[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

March 30, 2004

Hubert H. Humphrey Building
200 Independence Avenue, SW
Room 505A
Washington, D.C.

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

TABLE OF CONTENTS

P R O C E E D I N G S (9:10 a.m.)

Agenda Item: Call to Order and Welcome and Introductions

DR. COHN: Good morning. I want to call this meeting to order. This is the
first day of two days of hearings of the Subcommittee on Standards and Security
of the National Committee on Vital and Health Statistics.

The committee 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. I am the National Director
for Health Information Policy for Kaiser Permanente.

I want to welcome subcommittee members who are here, other staff and,
obviously, others in attendance. I also want to welcome those listening in on
the internet.

As always, I want to remind everyone in the room to speak clearly and into
the microphone, so that those on the internet can hear our deliberations.

We have a lot to cover over the next couple of days, next two days,
specifically. The Medicare Modernization Act of 2003 calls on the Secretary of
HHS to adopt standards for e-prescribing, and the NCVHS has been directed to
develop such standards recommendations. This is the first formal public hearing
on e-prescribing standards by the subcommittee and NCVHS.

The hearing today is intended to provide background to the subcommittee and
others in attendance on the state of e-prescribing and assure that we all have
a common understanding of the legislative language directing our work.

We are thankful to have Karen Trudel from CMS, who will begin after
introductions and other business from the subcommittee, by discussing the
Medicare Part D Benefit and how it all – the legislative language and how it
all relates to our work.

We are also pleased, hopefully, to be able to welcome Jonathan Teich, who I
think we’ll see in a little while, who’ll be talking about the state of
e-prescribing. We’ll hold formal introductions for when he arrives.

After lunch, we continue with a discussion of e-prescribing standards. We
have Lynne Gilbertson, who is Director of Standards Development for NCPDP, and
Bob Beckley, who is on the NCPDP Board, who’ll be talking about that.

And then we move on to a discussion of federal perspectives on e-prescribing
from the FDA, VA, DoD, and, I believe, and others.

Obviously, I want to thank personally both Maria Friedman, our chief staff;
Jeff Blair, our Vice Chair, for his tremendous work in terms of putting today
together, as well as Steve Steindel. I think without all of their work, we
would not have a session such as we are going to have today.

I want to emphasize that this is an open session. Those in attendance are
welcome to make brief remarks, if you have information pertinent to the subject
being discussed. We will also have time at the end of the afternoon for brief
comments by those in attendance.

Finally, for those on the internet, we will welcome email and letter
comments as issues come before the subcommittee.

In addition, be aware that we will have a number of other hearings on the
subject of e-prescribing this year and into next.

With that, let’s have introductions around the table and then around the
room. As always, for those of you on the National Committee, I would ask if you
have any conflicts of interest related to any issues coming before us today,
would you please so indicate during your introduction?

Maria.

MS. FRIEDMAN: Maria Friedman, Centers for Medicare and Medicaid Services,
lead staff of the subcommittee.

MR. BLAIR: Jeff Blair, Vice President, Medical Records Institute; Vice Chair
of the Subcommittee on Standards and Security.

Not aware that I have any conflicts of interest.

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

DR. WARREN: Judith Warren, University of Nebraska – excuse me – University
of Kansas, School of Nursing. (Laughter). I know. I know. You can tell the
history.

DR. STEINDEL: Well, we beat >um.

DR. WARREN: Yeah.

DR. STEINDEL: All of those states are so flat, it’s hard to tell where one
stops and one begins.

DR. WARREN: That’s right. That’s right.

AUDIENCE: Oohh.

DR. FITZMAURICE: But very fine states they are. (Laughter).

Michael Fitzmaurice, Agency for Healthcare Research and Quality, staff to
the subcommittee and liaison to the National Committee.

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

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services.

MR. SCANLON: Jim Scanlon, HHS, Executive Staff Director for the full
committee.

DR. GREENBERG: Marjorie Greenberg, NCHS, CDC and Executive Secretary to the
committee.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina,
member of the committee; and neither Kansas nor Nebraska are in the final four
– (laughter).

DR. HUFF: Stan Huff with Inter-Mountain Healthcare and the University of
Utah in Salt Lake City.

I have potential conflicts if we talk about ICD-10, PCS or HL-7 or LOINK(?).
I’m a cochair of LOINK. I’m a vocabulary cochair at the HL-7 and a previous
contractor with 3M some years ago.

MS. SQUIRES: Marietta Squires, CDC, NCHS and staff to the subcommittee.

MR. MANTOOTH: Mark Mantooth(?), Office of General Counsel, HHS.

MR. PIETRO: James D. Pietro(?), legal assistant, Buchanan Intersol(?).

MR. MURRAY: Tom Murray, American Medical Association.

MR. GILBERG: Anders Gilberg(?), the American Medical Association.

MS. MC KENNAN: Barbara McKennan, Astrasynica(?) Pharmaceuticals.

MR. BECKLEY: Bob Beckley with SureScripts and NCPDP Board member.

MS. GILBERTSON: Lynne Gilbertson, NCPDP.

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

MR. HOKE: Mike Hoke(?), Strategic Health Solutions.

MS. BRADFORD: Alicia Bradford, Consolidated Health Informatics Initiative.

MR. POLLARD: Michael Pollard, Medco Health.

MS. MC ALLISTER: Lane McAllister, Rx Hub.

MS. WALKOFF: Sheila Derryberry-Walkoff(?), Mayer, Brown, Rowe and Mah(?).

MR. RATHERMICK: Phil Rathermick(?), Express Scripts.

MS. BERN: Terry Bern, Rx Hub.

MR. BUSOWITZ: Roy Busowitz(?), NACDS.

SPEAKER: (Inaudible), Clarity.

MS. AKASKI: Irene Door Akaski(?), American College of Surgeons.

MS. HICKS: Brenda Hicks, Centers for Medicare and Medicaid.

MR. PERRINI: Michael Perrini(?), Pfizer.

MS. BODGETT: Holly Bodgett(?) – Centertech(?) and former Kansas resident.
(Laughter).

MS. FORD: Cheryl Ford, Consolidated Health Informatics.

MR. MARTIN: Ross Martin with Pfizer and a Connecticut resident. (Laughter).

MS. ECKERT: Karen Eckert, Medispan, part of Walters – Health.

MS. MONACO: Carol Monaco, American Osteopathic Association.

SPEAKER: (Inaudible), Veterans Affair.

SPEAKER: Jorge – (inaudible) – CMS.

MR. PETERSON: Matt Peterson, Fox Kaiser.

MR. HAUSNER: Tony Hausner, CMS.

MS. THOMAS: Steel(?) Thomas, the Pink Sheet.

MS. TOWNSEND: Jessica Townsend, HUSA(?).

MR. NOMAN: Mike Noman(?) Health Resources and Services Administration, HHS.

DR. BRAITHWAITE: Bill Braithwaite, independent consultant in Washington,
D.C.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics,
CDC.

MR. GORDON: Mark Gordon, American College of Physicians.

MR. HEINBERG: Gary Heinberg(?), law firm Akin, Gump.

MS. KING: Mary Lou King, Office of General Counsel, HHS.

MR. HUTCHINSON: Kevin Hutchinson, CEO SureScripts.

MR. WEINBERGER: Michael Weinberger, Johnson and Johnson.

SPEAKER: Alice – (inaudible) – Johnson and Johnson Healthcare Systems.

MS. MARON: Barbara Maron(?), American College of Emergency Physicians.

MR. HODGE: Richard Hodge(?) of Innis(?) Pharmaceuticals.

MS. FIGMAN-LUKE: Marilyn Figman-Luke, America’s Health Insurance Plans.

DR. COHN: Well, if we’re going to stay like this, we will have to find a
larger room. (Laughter).

Jeff, before we have Karen start, would you like to make some introductory
remarks for today?

MR. BLAIR: Sure.

The day has been set forth – the agenda was set forth by Maria Friedman, and
I wanted to acknowledge the work that Maria has done in creating the agenda for
today.

The objective of today is to give the subcommittee an introduction and
overview to the landscape in which we will be looking at selecting standards
for e-prescribing. We wanted to have an understanding of the different medical
domains and models that might be effecting e-prescribing.

The way the day is breaking out is that Karen Trudel will first be giving us
an overview of the law itself, and then Jonathan Teich, from the e-Health
Initiative, will be giving us kind of a perspective on the industry per se.

After lunch, we will have Lynne Gilbertson and Bob Beckley begin to review
what the standards are that are being in use today and how they apply.

And then we’ll be getting a look at the requirements for e-prescribing from
a federal perspective with FDA and DoD and VA.

I would like to indicate for all of those of you in attendance that this is
really the introductory session. This is the kind of first step into this arena
for the subcommittee, and we have a work plan, which is a 15-month work plan
which leads to final recommendations to the Secretary by June of 2005, with
interim recommendations by November of 2005, and the essence of the way we have
pulled this out is we are going to be looking to hear from all of the different
users of e-prescribing during May and July and August and find out how they
feel about e-prescribing standards from the standpoint of is it meeting their
needs, are there gaps, are there additional standards that need to be enhanced
or created, and then, in September, we’ll be reviewing all of that information
with the standards developers and the terminology developers to see if there
are plans to address the gaps, and then we will be creating, in September,
October and November, the interim recommendations to the NCVHS which we hope
will be passed in November and sent on to the Secretary.

And then during the first quarter of 2005, we’ll begin to look at electronic
signatures related to e-prescribing, and any other remaining issues that didn’t
have time to be resolved during the 2004, leading up to our final
recommendations in June 2005. So I think that that gives you an idea of where
we are going.

A copy of that work plan has been distributed to all staff and subcommittee
members, and, of course, it is open to the public. So you are free to get
yourself a copy of that, and that, at least, will wind up letting you see where
we are going and where our priorities are.

Simon, that is all, I think, I would have to say for introductions. You or
Maria may have further guidance.

DR. COHN: No, I think we’ll let Karen lead off today.

Agenda Item: Issues Related to the Medicare Part D
Benefit and E-Prescribing

DR. COHN: Karen we are glad to have you join us. Would you like to start?

I understand we still don’t have an LCD projector, but I think everyone
should have copies of your presentation materials.

MS. TRUDEL: Right. Right.

I am going to try to cover three things, and I’ll do it as quickly as
possible, because there are plenty of people that I think a lot of us are more
interested in listening to than myself.

The first will be what is required by the law? What functionalities we are
talking about with respect to electronic prescribing, to talk in more detail
about the timetable for the electronic prescribing requirements, and, third, to
talk about some other considerations that I personally have identified in terms
of making sure that e-prescribing requirements are implementable easily inside
the larger Part D benefit. So those are the things that I’ll talk about.

First of all, let’s talk about applicability. The electronic prescription
program is applicable to eligible individuals within the Part D benefit, the
voluntary prescription drug benefit program in Medicare. E-prescribing, very
unlike HIPAA, is – well, not unlike HIPAA, really. It is voluntary for the
providers, so that a provider does not need to submit prescriptions
electronically, but if he does, then needs to use the standards. So that any
prescription that is transmitted electronically does have to use the standards.

The objectives that are set out in the law for e-prescribing are, first of
all, patient safety, second of all, quality of care, and, third, efficiencies
in the delivery of care which obviously includes cost savings.

In terms of design criteria, there was a responsibility that there be no
undue administrative burden on providers, pharmacies or pharmacists, and that
the standards be compatible with HIPAA and health IT standards generally, and
that they permit electronic exchange of labeling and drug-listing information
as maintained by the FDA and the National Library of Medicine.

The specifics of the e-prescribing requirements go well beyond the basic
prescription that is a transaction that is when you look at the full scope of
what is required in e-prescribing, that part of the transaction is relatively
uncomplex.

But the legislation goes forward and requires that we build in eligibility
information, which includes formularies, and, in fact, the legislation permits
tiered formularies and requires us to work with the United States Pharmacopeia
to develop a model of categories and classes for formulary development.

It requires that we be able to provide to the prescriber drug information,
including the patient’s history and related medical history, and in terms of
related medical history, it states that the Secretary is to adopt standards
specifically to do this, that the standards would be as effective as specified
by the Secretary and it is clear that this particular provision of medical
history, because it has such a link to electronic health record would be on a
separate, but not necessarily unrelated time line.

The standards that are needed are, obviously, messaging, vocabulary,
knowledge representation, so that the data that is provided back to the
prescriber is provided in a meaningful way that is clinically useful at the
time of the prescription; and electronic signatures, clearly, there is a link
to signatures with prescriptions.

In terms of links to ongoing initiatives, this, obviously, does relate to
the FDA’s physician labeling and electronic drug listing regulations, National
Library of Medicine’s RxNorm and the FDA’s structured product label, and, as I
said, one of the requirements of the law, the design criteria, does say that it
must permit electronic exchange of labeling and drug listing information.

So what will the e-prescribing standards cover? In addition to enabling
transmission of basic pharmacy prescription data to and from doctors and
pharmacies, including the e-label, it will also cover transmission of data
about the patient’s drug utilization history, possible interactions,
information about the drug plan, including formulary and cost sharing, and
lower-cost, therapeutically-appropriate alternatives, and the standards must
comply with the HIPAA privacy rules.

The statute specifically requires that messaging that is unrelated to
appropriate prescribing, such as marketing, will not be permitted.

The NCVHS’s role is very clearly stated in the law, and that was to make
recommendations to the Secretary on e-prescribing standards in consultation
with a specific group of constituencies, including physicians, hospitals,
pharmacists and pharmacies, PBMs, state boards of pharmacy and medicine,
federal agencies and other electronic prescribing experts. This, clearly, is
one of the reasons that these hearings are going to take a period of time.

What the law requires, in terms of e-prescribing by participating
prescription-drug plans or PDPs, is that within a year of promulgation of the
final standards, prescriptions for covered Part D benefits that are transmitted
electronically must be transmitted according to the standards, and the PDPs
must issue a card that enrollees – or other mechanism of identification – that
enrollees can use to access their prescription drug plan. The card will use
formatting standards developed in consultation with the NCPDP, and I believe
that that is probably outside the scope of this committee’s work right now, but
just stating it to provide some context.

The law does require a pilot project once the Secretary has adopted or
announced the initial standards. Those standards will be pilot tested. The
pilot will run from January 2006 through December of that year, and it will be
completed prior to the promulgation of the final standards. The law says that a
pilot is not needed if there is already adequate industry experience with
whatever standards the Secretary is planning to adopt.

And there will be voluntary participation in the pilot plan via agreements.

There will be an evaluation and a report to Congress no later than April 1,
2007.

The law also provides a safe harbor. The Secretary, in consultation with the
Attorney General, will develop safe harbors under anti-kickback and physician
self-referral laws. That will permit hospitals, plans, PDPs, others to provide
physicians with non-monetary remuneration, whether that is software or
technology services training, whatever, in order to make them able to
participate in e-prescribing.

The time lines for these provisions appears to be quite liberal, but really
is not. The hearings, clearly, will be NCVHS hearings, will go on through
September of 2005 – actually, I think it’s June. The Secretary will announce
the initial standards in September of 2005. As I said, the pilot program begins
in January and runs through December of 2006. The report to Congress, April of
2007. The announcement of final standards via regulation, a year later, April
2008, and the standards to be implemented, a year after that, April of 2009.

The critical challenge that I think we all are facing is to assure that
e-prescribing standards can be successfully integrated into the Medicare Part D
implementation.

Some of the things that I am concerned about is assuring that the electronic
prescribing standards are consistent and workable with the claim and
eligibility standards that will be used to actually submit claims from
pharmacies to the PDPs to make sure that the data content is consistent, that
we are able to maintain information from the prescription all the way through
to the end of the process consistently.

I’m worried about interoperability. There is an ability for more than one
PDP per region, and, in fact, that is expected, and since patients can,
obviously, select their physician and they are able to select their pharmacy
under Part D, that means that all pharmacies and all prescribers are going to
have to be able to do business with a number of different PDPs, which brings
interoperability issues, technology issues and that is the concern that we need
to address.

Let’s talk for a moment about what is in Part D. The coverage includes most
FDA-approved drugs and biologicals. It uses the Medicaid coverage decisions
definitions. There are a few exceptions. Part D includes other items that
aren’t normally considered covered – smoking cessation agents, vaccines and
insulin, insulin-related supplies, such as syringes, needles, alcohol swabs and
gauze, but not lancets and test strips.

Excluded from Part D – and this is the most important thing in terms of
scope – are the drugs that are currently covered under Medicare Parts A and B.
That means that, for instance, drugs that are prescribed and dispensed from an
outpatient hospital pharmacy are not covered under Part D. Oral drugs that are
currently covered under Part B of Medicare, like EPO, are not covered under
Part D. So we are not talking about a hospital pharmacy environment. We are
talking strictly about a prescriber to retail pharmacy environment.

Other items excluded from Part D are agency use for anorexia, weight loss or
gain, agents to promote fertility, symptomatic relief of cough and colds,
prescription vitamins, et cetera, non-prescription drugs, out-patient drugs,
for which the manufacturer is seeking to require associated testing or
monitoring services and barbiturates and benzodiazepines.

That concludes my remarks. Are there any comments or do you have any
questions I can answer?

DR. HUFF: So forgive me if I’m naive, but would IV medications that were to
be administered at home be covered under this plan? So if a physician
prescribed an IV to be given or a home health service – drugs given through a
home health service, would those be covered under this?

MS. TRUDEL: If it is covered under Part B of Medicare, it’s not covered
under Part D.

DR. COHN: Stan, did that answer your question or is that something you need
to keep as an issue to explore further?

DR. HUFF: I don’t know what’s covered under Part B, so – (laughter).

DR. COHN: That’s why I was asking you the question whether –

MS. TRUDEL: My best guess would be that this would very likely be covered
Part B services.

DR. COHN: But I think that that is an issue that we need to be very clear
about what is Part B, though. Of course, it does beg the question of we
certainly don’t want to live in a world where we know exactly what is happening
with Part D covered services but don’t know anything about any Part B drugs
that the patient may be administered or otherwise getting. So there needs to be
some way to handle both.

MR. BLAIR: Karen, there’s two different references in the law. One is to
medication history, which is a little more clear, but the other one is to
patient history, and I couldn’t find very much of an explanation of what was
meant by patient history. Do you have any insights on that?

MS. TRUDEL: I would agree that the statute isn’t particularly clear in
defining any one of those things, but medication history, to me, is exactly
what it seems to be, the patient’s current and previous history of
prescriptions, including any allergies. That seems a little bit easier to
quantify.

I think there’s a lot to discuss with respect to medical history, because
there is a lot of medical history that is relatively irrelevant to prescribing,
and I think there are some questions there about what are the pieces of
information that are most germane to quality as it relates to prescriptions and
to medications. So I think that is open for some discussion in terms of both
relevance, the availability of those pieces of data, how those pieces of data
might be gotten to the prescriber, and any privacy implications also relating
to that. I think there are a lot of open issues there.

Kelly, do you want to add anything to that?

MS. CRONIN: Not right now.

MS. TRUDEL: Okay.

DR. STEINDEL: Karen, I am equally confused as Jeff and I think everyone else
is about the statement, patient history, and I do think it is something that we
need to define better, but one thing that I might want to ask is, coming from
the laboratory community, where in Medicare they were charged with giving –
quote, unquote – diagnosis codes for patient history for the reason why a
laboratory test is done, would that suffice for patient history? That is a
question that I know you can’t answer, but I’m posing it like to the
subcommittee as something to explore.

DR. FITZMAURICE: It seems to me that there is a large task involved, not
just with e-prescribing, but also with getting some of the Medicare databases
in shape so that they can be accessed in real time for the e-prescribing.

Are there plans being made to make things like eligibility tables,
coinsurance and deductible tables made available to prescribers or to
pharmacies in real time from the HIPAA database, from the Medicare databases,
and would this be accomplished by the web or does everyone have to have a
secure line directly to Medicare?

I realize that is a technical detail, and you could probably say, well, they
are working it out, but is there discussion of this and how to make these
databases available to the industry?

MS. TRUDEL: Definitely. There’s definitely a clear understanding that much
of the retail pharmacy world is doing its business real time, and, clearly,
that is something that they are thinking about in terms of how do you implement
the payment part of –

DR. COHN: Michael, can I just clarify? Because my reading of the legislation
is a little different than yours. I hadn’t heard that this was a transaction
between a pharmacy and CMS, but more between a pharmacy and a prescription drug
plan which needed to be responsible for all of those things, but I didn’t think
of that as a responsibility of CMS.

DR. FITZMAURICE: Well, I’m thinking of the business rules and what makes the
electronic community work better and faster and smarter, and what information
might a doctor want – eligibility, coverage, drug formulary –

DR. COHN: Yes, but that is all from a prescription drug plan.

DR. FITZMAURICE: And then the pharmacy, when filling it, would certainly
want to know how much should the patient be charged when the patient walks out.
That’s not part of the e-prescribing from the physician to the pharmacy, but
it’s part of making the whole system working better.

MS. TRUDEL: And, again, I think what we are talking about here is not
necessarily people querying Medicare databases directly, but how to make data
appropriate through the transaction available to the people who need it at the
time that they need it. So I would go farther than to say real-time access to
Medicare databases. What I think we are trying to do is to make sure that the
appropriate data is available to the right people at the right time.

MS. CRONIN: I think it is important to also know that there are private
organizations that are already providing this information, such as ARC(?), Hub
and SureScripts, which we’ll be learning about through the hearings over the
next several months, and I don’t know that we know enough at this point, in
terms of what kind of data we are going to be getting from the PDP sponsors,
once this is implemented. So I think, in the short term, we’ll probably be
looking to learn from what is already existing in the private sector to make it
work.

DR. COHN: Michael, you had a followup question. I’m sorry.

DR. FITZMAURICE: Yes. Karen, you mentioned that you wanted to make sure that
the e-prescribing is consistent with the claims and the eligibility standards
or the files. Is there also work being undertaken to look at the data content
of the existing files to make sure that the definitions are known and
consistent, so that when the standards are developed for e-prescribing that the
elements we have in common we can pull from those definitions?

MS. TRUDEL: That is definitely part of the work that we need to do, but,
again, we are at the very beginning stages of a lot of it.

MR. REYNOLDS: Along the same lines – and I know we keep talking about the
same subject, but if you think of the flow of this whole process, it would
appear that the Medicare system would be the only one that would have most of
this medical history, and it will be key, I think, to this committee, and I
appreciate your comments and I’ll be looking forward to hearing what that is,
but if it is not in the Medicare system, then it would appear that more
information would have to be gathered than is currently dealt with between the
pharmaceutical situation and the drug store and the physician, and so I think
that is going to be, Simon, key to really understand that early on, because
that can change dramatically, the whole gathering of information and the whole
flow of information that the industry is dealing with currently.

MS. TRUDEL: Right. And, again, I think one of the things that it will be
interesting to learn about is the extent to which some of the pilots and
demonstrations that are ongoing actually use medical history to inform the
prescriber and which pieces of information – rather than the entire health
record, which pieces of information are deemed to be the most pertinent.

MR. BLAIR: Karen, maybe you could provide the subcommittee with some help on
this topic. As you know, when we have been working on our plan, which was based
on Section E of the Medicare Prescription Drug Improvement and Modernization
Act, we identified the requirements, both the contextual requirements and the
standards requirements, and prioritized those and figured those were the things
we needed to address.

It was clear that electronic signatures was important, and so we added that
to the work plan, but were unable to locate in the law – in that section at
least – any references to a requirement for electronic signatures. I am
assuming that it must be someplace else in the law, but it would really be
helpful if we could get some help in locating where electronic signatures is
referenced in the law and what the requirements for electronic signatures are
related to the prescribing.

DR. COHN: I was going to try to answer that one, and Karen may want to chime
in, actually, to it.

I’ve read the legislation, somewhat painfully, but – and, of course, you
don’t remember every aspect of it, but I don’t believe that there is actually
any reference to electronic signature, digital signature or anything else in
the Medicare Modernization Act. Actually, the references to electronic
signature actually come from the HIPAA legislation, and, obviously, were never
implemented as a standard.

I think the reason – and, Karen, I’ll let you join in on this one, but I
think the reason that we have all been talking about the electronic signature
is more related to the issues of any sort of narcotic prescription or any other
–

SPEAKER: Controlled drugs.

DR. COHN: B controlled – thank you – controlled drugs, that they are sort of
a common-sense issue related to the fact that whatever we do with e-prescribing
needs to be sturdy enough to enable us to do that, so a clinician, physician
who is practicing medicine wouldn’t have to do something different when it
comes to prescription-controlled medication.

Karen, do you have any further comment?

MS. TRUDEL: No, that is absolutely right. There is no requirement in the MMA
for electronic signatures for prescriptions. So what we are really tracking
back to is any kind of requirements in the DEA’s law and regulations, and we
will need to work with them fairly closely on that.

DR. COHN: Other comments or questions on this part?

Oh, I’m sorry. Steve.

DR. STEINDEL: Yes. Isn’t there some requirement for signatures from the
e-prescribing laws at the state level?

MS. TRUDEL: Some state laws do require that, yes, definitely, and, again, it
can depend on whether you are talking about a controlled substance or not, but
in terms of is there anything in the MMA itself, the answer is no.

DR. COHN: Other questions or comments?

Okay. I think we bookmark a couple of issues, and, obviously, we are just at
the very beginning, but, clearly, this issue, I think, that Stan brought up
earlier about Part B, and probably even – for that matter – a little bit about
Part A, about what medication is covered and how those relate to the Part D
benefit, just to make sure that whatever we do has some extensibility off into
those areas. Obviously we heard, I think, a fair amount of questioning relating
the application to medical history information which will be something I’m sure
we’ll be continuing to mull over as we go through a number of hearings, and
then I think just sort of a general realization that we are just at the
beginning of our process here as opposed to midway through.

Now, our next speaker is Jonathan Teich. I don’t believe that he is here
yet, so what I am going to suggest is that we take our 15-minute break now and
we will reconvene, hoping we will find him – have him join us, or, otherwise,
modify the agenda when we return.

MR. REYNOLDS: Could I ask one quick question before we –

DR. COHN: Harry.

MR. REYNOLDS: So are we, in fact, adding electronic signature to our task –

DR. COHN: Well, we’ll be talking about that this afternoon. We’ll be
reflecting on our work plan.

(9:48 a.m.)

(10:18 a.m.)

Agenda Item: State of the Art
E-Prescribing

DR. COHN: Well, Jonathan, we are very pleased to have you here.

I was going to sort of introduce you as being from Partners Healthcare in
Boston, but I understand you have recently taken on a new role as Chief Medical
Officer for Health Vision – is that correct? – so welcome and congratulations.

I understand that you are presenting basically for the e-Health Initiative
today in your role working with them around sort of the future and the art of
e-prescribing.

DR. TEICH: That is correct.

DR. COHN: Okay. Well, welcome, and thank you for joining us.

DR. TEICH: Thanks, Simon.

I think handouts are circulating as we talk.

We were doing a lot of scrambling to get the handouts as well as the
projector, I think, all appear at the same time, and we had a race to see which
one would get here first, and I think both arrived at the same time. The lesson
I think we can take from that is that nowadays there is so much technology that
it serves as its own backup. We can have handouts. We can have projectors. I
can give you each a small thumb drive that has the presentation on it. There’s
the times when you had to have a few extra transparencies with you, just in
case everything kind of hit the fan are now past us.

Thanks for the introduction, Simon.

I speak, indeed, for the Foundation for E-Health Initiative, and also for
about 75 persons, some of whom are in this room, from pretty much every
possible sector of the prescribing process – physician groups, patient groups,
some of the information brokers that are involved, drug companies, pharmacy
representatives, PBMs and many others who joined with me over the past 12
months to create the E-Health Initiative’s Rapid Acceleration of Electronic
Prescribing Project, which we will describe in the context of this talk, and
all these people have worked very hard to look at every possible aspect – what
are the things necessary in terms of standards, in terms of incentives, in
terms of appropriate design criteria, in terms of usability and in terms of
data exchange – all the things that are necessary to take these prescribing
devices and make them serve the greater needs of safety and quality, improved
cost profiles and much better communication and data exchange.

So this morning I was asked to give something of an Electronic Prescribing
101 talk, talking about – really giving a background of what electronic
prescribing is, talking about some of the many different aspects of it that I
think people don’t quite realize, and then going on to talk about some of the
areas that we have worked in in our project, particularly in areas of how can
one improve the process, what is necessary from a policy standpoint to grease
the skids, so that manufacturers can make better products, so that physician
groups can use them better, that pharmacists can be able to make much better
use of the whole piece of information, all in the name of better patient care.

So the first thing that is worth saying is that we are talking Electronic
Prescribing 101, and when we say electronic prescribing, we are looking at
pretty much any system that uses a computer to assist in creating a
prescription in one way or another.

The definition of electronic prescribing has been debated in great part
among our people because there are so many new aspects to it right now.
Electronic prescribing includes not only using a computer to make a
prescription, it also includes being able to get that prescription sent over to
a pharmacy, whether it be a brick-and-mortar pharmacy or a mail-order pharmacy.
It includes all the aspects of what we call clinical decision support, all the
different things that use alerts and reminders and various other kinds of
complaining to get you to do the right thing to prevent safety errors, all of
the different things that are involved with integration with the electronic
health record as well.

So we will talk about some of these different levels. We will spend some
time talking about the promise of electronic prescribing that we can tell from
existing studies, the potential for it and what is necessary to make this
really work in the most optimal fashion. What is the barrier right now? Why is
it that only a small percentage of physicians right now are actually using
this? What are some of the things that we and you can all do to get past this?

Actually, if you’ll excuse me for one moment. I see a couple of slides have
been hidden, and I am going to take the time to get them all unhidden, so that
what I show you matches what is in your books, and so that I am not surprised
either.

So this gives you a simple look at one aspect of electronic prescribing.

As Simon mentioned, I do several things, so I’ll get my own disclosure out.
I am a physician at Brigham and Women’s Hospital and Assistant Professor at
Harvard Med, worked developing the Brigham and Women’s computerized order entry
systems and some of their clinical decision support and electronic medical
record systems for about 10 years, and then, not quite so recently, Simon,
actually, about four years ago, went to help in the formation of Health Vision,
which is a company that produces various kinds of clinical information systems
across the secure internet as well as community systems. So I am not only the
speaker for the group, I am also a client – (laughter) – and, as I mentioned,
our group comprises many people from public sector, private sector, commercial
and academic, and, really, one of the things I would like to thank the Health
Initiative for is their uncanny ability to get people into a room who possibly
may be at each other with knives and hammers if they were finding each other in
a different room, and somehow getting everyone to check their egos at the door
and being able to work together on a community project like this.

So this is an electronic prescribing application, and, in this case, it
shows you a couple of typical aspects. This is what a doctor might see when
they go to write a prescription.

Up on the top, I see the patient’s existing medications and I can manage
them. I can renew them. I can change them. I can discontinue them. I can print
out patient educational materials, whatever else needs to be done. If I get a
renewal request from my pharmacy, I can see that and send that back out to the
pharmacy. If I get some new information from my payer that tells me the patient
has changed medications and the patient has allowed me to see that, I can see
that as well.

So I can manage medications up at the top.

Down at the bottom, I can simply – I can choose from some of my favorite
prescriptions or I can choose any particular drug name that is in my dictionary
and write a prescription about that.

The fact that there is a favorites list gives you one hint of some of the
work that we have done, because, from a physician standpoint, what this has to
be is fast. In terms of what a doctor does during their day, speed, speed
usability, cost profile and then probably speed are their top five or six
criteria. So anything I can do to, for example, have their most common
prescriptions appear quickly will make their lives better and will make them
much more likely to adopt this technology.

Having chosen the medication – in this case, baby aspirin – I have what
amounts to a prescription form here. So these things have all been pre-filled
because the dictionary knows pretty much that baby aspirin typically gets
prescribed in this way – one capsule a day for a month – and all I really have
to do – if this looks okay to me – is say, done, and that prescription is now
out and ready to go to the pharmacy in one paper or electronic form.

There are some other things up here that are worth noticing. Up near the top
there are a couple of lesser drug interactions, really moderate alerts telling
me that some of the other drugs that the patients take may interact with this,
and this is listed here on this form, because they are actually possibly lesser
importance or they are listed as moderate. I’ll show you in a second what it
looks like when you get a really big, Harry, please pay attention to this
alert.

Down at the bottom, I have a couple of various kinds of options, so I can
choose to add this to my favorite list. I can print out do not substitute or
whatever is required by the different states. Each state has their own
particular wording for this, which dries the manufacturers of these products
crazy, and which we’ll talk about a little later on. I can print out
information for the patients or for myself.

So starting from core prescribing, I have now layered on some clinical
decision support. I have layered on some extra information. I have layered on
the ability to send this directly over to my pharmacy and many other
possibilities.

This is a major alert, and, really, one of the last things I’ll need to show
in the basic introduction. In this case, this says that two things have gone
on. Number one, up at the top, it says the patient is being prescribed aspirin,
but the patient already takes another nosteroidal anti-inflammatory agent, in
this case naproxen, and so while it is possible to give a patient both aspirin
and naproxen, one should do it with care, and so it is worth making sure that
we know this.

Secondly, down at the bottom, it says there is a major drug interaction
because this patient also takes warfarin, also known as coumadin, a serious
blood thinner, and aspirin also is a blood thinner, so very, very few people
should be on both of those together. So the fact that the system knows that
this patient already takes warfarin puts it in position to give me a resounding
alert when I ask it to order aspirin. This is a large part of the promise of
electronic prescribing. Many, many errors of this form happen every day in this
country. There are numbers to support this, and having alerts like this has
been shown, in many instances, to lessen, by a significant amount, the number
of such errors, and the number of adverse events that come from them.

DR. COHN: Jonathan, could I just ask a question, just in the interests of
full disclosure –

DR. TEICH: Sure.

DR. COHN: – since I see this appears to be a product that looks like you
have probably been involved developing?

I just was trying to figure out whether or not – is this a specific
e-prescribing application or is this a module within a larger application, and,
if so, is this practice management software, is this electronic health record?
What is this?

DR. TEICH: Sure. Absolutely, Simon. This is a – this happens to have been
developed by us, but it is typical. You will find this in many – I just happen
to have more easy access to those slides. There are a number of major vendors,
manufacturers that produce these things. In this case, this happens to be a
desktop application in the setting of a larger electronic medical or electronic
– electronic medical record. So as I see down the side here, you’ll notice I
can also look up patient’s lab results. I can look up reports. I can send out
charge coding. I can do problemless management. So, in this case, this
application is integrated within a full-scale electronic medical record, and,
shortly, when we start talking about the different levels of sophistication of
electronic prescribing, that will become very important, because, in fact, the
more supplemental information I get, the more I am able to provide more and
more active support to the physician, the pharmacist and everyone else.

Clinical decision support, as I mentioned, is really active participation in
guidance, in routing, in feedback, tells me where to send this, what to do with
it. There is safety-based clinical decision support, which I just showed you,
passive kinds, such as asking for a reference to be displayed or active kinds
like what just happened. The computer actively looked at the order and said, I
better tell you about this. This was a reactive alert, in that it reacted to
something I had done, the ordering of aspirin. There are also proactive
support. For example, I may start with the program and say, my patient has
ulcers, colitus. What should I prescribe, and it might give me a list of
various kinds of typical medications or even typical drug regimens that would
be appropriate for this.

There is also reimbursement-based clinical decision support. In the
electronic prescribing world, that typically revolves around formulary issues
where I know that my patient’s payer will support one drug of a given class
over another, and if I happen to order the more expensive one or the less
desired one, as far as the formula is concerned, it will at least let me know
that and let me know the others that are in the class.

There is also just-in-time information, the ability to actually pull up
patient reference material, physician reference material, any other kind of
things that are germane to the process right at the time when I am ordering,
and all these things. There’s a whole science and a whole skill behind all of
these. Certainly, people have learned over the years the best ways to show this
so that it has the least impact on making life harder and the most impact on
making sure people actually see the alerts when they are needed and not when
they are not.

Electronic prescribing also takes the form of hand-helds, and you have
probably heard quite a bit about that. This is a screen from a hand-held
device, which shows an electronic prescribing application.

In response to Simon’s question, this one is a standalone application. It is
not, at this point, part of an integrated record. Typically, the prescribing
applications today that are on PDAs, handheld devices like this, are often
purely prescribing and prescription-management applications. Although, there
are some now which start to include integration of results and electronic
health records as well.

The choice of using one or the other has a lot to do with the logistics of
the physician’s day, and it may be that if a doctor is roaming around, going to
several different exam rooms, it is maybe more convenient to have one of these
things that they can go with and travel quickly or to have a wireless laptop,
such as this, a little bit heavier.

If the doctor tends to work from an office-based practice and uses one
place, they may find it more desirable to use the desktop, which has a little
bit easier input, but both of them do essentially the same thing and can run
off the same kinds of data, and this is really included to show you that both
of these occur, and many programs now in many states are supplying physicians
based on payer support with devices just like this to be able to both write
prescriptions and to send them out appropriately.

Active prescribing support means you can go a little bit farther than just
warning someone when I ordered a drug to which the patient is allergic or a
drug that interacts with something else.

The active prescribing support refers to the fact that these things can
guide care to a little bit higher degree. It can look at a patient’s list of
diseases from a problem list. If it is part of an electronic medical record or
if it is connected to a larger electronic health record, it can look at the
patient’s problem list and realize that this patient, for example, has
hyper-cholesterolemia, but is not on a statin, so it can give you that kind of
proactive guidance.

It can know that you are on some sort of disease-management protocol, so a
patient who is on a diabetes protocol, it can tell you that the patient’s
hemoglobin A1C, the chief marker, has been elevated, and that perhaps there
should be an increase in the patient’s drug regimen and will give some
suggestions about that.

So as well as giving you just sort of one-for-one,
you-do-this-I-tell-you-it’s-bad kind of feedback, these systems, as they get
more sophisticated, can start talking about entire protocols of management.

From the pharmacy side, we can send you a reminder that this patient is due
for a renewal, and if the patient hasn’t come in for a renewal and quite some
time has passed, perhaps the patient is having trouble complying with his
prescriptions, perhaps he is not able to afford them or take them in the right
way, so perhaps a reminder can come out that says, gee, based on what I gave
your patient, she should have had a refill right about now, but, in fact, it’s
two months later and she still hasn’t done it. Maybe you’d like to check into
this.

So there’s a variety of ways that you can get supplemental information,
subject, of course, to patient permissions about confidentiality and privacy in
allowing you to do this, that really can make this do much, much more as you
sleep and it thinks and gives you some extra advice.

These things do not set plans of care. They do not make diagnoses for you.
They are not like an expert consultant that tells you what you should be doing
with your patient.

We like to think that they are more like a really, really meticulous medical
student who doesn’t quite know exactly what to do, but says, boy, that number
is really high. I’d better tell somebody – (laughter) – and that is probably
the best way in which these things work.

Communication has also become a significant part of the electronic
prescribing world, and here I am showing just a few of the various transactions
that go on among the physician, the patient, the pharmacy, the health plan.

From physician to pharmacy, obviously, we want to send a prescription that
can be sent in by paper. It can be faxed. It can be phoned in, and, more and
more, it can be done through an electronic communication, which makes a lot of
things easier.

The pharmacy can call back because they found something wrong with the
prescription or they can send you reminders because renewals are due.

The patient can request renewals. Currently, they do this by walking into
the doctor’s office and saying so. More and more, patients are being allowed to
do this, to some extent, on line, using public internet sites that their
doctors provide.

Patient to the pharmacy, again, presenting script, requesting refills,
having the pharmacy tell the patient they are due for a refill.

All these different chains of communication, claims and approvals that go to
the health plan. Health plans now have the ability, in some cases, to combine
and aggregate a patient’s medication regimen from many, many different
physicians, and be able to supply that in one lump, so that you get an
organized view of what the patient is taking, regardless of how many doctors
and nurses they are seeing.

So all these different communication channels go on every day, and over the
past – especially over the past 24 months, there has been a great deal of
activity in trying to make these things work much better, trying to make them
much more universal and to set standards, some of which you’ll hear about from
myself and others later today about making these things universal, so that one
system can talk just as well as another one can.

At a higher level, once you have gone past basic prescribing, clinical
decision support, extra information, communication, now we talk about the issue
of integration with the entire electronic health record.

Here, we look at the medications on the right there in context. This is a
patient summary, and the patient shows – this is what I would look up when I
first see the patient and want to get an overview of what is going on. Here is
the patient’s problems. There’s their procedures. This patient had a flu shot.
Patient’s recent laboratory tests. Patient’s allergies over here. Recent
visits, and their medications.

So, again, here is the medication application in context of an entire health
record, and, again, there is yet more value to be obtained here, because, now,
I have access to the patient’s problem list. I have access to allergies. I have
access to laboratory results, which may tell me that that hemoglobin A1C is too
high or that INR is too low and that I have to adjust medications accordingly.

So, in many cases, the more information we can get, the better we are able
to help the physician, the patient, everyone else support this.

In our work, we established this pyramid.

The e-Health Initiative’s report on electronic prescribing is going to be
coming out officially in a presentation in this town on the 14th of
April, and you are seeing some advanced notice of some of these things, some of
the findings that we’ve got.

This pyramid really indicates several different things. It shows where you
would like to get to and how you can get there. So at the different stages are
the different levels I talked about – basic prescription entry, checking
allergies and formularies, being able to manage the entire medication profile,
being able to have extensive connectivity and being able to be connected to
electronic medical record applications. All of these are possible. There is no
question that, as you go to higher levels, you get more benefits, and, in fact,
if you look at some of the work done by Center for Information Technology
leadership in Boston, who have done analysis of value of these, the curve
actually gets kind of steep as you go higher and higher. So, in fact, you get
more than just a linear level of benefit increase as you go up.

At the same time, we recognize that there are practices in one context or
another that want to start small or have to start small, do not have access to
some of these features. So we would like to make it possible for people to get
in at a variety of different levels, and perhaps this could be not only a
statement of value, but also a statement of a ladder pathway, so that in places
in the country where, in fact, connectivity is not very good, where electronic
medical records are not widely used or where, for cost reasons, they are not
ready for it just at that time, people can start out with something which gives
them a significant amount of benefit and then be able to have a pathway to go
to higher and higher levels as well.

So all these are important. If one was considering defining an electronic
prescribing application, I think that it would include all of these things,
and, in our steering group, when we met about this, there was a great deal of
debate, and we did really reach the conclusion that all of these comprise
electronic prescribing, but, again, value goes up as you go up the chain.

The promise of electronic prescribing has a lot to do with the different
kinds of things it can prevent, the different kinds of things it can support,
quality, safety, cost, pictures.

Much of the information in electronic prescribing comes, right now, from the
inpatient sector, as we have much more data on how medication ordering goes in
the inpatient, order-entry environment.

Computerized physician order-entry systems have had significant impact
inside the hospital in preventing adverse events, in supporting better use of
drugs of all kinds, and, in fact, in supporting better drug utilization as
well.

This data from our work at Brigham and Women’s shows the impact of an
inpatient prescribing system, and, in this case, what we are looking at is
before order entry went into place, about two percent of all orders for
medications had what the pharmacist considered an overdose. It was an excessive
dose, too much narcotics, too much lasix, whatever it might be.

Immediately after putting in a computerized system, which didn’t have very
much clinical decision support at the time, but which had simply dose guidance,
that number dropped by a factor of four down to 0.5 percent. Significant number
of fewer errors, and we noticed a significant number of corresponding adverse
events that went with that, and then, with additional improvements to the
system over the years, the number went down even farther.

So, clearly, the ability of the system, simply by telling you what the right
dose is, to be able to help you along, is very important.

If you look at how many doctors work – particularly younger doctors – when
they are looking for a dose for a drug, they know the patient is supposed to be
on amoxacylin. I don’t really know how much amoxacylin, so I’ll go look in this
little book, and it says, oh, you know, sometimes it’s 500. So I think, okay,
I’ll write down 500. There is sometimes a culture of people who want to make
sure they get an answer and aren’t quite sure whether it is the right answer,
but getting an answer is sometimes better, so sometimes people jump the gun on
that, and having something like this, which gives you a better, more
sophisticated guidance is very important.

In addition, the ability to promote appropriate drug use can be very
powerful. This shows an intervention which fostered the use of a recommended
formulary-based H2 blocker, essentially an antacid.

There were several different kinds available, and because of formulary
reasons – in this case, it was cost-based – the hospitals, pharmacy and
therapeutics committee recommended using one instead of the other, the favorite
one was only getting about 15 percent of the prescribing share, until a simple
intervention went into place inside the order-entry system, which said, we
really would like you to use this, and, as you can see, almost immediately, the
number went up to 85 to 90 percent.

Fortunately, not every intervention gets this kind of almost sheep-like
compliance. We do want people to be thinking about their interventions. The
doctor is supposed to make the last choice, but it is important – very often,
they didn’t have a problem with this. There was no real difference to them, but
since this thing was presented to them at the right moment, they remembered it
and were able to do it, and, again, there’s that medical student, again. They
present the information to you at the right time. You probably already learned
it, but because it is there when you are prescribing, you can do this.

There is less data right now on the impact of ambulatory prescribing
systems, because they are so new. There is, however, an increasing body of
studies which shows that this is going to make a difference.

Again, this is work from CITL.

Savings from preventable adverse drug events in the office. Two million
adverse drug events – according to extrapolations – can be prevented using IT
in the ambulatory practice, accounting for – if you divide it by the number of
visits – about $4 per member per year.

In addition, there’s about 10 percent average rate of overused medications
that are medically unnecessary, possibly about three to five percent under use
of necessary ones. When you average it all out, you get about $35 to $70 per
member per year from overuse and under use. So from a financial picture, you
are not only saving money from preventable adverse drug events, you are saving
money from overuse and under use of medications to the tune of somewhere
between $40 and $75 per year per member. Part of the difficulty comes with who
that savings actually passes onto.

So we talk about the promise. We can see this thing can make costs better.
We can see this can make safety better. We can see that it can promote quality
through proactive interventions. We can see that it can make communication
better and allow us to keep better overall integrated records – things aren’t
lost in between different physicians – so that patients don’t get as many
medications from different physicians, so that patients, in fact, who are
trying to abuse the system have a harder time going to different physicians and
getting the same medication, but there are still significant barriers.

Doctors are concerned about several different things. Right now, penetrans
of electronic prescribing in the physician community in this country is –
depending on which study you read and how you define it – somewhere between
five percent and 18 percent, so definitely not a majority. It has been growing,
primarily due to many payer-sponsored programs and pharmacy-sponsored programs
that are actually pushing these devices out at little or no cost to physicians.

You have heard probably about many of those in different areas. There is one
up in my area – there are two up in my area right now from two different
payers, from Blue Cross and from Tuft’s in Massachusetts, and all this is
applying costs – there’s a problem in that that cost-free basis for physicians
may not be a sustainable thing, and they may have to be paying for it after the
trial is over. So there is some concern about that.

But from a doctor’s side, what are they concerned about? Why don’t they go
into this? They are concerned about cost. They are concerned about the fact
that they have to buy it, that they have to install it, that they have to pay
various kinds of costs, possibly, for connectivity, if they need to, and they
are concerned, even more, as I mentioned, about speed, about time.

When you first start using these systems, like any other piece of
technology, it takes a little bit longer. We have been able to show in the
inpatient environment that that time extension goes away after about four to
six weeks, but during that time, you have some decreased productivity. You do
not currently have any kind of direct reimbursement for using direct
prescribing on an electronic basis. There is not an RVU attached to it, and
there is really no reimbursement right now for costs and for resources.

The safety improvements have to be completely documented. There has to be
really kind of a bandwagon, a swell of support, in much the same way that has
been happening on the inpatient side. Those improvements need to be
demonstrated clearly, and they need to be fully publicized.

And since it is not considered the standard of practice since one isn’t, in
some sense, required or expected to do this, then, there is a need to say,
well, maybe somebody else should be first.

Obviously, several things have happened to change that. Certainly, the
passage of the Medicare bill last year has gotten a lot of people to notice
things. It did not include a mandate, which was fine with many folks, but it
did include various kinds of expectations about how payment will be going on
and how demonstrations will go on, so that, in fact, people are starting to see
that this is coming.

There are laws in a couple of states. Florida has a law mandating legible
prescriptions, which, if – I believe if I was a Florida physician probably is
the same thing as mandating electronic prescriptions. California has laws
mandating information technology in one kind or another. So there has certainly
been a groundswell of various kinds of things on the policy side as well that
have started to make this standard of practice.

There has been a cost issue in that, in many cases, hospital systems have
been desiring to provide this technology out to their physicians in their
community, but haven’t been able to do so because of potential anti-kick-back
laws.

Over the past two days, we noticed that CMS has put in an NPRM of an
exception to this specifically for community-based health information
technology, which we applaud because as the CMS notice itself said, we don’t
think this constitutes any kind of potential for abuse. We think it constitutes
a great potential for improving care and for extending the community out. So
those may be some potential incentives that have already happened that are
bringing this forward.

So in our steering group, when we looked at the different kinds of members
of the prescribing chain – to the pharmacist, to the PBM, to the manufacturer
of systems, to the manufacturer of drugs – it came to be clear that while there
are some barriers in all different steps, probably the largest barrier right
now is in the physician’s office.

There are various positive economic directions for most of the other people
in the chain to be able to use this. So from a business model, the pharmacist
probably gets some certain benefits because of better clerical support, because
of better record keeping, less transcribing they have to do, the ability to do
things like promote refills. From the standpoint of the vendor, obviously, it
is useful because they can get more systems out. From the standpoint of the
payer, the ability to do advanced compliance with formulary is a cost benefit
to them.

So, really, we were concerned primarily about physicians and the fact that
it is the physicians who need to have the appropriate usability and design
issues, as well as the appropriate incentive issues.

So from a doctor’s side, carrots and sticks. There need to be proven –
Safety quality improvement, as I mentioned, it has to be easy and fast to use,
and there have to be some kind of financial balance sheet one way or another
that makes some kind of sense, and whether that comes in the way the cost
picture goes or some other things that we’ll talk about later in this hour,
certainly, that is probably one of the things that physicians look at as they
look at their barely-breaking-even kind of day.

The e-Health Initiative and the Foundation for e-Health Initiative, as you
are aware, is a pair of connected non-profit groups that are in the project of
trying to combine different forces, different stakeholders in many, many
different ways to work on policy issues, to work on better planning issues and
to do anything possible to try and create a much-better-connected healthcare
community through electronic information technology.

There have been projects from eHI on to connecting for health. Many of you
are familiar with this in terms of standards and tools for interconnectivity
among different hospitals and different health plans and different health
providers within a community and even nationwide. There’s been – the newer
aspect now has been a grant program that has been able to support various
communities in developing these connected health systems.

eHI has developed the Electronic Prescribing Project. This was founded about
a year ago, and, again, as I mentioned, this is this multi-stakeholder group
devoted to the rapid adoption of computerized prescribing, and, more
particularly, to the rapid adoption of the benefits of computerized
prescribing, and so we have all these people working on this to try and create
a unified voice for practical and workable incentives, and one of the good
things about having all these people in the room is that we hope that the
findings that we are talking about today and publishing on the 14th
are such that no stakeholder can say, hey, you forgot to consult us when you
made these.

Looking at design input, so we can get useable and fast systems, making sure
that the manufacturers know at least how to set a floor under themselves for
good design and to support demonstration projects that build some momentum and
awareness, confirm the value and help identify the best practices, many of
which are coming through the connecting communities project.

The electronic prescribing group has a steering group of about 35 persons –
again, a number of you are in this room – and under the steering group, we had
several different discussions. We looked at chief guiding principles. We looked
at the core issues that are going to make it important. We looked at the major
things that we needed to say so that people outside had a common voice on what
electronic prescribing is and should be, and, as I’ll get to in a moment, we
established two different areas in incentives and in design implementation.

I have mentioned the stakeholders several times, but now you have a paper
copy of that.

The first thing the steering group did was look at guiding principles, and,
as you can imagine, with this many people, different kinds of stakeholders in
the room, it was a very animated discussion, but, really, these are the primary
things which came out. These are the guiding principles that have to come out
to make electronic prescribing both workable, adoptable and of high value.

Number one, obviously, there needs to be implementable and useable systems.
They have to be something you can put into your practice or your pharmacy. They
have to be something that you can easily use and that handle the different
kinds of work conditions that you want.

Number two, it has to work in a variety of different practice settings. Many
of us who are in the group tend to be fortunate enough to come from larger
academic areas or places where they allow us time to go and have these
discussions, but we have to realize that there’s small practices, large
practices, rural, urban, many, many different flavors, which have different
criteria to them. So when you develop these systems, when we develop things
like the pyramid, we have to understand that different practice settings will
have different kind of capabilities and we need to be able to support all of
those to one degree or another.

Number three, there are areas where standards are very important. In some
cases, standards have been well adopted and well established. In other cases,
there are certain standards which are not yet well established and which are
causing some concern, including state-to-state variations of prescribing
standards, as well as standard dictionary forms for different kinds of
medications at the doctor level.

Number four, we want to encourage the creation of appropriate incentives and
appropriate education to support electronic prescribing.

And, number five, definitely placed here so as to be not least, that
electronic prescribing needs to encourage the physician-patient relationship
and has to encourage choice. There can be nothing in the computer that suddenly
tells you, hey, why don’t you go over to Joe’s pharmacy, even though you really
want to use Jane’s pharmacy. Why don’t you use Payer Y, even though Payer X is
doing the following.

We do not want to make electronic prescribing a tool for advantage. We need
to make it a tool for opportunity, and the choice of what to do and where to go
to get drugs dispensed needs to reside clearly in the hands of the patient and
the physician or other practitioner.

So there are a couple of key objectives.

Design and implementation. That group was established to develop and widely
disseminate general design and implementation techniques to two different
groups in particular:

Providers, so that they could understand what it is that they should be
expecting.

To manufacturers, who have come to us and told us that they have good
designers, but they would love to have some common tools to work with and have
some common information that has worked elsewhere, so that they can make the
best design quicker, so that they don’t all have to do the same R&D.

To encourage development of excellent tools, that has to support the
workflow of the physicians that have to support patient safety and that is able
to educate both patients and their own care givers. That group was established
and many of those findings are what we are doing right now.

The incentives group was chartered to identify and promote the adoption of
financial incentives, regulatory incentives and any other kinds of incentives
that could present compelling forces to generate accelerated adoption, to
enhance cost effectiveness and to increase value to all parties that are
involved in the use of prescription medications.

I am going to talk a little bit about some of the design issues that are
germane to some of the things that the NCVHS requested of me in this particular
talk.

The Design and Implementation Group looked at the different stages of
prescriptions and prescription writing and prescription management and set up
six different subgroups that looked at various different aspects.

The Incentive Group particularly worked on two different areas, pay for
performance and education.

On the Design Group, the work that has come out has essentially been geared
in imperatives. All of this is supported by about a 100-page report, with a
number of different specific examples, specific worksheets, and, in some cases,
how-to guides for getting some of this done, but, certainly, there is a
usability imperative, and I have mentioned this several times, so you know it
probably is important.

Obviously, speed and convenience, easy implementation and – I don’t think I
meant to write speed twice, but I think you get the idea at this point. You
have to support the actual models of prescribing. We can say, well, a
prescription is something written by a doctor. Well, that is not necessarily
true. In most states, nurse practitioners and midwives can write prescriptions
of various kinds. Obviously, when I include doctors, I include both D.O.s as
well as M.D.s and dentists, and, in many practices, there’s different kinds of
work flow. Sometimes, someone who is not fully authorized to write a
prescription may generate the initial prescription, have it go to the doctor
for signing. So we think about a Level 2 user like a nurse who can do that,
perhaps even a Level 3 user, who might be a medical student or a resident who
needs to write things that can’t go forward until the doctor signs it.

So you have to actually support the kinds of workflow that actually goes
forth in a real provider office, and some of the applications that are out
there right now do not do this, and so when we looked at our design criteria,
we wanted to make sure that people knew what it was that makes prescribing
actually work in a real practice and to make sure that all the manufacturers,
as well as all the providers, had an expectation that they could do some of
these things.

It needs to be accessible in all places where prescription writing is
needed. Prescriptions are written in your receiving office. Prescriptions are
written in the exam room. If you consider it to be ambulatory practice to
include emergency and urgent care, prescriptions are written there, and, very
often, prescriptions are written or generated from your home, when someone
calls you up or when your office calls you or perhaps you had a different
practice that day. So there is remote writing as well, something which is very
well fostered by electronic prescribing, something which is, in fact, very hard
to do in the paper world.

We know that people are worried about making processes harder, worried about
if I have to sign into a computer, it’ll take longer. If I have to type
something, it’ll take longer. There’s much less techniphobia than there was
when I started in this business 15 years ago, but, certainly, there is still
some skittishness.

So to balance out some of these things, one has to make some things easier.
Refills are much easier to do when you already have an electronic list of the
patient’s existing medications. Most prescribing applications that are out
there in the market right now can do refills of about 10 different medications
in about 10 different seconds, and that is much different than a patient who
comes in for their annual checkup and says, well, doctor, I’m here. Here are my
13 medications. I need all of them renewed; and, by the way, this is a
10-minute visit, and it takes me about 9-1/2 minutes to write all those things
out longhand. So it is important to be able to have this kind of tool. So that
is clearly an advantage.

 

Favorite medications, as I showed you on the first screen is an advantage,
being able to do certain kinds of things like split prescriptions. Very often,
a physician will want to write a patient for a long-term medication that is
going to be given out by mail order. The patient wishes to do mail order
because of convenience and cost issues, but, at the same time, it is going to
take a week or more for that mail-order prescription to get there, so the
doctor splits it. They give the patient a paper prescription for the first
week’s worth, and then send something off to the mail order. There are
applications now which support that, so that in one flick of a button you can
actually send both of those things out.

So you have to look at the workflow that goes on in the office, support the
things that work better, the things that you can gain advantage of, and then
try and make those better.

Obviously, there is a great deal of efficiency gained – and this has been
demonstrated already by several studies – from a reduction in pharmacy call
backs, because the prescription has been checked, to some extent, beforehand,
and, also, more and more now because the call back happens on an instantaneous
basis, so I don’t have to wait until a patient arrives at the pharmacy before
the pharmacist is able to have their say. The pharmacist sees it right away.

So many, many different processes can be made easier. These have to get into
the regular flow of all products that are out there so people can make use of
this and like the systems they are doing.

Safety, we have mentioned several times, but since this is really the
fundamental good goal coming out of this, we care a great deal about it.
Obviously, supporting safe care through proactive and reactive guidance, being
able to facilitate, as I just mentioned, instantaneous order feedback and
compliance initiatives from the pharmacy, being able to have both basic and
advanced clinical decision support, being able to comply with guidelines and
help promote the appropriate use of medications for patients who should or
should not be on them, and, again, obviously, being able to instantaneously
provide educational materials.

Prescribing applications in the computer can have instant access to the
appropriate questions and answers. You may think about as you are prescribing a
drug, gee, can I use this in pregnancy, and instead of having to go off to a
reference book, the answer may be one button away on the screen. So safety
imperatives must be part of all prescribing systems.

Reimbursement imperatives come from various things like formulary support,
and this includes the ability to display that certain medications are favored
or not favored, on or off formulary, have higher copays, that alternatives
choices are not only available, but are instantaneously displayed on the
screen, that the reasons for the alternatives can be displayed, that drugs
which require prior approval can get so right away, instead of after three
different phone calls back and forth to your pharmacist, that drugs that are
approved only for limited use can be encouraged and enforced to do so in that
way. All these things happen through what amounts to relatively basic logic,
but stuff that can be included in every system.

Prevention of overuse and under use, as I mentioned, the cost correlates of
safety, the fact that preventing adverse events, in its own sense, not only
makes people healthier, but also saves money because of all the extra testing
that is not needed, the extra care that is not needed.

Substantial financial savings are possible, and, again, as I mentioned,
these tend to be right now, not generally directed right at the physician, and
so there is, in some sense, an incentive imbalance that needs to be worked out.

And then, finally – actually, not finally, but next – connectivity.
Connectivity provides a bunch of different benefits, as I mentioned earlier on,
but just to list them again, the potential for access to a complete medication
regimen, including things you get from multiple practitioners and things that
you may even have yourself enlisted on your own personal health record.

The ability to enhance efficiency for all, as you can see, quickly, how to
renew medications that go across different practices, the ability to have that
connectivity that can enhance anonymous aggregated data for research, so that
we know what drugs are having what effect on what problems, so we know the
prevalence of use of various things, so we know the prevalence of various kinds
of adverse events, and also for things like public health surveillance, because
the enhanced use of certain medications at a time may indicate that there is an
enhanced problem going on in that community. If I suddenly see a lot of people
using flu vaccines and anti-flu medications in a community, that may indicate
that there’s some sort of epidemic going on locally that may be a public health
concern.

Two-way communication is very important, obviously, and connection to
inpatient systems is equally valuable.

We want people to be able to have medications in the inpatient setting, be
able to transfer them readily into the ambulatory setting, because, believe me,
they are not, most of the time. There is a great deal of disconnect in going
from the ambulatory care into the hospital, getting the right medications and
then getting them turned back into ambulatory medications on the way back. That
is a significant source of omissions, a significant source of new interactions
and a significant source of errors.

We want you to be able to have your ambulatory record, your inpatient
record, your home record, be available to all your practitioners, even if I use
a system made by one company, you use a system made by another company, you use
a system made by a third. So the ability to have not only data standards, but
also operability standards and connection standards, so that these systems can
all talk to each other makes life much, much better. Some of these things are
now accelerating rapidly. Some of them are still very much in their infancy.

And then protection for the patient. Some careful reuse of this data is
important and valuable – as I mentioned, safety, public health surveillance.
There are other concerns, whereby getting aggregated data is going to make a
big difference to the state of public health in this country. At the same time,
I did say anonymized and I did say aggregated, and one has to be very cautious
about this to make sure that provider and patient worries about data being sold
and used inappropriately, or, simply, significant violations of
patients’privacy and confidentiality have to be protected.

I don’t see this as a significant technical barrier. I think that these
tools are well in place at this point. Certainly, a lot of the momentum
generated by HIPAA compliance work over the past several years has generated a
lot of work in this area. So it is not a technical barrier, but it is something
that has to be done correctly, and there have to be guidelines for its use.
And, again, the choice of pharmacy must also be protected.

And then, finally, in terms of the general specific areas that the design
group has worked on, standards and regulatory concerns. I know we are going to
hear some more from NCPDP later on.

There’s a number of places, in particular, where varied standards – that is
sort of an oxymoron, I guess – make development difficult for manufacturers,
make it expensive for providers.

I have a book on my desk which is about 150 pages thick which contains the
prescription form requirements of the various states and territories, and there
are 50 states and six or seven territories that are listed, and that makes 57,
and there are about 65 different variations on the theme, including some that
happen within a state.

Most of these things are states that are doing pretty much exactly the same
intent and same philosophy, but one state actually requires you to say dispense
as written, if you don’t want a substitution. Another one requires you to say
the words, do not substitute. Another one requires no substitution permitted,
and each of these must be different. So if you are a manufacturer of a computer
system, you have to keep track of these 57 different rules and be able to keep
them up to date. Some require the name to be on the top. Some require the name
to be on the bottom.

So, in many cases, some of these things are simply formulaic and are simply
arrived differently because people arrived at them differently through state
boards. It would certainly make life a lot easier and probably make adoption
smoother and probably less expensive if there were a way to somehow reconcile
some of these differences.

Formulary conventions are problematic right now. The world of electronic
supply and delivery of formulary information is relatively new. There are some
companies out there now that do brokerage and that they maintain the
formularies of several different payers and they provide this in a computer
file. So a prescription application can say – when I type out Nexium, it’ll
say, well, this patient is from Connecticut and uses Aetna, and in Connecticut,
the Aetna plan would rather use X drug instead of Nexium, but in a different
state, a different plan, they might rather use Nexium instead of something
else. So that is okay to have different formularies, but the data conventions
right now are in their infancy and it’s not so much that you have to deal with
the different formularies as that you have to deal with the different
brokerages and different standards, and that is something which needs to be
improved.

Drug dictionaries. When you write prescriptions, you are using some basic
dictionary of drugs. They come from various companies like First Data Bank,
Multa-Medispan(?). There are about six different providers of these, and the
physicians need to use them so that they can, obviously, pick drugs, so that if
they misspell a drug, they can see it quickly. So if I want to write
amoxacylin, it says amoxacylin, and not what the pharmacist wants to see, which
is the 45 different packages of amoxacylin.

Right now, the coding systems are favoring pharmacists and work very well
for pharmacists, but at the doctor level, it is sometimes difficult to be able
to select and convey a drug at your level when what I really want to see is
amoxacylin capsules and move on from there.

There is work that has gone on at the NLM, the RxNorm project, which is
really trying to provide a solution to this, and we look forward to rapid
completion and adoption of things like that.

So there are places where standards need to be continued to be updated,
where being able to put various kinds of codes into a script standard message
or an HL7 message need to be taken care of, and some of these things are things
that we have been pushing for in our group as well.

So from a development standpoint, there’s a number of different things that
are needed to make these things more useable, to make them more connectable, to
make them less expensive, to make them easier to generate the benefits that we
care so much about.

I am going to talk somewhat about the incentive program, as my last major
topic. As I mentioned, we established a large incentive – as well, comprised of
the same stakeholders, and they really looked at many, many different
categories of potential incentives for their potential impact and for their
potential feasibility, and they looked – as you can see in your handouts –
about different kinds of economic incentives, whether it be malpractice reform,
whether it be handoffs from the pharmacies in exchange for better data, whether
it be internal policy things, like credentialing, all of which had to be done,
obviously, without generating any kind of kickback concerns.

Public policy incentives. We were concerned about these three acts. As I
mentioned, there has been various kinds of progress in at least two of them so
far that are making a significant difference to us, and the ability of various
kinds of patient safety incentives, like accrediting groups. Jayco(?) is now
including some of these techniques. The Leap Frog Group and other sorts of
business consortia have been working hard to try and put out various
recommendations and try and use their influence to make this standard of care.

Error reporting projects, such as those coming out of CMS itself, as well as
things coming out of premier and other large groups, and, again, purchaser and
consumer education plans, so that people realize what these benefits are and
realize that, in fact, they probably do want to have some of these things,
because it makes a big difference, so that purchasers and consumers, the
patients, can put a little bit of extra pressure and incentive, saying, I would
really rather have a physician that uses one of these systems, because I know
it is going to make my healthcare better.

The group rated various of these tools in terms of their impact. Some of the
things which came up very high included pay-for-performance programs. As I am
sure most of you are aware, pay-for-performance programs are a growing body of
programs in which purchasers are providing indirect and sometimes direct
reimbursement for the maintenance and achievement of various kinds of care
criteria, like the appropriate measurement of hemoglobin A1C in all diabetics
or, even better, the appropriate maintenance of low hemoglobin A1Cs in all
diabetics, appropriate use of eye examinations and foot examinations and so on.

So that right now, there are a number of projects – I think it is getting
past the stage of a pilot – where providers can see direct reimbursement in
exchange for providing better care. Certainly, electronic prescribing is one of
the key initiatives in many current pay-for-performance programs.

Direct reimbursement for utilization of information is happening through a
number of indirect channels. The idea of pharmacies defraying costs certainly
has a high impact, although there was a concern with feasibility on those.

Transaction fees, again, high impact balance with some concern about making
sure that we are not simply incentivizing people to write for more
prescriptions. And various other ones.

And when this came out, these high potential incentives came out of the
impact multiplied by the feasibility.

Number one, economics, specifically, reimbursement for utilization of the
electronic prescribing in the form of resource value units in the form of
actual credits that one can give. Just as one documents various kinds of
medical decision making, so one can document the use of electronic prescribing
and be able to use that as an RVU-based item.

Pay for performance is certainly one that has been favored, and there have
been some work inside our document about having specific pay-for-performance
guidelines.

Having third parties be involved – payers, pharmacies, transaction brokers –
in terms of not so much incentivizing specific individual prescriptions, but in
terms of looking at aggregated defrayed costs and trying to figure out how that
financial incentive can be moved up and down the chain.

And, again, the Medicare Act, Stark relief, these things were written before
some of these things occurred. The Medicare Act’s impact is still not known.
Many of you folks are helping us make that impact, and, certainly, it is well
known to the people in our incentives group that this is probably going to be
one of the big drivers in helping this to be adopted and helping this kind of
safety benefit to come out to the entire country.

So, in general, from a policy standpoint, there are a number of things that
have to be done.

Certainly, we want to promote standards-based systems. We want to promote
appropriate codes, so that people don’t have to do multiple different levels of
development, supporting multiple different manufacturer standards. We want to
have the rapid development of state bridging standards, where possible, so that
these things can be unified, all in the name of making it possible to develop
these things one time and not 57 times.

There needs to be a floor of good system criteria. Many of the imperatives
that I listed earlier on in this talk talk about things which all systems
should have in one form or another, and should be able to demonstrate they
should have, and should be able to show it in a way that is clearly available
to those that are going to purchase these systems.

We want to promote collectives, like ourselves, that do common research and
mutual education of such criteria.

Some of the things that go on, providing learning centers, so that both
providers and manufacturers can get together and see new things as they come
out, perhaps learn from each other, all without suppressing the natural forces
of competition and independent innovation, but giving people a piece of
groundwork that they can use to build upon.

We clearly want policy to support quality as probably the most important
single goal through measurable clinical decision support, and whether that
means that incentives are provided for the use of clinical decision support
itself or whether incentives are provided for the actual ability to measure
different kinds of outcomes, they need to be ones which are readily easy to
measure, but the ability to provide some kind of supports that people have that
extra incentive to support quality, all providers want quality, but they
understand the realities of their own business, of their practice as well, and
any ways to support this, encourage it are going to be well rewarded and
increase adoption and increase quality.

And we also want to state that electronic prescribing – this whole project –
talks about one particular application, but it is important to realize that
there is an entire model available here for design, usability, incentives,
policy that applies not just to prescribing. It applies to the entire world of
electronic health records. It applies to necessary things for the development
and furtherance of the national health information infrastructure.

We see electronic prescribing as not just a standalone application, but as a
collective part of an electronic record, and we see some of the techniques and
brainstorming that was done over the past year as possibly useable and
utilizable for these other applications as well. So we really encourage you
folks to help us all out with this.

Ambulatory prescribing has substantial potential. We have seen, now, studies
that came out recently. You know, 10 to 20 percent of all Medicare patients
have some sort of adverse drug events every year. It has substantial potential,
and compared to some more expensive systems, like full-flown inpatient CPOE, it
may be easier to implement, because of the lower incremental costs.

Usability and incentives are needed to provide adoption and clinical
decision support. Communication and data integration are needed to promote
quality, and standardization makes it easier, makes it cheaper, makes it more
portable, makes it more compatible.

And we do hope that electronic prescribing will be able to – the migration
step to having high-quality, high-value electronic health records throughout
the whole country.

That’s my talk. Thank you for that, and I’ll take any questions.

DR. COHN: Okay. Jonathan, thank you. I expect the committee does have –
there’s really a time for questions and discussions.

I actually wanted to start with one myself here.

Thank you for, I think, a very illuminating conversation about
e-prescribing.

I guess, as I am thinking about all of this, and I am just curious about
your thoughts, I mean, you mention this as a model for NHII and things like
this. I guess I am sort of wondering whether this is really the wedge for NHII,
only because I am having a hard time imagining – I mean, this feels like one of
the main pieces of an NHII, and I guess – so I am curious about whether that is
consistent with your view or not, number one.

And number two is – and I asked this question earlier about this as a module
versus this as a free-standing unit, but, from your view, as we move into the
later part of the first decade of the 21st Century, do you think
that there’s actually a reasonable business case for having just a single
module that is e-prescribing or is anyone who is going to be looking at these
going to be logically wanting to bundle this as part of practice management
systems, EHRs or other things, just because of the efficiencies of scale there?
So two questions.

DR. TEICH: Sure. Once I get past three facts, I have to write them all down.

DR. COHN: Sure. First of all, the question was is this –

DR. TEICH: No, I got them. I got them.

DR. COHN: – the wedge, and then other question is –

DR. TEICH: I got it.

DR. COHN: – modules versus other pieces.

DR. TEICH: Yes. Certainly, one of the things I have learned from having feet
in both academic and business worlds over the past four or five years is that
the drivers have a lot to do with what gets publicized and what people think
other people are doing.

Right now, electronic prescribing is a hot topic. It’s a hot topic because
of certain key studies that have been now coming out showing error-prone
prescribing, because of the publicity attendant on those studies that have been
given in the news media, and it is hot because payers have gotten on the
bandwagon and said, well, let’s start supplying some test projects. So it’s hot
because there are a number of well-regarded and well-publicized projects out
there saying, electronic prescribing is good and we are going to test this in
Boston. We are going to test this in Oakland. We are going to test this in
Seattle, and the reason I am using that publicity example is to say that the
same should probably be true of electronic health records in general.

Certainly, yes, to me, electronic prescribing has its best potential as a
module. It is available as a stand-alone application, and, again, just like
that pyramid, there are things you can do at a lower level, but that pyramid
fits inside a larger pyramid, says, you know, as you go up in electronic
prescribing, so you can go up in sophistication of electronic records in
general, and, again, with each of those different additions, you gain sometimes
a little bit, sometimes a lot more safety and quality.

So, to me, there’s no question that a), you can use electronic prescribing,
basically standalone, but once you have done that, you have now done patient
identification, you have now done system login, you have now done registration,
you’ve done basic connectivity. So you have done a lot of the infrastructure
that you are going to need to do electronic health records. You know, in the
work that we do in my own company, we certainly have been able to leverage
applications on top of a core infrastructure.

So once you have done one thing, then, in fact, you might have your wedge.
It may be that in getting electronic prescribing rolled out, if we do it
skillfully, we will have not only that application, but also the tools to
promote the infrastructure for many other applications, problem management,
disease-management tools and so on.

Jeff, you have a question?

MR. BLAIR: Yes. Jonathan, could you help me understand – it appears to me as
if some of the early e-prescribing systems that are out on the market today,
some of them appear to be physician- or
electronic-health-medical-record-centric and/or with a practice management
system. Whereby, they get their eligibility information from the practice
management system, their electronic health record system is able to supply
medication history, patient history, possibly even formulary information, and
they could work with a network to pharmacies and pharmacists. So that is one
model that appears to be out there.

There is another model which appears to be out there, whereby the
formularies and the eligibility benefits are checked by a pharmacy-benefit
manager who is creating a network, and, in that model, I wonder whether the
physician has the same freedom to be able to prescribe the drugs that the
physician feels is most appropriate, especially if a pre-existing condition or
authority is required and how fast that could get back.

And then there is a third model that appears to me which is – I would think
of as pharmacy-centric, and the implications of these different models, in
terms of who is the source of the data, who controls the data and how do you
challenge the data during the prescription process.

I am trying to understand the implication for standards, because our role is
what e-prescribing standards are needed. How does this effect our understanding
of what standards are needed for e-prescribing?

DR. TEICH: That’s a great question, Jeff, and I think I will try and answer
in a couple of different ways.

First of all, you are correct. Actually, most electronic prescriptions that
are written today are, in fact, written through existing electronic medical
record applications. So while the standalone systems and the handheld systems
are getting the most newspaper buzz and have some of the most kind of glitter
around them, certainly most of these things right now come from integrated
applications that have been in place for five to 10 years.

You are really asking whether it makes a difference who has provided the
application and who has directed the adoption of the application, as far as
what one does with it and what I feel compelled or somehow pressured to do with
it, certainly, from the standpoint of the payer and the PBM that is associated,
they have a primary goal, I imagine, to help deliver drugs very well and to
help provide information and also to manage costs by providing the drugs that
work well for their payment model.

Where PBMs have provided systems and where they are backing them, you
sometimes see, in current practice, that there are such things as targeted
alternatives that appear.

Targeted alternative means that as I go into a drug, it may say, well, if
you are ordering a drug for – if I am ordering a drug for ulcers, colitis, they
say, well, we recommend you use this particular drug. So it’ll actually say it
up front. When it is listing the drugs by indication, it’ll say, you know,
here’s a really good one and here’s five others. You might see that. You don’t
see what I think would be the more egregious thing, which says, you know, gee,
I would like to prescribe Drug A, and have it come up and say, gee, why don’t
you prescribe Drug B, because we think it’s a nicer drug? So that doesn’t
really happen very much. What you do see, obviously, is the existence of a
formulary, and the fact – I’m not here to challenge the existence of a
formulary. I think they have their significant values in various ways, but,
certainly, it is imperative, as long as there is a formulary, to make people
aware of it, but not to make it overly difficult to continue with the choice
that the physician and the patient have, and, again, it all comes down to
choice.

The same thing is true of networks that are being provided now by pharmacies
or by pharmacy networks that come from – you know, SureScripts certainly is
pushing some things out, and that is getting a lot of physicians to adopt
these, and, certainly, Kevin from SureScripts is over here and is a member of
our steering committee and was not only an agreer to, but also one of the chief
proponents of making sure that total choice is preserved in the
physician-patient relationship.

So I think the answer is can I make technology such that it constrains what
I can do and such that it overly influences what I do and puts the drug they
want in big black letters and puts the ones that they don’t want in tiny little
yellow letters? Yes, that is possible. We haven’t seen people being quite so
crass, but I do think that it is probably necessary to incorporate in whatever
kind of procedures you do the fact that that choice must be preserved. So by
whatever means necessary, we want to make sure that the axis of prescribing and
prescribing choice rests with the provider and the patient, subject to at least
being able to see all the information that is available on cost and other
issues.

Does that answer your question?

MR. BLAIR: Yes, in part, and only try to bring it down to a particular
standard here.

It is my understanding that if a preauthorization is required or a physician
to override the guidance of the formulary, that that happens to be one of the
standards that is not yet in place yet, and that that would be a gap. Is that
your understanding, too, that that would need to be a standard that needs to be
developed?

DR. TEICH: There is – in fact, I should probably ask someone from NCP to be
on this more than myself. There are a variety of transactions that go across in
the messaging standards that are more than simply the sending of the
prescriptions, as you are aware, and some of them include eligibility requests
and various kinds of compliance. Someone may check me if there is a specific
one for gaining immediate prior approval. I don’t know if anyone can answer
that for me.

Bob Beckley is one of the people who has designed the NCPDP standards.

MR. BECKLEY: There is prior authorization capability within this crib
standard that can work two ways.

If the prescriber is aware of a prior authorization prescribing – writing a
prescription, then that can be forwarded at that time, so when the pharmacy
gets it, they can immediately dispense it and have the prior authorization.

If it is not caught at the time the physician writes the prescription, when
the pharmacy goes to adjudicate the prescription, the message comes back, prior
authorization required. There is an electronic transaction again. You don’t
have to go to paper or telephone to query the doctor indicating that a prior
authorization is needed, please obtain one and resubmit, and then the pharmacy
can proceed with dispensing – getting a prescription paid for, adjudicated and
dispensing the prescription. So it has been taken into account in the standard
to message back and forth electronically. Proactive is much better than having
to go back later and ask for it, though.

DR. TEICH: Thanks, Bob, and that is clear to me now also. I realize that is
the case. When I prescribe, I can see the prior authorization is flagged, so I
can generate the necessary work myself, and, as Bob mentions, if I don’t, and
if it happens to be going instantaneously to the pharmacy, they are going to
see it, and you can be sure that they are going to send me back some
information on it.

I saw a question in the back?

SPEAKER: I just wanted to make sure I understood all parts of your question,
because I think Bob was referring to the communication between the pharmacist
and the physician about the prior authorization or existence of it, but not the
communication between the physician and the payer who has to give that prior
authorization clearance, and that is not currently part of the script standard.

DR. TEICH: Right. I think that is correct. Yes, I think the actual
authorization transaction itself, I think, is not yet in the standard.

DR. COHN: Yes, and I think Bob is actually nodding his head, as I
understand, so – okay.

DR. FITZMAURICE: You talked about some standards that were needed,
desirable. You mentioned RxNorm as one of them.

If you were to put a top five standards that are needed to make this work,
what are the areas of standardization that you would like to see done first to
make e-prescribing work? Are we talking vocabulary here? Are we talking about
classifying NDC codes? What would make it work?

DR. TEICH: The top five standards. Well, let me give them to you in
desirability, which may not be the same as feasibility, because some are more
complex than others, but, certainly, I think that the two that come to mind
immediately is number one would be a prescriber-level vocabulary, so I think
that is probably very, very high up, because I think that, right now, as people
will know, when I send a prescription along, the script standard will handle
NDC codes which can be adapted, more or less, from the prescription level, but
sometimes there are some difficulties in sort of getting that mapping to be
done, and what happens, more often than not, I am informed, is that it comes in
as a piece of text that says, you know, amoxacylin, which has to be hand
carried. So you gain a potential source of error in that transcription and you
lose some potential for feedback and data gathering.

So I would say that that is certainly one of them, plus the fact that if I
could do that and if I could normalize it across the current providers of these
dictionaries, then I wouldn’t be worried that when I went from one dictionary
provider to another I would have slightly different allergy warnings and
slightly different interactions and something that used to be permitted was now
not permitted.

So one of the things I care about is where there are standards that have
been established in – not silos, but in manufacturer-specific context, I would
love to bring those back together. So that is probably first.

I think second is the overall issue of the different prescribing forms
required by the states. Certainly, in terms of things that we see on a weekly
basis, we try and build these out. We’ll provide a practice in Maine with a
prescription application, then we’ll go to provide one to a practice in New
York, and it turns out the prescription has to be different, and then we go to
the Midwest, to Minnesota, and the prescription is different there.

DR. FITZMAURICE: Are you talking about different information or just
different locations –

DR. TEICH: It is really a matter of – most of it is different locations and
different forms. There are a couple of things that are more substantial than
that, but a large part of it is simply being able to put the right words on the
right form in the right place.

So those are two. There are certainly a number of other communications
transactions that should happen, that should go forward. We just mentioned one
of them. So we really want to get every possible eligibility piece together.

Those are the ones that come to top of mind, and then if I look at my cheat
list over here, I think probably the ability to have formularies come through a
standard form right now. There are three or four major suppliers, brokers of
formula information. Some of them are independent. Some of them come through
the payers, and they are providing information, but they are providing them in
different formats, and, along with that, is that we don’t have a unique
identifier for payers in the first place. The ability to have some sort of
numeric or coded value for the payers and the plans themselves means that when
I go from practice to practice I have to take the words that they have been
using for Blue Cross/Blue Shield Preferred Health of Texas and be able to
translate that to my master list, when the next people over in the next town
call it Preferred Health Blue Cross Texas Blue Shield.

DR. FITZMAURICE: So would the HIPAA unique health-plan identifiers help out
on this?

DR. TEICH: I think that has to be a – that or something that goes along with
it, would probably be a significant –

DR. FITZMAURICE: You won’t have it for years, but –

DR. TEICH: It’s a big deal and it causes a lot of – those things that I have
mentioned cause a lot of hassle at the time of implementation, at the time I
bring up a new practice, and if I go into a new practice and say, here’s your
application, we are ready to go, and I say, wait a minute. This isn’t how I say
this. This isn’t how I say that, it costs time and it costs productivity, and
it starts getting people cranky.

DR. FITZMAURICE: Thank you.

DR. COHN: It’s actually the first time I’ve heard somebody recently bring up
the health plan idea in a business case recently. So thank you for reminding us
that that is one of the unmet HIPAA regs.

MR. BLAIR: Jonathan, can you help us understand a little bit better the
areas that get involved with drug-to-drug interactions, drug-to-allergy
checking, drug-to-patient-weight-and dosage-forms checking?

There’s two aspects that I would like to have a better understanding of. One
of them is that it appears that a lot of those functions within the acute-care
center are referred to as clinical decision support, and within the ambulatory
sector, they appear to be referred to as drug utilization review. Are they the
same things or are they different? Is it just different terminology?

And the second question related to these are if they are different and the
drug testing, for example, is being putting forth, our expectation for these,
in terms of the requirements for clinical specificity, is that executed with
the same level of specificity in the ambulatory sector as has been the
expectation in the acute-care center? Is there a difference?

DR. TEICH: Every time Jeff asks a question, I have to write a lot of notes,
because he asks so many good things at once.

Let me take a couple of these. Clinical decision support versus drug
utilization review. Here’s how I define them – and I think this is probably a
reasonably general standard.

Clinical decision support is probably a super set. Clinical decision support
is all the different things that one can do to alter, promote, remind, educate
and in one way or another give extra information to the physician or pharmacist
or payer, all the different things that we can do so that primarily at the time
of doing a certain transaction they have every piece of information that is
necessary to do it right and that if they see all that information and still do
a little bit wrong, they have some more information to help them possibly make
the best decision. So it’s just that. It is information, whether it’s active or
passive, that helps support the making of the best decision, and that decision
could be a safety issue. It could be a cost issue. It could be a patient
convenience issue. It could be a logistical issue. So CDS is – most people
think of CDS as alerts and reminders, and that is probably a pretty good basis,
but it’s alerts, it’s reminders, it’s guidelines, it’s proactive things, and it
probably also includes those alerts necessary to support drug utilization
review.

To me, drug utilization review really deals with exactly those words, with
the appropriate utilization of drugs themselves, with not taking a drug that is
supposed to be given for one month and overusing it, with not using drugs
outside of their proper indications, with not using drugs that are going to
breed excessive bacterial resistance for an infection when something better
would do.

I wouldn’t consider, for example, an allergy warning to be an example of
drug utilization review, but I would consider a formulary warning to be such,
and I would consider a warning that says there is a more appropriate drug than
what you have ordered based on certain patient characteristics to probably be
an example of drug utilization review.

So, to me, that is a subset, and I invite anybody else that wants to to
correct that or amend that definition one way or the other, because I just came
up with it off the cuff. In fact, I’ll take amendments before I go to the next
part of your question.

Okay. So move to next.

As far as the B in our report, there’s a large table of many, many different
kinds of clinical decision support interventions. What is involved with them,
which one of them, according to our group, seems to be most necessary at the
basic core and which ones are also important, but should be added incrementally
or can be added incrementally, and, certainly, some of the things you mentioned
is that some of these are dictionary bound. Allergy checking and drug
interaction checking are dictionary bound. I don’t know if Drug A interacts
with Drug B unless the same person who provided my drug ordering dictionary has
also provided an interaction table that says that these things interact with
those things.

Again, among the different manufacturers – and I have had intimate work with
probably four different manufacturers of these – they are pretty close, and I
would say they are probably about maybe between 90 and 92 percent identical,
but there’s a couple of differences here and there. So, presumably, most of
those are insignificant. I have never found a place where I found one where a
real big one has been missed, but I think that in terms of ambulatory versus
inpatient, it is probably just as specific. They are probably just as complex,
and, in fact, it is probably even more complex.

One of the things about ambulatory care is that I’ve got a bunch of other
medications. On inpatient care, I’m giving the stuff that I’m used to giving in
the pharmacy of my hospital. Ambulatory care, I’ve a patient who is taking my
medications and medications from a psychiatrist that they see in another town
and medications from an orthopedic specialist somewhere else, and who takes St.
John’s Wort at home and various other kinds of over-the-counter medications and
who drinks a lot of grapefruit juice, which itself has a lot of drug
interactions. So, in many ways, the fact that there’s so many sources of data I
might not know, there’s such a wider range of medications that can be used and
also that I have so much less controlled an environment in ambulatory care than
I do inside a hospital are all reasons why, in fact, there are probably more
ways to have errors occur in ambulatory care, not to mention compliance. If a
patient doesn’t take the medication or takes them too much, that’ll happen.

I=m an emergency physician when I practice and I see a lot of the results of
these. I see a lot of people who come in with adverse drug events, primarily
from kumadin, in fact, but from many other things. I’ve had patients who were
prescribed theopholin for asthma and then they got more sick, so their doctor
told them to increase the dose, and that was fine, but then they got even more
sick, so they increase the dose by themselves, and then, after that, they
started getting a little shaky and got an upset stomach, as theopholin will do,
and then they said, well, gee, I have an upset stomach. I better go to my
medicine cabinet and take some of this tagamet I have, which is an antacid, an
H2 blocker, which happens have a significant drug interaction with theopholin,
and this patient comes to me with a heart rate of about 200, about to lose
their life.

So you can see that there are many things that the non-controlled
environment does to make these things harder in the ambulatory care area, but I
think the dictionaries need to include alternative medications, foreign
medications and so on to be able to handle this properly.

MR. BLAIR: Thank you.

MS. CRONIN: Jon, I’m just wondering if you would comment on the need and the
feasibility of having standards that would allow for the differentiation or
severity rating of drug interactions?

DR. TEICH: Sure. The simple answer to this is we certainly had better.

If I were to show you every drug interaction warning that was available in
the pharmacy drug compendium or even more so in the PDR, you would be spending
a great deal of time dissecting the warnings for each and every drug that you
order.

There needs to be some kind of parsimony – some kind of restrictions in the
way that interactions are displayed, simply to avoid saturating them. If you
display every single warning, then, what is going to happen is people will
develop weariness and will ignore every single warning, including the most
important ones. So you have to be careful how many different things you throw
at a practitioner at a time.

Now, most of the major providers of dictionaries do, in fact, allow them to
have different levels. One manufacturer provides Levels 1 through 9, one has
minor, moderate and major. In general, whenever I have been involved in the
development of a system – whether academically or commercially – we have, in
general, given people the choice, and almost always they choose to show only
the major ones.

My own laboratory did a study about five years ago where we looked at all
the ones that we didn’t show and figured out how many errors would have come
from them, and over about 150,000 medications, we found one. So, certainly,
that one error that would have happened was probably offset by the many, many
more errors that would have happened if people were forced to see so many
warnings that they didn’t see the ones they wanted.

So the answer is yes. We need to have a breakdown, especially among drug
interactions, and I think this is something which is not very standardized. I
think this is one which is probably more done by feel and by local pharmacy
expert choice more than anything else, and I’m not quite sure – really, we
haven’t addressed the issue of how one would approach that, Kelly, but I think
that you are absolutely right. That is one of the ones that would be very
important to have.

MS. CRONIN: Yes, I just heard that in terms of user preference and potential
barrier to adoption is – you know – having people just inundated with these
pop-ups, and they’ll eventually just switch off the function if it really
irritates them and takes up too much time.

But, at the same time, if there is a lack of evidence base to have a
systematic way of categorizing these, then how do we handle it?

But then, again, you don’t want, perhaps, a small firm that is under
resourced to be coming up with their own categorization scheme that really is
very divorced from any level –

DR. TEICH: There was a paper – a commentary that Lucian Leap(?) wrote, I
think, a couple of years ago, which – along with several other people – which
said we want to have evidence for everything, but we can’t practically get
evidence for everything tomorrow. So we have to make some good guesses, too,
and I think that probably applies here. I think that it would take a humongous
amount of research to try and develop exactly which one of these things were –
you know, the project that we did, plus many, many more like it.

So I think there has to be some room for saying let’s get a good guess
together, but I think that good guess could be a consortium good guess, instead
of an independent good guess, and you could get your first data and your
Medispan and your – together and say, why don’t you guys make a good guess
together? And I think they can do that without upsetting their competitive
advantage over each other.

How are we doing on time?

DR. COHN: Well, we’ve got a couple of more questions here, and, Jon, I would
comment, the private pharmacists also have had a fair amount of experience with
these drug interactions. My understanding is that generally there are very few
medications that you can prescribe together that don’t have some sort of an
interaction, and I am sure you and I have had the same issue there.

MR. REYNOLDS: Jonathan, thank you. Excellent presentation.

DR. TEICH: Thanks, Harry.

MR. REYNOLDS: One point that you didn’t hit on was the related medical
history around the bill, and with all the work that you have done, surely – and
including the HR that you showed us – surely, you have thought about that some.
Could you give us some insight on what – if you were defining what that ought
to be, what it is?

DR. TEICH: Are you talking about medication history in particular –

MR. REYNOLDS: I’m talking about – in the bill, it talks about related
medical history.

DR. TEICH: Oh, yes, yes, yes. Yes, that refers, I believe, to the other
pieces of information that are necessary to make prescribing, in particular,
and also all health care, to be better, since you are looking for those pieces
of information that are necessary to make records complete and also to support
the kind of clinical decision support that you can support.

Underlying that pyramid that I showed, there’s a couple of tables in our
report which talks about the fact that, at the lowest level, if one had just a
standalone application with nothing else – which very few people do nowadays –
you would at least be able to check drug doses. That wouldn’t be patient
specific, but you would be able to say, here are the typical doses given for
this drug.

To the next level, if I can catch key pieces, and they include allergies,
which is patient specific, patient’s age, obviously and sex, those are things
which are easy to catch and which tend to drive quite a bit.

The next level above that is having the patient’s other medications, because
that is what generates both the drug interactions, the therapeutic duplications
and so on – and I’ll put a placeholder there, because there’s various ways to
supply that – and then above that are access to things like problem list, which
certainly is a major driver. So that is a big step, because diabetics can only
get certain things. People with hypertension can only get certain things.
People with ulcer disease can only get certain things.

It is even more complex in the infant world, when you have to worry not only
about the size of the baby, but also the various problems they are going
through.

So being able to capture problem list. There’s – trying to think of what
else comes to mind. Recent procedures are important. So I think that – the
typical aspect – if you look at the front screen of most electronic medical
record products, they have problems in medications and allergies and sometimes
health-maintenance issues and recent visits, something like that, and those are
there by consensus, but those are there for a reason. Those tend to be the
first things you want to look at, and those tend to be the things that drive
others.

So in terms of the required history elements, I think those are some of the
most important.

I did want to mention – I think I mentioned briefly, but not completely,
that there’s work right now going on where the complete medication history can
be supplied, not just by you asking the patient or not just by the patient
putting it in themselves, but also by collecting claims which have come form a
variety of different sources, and being able to aggregate that back into a
message which may come from the payer channel that says, here’s all the claims
this patient has made for medication. So you have a pretty good sense of what
they have filled.

So there’s a couple of ways, but problem lists can be collected, either by
hand – as many are – or by ICD9 codes that have come out of various previous
visits. Allergies usually are connected by hand one way or the other.
Procedures can come from ICD and CPT codes – so many of these things can be
collected indirectly with reasonable specificity, through automatic sources.

Does that answer your question?

MS. CRONIN: Actually, I sort of have a related question.

In the one diagram that you had in your presentation, on page 6, with
communication, all of that information, I am imagining, is probably mapped out
in your more thorough report, but that is something that I think would be very
useful to the committee moving forward is to know exactly how that information
is going to be exchanged across the various parties.

And you also mentioned in your presentation that you think guidance is
necessary to assure the appropriate sharing of data. Is that a specific
recommendation that you would make to the committee?

DR. TEICH: Second question first, yes, it is. There is – I don’t think
anybody wants to reveal private information. I don’t think anybody wants to be
malicious about any kind of untoward use of information, but I think that, in
the heat of battle, it is sometimes possible to go over a line without
realizing it. So I think it is important that we make sure that we are
preserving individualization of data for privacy, not for every circumstance.
Just as HIPAA gives emergency openings, so we need to have those as well, but
the ability to make sure that confidentiality is protected, and, certainly, the
ability to put some fairly useful and real guidance about the use of selling of
data.

There is some benefit to be able to have organizations in the private sector
that protect data and make use of it, so that people can share it for quality
reasons for one purpose or another. I support the purpose of that in general,
but it does have to have certain kinds of safeguards, which I think a good
company would not have a problem with, but it is probably worth having them
there to make sure that things don’t go over there and so people can actually
stay clear of them.

As far as the various kinds of communication standard, am I right, Simon,
that we have a presentation from NCPDP later today?

DR. COHN: Yes.

DR. TEICH: I think you’ll probably learn as much from there as I can
possibly tell you about, because these folks have worked on it quite a bit
longer and in much more detail.

MR. BLAIR: I am assuming this is the last question, so it’s –

DR. TEICH: Yes. Oh, yes.

MR. BLAIR: – it’s sort of to ask for a summary, and the summary that I would
ask for is, given what you have shared with us, do you have a list of message
format standards, identifiers, terminologies that you think national
standardization in those areas should be considered high priorities that we
should focus on?

DR. TEICH: The B

MR. BLAIR: It sounds like you have a report coming out.

DR. TEICH: I don’t know if that’s a summary.

MR. BLAIR: Yes, I think you have a report coming out, don’t you? (Laughter).

MR. BLAIR: Yes, yes. I think I may have to refer you to the report for some
of that.

The summary is ambulatory prescribing is good – (laughter) – and that it can
be better in a variety of different ways, and, yes, we have done a fair amount
of work on the particular kinds of standards that we think are important, and,
again, I mentioned some of them in response to Mike’s question, and I think
that if I were to try and remember them right now, I would probably do
disservice to some. So I will say that in a couple of weeks, when the report
comes out, we’ll have this in a much more comprehensive form than I could
probably give you off my cuff right now. So let me dodge the last question.

DR. COHN: Well, Jon, I really want to thank you for coming, and I think this
has been very valuable for the subcommittee and for, obviously, others in
attendance.

I actually hadn’t realized that your report was coming this quickly, so we
are obviously delighted. We’ll be looking forward to it, obviously, middle of
April, and I suspect once we see it, we probably will have additional
questions, so, hopefully, we can call upon you for some of your expertise in
the future as we move forward in this.

DR. TEICH: Sure. Thank you.

DR. COHN: Thank you very much.

Now, the committee will take a lunch break. We will reconvene at 12:50 for
afternoon session.

(11:50 a.m.)

(12:58 p.m.)

Agenda Item: E-Prescribing Standards

DR. COHN: Well, this afternoon, we delve further into e-prescribing
standards. We are delighted to have Lynne Gilbertson, who is Director of
Standards Development for the National Council for Prescription Drug Plans, and
Bob Beckley, who is on the Board of Trustees for NCPDP and has worked for
SureScripts, and I am looking at your title here, you’re Vice President for
SureScripts.

Obviously, want to thank you both for joining us, and, Lynne, are you up
first?

MS. GILBERTSON: No, actually, Bob is going to start and I’m just going to
chime in.

DR. COHN: Okay. Thank you.

MR. BECKLEY: She’s color commentator.

MS. GILBERTSON: Yes.

DR. COHN: Okay.

MR. BECKLEY: First of all, we would like to thank you for allowing us to
present today.

Wanted to give you a little background on the two of us. Lynne Gilbertson
and I, we have been members of – before she was an employee of NCPDP, we have
been members of NCPDP since around 1988-89 time frame and were both involved in
the very beginning of what is called the SCRIPT Standard from NCPDP. We started
working on that project back in the mid >90s. I played a role – I was
cochair of that workgroup, and I played a role in writing that standard. Lynne
is the author of the original implementation guide, which is about a
hundred-and-something pages, and so we have quite a bit of history of watching
this grow.

One of the interesting things about this standard versus many other
standards, many standards – whether they are X-12 or NCPP(?) Standards, HL-7 –
they are developed based upon a current business need or practices that are
already in progress, proprietary standards that need to be merged so that
everyone can utilize them.

NCPDP saw electronic prescribing coming many years ago, and a standard was
developed in kind of like what we think is going to be happening, and the
standard was approved back in 1997, and when did it become ANS? Do you
remember, Lynne, when it became ANS? I would say like 2000, something like
that, it became an ANS standard, long before there was significant use of the
standard.

So we have placeholders in here that some people may not know about for
future capabilities, and we are going to touch on those today, as well as what
the standard will currently do, and so, hopefully, it will be enlightening and
give you a little more information on what the SCRIPT Standard can do and what
its potential is, and that is just as important as what it can do right now.

Three main areas. We are going to talk about what is electronic prescribing
for multiple definitions, and they all are a piece of electronic prescribing,
and we want to kind of set the framework for you what we are going to talk
about and what we see as electronic prescribing, and what a SCRIPTS Standard
addresses.

What is the actual standard? We are going to go into a little bit of detail.
I am not going to go whip out the implementation guide or the standard. I see
the – I’ve sat behind Stanley. He’s got it open over there, but I am going to
give you, at a little bit higher level, what the data pieces are within the
SCRIPTS Standard to give you an idea what its capabilities are, and then the
current status of electronic prescribing in the industry, again, our definition
or our current view or our piece of the electronic prescribing puzzle.

We like to break it down into two parts. Part 1, electronic prescribing is a
two-way communication between physicians and pharmacies, and that is the first
thing that the standard addressed. It will do new prescriptions, refills,
authorizations, change requests, et cetera. We do not look at electronic
prescribing as faxing or paper scripts. Electronic prescribing means computer
to computer. So it leaves the physician’s office, sent electronically, received
by the pharmacy’s computer and taken right in. One of the things that we are
talking about is efficiencies, reduction of errors, et cetera.

If you print it, you can still read it, yes, but someone then has to enter
it into another computer and will have fat fingers, and we all need glasses
sometimes that we don’t have on or et cetera. So there are still opportunities
for errors. Computer to computer really minimizes that, and, more important,
the efficiency. Someone’s not carrying in that piece of paper and then waiting
20 or 30 minutes to get the prescription filled. It’s already at the pharmacy.
It is already being filled while you are in transit to the pharmacy.

Part 2 is what we classify as the area for potential that the standard can
address or is in the process of addressing, and those are the things that we
have talked about also today – eligibility, formulary information, medical
history – and we’ll touch on those on what the standard could potentially do
with clear business requirements and needs from all parties involved.

I think there was a comment that we need more input from the physician side,
which is what we hear at NCPDP at lot. We hear we need more information from
the physician’s side because this is the – you know, SCRIPTS Standard was
mostly input from the pharmacy side.

And one more plug for pharmacy: We see this as a triangle. We saw the
triangle earlier. That triangle is excellent. We see the triangle as patient on
the top, physician on one point and the pharmacy on the other point, and that
is the healthcare triangle of the parties that have to communicate to each
other to give proper healthcare to a patient. So pharmacies are very involved
in electronic prescribing. They are just not the end point where a piece of
paper gets dropped off.

One other thing, the SCRIPTS Standard is addressing the electronic
communication. It is a messaging format. Some of the things we have talked a
little bit about today are also potential workflow standards. This is a
messaging standard, like your standard transaction sets. So we need to also –
you know, you may say, well, how does that data get into that message? That’s
workflow. That’s a software vendor’s piece of the puzzle, how they take the
information or how they take the workflow, as Jonathan was showing earlier, and
they take the information, display it to the end users, so they can make
decisions, but when they are ready to send it to the pharmacy, then it goes
into a standard format, in a sense. So we are going to be talking about the
electronic message of communicating between a physician and a pharmacy.

SCRIPT, as I mentioned, is a standard created to facilitate the electronic
transfer of prescription data between pharmacies and prescribers, an important
thing. This is not a batch standard. It is real time.

When a prescriber – we use the term prescriber, because it could be a
physician, a nurse practitioner, a physician’s assistant. When a prescriber
writes a prescription they can transmit, it doesn’t batch up every 10 or 15
minutes, send a bunch of messages out to the pharmacies. It goes immediately,
because that patient could be just three floors upstairs going down to the
clinic pharmacy. So it goes immediately to the pharmacy. So real time is very
important.

Here are the current messages that the SCRIPTS Standard supports: New
prescriptions from the physician to the pharmacy, prescription changes
initiated by a pharmacy going back to the physician – and I’ll explain a little
bit more about that in a minute, but it is basically I have run across a DUR.
Pharmacies have complete clinical systems. Every prescription, before it is
filled – whether it is a refill or new Rx B goes through an entire DUR process
in a pharmacy, drug-to-drug interactions, drug-to-allergy, drug-to-disease,
dosage, et cetera, age, the entire thing. The pharmacy could come up with a DUR
situation that the physician may not have been aware of, and a change Rx is one
of the ways that you can communicate back to the physician if we have run
across this situation. Pharmacies also catch formulary issues they could send
back electronically.

Refill requests. A very, very important message. Refill requests. When
people say electronic prescribing, especially when you talk to physicians the
first time, they think new Rxs only. Refill requests are huge. It is an
incredible time saver for both the pharmacy and the physician. Imagine – here
is my perfect scenario, and it is happening today. Eleven o’clock at night, I
take my last pill, whatever I am taking, and that is when I realize I’m out. I
go over to my telephone. I pick up. I call my pharmacy. The IVR system, the
automated voice, answers the phone. I punch in my refill request. It says, I’ve
got your prescription, Bob. It’ll be ready – and it may even indicate, Bob, you
don’t have any refills left. We are going to contact your doctor for you. If
you want me to do that, punch in one. I say, yes, please do.

When I hang up, the pharmacy system knows there are no refills left. It
knows if the doctor or the prescriber is electronically enabled, and a message
is sent immediately to the physician, the prescriber, saying, can we get more
refills for Bob? at 11:05 at night.

When the physician comes in in the morning – when the physician’s office
come in in the morning, they have a nice screen of all their refill requests.
They gather the charts – instead of paper lying all over the floor from the fax
machine, the little blinking light on their answering machine – Imagine Monday
morning. The little blinking light on the answering machine saying they have
all these messages someone has to transcribe before you can start to pull the
charts, but the best part is, after you approve or disapprove the refill
request or renewal, as we also frequently call it, is, now, you have to –
everything back up and put them in the right order to call the 30 different
pharmacies or 20 different pharmacies you have. So I have – here is Pharmacy A,
B, C – these are faxes, these are telephone calls.

Electronic prescribing, if the system is set up right, you go back to that
one screen, you answer all the questions and you hit transmit, and they all go.
They’re gone.

Out in the real world today – and we’ll have a little bit more of this at
the end, but I’ll give you a little piece up front – we know of an
eight-physician practice that went electronic prescribing and they had
connectivity to over 80 percent of the pharmacies in their area. They had a
nurse that spent full time talking to the pharmacies, over eight hours a day.

That nurse now has the additional – now spends three to four hours a day
with patients and the doctors versus working on answering phone calls and faxes
for the pharmacy. So refill is huge. Refill is very large, and that is why I
want to spend a little time on that. Sometimes that is overlooked. That is a
two-way communication between the physician and B the pharmacy and the
physician, and one that is frequently overlooked by physicians’systems. They
incorporate new prescribing. They incorporate it, but they cannot receive a
refill request. They have the history on their system, but they don’t have the
two-way communication. That is a very important piece. It is one of the – we
talked about return on investments, it is a huge return on investment for the
pharmacy side to incorporate this functionality.

Prescription fill status. This is another big message. Imagine every time a
prescription was filled by the pharmacy if a message was sent to the subscriber
saying, Lynne picked up her medication. So the next time Lynne goes back to the
doctor and she says – the example was they were increasing – I think that that
Jonathan gave – they kept increasing the medication for asthma, I believe it
was, because it wasn’t working. Lynne tells the doctor, oh, I’m a very
compliant patient. I’m doing exactly like you say, but then physician or the
prescriber takes a look at the information provided by the pharmacy that
indicates that Lynne is getting refills every 45 to 50 days, and it’s a 30-day
supply. Evidentially, she’s not a very compliant patient. So instead of
increasing the dosage, you need to counsel Lynne on being a compliant patient.
Fill status notification is a very important one.

Prescription cancellations. If you are in the middle of a therapy and the
patient comes back to the physician and they have a rash or it’s not working,
physician can notify the pharmacy to stop that medication. No more fills,
please. Especially when dealing with elderly patients, they just – when it’s
empty, they go back.

There are some systems that you can sign up for. If you are on a maintenance
medication, you can sign up for your pharmacy to prompt you when it’s time to
get your refill. Well, if that cancel notification is not sent out, it’ll
prompt the patient to get their refill. So cancellation is very important also.

And there are also housekeeping transactions revolving around if there’s
mailbox and changing passwords, and you can also request a return receipt on a
message. So there are many messages within the SCRIPTS Standard besides just
sending a new Rx to a pharmacy.

So let’s talk a little bit about pharmacy-initiated messages. I’ll just go
over these quickly. A pharmacy initiates a refill request, also called a
renewal authorization. They initialize a change request, which could be because
of a drug utilization review. It could be formulary. We talked a little bit
about prior authorization. It could also be about – I mean, it could ask for a
generic. The doctor wrote brand and the patient realizes what that’s going to
cost them, and they could ask to go to generic. There could be other types of
questions around that prescription that the pharmacy could send back to the
physician electronically. Nothing is worse than getting an electronic
prescription and then calling the doctor back asking a question. Let’s do it
electronically.

I mentioned the fill notification. Every time that prescription is filled –
or more importantly, there’s also what is known as a non-fill. I’ll give you an
example of that real quick. The physician sends an electronic prescription to
the pharmacy and the pharmacy fills it, and it goes into what is known as a
will-call bin for when the patient comes in. If that script isn’t picked up in
a certain period of time, all pharmacies have a routine where they go back and
they return to stock what was in the will-call bin. When that happens, a
message gets sent to the physician saying it was not filled. You wrote this
prescription, the patient did not pick it up. Again, the physician knows when
the patient comes in the next time with the same condition what is happening on
their medication side of the situation.

And then respond to a cancelled Rx. The pharmacy telling the physician, I
did cancel that prescription. I will not dispense any more. It is deactivated.

Physicians can initiate a new prescription. They respond to a refer request,
respond to a change request, and they can initiate a cancel request.

I’m going to go a little bit now into the details of what is actually in the
SCRIPT Standard.

Everything is broken down into data segments. So, first of all, you have
your header, which basically has your sender and receiver information, routing
information, where this is going to go, so when a physician has it, they ask
the patient what is your pharmacy of choice? They enter that information. It is
usually from a drop-down screen, XYZ pharmacy on Main Street, Washington, D.C.
Boom. And then behind the scenes, the routing information is included so that
it can be directed to the appropriate pharmacy. There’s a physician segment, a
pharmacy segment, patient information, drug information. Remember I mentioned
some futures? A coordination of benefits segment, which is payer information.
That is not used right now. An observation segment, which is not fully
developed yet, but things like weight, labs, other things like that to show lab
values could be included in this segment to be sent, but they are not being
used right now. We have a tough time getting ICD9 codes?

MS. GILBERTSON: Diagnosis codes.

MR. BECKLEY: Yes, diagnosis codes. Pharmacies – diagnosis codes. So that is
why that segment is not development. When we talked about it, the whole room
went up in a laugh, when we – well, maybe they’ll send us lab values. Yeah,
yeah, right.

And then the trailer information, which says that the message is intact,
tells you how many segments are there, byte count, et cetera, and that is the
entire message.

So, as I said, the header segment, it contains a version number, the message
type – is it a new, refill request, et cetera. There are trace numbers in there
assigned by the originator and has to be echoed back by the responder, so that
systems, on both sides, can track, and when a message comes back, things do not
have to be serial. So when it comes back, you can match back up and process the
messages appropriately.

Sending and receiving identifications. Physician. I am Physician Joe. I am
sending it to Pharmacy XYZ. Things that are used for that right now are DEA, we
were hoping the MPI, HCIdea, but, mostly – I have it underlined – is trading
partner identifiers. In the networks there right now, the trading partners
agree how they are going to identify a physician or a clinic.

MR. BLAIR: I think that you would probably need to tell our subcommittee a
little bit, HCIdea, what that is, and what the role of EA codes as identifiers
are as well.

MR. BECKLEY: Well, I’ll let Lynne tackle that one.

MS. GILBERTSON: Oh, okay.

MR. BECKLEY: Color commentator.

MS. GILBERTSON: With Randy in the room. (Laughter).

HCIdea is an NCPDP-formed company that was formed as a result of the
membership in the industry coming forward and not wanting to use what is
commonly used for physician identifiers in the claims-processing world, which
is the DEA number, and it is recognized that the DEA number should be used for
controlled substances, but it’s like a Social Security number. It’s kind of a
de-facto standard. So it was being used in many, many claims that were not for
scheduled drugs, for example. So HCIdea is an enumeration of an HCID which
cross references DEA numbers, state-issued ID’s, Medicare numbers, Medicaid
numbers, UPNs, just about anything you can think of that are used for
physicians at this point with – right now, it is addressing prescribers, since
that is the first pharmacy need at this point. It will cross reference to the
NPI as well, and, as of now, I think there are over a million enumerated
numbers – or prescribers, at this point.

Does that answer you?

MR. BLAIR: Yes, I think one of the other aspects is, if I recall correctly,
unlike the NPI, there’s multiple pharmacy sites. HCIdea is able to handle
multiple healthcare facilities and multiple pharmacy sites, which NPI is not
able to handle.

MS. GILBERTSON: Multiple prescriber sites. That’s correct. It’s much more
detailed. It would be interesting to see that cross reference, since the NPI is
a more bubbled-up summary level than what an actual tip of the nose prescriber
on HCIdea would have.

MR. BLAIR: And the point of that is that even when NPI is available,
there’ll still be a need for HCID.

MS. GILBERTSON: Yes, that is correct.

MR. BECKLEY: One of the other things – it seems like in our understanding of
NPI, it is more payer specific. So if you have, let’s say, a hospital or
emergency room where the physicians are an employee of the hospital, the NPI is
more for billing purposes. So they all may use the same NPI, because it’s who
do we pay for the services, while that doesn’t tell a pharmacy where that
prescription came from, who was the doctor that wrote it. So, as Lynne said, we
need tip of the nose, who is the prescriber, not where do we send the check,
and our understanding is the NPI does not go to that level, and if there are –
and so that is what really is needed. You need to know where can I – think
about I am sending out a refill request to a physician. I need to know where
that physician is and which location. If that physician practices in a hospital
or in a clinic, I need to know where that prescription is written, because that
is where the refill request needs to go back to. So I need to know location. So
we need to know who they are and also their location, because that is how I
have to route the message.

Picture using a telephone. If I am calling the doctor for a refill, I call
up on the system what the prescription was. It points to the doctor record and
the location that doctor came from, and that is how I know who to call. Same
thing – prescribing.

I’ve got Simon’s curiosity – (laughter).

DR. COHN: Well, I was going to ask later on – brought this up, because I had
the same questions about this. So do physician providers know that they have an
HCIdea or is this something that is – I mean, who and how do you get this? The
reason I am, obviously, asking is is that I – I mean, for example, I have never
applied for anything like this. I mean, is this something that I would be
tagged with as I write prescriptions?

MS. GILBERTSON: That is correct. That is correct. There isn’t an enrollment
process. There are data supplier – like, for example – and I’m going to be out
of league, because I am not involved in that part of the business, but
Medicare, Medicaid’s payers, pharmacies, anybody who has databases that have
prescribers enumerated on them, they all are aggregated at one point, meaning
all these files could come in and they are scrubbed multiple times to ascertain
you’ve got one tip of the nose person. You’ve got the right address, and you’ve
got the right ID’s for that person. So it’s all done kind of behind the scene.

And just as an FYI, this was not intended to replace NPI or anything like
that, but it was a need of the industry, and the NPI was not available for all
these years, and so something – the industry came forward and said do
something.

DR. COHN: Just one final question on this one – at least for me, hopefully.
Maybe they have their questions answered, but is this something that has uses
beyond the SCRIPT Standard? Is this used in other –

MS. GILBERTSON: Yes, it is not intended for a specific standard, as much as
it is intended as an enumerator. Where it specifically probably – the first use
would have been in the claims-processing world. How many different ID’s does a
given prescriber have that a pharmacy has to know to be able to bill a claim?
So that is where it came first, but, obviously, SCRIPT is one more standard
where you need to know the tip of the nose.

MR. REYNOLDS: On the NPI, the industry is going to have to have NPIs down to
the individual provider level anyhow, because even though it’s sent in from a
clinic, you are still going to want to know what the doctor actually did. So I
am struggling, at a time where we are putting out the NPI, that we have another
standard that is being considered. So I – may not do it right now, but my
understanding of the NPI and the way it has been reviewed is not what I think I
heard.

MS. GILBERTSON: And I can’t quote the NPI regulations back, but I do believe
there is the ability to enumerate at an organization level or at an entity
level. I think those are the two, or entity and a person. So there is a bit of
a subset and a super set as well.

MR. FITZMAURICE: Can a physician have more than one HCIdea ID or is it just
one per physician?

MS. GILBERTSON: One per prescriber with – it would have a cross reference to
all those other ID’s they might have.

MR. BECKLEY: Plus multiple location codes. So no matter where you practiced,
we would know it was you, but then we would also know A, B or C.

DR. COHN: And the NPI doesn’t have the location codes.

MR. BECKLEY: I believe it can have two addresses. So if you were at more
than two, then, you have a problem.

DR. COHN: Okay. Karen, I think you have a question.

MS. TRUDEL: No, I just want to make a clarification. The NPI is intended to
enumerate the tip-of-the-nose provider, so to speak, and we very deliberately,
because of the avalanche of comments we received about the inability to keep
practice location information up to date, did not do that. So that is – if that
is a business need, it is not one that is addressed by the NPI.

We have met with NCPDP over the years B we CMS – and I view the HCID project
as having a useful life into the future as a master prescriber registry index
kind of thing, so that over and above just being an identifier, it is a cross
reference repository that has useful information in it that I think will
continue.

MR. BECKLEY: Okay. We were talking about sending-receiver identifiers in the
header segment. I didn’t think we’d get hung up in a header segment, but that’s
– the other identifier we use for the pharmacy, to identify the pharmacy is
what is known as the NCPDP provider number. It was formerly called the NABP
number. Every pharmacy has one. It is unique to that pharmacy. It is dead on.
You can’t be a licensed pharmacy without your NCPDP number. So that very
clearly identifies the location of that pharmacy and where it needs to be
routed.

Let’s talk a little bit about the physician segment. Again, we have already
mentioned –

MR. BLAIR: Question.

MR. BECKLEY: Yes, sir.

MR. BLAIR: Will mailing facilities have an NCPDP number?

MR. BECKLEY: Mail-order pharmacies?

MR. BLAIR: Mail order.

MR. BECKLEY: Yes, they do.

MR. BLAIR: Good.

MR. BECKLEY: They do. Any –

MR. BLAIR: What about internet sites?

MR. BECKLEY: Yes, they do. You can’t get a third-party claim – First of all,
I know you can’t get a third-party claim paid without one. That is why there
are also some dispensing physicians. They also have NCPDP numbers, because that
is how you get paid, and, number two, I think in many – also in many states, I
believe, when your pharmacy is being inspected to receive your license, they
ask you what your NCPDP number is before they’ll issue your license and allow
you to open your doors. So mail-order pharmacies are included in that, yes.

As we said – we have already gone over the identifiers. The segment also
contains the physician’s name, practice name, address, all types of
communication identifiers. Basically, this is – where you have a code saying
this is an email address. This is a cell-phone number. This is a pager number.
This is an office number, et cetera. Important information. Authorized agent,
physician’s assistant and nurse, et cetera.

If the nurse is typing in the new prescription on behalf of the physician,
because they put it on the chart, then the pharmacy wants to capture that
information, and there is a place for that on there, and we are also in the
process of working on an enhancement for also a supervisor, going back to,
let’s say, a hospital situation where you have someone writing under the
supervision of a physician. You need to know who the supervisor is, also, for
that to be retained at the pharmacy site, in case there is an audit later.

So the physician segment pretty much tells you everything, where the
physician is, who all is involved, is there any supervision or is there an
authorized agent acting on behalf of the physician.

On the pharmacy side, we talked about the pharmacy identifier again.
Pharmacy name.

Yes, sir. Do you want me to go back a slide?

DR. HUFF: Yes, because I am going to ask Carol’s question before she – is
this really a prescriber segment? Does it have to be a physician?

MR. BECKLEY: You’re correct. It’s a prescriber segment. The label name – it
is a prescriber segment, because if the state allows a physician assistant to
write a prescription, then the only thing that would be on there would be the
identifier for the physician assistant, if they – or nurse practitioner. You
are correct. It is a prescriber segment.

Yes, sir.

DR. STEINDEL: If the physician has multiple locations, the address that
appears is the address that it is ordered from?

MR. BECKLEY: Correct. Because that helps the pharmacy when – and in the
pharmacy system, when you dispense, it is linked to physician record and to the
specific address. So if a physician has three addresses, it is linked to the
right one, because we have to know who to call. Hopefully, we don’t call or
fax. We have to know what location to send that electronic refill request to if
it is a maintenance medication. So yes.

MS. GRAHAM: The authorized agent. Is that identified by their name or how is
–

MR. BECKLEY: Right now, it is mostly name. It would be Nurse Bob or, you
know, Office Manager So-and-So, whoever actually did the keystrokes, and
usually the way that is captured is I believe in most of the physician systems,
whoever logs on it captures their user, their log, their user name and password
and what their access levels are, and so, at that point, then, if they are just
responding to refill requests on behalf of the physician, it captures that. Bob
responded on behalf of Physician So-and-So. Physician had the charge(?),
checked them all off and handed – same thing as if you call in. You know, XYZ
Pharmacist, this is Bob from Dr. Gilbertson’s office. Here are your responses.
Same thing.

We talked about – Jonathan, I think, mentioned some of the states. Some of
the states require that information on electronic prescribing. They want to see
who the authorized agent was.

Pharmacy identifiers. That was pretty straightforward.

Yes, ma’am.

DR. WARREN: You said something about supervisors –

MR. BECKLEY: Yes.

DR. WARREN: Is that bullet not on there? Is that folded into one of those
items?

MR. BECKLEY: Right now, this is an enhancement to the standard that is in
process.

DR. WARREN: Okay –

MR. BECKLEY: That’s a business thing that’s come up. People have said, hey –
especially in the teaching environment –

DR. WARREN: Right.

MR. BECKLEY: – we need to know who the supervisor is –

DR. WARREN: That was my next question.

MR. BECKLEY: – and so we are adding that in there.

Pharmacy identifiers. Pharmacy name. The pharmacist’s name. That is usually
not when you are sending it to the pharmacy, but, sometimes, when the pharmacy
has a question or they are asking a refill request, you can identify who is
requesting this information. The address, and, again, the communication
identifiers, in case you need to fall back to telephone communications.

In the patient segment, when a new prescription comes down or a refill
request goes to the doctor, patient’s name, birth date, gender, an identifier,
which is really tough, sometimes a Social Security number, many times, you
don’t get that. Frequently, it is clinic specific, which doesn’t do a lot of
good if you are trying to take a look at the entire medical record. I’ll get to
more on that a little bit later. At the end, I have a couple of comments about
identifiers.

Patient address information and communication identifiers. Much of this is
needed, especially if it’s a brand new patient for a pharmacy, because they
have to set up a patient record, and the more information they can get, the
more they can set up the patient record before the patient comes in.

There are some pharmacy systems that will actually create a patient record
from what the doctor sends or the prescriber will send. It’s like cut and
paste. They hit add this patient – If it is an existing patient, then it’s
matched.

The drug segment. Here’s the biggie. Okay. In a text strain(?) – we have a
spot for the text strain, which is just like if you wrote it out today, drug
name, strength and form. Lipitor 40 milligram tablet. Text strain.

Then, you can also send a code – an NDC, a UPC, a manufacturer’s code. All
those codes are acceptable and there could be more identified if there are,
because you just have a qualifier after it saying this is the identifier that I
am using.

There is also a spot for the form encoded. Is it a tablet, injectable,
patch, cream? Go down the whole list. You should see the appendix for all the
different forms.

Drug strength code. Is it milligrams, milliliters, vials?

Generic drug identifier. This is one we have talked about quite a bit
already. We have mentioned the multiple drug databases. Unfortunately, if you
have – let’s say you’re using XYZ. I won’t get into – I’ll just – using XYZ.
They may have an identifier for a class of statins that’s A. So if the
physician sends an A to the pharmacy, but the pharmacy uses Drug Data Base B,
statins to Drug Data Base B is a C. There is no cross reference. One of the
things that are being worked on is a cross reference between the different drug
databases, and we mentioned before First Data Bank, Medispan, Multim(?),
Macrometics(?), I mean, I think there are about six, but they are working to
how that we can send more codes, versus less texturings, and no matter what the
database is on the other side, it can be translated correctly. These codes are
what drive the DUR process. The GCNs, the GPIs, et cetera, those database codes
are how those drug databases determine drug or drug interactions, drug to
diseases, et cetera. They even have codes for allergies, and they may not be
the same either.

MR. BLAIR: I had hoped that we would have gotten a little bit of this in our
previous presentation.

Can you explain to us, in the models where you have a prescriber using an
electronic health record, their interaction with drug-knowledge bases to be
able to do all of these interactions before they send the message versus how
that interaction takes place when you have a pharmacy benefit manager-centric
network and when that pulls that in versus it being pulled in at the
pharmacist’s level at the end of the message? Could you help us to understand
when it is pulled in how it is pulled in and if there is an alert or warning or
reminder of a drug-to-drug or a drug-to-allergy, how does that get back to the
physician, the prescriber for them to react to it?

MR. BECKLEY: Okay. We’ll walk down the process, and there are some ifs in
there.

If the prescriber has drug-history information and they have a database with
the algorithms that will determine if there is a drug-to-drug interaction like
we saw Jonathan put up earlier, at that time, the physician will see a message
saying there is a potential drug interaction with the appropriate severity
level. So if that information is available to the physician, it will be
displayed at that time. The prescription is sent to the pharmacy.

MR. BLAIR: So the resolution of any drug-to-drug interactions or
drug-to-allergy is done by the prescriber before the message is sent.

MR. BECKLEY: If they have the appropriate information.

MR. BLAIR: Okay –

MR. BECKLEY: And that is a very big if.

MR. BLAIR: Is that true of formulary information as well?

MR. BECKLEY: If formulary information is available, yes, that can be also
resolved before the prescription is sent to the pharmacy.

MR. BLAIR: All that before the message is sent.

MR. BECKLEY: Correct.

MS. GILBERTSON: Something that would be of interest, as I try to drop down a
little level, is there is a concern at what level you can tag drug interaction,
and one of the things that I always use as an example is what if you are
allergic to the binders in a particular pill. You may have to go down to an NDC
level to actually know what the ingredients are in that makeup to get to the
level of I am allergic to cornstarch versus flour, whatever it might be. So
there’s different levels of the if in the condition that Bob mentioned.

MR. BLAIR: Could you take us through the other two scenarios?

MR. BECKLEY: Sure. So, now, the prescription gets to the pharmacy.
Regardless – in today’s environment, regardless if it’s paper or electronic,
the pharmacy always does a drug-to-drug interaction. They have – their history,
they have any OTCs the patient has made the pharmacy aware of. They also
usually enter prescriptions they may be receiving from any other location,
whether it is a community pharmacy, medications received from mail order or at
the pharmacy next to their house and they’re getting the one next to work. All
this is used to perform the drug-to-drug interaction at the pharmacy.

If an interaction is indicated at the pharmacy, then a communication goes
back to the physician, telling the physician, I have run across a situation. Do
you want me to proceed? Do you want to prescribe something else? Do you want to
cancel this prescription? And then the physician responds, and they proceed
accordingly.

MR. BLAIR: Now, how common is it that the pharmacist will have information
about allergies or recent lab tests?

MR. BECKLEY: Allergies, very common. Lab test, not, because, again, many of
the pharmacies will actually – some of them do it on an occasional basis. Some
of them anytime you’re a new patient, they’ll sit down and ask you questions or
give you a form to fill out, so that they try to find out what your allergies
are, so they can do the drug allergy interaction check.

But labs, they can’t really ask the patient their labs, and it’s not very
common that the pharmacy gets lab values from the physician.

MS. GILBERTSON: And there is one more DUR checking that can happen and that
is when the pharmacy actually submits –

MR. BECKLEY: Right –

MS. GILBERTSON: – a claim, through the payer or the PBM. They have drug
interaction modules that they are checking as well, which they can respond
back, because, for example, the payer may have knowledge of other pharmacy
prescriptions that that particular pharmacy might not have knowledge of. So you
get other pharmacy indicators, things like that. So it’s the triumvirate again.

MR. BECKLEY: Right. But there’s one piece that is missing, though. That
interaction could come up three times and set off three alarms, because people
aren’t passing information down to the next one, so that they know, and the
prime example that happens every day today is the pharmacy knows of a drug
interaction, has discussed it with a physician, the physician has approved it,
said, yes, that’s okay. They are no longer taking that medication anymore or
whatever the reason, and they send it to the payer, and they tell the payer, we
know this interaction. It’s okay. Guess what happens? The payer still rejects
it, sends it back and says, do you know that you have a drug-to-drug
interaction? And the pharmacy turns around and says, yeah, I already told you
that.

We need to cut down on the noise, as it is called. So when you do pass it
on, you recognize it and say, I do not have to raise the red flag on this one.
They already know about it and they have gone through the approval process. So
that has to happen. The physician knows about it, then you can tell the
pharmacy. The pharmacy knows about it and got it approved, they need to tell
the payer, so that we don’t echo it back up the chain.

MR. BLAIR: There is a third scenario on this that I would like to
understand, and that is where we have a pharmacy benefit manager network. How
does all this work when that network is connecting the physicians and the
pharmacies?

MR. BECKLEY: Well, when the – take the easy part first. When the PBM is
connected to the pharmacy, which they are right now, that is – I call that the
payer. The payer could be the actual insurance company or, frequently, it is a
pharmacy benefit manager PBM. The PBM does the interaction check and sends the
message back to the pharmacy during the payment process. If the payer or the
PBM is providing the physician with information, medication history, formulary,
et cetera, then the physician system would catch the DUR when they are actually
writing the prescription and it would be handled there.

MR. BLAIR: Now, let’s see if I understand this. If it is the PBM, which you
refer to as the payer –

MR. BECKLEY: Payer/PBM, right.

MR. BLAIR: And they are providing the medication history upon – the
drug-to-drug interaction occurs that is based on payment information as to what
other drugs the patient has, is that correct?

MR. BECKLEY: That payer has knowledge of. In other words, really say covered
drugs. If it is a cash prescription, the PBM would not be aware of it. So if
it’s a cash script, then, that wouldn’t be included in the process. The
pharmacy would know about it, but the payer wouldn’t.

So in talking about Medicare D, they would have all the information except
for things that aren’t covered by D, which would be cash scripts, and that
information would have to be gathered from somewhere else, pharmacy, because
the pharmacy has the information.

MR. BLAIR: Is it inaccurate for me to observe from what you have just told
me that if the PBM or the pharmacist is doing the drug-to-drug interaction and
the formulary checking, rather than having it done with an electronic health
record, the likelihood is that it will not have as much information for
drug-to-drug interactions or drug-to-allergy or drug-to-lab or drug to other
diseases as if that is done with a physician with an electronic health record?
Is that an inaccurate statement?

MR. BECKLEY: I would say it is. I would say –

MR. BLAIR: Okay. Please help me understand why.

MR. BECKLEY: I would say that the pharmacy and the payer, if it is not a
cash script, both have the information to perform the drug-to-drug,
drug-to-allergy interactions, and the payer is not going to pay for that
prescription unless it is on formulary, and so when they reject it, it comes
back. The patient has a decision to make: Stick with this and pay cash or ask
their physician or have their pharmacist ask the physician to prescribe what is
on the formulary. So it gets caught maybe a little bit farther down the road,
but it does get caught. There aren’t DURs that slip through. Pharmacies catch
them. Payers catch them, and the same thing goes for formulary.

DR. COHN: I think what I’m hearing is a relatively redundant system with
lots of checks, and I’m not hearing so much different models. I’m just hearing
how many layers of checks that there may be occurring. I mean, given that – I
mean, and whereas, on one hand, one would like to make it more efficient, I
guess I’m wondering, given that we have a relatively – I mean, not a very well
organized healthcare system currently, there is probably some value to that. I
mean, sometimes a physician might be able to catch things. Other times, a
pharmacy might be able to catch things. Other times, a PBM might be able to
catch things. I mean, one can imagine situations where a patient goes to
multiple different physicians, which may not be affiliated, where the pharmacy
might catch it because the physician doesn’t know all the medications the
person is on, and, similarly, they may go to different pharmacies. Am I missing
something here?

MS. GILBERTSON: No, that’s correct. It takes the different parties to know,
because they only have particular perspectives at that point. Just like this
morning, when, you know, you talk about adverse drug events, if the patient is
taking four or five of their medications and neither the doctor, the
pharmacists know, he’ll probably show up in ER, because that is not something
you are going to catch.

DR. COHN: Well, I guess one hopes for some administrative simplification,
which I think Jeff was going to as he was talking about these various models,
but yet one needs to do that with great caution. Probably none of this is
helped by the fact that there are multiple different databases that everybody
is screaming against on this one.

Jeff, is that sort of where you were going with this one?

MS. GILBERTSON: Billion claims can’t – I mean, there’s four billion claims
going through.

MR. BLAIR: There was one other last piece that is an aspect of this – and,
Simon, thanks for bringing up the point that there is value in redundancy in
this way.

Given that either the PBM or the pharmacist would identify either that the
drug is not eligible within the formulary or there’s some other reason why a
different drug should be prescribed, whether it is generic or something else,
are each of the scenarios fairly much equivalent in being able to get back to
the prescriber in a timely manner where the prescriber has another opportunity
to either justify why they made an exception or ask for special authorization
for that drug or are there problems in closing the loop for that last piece?

MR. BECKLEY: If it is done in – we talked about a true electronic form, it
can be done very quickly, and there’s not a problem with closing a loop,
because a physician would send it down, if the pharmacy catches a DUR, they
immediately send an electronic message back saying here is the situation. If it
goes down to the PBM/payer and they say it is not on formulary, they message
back the pharmacy, you know, it is going to be a higher copay, and, again, the
pharmacy can electronically message the physician and say, do you want to do
something? The patient would like to go with the generic or the patient would
like to go with the preferred medication. So it can be done electronically.

When it’s done via phone calls and faxes, yes, it’s very inefficient and
very time consuming.

Did that answer your question, Jeff?

MR. BLAIR: Thank you.

MR. BECKLEY: Steven, you had a half hand a while ago. (Laughter).

DR. STEINDEL: Yes, I have a question about – as was described, it sounds
like we have data residing at multiple different sites, and there’s a
dis-synchronization of the data, that the data can be the same at the three
sites, it can be different. The sites can be holding different parts of the
data, and one thing that was pointed out, this difference sometimes is good
from a patient’s safety point of view, because, now, we can catch more errors.

Sometimes, from a patient’s convenience point of view, it might be bad, as
you pointed out with the scenario where the physician said go ahead and do it.
It was passed on to the pharmacy, but the PBM hadn’t gotten the message, and
then it delayed the prescription. So there are scenarios where we have pros and
cons there, but we have a redundancy.

The question that I have is should this be an area where the NCVHS should be
looking at in terms of standardization?

One of the problems that I see, for example, is is you have there the
generic drug identifier. You have Drug Data Base. You have RxNorm. You have
NDF-RT. We have heard other drug identifiers out there. You know, it seems to
me that there’s a lot of ways we are identifying drugs today, this one area
that the question comes up concerning standards.

What Lynne brought up earlier, that even if we go to the – sometimes we have
to go down to the NDC level. Sometimes, we do not, and so I would like some
guidance on where we should be looking in terms of recommendations for
standards.

MR. BECKLEY: What I think is needed, because the drug databases are an
integral part of physician, pharmacy and payer systems – We cannot replace
them. We have to use those that are there, but establish a linkage between them
that is a common identifier, so that if someone with, again, Drug Data Base A
sends me something, and I have Drug Data Base B, I can take it, make it work
within my system. So I guess I would say a cross reference that’ll take me to
the proper level, so that I can do drug utilization review, I can clearly
understand the prescriber’s intentions. You know, what drug, what the form and
strength were, et cetera, and you can’t say statins because the doctor may want
Lipitor versus Zocor. So I need to know those type of things if we come up with
global identifiers.

MR. BLAIR: Just a point of clarification. When you say the drug databases,
you mean the commercial drug databases –

MR. BECKLEY: Yes, First Data Bank, Medispan, et cetera, yes.

MR. BLAIR: That mapping capability, is that a different kind of mapping
capability than we were referring to back in – we, NCVHS – was referring to
back in November when we indicated the role of RxNorm and the mechanisms of
actions of –

Pardon?

MR. BECKLEY: I would like to direct that question – there is someone in the
back row back there, Karen, with Medispan, and if Karen would come to the mike,
I think she would be best to address that versus us playing a translation role.

MS. GILBERTSON: One thing you would have to be careful of is that you can’t
broad stroke it and say one solution will solve all. That becomes a very
dangerous – as Steve mentioned that you can’t just say if I have one code then
it will answer all the questions I will need to ask, because different
providers of service have different questions they have to have answered.

MS. ECKERT: The mapping that we had talked about in November of drug
database codes to RxNorm is included here. The mechanism of action and such are
things that are not currently captured in script, so it wouldn’t be those
identifiers. However, I believe there are some additional identifiers allowed
within script that are not covered by RxNorm. So it may mean that in a future
time that we need to have mappings for those also.

Additionally, this code is at a higher level that you can do base screening
of inactive ingredients for a product, but the use of the NDC at the actual
pharmacy level or at the payer level can get you to the significantly inactive
ingredient for interaction or allergy purposes that you may not be able to get
at this higher level.

Does that help?

MR. BECKLEY: Help or confuse. You were good.

MS. GILBERTSON: She did it in like – what? – fifteen, twenty words. You’re
good.

DR. HUFF: So I want to focus in some more on these – I mean, there are two
ways – and this is classic interface theory. There are two ways to do this. You
can have a cross index, in which case everybody has to know everybody else’s
code, or you can have a central identifier that everybody knows the mapping to,
and then you send one identifier in the message and everybody then knows the
mapping to their database or to the set of databases that they understand, and
so – I mean, what you would like, I think, is – I would at least conjecture
that you would like something like RxNorm that is a non-proprietary code that
everybody knows the mapping to, and we may need to buff that up.

I don’t know if it meets the need, you know, whether it is sufficient for
our needs, but rather than allowing any code to – you know, if you allow any
drug-knowledge-based vendor’s code to be there, that implies that the sender
and receiver have to be aware of those – the cross mapping for every
terminology. Whereas, if you standardize the code that is sent there and people
know the mapping to that code, then they don’t have to know their own in the
standard code. So it changes it from an N-squared to an N problem in terms of
mapping.

But the other question is why – or is there – pose it as a question. Is
there a reason why the drug code should be NDC or UPC or the manufacturer’s
code? Could the same thing be set up there? I mean, could – if it was properly
administered, could that always be an NDC code? And then you would know if
cross mapping to the UPC or to the manufacturer’s code.

MR. BECKLEY: Yes, if – you know, if everyone would agree that we are going
to send this. Now, of course, the doctor doesn’t prescribe by NDC. One of the
issues with NDC is it also includes pack size. Well, if we chopped off the pack
size, you know, if you want Lipitor 20 milligrams, that’s nine digits and you
know exactly what –

DR. HUFF: Yes. So if it was a code for – finished those form instead of the
NDC code or something similar.

MS. GILBERTSON: I’m just thinking that not every drug – what with the use of
the HRI and things like that, too, I don’t know if we could broad stroke, say,
there’s NDC for everything.

MR. BECKLEY: Especially, if it’s a compound. Then, you know, that poses a
little bit of a challenge, too. You kind of go into free text on that.

But here is what is happening: Everyone is sending a drug name, because they
clearly – like on a paper – piece of paper – tells the pharmacy that’s their
double check. That is always there, and then if the codes are sent, that helps
them through work flow, automation, time savings, but they always have that
name to double check. Anything that can – I think – help with the matching
process, reduce errors, improve efficiency would be a big plus, and if it is
something better than the NDC, then we could move the generic drug identifier
up to the drug code. Yes, that drug code is just the field that has an
identifier. We could put anything in there. All we gotta do is come up with an
identifier code for it to say this is this code, which, as you would say,
everyone could cross map to their own databases then. That would be a great
solution, and I think you said we may have to buff it up. As Karen says, the
RxNorm will do some of it, but it may need to do more. If that’s what you mean
by buffing it up, then I think the answer would be yes.

The last thing – and this is something new we just added to the drug segment
is a full unabbreviated drug name. We have run across things where that drug
name, strength and form is also – called label name. You ever looked at the
name of a drug on the bottle? It’s 30 bytes total. It’s not enough. So there
are so many abbreviations that it is starting to cause problems, and because of
– you know – we’ll say non-proprietary generic identifiers, we have gone with
about 200 bytes, so you can have a full, unabbreviated name, if the physician
chooses to send that down. So that field could be eliminated totally.

Other things in the drug segment, we talk about the quantity and the
qualifier, how many tablets, how many grams, et cetera, dosage instructions,
which is SIG, which is text. We have space for a codified SIG. Notice the
parentheses. It is not used right now because there is no standard SIG.
Effective date and written date. Day’s supply. Dispenses written code, which is
your brand, you know, must-be brand. Number of refills allowed. All of this is
part of the drug segment, and the drug segment can have multiple occurrences,
and – on a new Rx, you would just have one, but if the pharmacy is going back
to the physician and saying this is what you prescribed. Okay? This is what I
would like to dispense. It’s the generic or it’s another one because of
formulary issue. Okay? Those type of things can happen.

Here’s – as you see – formulary alternative. You can also come back and say
here is the preferred. If you dispense this, I need a prior authorization. So
when a pharmacy communicates with a physician, they can give them more
information, so they can make a decision. So that segment, depending on the
type of message, could occur multiple times in its tag for what this particular
occurrence means.

DR. HUFF: Back on your last slide, the quantity and qualifier, I mean, your
examples are for usual tablets. Do you also support orders or prescriptions for
IVs, so you could specify an IV right here or how have you guys approached
that?

MR. BECKLEY: We haven’t approached that. The IV – if it is multiple – it’s
like a compound in a way. If it is multiple ingredients, one thing I didn’t
include in here is – well, there’s a little bit more, but there was a free text
segment, where complex messages can occur. So if I want so much of this, so
much of this, so much of this, then I could spell it out for the pharmacy or
the specialty pharmacy that would do the IV. It is not codified in those areas
up above.

DR. STEINDEL: In our last presentation, one of the points that was made was
the variety of state laws in terms of prescribing, and one of the things that
was pointed out where a lot of variety existed was dispense as written, and you
have a dispense as written flag.

Now, generally speaking, e-prescribing is under another set of state laws. I
know Georgia is discussing one right now. So I am kind of in the middle of
hearing about it, since our legislature is in session, which is a good time to
be out of the state, as John Lumpkin always pointed out to us – (laughter) –
and when you just have dispense as written there, I assume that is accepted as
dispense as written by every state that SCRIPT Standard is used and you don’t
have to worry about adjudicating that.

MR. BECKLEY: There have been a few challenges. For the most part, yes. There
have been a few states where the law or the regulation – and they differ – was
written must be in a physician’s own handwriting, and what usually occurs is
business partners go to the state board of pharmacy, talk about electronic
prescribing and you cannot have in a doctor’s own handwriting, you know,
medically necessary or brand required, and then they changed the reg or the law
for electronic prescribing to have it indicated electronically, and we have not
had a problem with that. It takes a little bit of work, but it has not been a
significant hindrance.

So the other nice thing about electronic prescribing, too, is you get out of
what’s on the top and what’s on the bottom and what’s on the side. In
electronic prescribing, it doesn’t matter. So a lot of those things go away. We
have not seen – we have – changing hats for a minute. When I work on the other
side, we try to do electronic prescribing in states, we have what we call our
problem children. You mentioned one of them. Okay?

DR. STEINDEL: They’re trying to solve it. (Laughter).

MR. BECKLEY: There are some others, but, for the most part, it is frequently
we – you know, they are contacted by the partners who want to do electronic
prescribing. Some of them say, fine, as long as you follow our regulations.
Others say, please tell me how you are going to do it, and then you get back a
letter or a telephone call saying it’s fine.

Two states, Ohio and the State of Washington, actually ask you to come in
and demonstrate your software, whether it is prescriber software or pharmacy
software or someone in the middle acting as – the different terms are used, but
as a router, a messenger services broker, whatever you want to call it. So you
can tell them how it is flowing, and you get approved.

So except for the few quirks here and there, it is – for the most part,
electronic prescribing is getting rid of the big book, because they can’t get
down to the level of where you have to print your name.

Just a couple more things in the drug segment. We talked about drug
utilization review information.

Oh, I’m sorry. I forgot you, Karen –

MS. TRUDEL: You mentioned a slide or two ago – and I just didn’t want to
lose this point – that there was no standard for a codified SIG. Has there been
any groundwork done at all on that or –

MR. BECKLEY: It is one of the bloodiest conversations there is.

The concern is – and some of it is on the actual pharmacies that they are
concerned about clearly understanding the physician’s intentions, and if it’s –
the physician types in one thing and then it is translated into a code and sent
to them, they are concerned about was it done correctly. They like to see it
written out what they’re used to.

Then the other issue is, if you standardize it, imagine trying to convert
pharmacy systems where four billion prescriptions are dispensed per year, and
five-six years of history on there, translating all those SIGs now to a new
SIG, that scares the living daylights out of folks, because if that
prescription is translated incorrectly, the next dispensing could have
catastrophic consequences.

So people are really B because SIGs in different systems work different
ways. I mean, what it prints on the bottle, what’s stored off is very
different. One TID, I could get two or three different interpretations of what
that is, especially based upon the size of the T, capital or small. Okay? One
tablet? One teaspoon? One tablespoon? We actually have issues. I have seen it.

DR. COHN: Well, that’s interesting, because most pharmacists I have talked
to have trouble figuring out whether it is a T or not. (Laughter).

DR. FITZMAURICE: What does SIG stand for?

MS. GILBERTSON: We have been through about three different –

DR. FITZMAURICE: What does SIG stand for?

DR. COHN: Oh, it’s the instructions for how you take the pill.

DR. FITZMAURICE(?): Signature.

MS. GILBERTSON: Yes, it’s – no, it’s SIG.

DR. FITZMAURICE: It’s not the electronic signature? It’s –

MS. GILBERTSON: No, no, no.

MR. BECKLEY: It’s instructions.

MS. GILBERTSON: It’s SIG. It’s instructions. Yes. We always try to make –

DR. FITZMAURICE: Must be Latin.

MS. GILBERTSON: We say SIG.

MR. BECKLEY: It is Latin, yes.

MS. GILBERTSON: Yes, but the last time I looked it up in the dictionary, it
said SIG was the definition.

MR. BECKLEY: Did I answer your question, Karen?

MS. TRUDEL: Yes, unless you’re talking about HL7.

MR. BECKLEY: Going back to drug utilization review, we mentioned that in the
SCRIPT Standard, we can pass back and forth drug utilization review
information. So, Jeff, going back to one of your comments, if the physician
identifies a DUR and says it’s okay, they can pass that information down to the
pharmacy, so the pharmacy doesn’t call the doctor back and say, do you know
there’s a drug interaction? Or if the pharmacy catches it, and the physician
did not, the pharmacy can send a message to the physician and say, I have
identified a potential drug interaction. How would you like to proceed? The
SCRIPT Standard already has that in place. Not only does it tell you the DUR
reason, it can tell you the action taken, the final result, and we were talking
about identify the coexisting agent contributing to the situation, but guess
what. That piece of data is not used, and that goes back to my initial thing.
When we identify it, we have to pass it on down the road. The standard can
handle it. People aren’t using it.

DR. HUFF: One more question.

MR. BECKLEY: Yes, sir.

DR. HUFF: I don’t know what the proper – I’ve heard a lot of different names
for it. When you have a recipe or a concocted drug, is there a way that you can
specify codes for the ingredients that are part of that concoction, as opposed
to just having a paragraph that says what to do?

MR. BECKLEY: Not in the standard right now. Is there a way? I can tell you
what a pharmacy does, frequently. If you send them the text string, they will
actually break it down by the ingredients, and their pharmacy system will know,
by NDC, what each of the pieces are and how much of each, because they need to
break it down into pieces to do the DUR check. I mean, they know it’s water.
They know it’s this. They know it’s that, et cetera, because they have to go to
that level for the DUR, and they also have to go to that level, frequently, for
submission of payment, but how it comes to them, frequently, is in text. Could
we send compounds down using the codes? Yes, we could. It would just require, I
think, a little more work on the physician’s system.

DR. HUFF: How would you do that? By just multiple drug segments?

MR. BECKLEY: Yes, that’s exactly –

DR. HUFF: Each with an ingredient in the drugs?

MR. BECKLEY: Um-hum. Exactly right. You just have multiple drug segments,
and you identify that you have a compound coming, so you know that the multiple
drug segments all make up one medication, one solution or whatever it happens
to be. Yes, that is the way you would do it.

DR. HUFF: And coming back to the SIG in the other part, is the freehand SIG
part – contains the frequency? There’s not a separate field to say VID, TID?
That’s included as the free text part of the SIG.

MR. BECKLEY: That’s included. One tablet, three times a day. That’s part of
the SIG, correct. Um-hum. That is correct. Or take as needed for pain. Take as
needed for pain, PRN, as needed.

MS. GILBERTSON: Over the years, we have discussed multiple times the
addition of compounds into the SCRIPT, and also – what’s the other one?

MR. BECKLEY: I don’t know.

MS. GILBERTSON: Compounds and –

MR. BECKLEY: IVs?

MS. GILBERTSON: No.

MR. BECKLEY: Which is a compound.

MS. GILBERTSON: I just lost it. Compounds and whatever – oh, and codifying
of SIG. We have had different proposals brought forth and they usually just
don’t quite meet the needs of the industry, so they haven’t been brought
forward. It’s like any standard. If there is a business need brought forward
that can satisfy that business need, then it can be added to the standard. It
just – either the timing wasn’t right or the codification wasn’t close enough
or – one of the things that came – as Bob mentioned earlier, over and over and
over again, when it comes to a SIG is that any codification is fine if it is
agreed to by the industry participants, but that – quote – text must be present
as well, and whether it is – you know, and in a workstation environment, I
mean, the prescriber is not writing on the terminal screen the free text
message. She is probably choosing it from a list box or a drop-down box or
whatever, but they want the intent of what the prescriber wanted to see if he
would have – as he would have prescribed it, not something that has been
translated and translated back.

There’s a couple of examples. In fact, in the e-High(?) White Paper, there’s
a little appendix we added dealing with the codification of SIGs, and there’s
one good example of mistranslation where it was supposed to be two a day or
something like that and it ended up being translated to put in left ear.
(Laughter). Those are the kinds of things that just can’t be allowed to happen.

DR. HUFF: So I guess the thing I would point out – I mean, is that if you
don’t in-code at least the frequency and maybe some other parts of the SIG,
then there are certain kinds of dose checking you can’t do. You can’t know
whether you are exceeding the total daily dose of this medication or, for that
matter, you couldn’t sum and know whether you have exceeded the lifetime
allocation of this medication, et cetera.

MR. BECKLEY: The pharmacy seems to do that, though. When they get the
medication and they enter one tablet three times a day and it’s 90 pills, then
the system calculates a 30-day supply. In other words, when the pharmacy system
gets it and they input the data, it prompts them so that they can determine
duration, day’s supply, how long it will last, et cetera. So there are some
things that happen at the pharmacy, because –

DR. HUFF: With manual intervention, you can do –

MR. BECKLEY: Yes, sir. Yes, sir. Um-hum. Some automation. It depends. If
it’s one tablet, three times a day, and it’s 90 pills, system calculates 30-day
supply. Those type of things are fairly straightforward, but some of them – as
needed, then, you know, it’s – it goes from there.

One thing – I have trailer segments, which we don’t need to go into. Just
some validation checking, but I didn’t give you examples of the coordination of
benefits segment, and the observation segment, because I said they weren’t
being used, and I want to go back to what Ross said earlier when the question
was prior authorization. I mentioned that we can do prior authorization once it
gets to the pharmacy and the pharmacy goes back and says to the physician, I
need a prior authorization number. Let me tell you what some of the author’s
intentions were, since some of us are here.

The coordination of benefits segment. The physician could send to the payer
– if they know who the payer was – in the coordination of benefits segment,
they say – I already have a patient segment. I have what the drug is. I don’t
need the pharmacy. I can identify who the physician is and there’s already a
field that says I need a prior authorization. So I could send to the payer a
request from a physician’s office for prior authorization. Now, have all the
details been worked out to flush out any new data elements that may be needed?
Have the business – been clearly identified? No, but can the standard do it?
Yes, with minor modifications. That is just one example of what it can do. Can
it do an eligibility check? There is work going on right now or will be very
soon to use the SCRIPT Standard to – query for an eligibility check. The
standard can do much more than it is right now.

And that leads me into what is the current status of electronic prescribing?
And that is what I wanted to share with you last. I’ll talk about some past
problems, and I’ll tell you what is happening today.

In the past, very few pharmacies were directly connected to physician
practices. Electronic communications meant faxes or typed prescriptions that
were handed out. Only new Rxs were being addressed. Electronic prescribing
didn’t fit the work flow in a physician’s office. It was very, very cumbersome.
We didn’t see tangible benefits, and automation was being driven by a few very
small software vendors that disappeared, the dot-com era.

What happened was, I’d go into a doctor’s office, say, here, here’s this
handheld device, and you can only talk to Pharmacies A. Try it. Well, after
about one or two times, realizing that that was only five percent of my
prescriptions that I write that went to Pharmacy A, the handheld went in the
drawer.

Today, this model has changed significantly. Today, the model – there are
over 75 percent of the community pharmacies have true electronic prescribing.
If the docs were there, they could receive and send electronic prescriptions.
They can do it, and I have a couple of charts that actually list pharmacies for
you, to give you an idea, and they all are utilizing the NCPDP SCRIPT Standard.
There’s no hybrids. There’s no –

MR. BLAIR: Could you elaborate on this just a little bit more.

MR. BECKLEY: Sure.

MR. BLAIR: Seventy-five percent of retail pharmacies in the United States B

MR. BECKLEY: Um-hum.

MR. BLAIR: Have the electronic equipment in place to receive an electronic
prescription. Is that correct? Is that what you are saying?

MR. BECKLEY: Yes, and also send refill requests.

MR. BLAIR: And send refill –

MR. BECKLEY: That’s correct. Yes, they do.

MR. BLAIR: Is there a disparity or a grouping where that happens to be that
certain states have basically close to 100 and some have close to zero?

MR. BECKLEY: No. The issue is when I say 75 percent is in working with all
the software vendors, some of them have completed it and pushed it out to all
their customers. You have some chains, like – I’ll just say example of
Walgreen’s. They write their own software. They’re done. You have other
software vendors that have many customers. They may be almost done with it, and
so that is the 25 percent. It’s not that someone cannot do it or has chosen not
to do it. It’s just where are they in their software distribution or software
development and distribution, and that gap is closing very quickly. If I’d have
made this presentation fourth quarter last year, the number would have been 50
percent. Hopefully, by the end of this year, we will be in the 90s. So it’s
more of a – when I present it today, it’s 75 percent. So it’s not a state
issue.

What happens in a state – in Steven’s state – (laughter) – is the pharmacies
just turn it off. The functionality is there, but it’s not enabled. I mean, the
software goes to everyone. It’s there. It’s just you don’t turn it on until the
law allows or there is a doctor ready to communicate with you, and that leads
right into the next bullet point.

Approximately three percent of the prescribers have true electronic
prescribing capabilities, and I have a little – things to back this up.

Now, we are making progress. This just came out. I mean, we got permission
to put this information – please note the footnote at the bottom. This is from
a survey, taking the pulse – Version 4.0 study, March 2004, Manhattan Research.
I mean, first of the month. Here’s the trends.

Seven percent of all physicians use an electronic prescribing system, but of
that seven percent, only 41 percent are connected to the pharmacy. So that is a
net of three. What that means is their definition of electronic prescribing is
I put the information in and a piece of paper comes out. Okay. That’s – you’ve
taken care of part of it. Okay?

How many of them can actually send it to the pharmacy electronically? That
is how you get down to three percent, but the number is changing quickly. If
we’d – again – done this earlier in the year, that number would have been
smaller. There are many roll-outs going on right now. I heard someone say, tell
me about the pilots you have going. There are not pilots going on. There are
active, full-blown programs going on in entire states, and the numbers are
ramping up very quickly, but those are presentations later. Okay?

But I want to make it – there are not pilot programs out there. There are
full-blown implementations. This is way beyond pilot stage, when physicians are
talking to pharmacies and sending information back and forth electronically.

The rest of the information: Thirty-seven percent of the physicians are very
interested or somewhat interested in using an electronic prescribing system in
the next 12 months, and that includes sending it electronically to the
pharmacy, not just doing something in their office.

The top three drivers: Increased accuracy, 47 percent. Reduced pharmacy
calls, 45 percent. You see how close that is? That is why that refill request
is so important. Many of their calls are for refills. Can I have more? Can I
have more?

Commonly-used Rx list, 42 percent. That little drop-down menu that Jonathan
showed. Remember he pointed that out? Another one of the major drivers. Quickly
being able to prescribe, but yet accurately.

Now, I mentioned 75 percent of the pharmacies. I have put up a pharmacy list
of partners that I am aware of that can do electronic prescribing. I’m not
going to list them all. Some of the names you may not know because they are
parent companies. When I say Ahold, I’m talking about Giant Foods here, Stop
and Shop up in Boston, BuyLow(?) down in South Carolina, Bruno’s in Atlanta –
Birmingham. You see Albertson’s Osco. The list goes on and on, and the
independent pharmacy software vendors, which also include the independents.
There are about 55,000 community pharmacies in the United States. It’s almost a
50-50 split, and they are all participating.

Now, here is where the progress is being made. Physician technology vendors
are coming on board, and this is, again, a partial list of physician technology
vendors that have committed and written to the SCRIPT Standard and are
communicating or are in the process of developing their software, and it is a
significant list, and that is what I said in that earlier slide, progress is
being made. Progress is being made. They have seen the light, so to speak.

The important thing was the pharmacy connectivity is there. Someone had to
get there first. That’s been one of the big issues with electronic prescribing.
You talk to a doc. How many pharmacies are there? You talk to the pharmacy, how
many docs are there? Pharmacies said, okay, enough of this. We’ll write it.
Hopefully, they will come, and they are. The physicians are coming, especially
when they see the benefits of especially some of the refill requests.

As I said, pharmacies put a stake in the ground in implementing electronic
prescribing in hopes the physicians would then join. This hope is coming to
fruition. Millions of true electronic prescription messages will be sent in
2004.

Little bit about the barriers. As I said before – you brought it up, Steven
– the state regulations are really not a barrier. Sometimes, they are a bump,
but, for the most part, all of them have been resolved in a very timely manner.
Depends on whose definition of timely, but sometimes it takes a few months,
especially if you are dealing with legislative law instead of a regulation –
legislation. You have to go through and get it changed.

Electronic signatures are not a barrier. Electronic signatures – difference
between electronic and digital – because of the way the SCRIPT Standard has a
unique identifier for that physician. It is attached the time it’s sent.
Electronic signatures are not a barrier. We haven’t had any problems with any
states. That’s not controlled substances, mind you. That’s not controlled
substances. I saw you coming. (Laughter).

DR. COHN: So what happens with controlled substances?

MR. BECKLEY: Controlled substances, which are about 15 percent of the
prescriptions, Schedule 2 through 5, handwritten.

DR. COHN: Interesting. Okay –

MR. BECKLEY: Handwritten. I mean, one would like to see it, but the regs
that are coming down, we’ll have to see, because they haven’t gone out for
comment yet.

DR. COHN: Okay. And that is usually a combination – I guess I have to ask
later on, but it’s usually a combination of state regulations plus DEA.

MR. BECKLEY: It’s DEA.

DR. COHN: It’s all DEA?

MR. BECKLEY: DEA, um-hum. Mostly DEA, yes, sir.

The biggest barrier or hindrance into electronic prescribing is educating
the prescribers to the benefits of electronic prescribing and letting them know
of the pharmacy readiness. Many of them do not know that percentage of
pharmacies that are ready. They think electronic prescribing is just Rxs. They
don’t see the benefit or they are not aware of the significant return
investment for automating refills and changes, et cetera, and when they
understand that or when their office manager understands that, adoption goes
very quickly and very easily.

Standards. The transmission standard, in our opinion, is not the issue for –
pharmacy or physician software vendors. I think you have seen the numbers. They
are adapting it. They are sending it. It’s working.

Code sets, I say, not a major issue. We are doing it right now, but some of
it is being done with text versus codes, but it hasn’t stopped the advancement
of electronic prescribing. So we can continue while we develop code sets. It
doesn’t stop us, but one of the major barriers is a standard identifier for
patients, physicians and payers.

Now, we talked a little bit about the physicians, but medication history,
beyond Medicare, how do you do that?

You have to go to databases that try to – you know, through algorithm
determine, because everyone has a different identifier. For every physician
practice you go to, for every pharmacy you go to, if you switch payers, your
numbers probably change, and I know that came up in Chicago. Karen and I were
reminiscing about a few – what was it? Ninety what? Ninety-seven something?
Chicago. It was ugly. It was ugly as all get out.

And we already heard today, and a standard payer identifier. Those are three
– beating someone to the question of what are the three major identifiers.
Those are the three majors that would really advance and make electronic
prescribing easier. The other code sets will definitely help, but they haven’t
stopped the progress. People have come up with workarounds for these others.
Okay?

MS. GILBERTSON: One of the interesting things with the standards for payers
that was mentioned earlier, will the health plan regulation help us out, and it
is one of the things we are kind of waiting with bated breath, because, right
now, the billions of pharmacy claims that are billed each year electronically
are using what is called a bin number, an identification number that can go on
the standard card, which is also one of the attachments that was available to
the committee. How will that function in the new world? Will that create
another cross reference that – well, this is the number that you have been
using for years to identify your pharmacy benefit package for billing of
claims, but, now, you have a new number that you somehow have to cross
reference to as your health plan ID, and that could be an interesting challenge
to get around, because it may cause more headaches with another cross mapping
going on.

The other thing was the – when Bob was mentioning about the work flow, you
have now the introduction of the physician office asking for prescription
benefit information. I don’t think anybody probably gives their doc any
information about their prescription benefit today. So whether you give the
standard ID card or whatever, the physician’s office has to include that in
their workflow as well and recognizing even if I do have a standard pharmacy ID
card, that I know where the identifiers are for routing to a particular benefit
package, it is still adding that into my system and being comfortable with it
and asking changes every year, if your benefit program changes. Not
insurmountable, but just a different aspect that the provider system is not
used to doing today. So those are just some things to bear in mind as well.

MR. BECKLEY: I was going to add one other additional thing is Lynne
mentioned the bin number. I believe that used to stand for banking
identification number, routing. Electronic prescribing is very similar. One of
the examples that we use out there is, like the ATM networks you don’t care
where you put your card in. Karen pointed out earlier, you don’t get
advertising when you go through prompts. As soon as you put your card in, it
comes up with basic information. You enter it. You know it goes to your bank.
You can walk up to any machine, and you are going to get your cash, and
everything is handled behind the scenes.

So think of – you know – this standard here is like a banking standard. It
is a standard to communicate those type of important information.

MR. BLAIR: Two questions. One is you say we still have a problem with the
provider identifier. Why do we still have a problem, if you are able to use
HCIdea?

MR. BECKLEY: If we get – with anything, it’s getting full adoption. If
everyone would adopt HCIdea, I think that would – if everyone would agree upon
an identifier, and – you know – Simon asked the question. He wasn’t even aware
of it. If people became more aware of it and it got backing, I think you could
resolve the issue, because the HCIdea would take it down to – you know – the
person and the location, which is what is needed for electronic prescribing and
for claims adjudication.

MR. BLAIR: Okay. The other question was on your list you didn’t list the
issue we previously mentioned which was the need to be able to map the
ingredients and drug identifiers to a referenced drug terminology like RxNorm,
but we don’t know if that is adequate the way we have envisioned it so far. Was
that just omitted or is that a separate issue?

MR. BECKLEY: The code sets for those things are not a major issue that
prevents electronic prescribing from moving forward, because there have been –
we talked about – there have been ways that’s been worked around or handled.
Multiple checks of DUR, as you go down the path. You get the text string. It’s
not prohibiting electronic prescribing from moving forward. It could definitely
enhance it and make it easier, yes, but it is not what I was calling a barrier
of electronic prescribing, where these others are more of a hindrance where you
have people coming up with their own proprietary identifiers. A calls doc this
number and B calls doc this number, and those are more of a barrier than the
code sets for the drugs, but that would definitely help with safety and
efficiency if we can get those, but I didn’t classify them as major for
implementation.

MR. BLAIR: One more piece, because in the Medicare Prescription Drug
Improvement Modernization Act, it also looks for us to explore the area of
eligibility checking, and we have, of course – you know, one of our HIPAA
transactions with ASCX12 is an eligibility check.

MR. BECKLEY: Correct.

MR. BLAIR: How do you deal with eligibility checking in your environment?

MS. GILBERTSON: HIPAA also allowed the NCPDP format.

MR. BLAIR: Telecommunications –

MS. GILBERTSON: Yes, used for eligibility, which, you know –

MR. BLAIR: Um-hum. So it’s done that way.

MS. GILBERTSON: I mean, currently, from what I understand in the medical
world of eligibility checking, you get a larger disclaimer of what may or may
not be available on that moment of the transaction than you do get what you are
eligible for. So I think it’s the maturity of – if you mention the X12
environment of the 270-271 of good information that is returned to the provider
based on that 270 request, but I remember environments where you got a little
bit about, yes, this is a patient. Yes, we think they’re covered, but here is
the disclaimer of we are not saying we are going to pay for anything at any
particular point in time. So that maturity will be helpful.

From the pharmacy side, the eligibility transaction – oh, gosh, out of
billions of claims that are filed each year, maybe there’s 10,000 eligibility
checks that are done, because if you can wrap it, once again, in a stronger
transaction, which is the claim – check eligibility, check DUR, check
formulary, check benefit, check –

MR. BLAIR: One piece I still don’t understand. I’m a physician, then I would
use the SCX12N to be able to check the eligibility with the health plan.
However, if that message is now in the pharmacy location, you’d be using the
NCPDP telecommunications standard to check with – with who? Would it be the
same health plan? Would it be a PBM or what – is there a disconnect here with
the fact that we are using two different eligibility standards, possibly, where
one might wind up getting, yes, the individual is eligible, and the other one
would wind up saying, I don’t know who that individual is.

MS. GILBERTSON: It wouldn’t so much be two different transactions as it
would be the questions you are asking.

For example, you would be requesting eligibility on medical benefits versus
a pharmacy benefit. So that might determine – at this point, set aside which
standard. It really doesn’t make any difference. It is who is communicating
with who, and so you’ve got a prescriber, who, when they are in the prescribing
mode, may need to check with the pharmacy benefit program, the PBM, and when
they are checking – I don’t know – some medical benefit, they would be – it
could be the same entity if coverage is through both, but, very often, it is
separate coverages, and how many people carry two different cards in their
wallets?

MR. BECKLEY: There is the – the pharmacy doing the eligibility payment,
that’s very mature. That’s being handled every day, you know, four-billion
times a year. The physician asking for prescription eligibility is infant, if
that far along. There is some work in that area. There is some work starting at
NCPDP in that area, because you are talking to, in the most part, the same –
you are talking to the same entity. The physician is asking the same entity,
the same PBM that the pharmacy will submit the claim to. So, as Lynne was
saying, it goes to the same B pretty much the same person, the same PBM or
someone acting on their behalf to have it checked, and so, you know, that
entity receiving it is not a 270-721 type of entity, and it is definitely not
batch. It is real time, and that’s why, probably, you know, if the business
dictates it, it’ll probably be part of the SCRIPT Standard, because that is
what the PBMs will receive. That’s what’ll be interactive instead of batch
mode. So I don’t think it’s a disconnect. I think it’s an area of infancy.

DR. COHN: I think Karen had a comment or a question and then –

MS. TRUDEL: Yes, I would just like to kind of summarize that, because I
think it is an important point. It sounds as though the current modes of
communication in the industry are from the prescriber to the pharmacy and from
the pharmacy to the PBM and that there are two fairly mature standards that
support those lines of communication, and that the Medicare Modernization Act
envisions an additional line of communication that may be directly from the
prescriber to the PDP, the PDM plan, whatever you want to call them, that is
not mature and the line of communication isn’t even very well exercised today.
Is that basically what we are saying?

MR. BECKLEY: Not well exercised? That’s probably correct. There are
advancements in that area, and NCPDP is working on that as business needs are
brought forward.

MS. TRUDEL: That is certainly a gap area, right?

MR. BECKLEY: Yes, but in progress. In progress.

MR. HAUSNER: Hi, I’m Tony Hausner with CMS.

I was interested in your thoughts about standards related to the medication
history and patient history.

MR. BECKLEY: I had a bullet that, you know, I think, an identifier, so that
you can pull from multiple sources, is going to be very important, because
depending upon what system you are in, whether it’s a physician’s or an
electronic health record, if you are in a pharmacy system, if you are in a
payer system, you have different identifiers everywhere.

So to do medication history, there either has to be a master index that is
built and maintained all the time or we need to come up with a standard
identifier, and then it becomes easier to find that information and bring it
together. That is one of the major hurdles.

In electronic prescribing, it is being discussed. It is – I liked Karen’s
comment earlier today. It is something that is in there, but it is probably on
a separate time line.

I used the example if you’re from Boston, medication history is like the big
dig. It is going to take a long time to – and, as we go along, we are going to
hit soggy spots. That was a landfill that we have to pour concrete into to
shore it up. Okay? (Laughter). I mean, the big dig. All right?

Where electronic prescribing, except for the medication history is – you
know, you are just maybe expanding an existing highway or you are putting in a
two-lane road to start some traffic. Huge difference. It is what we all want to
get to, absolutely. It is going to just take a little longer and quite a bit
more work. I think the term before, buffing up, doesn’t even fit.

MS. GILBERTSON: The medication history that we do have available today would
be, for example, a pharmacy or a prescriber to the PBM, using the identifiers
that that PBM has for that patient. So there’s some infrastructure there. It’s
how far outside those lines you can go, and, you know, if you have to query
four different PBMs for history over the past two years, because the patient
has jumped coverage different times, that adds complexity, but if you start out
slow, I think there’s some identifiers that can be used and some relationships
that are built or being built that can start facilitating some of that and
have.

MR. BECKLEY: I was going to say – one other comment. If you’re talking
medication history versus medical history, there is one place that you can get
the medication history. All medications have to be dispensed by a pharmacy,
whether it’s cash, third party, it has to come out of a pharmacy, mail order,
community pharmacy, et cetera – okay? – internet. Has to come out of a
pharmacy. So if you have a standard identifier, a physician could get – say to
the patient, what pharmacist do you go to? You could get medication history
with a few queries, versus having to query – you know – the nation or trying to
have this big database in the sky.

MS. BERN: Hi, I’m Terry Bern from Rx Hub, and I am responsible at Rx Hub for
implementing all of the standards – PDP standards as well as X12 standards –
and I did want to make one clarification on eligibility, because I am familiar
with both, telecommunication and X12.

The X12 standard was designed to obtain eligibility from a doctor to a
payer, and so that standard can be utilized within our model between the doctor
and the PBM. We do have a lot of experience with that, and that standard is
designed to give back information about the patient, what their identifier is
with the payer, and we can go to multiple pairs, et cetera.

So in the absence of having a standard identifier per patient, that actually
is a good model, and I wanted to make that clarification, because the X12
standard is useful for that to go to the PBMs as well as the health plans.

In addition, that model helps us implement – or that X12 standard helps us
implement our model for obtaining drug history from the PBMs, because they are
able to tell the doctor or the point-of-care application what the identifier is
for that patient and where to get that patient history.

Now, today, we can only get it from the PBMs. In the future world, we
probably need to develop a standard where we can get it from any entity,
because, as Bob said, the pharmacies dispense drugs that are cash only.
However, a patient could go to multiple pharmacies as well, and so there isn’t
one central place where you can get the information, which only iterates the
need for a standard to get patient history from any entity that has it.

DR. COHN: Actually, I wanted to run back to the eligibility issue, also –
I’m trying to remember exactly what I was going to ask, at this point, or
comment on.

I guess, without trying to answer the question about eligibility, it occurs
to me under the Medicare Modernization Act that, obviously, there are a bunch
of prescription drug plans, some of which are existent or are going to become –
they’ll become, over the next year, year-and-a-half, as well as a group of
Medicare Advantage Plans, at this point, which include both the current ones,
but also regional PPOs, national PPOs and others, all of which will be in the
Part D business, and I think that maybe we need to talk to them and ask them
how they would best like to handle some of these eligibility issues,
recognizing that right now, in many cases, PBMs act as their agents, as I
understand, to handle eligibility issues, but we probably ought to ask sort of
their choice of models and what would make sense to best support eligibility
with them, recognizing that, at the end of the day, they may choose to have
agents or they may choose not to have agents, and we ought to ask.

Karen, what are your thoughts on that?

MS. TRUDEL: Actually, I was going to add a point that this is complex enough
without adding on more complexity that we don’t need, and I think –

DR. COHN: Okay. Have I gone beyond –

MS. TRUDEL: – that it is important for people to realize that in the health
industry as a whole identifiers may be a problem, because there are different
payers. We are talking about a Medicare-only environment. Medicare does have an
identifier for all of its beneficiaries, and it will have a process, whereby
each of those beneficiaries who decides to participate in a plan will elect
which one – one – it chooses to participate in.

So, in a sense, we are looking at a much more homogeneous closed environment
than you will see if you are looking about – into how to implement this on a
nationwide basis, and so I would suggest that while some of these issues are
important and they probably need to be communicated to the Secretary, I don’t
think that is necessarily something that is beneficial to spend an awful lot of
time on, in the context of MMA and the deadlines that this committee has.

DR. COHN: Sure. And I guess, just to clarify, really, what I was commenting
about was is that we should probably clarify with the PDPs that they are
comfortable – you know, recognize that they have a choice of the X12
transaction for eligibility or the NCPDP transaction is a recommendation one or
both or what? And that was really B I was not trying to reestablish a patient
identifier, because we do, thankfully, have HICK(?) numbers.

MS. CRONIN: Simon, I’d just like to add on to that. I think that when we
have the opportunity to get testimony from what we think will be the PDP
sponsors in a couple of years, it would be very helpful to find that out, but,
also, get their specific feedback on formulary standards and how they think
they might be dealing with standards around classifications of drugs, in
particular, and, for example, therapeutic categories that might enable
therapeutic interchange. So I think there’s a lot of issues that we’ll need to
ask them about once they are in front of us.

MR. BECKLEY: Also like to say – you know, you’re talking about – bring the
pharmacies to the table. Bring some of the larger chains that write their own
software and know all the things they have to do. I think they’ll bring a very
interesting perspective to you. Also, on the DUR, when you’re talking about
DUR, I think it’s – Roy Busowitz is here. I think over 90 required pharmacies
to perform DUR. Is that right, Roy?

MR. BUSOWITZ: That is correct.

MR. BECKLEY: And so they have been doing it for 14 years, detailed DUR, and
that is when the drug databases started. So they can give you a very good
perspective of feet on the street what it means and how they do it, et cetera.
So bring the pharmacies in, and I know there’s a lot of them that would be more
than happy to testify. We’d be happy to help you with that, too.

MS. GILBERTSON: In addition to our testimony, we included a pharmacy ID card
fact sheet. It’s just a couple of page sheet, just to show you what the ID card
on a high level summary looks like. That was referenced in the Medicare bill,
and, also, there is just a – I think – a two-page document. Jeff had asked us
if there was any thoughts that we could provide back to the committee of things
to look forward in testimony going on this summer. I think I could probably add
10 more items to it, but one of the things was who to invite to the hearings,
and things like that. So we stand ready to help.

DR. COHN: Okay. Lynne, thank you.

MR. RATHERMICK: I’m Phil Rathermick with Express Scripts.

May be a semantic issue, but I wanted to just raise the issue, because I
don’t think the opportunity for preemption should be understated.

The comment you made about state regulation not being a barrier I agree with
in the context that, in most states today, you can do electronic prescribing.

The difficulty with having different standards and the vendors having to go
state to state to get approval is an issue, and, from a pharmacy perspective,
we operate pharmacies in five states that are subject to five states’boards of
pharmacy, and allocation of clients and members to pharmacies isn’t intuitive,
necessarily. So if a script came to Express Scripts and we have to fire it off
to a facility in one state or another, we have to get to sort of a lowest
common denominator, and so it is important to recognize, for this committee,
that to set a single standard for both authentication of end users and what
constitutes an acceptable script for the pharmacist to fill without having to
look at different state regulations is very important, and I just wanted to
make sure that that was clear.

MR. REYNOLD: Back to Karen’s comment a minute. There’s a significant
healthcare industry out there right now that is using automated scriptions from
the pharmacies to the PBMs, using NCPDP, using the other things that are going
on. So, although I understand that the committee is focused on that, I hope
that the NCPDPs and the other entities that are out there keep in mind that
since there is mention in HIPAA of NCPDP and a mention in other things that are
going on, that the whole industry is not lost sight of, because, otherwise,
then, what the government does becomes a standard, because if we are doing our
job, we don’t want the doctors and the pharmacies to have to go to many
standards in many ways for this industry.

So I’d like to also put that on the table as a consideration, because it is
the same doctor. It is the same pharmacy and it is the same PBM. So I think
that is something that – I know we can’t dwell on it, but I believe it is
something that if we are shortsighted in doing it, then we are doing a
disservice to those three entities that I think – that are already out there
leading the way, so that this can be a piggyback. This is not a new discussion.

MS. CRONIN: Simon, can I just add one minor comment?

DR. COHN: Sure, Kelly, please –

MS. CRONIN: The subcommittee should probably stay in touch with what is
happening with the NHII subcommittee, because there is going to be a lot of
activities over the next year or two at a state level, where they are going to
be, perhaps, developing local indexes, and there’ll be other mechanisms for
perhaps looking at a unique identifier that would be perhaps beyond an
incripted SSN or whatever we are dealing with within Medicare.

MS. GILBERTSON: You want to get some PBM interest, just ask the PBMs how
they are jumping through hoops to modify from use of SSN to a non-SSN when it
comes to the State of California and Minnesota and wherever else. It’s tough.
Now, you have cross references of cross references of cross references.

MR. REYNOLDS: I would say within the next 18 months most every payer would
have probably transferred from a Social Security number to some unique
identifier that is outside SSN. So, as we deliberate this, that is going on
full speed right now.

MS. GILBERTSON: And some of those identifiers are assigned by the health
plan, some are assigned by their agents. Some are B you know, they are all over
the place.

MR. REYNOLDS: Some are grabbed by the employer.

MS. GILBERTSON: Um-hum.

DR. HUFF: Just a quick question about access to the standard and how much
does it cost and how do you license the use of the standard?

MS. GILBERTSON: The NCPDP standards, as an entire package, everything that
we publish, is available for $650 for the entire package, and that is telecom,
script, pharmacy ID – it’s everything we publish, that whole package comes out.

There is also a yearly membership that is $550 a year, and with that
membership, you receive the entire package of standards, as well as access to
the members-only section of the site, and free attendance at any of the
workgroup meetings, things like that.

One of the things that is of interest is – I happened to be at a HIPAA 3
summit not too long ago and it was – maybe a HIPAA 8, a HIPAA 8 – and the
discussion of the organization of X12 or the organization of NCPDP or the
organization of XYZ doesn’t create a standard. It is the participation of the
industry, and one of the things that we like to remind folks is that you don’t
have to be a member to participate in the standards development, because most
of our work is done in task groups, over phone calls, and, at that point,
anyone is allowed to participate. So we hope it is never seen as a barrier,
because it is what the participants want, because I don’t sit and dream up
these standards, even though once upon a time we did. It is really what does
the industry want, as we move forward, and it is important, because if it’s not
you, who is getting involved?

MR. BECKLEY: To use the standard, there is no fee. I mean, you were asking –

MS. GILBERTSON: That’s true. Licensing.

MR. BECKLEY: – what is the licensing. There is no licensing. It is basically
– if you are a member, $550 a year, you get the documents, you get the
standard, the layouts, the implementation guide. If you are not a member, we
charge a little bit more, so do you get the drift of what we want you to do? We
want you to be a member.

MS. GILBERTSON: The doctor doesn’t have to purchase the standards.

MR. BECKLEY: Right.

MS. GILBERTSON: They are not going to code to it –

MR. BECKLEY: Their software vendor does. So you take a large software
vendor, they have a representative there. They program it. The physicians don’t
have to know about NCPDP. The same thing goes for the pharmacies. Their
software vendor belongs to NCPDP, helps write the standards, and they – you
know, they put it in their software, and the pharmacists just use it. So there
is no per-site licensing. It’s just how you get the documentation so you can
code to it.

DR. COHN: Well, you know, with this, I am going to suggest we take a
15-minute break.

We thank our presenters for the great conversation. (Applause).

(2:47 p.m.)

(3:07 p.m.)

DR. COHN: Okay. The next session actually begins with an opportunity to hear
federal perspectives on the e-prescribing, and I think we’ll be hearing from
FDA and the VA. We are obviously glad to have you both here, and, then, from
there, we move into an open-mike period, and, then, from there, into
subcommittee discussions of the testimony of the day.

Agenda Item: Federal Perspectives on
E-Prescribing

DR. COHN: So, Randy, would you like to lead off discussions representing the
FDA, please?

MR. LEVIN: Okay. Thank you.

I just want to mention that because of budget problems at the FDA, we will
have no background on our slides, okay? (Laughter). You’re aware of that.

I’m going to talk a little bit about what FDA is doing to support the
electronic prescribing, and a lot of this work is interagency work. So it is
involving a lot of work we have done with the VA, with the National Library of
Medicine and with ARC and some other groups, and it focuses around something we
are calling structured product labeling, which is a computer file that contains
information about medication. It’s what is being proposed as a standard for
exchange of medical information between the FDA and the pharmaceutical
companies and the manufacturers and with the NLM and with information
suppliers. It is an HL7 XML standard, based on the clinical document
architecture, and it is currently being balloted at HL7. It has passed the
committee-level ballot and is going for membership ballot this May.

The source of information for this – the structured product labeling would
be a professional labeling for prescription drugs, but also includes – will
include the over-the-counter drugs, and we’ll get that from Drug Facts, from
over-the-counter drugs, and information from drug listing.

The contents of SPL, we would include things of how to use the medications,
things like dosing recommendations, when to use the medication, indication –
like indications, clinical effects, including interactions and adverse events.

Description of the medication, including the various names of the
medication, ingredients, strength, appearance, dosage form and codes related to
those – the names and ingredients.

How the medication is supplied, name, package type and quantity, and the
distributor of the medication.

So here is a – just showing now we are going to have – break the labeling
down into sections. So each section of the labeling, like indications or box
warnings or dosage administration, will be divided into sections that will be
tagged as a blob of text. So this is taking the current labeling information,
dividing it into these sections, but – and what we have heard is that we need
more data elements actually captured that could be used in decision support
systems like what would be used at the VA, and a lot of this information has
come, actually, from the work that we have done with the VA and others, where
we would take and have data elements for specific parts of the information that
is in the drug labeling. So this would include things related to the active
ingredient, including codes for the active ingredient, names, and I’ll go over
this in more detail, but also the mechanism of actions and clinical effects,
things related to the drug product and package product.

So for the active ingredients, the things we are talking about, the data
elements we are talking about are a tag for the active-ingredient name – this
would be the established name and this would be what we would refer to as the
established name for the ingredient – the ingredient ID, which we are calling
the unique ingredient identifier, UNII, for the whole substance, also, an
ingredient ID for an active – if that’s different than the substance.
Sometimes, there is an active portion of the ingredient and we would identify
that as well, as well as for the active ingredient, the activity of it. That
would be a mechanism of action or physiologic effects, and the clinical
effects.

For the clinical effects, some of the – what we have seen requests for are
to categorize the clinical effects, such as if it is an adverse event or a drug
interaction or a food interaction or some other types of interactions, and to
describe that are there contributing factors to this interaction, such as if
you take the medication with a meal, you are going to have a consequence of
decreased absorption, so capturing the contributing factors as well as the
consequences of those factors. So if you take the medication with another
medication, you’ll have a certain interaction, and describe those things in
data elements.

Then also describe where the information is located in the labeling text, so
that – so you can actually see more detail about it.

The things that we heard are important – some idea of the frequency of the
clinical effect, some idea about the severity of the effect and if it is
related to any special population. So these are some of the data elements that
we have heard about that would be helpful if they were tagged and then provided
in the labeling, in the structured product labeling. So it would be available
as machine-readable information.

Then information about the actual finished dosage(?) form. This is the –
could be the pill that you are taking. This would be the ingredients that are
in this, the medication, the strength and dosage form, the color and shape, if
it’s scored, things like coating and other things that might be related to the
appearance of the product.

The manufacturer, the labeled route of administration, inactive ingredients
and imprint coding. That’s things that are actually on the finished dosage form
used for identification. So these would be things that would be related to the
finished dosage form.

And for an active – inactive ingredient, we would also have a name for the –
I mean, for the inactive ingredient and an identifier for inactive ingredients
as well.

For the product itself, there would be – usually a product is confined to
one of the finished dosage forms, but can be related to a multiple finished
dosage form, but it has a trade name, an established name, which we would tag,
as well as a product code, and this is a code that would be for minus the
packaging information that – this is what was talked about before that there is
– there would be a product code, a drug product code.

And discussion about the indications, and some of the ideas about
indications would be that have some – the name of the indication, some grouping
of the indication that – the type, the disease, conditions, sign or symptom.
What is the severity that you are treating? What is the intent? Is it treatment
prevention? Mitigation, cure, diagnosis? Is it a primary adjunctive treatment?
Are there any exclusions for use, such as shouldn’t be used in pediatric age
groups? What are dosing and monitoring issues about the – for the indication?
And things about dosing –

DR. HUFF: I know, in times past, we talked some about whether that – the
name of the indication could be coded rather than text, but you are still at a
level where you think you just support X names for these indications?

MR. LEVIN: I think with the structured product labeling, you can go with
either. You can have coding and we can have names. So one of the – I think they
were – for the last discussion – talking about that if you have text, that is
one thing. If we can do it without the codes, but we can – we can work with
codes as well. So, I mean, these are things that are open for discussion. These
are the requests that we have seen that we’re – things that we are aiming for.
So that is definitely something that we could consider.

Then dosing, things like the initial dose and the usual daily dose, the
do-not-exceed dose, and if there’s a – you need to change your dosing for
special populations.

We looked – when we were working on this with – in our – looking at the
different requirements and trying to model dosing, it was very difficult, but
these were some of the key features of dosing that seemed to be helpful as far
as if they have that immediately available.

And then if there are some issues about monitoring, these are things that
people talked about with monitoring. If you have to measure liver-function
tests to note that, to say how frequent you have to do that, and, again, to
reference if you need more details into the text.

So these are some of the data elements that were discussed to describe the
products including the indications and dosing, and then when you package the
product together, you have a package type and you have a quantity, and this is
where the National Drug Code comes, and this is the level – down – all the way
to the packaged product.

But there are codes before that that would be that the ingredients has codes
and the drug product itself would have codes.

Now, the proposal for this is really a partnership between many different
groups, and one would be the FTA, the manufacturers, repackers and relabelers
of the product. Now, these are the people that would provide the information
that we have just been describing. So they would collaborate with the FTA to
provide the information about the products, including how they are distributed
and how they are packaging it.

Then, there is a collaboration between FTA and the National Library of
Medicine where we would provide the up-to-date information in this XML, the
structured product labeling XML file, and the National Library of Medicine
would make that available in the daily med repository.

At the same time, the National Library of Medicine would take the SPL and
link it to other features that they would have, such as the RxNorm, and this is
where the labeling and RxNorm get – together.

The labeling information supports the NM in their creation of the RxNorm
because it provides information about new products that are available, so they
can see what the up-to-date products are. It gives information about the
ingredients. It gives information about the strength and dosage forms and route
of administration that helps them to generate the RxNorm. So this would be
supporting the RxNorm, and it would be part of their repository of information,
their daily med repository of medication information.

And, then, finally, the health information suppliers, which you have heard a
lot in the previous discussion, they are providing the information to the
various groups, and they would be able to have access to this information
through NLM, so they could use that in their systems, whatever those systems
would be, decision-support systems or whatever, that they would be available
for them to use.

So all the decision-support people – the information suppliers there who are
established – we are hoping to have them use this as a source for information
that they would use in their systems.

So the flow would be coming from the manufacturers, repackers and relabelers
would have – if they have new medication or if they are marketing new
medication, they are changing their packaging, they are changing their
labeling, they would submit that information to the FDA, which we would then,
in our systems, be able to generate the structured product labeling that we
would send to the National Library of Medicine. They would make that available
to the health-information suppliers and they would use electronic prescribing
systems or whatever to get it down to the user. So it is this collaboration
between all these different partners to have this work.

Just to show you – here are some of the – what we have been doing most
recently is been working with ARC on trying to get this done with – they have
been supporting us with this activity, and we are looking forward to have the
SBL available for approved human prescription drugs is our Phase One, our first
goal, and we are looking to start this in July of 2005. The system is up, that
we would start to roll out the new medications with this SPL for – available
for download.

To do that, there are certain regulations that we need to have in effect to
help us do that. One is an electronic labeling rule which requires
manufacturers to send in their labeling in electronic format. So we have that.
That rule is finalized. It will go into effect in June of this year, and, in
there, we have a transition where we would transition from what we currently
get the labeling in in a PDF format to the structured product labeling, so that
the manufacturers would transition over from the current format to the
structured labeling format.

The other regulation is the professional labeling rule. This is the – this
is a rule that was proposed to require the manufacturers to define a highlight
section of the labeling, among other things, but the major push of this is to
show off highlight section.

What this is is key information from the labeling that the prescribers use
the most. The labeling has a lot of information. This was going and looking –
talking to the different users of the labeling. This is information that we
found that was key for the prescribers.

Now, we are using this into defining some of the things that we would tag,
indications and clinical effects. What clinical effects do you tag? You want
only to tag the important ones, the ones that you want to see, and that was
brought up in earlier discussions? What level? Who decides? How do you decide
what to tag? And that was part of this highlight section. It was to bring out
the key information. That would be things that the FDA and the manufacturers
would work together to bring forward.

So we need that highlight section that highlights area to help us move
forward with tagging this important information for the labeling.

Now, right now, that was a proposed rule. We had received comments, and,
now, we are moving toward finalizing this rule, but it still has to go through
the procedures for finalization, but, in order for us to get where we want to
be with the information that we – that was described before, we need to have a
professional labeling rule to go through.

In this Phase One, we would introduce the SPL as a standard for
communicating the information. The UNIs, which is unique ingredient identifiers
for the active and inactive ingredients, and then medication terminology, which
would include terminology for indication, anything that – those things that we
can establish, then we can add to the structured product labeling. So the more
terminology standards that we have, the better we’ll be, and the more helpful
the standard will be.

Some of the systems that we are working on to get to this point is a
substance registration system, which is where we assign our unique ingredient
identifiers. This is based on molecular structure or the manufacturing process.
We have a set of business rules that we follow of how you actually draw the
molecule, so it’s – everything is drawn in a standardized way. It’s not a
simple process to go through and set all those standards, but we are working
through that, and we have already set certain – the easy ones we have already
done and we are putting those into the system as – already entering them into
the system.

Things, when – there are different ways to draw the – centers and other
specifics like that. We have to work on those details, but that is a smaller
percentage, and then we have substances that don’t have molecular structures,
such as botanicals, and we have specific rules of how we define what a
botanical is and assign an ingredient identifier to that.

Then the other system is the electronic labeling information processing
system or ELIPS, and this is a system that will help us do a content management
of the labeling information, help us review the labeling, and move that into
SPL and for export to the MLN. So that is in Phase One.

Phase Two, we are looking to add the availability of the other human drugs
to this, and that would include the over-the-counter drugs. We are looking to
start that and to start to have those things moving through the system July of
2006. This requires us to finalize a rule for drug listing. The drug-listing
rule would require the repackers and relabelers to come to the FDA for sending
them the information about their new products and for assignment of codes and
the National Drug Code and the drug product code.

So that’s the standards that would be introduced into this section.

We have a system that we are working on, an electronic listing system that
we call eLIST, which we have already gone through a pile – that was a couple of
years ago, when we were just – this, and where people would go on line and
register their products and work with registering their information.

We also register all facilities where drugs are manufactured and repackaged
for inspection purposes. So that would be part of that Phase Two.

DR. HUFF: Is that an enhanced National Drug Code or is that –

MR. LEVIN: This would be the National Drug Code where we would take control
of the National Drug Code.

DR. HUFF: You need new regulations to do that?

MR. LEVIN: That drug-listing rule. That –

DR. HUFF: Drug listing will do that.

MR. LEVIN: That would do that.

Currently, the way that the National Drug Code works is that you – companies
assign their own codes and then come to us with the registration information
after they – the listing information after they have assigned the code, and I
sort of look at it like if the Department of Motor Vehicles gave you your
license plate for your car first and then said, okay, here’s a card. Fill this
in with your information about your car and send it to us, and they wouldn’t
get many of those cards coming back. So that is the way we do it right now. The
numbers are assigned first, then we ask for information to come later. We would
like to reverse that, where the information comes in first and then the number
comes with the information, but that would require a change in our regulations,
and that would require this rule to go through.

Just to lay it all out, people who want to look at this visually, this will
get pretty confusing, but if you follow with me, here is our goal is to improve
– we are looking at to improve patient safety, because we think that if we
improve the access to information, this will lead to improved patient safety.

Electronic prescribing, all the other benefits of having labeling in an
electronic format. It goes from the SPL, from the FDA to the National Library
of Medicine, the Daily Med(?), to the health information suppliers to get to
the patients. So that is the partnership.

It starts with some drivers on one end that we need certain rules and
regulations that – the electronic labeling rule, the professional labeling rule
and the drug listing rule, that drives the source of the information. That is
the manufacturers of the medication as well as the repackers and relabelers who
are working for the distributors and medications. They provide the information
about the product. They provide when to use the medication, how to use it,
description of the medication. The repackinging relabelers provide how it is
supplied and who the distributor is of the medications, and they would use
standards to do this, and we would use the structured product labeling. We
would use standards for indication if we could, codes, and names, as well as
classifications, and we are looking to the VA National Drug File and the FRT
for that kind of information using those codes and those terminology, drug
interactions and adverse events, how to use the medications to have standards
on how we represent dose and the things that we describe, description
medications, standards – the unique ingredient identifier, the ingredient
names, standard names, strength, appearance, standards for appearance in dosage
form, and then how supplied – the names, the product names, the package types
and the quantity, and also the distributors. Those go into these two systems,
the ELIPS System and the eLIST System, where FDA approves labeling and approves
the changes. They also, through a listing, do their qualify control and
generate National Drug Codes and drug product codes –

So this is what we are working on for supporting the electronic prescribing,
again, with various partners, again, from National Library of Medicine, one of
our – partners. VA has been helping us a lot, people from NIH and NCI with
terminology, working at HL7. ARC has been supporting that, and our task master,
Mike Fitzmaurice. I mean, our collaborator – (laughter) – has been helping us
with – so that we can have this happen.

DR. COHN: I guess I am presuming that at least some time by the end of 2006,
this data will be time line, because of the way you are going to be changing
how numbers are given out.

MR. LEVIN: When we get that drug-listing rule –

DR. COHN: Yes.

MR. LEVIN: B and that is what we are looking at the beginning of – in the
middle of 2006 that that would be – we’ll start to working with that, and then
it takes time – for example, with the labeling, once the structured product
labeling goes in effect and we can start working on that, it will – new drugs
coming through will get the structured product labeling to have the previous
drugs to convert to structured product labeling, once a year, manufacturers
have to file their labels with us. So over the year, we will gather up all the
labels for the rest of the prescription drugs.

DR. COHN: Okay. Well, make sure I understood, because you are talking about
a couple of different things.

MR. LEVIN: Yes.

DR. COHN: To me, the fundamental issue with all of this is the timeliness of
the data.

MR. LEVIN: Oh, the timeliness of the data. I’m sorry.

DR. COHN: The timeliness of the data.

MR. LEVIN: I’m sorry.

DR. COHN: And so what I was thinking I was seeing with what you were
describing was is that in the middle of 2006, you are expecting final rules
that because people won’t get a number until they send you the information will
help ensure the timeliness of information to make all of this work. Am I
misunderstanding something or is that correct?

MR. LEVIN: What we – first the – that people right now, when they assign
their own National Drug Code – assign at any time, so that they always have a
National Drug Code, we’ll make sure that they can assign their National Drug –
we’ll get them a National Drug Code before they market their product.

In 2006, we are looking at that the rule would be implemented, the systems
would in place that we can then start to take advantage of that, that we would
then be able to generate the list of National Drug Codes that we would have the
– we would have control over the National Drug Codes at that time.

DR. COHN: Okay. I think you’re agreeing with me.

MR. LEVIN: Yes.

DR. COHN: Okay. Thank you.

MR. BLAIR: Randy, first of all, let me applaud all of the work that you are
doing with the structured label identifier and the structured labeling and with
the professional labeling and the way that you’re working with all of the other
agencies and the drug knowledge base vendors, so that this all fits together.

MR. LEVIN: That usually means there is going to be a hard question that is
going to follow that. (Laughter).

MR. BLAIR: The hard question is my understanding of the National
Prescription Drug Improvement and Modernization Act – see, I haven’t learned
the abbreviation for it yet, you noticed –

DR. COHN: The Medicare Modernization Act –

MR. BLAIR: Is that what –

DR. COHN: – of 2003.

MR. BLAIR: Yes, okay – has indicated to us that, after NCVHS gives its
recommendations on e-prescribing standards that the Secretary, at the beginning
of 2006, would begin demonstration projects of e-prescribing, and is there an
aspect of all of the things that you are doing where you would need either help
or support in order to be ready to support those demonstration projects in 2006
where the NCVHS could identify that and support you?

MR. LEVIN: I think that some of our – the pieces that are going to be
potential trouble spots for us would be the regulations, as far as moving the –
having the regulations move through, because that requires, as the people from
– as you know – from the work that you do in CMS and other areas – that does –
requires a comment period and respond to the comments, and depends on the
support we have from the regulations how that moves through, but that is one
potential problem for us.

The other thing that where you can help is that the terminology, if you have
terminology standards that we can then incorporate into the SBL, and the things
that you’d like to see in the SBL, those types – giving us those types of
requirements, showing us what you want us to incorporate, that would be very
helpful that you can supply that kind of information to help us, then, address
the – you know, what you need for those pilots.

MR. BLAIR: Thank you.

DR. STEINDEL: I think, Randy, you just answered one of my questions, which
was the numerous places in the SBL tags that I saw places that we could use
standards that have already been enumerated –

MR. LEVIN: Yes.

DR. STEINDEL: – by CHI and otherwise, and I was wondering if you were
thinking about using them, and you seemed to indicate yes you are.

MR. LEVIN: Right. Yes.

DR. STEINDEL: That was my first question.

The second one that I had was I noticed in various places there were some
items in the SBL, like, for instance, the one that came to mind, because this
was brought up earlier, was the severity of the indication – severe, moderate,
et cetera, whatever scale we are using. Is that going to be assigned by the
manufacturer? Because you seemed to indicate that everything from the label is
going to come from the manufacturer, except for some stuff, you know, like
bookkeeping type things –

MR. LEVIN: Right. All the – the things – those are requests that we have
already received for what should be in there. So we are going to be vetting
that through – but it is a collaboration with the manufacturer. So the – it was
a collaboration –

DR. STEINDEL: Um-hum.

MR. LEVIN: B between the manufacturer and the FDA.

DR. STEINDEL: So when the manufacturer is submitting their label for
approval and they put in there that this indication is severe –

MR. LEVIN: Right.

DR. STEINDEL: – you would be passing on that as –

MR. LEVIN: Yes.

DR. STEINDEL: – yes, this is correct?

MR. LEVIN: Absolutely.

DR. STEINDEL: And you would be asking for evidence for that?

MR. LEVIN: Yes.

DR. STEINDEL: Okay.

MR. LEVIN: Yes. So that – yes.

DR. STEINDEL: I wanted to see what the process was going to be there.

And the last question actually relates to what Simon was asking about
timeliness, and there is a stage when – I noticed two things with regard to the
structured product labeling itself. There are places when there’s obviously a
totally new drug coming out, and the structured product label is totally new
and it goes through the usual type of approval process, and there’s a second
case when the NDC code changes, like when you change from a 12-blister pack to
a six-blister pack, I understand, now, you get a new NDC code for that.

MR. LEVIN: Right.

DR. STEINDEL: How is that going to be handled with respect to the structured
product label? Would you be submitting a whole new label to the National
Library or just that portion of the label that indicates the change?

MR. LEVIN: Well, the actual handoff of what we are going to be giving to the
National Library, we are still working on the details of that. Right now, it
looks like we would just give the structured product labeling the whole piece,
when any part changes. Remember, even a part of the labeling, someone might add
a new adverse event, and the labeling would change, too.

When someone comes in with a new package type, that will come through the
listing portion of that, because, many times, it’s just a repacker that is
going to be supplying that, and they don’t have to supply the rest of the
labeling information. That will all stay the same. So the labeling is divided
into these pieces. So they might just change one section, one part, and that is
all that we would capture.

DR. STEINDEL: Okay. And this gets me to the second side of the question
which has to do with the extent of the change of the label. There are two areas
where a time delay can occur, and one is the time that it gets into you to do
your review, an actual review, which is what occurs today, and the second is
the actual assignment of the NDC code and release to the library, and I could
see something where you were talking about it comes just through the listing
service. That could be a kind of a perfunctory thing where it might come
through very quickly.

MR. LEVIN: Right.

DR. STEINDEL: And so what I was concerned about, from a timeliness point of
view, are you giving yourself any requirements in the regulation that you are
proposing where the FDA needs to assign things within a certain time period?

MR. LEVIN: Yes, let me speak from what the comments that we have heard from
the outside, because the rule hasn’t even been proposed, and what we have heard
is that the National Drug Code, the code needs to be known to the manufacturer
in advance of their even marketing the product. So we would need to have that
kind of arrangement that the code is available to them ahead of time, because
they have to print the packaging and do all the other preparation. So it has to
be – that is the time when we have to have that built into the system, so that
people can get their National Drug Code ahead of time. Just that we need to
know some information about the product at that time as well.

Does that answer your question?

DR. STEINDEL: Somewhat.

If I was repackaging –

MR. LEVIN: Yes.

DR. STEINDEL: – a product and I needed a new NDC code –

MR. LEVIN: Right.

DR. STEINDEL: – and I wanted to market the product in July –

MR. LEVIN: Right.

DR. STEINDEL: – for instance, and my experience shows that I could ramp up
this type of manufacturing in two months and distribute it, would I have to
come to you in July of the year before to get the NDC code or in May?

MR. LEVIN: I don’t have those details, but we have heard from the outside
various timing issues, and we’ll – it’ll be, hopefully, appropriate to that,
and that would be part of the proposal, the rule and the comments and making
sure that we got the numbers right, because we have gotten a lot of feedback
about that.

DR. STEINDEL: And I think, Randy, that does answer my question, as long as
you were passing it out for comment.

DR. COHN: Well, welcome.

DR. DE LISLE: Yes, good afternoon.

I was asked to come to give you some perspective about the VA.

The VA is – I am a practicing physician. I am also an academic, and I have
an interest in medical informatics. So what I will tell you is really sort of
practical issues that arise in the system where all of what you are discussing
now is – or much of what you are discussing now have already been accomplished
for several years, and so we are wired to the hilt and now what?

And I don’t want to say that the VA is this normal healthcare system,
because for a U.S. healthcare system, it really isn’t. I mean, it is – when we
have a captive patient population, we have economics – we have a global budget
and we have economics that are aligned for waste management of resources, and
so I’m not sure whether the rest of the U.S. system will ever evolve that way,
but if I can give you sort of a picture how this electronic system that you are
envisioning – you know, one key component is establishing standards, how does –
has a chance to evolve in the future.

And I’ve been making this talk as I went this morning. So I have been
adapting it all the time. We’ll see how this current iteration – whether or not
it pleases you guys. (Laughter).

So what’s – we call our patient record CPRS, Computerized Patient Record
System, and so I’ll use this jargon, but I’ll spare you of any other jargon,
hopefully, for the rest of the afternoon.

The current generation started in 1997, although the infrastructure and the
standardization of the informatics has been ongoing for 20-or-some-odd years at
the VA. So the system was ripe for putting an electronic patient record.

It is now in place in 153 hospitals, 800 clinics in which 1,000 full-time
physicians and 30,000 part-time physicians work. I think it is fair to say that
for the residents and interns that come in and out of the VA that we have
trained over 100,000 physicians over the years with an electronic patient
record.

The prescription itself, it is used currently for – about 95 percent of VA
prescriptions are prescribed electronically. Whereas, the rest of the five
percent, that is basically the written prescriptions that are required for
controlled substances, essentially. That’s the last bastion of written,
longhand prescriptions.

Most treatments – if you are looking at VA’s with brick and mortar, that’s
nice, but, really, the VA system is principally an outpatient, ambulatory
system. So, for example, our little hospital in Baltimore is only 300 beds, but
we see – the VA system sees 600 (sic) outpatient visits a year, so – which is
11 times more than the University of Maryland Hospital, which has 1,000 beds.
So it really is mostly an ambulatory system, believe it or not.

Seeing a very old population that has a lot of chronic disease, very much
like the rest of the U.S. population will be in half a generation from now. So
we are just out there as a pilot project, if you will, for this whole
enterprise.

We have done 102 million prescriptions last year – and I thought that was a
pretty big number, until I heard the four billion prescriptions that were
prescribed by the industry electronically – and over half-a-billion
prescriptions since the inception of the system. So we’ve kind of been there,
as far as the e-prescription is concerned.

Now, as much as this talk – there’s been many technical issues here with the
e-prescription and the transactional aspect of the e-prescription. Here is the
really practical problem of the practicing outpatient physician. He is seeing –
and I am just going to lay it out to see that – I’m an intensivist. I don’t do
outpatient care, because I can’t handle this. (Laughter).

This is a 73-year-old guy who comes in with a three-day history of cough,
produces a bit of sputum. He’s on 13 drugs. That’s our standard veterans. They
are from six different providers for seven different diagnoses. We know these
drugs. We know which provider started the whole show, and we have these
diagnoses on our problem list in our ICD9 codes. This we do know, but it
doesn’t help you at the point of service when you have 15 to 30 minutes to deal
with this guy’s productive cough, and there were 10,000 clinical trials last
year, meaning that none of us can really aspire to catch up with all of the
science out there.

So this, to me, is much, much more difficult to deal with than any
critically-ill patient – okay? This is a very scary problem.

And, now, how is pharmacal therapeutics? What is that all about? Well, we
figure out if a drug is needed. You have it there. Then we pick one among
alternatives.

See if I can travel a bit.

We prescribe it, and then someone delivers it, and, if we are lucky, we
reevaluate this pharmacal therapeutic at a later point in time to make sure it
is safe and effective, and if the drug is needed, you continue it. If not, you
stop. So that is the simplest expression of pharmacal therapies, and the reason
I put it out there is to sort of get to a model of where the e-prescription
system need to evolve.

Those are the current systems we have in place when we pick a drug. We have
to sort of figure if it is on the formulary. If you are the VA, you are lucky,
because there is only one formulary, but there are some kinks to that.

If it’s not on the formulary, you’ve got to go to the non-formulary request
process, which is a complex process in its own. It’s got all kinds of flaws.
Either way – or if it’s under-formulated, it might be subject to restrictions,
and there’s all kinds of restrictions, and there is no nomenclature for the
restrictions, and there’s no algorithm that has been invented for the formulary
restrictions.

So either way, if it is restricted or part of the non-permanent process,
there is this justification process by which the doc sort of justifies what it
is that he or she is doing, and that justification process also is not codified
or specified in any way, form or fashion. There’s no accountability there.

Now, if you are lucky and if you go – if the drug is not restricted, you get
down to the best practices, and, as you well know, the best practices are out
there. Maybe they are on the web, but they are in a 125-page format. They are
really not useful for the 15 minutes I’ve got to deal with this patient. So
this is a big – Outside of the inclusion or exclusion from the formulary, all
these other restrictions here are flawed to a great degree. All these – could
help us to best treat our patients are flawed.

Now, comes the time – so we basically – the drug is on formulary, we
prescribe it, and that is good.

Now, the pharmacy people, that’s what they do. They make sure that the right
drug goes to the right patient and at the right time for the delivery system.
This, comparatively, although we have been spending a lot of time making sure
that the drug interaction and drug allergy interactions are correct, this is a
much, much more robust part of the pharmacal therapeutic process. So,
comparatively, here is not a big issue, as far as I can see it. That, here, is
a situation –

MR. BLAIR: Question.

DR. DE LISLE: Oh, I got myself in trouble already. (Laughter).

MR. BLAIR: Question.

DR. DE LISLE: Yes, sir.

MR. BLAIR: In order to put your comments in context a little bit, are you
using current standards, so that as you are making your observations and
comments about what works and what doesn’t work, we would sort of know whether
you are using current standards and how well they are working or not.

DR. DE LISLE: I have done this analysis for our own healthcare system, which
is probably much more advanced as far as applications of the standards than is
customary. So that is my own observations.

So then we evaluate the drug, and you get into the reevaluation process,
which we just talked about.

MS. GRAHAM: I just want to clarify. I mean, I think the point about – I
think it’s been raised earlier, when you get to say the – you know, going off
formulary, there isn’t a standard – and I think it has been reiterated earlier
today – for how you present your justification or how you communicate that it
has been approved or – for many of those things, a standard does not exist or
isn’t widely known about. We do use standards for order checks, for drug-drug
interactions, drug-lab interactions, those kind of things that happen in our
system at the point of physician order entry. Before the order is even signed
off on, those feedback mechanisms are coming back to the provider.

I think when Dr. DeLisle refers to the secondary thing, it is much like it
going to the retail pharmacy, where the pharmacist then gets involved with the
order itself and the delivery modes and further checks on that.

DR. WARREN: Yes, but what standards –

MR. BLAIR: Yes, what standards are you using –

DR. WARREN: The name of the standards you are using –

MR. BLAIR: – so that we can put this in context.

DR. STEINDEL: What about drug interactions?

MS. GRAHAM: Drug interactions are based on commercial information. We use
NDFRT. I mean, I think some of that – and that is probably – Dr. De Lisle was
really asked to talk about how it works from a clinical perspective because we
thought you had probably been talked to death about –

DR. STEINDEL: But, basically, what it comes down to is for things like
drug-lab checking, drug-drug checking, you are using your standards.

MS. GRAHAM: Right. Correct.

DR. STEINDEL: But you have developed –

MS. GRAHAM: Correct.

DR. DE LISLE: And not only that, but for the drug-drug interaction, we are
left with – we have a standardized drug nomenclature. That’s nice, but then the
algorithm as to whether this particular drug-drug interaction and the patient
that’s got 13 medications is really – the algorithms are not built. We have to
build them one after the other, and that is a very local issue. So that part of
it is not standardized. We would very much appreciate if – the enormous amount
of work that would take to develop such an algorithm, we would very much –
would like to take advantage of it.

MS. GRAHAM: And checks against things like problem list are truly based on
ICD at this time. I mean, it’s at that level. So if you have something that is
based on something that exists on the patient’s problem list or on a prior
problem that has been codified, it’s based on the ICD level, which we recognize
is not granular enough for many purposes.

DR. STEINDEL: But we’re talking about the ICD code at that point, but the
actual algorithm for doing the checking is something you have developed.

MS. GRAHAM: Right.

DR. DE LISLE: So, and, again, I just wanted to put things in perspective a
little bit for our system. The major failures in pharmacal therapy is to figure
out whether the drug is needed in the first place, whether we picked up the
most efficient drug, secondly, and whether we are evaluating a theory
altogether. So those are the major failures.

The thing that can help us do this are the best practice guidelines or the
science that is out there, and it really is not there at the point of service.

So what we have had to do to bring those practice guidelines into our
process is really to put the practice guideline there at the point of service
when there is a prescription. Doesn’t get the doctor to think about a drug that
he is not thinking of, if he is not thinking about prescribing anything, but if
he is thinking of one drug and he goes there, we can actually grab this doc and
deliver science to him.

Now, this is our electronic patient, electronic order entry window, and you
have seen – most of you are more familiar with these than I am. So, but it
basically gets you to name a drug with a dosage that actually exists, a route
that we carry and then a schedule that makes sense, and so all of this is – and
then where to pick it up. None of that is particularly exciting as far as – is
particularly novel, but, as you noticed, there is – and the features, the
robustness of not being able to misspell a drug or write the wrong dose is in
place, so we don’t even think about this anymore. The problem is there is
nothing in this order entry that helps me decide whether the patient needs
purowsonide(?) or not in the first place or whether his dose needs to be
increased or decreased. This is a different problem.

So we would like to have beautiful software – (laughter) – that will let us
do these things, you know, especially in your case, extend the deadline – you
know – if I continue like this, but, basically – and our reality was something
like this, which is far – it doesn’t get us anywhere near to stuff we want to
do in pharmacal therapeutics.

So what we have done – what the docs have started to do at places is
highjack sort of unfamiliar features of our electronic patient record to go
into the prescription process so as to supplement science or – to those poor
docs out there that are trying to survive, and, basically, here is a – if you
typed in the name of Amiodarone, this is a template that would appear before
you were sent to finally order Amiodarone. Amiodarone, for those of you that
are not in the medical field, is a medication for heart rhythm, and so you have
a little B and the format of these templates has evolved over time, based on
feedback from providers and based on what we have learned about provider’s
behavior in these templates.

So here is a little introduction. They want to know what they are getting
into first. Here’s an entry to the logic of the tool, and, finally, here is a
feedback button that they can click. When they do so, they get into our PNT
feedback, and I can look at this every morning to see if somebody has safety
issues with the tool, issues about the science itself, issues about the logic,
the English or they are simply not happy about the system in general, and we
have canned answers for many of these things – there’s been over 30,000 of
these things that have –

So back to the tool. Most commonly, a primary care doc would click on
continuation of therapy here, and then they would get an entry into a logic
which was that the Amiodarone was originally prescribed for atrial
fibrillation. That would be the most common cause of prescribing Amiodarone. So
it’s put out there first.

Now, under that rubric is – first of all, there’s a – we know that the doc
will need the electrocardiogram to make an appropriate decision about this
patient. So there’s a drill that went into the electronic patient record and
retrieved the latest EKG along with its readings – interpretation. So, and,
here, we have a series of questions about the EKG to see if this patient fits
the profile for a continuation of therapy for Amiodarone, and the patient might
not have had an EKG, at which point, we sort of get them to order an EKG before
they go on. They do get to go on.

So, here, for example, we say that the EKG had normal – rhythm, and you have
a date. It was done in the last year. So the doctor would click here.

Now, you notice that we have all this information there. We don’t have the
software to be able to make the decision for the doc, because we could push
this one step further if we had these features, but, nevertheless, the doc
would then enter into the – the therapy for Amiodarone is now justified.

Then we tell them to look – there’s a couple of trials that came out that
say that perhaps this is not the safest way to go about treating atrial
fibrillation, and if they don’t believe us, we deliver – if they click on this
hypertext, we have the full article in the New England about those two trials,
but, basically, it’s – you know – but, basically, we don’t tell them that this
is current practice, now, that they should get off Amiodarone, put the patient
on another medication that is safer, but we do give them the information, when
it counts, when they are thinking about this.

Now, the problem with Amiodarone is that it is a very toxic drug. You have
to do five tests regularly and check their results, know how to interpret these
results, whether they need to stop Amiodarone, crank the dose up or down or
whatever. It is very complicated to prescribe Amiodarone. It is very time
consuming. Think about even with an electronic patient record, that you need to
order pulmonary function tests, liver function tests, thyroid function, chest
Xray, an opthomology exam, each of them with their different monitoring
requirement over time.

So what do we do? Let’s pick one that would be the thyroid function, that we
tell them about what the requirements – the monitoring requirements would be,
and then we would build a drill that would get the TSH out, tell them what it
is.

Underneath here, if they don’t know what to do with hyperthyroidism or
hypothyroidism in the context of Amiodarone therapy, there are papers hidden in
there to tell them what to do, because they might not know. I certainly don’t
remember, and then here is a logic that allows them to pursue ordering this
medication. So it is very complicated to order Amiodarone.

When they are all done with these five tests and checked the old results and
reordered it for future’s sake, they get to this – they finally get to order
Amiodarone – we have this window that we were talking about before – and here
is an army of tests that is being ordered right now automatically for them.

Now, we know why they are there, and we know that they are ordering a chest
Xray for the purpose of Amiodarone therapy. So we can prefill the chest Xray,
because, think about it, when you are ordering a chest Xray, you gotta order –
you gotta figure out where – what kind of Xray that is that’s a two view and
lateral, gotta give a history, and we can fill the history because we know –
they can modify anything they want, and that way we could fill it to the max,
and so on.

So, now, while they were clicking – they finally get to order Amiodarone.
While they were clicking, we were generating a text down here, which really
documents what they have just done automatically, and that text, if they are
continuing Amiodarone therapy, originally prescribed for a fib. The patient now
is in sinus freedom(?). I have ordered all of this. Leave me alone. (Laughter).

But that is now structured text, which we, again, go and mined for with – we
don’t need to have sophisticated text analysis, we are just checking whether
the strings are there or not, and whether we have extra characters, because if
you have extra characters – characters that are not predicted – then that
provider was not satisfied with that. The matter is a safety issue with an
unsatisfied provider, so we want to know about these notes where extra
characters were added.

So does that work? Yes. He ordered a whole bunch more tests when this was
implemented. This is pre – the difference between the sixth month time for
people who did not use this software tool and people who have used these
software tool, as far as improvement – baseline of ordering all of these tests.
So our process is better.

Is this silly to do all this ordering or not? This is where we are at right
now. Well, some of it isn’t – TSH is abnormal in a third of these patients. So
those are brand-new patients with hypo- or hyperthyroidism, and hyperthyroidism
is contraindicated with Amiodarone.

So this is certainly not silly. Some of that might be silly without any
symptoms, and we are looking into whether this is useful or not, but we can at
least have a shot at performing a service to the patient.

So the evolution of the e-prescription – and that’s – the whole impetus of
this presentation is there. We now deployed the logic of evidence-based drug
utilization. We provide context-sensitive information. We mined for the data
from the EPR. We accessed supportive literature through the hypertext. We
automate actions – it takes, on average, 5.4 minutes to fill the Amiodarone
tool, which is an enormous amount of time. I say to my programmers, we’ve got
15 seconds with that doc, 30 seconds max. This is a very, very long tool, but I
put it out because, you know, the alternative of doing everything manually is
somewhere close to 15 to 20 minutes. So it’s a good tool from that standpoint,
and then it allows the feedback.

So what have we learned through the e-prescription process? The rules had to
be embraceable. This is a safety tool. Other tools are – address high-risk
medication. We have medication for – 14 medications. Again, this is one VA
center. Other VA centers are doing it differently, and there is a lot of
creativity that those kinds of tools have afforded us – have afforded to get
the docs on board.

The goal really – reducing wasteful use of medication is not something to
shy away from. The docs will embrace that. They know that if somebody is
overusing a – somebody else isn’t getting his wheelchair. So you gotta pick
your choices, and, again, the economics are aligned for waste to be meaningful
to these docs. They may be a very special case.

Whatever toy you have there that brings the science to the point of service,
and the process by which you do it must be both practical and credible. We have
heard about this earlier today, but that cannot be emphasized enough.

The credibility part of it, bringing the papers and the science – if you
don’t believe me, you can feedback to me and we’ll talk about it. That brings a
whole lot of credibility to the system.

The PNT activities were completely wrong for creating these tools,
maintaining them. They were not the kind of people that were required to be in
the PNT activity to take use of that. So we are not(?) building a surveillance
system even for drug utilization.

Now, what is our interest in the standards? I think we have mentioned we
have our own – we have developed our own drug nomenclature, which is immensely
useful. It allows me at my desktop to actually have all the pills that have
ever been prescribed at the VA. I can compare my center to a different center
to see whether we have access utilization. It is strictly utilization data. In
that sense, it is somewhat limited, but it gets you a start – some start for
generating a hypothesis.

The lexicons for adverse event and drug allergies. Now, the docs are
entering this – these drug allergies in free text right now. We can’t use this
for alert systems. So we are starting to develop a lexicon, and now the docs
are bypassing the lexicon, because they don’t know better. So there’s all kinds
of implementation issues about lexicons for adverse events and drug allergies,
but that is a basic for being able to implement algorithms that will check for
these events as the docs enter them.

I will talk to you a little bit about the formulary themselves and their
formulary restriction rules to sort of somewhat formulize(? this. I’m not even
sure what form that might take or whether it is even useful at this stage to
even think about this.

The interface to the clinical guideline rules. Now, the clinical guidelines
keep changing. If there was a way to have a standard that would interface with
our tools that are taken straight out of the clinical guidelines, that would be
nice – that is probably pie in the sky, at this stage of the game.

Now, but what I do want to emphasize is that whatever standards are put
together that the interface with the data elements from the electronic patient
record is absolutely critical to – for the good practice of medicine, and I
think we are getting an enormous amount of interest from our providers.

Yes, their autonomy gets hampered, but, you know, our autonomy gets hampered
every time we stop at a red light. The key here is if they have – is a goal
that is embraceable, and good medicine as a basis, then you’ll have your docs
on board. It has to be implemented extremely cautiously, but with embraceable
goals.

So I had some things to plug in from the pharmacy folks, so one question was
will authentication standard use technology as secure as that being developed
by the DEA, et cetera. Those are questions for the group that I was asked. Sort
of – bit of a disconnect now, but let me put it out.

Will e-prescription standard allow for different transmission standards? So
the distinction between the transmission and the transaction standards.

And then the NCPDP – I think the VA folks would love to have the
prescription standard harmonize with HL7, which I believe B again, I’m not a
standard guy, so I’m out of my depth here, but, you know, if you give us the
data elements, we’ll use them.

So here it is. This was our attempt at really using all the toys –
(laughter) – intelligently, and God knows that a lot of work remains to be done
there.

Any questions?

(Laughter).

SPEAKER: You might want to talk to Gates about licensing that.

DR. DE LISLE: Well, I mean –

SPEAKER: The interface.

DR. DE LISLE: The interface. Well, you know, I think people get all hung up
– especially the teckies(?), get all hung up with the software itself and the
features and all of this, and what is really important isn’t so much a software
feature, but really the rules, the scientific rules that – and the science on
which the rules are based, and this looks a lot more complicated than it really
is, if you’ve got the system geared up.

For example, one Thursday afternoon, we had a drug company that could no
longer supply Filodapine(?), and they said, well, we don’t have it anymore. We
can’t make it anymore, and that happens for a big system like VA, which now,
you know, gets drug – buys its drugs with DoD at times? We are buying an
enormous amount of drugs, so if there is anything wrong in the supply chain,
then all of a sudden, whoops, there is no more drugs for our veterans. That’s a
big deal.

So we turn around and say, well, gee, you know, we have 3,200 patients on
Filodapine. What are we going to do?

Well, you can have two choices. You could switch to Ladapine(?), which is
the equivalent drug, and the system would take $1 million a year in costs.
That’s the dumb thing to do.

The intelligent thing to do, and the hard thing to do is actually to go
review four sets of guidelines for hypertension, congestive heart failure, et
cetera, and extract from there the key elements for – that pertains to
long-acting chasm-channel(?) blocker. Deploy that on a tool like this and then
send out all the providers, elicit their patient on that particular medication
and get an evidence-based medication switch, which we had to do, and we could
do this in 48 hours, essentially.

So this is a lot easier than – once you get the system set up and you’re got
the tools in place, you can really respond to these things very well, and, you
know, how many patients ended up on Ladapine? Eighteen percent of those that
were originally on Filodapine.

So, again, there’s enormous potential for – if this is done right, at the
limit, the major – I think that the major improvements will be for the
application of medicine.

DR. COHN: Well, thank you.

Questions? Comments?

DR. STEINDEL: You said earlier that the VA system was a bit unusual because
it is more or less self contained. Now, after you have gone through all this
decision chain and you are actually prescribing the drug, it goes to your
internal pharmacy for dispensing – and if you have to go to an external –

DR. DE LISLE: It goes to a mail order pharmacy, about 80-85 percent of our
drugs go to mail order.

DR. STEINDEL: But what is the transmission standard that is used to the mail
order pharmacy?

MS. GRAHAM: It’s our internal email system –

DR. STEINDEL: Okay. That’s what – really, the question I was going to get at
about was what type of transmission standard do you use when you order
externally, and it doesn’t sound like you do much ordering externally.

MS. GRAHAM: No, but we are – yes, we have very few people that have
insurance coverage, but we are developing and putting in retail pharmacy
capability between our pharmacy and retail pharmacy. I think – hence some of
the questions about the interface and the harmonization of standards.

DR. DE LISLE: Um-hum. And even in a system where we are supposed to supply
all the drugs to the veterans, you know, they have a copay. So $7 for a bottle
of aspirin, forget that. These guys get it over the counter, and so, even in a
system like this, we have a devil of a time keeping a reasonable drug history
for – you know – certainly herbal medications or over-the-counter medications.

DR. FITZMAURICE: As you described the VA system throughout, I got a little
confused, and part of the confusion was you showed how it worked. You showed
that it took longer than you wanted it to work, four or five minutes, rather
than 15 seconds, but you showed that it was faster than 15 minutes, which it
would otherwise take. Do the docs like it or do they just turn off an awful lot
of the parts of it?

DR. DE LISLE: I mean, nobody likes to stop at a red light. So they need to
be convinced that there is a good reason for that, and so the – nobody likes
red lights. I would say – blanket statement, they don’t like it, but they can
live with it, and they do get a lot of pride when they are – you know – picking
up a hypothyroid patient that they would not have normally suspected.

DR. FITZMAURICE: Now the VA has maybe one of the best patient-safety
reporting systems in the United States so far. Is there any feedback or any
input from that system to your system, so that you can target particular areas
where you know we’ve got a lot of adverse drug events for these particular
drugs. Let’s put something in here, and this is the reason why, because we have
had all these things, so you can get a sense of communicating priorities to the
physicians. Is there this interchange between the patient safety – reporting
and the drug-ordering system?

DR. DE LISLE: Again, I am out of my area of expertise. Certainly, the NASA –
we have a reporting system that works out of NASA, and, in the interest of
keeping the providers’confidentiality, and the NASA reports back to the sites
from time to time. Most of the time there are things like, you know, you
shouldn’t put that kind of canyon(?) on somebody’s nose if they can’t tell you
that they’re – if they can’t cough, for example. So there’s all kinds of safety
issues that are reported, and, so far, the drug – do you know what the
drug-safety issues have been? I can’t recall them –

MS. GRAHAM: We actually have a mechanism – it is something that we can
correct with the electronic record. Then, we work with the National Center for
Patient Safety to say make a new order check or make a new provision, and I
just wanted – some alerts in different parts of the system can be turned off,
but some can’t. Some are mandatory. Some are set at the institution level and
not left up to individual providers, but, as was mentioned earlier, we have had
our issues, too, with overloading providers with alerts, with being very
careful, cognizant that alert overload kind of gets people to the point where
they are desensitized to the alert, but, on the patient safety, we try to bring
that feedback back, loop into the system into the practical way.

If we don’t change a system, it is sometimes is done by education to
different providers.

DR. DE LISLE: I think an overall project that emerged from the sort of
aggregate data through NASA has been the issues of anticoagulants in hospital,
and in particular heparin errors in just putting an extra zero and just
mechanical calculation errors that result in overdose or under-dose of heparin,
and so what our pharmacy has done is they bought a whole bunch of pumps in
which these calculation were already pre-inputted, and then we created quick
order sets that would just name the dose or the protocol that you wanted the
patient to be anticoagulated by, and from there – from that order, which is
pretty robust, going into the – directly going into the – what is that? Lara(?)
pump, some delivery system.

MS. CRONIN: I’m wondering if the VA uses NDFRT to inform their formulary
standards, in particular like, say, with the Cox 2(?) example that you gave
earlier, if, you know, you hadn’t restricted use for people who might be at
high risk for a GI bleed, would the formulary standards allow for an automatic
prompting of replacement with another – and would it do that through the
classifications that are in NDFRT?

MS. GRAHAM: It won’t do it at this time.

DR. DE LISLE: No. I’m not aware that we can use these algorithm as deep into
the – we had to generate – we had to read the literature and generate these
workaround tools to get to the Cox 2 utilization.

DR. COHN: Yes. Though I think, Kelly, there is probably no reason why it
couldn’t be –

DR. DE LISLE: Right.

DR. COHN: – because it clearly makes the distinction.

MS. GRAHAM: Yes, exactly.

DR. COHN: And so you could choose to run things off of that.

I was actually going to comment that I think one of the things he’s done a
very good job is reminding us of the complexities of not just formulary
management, but formulary and the provider interface, and having it be
something that turns out to be a value added as opposed just to complexity, and
I want to thank you.

DR. DE LISLE: I’ve got a whole talk strictly on management issues of
actually getting to operationalize formulary restrictions, going from the PBM
review of the literature and the science to the point of service without losing
your providers in between. We have learned a tremendous amount about how to
keep the providers in the loop and actually use them as an asset, rather than
getting all aggravated.

DR. COHN: Yes. I expect that that will be one issue that will be coming back
to –

DR. DE LISLE: It’s a big deal.

DR. COHN: – probably again and again, as we get into this area.

Well, thank you so much. (Applause).

Agenda Item: Open Microphone

DR. COHN: I think our next session is really an opportunity for open
microphone, if anybody wants to make a comment from before or – Actually come
to the microphone. Please introduce yourself, and I guess we would ask if you
could keep it brief, as opposed to longer, if possible. Thank you.

MR. RATHERMICK: Again, I’m Phil Rathermick with Express Scripts.

There has been a lot of conversation about formulary today. I wanted to make
sure that people understood the difference between formulary and benefit,
because it is an important distinction.

A health plan can have a single benefit and have hundreds – a single
formulary have hundreds of benefits. So as you are creating a standard, it is
important to allow for the provision of both, not to say that the systems
behind all this could necessarily get there today, but it is important to
understand that you have to allow for both.

For example, a health plan has numerous customers. A PBM has numerous
customers that are health plans. So it gets exponential. A health plan may pick
a formulary agent, say, a statin, that is preferred, but a better example might
be like non-sedating antihistamines. Now that there is one over the counter,
there may be a preferred agent on formulary, but individual payers, individual
clients of the health plan may decide not to cover non-sedating antihistamines
because there is an over-the-counter option available. So just to say an agent
is on formulary, may not be enough information, because the person could get to
the pharmacy and find out it is not covered.

Formulary, by itself – yes or no, formulary answers doesn’t tell you
anything about tiered benefits, so it is important for people to understand
that for a physician to make an informed choice with their patient, in addition
to knowing yes or no with respect to formulary, they need to know the benefit.
So even if it is relative value. Is this a $5 drug or a $50 drug? One brand may
be $25, because it is preferred. Another brand may be $50 because it is
non-preferred, and we talk about encouraging choice, which is important, but if
you don’t get enough information to the physician to choose the lowest cost
alternative, the patient may get a surprise at the pharmacy and end up not
filling it, in which case you have clinical implications, because they are not
getting the drugs they need. So I just wanted to make sure everybody understood
that.

MR. CRONIN: Can I ask for a point of clarification?

MR. RATHERMICK: Sure.

DR. COHN: Well, someone’s got questions for you. Kelly, you first, and then
Jeff.

MS. CRONIN: Sorry.

DR. COHN: No, go ahead. Go ahead.

MS. CRONIN: So you are then advocating or recommending that the committee
give serious consideration to developing formulary centers that would include
representation of cost-sharing schemes or out-of-pocket costs for the various
therapeutic options.

MR. RATHERMICK: I think it is important to allow flexibility in the standard
again, because there’s systems questions. In other words, today, we might be
able to give relative copays and we may not be able to get to member-level
benefit, to, say, a $5 versus a $50, but we may be able to say this is – you
know – one dollar sign and this is three dollar signs.

We are – you know – we and other PBMs are trying to enhance our systems to
be able to get to member level, but it is complicated.

My concern is if you create a standard that doesn’t contemplate that, it is
sort of like NCPDP, you’ve got to have a place for it, so that if the
information is available, you can send the information, and then the
application provider, the software vendor has to be able to know what to do
with that information, and so it is just important to understand that it could
come, and if it comes, you gotta have someplace to put it.

MS. CRONIN: And is complication primarily due to the type of eligibility?
For example, if someone is 150 percent of the federal poverty level, then they
might have a different cautionary scheme versus –

MR. RATHERMICK: Certainly, in the Medicare context, that will be true. You
know, whether they are TA or not TA, there may be a different benefit, so to
speak, figuring out whether this is covered or whether it is just 100 percent
copay, those kinds of things. That is a little bit different question, but –

MS. CRONIN: So the complexity is beyond that.

MR. RATHERMICK: The complexity I was referring to is a systems question. In
other words, can the system identify you uniquely and get to – all the way down
to your individual group. In other words, you are a Blue Cross/Blue Shield
member, but you work for GE or – bad example, but, you know, your employer is
going to have a particular benefit plan. They make specific coverage decisions
about what you can get, even if they subscribe to the Blue Cross/Blue Shield of
Massachusetts formulary. So Viagra is a good example. On a lot of formularies,
but individual companies make decisions as to whether that should be covered,
where there’s quantity limits. People have talked today a little bit about
prior authorization. That is a benefit question. That is not a formulary
question.

DR. COHN: Jeff, did you have a question?

MR. BLAIR: Yes.

DR. COHN: Please.

MR. BLAIR: NCVHS, in the past, has looked to be able to help patient care
and patient safety and efficacy by looking at either message format standards
or identifiers and standardizing those identifiers for the healthcare industry
to use or look to have national standards for clinically-specific terminologies
or other terminologies.

As we are going through this process on a-prescribing, I have heard a lot of
complexity described. I have sort of been trying to listen for where is it that
NCVHS needs to consider or recommend a national standard that will help the
industry? Somehow it seems to be eluding me.

MR. RATHERMICK: Is there more? (Laughter). I don’t want to interrupt you.

MR. BLAIR: Are you saying that there is a national standard relevant to the
communication of benefits or formularies that needs to be put in place that has
not been adopted?

MR. RATHERMICK: Well, a lot of this capability exists today. In other words,
a lot of the software vendors that are providing electronic prescribing today
allow for provision of formulary information, and they allow for some level of
benefit information. Most of them use sort of a red, yellow, green kind of
schematic, where green is, obviously, full throttle. Yellow is approved, maybe,
but, generally, yellow is like the preferred brand; and red is either off
formulary or the non-preferred third tier, something like that, and there’s
some different questions about how those are interpreted, because there is a
difference between third tier and not covered, obviously.

With respect to that kind of information, I guess what I am responding to is
a concern that, to the extent we create standards for provision of formulary
information, and people do formularies a lot of different ways, whether we
necessarily need a standard for provision of benefit information, I suppose, is
a debatable question, but my concern is that we not create a standard that
precludes the availability of that information, because that information is key
to the decision making on the other end.

DR. COHN: Yes, Steve, and then I have a comment, please.

DR. STEINDEL: Yes, I have a question. Thinking about this several times
during the presentations today, and I think your call for a formulary benefit
type standard is the vehicle that I can ask the question, but the Medicare drug
benefit payment point of view from the person is very complex, and we have
heard a lot about the patient coming into the pharmacy and getting sticker
shock, and that the patient is walking out of the pharmacy, perhaps not getting
the drug, and then we have periods where the copayment for the drug that the
patient is picking up from Medicare – under Medicare changes. Does our
standard, whatever standard that we have to recommend in this area, have to
take that into account and present that information at the time of the order,
the prescription itself, which may change in the middle of the prescription?

MR. RATHERMICK: I guess what I envision as a standard is more a transaction
standard. So to get to your issue, if the copay were to change midstream, it
speaks to a question of real time availability of information. So I guess, in
that instance, I would envision a transaction going back to the PDP or – you
know, the PBM behind the PDP perhaps, and there being enough information in
that system to determine whether today the copay – and I’m not particularly
familiar with the scenario you are describing, but if the copay goes down
because they have met a certain coinsurance or it goes up because their TA is
over something like that. There should be enough information in the system to
allow that, but what I envision is the standard is really a transaction
standard. In other words, like NCPDP, where you have set up a mechanism for
people to communicate information in a standard way, so that everybody is
speaking the same language, essentially, as opposed to – someone today
suggested that we create a standard for formulary, which I think is more
problematic than it looks like on its face, but to the extent the transaction
standards support the provision of formulary information to people, that is a
good thing. If we are trying to standardize the industry so everyone’s
formularies look the same, that is more complicated, and I think it is going to
be harder to get to.

DR. COHN: I just wanted to comment. I actually wanted to thank you for
clarifying – that someone obviously has to write prescriptions. I think it’s
very much in patients’benefits to know what they are getting into before they
leave the doctor’s offices, and, certainly, I think providers and physicians
generally would like to be able to order medications that they can feel
confident that the patient can afford, and, obviously, I think we have talked
about formulary as a piece of that. I really want to thank you for adding sort
of this benefit piece to the equation, and I think – we are going to actually
talk about – probably as we talk more to the standards groups and others –
about that capability.

Obviously, the Medicare benefit itself is a – Steven, you commented at the
extraordinarily complex benefit. People described it as something that did not
occur in nature with the donut hole and all of this stuff, but, certainly, it
will need to be very flexible to be able to support that, but, certainly,
everyone might benefit from this sort of additional functionality. So thank you
very much.

Other comments?

MS. BICKFORD: Carol Bickford(?), American Nurses Association.

I was pleased to see that Stan Huff commented that we had other prescribers
besides physicians – (laughter) – but I want to take that a little bit further.

DR. HUFF: I’m educable.

MS. BICKFORD: Thank you.

I would like to take it a bit further and clarifying what the definition of
e-prescribing is. Is that related only to pharmaceuticals? Is it related to
durable medical equipment? Is it related to orders for ancillary services; for
example, PTOT? Does e-prescribing support me as a registered nurse in my
order’s activities as I am establishing initiatives?

Prescribing is sort of an artificiality of our system in that we have to do
prescribing to make the resources happen at the place. If we had a plan, we
identified that the plan was, what we wanted done, and it automatically
happened, we wouldn’t have to have prescribing. So I am raising that as a
question to confirm that prescribing is going to be addressed as more than just
pharmaceuticals. Is that correct or are we only focusing on that?

DR. COHN: Carol, did you want an answer from us on that one?

MS. BICKFORD: Yes, please.

DR. COHN: Okay. The prime focus of the subcommittee work at this point has
to do with meeting the requirements of the Medicare Modernization Act, which
specifically relates to Part D, drug benefits. So it is not the larger issue of
all orderables, which I think is what you are getting into, but, certainly,
we’ll obviously be talking about that as we go forward, but, certainly, there
is a point at which – only a pharmaceutical versus ordering a lab test versus
ordering PT and OT, it all begins to – they all begin to merge a little bit,
but, certainly, our main requirement is really the Part D benefit.

MS. BICKFORD: Well, in light of that comment, is there the expectation that
you, as the advisory body to the Secretary, will be thinking about the
implications and the generalizability and the applications for the bigger
picture, even though an example of that is the NCPDP presentation that we just
had? Could all that structure that has been put in place be supportive of the
durable medical equipment that has to be used in conjunction with some of the
pharmaceuticals related to – for example, the syringes and insulin pumps that
are associated with insulin therapies for your diabetic patient? You can’t have
the two separate. They are part of a systems piece. It becomes somewhat of a
hybrid.

So I am asking if, as you are moving through this use case, that you are
actually thinking of the bigger picture and the important issues that need to
be attended to, so that this could, perhaps be an exemplar for future work that
this type of coding structure, this type of thinking may have application to
other commodities or resources.

I had a question in relation to the FDA, but, of course, he has left, so he
can’t answer it, and that was his discussion about it being human
pharmaceuticals. Is that the sole activity that they are working on or are they
going to be able to translate that into the animal products as well? Do you
know, anyone?

MS. CRONIN: I am still officially employed by FDA, so I could comment on
this.

As far as I know, there’s no immediate plans to bring that in, but I know
that the structured product label and daily med, in general, is of great
interest to some of the other centers at FDA and there is sort of active
consideration as to whether or not that could be expanded, but there is no
immediate plans.

MS. BICKFORD: Okay. And, again, that is an example of thinking about it from
the big picture and then utilizing that same technology to another application,
trying to attend to the issues to make it a more useful initiative.

And, in light of the FDA’s initiatives focusing on the human piece, I would
want to be sure that there’s consideration of hybrid products – that may be
mechanical as well as biological in their coding structure and their plans to
accommodate the naming and the components of it. As we are doing the evolution
with the human genome sorts of things there may be a combination of inanimate
mechanical plus the biologics attached to it that could be considered a drug.

So I am just trying to be thinking outside the box, being prepared for some
of the new technologies that we haven’t a clue what is coming down the
pipeline.

DR. COHN: Carol, thank you.

MR. HUTCHINSON: Hi, my name is Kevin Hutchinson. I’m the CEO of a company
called SureScripts.

First off, I want to take the time to thank the committee. I am assuming
that these high-paid positions of sitting on this committee will be worth it at
the end of this program. You have a large task ahead of you in this space, in
the sense that – a comment that I think Harry made earlier about the impact –
this is only focused on Medicare, and we realize this, but I just want to make
sure the committee understands and appreciates the sensitivity to what will be
decided around these standards will impact work that has been going on now in
the industry for years.

The good news is there is a lot of work out there. The bad news is, you have
the task of sifting through a lot of the work that is out there and coming up
with what are the standards that we need to address.

There is great work that has been done by the pharmacies. There’s great work
that has been done by the PBMs. There’s great work that has been done by the
payers, and a lot of organizations, manufacturers that have gotten involved in
this space, position groups and position associations taking positions on the
rollout of electronic health records and the standards that they have for the
exchange of information.

I would submit that there are two standards that you have to focus on. We
have to figure out if they are black and white or if they are grey, but there
is the technical standards of the exchange of information that we need to be
able to do electronic prescribing, and then there are workflow standards, and
which standards are we focused on with this particular process? Are we
determining what the workflow standards should be in a physician’s practice?
Are we determining what the workflow standards should be in a pharmacy? Are we
determining what the exchange – the technical exchange standards should be
between clinical applications to safely exchange and do electronic prescribing,
and that is a big task alone is just defining where do you stop in the
standards work, because you could do a lot of things in this space.

The further you take the standards work, I will tell you, you will have to
start holding these sessions in the MCI Center, because you will be getting a
lot more interested parties that will be coming to this table the further that
the standard work is begun.

The good news is that the comments that were made earlier, there is a lot of
progress in this area. The pharmacies are getting connected. The PBMs are
delivering formulary information electronically. Medication history work is
begun. There is a lot to learn from and look at – HL7 standards, NCPDP
standards – a lot of collaboration amongst competitors as well as complimentary
companies, manufacturers and pharmacies and payers and PBMs that is beginning
to happen in the industry. So the good news is the way this is on a move, and
we are very excited about that, but I just wanted to stop and applaud you for
the work that you are doing.

DR. COHN: Well, thank you. Hopefully, you’ll still be applauding us in six
or eight months. (Laughter).

Jeff –

MR. BLAIR: Yes. Well, thank you very much for your comments, and if you have
watched our committee, we have never stretched our scope of standardization to
workflow. So since you mentioned that, I sort of want to know if you know
something that we don’t know. (Laughter). Are there any workflow standards that
are being widely adopted that have been developed and supported by an
ANCI-accredited, standards-development organization where you feel we should
consider it, because it should be applied nationally? Is there something we
don’t know?

MR. HUTCHINSON: I don’t believe there is something you don’t know, and I
don’t believe that there are ANSI-accredited workflow standards that exist –

MR. BLAIR: Okay.

MR. HUTCHINSON: – to my knowledge in this industry, but there are things in
this Medicare legislation, things like no commercial messaging, and which we
support 100 percent, and, actually, one of the things that SureScripts requires
in all of our contracts – we are like the ATM network of prescriptions in the
sense that we route them to pharmacies or mail order, whatever may be the
choice of patient for pharmacy and whatever the choice of therapy should be,
and we enforce those rules of choice of pharmacy, choice of therapy, but in the
legislation, it talks about no commercial messaging, but it doesn’t define what
you mean if you talk about a standard, and this could impact a workflow
standard of what you mean by commercial messaging. If it is only clinically
based, if it is an evidence-based message, like a drug alert, that is okay, but
if there is another type of message that pops up when a physician is in the act
of writing a prescription, what determines whether that is a commercial message
or an evidence-based message? And that will impact workflow. It will also
impact adoption by physicians as well.

Thank you.

DR. COHN: Any other – anyone else wish to make any comments? No?

Okay. Well, now, it is time to put this altogether and figure out our next
steps.

MR. BLAIR: That’ll be easy. (Laughter).

DR. COHN: That’ll be easy.

Jeff, you have some comments?

MR. BLAIR: Well, let me just – yes, let me make a few comments.

First of all, I want to thank all of the folks that have testified to us
whether they were scheduled speakers or folks that have spoken to us in the
last 15-20 minutes. I think that a lot of this – this is our first day. This is
our introductory overview day, and for those of you who may not be aware of it
in the audience, we have a work plan to solicit input and testimony during the
summer, during the fall and during the winter and spring of next year before we
come up with our final recommendations in June of 2005. So this is to get us
started, and maybe the thoughts that I have at this point is maybe if – Simon,
if you feel comfortable with this – if maybe the subcommittee members and the
staff to the subcommittee could identify the things that they think are
important lessons learned that we have learned from these particular hearings
here, so we capture all these ideas. I’m not sure that we had a central
individual that was capturing all these things, so I think maybe this is our
opportunity to do that, and at the same time that we are capturing the lessons
learned from those things, if that could include either testifiers that we need
to hear from or areas of standardization that we need to consider that we
haven’t already identified.

DR. COHN: Sounds good to me, as well as topics that need to be handled in
upcoming hearings.

Would anyone like to start?

MR. BLAIR: Let’s see. By the way, I’m only capturing these things on my
Dictaphone, which is a less than ideal way to do that. Is there an individual
on the subcommittee or the staff that –

DR. COHN: I think Marjorie. Yes.

I’ll just start from my notes here, and I’m not sure that I wrote down so
much what I learned, but more what I – as I was reflecting on both our project
plan and other things, maybe what we hadn’t thought about and things that we
needed to include, and I was both – once again, having read on the plane
yesterday the project plan – thank goodness for long flights – and also
reflecting on what we heard today, I was sort of struck that I do think we need
to make time for some experts on patient safety to come and specifically talk
to us and share their thoughts about how patient safety can be assisted and
encouraged with ambulatory e-prescribing, just to make sure that we aren’t
missing something that is sort of obvious here as we go forward. So I thought
that was sort of a – I mean, we talked about it a little bit today, but not
really a full-throttle piece from quality experts.

The other piece – and, once again, this may be more of a terminology issue
more than anything – had to do with the people we were going to have testify,
and I see that we have PBMs, we have pharmacies, we have providers. In many
ways, I think PBMs are really – you know, it is always – our agents are the
payers, but I think we need to find some payers specifically that we need to be
talking to to make sure that we are meeting their needs, and, obviously, at the
end of the day, of course, CMS is the payer of last resort, but it is also
going to be working through intermediaries, prescription drug plans, Medicare
Advantage organizations, et cetera, and it might make sense for us to – once
again – when you figure out when we include that. That is probably a summer
activity, I would imagine, but that is a group that we need to make sure that
we are getting feedback from.

I remember Stan about complexity, I mean – oh, actually Stan brought a
comment early on about this issue of really what is in Part D versus Part B
versus Part A, in terms of prescriptions, and I think probably we need a little
bit of a briefing about where the line is there. I mean, Stan asked questions
about IVs at home and home health medications and all of that, and even though
I consider myself sort of knowledgeable about this area, I, for the life of me,
don’t know whether they are Part A, Part B or Part D services, and I think we
better make sure that we are clear about what is in the world of Part D and how
all of this sort of splits out.

I think it was also – I mean, Carol Bickford, when she was talking, you
know, because we know that, for example, syringes for insulin are included in
all of this stuff, but how much more in the world of DME and others are really
included? And Karen is asking no, but I do know, for example, some of that is
included in Part B. So, once again, those issues of where the lines are for the
Medicare benefits. Anyway, I’ll stop there.

Stan, do you have comments?

DR. HUFF: I don’t know what level to tell you on – to get to. I mean,
obviously, I focus on things I know. So – you know – I’m interested in what –

DR. COHN: Will you email that to us –

DR. HUFF: Sure. I’d be glad to email this, but, you know, what – my
perspective is that it would be nice to get to one set of drug codes that are
used in the standard, and it ties into the drug codes we hope the FDA is going
to provide, or, you know, a combination of RxNorm and/or new product ID’s and
those sort of things, which I think are things that we would go on.

I think some of the other things I would probably characterize is there may
be some situations where things that we need to do aren’t already a standard
part of the SCRIPT Standard and rather than talk about the individual things, I
think we need to think, again, about what is the process for how the standard
gets updated, so that we are not locked, you know, for a 10- or 20-year period
with something that needs enhancement and additions. We need to think about
enabling a process that allows enhancements to be made, and that is done in an
orderly way – orderly and timely way to the standard.

Surprised to learn about controlled substances not working in the SCRIPT
Standard. So I need to think about – I think we wanted to cover that. So we
need to think about how that works and how maybe digital signatures, then, have
to become a part of that standard or some new version of the standard.

This came out of a lunch. One of the other things that comes up as a
question is while there is some redundancy in how checks are done at the
provider versus the pharmacy versus the payers or PBMs, one of the things that
would seem to me – well, I won’t try and bias the discussion, but you could – I
mean, one way to do this is have the provider send all of the information they
have to the pharmacies, including problem lists and medications and other
things, so that they could do more work or we could make some – in a sense –
this kind of workflow related things. I mean, do we really want to do that or
do we want to make some statements about the fact that we think a particular
kind of checking – or maybe even say, the kind of checking we expect to be done
by the prescriber versus the kind of checking that would be done by the
pharmacy, so that, in fact, I don’t have to send my entire medical record to a
pharmacy for them to be able to do their job correctly.

So it’s – you know – what is workable and what is feasible in terms of who
does what kind of checking where.

I think that’s a summary, but I’ll be glad to send you my notes.

DR. COHN: Okay. Harry.

MR. REYNOLDS: Yes, I – first word is wow. We heard a lot today.

The way I tried to take some notes is to try to put together an overview
packet of what we have to think about, and I think that – for example, some of
the excerpts from each of the speakers.

Karen did an excellent job talking about what the regulation includes, the
basic prescription – so those are kind of – trying to draw box around this, so
when you listen and – standards, and I think some of the speakers at the end
said this can get real big, and we gotta – I know, I, at least, am going to try
to stay very focused on what actually we are supposed to be delivering.

The standards – she mentioned four standards that we needed. So these are
kind of – these are almost like guiding principles, and that is what I tried to
listen today. What are the guiding principles? What are the legislative things?
What are the things that kind of draw a box around this thing? Because this is
a huge industry doing a lot of things a lot of ways.

Her slide 8 that talked about what is our role, that is another key one to
just continually for me to keep in mind.

Moving to Jonathan, the whole idea of speed, making this – it is going to
have to be easily useable by the physicians, I think, is a key mantra, and the
pharmacies and anybody else, but I mean, that is a mantra that has to go on, if
we are truly going to try to be successful.

His slide 12, which was the one that talked about the communication, so that
we keep in mind how everybody is talking to each other, so we don’t miss – as
we are trying to set up a standard, we don’t miss how people are working
together.

His slide 21, which was the doctor concerns, which he gave a good list of
those.

He had some guiding principles that they had used on his slide 26.

He was willing to share some items on related medical history, because I
think the last gentleman that spoke, this idea of workflow, depending upon how
some of these items get defined, like what would be the medical history you
would want, it can dramatically change the workflow process. Right now, that’s
going on whether in a doctor’s office or pharmacy, PBMs, payer sending it to
PBMs, whether it is Medicare, whoever it is. That is the kind of thing that
silently changes an entire industry’s workflow process, depending upon what
data you have to have, where you have to have it and how timely it has to be.
So that is one that – when he said the word workflow, that is exactly what I –

Refill requests appears to be an abundant area or making a big difference.
Sounds like the initial script does one thing, but the refill appears to be
something where we can actually really help the environment on how to do that,
so focusing on getting that done, I think, would be excellent.

The whole idea of the formulary versus the benefit versus eligibility,
whether or not – when we say – up until the statements earlier, when somebody
said eligibility to me, I thought one thing, and when they said formulary, I
thought another thing. They just morphed it together, and so we are going to
have – you know, trying to sort that out as to what is an eligibility
transaction and what does formulary deliver back is something I know we are
going to have to keep in mind.

So, you know, just trying – in my own mind, I’m trying to put together an
overview, and what we have done in other times is, if we agreed as a committee
on some guiding principles or some things we want to remember – maybe even
having those charts on the wall, a few of them, so that we just continually can
focus back to something rather than everybody trying to keep this mass of paper
and the next 25 presentations together, may be something that would be helpful,
so that even if we are talking – somebody is presenting or something, we could
say, so how does that relate to what we thought we had to do here? Because that
is going to be the hard part.

We heard a lot of data. Trying to make it into something is going to be, I
think, what is preeminent in my mind, and so that would be my recommendation,
rather than making specific recommendations, that would be what I would think
maybe is a way to keep us together.

That’s all I have.

DR. COHN: Steve.

DR. STEINDEL: I think Harry did an excellent job of summarizing a lot of
what I was thinking, and I would like to see the notes as well.

Two things that came to mind. One was the thing that we have been talking
about and discussing is the medical history part – how we’re going to attack
that, and I think we got a good description that probably – if we look at the
problem list in recent procedures, that might be a good way to encapsulate
this, and so we need to have some discussions in that area.

The physician’s choice thing and the speed issues, I think, is something
that we need to consider very highly, but what really got me fascinated from a
standards point of view, aside from all the other standards we have enumerated
in various discussions in the work plan, was one thing that hadn’t come up, but
came up, I think, very strongly in the NCPDP discussion, and that is the issue
of identifiers. That seemed to be a very – a bigger issue than I had originally
thought it would be, and this is something that we have identified at CDC in
the area of messaging. It is very critical to have identifiers that allow you
to have some intelligence about what you are sending, where you are sending it
and what is at the location, and we probably should spend some time exploring
that. The main identifier was the one that was the provider identifier and I
thought was incomplete from our standards point of view.

DR. WARREN: I have been sitting here and thinking about what it is I know
and don’t know. I probably have a longer list of what I thought I knew, but
don’t, or some of the assumptions that I had made of a practice I’ve spent all
my career in, and, now, I am hearing things that I never knew about, and that –
so I need to spend some time really thinking about the prescription.

But I am also caught on this medical history thing that some of the
questions that came out earlier is we only want to send the relevant medical
history with the prescription, and so I am immediately caught with, well, who
decides what is relevant? You know, if it’s an automated thing that comes out
of an EHR, can we automate that, and how would that happen? So I am still kind
of stuck on what medical history is.

And, then, there was another comment made when we were listening to the
NCPDP about, well, we can just put some queries together and get the history of
the pharmaceuticals, and I would like to explore that a little bit more,
because, I mean, I can put together a whole set of queries in almost any
database. Now, how long it takes me to do that and what is involved in writing
those queries is a whole different issue, but I think we need to explore some
of that, because that does have to do with some standards that come in there.

And, then, in watching the VA demonstration, we were looking at a lot of
their interfaces, and I kept going back to the time issue, and that was a
question that I had asked Karen about when she was talking about we need
standards for knowledge representation, because I come from a fairly academic
perspective on what knowledge representation is, and she was also including
what the displays would look like, which is not something that I would see as
knowledge representation, and so, now, I am struggling with is the way we
display the information also part of what we are doing and looking at?

I know. I’m just trying to say, these are things I’m confused about.

DR. COHN: No, I agree –

DR. WARREN: And I don’t know if they are in scope or if they are out of
scope, and some of the things I would like to do that.

And then you talked about patient safety, and so do we also look at some of
the quality indicators that are coming out being mandated but have to do with
adverse drug events?

DR. COHN: For the ambulatory environment.

DR. WARREN: Right. And some of those are for the acute-care environment and
some are for ambulatory. So do we need to be sure that these standards can help
work with those or are we, again, developing standards in silos for each kind
of application that we are doing? So that is where I am coming from.

DR. FITZMAURICE: This is good. It is hard to summarize, so I don’t think I
can. I am just going to pull some nuggets that triggered some of my thinking,
to the extent that I was thinking.

For example, this morning, it was very well put together, and I think Steve
and Maria are to be congratulated.

We heard what MMA requires, then we heard the functions described desired by
clinicians and by pharmacies, and then we heard the functions permitted by the
NCPDP SCRIPT Standard, and there is more there in all three of those than I
would have thought coming in, particularly in the SCRIPT Standard. I didn’t
realize the amount of anticipation of the business need for information.

So my next thought was that I would like to see, at least in my mind, a
mapping, a schematic representation of scenarios and functions that could be
performed if standards were available, and so I am thinking of here is a
function. What information is needed, and then who supplies this information?

And, again, our lunchtime discussion with Stan and Jeff and Steve, we had
some discussion about, well, should it come from PBM? Should it come from the
Medicare program? Should it come from the health plans? Should the patient have
to carry it around? What is the cost and what is the benefit of that?

But the key to all of this is access to information to making these
decisions and to making the workflow move more smoothly.

We learned of the information needed from the testimony and the information
sources, and so we kind of have to think about what information needs a
standard representation, and does one exist? Do many exist? And we saw that, in
many cases, many exist. Does it need a reference terminology, a reference, so
that everybody can point to it?

Stan informed us that that is the most efficient way to compile information
and to retrieve it. At least, I think that is what Stan said.

We face this when we talk not only about drugs, but when we talk about
guidelines, when we talk about decision rules and when we talk about priorities
for alerts and reminders.

And, then, finally, electronic signatures remain very problematic,
especially if you think digital signatures, rather than pictures of signatures
or some other way to electronically represent a signature. It boils down to how
do you authenticate who the person is that is sending you the information, and,
then, secondly, how do you authenticate that the information is valid. If you
believe the first person, then you put the trust in the person. I don’t see the
industry solving the digital-signature problem with a standard yet, and so
maybe we’ll learn from that in the coming year that something does exist that
fits well within business use.

DR. COHN: Okay. Jeff.

MR. BLAIR: In a sense, I’m pulling together a lot of the things that a lot
of folks have said here. I’m sort of grouping them into areas that I think we
have to follow up on, and I’ve got eight items.

The first four of the eight were things that the law told us were areas we
should look for for standardization, and the first four are ones where I have
heard many people wind up saying that they think we’ve got gaps, and we’ve
gotta either get more information or question whether or not standards are
really needed in these areas, and, if so, what kind of standards.

One is medication history. Do we need standards for that either in terms of
messages or in terms of content?

Number two is medical history. What information from the patient record
should we consider required, and if we say it is required, what entity in that
environment is expected to provide them and share them?

Number three. This was an area I thought we were okay on, but, now, there
seems to be some questions about consistency and connection, and that is
eligibility standards. Okay?

What was my fourth one? I may have to come back to the fourth one. That was
one, two, three, four. Three out of the four.

Okay. The other areas that the law didn’t identify that we seemed to have
learned as issue was the identifier standards. NCPDP pointed out to us that
they have come up with HCIdea and that that will still be needed even after the
NPI is available, and I think we need to get a better understanding whether
that needs either better recognition or support or whether that meets – you
know, fully meets everything we need.

The other area was, as Stan said, do we need to look at little bit more
closely at whether RxNorm in the portions of NDFRT and FDA’s code is sufficient
now to support the needs of e-prescribing or do we need to – I think you said
embellish them or buff up – buff up? So that was another one.

The other new area to look at was Simon’s, which was to look at patient
safety.

And then Carl Bickford challenged us to take another look at our scope, the
definition of e-prescribing, and make sure that we don’t leave off certain
things like syringes and insulin pumps and things like that, and make sure
that, while we don’t necessarily extend it beyond what we need to, that we
don’t define it so narrowly that we make some things not practical.

There was a fourth area that was in the law.

DR. COHN: Decision support, Jeff?

MR. BLAIR: Pardon?

DR. COHN: Decision support?

MR. BLAIR: Well, you know, the law didn’t use the words decision support,
and I tended to infer that, from both the medication history and the medical
history, that it was drawing upon that for the interactions. So I kind of
figure that if we understand those better, we would understand the
decision-support requirements, but that, you know, we could interpret that
differently, but that was the way I was looking at it.

So I have left one of the four areas of the law, and I guess I’ll have to –
yes, yes, on the plane back, I’ll remember it, and I’ll leave Maria a voice
mail or –

DR. COHN: Yes. Jeff, might it have had something to do with formularies?

MR. BLAIR: Yes, thank you. That was it. Thank you. You got it, and that was
the law also indicated we should examine what standards might be appropriate
for formularies. We got a little bit of guidance here is that I don’t think we
want to standardize formularies, but do we need to examine whether formularies
are communicated in a standardized manner or not.

Thank you, Simon.

DR. COHN: You’re welcome. Now, you don’t have to stay awake all night
worrying about that one.

Comments, Steve?

DR. STEINDEL: Jonathan Teich mentioned this in his presentation, I just want
to raise it, and that is are there any special considerations that we have to
give to privacy and confidentiality with respect to e-prescribing above what we
consider with respect to the HIPAA requirements?

One of the things that concerns me was we have heard several times – the
lunchtime discussion the four of us had was a realization that there is going
to be a lot of this information available to a lot of people, and is there any
consideration that we need – any further consideration that we need to give in
this area? And one thing Jonathan specifically mentioned was the ability to
make sure that there are good protections to prevent the ability to sell any of
this information, the marketing aspect.

MS. CRONIN: Steve, I’d just like to add onto that. If there is clear
consensus across the subcommittee that that is something that should be
happening internally within HHS, in parallel with the hearings and everything
else that you are doing, then that would be helpful to know, when you are ready
to tell us.

DR. COHN: You know, that is actually something we could also refer over to
the Subcommittee on Privacy and Confidentiality. Well, I mean, just – I mean,
we can handle it ourselves, but it is something that we could ask –

DR. STEINDEL: (Off mike).

DR. COHN: Well, that’s a question.

You know, a lot of the issues around the privacy and confidentiality really
get back to this issue of medical history information, which I have got to say
that I have read about 12 times, and I can’t, for the life of me, tell whether
it has the same urgency or scope issue as the other pieces.

DR. STEINDEL: (Off mike).

DR. COHN: What?

DR. STEINDEL: (Off mike).

DR. COHN: Well, medications are already – I mean, those already go around a
lot, I guess – I mean, I think I would be a little more concerned about the
medical history aspects.

I’m sorry. Maria.

MS. FRIEDMAN: But you can infer medical history from the medications. You
know, if somebody is getting AZT, you have a fairly good idea of what is going
on with that –

MR. BLAIR: But at least my perception of what they may be asking us to do
when they say medical history is identify allergies, other disease conditions
and symptoms, lab tests, which one of those, and to what degree, do we need to
consider that is included in the e-prescribing process, and, if so, how do we
communicate it and to who.

DR. COHN: Gail, were you going to comment?

MS. GRAHAM: Well, I just – that whole discussion of all of those aspects and
how you have the timing of that in isolation from the electronic health record
adoption, seems to me, to be a little problematic.

DR. COHN: Well, I am actually reminded of the pyramid that we saw earlier
today, recognizing that you can do a lot of e-prescribing without an electronic
health record.

MS. GRAHAM: Right, but when you start broaching those things –

DR. COHN: Yes.

MS. GRAHAM: – the you get beyond that.

DR. COHN: Yes. You know, recognizing that – I mean – the intent of today, I
don’t think, is to answer all the questions. If we answer all the questions, we
wouldn’t have to hold anymore hearings. Now, don’t clap right now. Don’t clap
yet.

But certainly – you know, one has to recognize in all of this is we
recognize the issues and questions we have is that I think we have heard today
there is a lot of activity and a lot of what appears to be very successful
activity going out, out in the private sector with e-prescribing. I mean, above
and beyond what the VA is doing or other integrated healthcare organizations
which I may represent, but I think that some of these things are things that we
really need to be asking people that are doing demonstration projects, other
vendors and all of this stuff, about their thoughts about a variety of these
issues, you know, what, if any, medical information needs to go around, you
know, confidentiality issues, and I think – I mean, today, we have heard a
variety of other pieces in this thing.

So, I mean, it may be great wisdom, Jeff, that – as I am remembering, I
think our next set of hearings talks to some of those groups, and so maybe some
of these things are things that we can get further wisdom on there, because I
don’t think I have heard anything so far – you know, there is obviously this
issue of perfection –

MR. BLAIR: There you go.

DR. COHN: – which I –

MR. BLAIR: Don’t let the perfect be the enemy –

DR. COHN: Of the good –

MR. BLAIR: Yes.

DR. COHN: – and all that, and I think that – certainly, I think what we
would all like to see – I mean, on a good day, I sort of say, geez, maybe by
the time we get ready to say something, maybe the whole industry will be
implemented, and things could be worse than that. I’m not sure I’m quite
expecting that, but it would be a – certainly, a very nice outcome to these
conversations, and have them be on the right standard, so we wouldn’t even have
to worry about it. Maybe that is a little hopeful, but, certainly, the fact
that we are beginning meeting and talking with all of them in May, these are
some questions we can begin to ask.

Comments? Questions? Looked like, Kelly, you were going to make a comment?
No.

SPEAKER: Sort of in line with your comment about perfect being the enemy of
good, one thing, in my job what I do is I deal with all these software vendors
who produce these e-prescribing applications, and one thing I think it is
important to keep in mind is the standards that are created could encourage
adoption, which I think is part of the purpose, or it could kill the whole
thing, and so it is important to keep in mind that there is the workflow issue
that Kevin raised, which is – I don’t know that we want a standard for
workflow, but certainly workflow has to be considered. In other words, if you
create so many requirements that physicians are sitting there waiting forever
for a response from these systems, they won’t ever adopt.

And the other thing is the way the legislation was created, it allows for
standards, but it doesn’t provide money for implementation. So you have to keep
in mind that as the industry exists today, this is still a commercial
enterprise, and so it has to be a standard that is implementable within some
reasonable business model that people – somebody will pay for, and I just think
that that is kind of a good starting point to keep in mind.

DR. COHN: Thank you. Back to reality here a little bit –

Kelly, it looks like you want to make a comment now.

MS. CRONIN: Well, only to clarify for those of you who haven’t combed
through every page of the new law. There are e-prescribing grants that will be
available to providers in 2007, if, in fact, it is funded, if appropriations
allow for it, but, again, that is just the provider element, and that is not
really getting at potential burden to industry.

DR. COHN: It would be nice if we could do this in a way where the business
case is so obvious that there was obvious reasons to implement, which really –
there’s a lot more than grants, but we do appreciate the fact that grants might
be available if Congress appropriates the money for 2007. I don’t mean to put
it that way, but – I’m reminded that that isn’t always necessarily something
that happens.

Other comments or thoughts on this?

You know, certainly, as I said, I don’t think we have the answers at this
point. I think we do need to collect everybody’s notes so we can read them, of
course.

MS. FRIEDMAN: Or if you could email them to me, that would be great.

DR. COHN: Yes, maybe we should email them to Maria, and put them together,
because I think what we have is a number of questions to ask the next set of
testifiers.

I guess, from my own view, it would be nice if there was a way, at our next
hearing – and I’m not thinking of a major exploration into patient safety
lasting several days, but it would seem to me if we could have an expert come
and meet with us to talk some about the patient safety aspects of this earlier,
rather than later, just to make sure that it doesn’t change either our thinking
or priorities or anything else, it might be useful for an hour –

MR. BLAIR: You know, Simon, may I suggest, there’s two or three individuals
who have really focused on patient safety, who are also considered industry
experts on e-prescribing, because they have looked at the patient safety from
the viewpoint of e-prescribing, and that may mean we could kill two birds with
one stone.

DR. COHN: Well.

MS. GRAHAM: I’m sure Dr. Bayshon(?) could assist, if desired, as well.

DR. COHN: Okay.

MS. CRONIN: David Bates also comes to mind. Yes.

DR. COHN: I didn’t want to name names –

MS. CRONIN: He’s done extensive consulting with FDA, certainly, and in bar
coding and a lot of other issues.

DR. COHN: Okay. Well, it sounds like – once again, I don’t think they should
take over our May hearing, but at least a session to talk about this one, I
think would be useful.

Well, I mean, I’m trying to think of what other – do we have other issues
related to e-prescribing today? I mean, we can all cogitate over it, and if
there are other issues that come tomorrow, we can, of course, talk about it.

Now, I just wanted to briefly remind everyone that tomorrow morning starts
at 8:30. So – and, obviously, our focus tomorrow is on HIPAA. We begin with a
discussion with a HIPAA update, which I think, Karen, you’ll be here to – oh,
Maria? Oh, Maria is going to be presenting. Okay.

Then we follow up with meetings with – other testifiers on the status of the
HIPAA implementation, followed by our yearly report by the DSMOs. I think after
that, we’ll be spending time talking specifically about some specific DSMO
recommendations.

So, anyway, that is what is planned for tomorrow. I look forward to seeing
you all bright and early at 8:30, and the meeting is adjourned. Thank you.
(Applause).

(5:17 p.m.)