspellings
and name variants, Bill and William is just some, and in large practice
settings you can have hundreds of people with the same name, John Smith, I
think we have 400 of them in our Wishard hospital.  So a chart number, a
combined identifier, would be better to have available in these systems.

But further the pharmacy systems need to have a lot of data about the
patient so they can match up with the system the person as they know it in
their pharmacy system so you really have to send a lot of information along
which really means that stand along e-prescribing systems don t work very well,
you ve got to be interfaced to your office management system to pull out all
those other pieces of data because writing a prescription by having you type in
an insurance number and all this other stuff would be too painful.

Now furthermore because of the numbering issues and identifying issues
pharmacies I think generally have to kind of double check things themselves to
see they ve linked it up right so it takes just a little nudge off of the
benefits and the efficiencies they could otherwise get if it just flowed in
computer to computer.  And so the bottom line of all this is that I think
we ve got to, I mean in the long haul focus on a patient identify in some
fashion and I know we ve been over that a long way but swipe cards that would
pass all this stuff and you could swipe it on your e-prescribing system.
The use of a universal person identifier that we talked about or some mechanism
that would permit automatic solid and easy linking between this prescription,
in the practice and the prescription person in the pharmacy system and this
influences the other steps, like trying to get a medication profile from the
collective of all the pharmacy prescriptions that are written and stored.

The prescriber, this is the physician or nurse practitioner writing the
prescription, the system also has to have them identified, that s the one
element that s kind of iced even though it isn t quite done yet, I mean we re
waiting for the NDC but there are things that work, the DEA number, even though
it might be somebody illegal in terms of what the FDA says you can do with it
and a universal, doctor s license numbers, there s file out there and that s
just a one time load and that sort of all works.

The medication, now here the reader should beware, the reader, the
medications can be identified at different levels of granularity.  The
FDA s National Drug Code, NDC, is the finest grain level and one NDC record
specifies a medication, a manufacturer implying a brand name often, the dose,
the formulation, and sometimes more.  As it happens the NDC number is the
lingua franca for most pharmacy systems because it s printed on all the
medication packages so you can get that in hand automatically.  But it s
not without problems and I won t belabor some of the problems of the NDC
number.

But physicians would find an e-prescribing system that would require them to
identify the medication at the NDC level to be very painful, there are just too
many of them, I think there s 120,000 different codes and so if you type, I
tried this on the FDA website, you type in PRO, which is the worst string for
finding drugs in any of the systems I tried it on, a lot of drugs get the word
pro into them somehow, or the brand name.  So you come up with 1,008
different records when you type in PRO.  And you type in ceph, which you
think is a little bit more limited, you still get 208.  So that doesn t
work but most systems provide something in between the provider and the NDC
code that help solve it and they do it at two levels, one of them actually has
the generic drug and dose which really looses it down a lot, another one has
the generic drug and route and the other one adds the dose to that which gives
you a few more but it s probably still workable.

Now the message to the pharmacy must contain the NDC code, that s by the
script standards requires that, and it may contain a more general identifier
supplied by one of the drug knowledge base vendors.  Now the problem is
the prescribing may be writing, I don t care much about what dose or pill size
it is, and then the pharmacy may not have all that, the exact brand names the
NDC said and that doesn t matter because they said you can, and so they got to
match up these two more generic codes but they don t all use the same.  So
there s a bit of a problem there that you ve got four or five probably two big
ones, what I call generic codes but they re really hierarchical codes and GPIN,
there s some names for these things from the knowledge base
manufacturers.  But that creates another a little bit of a problem and
requires, also adds to a little bit of pharmacy work of figuring out, looking
at it by hand instead of doing it automatically.

Now the medication instruction, I guess this isn t really a problem except
that in this current standard it s only sent as text even though the pharmacy
system may be putting in TID or some coded structure saying what it is.
And I think they get 140 characters for the sig which actually in some cases
might be a bit short.  So the pharmacies then have to recode that sort of
when they put it in, again, a little loss of efficiency that might be dealt
with.

The fifth thing is the insurance company and plan and the only reason this
becomes important is because for my IC patients and my practice it s
nightmarish dealing with these formulary constraints, it s absolutely
impossible.  We get every week or month we get another little booklet from
some pharmacy company, they re all done differently and you can t easily get
them electronically, so that would actually be a big motivator for me to be on
an e-prescribing system.  But to know what the formulary is you have to
know the insurance company and the plan have to both be gotten into and be sent
the other place.  So this is one more step and that actually is not a big
deal when you re connected to the office management system but it s just
something you have to remember, it has to be part of the flow.

And then delivering this information doesn t necessarily get you to what
we d really like is to have any patient you typed in something on, you know
what prescriptions you really could write and you could know something about
the co-pays if there are differences that might really bankrupt your patient.

The sixth thing is the destination pharmacy and this is a subtle thing and
it isn t, I don t know that it s a problem everywhere but in many states an
electronic prescription has to be delivered to a specific pharmacy, at least it
did used to be, someone knows it s all been changed and we ve got the laws all
fixed then tell me afterwards or tell me in the middle of this.  But this
is one more step and it doesn t necessarily work in the workflow, I mean you re
writing a prescription after you see the patient, now you go back and find out
what pharmacy are you going to be nearby today, or the patient may not know,
they re going to pick up their kid and they get a call to do something else, so
it s a bit of a snaggle.  And I think it would be important to use
restrictions on these matters such that you could send that prescription to the
pharmacy central, like the main chain, and you go to any of that chain which is
likely where you have to go to anyway because the insurance constrain, or maybe
better yet some kind of a clearinghouse where when the patient got to any
pharmacy they could pull the stuff down and they could get it filled.

Now the big benefit for the physicians, there s two big benefits I think to
the physicians.  The first as I alluded above is getting that insurance
company formulary stuff built into the prescribing process so you don t go
through all this horrendous stuff, I can tell you stories, Medicaid, you have
to call this number now, the patient comes back two days they haven t gotten
their acid suppressing medicine and so they re stomach is all burning up and
then they say you ve got to call Medicaid to get prior approval, you call the
number and they go oh we re not the number anymore it s a different place, then
you call that number and they go oh well, they tell you something else.
Then you go to the pharmacy, it s just like you can t get from here to there
with some of this, it s designed that way maybe, of course the patient saves a
lot of money on those prescriptions that we can t get filled.

So I think it would really be a huge benefit so what you d like to have is
you re typing in there and it just gives you the drugs that are on the
formulary, you could maybe click on a button and see everything but you d like
to have it so you re not going down a wrong path picking a drug and say no,
this is not a drug your patient can get.  Now you might argue they could
still get it but practically speaking people can t afford to go off their plan
for drugs that aren t them at all.

So what we would like to have it all connected together so these
capabilities are available in some e-prescribing systems but I haven t tried
these programs to know whether there s a long delay, where it goes out to
search for something and finds something seamlessly, it would have to be
seamlessly.  And I also understand this is incomplete and I m sure there
are people in the room know this better, that much of this comes from one big
consortia of three pharmacy benefits managers who then have the plans for all
those managers, and there may be other sources as well.  But none of them
have all of them, and none of them have even, they probably have maybe over
half or maybe 60 percent but I think there s still a lot of them you re not
going to get.  Medicaid is generally not part of this, Medicaid of Florida
has put a thing where their physicians can write prescriptions for Medicaid
patients only but now no one else is on that system and they get the reminders.

So prescribers really need access to the formulary constraints from all the
payers through one seamless mechanism and NCVHS needs to find a way to
encourage collaborations of the payers through some kind of mechanism, I don t
care what it is, build on what s out there and so that this can happen.

Now the second big pay off is the medication profile based on all the
prescriptions filled for a given patient.  Now if you do an e-prescribing
system you do accumulate the drugs that you ve written or your office has
written but it doesn t give you as much as you d get if you knew what they
really got and you d also know what they had in the ER, you d know what they
had from the office down the street.  I think this would be a Godsend for
patient safety because providers could finally really know what the patients
are really taking.  We don t know now, they bring in the bags and you go
through the bottles and all that and you still don t know, or it s a pink pill
and a red pill and Dr. Jones gave me a white pill, so it would be way more
benefit and all the reminders on earth if I could just see out of my windshield
when I m driving to know what they re taking.

And we could intervene on both the redundant prescription and patient
non-compliance because this could also tell us what they re refilling and
there s ways, there s formulas and stuff and pharmacy systems can do this and
say this patient is not taking enough of this as prescribed or something.
So one day you d like to have on the e-prescribing, now the first time they use
the prescribing system they don t have to go in and type in all the drug, the
just pull it down from the central source so it s sort of what, it s the
infrastructure thing that we really need to kind of innovate and get all the
stuff stimulated.

So at least one consortium, I guess it s RxHub has the beginning of the
capability to do this and I don t know how well formed they are, but they
actually have the ability to send prescriptions down to you from those pharmacy
managers they work with.  So an e-prescribing system should provide a
medication profile from the pharmacies that provides information about all the
pharmacy sources in a single unified view, physicians shouldn t have to log
into different systems to get this view and when needed the system could also
provide a list of every individual prescription but what you really want is a
profile which is a more sophisticated computed thing.  So this lean and
more useful version which only the most recently prescribed and not
discontinued prescriptions for each distinct generic drug boil down, there s a
boiling down here that I could spend a long time on you need to do, so you
really need to have a common one of these generic codes to make this boil down
right.

So you also have to be able to know who the patient is from these different
systems and that s not trivial, I mean you really need to know, if you ve got
five pharmacy systems who s the same person or the same pharmacy system.
Pharmacy benefit managers probably have more information that could help with
this more then the individual pharmacies.

It would also mean that you d really like to have the physicians when they
do e-prescribing be able to explicitly D/C a drug because now the inference is
they re on it if it hasn t expired and as a result in some of the pharmacies I
worked with we ve got three active prescriptions for the same drug because you
rewrote it with more refills and they weren t really out yet and they don t
necessarily take them off although computationally you probably could.  So
you d really like to say he s not on this one explicitly just as an order,
that s what you do on inpatient but it isn t generally the practice in
outpatient, I m not sure there s even a mechanism to do it.  I would be
there is for the script system.

So now e-prescribing systems can provide other benefits to the practices
including more refilled streamlines but I have to confess the recent way
they re doing faxes ain t bad, they ve got these pre-printed forms and it s all
bolded and you hit this and hit that so it s not as competitive as the old
faxing, people can live with the new fax one.  And the safety advantages
for the e-prescribing should be equalable by the pharmacy prescribing, that is
the same computer program can be checking things in the pharmacy side.  So
I don t think that that s the main reason to do it but I think there could be
huge advantages on those two other things.  Physicians would love it and
they would go for it in an instant if you could get through some of these
barriers.  They may love it in addition because I write prescriptions in
our own pharmacy system daily, and I write all my prescriptions that way and it
is a good deal for us, for me, I like it, everyone doesn t like it.  So I
don t know that you need to have this other stuff but I think if you had this
other stuff it would really make it downhill.

Those are my thoughts.

DR. COHN:  Thank you.

DR. MCDONALD:  Can I go now?

DR. COHN:  I think we have people who want to badger you in the
audience or the full committee first.  Anybody have a question?
Steve.

DR. STEINDEL:  Clem as usual very good, thank you, we miss you.  I
have a couple of questions concerning medication, you said that it would be a
simple world if drugs were identified by a generic name and route, have you
thought about the RxNorm?

DR. MCDONALD:  Well, I didn t want to pick particulars but it gets
complicated and this is a longer discussion.  Basically you don t want to
go at the level of detail of the NDC, it would be nice if there was a common
thing across the pharmacies to accomplish these other things and RxNorm I think
would supply all that.  Rx-Norm, I would wish for one more thing but it s
hard to ask for it because what I would wish for, you could ask for dyjockson
oral pills but still be able to ask, but you can t do that for topicals and
liquids, and when you look, it s more symmetric to say you always have to say a
pill size or a concentration, that s what RxNorm now is doing so there s
nothing bad about RxNorm but if you could take it a step down where I didn t
have to put the pill size as I prescribe because I can say I just want them to
get 500 milligrams, I don t really care which pill size, whether it s two 250s
or one 500, and maybe fewer things in the choice, people could argue about
that.  But I think the key thing is to have something that s like RxNorm,
the things that are in some of these knowledge bases are quite good, I know
some of them well and they re hierarchical and I m a fan of them, it s just
that somehow they either got to map, they got to get together, we ve got to get
something where there s a one way to do this, there s one way to get across
these things and it s not crucial that it be RxNorm versus one of the
hierarchical codes in one of the knowledge bases, it s just crucial that they
don t create walls between the people who chose one version and another version
and RxNorm might be a good lingua franca.  I like RxNorm.

DR. STEINDEL:  My next question actually in one sense doesn t pertain
to what we re looking at under Part D of MMA but just a general question, when
you talked about a medication list and you specified all prescription drugs on
a patient which is what they re asking for under MMA and I think we ve seen
that, but as a physician would you like to also see a list that contains the
other types of medications they might be on like over the counters or herbals
and other stuff like that?

DR. MCDONALD:  You may be getting me in trouble here.  Firstly
it s all a good idea to walk before you run so I wouldn t want to say give me
everything if I m not going to get something, the first thing is get the
prescription medications.  The other ones that have the most problems, the
most challenges, they re the ones that you re managing typically, are they
getting their insulin, are they getting their blood pressure medications, and
if they take an extra days block when they re drinking one night I mean I don t
care as much.  But it wouldn t hurt, I think it will be a lot harder to
get to that, it will require more data input and I wouldn t want to make that
an obstacle.  And the herbals are even tougher in a bunch of different
ways, I think we get snaggled in privacy and all kinds of other stuff if people
when they go to a regular store have to somehow record it and if someone in the
office has to take time to gather this history that s going to be another
snaggle and a cost and a barrier.  But if you gave me the prescriptions
I d be smiling all day long.

DR. STEINDEL:  We ve heard that several times.

DR. COHN:  Jeff?

MR. BLAIR:  Clem, could you give us some guidance on
preauthorization?  What we ve been hearing is a little bit of tension
between the PBMs versus the prescriber as to what is the threshold of
difficulty, maybe you could even help us zero in on what would be appropriate,
in other words if a prescriber winds up wanting to prescribe something that s
not on the formulary and they need preauthorization typically the prescriber
wants it to be very easy for them to go ahead and go forward, on the other hand
the PBM doesn t want to necessarily totally block it or make it impossible but
they want to make it a little bit difficult because they re trying to do a
little bit of guidance where there might not be what they perceive to be as of
use.  Do you see a threshold here between those two views that may be
helpful to us?

DR. MCDONALD:  Yes, well I have some thoughts on it.  I just want
to make one other comment which I don t have in my written testimony and that
is in the law it does not assert that providers need, prescribers need to enter
the prescriptions and I hope we don t slip over into the world where they must
because I think that could be, it could shut down offices.  Right now you
do an awful lot with nurses and your office staff and I should point out the
pharmacies usually have, I don t know how usual, usually have pharmacy techs
enter it, that entry class is real.  In some environment it works and you
enter it yourself.  But getting back to your question, the needing of
preauthorization is tantamount to not doing it, you just can t, you might as
well not have it on the formulary, it s horrible, preauthorization is
death.  What you re really faced with in most of the insurance companies
is just payment differentials, they have to full or they have to pay different
co-pays, and that s a little, you can manage that.  The patient really
wants, Medicaid has absolute and that s the one you cannot get from here to
there half the time, you just can t do it.  So I think we ve got to really
worry about so-called preauthorization, it s just so much, however you do it
it s a delay, there s mix-ups, not knowing which is what, they get to the
pharmacy they can t get it, you call back, now the office is closed, then you
have to get the right paperwork to figure out who to send to what.  So I
think the preauthorization is really awful, I mean there are cases where they
just don t allow it, it s got to be prescribed by a specialist and so be it —

MR. BLAIR:  I m wondering if what you re saying is consistent with what
we heard from Dr. Chess and my understanding of what he was saying was if you
provide me in the formulary the cost of what it would cost for a medication
choice that s on the formulary and the cost of a medication that s not on the
formulary and I share that with the patient to see if they could pay the
difference, that that would be the information that you d want and not have to
go through, not have to deal with preauthorization.  Is that correct?

DR. MCDONALD:  That s correct, but it s more then that, even when
there s no preauthorizations you want to do that because there s penalty to the
patient by making a choice that you didn t know about, the $10 dollar co-pay
versus the $30 dollar co-pay.  There s clearly inducement being imposed
and I don t know that it s wrong because the cost of drugs is so high, and it
keeps changing.  Medicaid I think today if I write generic Emprisol(?) I
can get a PPI to the patient, if I write anything else I can t.  So that s
what I m going to do, you can maybe dance and scream and somehow you might be
able to get through with a call to get them to let you put emprisol or
something else on it but I m just going to do the easy way, I don t think
anyone, we don t know that there s any difference, that it s going to make any
difference to the patient.  So having the information about what s on the
formulary and what are the co-pays for the patient is very, very helpful,
actually wouldn t hurt to see what the prices are because for some patients you
might even negotiate some different kinds of approaches to things if it s very,
very expensive.

DR. COHN:  Jeff, can I ask a question, follow-up?  Obviously we re
talking a lot about the formulary and it s actually been an issue that we ve
all been talking about, it s sort of this issue of presentation of the
information and obviously at one extreme is this issue of
preauthorization.  But even before that is all this issue about financial
data, co-pays and all of this.  Now I wasn t sure whether your system has
any of that information in it —

DR. MCDONALD:  This is what is particularly frustrating, have a tool
and we load it by hand, well, we have our own pharmacy which is a county
hospital which tends to be the pharmacy of choice in the community, people that
don t have enough money to pay their health care.  But we have, there s
two other big ones, we actually load it in by hand once and it s beautiful,
reading everything and figures out it goes here, but we couldn t keep up with
it, there s actually ten of them that we get that are significant numbers and
we can t get any of it electronically, let alone being a standard way, it just
comes as books, so we don t have the capability operationally practically,
except in our own pharmacy, in our pharmacy at our hospital it s pretty
severe.  And they make deals, they get deals and those are the drugs that
you choose selectively, it s not on the formulary.  And I think that s
what the pharmacy benefit managers do too, they make a deal so they get a
better price and that s the one of the three of these drugs which are
undistinguishable from clinical trials so I don t feel that s horrible, it s
just that I can t keep track of it so I m writing Benazepril and also
Ceniprol(?) and then the poor patient is put through all these hoops.

DR. COHN:  So just to make sure I understand, it s sounding to me like
what you re saying is if there was some easy standard fashion to get that
information from sort of the minds of the health plans and PBMs and whatever
and easily be able to upload it relatively frequently into your systems, that
makes for a good day.

DR. MCDONALD:  Right, I wouldn t mind if it goes out to a website and
checks it on the fly because it changes a lot.  It s the challenges, and I
should point out there is a consortium of PBMs that does have that available,
and it is I think, just as inference, many of the e-prescribing systems say
they have it and I think that s where they get it but there may be other
source, someone else may have compiled it, but that s probably 10,000
formularies, or 5,000, it s a lot of formularies but it ain t all of them, I
know Anthem in our state isn t part of it and that s a big payer and Medicaid
isn t part of it.  Medicaid also has it on their computer and we re not
allowed to get to it, so what we do get from Medicaid is very quickly a note
saying oh do your realize this patient has gotten three narcotic drugs in the
last two days, but we aren t yet, hopefully that will change where you could
poke in and there would be some standardization to it so either a system of
taking it in or you get something, what you d like to do is get the drugs,
you d like to get your drug menus of what you re going to write be constrained
and not have to choose it and say wrong answer, try another one, wrong answer,
keep opening the door and which one s the tiger going to come out, just see
these are the ones, or you see it on the screen, but I wouldn t mind having it
all squish down, these are the ones you got and then you can click on some, say
these are the ones that might be a problem.

DR. COHN:  So let me just make sure I understand because you mentioned
earlier about the web, would having this up on a web, one for Medicaid, one for
whatever —

DR. MCDONALD:  If an application could address it, if an application
could probe it, not if you had —

DR. COHN:  So you don t want yourself to go to a website —

DR. MCDONALD:  A server somewhere —

DR. COHN:  I just wanted to be sure about that one because it seemed to
me a little overwhelming also.  Harry?

MR. REYNOLDS:  We ve heard a lot about prior approval, I ve heard that
actual prior approval in drug situations is less then two percent, what would
you put it at?  Not knowing what s on the formulary —

DR. MCDONALD:  Outside of Medicaid it s pretty rare in my environment.

MR. REYNOLDS:  I just wanted to bring it, we re spending a lot of time
on it and I think it is under the general practice a little more outlier as a
real prior approval, not situations where somebody doesn t know what is or
isn t on the formulary, that s a different question.

DR. MCDONALD:  I mean it s not that you can t get it, it s the cost
changes is what happens.

DR. COHN:  So knowing the benefits of the co-pays and all that is
probably the more importance piece.

MR. REYNOLDS:  Because that s a subject where you re kind of going
outside the process and there s something going on and it probably may never
get away from some kind of an interaction back and forth at least from a
standpoint of a covered drug, whether it s —

DR. MCDONALD:  The pressures are enormous and the reason why Medicaid
is going to these steps is because they ll have to sell Indiana to some other
country to pay for the cost I think, I mean they really are blossoming, I don t
know how you get money when you re a state and you can t get any more taxes out
of people, maybe we d have, well, anyway, sell names of things.  But I
understand it but they end up with these vectious(?) things aren t really right
and the rules aren t really right and the rules are flipping and changing all
the time and you can t keep track of it.  I don t know the answer on the
drug side but I personally am a fan of old cheap drugs because you re never
surprised by the old cheap drug and the new great drug is the one that two
years later ooh boy, it kills the liver and things like that.  So you know
all its good parts and bad parts.

DR. COHN:  Well said.  Was there somebody who was, a question or a
comment?  Just introduce yourself —

MR. SHEATH(?):  My name is Tony Sheath, I am the managing partner at
Point of Care Partner, it s a consulting concern, 80 percent of our business is
in  electronic prescribing.  We also produce a newsletter called
e-Prescribing Perspective, it goes to about 400 stakeholders in
e-prescribing.  My clients include pharmaceutical manufacturers, insurance
companies, PBMs, and a number of the different technology companies.  I
just wanted to give that sort of as a background to let you know sort of where
I m coming from.  I ve been in electronic prescribing for ten years, the
first five years, in the mid-1990s I was the product manager for an electronic
prescribing solution that no longer exists and five years prior to starting my
firm I worked for Medco Health Solutions who s represented here today.

What I wanted to do was shed light on one of the things you ve discussed
today which is formulary aggregators and as Dr. McDonald had mentioned RxHub is
indeed one of the formulary aggregators.  In my experience there are five
companies that aggregate formularies, four of which provide them today to
technology companies, to electronic prescribing solutions or to electronic
medical record companies.  Those are RxHub, who has been mentioned today,
CAQH, who testified to you guys last —

MR. BLAIR:  Could you start that list again please?

MR. SHEATH:  Sure, RxHub, who you ve discussed today, CAQH, who
testified at your last hearing, Medi Media, the infoscan formulary and by the
way they re here today, and the fourth would be Proximet(?) who also testified
to you today as a switch, as a continuity company.  Proximet also provides
some formulary and Dr. Jack Gynan(?) mentioned that last time.  The fifth
company is Epocrates(?), Epocrates is a reference company who has been
mentioned today, they do more sort of reference information relative to drugs
but they also have a formulary reference that they have in their hand
held.  To my knowledge Epocrates does not today provide the formulary
aggregation to any sort of a solution to electronic medical record or
e-prescribing company, however they are integrated with at least one of the
e-prescribing companies, that being Doctor First, that however is back, not
formulary, it s back to the referential solution.

I just wanted to sort of, because there s been a lot of questions about that
and I just wanted to sort of level set on that particular point.

DR. MCDONALD:  Does anyone have them all?  Because I didn t know
if I was right on that.

MR. SHEATH:  Well, I would say that Medi Media is pretty close to
having them all, RxHub as you represented today has the three largest PBMs
which represent I think 140 million lives between the three PBMs.  And I
don t know Brian, if you want to say anything, Brian from Medi Media is here as
well.

DR. COHN:  And I think we have written testimony from you also.

MR. DANBERGER(?):  Yes, you do.  Brian Danberger(?) with Medi
Media, I m president of Medi Media Information Technology, it s a division to
develop the formulary database.  I d like to thank you, it s an excellent
point, several points that you made in your presentation on the implementation
and the importance of the formulary.  We ve been working for five years or
more with the electronic partners, six years now, and prior to that in
publishing formulary information, in compendiums of formulary information, we
have 3400 of them so we may not be to the entire universe that folks are
looking for but there are 3400 organizations or benefits, three tier, two tier,
multiples in there for each plan, and 47 Medicaids for the states that have
PDLs.

Getting the formulary in and correct was actually the easy part, we didn t
know it when we started because it was plenty hard to get the methods down to
integrate these disparate preferred drug lists, formulary books, and we accept
information in a paper form, fax, email, post it note, napkin, any format that
we can collect it to keep it as up to date as possible.  But what became
the most difficult part as we started to roll out in the industry and license,
and we license to about 20 different vendors today, is identifying which
patient goes with which formulary, how do you create that connectivity there
because there is no identifier and you could be with a large health plan for
your member benefit and they re in your office and you say oh you re with Plan
X but not their pharmacy benefit comes from some other card or other system and
being able to identify that.  It s been a most difficult challenge for the
physician s offices that we ve worked with to implement this and we re
estimating there s probably over 20,000 physicians using our data in their
software platform with various levels of update.

DR. MCDONALD:  So the insurance company link is still tough.

MR. DANBERGER:  Yes, absolutely.  And it is a small number and
every quarter when we get our reported figures in from the vendors that are
using our file we re looking at what s the increase, how do we smooth it out,
what knowledge can we get, and when we put up a new practice we ll get the
listing in from those billing system that the physician uses and then we try
and make sense of that against the formularies that are out there and it isn t
a one to one correspondence, it s a many to one or many to many in some cases
to identify those.  So that s been the biggest challenge, identifying is
it a two tier co-pay, is it a three tier, is it just a flat open formulary,
whatever.

DR. COHN:  As I remember in your testimony you had been sort of
proposing some sort of a standard for benefits description on the card as at
least some sort of a solution to this issue.

MR. DANBERGER:  Yes, there needs to be some way to identify that, I ll
go back and use my personal health experience with my wife when she takes the
kids to the doctor and she says how come it s always the $40 dollar co-pay when
I go in and she has no idea how to figure out how to move that back but she
does know that there s a $40 dollar co-pay and she knows that there s one less
then that, so she can tell the physician that there s a three tier co-pay in
place but she doesn t know which medications are which or how to figure that
out or how to explain it to him and he s clueless when he s trying to write the
antibiotic for my kids.  So some way to identify that is a vital piece of
this whole puzzle as we re moving forward.

DR. COHN:  So that s described as the missing link to really being able
to leverage the formulary.

MR. DANBERGER:  And because we ve had six years of practice of
integrating formulary databases, actually we started in 1996, so that piece you
can get down, we linked all the major drug files, so you end up with a
crosswalk between them and yes they don t all exact, they re not totally
swappable, but those are things that you can overcome with dedicated people
from HL7 and NCPDP and figuring those things out.  And we re moving, that
car is moving down the road, but the one to identify which patient gets
connected to which formulary doesn t exist yet.

DR. COHN:  Well, thank you.

MR. SHEATH:  This is Tony Sheath again.  I d like to add one
additional piece of information, I mentioned that RxHub and CAQH were two of
the I guess four that provided formulary information.  RxHub and CAQH are
now working together so they ve sort of joined their formulary information
together and are providing that to different solution partners.

We re not to open mic but I wondered if I could sort of piggyback on
something that Brian said that I think is absolutely critical —

DR. COHN:  Sure, I don t think Dr. McDonald minds —

DR. MCDONALD:  I actually wasn t sure about some things so it s great
to have some clarity.

MR. SHEATH:  I want to sort of underscore something that Dr. McDonald
said earlier and also you actually asked some follow-up questions of Dr.
Kennedy and this came up, I read all the testimony from the last time, I wasn t
able to attend but I read, and some of the different vendors brought up the
challenge that they have of getting practice management information into the
clinical solution.  I think that s a real critical challenge, whether it s
a stand alone e-prescribing solution like some of them that talked to you last
week, Doctor First and Zicks Corporation, and Allscrips would be examples, or
whether it s an electronic medical record solution, they all still have the
challenge of getting patient demographic data from the practice management
system into their solution.  I was responsible for a pilot once in I guess
it was right around 1999 I think it was in Kokomo, Indiana, it was a 14 doctor
physician group and we implemented an electronic medical record solution.
We interfaced with a practice management system that didn t use HL7 so it was
the sort of proprietary solution that Dr. Kennedy was talking about this
morning, it took them three months, it took our technicians three months to
build that interface.  So it s clearly, I d like to underscore something
that Dr. Kennedy mentioned this morning, that the practice management, let s
call it the administrative world of physician s offices, is still exceptionally
fragmented, they do utilize standards, the standards that they tend to utilize
are HL7 and I m sure Dr. Huff and there are other people that can go into more
depth on HL7 then I can, but there are also many sort of homegrown, it s kind
of a cottage industry, there are still many homegrown solutions among practice
management solutions that don t use standards at all.  And so it s a real
challenge for those software developers that operate in the clinical world to
get information out of the practice management system, be it patient
demographic information or be it formulary information, it s just a real
challenge and I know that it s been discussed but I feel it s important to
underscore that challenge.

DR. HUFF:  I d just comment, just in Utah, I mean we re trying to
create interfaces to these practice management systems and it s just as you
described, I mean when we went into it we were thinking oh, if we did maybe
interfaces to the top five practice systems we would capture 80 percent of the
things and no, it turned out there was no vendor that had more then 10 percent
market share and that you had, to cover 80 percent was like 50 vendors because
there are just this huge number of sort of mom and pop software vendors that
have developed these office systems and it s terribly splintered, you d love to
have some dominant, Quicken or something that took over the office
practice.  And those small shops, they don t know about HL7, they don t
know X-12, they say what —

MR. SHEATH:  And many of the particularly the stand alone solutions,
they actually have to go to the step of asking their office staff to input
patient demographic information.  Actually what many of them do is they
get a download out of the practice management system, it s often one time, it s
pretty expensive to do a real time interface between the solutions.  So if
it s a one time sort of download then office staff needs to manually input that
information every time a new patient comes in.  Well, I had some
experience on Staten Island with a particular project and the one doctor I
worked with estimated that he saw as many as five new patients a week, I m
sorry, a day.  And so what it became was a burden to the office staff to
input this information.  So it s a real challenge that the I think the
committee really needs to sort of think about, is this sort of interface
between the clinical solutions and the practice management solutions, and one
more point I d like to make is that office staff often, because the practice
management solutions are used for billing mostly but many other things,
scheduling and other things, I don t want to down play what their value is, but
particularly for billing the demographics in the practice management system is
the source of truth .  So in other words they work very hard to make sure
that information is accurate, they re not going to want any sort of variance on
that side so the critical sort of link is getting information out of the
practice management system and into the clinical system, that s the critical
flow.

DR. MCDONALD:  Just to get back, I don t know that we ve tackled the
national number and all that, but maybe just a swipe card that had something on
it that everybody could understand, where you could make it faster to have to
load it into another system, or just some, we can t ignore that problem or the
set of fields you re going to send, or maybe you have some alternative ones —

DR. COHN:  Well certainly one has to be thankful that we ve already
done HIPAA now, at least there ought to be in the practice office management
system some standardization there even though currently a lot of people do have
older systems and we know that.  Jeff, you had a question.

MR. BLAIR:  Yes.  In addition to the impediment of having a
fragmented practice management system marketplace with a lack of standards, I m
hoping you re going to answer no to this question, has the HIPAA privacy regs
been an additional impediment for you to be able to get patient demographic
information into the e-prescribing systems?

MR. SHEATH:  First I ll admit that I m not the best person to answer
that, my understanding, I have four technology company clients and my
understanding is that it s not been a barrier.

MR. BLAIR:  Good.

MR. REYNOLDS:  Jeff, this is Harry, it shouldn t be unless somebody
didn t know how to use it.

MR. BLAIR:  Yes, I agree, I was just, I felt we need to know if it was.

DR. COHN:  I think Lynn Gilbertson wanted to make one comment
here.  By the way I want to thank everyone here for putting together ad
hoc real time expert panels, this is very useful.

MS. GILBERTSON:  Lynn Gilbertson, NCPDP.  Just one more thought
about the pre or prior authorization process.  If in the Medicare Part D
environment that percentage of how many prescriptions may require an
authorization is above what current practice is it needs to be part of the
consideration for the success of the program.

DR. MCDONALD:  What number?

MS. GILBERTSON:  Somebody cited —

DR. MCDONALD:  What number —

MS. GILBERTSON:  Or actually you did, no, I don t know, I m just
wondering if part of the Medicare Part D process will require more drugs to
have prior authorization, we may be in a bit of trouble if we don t address it
ahead of time.

MR. REYNOLDS:  In other words if most of us are experiencing two
percent and they go to 15 —

MS. GILBERTSON:  It is an issue, it s not something that s a tiny
problem.

DR. MCDONALD:  I d just like to clarify that Medicaid is not that low
and they account for a reasonable percentage of all the prescriptions, I don t
know what it is, but of the private, of the commercial insurance I d say it s
pretty low.

DR. COHN:  Okay, thank you.  Other questions or comments?
This was very good.

MR. BLAIR:  Clem since I can t see and since you ve answered all these
questions and I m really impressed with your breadth of knowledge and
experience —

DR. MCDONALD:  Well, I can fool you Jeff but I can t fool everybody.

DR. COHN:  Well, actually feel free to stay and listen, we re really
actually at this point going to move into sort of open microphone and see what
other comments or ideas that other people have, please.

Agenda Item:  Open Microphone

MR. ROTHERMICH:  Phil Rothermich with Express Scripts, I just wanted to
underscore something Harry said about prior auth.  We re talking about
managing exceptions with prior auth, I mean almost universally plans and PBMs
know that prior auth is disruptive so they use it when there s a clinical
reason to cover something in a very limited circumstance for a very expensive
drug.  So you have to be careful if you want to take down the barriers to
understand that the decisions may be, you think about unintended consequences,
decisions by a lot of health plans may be to just not cover it because what
they re managing is is expense and that s why there s a lot of prior auth in
Medicaid because there are certain people who need very expensive drugs but if
the plan covered it universally they d run out of money.

So with all the conversation about I m concerned that people are thinking
we ve got to solve this problem and so take down the barriers and make it
harder for people to use prior auth as a benefit tool, but the consequence may
just be that people choose not to cover things and that s I don t think what
people are hoping to get to.  So it is an exception, it s usually a rare
exception, there are other tools people use like step therapy and things that
are more common but in all cases that are benefit decisions used to manage
overall costs and those things you can t change.  So in order to
understand that a person is actually in the rare sort of exception circumstance
there s going to always need to be a dialogue.  So telling people PA is
required is one thing, but if you go and try and solve the problem and make it
all electronic you may end up with consequences you don t intend to get to.

DR. COHN:  And just to remind everyone, this subcommittee nor the full
committee is authorized to remove preauthorization or step therapy.  I
think our biggest concern is that whatever needs to occur can occur within
workflow and not become too disruptive to care, I think these are really the
conversations.  Other open mic questions, comments?  Whichever one of
you wants to go first.

MR. HAUSNER:  I m Tony Hausner with CMS, given that prior authorization
came up, we certainly, we just published as probably all of you know the
proposed rules on prescriptions drugs and we welcome comments on either side of
the fence as far as prior authorization, I don t think we state anything in the
proposed rules but there s a lot of areas that we don t state anything because
we re interested in public comment on these issues.

DR. SULLIVAN:  I m Tom Sullivan, I m a solo practice physician from
Massachusetts and I ve been involved sort of peripherally from a physician s
perspective in this area for ten or 15 years.  I agree with most of what
Dr. McDonald said, but I also heard some other comments that there were only
four formulary aggregators, or five or whatever, I want to point out that I
just finished a term as the president of the Massachusetts Medical Society and
about ten years ago we started a project to aggregate formularies and about
seven years ago we produced our first paper guide.  Things have changed a
lot in the last seven to ten years about how easy it is or difficult to
aggregate formularies.

At first the health plans just didn t want to sit down at the same table
with one another ten years ago, for no reason whatsoever, and then I think they
also didn t trust the medical society being the mediator because we have so
many differences in other areas.  But gradually over a couple years they
agreed that this might be a benefit of physicians making it easier to figure
out which patient was on which formulary.  And then the tiering process
came in, and that s t i e r, it was a lot of t e a r s on the physician
side.  And now that we ve moved to an electronic format all of a sudden
the health plans are acting the same way that they were ten years ago, in part
they don t want to sit down and put something that we ve been doing on paper
for ten years, almost ten years.  They see somehow the electronic, putting
this information into an electronic format is something very different and I m
not sure I can get to the bottom of it other then say they tend to be naturally
competitive, there s nothing wrong with that but again the formulary is a lot
more complex.

We ve proposed having web services that the medical society would host and
make free to the public and to every physician.  But again, I think part
of the difficulty is the complexity that has surrounded the health plans going
electronic with their formularies and the arrangements with the PBMs have made
this much more problematic, I think the PBMs have done a good job, I ve been on
a health plan formulary committee trying to pick the right drug for 15 years so
I think the PBMs have helped with that but there s also a lot of complexity
that has been involved with whose format and is there an opportunity for the
health plan to make some extra money by having their formulary in an electronic
format that s easily searchable, whatever, it just seems that this spirit
started many years ago, we succeeded when it was on paper and now its become
more difficult because there s a business that has built up around it.

So I also agree that preauthorization for us is really only a huge problem
with our state Medicaid and I think there are many people in Massachusetts who
would like to sell our state to another country, we get to talk about
that.  Thank you very much.

One final thing, I m actually going to be here tomorrow to talk about the
continuity of care record and that might help us with developing a standard
interface between these practice management systems and stand alone
e-prescribing, I ve been using stand alone e-prescribing, two different systems
for well over a year so I m pretty familiar with them and once again I think
this continuity of care record standard could help us, I agree with the prior
speaker that getting the practice management system information into the
e-prescribing or whatever other clinical module you re talking about and a more
fully functional electronic medical record could be at least a temporary
solution.

DR. COHN:  Tom, thank you, any questions for Tom?  You need to
come to the microphone, introduce yourself.  Tom thank you, we ll see you
tomorrow morning.

MS. HOWARD:  Good afternoon everyone, my name is Cynthia Howard, I work
at CMS with Maria Friedman.  I m a new kid on the block but I just wanted
to make a comment, I ve been hearing a lot about medication reliability and I
was a care giver for my mother for years and I made a database with her name,
address, phone number, Social Security number, her doctors, allergic
medication, all her medications on the list as well as any other pertinent
information, next of kin, her doctors loved it, even had copies of her medical
cards so that she went to her doctors so much that I couldn t keep up with
it.  So even one of my doctors even wanted me to make a blank database for
his patients so that they could start doing that because it s so much involved,
people bringing in bags of medicine that it s too difficult.  And then I
was able to detect if she went to an emergency room oh no, she had this before,
this doctor has done this, or this doctor has not done this, so it really
helped as far as the doctors.  I even invested in a fax machine because I
had to go back home, refax the new sheet, because the emergency room doctors
could not tell all the medications that she took.  So I was really
organized in that although they didn t want to see her but they loved to see me
because I was so organized in that respect.  Thank you.

DR. COHN:  Thank you.  Dr. McDonald.

DR. MCDONALD:  I just wanted to ask about the new regs, is that related
to the Medicare benefits, prescribing benefits?  And as you can maybe
reveal, it s probably big, they always are, is there anything in there about
actually accomplishing the prescriptions, we could get a view, physicians could
see all the prescriptions a patient is on if they re on Medicare?

MR. HAUSNER:  The only place where I see that offhand is medication
therapy management services that the prescription drug plans and, well
particularly the prescription drug plans, I think also Medicare Advantage Plans
are supposed to offer those services and the pharmacist then is supposed to do
these kind of brown bag consults and then work with the physician on
that.  So that s one service we re —

DR. MCDONALD:  Electronically is all, I mean I just, you have the power
—

MR. HAUSNER:  That has been programmed in there electronically,
presumably the prescription drug plans would have the capability of doing that
but that s not required in there —

DR. MCDONALD:  Are they going to report back to Medicare as the
hospitals do or Part B, are you going to get detail back centrally about
prescriptions?

MR. HAUSNER:  We will get all, from NCPDP we will get all the claims
that are filled by the prescription drug plans so we are getting that or at
least an extract of that, I guess we re going to get the whole thing and then
for our risk adjustment we re extracting certain data and I think QIOs will
have the whole data file from NCPDP available to them.

DR. COHN:  Good, maybe another source of data, or at least of the
drugs.  Other comments, questions?

MR. ZORRO:  Tom Zorro with FirstDataBank.  Just a couple things of
clarification, Dr. McDonald stated that NCPDP script standard requires NDCs, it
allows NDC but it doesn t require NDC, so you can use a lot of different types
of drug concept identifiers within script.  And the comment from CMS about
NCPDP providing any type of information about drug utilization, that s not
something they would provide, so the source of that information would have to
be the PBMs, it certainly wouldn t be NCPDP.

DR. COHN:  I think Karen can clarify that.

MS. TRUDEL:  Yeah, I think what Tony was saying was that the NCPDP
telecommunications format would contain the claim information that would go to
the PDP and then to Medicare for risk adjustment.

MR. ZORRO:  And that s certainly true.

MS. TRUDEL:  The format not the organization.

MR. ZORRO:  I also wanted to make a comment about the practice
management systems that exist in physician s offices now, and I think it s like
pharmacy was many years ago for those of us who knew that pharmacy practice
management systems were built kind of the same way, there was a lot of very
small vendors, some of them were mom and pop shops, they may only have two or
three installations.  And what happened in pharmacy as things became
consolidated and we started to get standards of some sort organizations and
businesses came to the forefront and said there s a way to make money here in
doing conversions from these mom and pop systems to a more standardized
management system.  And I think that the business of the United States is
business and I think that s what we ll see happen here so I think that some of
these things that are certainly going to be impediments to the immediate
acceptance of certain standards for practice management systems I think will
eventually be able to be met and taken care of.

PARTICIPANT:  Just a quick follow-up on that, as anecdotally you would
be incredibly surprised how many calls we get a week for someone who s writing,
came up with the great idea of writing electronic prescribing software and just
is inventing a new idea in their mind not having searched the universe yet,
doesn t have a drug database in their system, is looking for formulary
information, heard about us, tracked us down, whatever, and they re installing
their first doctor physician practice as a beta next week.  I mean it s
just incredible the number of companies that are starting up but in some ways
even in e-prescribing where we ve seen a number of companies go out of business
we also see continuing fragmentation as more companies say we can do that, how
hard could it be.

DR. COHN:  I think there s a role for standards in the United States.

MR. SHEATH:  I m sorry Tom, I have to beg to disagree.  My
experience is that these practice management systems, it s a very fragmented
market, its been that way for a while, there was some consolidation in the
mid-1990s where some of these companies started to buy up other
companies.  The conversion over to one solution has been very slow, it s
exceptionally complicated.  Doctor s offices and Dr. McDonald may be,
there are others that might be able to comment on this but doctor s offices
tend to not like to change their billing systems, their practice management
systems.  They do it but it s a major decision for them, it s not quite
the same, the physician office world relative to practice management is not
quite the same as the pharmacy world was and I would strongly disagree.

I don t know, I m sorry I wasn t at this last meeting, I don t know if this
is the place for suggestions but it seems to me that if at least all of the
practice management systems were on the same version of HL7, I don t know that
we need to create new standards but if there was some way that we could get all
the solution providers to be in the same standard that exists I think that
would go a long way, there d still have to be an interface between the clinical
system or the e-prescribing system and the practice management system but at
least it would be less complicated if everyone was on the same version of HL7.

DR. COHN:  Dr. McDonald you probably would agree with that comment —

DR. MCDONALD:  Well it s not so much HL7 although I work a lot with
HL7, it s just that we have this idea we re going to really get standards by
making two more new ones so now we got five instead of, I mean it s the wrong,
we ve got to be really conscious how hard this stuff is and in terms of office
practices, I think the offices think of that as like you re going to change a
ventilator on me, you re going to leave me off it for an hour, I mean it is
really, really tough and there s so many stories about guys almost going out of
business with switches, even in hospitals, I mean I can tell some of those when
they switch billing systems, it s just very scary.

DR. COHN:  Other questions or comments?  Comments from the
subcommittee?  I know it s been a long day, are there things that you
would like to comment or reflect on at this point?  Obviously we have
tomorrow and we ll spend all of Friday morning I believe with, we don t have
any testifiers on Friday morning, so we have all of Friday  morning to
also collect our thoughts and think about next steps but if anybody has
anything to say, Steve?

DR. STEINDEL:  Yeah, I would like to vote with selling Indiana.
And Simon, I actually do have a little bit more serious, I have some comments
to make probably on Friday but one comment for today that became very clear, I
think it came very clear in the Wellpoint discussion and that was also a little
bit in Clem s discussion, and I think one thing we need to be clear about when
we put this together is the use of the internet, that it can be used for
e-prescribing.  We had problems in the HIPAA world with the use of the
internet for this area and I would perhaps just like a quick comment from Lynn
Gilbertson, does NCPDP script preclude the use of internet?  I think no.

MS. GILBERTSON:  [Comment off microphone.]

DR. STEINDEL:  And I just want to make sure that we re crystal clear in
the letter.

DR. MCDONALD:  Sorry to be, I was always this way, I haven t stopped I
guess, but the issue when we say standards, we use it very broadly, what the
real issue is is we have, it s like when you put the gasoline hose into the
car, we have four or five coupling points and those coupling points the issue
really is the identifiers, that s where we re getting mostly stuck and I hadn t
even realized that there was even at the plan level, I just kind of assumed
that by golly they must have fixed that by now.  But it s these little
points of contact that are very special, now the messages work and all that but
it doesn t help if you don t have the same code in the spot or the same
identifier type or a way to get from one to another, they don t have to be the
same but we ve got to solve that.

DR. STEINDEL:  Just picking up on, I was going to defer this a little
bit to Friday but one thing that Clem did say that I don t think was clear to
me beforehand, and we have had it mentioned to us multiple times about the need
to have an e-prescribing standard that goes to the pharmacy, the specific
pharmacy, but you made it clear that that actually imposes some type of
workflow issues that we do need to consider.

DR. MCDONALD:  And you want to be able, if you want to get this
medication profile you d like to be able to get them all as one.

MR. REYNOLDS:  One concern, the patient identifier, at a time where it
wasn t picked up as part of HIPAA, when it was sitting there to be plucked out
of the air if it was chosen to be, and second at a time when most of the health
care industry whether it s hospitals, payers or others are running away from
Social Security number as fast as they can, spending millions of dollars
de-identifying individuals, I struggle with that, I will continue to struggle
as we talk about standards as to how we overcome or even consider making that
part of a standard recommending going forward in the midst of the fact that it
was there for their choosing for exactly the same kind of reasons.  And
second, the industry, everybody s trying to de-identify and now this, it
continues to come up, I m not negating any testimony, I m talking about the
reality of what seems to be the lay of the land so as we consider this, this
one is one I just continue to struggle with.

DR. COHN:  Well, Harry, let me give you a couple of good answers here,
one which is a good answer, another which is a conundrum and I know Karen
raised her finger.  The good news is in the world of Part D Medicare
members have HIC numbers and so they actually have an identifier that is used
by their insurance company, otherwise known as CMS, to uniquely identify the
member.  And so for Part D maybe we have a little bit of a bye on that
one.

Now on the other hand, on Friday at the NHII Workgroup meeting we were
lateralled by a request that we investigate the issue not of unique identifiers
but how do you uniquely identify patients in the health care system, and not
with the idea that there would be a unique identifier but recognizing that
there s probably pointers and a number of other approaches that might help as
all of this begins to come together in the world of the NHII and others that we
should be looking at and maybe these are master patient index approaches or
whatever.

So the good news is that for Medicare we have a bye, the bad news is that as
a subcommittee we don t have a bye —

MR. REYNOLDS:  You know against the testimony for Medicare, against the
testimony and against what happens in reality, we don t have a bye, because if
I am 64 and a half and then I got to Medicare when I m 65 I was identified as
one thing at 64 and a half, I go to Medicare I m identified as something else,
I m talking about the philosophy of the one patient, all their medications and
how do I identify.  Now any new prescription taken in Medicare at that
point is added, I might be taking ten, one or two might be new, you know me as
two situations, you don t know me as ten which is what the overall thought of
this thing is.  So I m not, yes, Medicare will work and I m not
challenging that but I m talking about the philosophy of what we re trying to
set a standard for, which is the full view of the person, and when they switch
coverages that s where it s always been a problem, when you switch coverages
you re a new person, have a nice day, here we go again.

DR. COHN:  Harry, I m saying that we re going to be in one way or
another —

MR. REYNOLDS:  I was being argumentative, I m trying, this is a
conundrum on how —

DR. COHN:  We ve got Steve and Gail.

DR. STEINDEL:  Just commenting Harry back, I think what Simon is really
somewhat, I hope what Simon is referring to, I think we have a bye with respect
to the pilots.

MR. REYNOLDS:  I agree with that.

DR. STEINDEL:  I don t think we have a bye with respect to the system.

MS. GRAHAM:  I just had, we just finished our workgroup under
Connecting for Health about identifying patients and our report is actually due
out next week —

DR. COHN:  It s already been released.

MS. GRAHAM:  And it s more to the use of multiple traits to identify
individuals.

DR. COHN:  Actually Gail it was released last week —

MS. GRAHAM:  The framework was released but the our individual report
—

DR. COHN:  Well, I was obviously being cute but obviously this is an
issue we re going to have to be talking about more, it s been requested that we
look at it.  I don t think it s needed for our September letter thankfully
but it s not too far off in the distance and it will probably be something we
handle over the next several months of hearings.

MR. REYNOLDS:  The fact that you ve taken it out of the September
letter is more then appropriate for my question.

DR. FITZMAURICE:  I just want to recall that it was about four years
ago that Congress told us not to do any work on final implementation of a
national provider without their explicit okay and they keep putting down in our
appropriations bills every year, and what we heard at the conference well you
may not need a unique patient identifier, you just put what you know about the
patient into a hopper and that machine goes out and links everything that looks
like what you put in the hopper.  I mean in that hopper most everybody
will keep the Social Security numbers, date of birth and zip codes and all of
this so you ve got a lot of information in there and it seems to me that the
protection that not having a unique identifier gives linking data is not so
great, they can link it anyway.  And so you may want to look at the
efficiencies of having a unique identifier, Medicare has one.

DR. COHN:  Other comments?

DR. STEINDEL:  There s a comment and what we ll see in the, Gail
probably can address this much better but we ll see in the Connecting for
Health report, there really aren ‘t that many efficiencies gained by having a
unique identifier.

DR. COHN:  I suggest we hold this particular conversation for a time
where we actually have some expert testimony as well as the benefit of the
final roadmap.  Are there any other comments before we adjourn?
Okay, well I want to thank everyone for really what s been a great day, I want
to thank our audience for providing expertise to the subcommittee, we will
adjourn and reconvene tomorrow morning at 8:30.  Thank you.

[Whereupon the meeting was recessed at 5:20 p.m. to reconvene the following
day, Thursday, July 29, 2004, at 8:30 a.m.]