[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Meeting of Subcommittee on Standards and Security

July 30, 2004

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

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

TABLE OF CONTENTS

P R O C E E D I N G S  [8:45 a.m.]

Agenda Item: Call to Order

DR. COHN: I want to call this meeting to order.  This is the third day of three 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 body 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 also the National Director for Health Information Policy for Kaiser Permanente.

I want to welcome fellow subcommittee members, our staff, and want to thank, once again, our staff as well as Jeff Blair, for his work putting these couple of days of sessions together.  I think they have been very interesting and helpful, and, obviously, others here in person.

I also want to welcome those listening in on the internet, and, given that we are going to be having a conversation this morning about next steps and review of what we have learned so far, I want to make sure that everybody can speak clearly and into the microphone, so that those on the internet can hear us.

Obviously, this morning, we continue our work regarding e-prescribing standards.

Specifically, we ll be starting out by talking through some diagrams related to information flows that we have been observing, occurring relating to e-prescribing, and sort of validate in our own minds where there are standards, where there aren t, you know, sort of what takes care of what in sort of that information flow.

From there, we ll be spending some time going through an analysis working document to identify sort of both our views of what is needed as well as potential gaps and other issues that we need to ask the standards-development organizations, terminology developers and others to help us with, both to validate as well as if there is, indeed, a gap or a limitation to get a sense from the industry about when and how these gaps may be resolved.

Finally, I think we ll be spending some time reflecting on the August 17th through 19th hearings to make sure not so much that we have the right people, but that we have the right interests represented and make sure that we really come out of that session with a comprehensive view related to our ideas, recommendations, gaps, so that we can share that information with the full committee in September, hopefully, in the form of some initial recommendations or for a set of recommendations for the full NCVHS in early September.

With that, I obviously want to emphasize that this is an open session today.  Those in attendance are welcome to make brief remarks, if you have information pertinent to the subject being discussed.  We also have time for brief comments by those in attendance, as required.

Finally, for those on the internet, we do welcome email and letters on issues coming before the subcommittee.

DR. COHN:  With that, let s have introductions around the table and then around the room.  For those on the National Committee, as always, we would ask if there are any issues coming before us today for which you have a conflict of interest, would you please so publicly indicate during your introduction?

Maria, would you like to start out?

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

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

I have potential conflict if we discuss or vote on anything relative to HL7.

MS. WARREN: Judy Warren, University of Kansas, School of Nursing.  Member of the committee, and I don t think I have any conflicts with today s agenda.

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina.  No conflicts.

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

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

MS. AMATAYAKUL: Margret Amatayakul.  I m an independent consultant and assisting the committee.

DR. LEVIN: Randy Levin, Food and Drug Administration.  Staff to the subcommittee.

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

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

MR. BLAIR: Jeff Blair, Medical Records Institute, Vice Chair of the subcommittee.  Many potential conflict of interest if CCR comes up.

(Introductions around the room.)

DR. COHN: Okay.  Well, welcome everyone.

I think we will turn the floor – actually, Jeff, do you have any introductory comments for the morning?

MR. BLAIR: No, I think you really covered it.  I think we are ready to dive in.

DR. COHN: Okay.

MR. BLAIR: Thank you.

Agenda Item:  Overview of List of Requirements/Gaps to be Sent to SDOs and Terminology Developers and Subcommittee Discussion

DR. COHN: Well, Margret, I think we ll turn the floor over to you, given that you have the PowerPoint presentation.  You are at the front here, so please go forward.

MS. AMATAYAKUL: What I tried to do was identify the e-prescribing information flow to assist us, really, in kind of an overview of all the different transactions, and I have divided the flow into prescriber, dispenser and payer roles, for the most part, and on this busy side here, you start off with the e-prescribing prescriber obviously needing to identify the patient, perhaps from the practice management system in the office, which, hopefully, would be an HL7 message going back and forth, though not necessarily as we heard yesterday.

In deciding that they want to prescribe a medication, the prescriber would look at indications and contraindications in order to identify the clinical drug to be put on the prescription.

The indications and contraindications might come from an electronic health record, which, obviously, would again require an HL7 interface.

There would also be information that would come potentially from medication-claims history, such as RX Hub, for example.

Information that would come from formulary, which, unfortunately, there are so many lines, but, today, it would come all the way from the PBM here, so that this dotted line here could represent the information coming from the formulary.

The prescriber may also have access to drug-utilization review, and this might come from the drug-knowledge bases.  It might also come, eventually, from the National Library of Medicine, which is looking to ultimately produce the DailyMed, which is a compilation of information that includes RxNorm, NDC, et cetera, and on my next slide, I have a little bit more detail about this.

In any event, you would get to the point of a clinical drug that you want to prescribe.  You might check eligibility and benefits and you might do this from looking at the patient s drug card that they bring.  You might also be connecting electronically, again, with the PBM who might access the health plan s enrollment database.

And, at this point, we have identified that this is potentially an X12 270/271 standard, but we are not sure whether that works.  So that is a limitation we are not sure about here.

If the prescriber needs a prior authorization based on looking here at the formula information and so forth, they would also potentially use an X12 and 278, or, more likely, today, call on the phone to get that prior authorization.

Ultimately, the prescription would be written with a sig.  The patient instructions and that new script would go to the dispenser.  It is possible that a network, such as SureScripts, could be used to receive a route that – as a switch, basically, to route that new prescription to the dispenser.

The dispenser would also look at eligibility and drug utilization, and that is done as a sort of a composite transaction to claim eligibility in DUR through telecom with the PBM.

The dispenser may find, for one reason or another, that a change needs to be made in the prescription, and they can then send a change request to the prescriber.  The NCPDP standard-for-change request can go back to the prescriber and the prescriber can respond to the dispenser that way.

If it is – however – it is a new script or a refill perhaps or renewal, that information ultimately gives us, from the clinical-drug information, the active ingredient, the drug component and the clinical drug, which the dispenser may also get information from the drug knowledge bases.  That, ultimately, leads to a finished dosage form and drug product, and, ultimately, the packaged drug, which has the NDC code, and, also, there is the structured-label component.

Once the drug is filled, there is an NCPDP SCRIPT standard to send a notification back to the prescriber of the fill status.  The prescriber can also cancel the prescription by sending an NCPDP SCRIPT standard to the dispenser.

Now, over here in the corner, I have tried to illustrate what the FDA role is and the pharmaceutical manufacturers role in getting that NDC code.  The FDA today provides a label or code which is a part of the NDC.  The pharmaceutical manufacturers add the drug code and that becomes the NDC, which may or, in a few cases, may not be equivalent to the UPC code as well, and then there are devices in there.  That is a high level overview.

I have color coded the drug terminology information, so you can see where these components come from.  So the yellow, the clinical drug information, which we would probably see as RxNorm here, includes the active ingredient, the drug component and the clinical drug and then provides the dosage form.

The NDFRT provides information to service a classification and drug-reference terminology for drug class mechanism of action, et cetera.

These all form what may ultimately be a DailyMed and then the NDC code, and I have also supplied a double line around the components of this that are in the structured label.  So those that have the double line around the box is what is in the structured label.

DR. COHN: Okay.  Now Why don t we go – Is there a third page or – I guess not.  There s just two pages.

I guess the first question is – and this is both for the subcommittee and others.

MR. BLAIR(?): One –

DR. COHN: Sure.

MR. BLAIR(?): This took care of, I think – I m sorry.

DR. COHN: Well, I was just going to ask her to validate that this is, indeed, right.  That was really what I was going to go to next.

And so, Lynne, do you have a comment?  Come up and introduce yourself and critique the overall model.

MS. GILBERTSON:  No, no.  It s amazing.

Lynne Gilbertson from NCPDP.

I just happened to think one component we may need, which is going to hurt blowing up the picture, but, from yesterday, didn t we talk about practice management system talking to the EHR and somehow the continuity-of-care record fits into that picture somewhere?  I m thinking we need an arrow between the EHR and the PMS somehow, and there may be another arrow somewhere else.  I m not sure what that third arrow was.

DR. COHN: Well, I guess the question would be is do you think the EHR/POMS is really what we are talking about?  Yes, I mean, I think what you are reflecting is is that there is – I think we have all sort of seen that there is a lot of administrative data as well as clinical data that needs to have an input here, and I think that is what you are describing, Lynne, isn t it?

MS. GILBERTSON: Well, there were so many terms thrown out – CPOEs and EHRs and –

DR. COHN: Well, okay.  Well, let s – Okay.  Well, you need to get to a microphone if you are going to make comments, but what I hear you are saying is is that there were a lot of acronyms yesterday, and, effectively, they – I think they fall into variance of clinical and administrative data, either comprehensive or semi-comprehensive, or, I guess, summary would be the better way to describe it.

MR. BLAIR: Can I ask you a question, since I can t see?

I think the essence of this is where does the medical – not medication, but the medical history come from and how does it flow?  And, Margret, I thought that you did have that on the chart in some way.

MS. AMATAYAKUL: Yes, the electronic health record is represented as a source of medical information.  I think what Lynne is suggesting is that the EHR and the practice-management system may be interfaced – hopefully, is interfaced, and we could have a connection here, and that also the EHR may produce a CCR, which is probably off here, because that information is really for continuity of care in going to another provider or may receive information on medication history from other providers.

MR. BLAIR: Could I suggest one thing on this, and that is since the law specifically called out for us to consider medical history as opposed to all of the information that might be in NEHR, maybe we want to call that out, and when you do call that out, I think from what we heard yesterday morning, it may come from an EHR, but it may be independent of an EHR and exist before there is an EHR.

MS. AMATAYAKUL: Right.

DR. COHN: Okay.  So the more generic term, medical history or whatever.

DR. STEINDEL: And that is what it appears to show now.

DR. COHN: Okay.  Now, Judy had a comment and –

MS. WARREN: Well, it was a clarification comment of the CCR is just a template pulling together items that are in the EHR.  So if you have EHR there, it encompasses that –

DR. COHN: Yes, but I think –

MR. BLAIR: That is not quite correct, because it could come from an EHR, but it could come independent, if there is not an EHR, from the testimony we were receiving yesterday –

MS. WARREN(?): A paper-based system.

MR. BLAIR: Well, it could be paper based.  It could be on a thumb drive.  It could be in electronic form.  It could be in any of the medias form.  So it is independent of each of those.

DR. COHN: Yes, I think we are getting caught up on what our visions of EHR versus whatever.  I think probably the way we need to think about this is more around medical-history data or clinical data, but, certainly, EHR is one source.

Were you commenting about what Judy said?

DR. STEINDEL: Yes, I was going to comment about –

DR. COHN: Okay.  Go ahead, please.

DR. STEINDEL:  – what Judy was saying.

Yes, I was thinking about this as well, and the way Margret has it up there now is she is indicating HL7 as the messaging standard between that, and, really, it is items like the CCR, whether it goes as an HL7 message or in some other form, is just a packaging of the medical-history information.  I think that is the way we should indicate it.  It is very similar to like a terminology standard, only a little more complex.

MS. AMATAYAKUL: So you are suggesting that I could substitute medical history for EHR, however that might come from, or do you want me to elaborate more that it might – medical history might come from an EHR, CCR, et cetera, if I can squeeze all that in the corner there?

DR. STEINDEL: Margret, I would like not to commit right now to do that, but I think we do need to modify the way the EHR and the practice-management system and the medical history appear in this chart, especially in light of last week s presentation from David Brailler(?).

MS. AMATAYAKUL: Okay.

DR. COHN: Maria.

MS. FRIEDMAN: I am concerned that if we just leave it with the EHR, it is too futuristic, and I agree with Margret s previous comment that the history can come from a variety of sources, at this point, is probably going to be some kind of extract from the chart, some kind of paper-based thing, whether it is from a CCR template or whether somebody just types up a document or hand writes something, and, then, at some future point, hopefully, it ll go to the EHR, and then there is kind of permutations in between as the technology and the providers –

DR. STEINDEL: Yes.  Maria, what I was thinking about, but I didn t want to express, because I haven t fully formed it, is some sort of graphic where there is a box that contains bins and the practice-management system sits in there and the EHR sits in there, and what we are showing is the information flow out of the bin, but not really designating where in the bin it comes from.

MS. FRIEDMAN: I agree with you, and I think that is where Margret s comment before about having something up in the corner detailing that, I just don t think we had flushed it all out.

DR. STEINDEL: Right.

DR. COHN: Okay.  Karen and then Gail.

MS. TRUDEL: Okay.  I am going back to the law here.

DR. COHN: Okay.

MS. TRUDEL:  And to try to set some context.  What the law appears to be contemplating is the electronic prescribing, the e-prescribing program, by which they mean the prescription-drug program or Medicare Advantage Plan that has a drug program, that the program would provide information to the prescribing professional or pharmacist related to the medical history concerning the individual.  So the notion here seems to be giving the prescriber information that they may not have, not how the information that the prescriber already has gets into the script.

So what I think we are talking about here is when you have a Medicare Advantage Plan, which obviously is going to have some clinical information about patients, how that information gets to the prescriber, as opposed to how the information moves around within their office.

MS. AMATAYAKUL: Can I ask –

DR. COHN: You know, I guess I need to look back at the language of the law here.  I guess I had never read this as a role that CMS was playing, but, obviously, we – I mean, you can either talk now or talk in August about the role that you would envision CMS having to actually get that information back to the provider at the point of care.

MS. TRUDEL:  No, no.  I m talking about the Medicare Advantage Plan, whichever – I mean, we are talking about MMA now, under MMA, not –

DR. COHN: Oh, now, you are talking about Medicare Advantage or PDP?

MS. TRUDEL: We are talking about Medicare Advantage Plans.  What the law says is whatever the prescription-drug program is is supposed to provide clinical information back to the prescriber.

DR. COHN: Right.  And I guess I am just asking, Medicare Advantage has a very particular meaning here.  Are you referring to Medicare Advantage Plans in particular or are you talking about the general world of Medicare Advantage and PDP and anyone offering Part D benefits?  And I guess I am asking is it that group or is it CMS behind them?

MS. TRUDEL:  No, no.  No, that s not what it says.

DR. COHEN: Okay.

SPEAKER: Can I – and, I mean, to be quite clear, it says the program, which means either a PDP or an MA plan.

DR. COHN: Medicare Advantage.  Okay.

SPEAKER: But in point of fact, I am not at all sure that a PDP that isn t also a Medicare Advantage Plan is going to have any clinical information to provide, except over and above medication history.

SPEAKER: Are you suggesting, then, we need another set of slides for that?  I think this is really –

SPEAKER: No, I m saying we are getting into an area of detail that is probably irrelevant.

DR. STEINDEL: Karen, the way I somewhat interpret what she said is the Medicare Advantage Plan and the information provided under Part D falls in this bin, and when we are talking about MMA, it is going to come out of that part of the bin, but we have always had the discussion around here that we want to try to make sure this encompasses things that is outside of Part D as well, the recommendations.  So I think we need everything in the bin, but I think in the letter we need to point out what is required under the law and what may be otherwise.

MS. FRIEDMAN: I would like to go back to my previous comment, because I think what we have up there is really great, just in general.  It is the general world, and from what Karen was saying, I think maybe we need to look at, in particular, what is required under the act for MMA in Part D and see if we can kind of tease out maybe some of that information flow and those data elements.

MS. GRAHAM: I just had a question about the reference to that you would send the paper documents – I didn t see anywhere for a provision – wouldn t that require the claims attachment provision to be –

MS. FRIEDMAN: It s gotta come from that – if you don t have an electronic health record now, you have a paper document or documents, you know, your medical card and all kinds of stuff.  Mine is in a ratty folder about an inch-and-a-half thick.  So somebody s got to take that information from the paper form and get it into the system somehow.

DR. COHN: Anyway, I – I mean, that is – we are getting into a level of detail that we can probably work out.

Now, you have been sitting there very patiently.  So why don t we let you – please introduce yourself and comment and then, Randy, we ll let you go next.

MR. BIZZARO: Thank you.

Tom Bizzaro, First Data Bank.

The committee has actually raised some of the concerns that I wanted to speak of when I first moved up here.

I think that Margret did a really nice job, in general, showing what the world could be, and it is not what the world is, and I would caution the committee to – as they make their recommendations – to try to go to the minimum set of standards that you think those minimum things that need to be done, but I would also encourage the committee to make suggestions for where you would like to see this go to.

I think for what I have heard the last couple of days about situations in the physician s office, now, and what they are going to have to do to populate an electronic-prescribing application with medical history, a drug list and a problem list probably is going to tax those offices.

My recommendation would be that, at a minimum, they have to have a drug list.  They have to have an allergen list and they have to have a mental conditions or problem list, and by having those three things available, you can do a lot of clinical screening at the physician s office.

To start doing more complicated clinical screening within an e-prescribing system, I think, makes it very difficult – an undue burden, at least at this early stage.

I also think application developers are going to start adding some of these other things as we talked about yesterday, because that is what will make them marketable.

I also have to tell you that, right now, for us, our largest growth area, the marketplace for folks looking for drug information is from, I think, those developers of these physician e-prescribing applications.  We get many, many questions about our content and its use in these type of applications, but I also have to tell you an awful lot of them are looking at just providing the drug descriptive information and no clinical information for those e-prescribing systems.

So what I would like to be able to do, as soon as possible, is to go back to those vendors who are looking to develop these applications and tell them that I can tell you with some confidence that the NCVHS is going to recommend that you have, as a minimum, this type of information and this type of clinical screening available, and I think that would help us avoid some of the issues out there with the legacy systems that are being built now that are going to be too minimal to meet the recommendations of this committee.

DR. COHN: Would you do me a favor and just restate what you thought were the minimal clinical requirements?  I have medical list, problem list and then I wasn t writing fast enough.

MR. BIZZARO: And allergen list.

DR. COHN: And that was it.

MR. BIZZARO: Yes.

DR. COHN: Okay.

MR. BIZZARO: At the very basic.  Then you are doing things like drug interactions.  You can do drug dosing.  You can do drug-disease contraindications, some of those basic things that you can do without getting into much more complicated areas of clinical screening.

DR. COHN: Okay.  Thank you.

Other comments?

Steve, is this on this one or –

DR. STEINDEL: On this one, with regard to the problem list, is ICD sufficient for problem list, in your mind?

MR. BIZZARO: You know, in the applications that I have seen, we use IC9 codes.  Do I think it is the best thing to use?  Absolutely not.  It is too general.

The other thing I think, Steve, the problem with IC9 codes is that they are established to help with billing.  So – you know – and this not my area of expertise, but I assume that in those physicians offices the IC9 codes are applied in a method to make sure that the billing is appropriate, not necessarily that the disease –

DR. STEINDEL: Yes, and the reason why I asked that question, of course, is if we once – you were stressing immediacy, and I think we could get ICD codes in in an immediacy basis, and what we have heard is that they are not adequate.

MR. BIZZARO: I can tell you that the common denominator for expression of codified disease is IC9 right now.

The other thing is that I know that SNOMED has a recommendation from this committee.  The Compendia(?) are looking at using SNOMED as a medical conditions ID in the future, but, right now, we don t have it, and we don t have – we are starting to see a buildup in the marketplace for that need.  So it is going to drive us to do it, and when I say us, I am talking about the Compendia, not First Data Bank by itself.

DR. COHN: Okay.  I want to stay on this issue for just a second.  I think Maria has a comment.

Jeff, do you have a comment on this issue or another issue?

MR. BLAIR: Well, actually, my thought was that I am concerned with the amount of time that we have today, that if we start going into recommendations, I think we are not quite ready to get into what we recommend and what we don t.  I think we need to stay focused on seeing if we agree on what are the standards, what are the requirements in the law, what are the limitations and the gaps, and if we get those in place where we can send it to the SDOs and other developers to say, how do you close these gaps, then we can start to pull together our recommendations after we get all that information in place.  So I think we are just a little premature for hitting what are we going to recommend.

DR. COHN: Yes.

Maria.  Margret.  I m sorry.  No comment?  Okay.  Randy.

DR. LEVIN: Yes, it s – going back to the diagram that we have out here, it is a mixture of things that we are doing now and things that – in the future, and it goes a little bit back to what Jeff was just saying, that this may be a little bit too early or – because you haven t really heard all the details, and I haven t really heard – at least for the FDA section – what all the – where you really want to be, where the 2B is and how far out 2B is.  I mean, how many years are you talking about in the future?

DR. COHN: Well, Randy, let me, first of all, ask do we have an accurate diagram of the 2B?

DR. LEVIN: No.

DR. COHN: Oh, we don t?

DR. LEVIN: It depends on how far 2B is into the future, that you want to describe.

DR. COHN: Oh, okay.  Were people aware when you developed this this was not the 2B architecture?  Okay.  So what does this represent at this point?

MS. AMATAYAKUL: In my mind, it helped me identify where we were today and where we were going, at least in the short term, and I know Randy had commented to me about the NDC code and the label or code down here, and I knew that these are too common.  These may go.  So – but, today, I felt like this was the best representation we had for that.

DR. COHN: Okay.  So, in other words, if we had some slides that showed sort of future visions, of course, they would all be faded out because none of them are here at this point –

DR. LEVIN: Yes, that –

DR. COHN:  – or even in the near future.

DR. LEVIN:  – how far you want to go to anticipate these things.  What do you really want the system to look like and at what time period?  It would be helpful at least to know where – what pieces would fit in there.

DR. COHN: Well, I guess I was just sort of thinking that it may be useful for us to see gradations occurring between now and 2009 or whatever or 2007, just knowing that there is that sort of frame.

Now, I am well aware that you have had historical problems giving us very specific dates on what the future looks like.  So I am not sure exactly how we handle that, but, certainly, any input you could provide would be useful, and I think we can – once again, I think that is future additional slides that we might want to have in an appendix showing sort of the future visions.

Jeff, do you agree with that?

MR. BLAIR: Yes –

DR. COHN: That s good.  Okay.

Other comments?  Mike, did you have a comment?  No.  Stan?  Judy –

DR. HUFF: Another thing that I think this slide doesn t show is some of the preload activity that was discussed yesterday.  So, you know, if, in fact, you are in a state where you are just creating this prescribing application and there were preload transactions that were discussed yesterday that aren t reflected here, too, where the PBM is actually loading the patient identifiers and other information to the system and the prescribers and the pharmacy ID s and all of that preload stuff, and that is not reflected anywhere here.

MS. AMATAYAKUL: The intent of this formulary here was to provide that, but I couldn t decide whether I wanted to chunk this up and indicate that it could be both batch and real time, so I left it at a higher level to indicate that that was the source of that information, whenever it might come.

MR. RILEY: (Off mike).

DR. COHN: Come and introduce yourself, if –

MR. RILEY: Bill Riley – Express Scripts.

The question, really, I had was really related to this, and it is – I don t understand what the purpose of this piece is, whether this is to show where we need a standard or whether this is to show how the process actually works, because if it is intended as a process flow, I am not sure I agree that the steps are the right order, and I don t know if that is what you want to do today to clarify that or really what you are trying to get to here, because if this is something we could comment on later about how the process – that s fine.  I just wasn t sure where you wanted to go and whether we needed to speak up or hold our peace.

DR. COHN: Yes.  You know, I think that we would take written comment from you about this, if, indeed, we have substantive errors.  I think my vision of this one – and I ll look to Jeff and Margret to make sure that I think we are all aligned – this is not meant to be a process flow at the level, for example, that you presented yesterday, but more to point out where there either are standards or need to be standards in place to support sort of the information flows.

So, I mean, I would reflect on what you did, take it maybe up a level, knowing that you had lots of little spots and – you know – in databases and all of that, which I don t know that we need here, but, certainly, if there are information flows that we have wrong or pieces that we really have out of it that aren t here, we do need that information.

MR. RILEY: Well, just for example, I mean, we talked yesterday about sort of preloading formulary and eligibility if that benefits, but if you are talking about how a script actually works, you gotta pick the drug before you can figure out whether there are contraindications.  You gotta pick the drug before you can – you gotta have eligibility and benefits before you pick the drug, because you gotta know which drug is not formulary, and, then, you know, there s stuff like that, you know – to file a claim, you gotta have the NDC.  So there s timing issues there.

DR. COHN: Okay.

MR. RILEY: And I don t know if you need to get into that today or not.

DR. COHN: I don t know that we need to get into that today, but we would really look forward to some of your critiques on that.

Margret, I presume you are in agreement with that?

MS. AMATAYAKUL: Actually, Lynne and I had a similar discussion, and the assumption – and, again, I mean, this is such a high-level diagram it is hard to show everything, but the assumption was that the e-prescriber here had in mind the drug and then went through to ultimately get to the point of a clinical drug that would be in our X norm.  That was what I was trying to show, not that you would pick the drug and then do these things.  Of course, that would occur here.  So –

DR. STEINDEL: But it is the same standards.

MS. AMATAYAKUL: Yes.

DR. STEINDEL: It is just when they are invoked, and this is the question that I have to Stan in bringing up the preload situation, you know, and batch versus individual messages.  Would we look at a preload message coming as individual, you know, in the same format as we are recommending for the others or would we just be recommending a single transaction and the preload could be a series of transactions or it could be – if they want to go with SureScripts, for instance, and that is their decision, it might be a proprietary format from whatever vendor they chose from preload point of view.

DR. HUFF: What I understood from yesterday was that there is, in fact – there are two different standards, one for batch-transfer formulary and one for real-time access to formulary and that they also had standards that are different than HL7 or other for preloading, for instance, all the pharmacy ID s, so that the physician would know – you know, you could load all of the pharmacy ID s into – and I think that is a different standard.  I don t – you know, I don t think we would propose to use HL7 for that.

That is one of the other reasons why I wanted to request – you know, because they sort of hit it at a high level.  They said there are these RX-hub standards that we are using for these preload steps, and we kind of glossed over – but, I mean, they were transferring pharmacy ID s and other things that you need to get to the provider system in order for them to start writing prescriptions and be able to direct the prescription to the right pharmacy and do all that sort of stuff.  So –

DR. COHN: Okay.  So I think Margret heard that.  So, basically, you would like some differentiation – once again, this is to help us with the standards piece.

DR. HUFF: Um-hum.

DR. COHN:  This is not a – this is the point of this one.

DR. HUFF: Yes, I, you know –

DR. COHN: So if you feel that making –

DR. HUFF: Yes, I am not being critical.

DR. COHN: No.

DR. HUFF: And we just heard it yesterday.  So I don t know how we could expect Margret to have – you know – magically reflected any of that stuff.

DR. COHN: Yes, and what I am hearing is that probably when we talk about these standards we need to differentiate between the real time single location update and the batch update.

DR. HUFF: Yes, and I guess if – you know, it does come down to a question what we are trying to accomplish in this diagram, and, in one sense, putting the coding systems and other things in here, I think, in some ways is confusing.  You know, you might be able to simplify this by simply indicating the information flows that happened between different systems and what kind of information it is, because that is what really gets – well, that would at least – that would be the blueprint for determining what messaging standards were needed, and then you could have a different diagram that said what coding systems were used in those information flows, and that would get you to understanding identifiers and coding systems that were used in particular message flows.

DR. COHN: Okay.  I guess I should just ask, Stan, because I do sort of understand what you are saying.  I am just trying to think of where up there you feel that we ve got into coding systems, and I guess I am sort of – I am seeing a lot of data up there, but I m just not sure if I see coding systems.

DR. HUFF: Well, I see clinical drugs and I see the FDA and RxNorm and DailyMed and NDFRT and all that stuff down in that corner and the drug-knowledge bases and –

DR. COHN: Oh, okay.  So, basically, I guess –

DR. HUFF: And all of this – you know – active component, ingredient, drug component, all that stuff, which are – those are details inside of a particular message or a particular system.

DR. COHN: Okay.  So you are talking about requirements.  Okay.  I hear what you are saying.  Okay.

MS. BYRNE: Can I make one clarification –

DR. COHN: Sure.

MS. BYRNE:  – just based on a comment, a couple of them actually?

If the intent is to try to have this reflect where we do need standards or where we have them today – this is Terry Byrne with RX Hub, by the way, Jeff, in case you don t recognize my voice yet.

There is a standard that – or lack of a standard, and Stan alluded to it, where, today, SureScripts, RX Hub, Proximeds(?) of the world are all feeding different formats to the technology vendors in order to share pharmacies that are participating in e-prescribing and physicians that are participating.

So I don t see that standard anywhere on here or the lack of it, and so – and whether they go with SureScripts or RX Hub to route this, the prescription – it would be nice if the technology vendors only had to – or if they chose to go with both – it would be nice if they had one standard to distribute that information, and we did portray that on our slides yesterday.  That was where we were sharing the information between the pharmacies and the prescribers.  SureScripts does the same thing.  Proximed does the same thing, but we all use different formats.

DR. COHN: Yes, Margret, so you know – you can see where that line is?

MS. AMATAYAKUL: (Laughter).  Well, two comments.  That is reflected in the other document, and –

DR. COHN: Okay.  Good.

MS. AMATAYAKUL: Because, you know, you can t get everything on one –

DR. COHN: That was brought up yesterday.  Sure – okay.

MS. AMATAYAKUL: The other thing is that I was trying to avoid making too many back and forths all the way across here, so I colored this and this the same color, with the assumption that today we don t know how this is getting over here, and so, therefore, I didn t put any line, but it is the same color.  So –

DR. COHN: Okay.  So I guess we know it exists.  It ll be – I mean, I think this is an important piece that we obviously want the industry to validate for us.  So comments like this – it sounds like Margret has the next version and we may seek additional comments from all of you about that.

MS. BYRNE: I do have one other clarification.

Margret, you commented that the eligibility can be retrieved off of the drug card, the eligibility and benefits, and, actually, in today s world, that is not always true.  There is no standard for – well, there is a standard, but it is not imposed for putting the PP on the card.  So you may have just a health-plan card and you don t understand who the payer is.

You also could not get those links to that formulary information off of the drug cards.

MS. AMATAYAKUL: Right.

MS. BYRNE: You wouldn t understand what formulary and benefit to use.  So the benefit doesn t really come on the drug card.

MS. AMATAYAKUL: No, I have it only going to the eligibility, but, yes, I mean – and the other document identifies that, but we are looking at potentially creating a new drug card for Medicare.  So that might contribute some thinking to that needs to be on there.  So –

MS. BYRNE: Okay.  Thank you.

SPEAKER: Pardon me –

MS. AMATAYAKUL: It may not.

SPEAKER: Still have to check with the system to make sure the person is still eligible.

MS. AMATAYAKUL: That s right.  That is why I ve got this line going here, but, yes.

DR. COHN: Michael, I think you had a comment.  I mean, okay, Margret?

MS. AMATAYAKUL: Um-hum.

DR. COHN: Okay.

DR. FITZMAURICE: I am amazed at how much at least I have learned in the past two days.  The information provided by the industry is terrific.  When I look at the pharmacy benefit, the PBM outline, it is amazing, and you can see where the data flows, and, you know, I think we ve got plenty of information that we can make a first cut at the standards in September, and it is somewhat like shooting fish in a barrel, but I am worried that we are aiming at the wrong barrel –

DR. COHN: Oh, well – (laughter).

DR. FITZMAURICE:  – because we are –

DR. COHN: That is an important conversation, please.  (Laughter).

DR. FITZMAURICE: We are charged by MMA with the Part D Program and the Medicare Program, and we don t know what the data flows look like in the Medicare Program.

I think what we need in September or afterwards is an architecture like this one or like the PBM architecture that shows what CMS thinks the Medicare databases required for Part D are and the information flows envisioned by the Medicare Program.  Then we can provide advice on what standards exist and what standards need to exist for Medicare Part D s program to work.

DR. COHN: Michael, I think I would actually fundamentally disagree with some of your assertions, and I -I have to look at Karen to see if I am right on this, but my understanding is is that the way the Medicare Part D Program is going to be managed and administered is through contractual relationships with a variety of entities that exist now or are likely to exist in the future, including some of those, maybe, Medicare Advantage Plans.  Others may be other entities in the healthcare environment, like other health plans or these new prescription drug plans, which are, once again, a type of health plan that may fall into exactly the sort of architecture.  I don t think – I think there is going to be data that needs to go to CMS, but they are not managing –

DR. FITZMAURICE: The eligibility file?  The EMED file and the deductibles?  Actually, I think they are.

DR. COHN: The PDPs manage the – I think, actually, PDPs do all that.

DR. FITZMAURICE: Right.  But the information has to come from the Medicare Program.  Medicare has the fiscal responsibility for all those limits.

DR. COHN: Is that true?

DR. FITZMAURICE:  Karen, what do you think?

DR. COHN: Or is this a level of complexity we don t need to go, please?

MS. TRUDEL: I would say that whether, for instance, eligibility data was residing at a – in a central Medicare database or whether it was housed in individual plan databases is irrelevant to the fact that there needs to be an eligibility transaction and what is the standard?

DR. COHN: That would be my view, yes.

MS. TRUDEL: So I think the internal architecture is transparent.

DR. FITZMAURICE: Um-hum.  But the information flows and their compatibility with the existing standards is a very important issue for how that information gets translated from the Medicare Program to these available databases, then to the actual actors, and we don t see an architecture from CMS that shows how that happens or the structure of their databases compared with the PBM databases.

SPEAKER: I think I can add something.  I mean, when PBM, you know, basically carves out the pharmacy benefit from a health plan, typically, we get eligibility from the health plan, and I see CMS acting as a health plan.  I mean, they are going to be – so we ll have an eligibility file, and we ll talk to CMS, but what we described yesterday is really the way it will work, and the eligibility file, whether it is us or an independent payer that is administering it as a PDP, will work just like industry works today, except CMS is the payer instead of a Blue Cross plan or somebody else.

DR. FITZMAURICE: And there is no issue with how you get the data from CMS about what their file structure is and how you make it compatible with your –

SPEAKER: Well, I think I agree with Karen.  I mean, I think that happens behind the scenes, and that is what we do all the time.  I mean, that is what we do with our clients, because we figure out how to get data out of their system, so we know when a pharmacy sends a claim that this person is eligible, and so we update our eligibility file on a routine basis with the plan, because you have people coming and going all the time.

DR. FITZMAURICE: Right.  So that maybe Simon is correct.  Not maybe.  You re always correct.  (Laughter).

DR. COHN: It is like shooting fish in a barrel, I think –

DR. FITZMAURICE: Then we can focus on the private-sector data flows and we don t have to be concerned with the data flows –

SPEAKER: My expectation is the system will work exactly the way the system works today, because, in fact, they are going to contract out to these private actors to administer the program, and it ll work just like any other client works today.

DR. COHN: Yes.

DR. FITZMAURICE: Sounds like you are confident of that expectation, and then we ll share your confidence.

DR. COHN: Okay.  Now, Jeff has a comment.  Steve has a comment, and then we need to somehow deal with next steps.

MR. BLAIR: First of all, I want to echo Simon s comment about the fact that this is a high-level conceptual document right now that was a tool for us to try to better understand where the standards are, what their limitations, what their gaps are at a high level, and, clearly, we very much would like to get inputs and corrections to make it richer, whether we make it – you know, separate out the messages and have a separate one for the – whatever, you know, improve it.

But my suggestion is that a lot of the comments that we are hearing really maybe shouldn t be directed quite yet to this high-level conceptual tool, but this was a tool that would enable us to go to this next document that follows, where we are going to look at each of the individual standards, discuss the limitations and gaps, and, I think, a lot of the comments that we ve got are going to be more appropriately directed to the next document, which is going to get down to a little bit more detailed level.

And so my suggestion would be that, for this morning, we go on to the next document with the understanding that Margret will accept improvements and – you know, information to improve this document, but that we go on to the more detailed level, which is the other document that Margret has for us.

DR. COHN: Steve, do you have a comment?

DR. STEINDEL: Just a general comment on what – I would be very concerned that if the standards that we recommend aren t used by both the public sector and the private sector for e-prescribing, and it was pointed out what goes on between the systems – the payers and the PBMs or whoever is behind the scenes – is really not part of this, but I would be concerned if Part D Medicare was using one standard for moving information and the private sector was recommending we were using another standard, which is what I thought Mike might be alluding to, and that would concern me a lot.

DR. COHN: Well, I m struggling here only because I am trying to think of the nature of the standards we are focusing in on.  I didn t see a lot going into our discussion about standards for transactions between health plans and PBMs.

DR. STEINDEL: Yes, I think you summed it up very well, Simon.

DR. COHN: And I am not sure that that should really be a focus of our overall conversation, except as it – obviously, we are talking about eligibility.  We are talking about all of these other things.

DR. STEINDEL: Yes, you know, even with eligibility, as Margret will probably point out later looking to the HIPAA transactions –

DR. COHN: Yes.

DR. STEINDEL:  CMS is using already.

DR. COHN: Right.

Okay.  Margret, I think we, overall, are hearing, a) that we are – you know, we may be shooting fish in a barrel, but we likely have the right barrel.  (Laughter).  I think we are – now, we obviously need to improve the barrel, probably paint it, after all is said and done, and all of this stuff, but I wanted to make sure, first of all, we were, as Mike described, even at the right barrel, and I think what we are hearing is a lot of people offering to help us improve it, and I think this, actually, is a critical document, because I think it is going to be likely an appendix to whatever we come up with in September, so I can imagine nothing worse than having these finely wrought-out recommendations and then have a diagram there where everybody says, well, geez, you ve got the wrong description of the industry.  So I would actually ask all of our experts who have joined us today to help make sure that this is accurate, recognizing it needs to be at the right conceptual level.  So –

MS. FRIEDMAN: Please send your comments to me, and I ll get them out to the –

DR. COHN: Yes, comments and critiques are appreciated.

DR. STEINDEL: I was going to suggest, Simon, it might be helpful if they had an electronic copy of it that they could comment directly on.

DR. COHN: Yes, I guess what I would –

DR. STEINDEL: And they can distribute it through Maria.

DR. COHN:  I m trying to think of how best to do this.  Yes, I guess if you would – those of you who are interested in commenting – I would say this also over the internet – if you would send to Maria Friedman at MariaFriedman@cms. –

MS. FRIEDMAN: Mfriedman@cms.hhs.gov, and if you do it this afternoon, I would appreciate it.

DR. COHN: Maria, you need to say it in the microphone.

MS. FRIEDMAN: Okay.  It is Mfriedman@cms.hhs.gov, and if you would send me an email expressing your interest this afternoon, I would appreciate it, and then I can get from Margret, and, then, hopefully, get it back out to you.

DR. COHN: Okay.  Well, thank you all.

MS. FRIEDMAN: Monday latest.

DR. FITZMAURICE: Is this something that we could put on the NCVHS website as a – like a working –

DR. COHN: I don t think it is quite a working document.  I mean, it is a working document, but, normally, we don t stick on the website working documents.  So it would be somewhat unusual.

DR. FITZMAURICE: On the other hand, people who aren t here may want to make comments, too.

DR. COHN: Well, that is why we made the comment over the internet.

DR. FITZMAURICE: Okay.

DR. COHN: So shall we move on?

Okay.  And just in terms of time management, at about 9:40, I am going to suggest we get into the next conversation about 15-20 minutes, and then we ll give everybody a break for a couple of minutes also, if that is okay.

Well, actually, I mean, should we take a 10-minute break and – Okay.  Why don t we take a 10-minute break, and then we ll come back.

(9:41 a.m.)

* * * * * * * * * * * *

(10:05 a.m.)

DR. COHN: We are reconvening the meeting, and I think we now move into the e-prescribing standards analysis working document, aptly described, and Margret, do you want to help us through this document or –

MS. AMATAYAKUL: Right.

DR. COHN: Okay.

MS. AMATAYAKUL: Okay.  This is the document that identifies the types of standards, the existing standards – We did include extensive use.  I don t know whether that is really necessary or not – and the standards, gaps and limitations, and the way I have set this up, I am suggesting that this entire document be sent to each standards-development organization and terminology developer, whoever else might be responding, and that they indicate at the top there that they – what respondent standards-development organization they represent.

Then there are instructions here that read, for each type of standard, identify whether it is the domain of your SDO or not.  So, in this column here, where it says, SDO address, yes/no, they would say yes or no, they address it or not.

If the standard is within your domain, describe how you can address the gaps, limitations identified and any additional gaps, limitations of which you are aware.  So they would put that information in this column here that says, how will SDO address.

And then, identify the time frame in which you believe the SDO and vendor community can implement new, improved standards, and I have this column here for SDO, time line, which has, near team, long term, and just as a tentative definition, I have provided near team equal ready for inclusion in demonstration project required by MMA starting January 2006.  Long term equal will not be ready for inclusion in demonstration project.  Enter estimated number of months.  So that is the intent there is to have this go to each SDO.

When the responses come back, then I would envision that we would set up some additional columns going out that way, out to the right, where we could identify the responses for each SDO.

MR. BLAIR: Now, some of the responses – we think, for the most part, the responses are going to be coming back on testimony on the 17th and 18th of August.  However, maybe some of them we could have come back electronically, if they are just small or minor.

MS. AMATAYAKUL: Right.

DR. COHN: Steve, did you have a question?

DR. STEINDEL: Yes, I have a question.  When we say ready for inclusion in demonstration project on January 2006, does that necessarily mean it is a totally-approved standard or it could be at various levels of committee ballot that – okay.  I think that needs to be clarified.

MR. BLAIR: Well, actually, I think the way the wording is is that it is – there could be variations on that, and I don t know if we want to get down to that detail, because – although, maybe you could wind up getting it clarified, but the basic point is that it is a standard which can be included in the demonstration project, you know, to – the demonstration project, for the most part, is to verify that the standard, in fact, meets the needs and under all circumstances.

MS. AMATAYAKUL: Would it have to say standards sufficiently ready for inclusion?

DR. COHN: Steve.

DR. STEINDEL: Perhaps that helps a little bit.  You know, what I am concerned about – because, for the demonstration pilots, it is going to be different than the systems – than the full implementation.  The full implementation would need approved standards, but I am not certain that the pilots themselves need things that have gone through the whole approval process, and I think that – as long as somehow that differentiation is made clear to the SDOs.

MS. FRIEDMAN: This is Maria, and I think that is exactly right.  That is the point of the pilot is to test some of these things, and I think sufficiently ready kind of captures it.  You want something that might be close to being fully baked, but you don t want something that is still real squishy.

DR. COHN: Yes, and, actually, I can even see where we might – we might have something that is a little squishy, that is squishy one way tested in one pilot and another way in another pilot.

MS. FRIEDMAN: And there is room for flexibility there.

The only other thing is that in order for it to be piloted in 2006, I mean, we are going to have to get the show on the road next year, so it ll be ready to go, so people will really need to have a very firm idea of what they have in hand and exactly where it is in the process.

DR. COHN: Lynne, you had a – I m sorry.  Jeff, Lynne had a question, Lynne Gilbertson.

MS. GILBERTSON: Lynne Gilbertson from NCPDP.

How would you like us to differentiate that we have lower hanging fruit than even near term that is in production, has demonstrated it is being used by the industry and meets all the criteria, basically, so it doesn t even need to be really – quote – demonstrated?

MS. FRIEDMAN: Let me ask you a question, then.  Why haven t we heard about it yet or have we –

MS. GILBERTSON: Yes, it is all like the NCPDP SCRIPT transactions, the things that RX Hub brought up yesterday.  I mean, these are transactions that are well being used.

MR. BLAIR: Yes, we actually are planning to include in the information that we send a list of the standards that we feel are available for use at no change. So those are kind of things that you are using now, and it is sort of an acknowledgment of that, and then this piece is what could we do to address the limitations and gaps of the demonstration program of January 2006.  So –

MS. GILBERTSON: Okay.  I just didn t want to have to modify the spreadsheets, so that we all put comments in that says no demonstration, production –

MR. BLAIR: Available now.

MS. GILBERTSON: Yes, and I didn t want to have to skew your figures because we started going outside the boxes.

MS. AMATAYAKUL: I think that would be an appropriate column just to verify – when we don t have a standards gap or limitation, verify that it is, in fact, in production.  I think that is a good – good addition.

MR. REYNOLDS: But isn t it true, if it is in production?  But it is not in production for Medicare D.  So we assume it is a standard that will handle it, but the whole purpose of the pilot is to make sure of that, because it is not in production for Medicare D, right?

MS. FRIEDMAN:  I think the notion – and you may have heard last week that we are going to be coming out with an MPRM in the near future to look at standards that don t need to be tested, the ones that are the low-hanging fruit, the ones that we hear are – well, from advice and consent of NCVHS and others that this is what the industry is using, and then the purpose of the pilots is to test some of these others.

MS. GILBERTSON: Does the pilot have a two-fold importance?  One is to just prove standards work outside of the Medicare world, but could be used in the Medicare world, and then another set of demonstration projects that are Medicare Part-D-related projects?

MS. FRIEDMAN: Now, the pilots are strictly under MMA for the Part D plan.

MS. GILBERTSON: Okay.

MR. BLAIR: I would guess, if I could volunteer this, Lynne, I don t think that Health and Human Services can definitively give you a complete answer at this stage until after we have gone through the process and you wind up giving your feedback of saying, here s the things that are available for production now.  Here s the things we could get available by January 2006 with additional capabilities and functions and here s the things that are longer.

I think HHS will probably take a look at that and they may decide that, okay, some of the things are in production now, but we are going to still do a pilot of what is in production now, because they have some additional questions.  That is their option.  They may do that.  They may reserve some of that for additional pilots January 2006.

So, in short, as they look at all this information, they may determine what kind of demonstration projects they have and what they want to test.

Maria, did I –

MS. FRIEDMAN: Couldn t have said it better myself.  Thank you.

MS. AMATAYAKUL: Okay.  So that is the structure, and, then, what I have done is I have listed all of the types of standards on the leftmost column, starting with identifiers, then going to messages, then going to e-signature standards, then going to terminologies, which includes codes, classifications and vocabularies, then going to medical-history functionality, and then going to important related issues.

I would point out to you that the identifier standards, although there are some standards that have been used and are used in NCPDP SCRIPT, in some cases they are like the DEA, which isn t really a standards-development organization.  So I have identified those.

In the message standards, I have started with prescriber messages, then gone on to dispenser messages, then health plan and/or PBM messages that might be between the plan PBM and the dispenser or between the plan PBM and the prescriber, and then the drug knowledge-base distribution.  So that is the sequence within the message category.

So, then, I don t know whether you want to ask questions or you want me to read this entire sheet going down or –

MR. REYNOLDS: Jeff, this is Harry.  How do you want to handle going through this – what do you want to accomplish out of this list –

MR. BLAIR: Give me a little guidance here.  I think we sort of need to come at some balance here, and I might ask all of you your thinking.  Should we go down each standard one by one or do you want Margret to kind of do it in groups and then if somebody has questions about the group – What is the inclination, you know?  What degree of granularity?

DR. HUFF: I think we ought to step through it and sort of maybe just go category by category.  I mean, we can say, okay, we are looking at identifiers.  We can look at that, ask questions and then move on to the next section – So we probably don t need to go line by line, but we could go section by section and see if we have any – you know, just take a minute to look at it and see if we have questions.

MR. REYNOLDS: Jeff, this area, I would agree, because I think our purpose out of this today is to be able to turn this over to the SDOs –

MR. BLAIR: Right.

MS. AMATAYAKUL: Right.

MR. REYNOLDS: So that they can work with it.  So that is really what we are trying to do today, not design anything, just make sure that this is an appropriate list to make available to them.  Is that your agreement?

MR. BLAIR: Yes, and what is your thinking?  My thought is some of the questions that came up earlier from – you know – from Phil and from Terry, if they feel like we have characterized this incorrectly in terms of or Lynne – I would really like to have them jump in and make a correction at this point, if we have phrased these things inaccurately.

MS. AMATAYAKUL: Okay.  So going through the identifier standards for providers, we have prescribers – that s physicians and others – where the existing standards are the DEA, the MPI, the HC Idea and communication identifiers.  Some of these have location and some of them do not.

Then there are dispenser identifiers; that is, for example, the pharmacies.  That is the NCPDP provider ID.

The patients, where there is the Medicare number for Part D, NCPDP SCRIPT has a patient segment that includes patient name, gender and date of birth, and there are communication identifiers in NCPDP SCRIPT.

And then the health plans, there s a standards-gap limitation.  The HIPAA health-plan identifier and PRM is expected in November.  Anticipated problem with no hierarchy included in identifier.  Will health plan include – PBMs, et cetera?

Then, the PDP, the benefit program under that, the PBMs.

And then I think Harry actually added for us, last time, the routing networks or switches, and that concludes the identifiers, and you can see they have already identified the gaps or limitations in each of those categories.

DR. HUFF:  So could somebody just say something more about the communication identifiers?  I mean, are those tracked, in the sense that they are assigned by somebody or are they just in a database for routing purposes?

MS. AMATAYAKUL: What I have put here is the limitation and gap is are these – part of patient identification?  If they are not, we probably can take them off of this list.  If they are part of patient identification, we can leave it on.

DR. STEINDEL: Yes, I don t understand why the routing identifier is in this list?

MS. AMATAYAKUL: The routing identifier –

DR. STEINDEL: Yes.

MS. AMATAYAKUL:  – is the routing network switches on line 23.

DR. STEINDEL: Yes, that s just an EDI mailbox message –

MS. AMATAYAKUL: Right.  Right.

DR. STEINDEL:  – and I don t think that is part of standards.  That is something that the EDI networks control.

MS. AMATAYAKUL: Yes, we can take this off probably.

DR. STEINDEL: I think –

MS. AMATAYAKUL: Okay.

SPEAKER: I think – I would agree with it.

SPEAKER: Yes.  I don t think we need that.

DR. COHN: Everyone –

SPEAKER: Yes.

DR. COHN: All in favor?  Okay.  Okay.  It s off.

Yes, Karen.  I m sorry.  Is there an issue on that one?

MS. TRUDEL: On provider identifier.

DR. COHN: Oh, okay.

Steve, are you done with your comment?

DR. STEINDEL: I had a comment on patients.  So Karen can go on.

MS. TRUDEL: Okay.  I seem to recall from the discussions about provider identifiers that there was a need for four different ones, not just the ones that are noted here, that you needed to identify the actual person – living, breathing person writing the prescription.  You needed to identify the organization that that person is with.  If it is the larger one – for instance, a practice or a clinic – that you needed to be able to identify the location of the medical record, not necessarily the office, and that you needed to identify the authorized person in the case where a nurse or some other office personnel is generating a prescription.

DR. COHN: By authorized, you mean the person who has approved the prescription?

MS. TRUDEL: Who is not the physician, but is authorized to –

SPEAKER: Like a nurse –

SPEAKER: The proxy.

DR. COHN: Oh, the one who can call in –

MS. TRUDEL: Like a nurse calling one in.

DR. COHN: Oh, okay.

MR. BLAIR: Karen.

MS. TRUDEL: Yes.

MR. BLAIR: I feel totally comfortable with what you said.  However, because there s different people using the word provider differently, I think you were referring to prescriber identifiers.  Is that correct?

MS. TRUDEL: Yes.

And maybe the way to do that is to just make those – Margret – subpoints under – okay?

MS. AMATAYAKUL: I ve go the location, but not the location of the medical record or the authorized –

MS. TRUDEL: Right.  Got it.  Yes.

MS. AMATAYAKUL: Yes.

DR. STEINDEL:  Yes, and, Karen, adding to that list, there was also, in some instances, a person approving the prescription.  In some states, you may have somebody who can write the prescription, but it then needs to be approved by another body.

MS. TRUDEL: The cosigner.

DR. STEINDEL:  The cosigner, um-hum.

MS. AMATAYAKUL: So that is a fifth identifier for a prescriber.

DR. STEINDEL: Yes.

MS. AMATAYAKUL: Okay.

DR. COHN: Well, it is a fifth use of an identifier.  I mean, hopefully, these aren t five separate identifiers.

DR. STEINDEL: Identifiers.  They are all probably the same identifier, but they are different uses.

DR. COHN: Yes, it s more the requirements.

Maria.

MS. FRIEDMAN: I seem to recall that, in some cases, they use the state license number as well as a combination of DEA and some of that stuff, too.

DR. COHN: Oh, as one of the numbers?

MS. FRIEDMAN: Yes, as one of the standard identifiers.

DR. STEINDEL: Comment on patients, and do we want to make any comment that we are planning to look at the identification of patients in general, Simon, or just leave it mute?

DR. COHN: Well, I think in this document I don t know that –

DR. STEINDEL: I don t think it is necessary.

DR. COHN: In here.  I think in the final document, what you are saying is very appropriate.

DR. STEINDEL: Okay.

DR. COHN: Margret, did you catch what we are talking about?

MS. AMATAYAKUL: So you – this is the way it is okay now, but you want identifier for patient for Medicare versus general?

DR. STEINDEL: No.

DR. COHN: No.  No, I think we were –

DR. STEINDEL: I think we are okay.

DR. COHN: Yes.

MS. AMATAYAKUL: We are okay.

DR. STEINDEL: Yes.

MS. AMATAYAKUL: As is.

DR. STEINDEL: Now, the second – the second comment I wanted to make concerning patients is the information that we heard yesterday about – you know, in the case where the patient is a child and we may have to identify the parent, and I was also extending that in the cases of geriatric where you might want to indicate the guardian, but, you know, we may need to discuss something about the second patient.  I don t know how we are going to identify that.

MR. BLAIR: I have a question.  I m sorry.

DR. COHN: No, go ahead.  I was just going to – actually, let me make a comment, and then, Jeff, you are on.

It was just the – I think the comment that Steve had made earlier that bears maybe on some of this is the comment that we, of course, are going to be looking later on in the year about this issue of how to uniquely identify patients, and maybe that is part of the answer to some of this conundrum here.

MS. AMATAYAKUL: We could use personal representative that is used in HIPAA to reflect that.

SPEAKER: That s fine.

Simon, can I make a comment on the same issue?

DR. COHN: Okay.  Jeff, same issue or different?

MR. BLAIR: Well, yes, let me go on this one first?

SPEAKER: Oh, that s good.

MR. BLAIR: I personally feel absolutely fine identifying the requirements that are here for patient identifiers.  However, Congress indicated a directive which constrained NCVHS, and I would like to ask either Karen or Maria or both to just make sure that we are going forward in a manner that is not violating the directive that we do not – you know – have explorations on unique patient identifiers.  Are we still okay?  Are we still within the bounds of what we could do without violating Congress directive on this?

MS. TRUDEL: Absolutely.  I think, again, I will be the person who is always saying let s remember this is Part D we are talking about.  There is a larger issue, but we are talking about recommendations for Part D, and under Medicare, we already have a patient identifier.  It is there.  It works.

MR. BLAIR: Fine.

MS. TRUDEL: So I think what the recommendations – if I can kind of free associate – might say is that this is not an issue for Medicare, but, in a larger world, where we are talking about e-prescribing across the board, this is something that would have to be thought through.

DR. COHN: Yes –

MS. TRUDEL: And I don t think we are on any shaky ground as far as that goes.

DR. COHN: Yes, but I think, as we talk about guardians and all of that stuff, that is still a Medicare issue, and so, in some ways, we do have to at least reflect on that a little bit.

MS. TRUDEL: Is that information communicated between, for instance –

DR. COHN: I don t know.

MS. TRUDEL:  – physicians and pharmacies?

DR. COHN: That is a good question.

DR. STEINDEL:  It was raised somewhat as an issue yesterday with respect to pediatric patients, which would probably not be an issue for Part D, and I am just wondering if it extends into the area of the elderly, where people may have legal custody and rights.  I don t know.  I don t know if it needs to be communicated.

DR. COHN: In a prescription?

DR. STEINDEL: In a prescription.

DR. COHN: And, obviously, think about it, it probably doesn t – it may not need to be communicated as part of e-prescribing.  I guess – people want to have it, but whether or not that is a data element that is really critical –

DR. STEINDEL: Yes, and I think, you know, picking up the prescription and stuff like that by another party is already handled under HIPAA.

DR. COHN: Yes.

DR. STEINDEL: The privacy rules.  So I think that is covered.  Yes.

DR. COHN: Okay.

DR. STEINDEL: We may not need it.

DR. COHN: Carol.

MS. BICKFORD: Carol Bickford, American Nurses Association.

I would like to speak to this question in relation to elder abuse.  I have a colleague who is dealing with that in their family and that some sisters, which are called the Witch Sisters, have engaged in discriminatory care for the elderly father, and so there are battles in relation to pharmaceuticals and the ability to look at this information, and they are in the courts right now determining who has the ability to serve as the custodian or the care giver for this individual.  So it s – the guardianship and the questions may have issue in certain situations.

DR. COHN: Thank you.

SPEAKER: I wanted to speak to the patient ID question, to Karen s point.

I understand the issue with using the Medicare ID number and how you are trying to stay focused on Medicare.

 The problem is the way electronic prescribing works today, physician doesn t find a patient with a number.  So if you wanted to rely on the Medicare number for electronic prescribing, none of the systems in existence today can support that.  So the way the systems work today, they use name and address, zip code, gender, so forth, and they go out and they do an eligibility transaction and bring back the person, and they load the systems, the electronic prescribing applications pull that demographic information from practice-management systems, so that the person is available for the physician.  So Suzie Jones walks in, the physician just hits JON and all the Joneses pop up and they click on Suzie Jones and they are good to go.

If you are suggesting you gotta use a Medicare ID number to identify a patient, first of all, the physician is going to have to have that number in front of them, and all these applications are going to have to be rejiggered, and all of the infrastructure that supports electronic prescribing today is going to have to be rejiggered to find that person based on a number, rather than based on these five data elements that we talked about yesterday.

DR. COHN: Okay.  Well, maybe help me with this one, because I guess I had always presumed that somebody who was on a prescription drug plan now or into the future typically has a number related to you from either the health plan or the prescription drug plan.  Now, that may or may not be the HIC number, but they have that, plus they also have their name and the other stuff, but usually that number that is given to them by the health plan is usually the first key on this one.  Am I missing something?  Are you saying that you guys –

SPEAKER: You may have a member ID number with your health plan and you may have the same or a different number, probably a different number, with your PBM –

DR. COHN: Oh, okay.

SPEAKER:  – but the way electronic prescribing works today, they only use those numbers because the assumption is that the physician isn t going to ask you for your card when they go to write a prescription for you.  They just won t.  So they need to be able to find you in the system they are using very quickly, because of the workflow issues.

DR. COHN: Okay.  So I think this gets back to our data – our discussion about MPIs.

DR. STEINDEL: No, this is a clarification question.

When the prescription is sent and a claim is filed, they would have to send the ID number for the claim.  We don t care how it is identified in the system or how it is loaded into the system.  The Part D – the Medicare number on Part D doesn t exist right now, because Medicare doesn t pay for outpatient drugs.  We are just looking at a different drug plan, and –

SPEAKER: Right. Well, I think –

DR. STEINDEL:  – for that number.

SPEAKER: Right.  And maybe we are talking about ID-ing patients in two different contexts, because –

DR. STEINDEL: Uh-huh.

SPEAKER:  – you are right.

DR. STEINDEL: Right.

SPEAKER: Once you do the eligibility transaction, what comes back would presumably include the Medicare ID number, because that would come from our system.

DR. STEINDEL: Yes, we are talking about it in two different situations, and even when we move into Part D, there may be a group of people in this country who do not elect to take Part D.

SPEAKER: Right.

DR. STEINDEL: So we can have people who are eligible who are still operating under the same system that exists today.

SPEAKER: Right.

I guess I was concerned because we are talking about eligibility in the context of sort of the diagrams we have been going through, and that eligibility transaction today is based on five demographic elements, rather than based on a Medicare number.  So it is an important distinction when we talk about ID, which case we are talking about, but I just want to make sure you understand that ID-ing a patient for electronic-prescribing purposes shouldn t be based on the Medicare number, because it is going to be difficult to support that in practice.

DR. COHN: Okay.  Do you have a question specifically for him before we –

MS. FRIEDMAN: I just want to make sure I understand.  So we are talking about ID-ing the patient in two different ways for two different situations, for e-prescribing and for checking in at the office, you use your magic five data elements.  For billing purposes, some other number –

SPEAKER: That s right.

MS. FRIEDMAN:  – comes into –

SPEAKER: That is adjudicating the claim.  That is at the very end of the process.

MS. FRIEDMAN: Very end, and so it is maybe one or more numbers – right? – depending on –

DR. COHN: Yes, and I guess I should clarify that this is what is used by those PBMs that are part of RX Hub, is that correct?

SPEAKER: That s right, but there are other PBMs that are supporting electronic prescribing that also, presumably, are doing something –

DR. COHN: Is this part of the RX Hub standards that we heard about yesterday?

SPEAKER: The ID, yes.

DR. COHN: Okay –

MR. MARTIN: If I could just throw in a suggestion here, because we are talking about two different things.  We are talking about searching to identify a patient in a tool.

This is Ross Martin from Pfizer.  Sorry.  He asked me who I am.  I had to think about that for a minute.

We are talking about searching for a person within a tool, which is what I believe you are referring to, which, certainly, you are not going to want a doctor to say tell me your serial number, or whatever, and go find that.  They are going to look by name, and that is fine.  Find those demographics, but transactional identifier that has to be unique, and one of the things you do with those five different demographic things that you find, okay, I assert that this is the one.  This is the one number.  Oh, yes, that is my number there.  The domain of this is a Part D identifier – assuming it is going – if it is going to be any different from a different Medicare identifier versus if it is just going to be the regular Medicare HIC number, then, that is the domain.  Then, there is the number.  Those two things together are kind of like an email address.  It guarantees uniqueness, assuming that there is no other U.S. Medicare Program that calls itself whatever they are going to call it as an extension, if you will.  So that uniquely identifies that person as the identifier for that transaction, and that is what should be the unique identifier in the transaction.  The demographic-information center not along with that, only kind of is like a check digit, if you will, for that identifier.  Does that fill your needs and make sense?

SPEAKER: Let the record reflect that we agree.  (Laughter).

DR. COHN: Okay.  So – can you restate this – (laughter).  Okay.  Everybody has comments, but I am just sort of making sure that we even understand what everybody disagreed to.

So what we are saying, I think, is that there s two separate things.  One is the whatever one does to –

SPEAKER: There is ID on the front end.  There s ID on the back end.

DR. COHN: Right.

SPEAKER: And the Medicare number works on the back end.

SPEAKER: And that is what we are talking about.

SPEAKER: Right.  Right.

MR. MARTIN:  and then there is identifying the – there is searching and finding a patient.  That is the one process, and then there is identifying that patient in a transaction, and that requires a unique identifier.

SPEAKER: So I think Karen was right.  As far as identifying a Medicare patient, the Medicare number works.  It just may not work for electronic prescribing.  So we just have to make clear that we are talking about –

DR. COHN: Okay.  Well, we are talking about two different business cases –

SPEAKER: Yes.

DR. COHN:  – and two different things sort of.  Okay.

No?

SPEAKER: But to create standards for electronic prescribing, you gotta have – you gotta be able to do the front end, and –

DR. COHN: Yes.

MS. TRUDEL: We are talking about the content of a transaction that is going from a prescriber to a pharmacy, and my question is does that transaction need to contain patient identifier, not information to search for the patient, not those five magic data elements, but does it need to contain an identifier, and I can t put my finger on it, but I seem to recall, in all the testimony that we heard, that that was just sort of assumed, but if there is no need in an electronic prescription to pass the patient s health insurance number from the prescriber to the plan, then there is no need for this requirement at all, and then the pharmacy will pick up the number and put it on the claim to send it to the –

MR. BLAIR: Can I jump in for a second here?  Because what we are doing now is we need to make sure that we are asking the right questions to the SDOs and the terminology developers and the identifiers, so that they could get these questions back to us.  We are going to run out of time if we try to solve the problem or come up with a recommendation right now.

DR. COHN: Yes.  We just need to make sure we are framing the questions, Karen –

MR. BLAIR: Yes.

DR. COHN:  appropriately.

Now, Scott, do you want to introduce yourself?  And you have a comment, and then we will wrap this part up relatively rapidly and move on to the other issues.

MR. ROBERTSON: Scott Robertson with Health Level 7, and echoing what Ross put forward, that the identification of the patient at the time of e-prescribing is distinct from how you communicate it in the message, so that it is not necessary for somebody to know serial number – you know – the Part D identifier, whatever, but also bear in mind that this extends to all of these other code systems that you are talking about.  You are not going to have a doctor putting in an NDC number to select a drug.  They are going to go through some process probably searching by name or whatever.  What is behind the scenes is what the standards have to support, both in terms of the proper code sets being available and being able to send them in the message.  So try to focus on the fact that this doesn t have to be user-friendly information.  An identifier can be completely behind the scenes and it may turn out that, in the future, we go to a grand – scheme kind of thing that is universal throughout the whole entire world, but that is way off in the future –

DR. COHN: Okay.  Okay.  Thank you.

I think we are done with this conversation.  I think what I am hearing, just if I can paraphrase, is that when there is an ambiguity, when we talk about this particular term, and probably, on one hand, there is clearly this issue of a health plan, a patient s health-plan ID number, which exists sort of throughout the world in various frames or whatever, but then there is also that issue about identifying the member person uniquely, and then we get into this issue of is it one number?  Is it a group of identifiers that uniquely link to them or whatever?  But I think what we are describing is is that there is sort of – in this single term, there is sort of a variety of different uses that we just need to reflect on.

SPEAKER: Yes, my last comment.  My concern with this approach to going to SDOs is it is sort of a shotgun approach to say we are going to identify patients, would this work?  As opposed to going to them and saying, you know, on the front end, we are going to do it this way.  On the back end, we are going to do it this way and asking more specific questions as to how they can – the standards that they have can be used for a specific purpose, because –

DR. COHN: Okay.  And that is what I was – I think – trying – I mean, are you in agreement with my way of describing it, that if we sort of separate this a little bit into recognizing that there is a number, recognizing that there is probably also a need for this unique identifier in the world of e-prescribing?

And, of course, that other piece, we are going to be holding hearings on later on.  This is uniquely identifying.  Do they actually – you know, is there really a need for a unique patient identifier or is it these algorithms that people just need to use, which you have suggested, and there seems to be a lot of them around.

So – but that is, as I said, an issue that we have already – has already been determined that we are going to hold hearings on.  So we could even reflect that in our letter.

Margret, are you okay?

Harry, are you okay?

MR. REYNOLDS: Well, I want to make –

DR. COHN: Oh, please.  Okay.

MR. REYNOLDS: Going forward.

I think we are really mixing apples and oranges in this thing a lot, hugely, and I think that everybody that is going to use anything in the health environment has an identifier.  Medicare has decided it is a Medicare number.  Others may decide it is this.  Others may –

The NCPDP SCRIPT has the ability in here to put X amount of patient information.  We are talking about a standard.  We got a lot of defense going on about the way people want it to work, the way people want the structure to be laid out, and that is not what this particular discussion is about.  It is about identifying patients and identifying providers and prescribers and doing this and doing that.  So once those are there, whatever is laid in front of it, you go to a doctor s office, you probably got a number in their office, too, that is a totally different number than you may have walked in with Blue Cross or Medicare or something else.

So the point is, as we go through this, if we get into designing – and that is hard part of all these charts.  You get into standards and then designing, and so I think if we continue to step back – Medicare has a number now and will continue to have a number.  That is a fact.  Can it fit in these records?  That is what the question is, and that is what we really want the SDO to tell us, and I think that is on every one of these.

Now, after we see that and they come back, then, decide which ones blow up what is going on or do something different, then that is another question.  That is my feeling, because if you look at any of the HIPAA transactions, I mean, you can t even go back to where that started.

DR. COHN: Yes.

MR. REYNOLDS: Wow, that goes on in a regular whirl.

DR. COHN: Yes.  You know, I think you are agreeing with me, but I m not sure.  Is there another comment?

MR. REYNOLDS: No, I am, but I am also making sure that as we keep going through this we are not hammering again that there are other processes.  That is a fact.

DR. COHN: Okay.

MR. REYNOLDS: People – we just keep getting –

MR. BLAIR: We just need to make sure that we are asking the right questions to the SDOs and –

DR. COHN: Yes.

Lynne.

MS. GILBERTSON: This is Lynne Gilbertson from NCPDP.

A question for Karen.  The Medicare number that a recipient has today that they would file a – I guess a medical claim on is that the same number that they will use in the prescription program?

MS. TRUDEL: I have heard of no discussions.  I, personally, have not heard of any discussions of assigning an additional identifier.

MS. GILBERTSON: Okay.

MS. TRUDEL: My best guess would be that you would concatenate the number that the person has now and the number of whatever PDP they sign up for and that becomes like a Part D number.  That would be my best guess.

MS. GILBERTSON: Because where I am headed with this question, as an SDO, I would be looking at this and saying does my standard support the Medicare number for Part D, and my question back would be what is the Medicare number for Part D defined as?  If it is their Medicare number that everybody knows and loves today, I can look at my code set and say, yes, patient ID has a value of Medicare, so I support it.

If I am being asked do I set up a separate code value because the Medicare number they have is a different entity than the Medicare number for Part D, I would answer the question completely different.  So you see the difference with what I am saying?

MS. TRUDEL: I would use, as an operating assumption, that it is just the one number.

MS. GILBERTSON: A cardholder is a cardholder is a cardholder, basically.

MS. TRUDEL: Use that as an operating assumption.

MS. GILBERTSON: Yes, and that s –

MS. TRUDEL: Certainly not making a statement of policy here.

DR. COHN: Yes.

MS. GILBERTSON: Right.  Sure, and that is how I would answer the question.

DR. COHN: Steve, and then we need to move on.

DR. STEINDEL: Yes, I know, but, Karen, getting to Lynne s question, a number is a number is a number, but if the SDL has set it up where they have a fixed field, they can only take 10 characters and we decide that this is a concatenated number, it now becomes 14 characters.  That could present a problem.

MS. TRUDEL:  You don t have to physically concatenate numbers.  You can do it –

DR. STEINDEL: No, I m just – you know – so –

MS. TRUDEL: Mike s nodding.  So –

SPEAKER: Two variables.

DR. STEINDEL: Well, they have to be able to accommodate that.

DR. COHN: Yes –

DR. STEINDEL: So that – you know – that frames the answer.

SPEAKER: You re right.

DR. COHN: Yes, I think maybe part of the other question here and what is going to – I am trying desperately to move us off of this one because we could spend the next eight hours on it, but probably another question for SDOs is whether or not their standard has a flexibility to handle multiple different ID s, because, as I said, I don t know that I believe that there has been any decision made on what the numbers should be, and it may be that there is a need for both a HIC number as well as a – you know, prescription-drug plans may assign their own numbers.  So the question gets to be – I would be asking more that generic question – is does the standard handle multiple different ID s?  So, anyway, just a thought there.

Okay.  Can we move on?

I think we have handled patients – I think – until the next time we discuss it.  We have health plans here.  Any further discussion on health-plan issues?

Okay.  And I think we decided to take routing network switches off the table for the moment.

Shall we move into the world of messages?

MS. AMATAYAKUL: Okay.  What I have done for messages is broken it up into prescriber, dispenser, et cetera, and just to help me ensure that I ve got a complete list, I have identified whether the prescriber, the dispenser, et cetera, either sends the message, receives the message or sends and receives the message.

So, for example, I have under prescriber messages, I have new prescription that is sent.  The existing standard is NCPDP SCRIPT.  The extent of use is there, and the standards gap and limitation is the test are – use in the demo for the new prescription, and then you can see there under the rest of them are initiate a cancel request, respond to change request, respond to refill renewal request, return receipt acknowledgment, fill status, eligibility, benefits, formulary, and that is where I have the pre-log batch, the real time, the dosing guidelines, the decision rationale, prior authorization to the pharmacy, request for prior authorization to be sought by prescriber – that would be the received part of the request from script, and then also the prior authorization from the payer, because the dispenser may send a request to the prescriber for a request for preauthorization, but then the prescriber needs to get the preauthorization from the payer.

Medication history there.  Drug samples, compound pharmaceuticals.  ADEs and allergy reporting.  Orders sent, but not completed and lab results for dispensers and prescribers.

MR. REYNOLDS: On prior authorization to the pharmacy, who is that being sent by?

MS. AMATAYAKUL: The pharmacy has a standard.  NCPDP SCRIPT has a standard that asks that it may be sent to the prescriber.  It says we need you to get prior authorization.  The prescriber then goes to the PDM or plan to get the – Now, they are doing it by phone, but, potentially, it could be the X12 278 –

MR. REYNOLDS: Okay.  So this is from the doctor to the pharmacy.

MS. AMATAYAKUL: Right, and, then, once the doctor gets that pre-auth, then they send it back to the pharmacy.

DR. COHN: Okay.  But you comment it is not used.  Okay.  That s fine.

DR. HUFF: Could you say what this decision rationale is again?

MS. AMATAYAKUL: That is where the prescriber has decided to use an off-formulary drug, and we had spoken a number of times about does that need to be communicated, does that rationale for that need to be communicated to the dispenser.

DR. HUFF: But isn t that just a data element in the message, rather than an independent message?  That is what I would have assumed is that it is just a data element in the message, not an independent message.

MS. AMATAYAKUL: I would hope, but I don t know.  So –

DR. STEINDEL:  I think the question we are asking is does it exist.

DR. COHN: And where is it and remind me why it is needed.

MS. AMATAYAKUL: The decision rationale?  We had talked about, in some of the testimony, that it may be appropriate to send the decision rationale to the dispenser so that the dispenser is not calling the prescriber back to say, why did you order this, even though it is formulary.

So if this is a data element, we could take it off here, but we need to put it somewhere, maybe in terminologies, but I don t know whether this would be a separate – I mean –

DR. HUFF: No, I can t conceive of it being a separate message.  I mean, that would just complicate things, because the physician made a decision at the time that he made the decision you are going to collect the information about why they made that decision, and you are just going to communicate that with the prescription.  So that is a requirement.  It is a requirement for the message, but it is not a separate message.

MR. BLAIR: Yes, but why don t we just indicate in here that it doesn t necessarily have to be a separate message?

DR. STEINDEL:  That was going to be my suggestion, because, Stan, several of the other things, like dosing guidelines for age, dosing guidelines, height and weight, they may not be separate messages either.  You know, they are going to be part of – they are going to be just part of a bulk message, and so I think we should just –

DR. HUFF: For the same reason, I would take all of those out and just put them as – because this is supposed to be a list of messages, not a list of data elements that could be in messages.

DR. STEINDEL: Yes, I think that is a matter of reformatting this, but I think we do need the SDOs to react to the capabilities of providing this information, and I think we need to reformat to indicate that this is not a separate message, but really data elements in the message.

MS. AMATAYAKUL: Okay.  Let me ask you about the format then.  What I tried to do was indicate by indenting that those were data elements that need to be present in that message above.  So would you like for me to put the data content in a separate column or in the gaps question or how?

DR. COHN: Yes, you know, I think the confusion is more the ordering probably, because if you think about it, you go – you start with NCPDP SCRIPT and then you jump to eligibility and then you jump back.  So it is not clear to me – I mean, if you perceived this as part of a transaction or a message, it probably should be at least listed all of the relationship to that one message.  Does that make sense?

MS. AMATAYAKUL: Okay.

MR. REYNOLDS: Don t you think they are gap questions?  It s just a gap question.  Is this data element?  It s a gap question.  Is the data element in the transaction –

DR. COHN: Yes, but which transaction?

MR. BLAIR: Could I suggest one thing?

MR. REYNOLDS: The one that is listed where you –

DR. COHN: PDP above –

MR. REYNOLDS: Yes.

MR. BLAIR: Can I suggest one thing, and that is that our format have some flexibility?  Because, on some of these things, we are not sure whether these are going to turn out to be limitations or gaps until we get the responses to these.

The other thing is we are not sure, in some cases, whether it is going to be data element within messages or a new message until we get the responses.  So if there is some flexibility in how we structure this and we don t structure it too granularly.

DR. COHN: That s a good point.

DR. STEINDEL: Yes, it s a good point.  We have that somewhat covered.  SDO address, yes/no.  They could say for height and weight, yes, I address it.  How?  Data element.

MR. BLAIR: Exactly.  Ask – you have how and they ll indicate how they –

DR. STEINDEL: Um-hum.  I have a question, Simon.

DR. COHN: Sure.

DR. STEINDEL: This gets back to what Bill Braithwaite(?) brought up yesterday about fill status and that that might be a privacy issue.  Should we indicate anything about optionality in this or should we just leave it mute?

MR. BLAIR: That may be – I think we have that in the open – excuse me – in the important related issues, which we ll have –

DR. STEINDEL: We ll just discuss it there.

MR. BLAIR: Yes.

DR. STEINDEL: Okay.  That s fine.

MR. BLAIR: We ll get to it later.

DR. STEINDEL: Um-hum.  Today, I hope.

DR. COHN: Okay.  I think we sort of stopped you right in the middle of this list and –

MS. AMATAYAKUL: So we got through prescriber messages, and we are on to dispenser messages.  So we have the receipt of the new prescription.  We have a refill request/renewal authorization that is sent from the dispenser to the prescriber.  We have a change request to the prescriber.  We have the DUR, formulary, dosing, dosing, height and weight and dosing age.  Those are part of the change requests.  So, again, this is the same issues before.  These are more like data elements within there, potentially.

Prior authorization to be sought by prescriber.  That is a message that the dispenser sends to the prescriber.  The fill status notification which the dispenser sends to the prescriber.  The respond to the cancel request.

Now, we have eligibility benefits, prior auth from the pharmacy to the payer and medication history.

DR. COHN: Comment, please.

MR. ROBERTSON: Scott Robertson with Health Level 7.

A general comment throughout this section – both the prior set of messages, these messages and potentially some following messages – that there are also HL7 messages that will address these, and we are going through the process of mapping between HL7 and NCPDP SCRIPT and the – messages to support those situations where existing installations that are heavily HL7 will be able to map into these.

Now, I don t know if you would want to – I don t want to take the committee s time now to point out individual things.  I could either work directly or I could just respond in written testimony adding those places where the NCPDP, HL7 script mapping will also facilitate these messages.

MR. BLAIR: Well, actually, we are hoping that you ll be testifying to us on either the 17th or 18th in response to these things with exactly that information is where the mapping is able to address these things.

MR. ROBERTSON: And I am just – I ll be happy to include that in my testimony.  I just wanted to point out that there is – I don t think we need to take the time to go through every one that happens.  I just thought I would mention it at this time.  I will include it, so that it can be incorporated in the final document.

DR. COHN: Yes –

MS. AMATAYAKUL: That is actually why – at first, I was going to set this up so there would be NCPDP and HL7, et cetera, but then I decided that it might be better for everybody to respond to everything, and then we could identify where the mapping is occurring.

MR. ROBERTSON: Well, in concert with NCPDP, we ll make it very clear, in either our individual or a collective response, where the mapping will facilitate interchange with existing systems that are possibly using not the standard that is listed right here at the moment.

DR. COHN: Okay.  I think the only thing I would ask for that is is that if you have the information before our testimony, so that Margret can begin to incorporate it into all of this, that would be helpful.

MR. ROBERTSON: We can communicate beforehand –

DR. COHN: Sure.

MR. ROBERTSON:  – to make it – facilitate things as much as possible.

DR. COHN: Thank you.

Okay.  Tom.

MR. BIZZARO: Tom Bizzaro, First Data Bank.

And this is just to the format of the document, because I am looking at this as if I am not sitting in this meeting hearing the discussion and still want to answer the questions.

Where you ask in the first column, types of standards, I find that confusing, because, if you gave me this and I didn t know what you were asking – you said dosing guidelines, types of standards, do they exist?  I would tell you no or just say there are no existing standards, so that is a gap, but I don t think that is what you are asking.  What you are asking, does your standard have the ability to send or receive this information?  And I would just like to see clarifying that column a little bit, Margret.

MS. AMATAYAKUL: So, basically, just include height, weight, and we know it is for dosing guidelines.

MR. BIZZARO: It could be for a lot of different things.

MS. AMATAYAKUL: Yes, okay.

MR. BIZZARO: Absolutely.  Yes.

MS. AMATAYAKUL: Yes, I like that better.

DR. COHN: Good.  Other comments about prescriber messaging?

DR. STEINDEL: Just, again, clarification question on – because we were discussing this earlier.  We have SDO addressed, yes/no.  We have how will SDO address, which assumes that the answer is no, and we were talking about do we want to know how they are addressing it today, and may want to change that to how does/will.

DR. COHN: Very good.

MS. BYRNE: Can I ask a quick question along those lines?

DR. COHN: Sure.

MS. BYRNE: What if an SDO doesn t address this, but some other entity does, like say RX Hub?  How are you going to get those answers?

SPEAKER: We d hope they would say that.

MS. BYRNE: Are we going to have an opportunity to respond to this spreadsheet as well?

DR. COHN: You mean RX Hub or you?

MS. BYRNE: RX Hub.

SPEAKER: Yes.

DR. COHN: Yes.

SPEAKER: Yes.

MS. BYRNE: (Laughter).

MR. BLAIR:  Yes, and I think – you know, I think that is part of our challenge is exactly what you say, and I don t know that we could – we know enough right now, so we will wind up – you know, maybe RX Hub will have some answers that NCPDP doesn t and that HL7 doesn t, and we ll get the information back, you know, through testimony and your written stuff, and we ll have to do a little bit of correlation in pulling it together.

MS. BYRNE: Okay.  Because I would be happy to respond to this if you wanted us to.

DR. HUFF: Yes, I don t think there is any question she should respond.

SPEAKER: Right.

DR. COHN: Yes.

MS. BYRNE: Okay.

MR. BLAIR: As we are going through, if you see that we are failing to ask an important question, let us know, because we are trying to make sure that this is complete and accurate.

SPEAKER: I think you are asking the right questions –

DR. COHN: Well, good.  See, we are at the right barrel.  Good.  Okay.

MS. BYRNE: Would you want – I was expecting I was going to respond to this offline, but if some of the information I don t agree with right now that is on here, would you want me to speak up now?

DR. COHN: You mean in terms of the questions or in terms of the –

MS. BYRNE: In terms of the way it is laid out, you know, such as medication history, and, some of it, I just don t understand, so I am not sure if you want to take the time.  I could work offline to –

DR. COHN: Okay –

MR. BLAIR: Why don t we get down to the – we haven t gotten down to the medication history yet.

SPEAKER: We just did.

MR. BLAIR: Oh, I m sorry.  I m sorry.  I was out of sequence –

MS. AMATAYAKUL: You know, I might make a comment that there is some duplication throughout the spreadsheet, because, in some cases, like here, you ve got medication history that is expected to flow to the dispenser, but, then – and that is in a message.  Then we also have medication later that relates to the terminologies that we are using.  So we ve got some of them in different places.

DR. COHN: Okay.  I don t think that is redundant.  I think one s a message and one is the data elements, just like we talked about identifiers.  So –

Please.

MS. BYRNE: Okay.  So then I have to go back to prescriber, if you want some comments on that, because, today, the NCPDP telecom message is not used between prescribers and anybody.  The telecom message is used by pharmacies to payers.  So I wouldn t include that as one of the eligibility transactions available for prescribers.

DR. COHN: Well, it says, not used by prescribers, right?

MS. BYRNE: Right.  But it is under the prescriber messages.  That s my –

DR. COHN: Oh.  Okay.

MS. BYRNE: Yes.

MS. AMATAYAKUL: But I guess the reason I put it there and then qualified that it wasn t used by prescribers is because we don t really know that the 270/271 is used by prescribers either.  So both of these are technically available.

MS. BYRNE: Actually, 270/271 is mandated by HIPAA to be used by prescribers –

MS. AMATAYAKUL: Right.

MS. BYRNE:  – for eligibility.  So it is used today, and it is mandated by HIPAA to be used by prescribers and payers.

MS. AMATAYAKUL: But we have some questions about how it is used and does it contain enough information, and there is an option that NCPDP telecom – I mean, maybe – I would be happy to take it off.  It is just that I wanted to be as inclusive as possible.

MR. BLAIR: Right.  Otherwise, it just becomes a gap.  So if we don t indicate that there is a standard that is out there that supposedly addresses this but it isn t being used, then this winds up allowing us to learn more about that.

MS. BYRNE: Right.  I guess I m saying that it is not a gap because the X 12 standard exists today and is in use, and why would we want to look at utilizing telecom in an area where it is not used today?  I guess that is my point here.

MR. BLAIR: So you are saying you don t want it in the questionnaire?

MS. BYRNE: I don t believe telecom falls under prescriber messages.  It falls under pharmacy-to-payer messages.

DR. COHN: Yes.  So your question here would be is whether or not – rather than specifying the NCPDP telecom – is are there any other standards that might be appropriate for this purpose?

MS. BYRNE: I guess I would have assumed that going through the HIPAA – (laughter) –

DR. COHN: Yes.

MS. BYRNE:  – during all that process, they would have looked to see if there was another standard, and since this was the standard that was named, why wouldn t we just –

DR. COHN: Yes.  No, and I think we are hoping to have a response back from X 12 –

MR. BLAIR: You know, I think we started with the mind set that you just expressed, and then we just simply found that there s certain pieces of information related to e-prescribing that weren t in NCPDP SCRIPT, but some of them were in the telecommunications.  So we felt as if – if we had too narrow a scope that – folks, forgive me for the phrase – might be blindsided – (laughter) – that there is another standard that does exist and just happens to be in the telecommunication one.

MS. BYRNE: Can I ask what research showed that the eligibility transaction didn t support everything we needed for e-prescribing?

MS. AMATAYAKUL: Well, the eligibility 270/271 requires an NDC code, which –

MS. BYRNE: No, it doesn t.

MS. AMATAYAKUL: For eligibility?

MS. BYRNE: No.

MS. AMATAYAKUL: 270?

MS. BYRNE:  NDC code has to do with a drug prescribed.  The 270/271 has nothing to do with that.  It has to do with is the patient eligible and where are they eligible and what are the characteristics of that eligibility.

MS. AMATAYAKUL: Right.  But one of the codes that is required in the 270 is NDC code.

MS. BYRNE: No, it is not required.

MS. AMATAYAKUL: Is it situational?

MS. BYRNE: It is there, but it is not required.

MS. AMATAYAKUL: Okay.

MS. BYRNE: And it is not used.

MS. AMATAYAKUL: It s not used?

MS. BYRNE: It s not used.

MS. AMATAYAKUL: But that is important for us to recognize that it does not accommodate our X norm and NDC is not used, so, therefore, how do you describe the specific drug, if you wanted to?

MS. BYRNE: Let me rephrase.  Maybe we are getting into too much detail.  I can certainly educate everybody on this at a later date or offline, but –

DR. COHN: Okay.  And I guess – let me just try to – not to solve the problem at the moment, but we were actually hoping that there would be some response – I mean, what we are doing here is – I think the intent is to just verify with X 12 that, indeed, this is suitable and appropriate, and it sounds like you can provide us useful additional information about that, and it s just – verifying that.

MS. BYRNE: Right.  Okay.

MR. MARTIN: For the purposes of the form, this is a general statement, with this as a specific example, because I agree with Terry that this –

MS. BYRNE: Let the record know that is Ross – (laughter) –

MR. MARTIN: This is Ross.  Excuse me.

MS. BYRNE:  agreeing with me.

MR. MARTIN: Yes, two in one day.  This is amazing.

MS. BYRNE: (Laughter).

MR. MARTIN: Perhaps you could have a column that says this is the kind of default answer that we are considering.  We, as a standards group – or we, as NCVHS – are asserting that, for eligibility, we are assuming that 270/271 will be used, and we are assuming that NCPDP telecom will not.  If anybody has any comment – but if you want to leave that in.  I think it probably doesn t even belong there, but –

DR. COHN: Okay.

MR. MARTIN: But if you want to leave it in, tell us what you think, what you are planning to say about this and we ll tell you whether we agree with you or not.

MR. BLAIR: Well, I don t think we are that far along yet.  I think that there are responses that you have to this questionnaire, plus the testimony on the 17th and 18th will help us determine what we should say.

MR. MARTIN: Well, but I thought you were going to be sending us a document that kind of asserts what your first pass is and what you have kind of identified as potential gaps.

DR. COHN: Yes.

MR. MARTIN: Right.  And that is what this is.  This is it.

DR. COHN: Karen, did you have a comment –

MS. TRUDEL: Yes, I think that a lot of the angst that I am hearing about this form could be solved by simply making it clear that whoever is responding is welcome to add their own points in the extent of use and gaps and limitations columns.  This is just, again, the committee s first cut, and, you know, I mean, if the comment that people want to make about the telecom standard is that it is absolutely not in use in this area and the 270/271 is a HIPAA-mandated standard, then that is – you know, that gives us that background.  This is not meant to be – to contain all of the information that anybody could ever say about extent of use and gaps.

MS. BYRNE: Okay.  That makes sense.  Then I have another comment about benefits in formulary.  I guess my question or I think clarification that we are going to need from an SDO perspective is what do you mean by that?  Do you mean the transfer of benefit information from a payer to the pharmacy?  Do you mean the transfer of benefit links?  That would be helpful, or, you know, we can clarify it, maybe, when we get it, but I think it is not quite clear here, especially since you named X 12 as a benefit transaction.

MS. AMATAYAKUL: Okay.  Are you looking at the prescriber or the dispenser?

MS. BYRNE: Yes.

MS. AMATAYAKUL: Okay.

MS. BYRNE: Yes.  Probably both, actually.

So my question is – okay.  Let s take the first driver.  What do you mean by benefits?  Is it the transfer of benefit information to the prescriber from the payer?

MS. AMATAYAKUL: Right.

MS. BYRNE: Okay.  And so – okay.  So we can probably clarify what transactions are used for what from a benefits perspective, because, you know, the eligibility contains the links and the downloads or the gap – there is a gap where there isn t a transaction – to supply the information.  Okay.

MR. MARTIN: May I suggest – this is Ross again for the form, that when you talk about a message, you identify the sender and recipient in your – as you batch these together?  And I know that will create some redundancy, but it may be helpful to distinguish from – with prescriber-to-payer messages, prescriber-to-pharmacist messages, and you can still do the send-and-receive thing in there, because – and you are going to have to do it the other way around, then, too, because you ll need to say, okay, here is the payer-to-prescriber section and here is the prescriber-to-payer section, because they have to both be able to send and receive, and I know that sounds redundant, but you want to make sure that you are capturing every type of transaction, and they may be a little bit different.

DR. COHN: Yes.  Ross, I think we are all nodding our heads that that is a good idea.  I mean, the good news about computers is you can keep extending these spreadsheets – (laughter) – as far as you want, but thank you.

You know, I think they bring up – and I think we are sort of – we are getting sort of done with both of these areas, but, Margret, are you okay?

I was going to – I guess I was – you know, somehow in our first area, we were talking about prescriber messages.  We seem to have gotten sort of focused on that decision rationale, and I am not sure that everybody sort of looked down quickly in the area below, in the prescriber area, which was – I mean, I m not talking about prior authorization at this point, but I am talking about medication history, the drug-and-allergy reporting, lab results and all of that.  I just want to make sure that everybody is comfortable with sort of the way some of that was described, and I guess maybe I would just ask a question on this one under medication history, and, once again, I am a little confused myself about send and receive, especially when you have a box there that is – I can t tell whether all those three are posited as send-and-receive capabilities, only because I guess I am a little confused about the CCR, only in the sense that I didn t think it had any send-or-receive capabilities.  I thought it was a database format.

MS. AMATAYAKUL: It is really – yes, but the ASTM component is the content, but the HL7, I thought, was the component that was going to transmit the message.  That is why I ve got ASTM HL7 there.

DR. COHN: Oh, okay.  So there actually is an intent, so maybe that s not widely used, but the send-and-receive components do not exist, I think.

MS. AMATAYAKUL: Not yet, but –

DR. COHN: Not yet.

MS. AMATAYAKUL: You would hope that the medication history could be both send and receive and that the –

DR. COHN: Well, no, I agree with you.  Just under extended use, I think – where you say, new, not widely used, it is even beyond that, that the basic – the send and receive don t exist at this point.

MS. AMATAYAKUL: Don t exist yet.  You want

DR. COHN: Yes.

MS. AMATAYAKUL: Okay.

DR. COHN: And that was really all I was going to say is I don t disagree with anything you just said.  It is just that it is – we got the database and I think we all agree that that is – Derek says they don t have an implementation guide yet.  It was just that the – if we are talking about send and receive here – okay.

Anybody else have any other comments in these areas here as we are talking through?

MR. REYNOLDS: On page 8, we heard about – we have drug allergy, DA, DL.  We heard some testimony on drug food.  Is it worth listing just so the SDOs answer or is it something we don t –

MS. AMATAYAKUL: I think I have that down in terminology.  Let me check.

MR. REYNOLDS: Okay.

MS. AMATAYAKUL: No, let me add that to – let me add that.

DR. COHN: Okay.

SPEAKER: Ask a question?

DR. COHN: But it sounds like we – where is drug food?

MS. TRUDEL: It is on page 11.

DR. COHN: Okay.  Well, we need to get there first, I think is probably the answer here.

MS. TRUDEL: It was also on top of page 8.

MS. AMATAYAKUL: Yes, yes, yes.

DR. COHN: Okay.  Well, it sounds like, based on this, we probably ought to – I think we are done with the Spencer(?) messages, it sounds like, and we really need to move forward.

Is there a question, comment, please?

MS. ECKERT:  Karen Eckert from Medispan.

Just got a question on the top of page 8, where you have –

DR. COHN: Okay.  We haven t made it to page 8 yet, I don t think.

MS. ECKERT: Okay.  I thought it was still the same section that we were in of the health-plan messages.  Okay.

DR. COHN: Okay.  Just sit here, because that is the next area we are going to go into.

MS. ECKERT: Okay.

DR. COHN: So do you want to do the health plan and PBM messages at this point?

MS. AMATAYAKUL: Yes, okay.  So the health plan and/or PBM messages, this would be between the plan and the dispenser or the plan and the prescriber, and I ll make sure that both sides are in each of these.  The enrollment and premium payment, obviously, is the next 12 message – probably not part of e-prescribing.  I didn t even know whether it was needed to be included in here or not, but – Karen is shaking her head no.  I can take that out, don t you think?  Okay.

DR. COHN: Yes.

MS. AMATAYAKUL: I just wasn t completely sure.

Eligibility information, telecom and 270/271 benefits, the formulary information, prior authorization and medication.  That is where I could also add the drug food, if you wanted me to.

SPEAKER: I m sorry.  I didn t realize we weren t on that page.

DR. COHN: We re getting there now.  Don t worry.

MS. AMATAYAKUL: And duplicate therapy.

DR. COHN: And I guess I should ask here, I mean, we are talking about – we seem to go – suddenly from standards, message standards to terminology as we move into this medication area.  Is that a –

MS. AMATAYAKUL: I didn t intend to, but I wasn t sure if the drug lab checking was an HL7 message, but I guess it must be if it s got –

DR. HUFF: Well, yes, I am confused by this part, because this, all of a sudden, becomes behaviors instead of messages.

DR. COHN: Functions, capabilities.

DR. HUFF: Functions or capabilities, not messages, because I don t think – I don t think we are speculating that we would send these results individually.  These would be things that would happen, and then you would send a message that said – you know, it is internal workings of the drug-utilization review.  So I don t think you would actually communicate it in this form at all.

MS. AMATAYAKUL: So I could take this out.

DR. HUFF: Yes.

MS. AMATAYAKUL: Okay.

DR. COHN: Well, do you take it out or do we call this DUR?

MS. AMATAYAKUL: Say that again, Simon.

DR. COHN: I said, do we take it out or we call this DUR or am I missing –

MR. BLAIR: Well, if you call it DUR, so many things that could or could not be under DUR.  I m sorry –

DR. COHN: Well, I was just saying that the title here is really DUR in its functionalities.

MR. BLAIR: One of the things was how do we wind up indicating that there is a request for drug lab and/or a response to it, and so I just didn t know how that function –

DR. HUFF: I don t think you would do that is my response.  I don t think you would request individually, please do drug-lab check.  Please do DA check.  Please do DL.

MR. BLAIR: What do we do so that that is not lost?  How do we designate this to indicate that that requirement of MMA is being done somehow or somewhere?

MS. AMATAYAKUL: Wouldn t it be the prescriber who would need that from their own lab, their own EHR or whatever, but, then – so that – we could put that up by the prescriber, but wouldn t that information need to ever go to the planner PBM?  There may be a couple of instances where a particular drug needs to have – for prior authorization, needs to have lab results, a company, the information in the prior authorization.  I don t know.

DR. HUFF: Well, again, we are confusing, I think, what has to be in the message from a message.  So, yes, that information might need to be in a message, but I don t think it is a distinct message type.  I can t conjecture a workflow where I would make an individual message for this –

MS. AMATAYAKUL: No, and it s not.  That is why it is indented under prior auth.

DR. COHN: Oh, subtle, subtle.  Okay.

DR. HUFF: We may want to –

DR. COHN: But then why are we talking about –

MS. AMATAYAKUL: I am willing to do whatever you want.  It s just –

DR. COHN: I m just trying to think of it being under – I mean, I guess I am sort of thrown with it being under prior authorization.

MS. AMATAYAKUL: What are the data elements that you want to make sure are in drug authorization –

DR. COHN: Well, I don t know that we know at this point.  Do either of you have comments?

DR. HUFF: Well, I would feel better about this if we took this into like a whole nother section of the document that said requirements for the messages or information – you know, information content and message or something like that, so that people could respond about the capability of the message meeting this requirement.

MS. AMATAYAKUL: Okay.

MS. FRIEDMAN: That gets back to the conversations we have had about the different types.  There s messaging standards and then there is content standards.

DR. COHN: Okay.

MS. AMATAYAKUL: And when I constructed this, I put the message and the content together and then put the terminologies separately.  So the terminology reflects what terminology, not what content.

MR. BLAIR: Well, actually, Margret, I think we could accommodate what Stan is suggesting –

MS. AMATAYAKUL: Oh, yes.

MR. BLAIR: We already have – and we might even actually label it that way.  We were forced to put medical history in a separate section because it was content and then this also would be content.

MS. AMATAYAKUL: So for each message you want the messages separate.  Then for each message you want a separate section that has got the content of the message, and then you want the terminology.

SPEAKER: Third set of standards.

DR. STEINDEL: I personally don t like the idea of the message separated from the content.  I would like to see the content – what we feel should be the content of the message and for them to react to it under the message.

I think the problem is the present format, in that the indent is too subtle.

MS. AMATAYAKUL: Okay.

DR. STEINDEL: And people do not understand what the indent means, and if we put it in a separate column –

MS. AMATAYAKUL: Okay.  Gotcha.

DR. STEINDEL:  – then people will understand this is the message.  This is the content that we think should be in the message.  Comment on it.

DR. COHN: Yes, I guess on even a more fundamental level here, now that I understand this is under prior authorization, I am trying to – in my own mind, figure out where we heard that essential data elements for a prior authorization message included these sorts of functionalities, and I just don t – I mean, maybe we heard that and I just wasn t – I think I was here – (laughter) – but I just don t remember that in our conversation.  So I think that it is very important that we –

MS. AMATAYAKUL: I ll go back and check that.

DR. COHN:  – recognize a prior authorization, but I am just not sure – there are lots of places where we want medication checking, but that is just sort of an odd place for it to show up.

MS. AMATAYAKUL: Okay.

DR. COHN: Now, we have two comments coming from two people who have been patiently sitting here, so please.

MS. ECKERT:  Karen Eckert from Medispan.

A lot of what I was saying is also where Stan went.

It is just when you have this originally saying the checking of the drug allergies and the drug labs, that is almost more a functionality of what recommendations of policy of what should be inside the system or what should be done at the e-prescribing system.  Whereas, I think the messaging content, as you have been discussing, should be the results, and that would just be my request is that you would limit this column to just the results of the drug allergy checking and the drug lab checking and any other checking that you want done, but – because the messaging is what you are going to send between systems.

DR. COHN: Okay.

Scott.

MR. ROBERTSON:  Scott Robertson with HL7, and I am just, at this point, going to be reiterating what Karen and Stan have said.  So –

DR. COHN: Okay.  So there is sort of an agreement on that.  Okay.

MR. MARTIN: I have a quick question.  It is something that I don t see here, and I know it came up a couple of times over the last few months in terms of a potential gap, and that is being able to – if a doctor does do a DUR and wants to be able to communicate to the pharmacy that they already checked something so that they don t get the call back, how does that message get to the pharmacy?

SPEAKER: That is what we are talking about – in script.

MR. MARTIN: In script.  Decision rationale is the name of that in this chart.

DR. COHN: Okay.

MR. MARTIN:  Thank you.  Thank you.

MS. AMATAYAKUL: Is there a better term than decision rationale?

MR. MARTIN: If you could just – like, somewhere in the footnotes – just define things for people, that ll help a lot, so that you get better answers back.

DR. COHN: Yes.

MR. MARTIN: The more you can describe what you are thinking is in the structure.

DR. COHN: Yes.  I appreciate that, because I am not sure that I saw that as DUR either.

MR. MARTIN: Yes, I mean, you could maybe call it something like reason for drug choice or reason for override or there are probably 10 synonyms.

DR. COHN: Yes, I think there s a couple of different things we are meaning by this.  One is this issue of – this is an off-label use and I sort of agree with it or I did DUR or whatever.  I hadn t seen this as a statement that I have done some sort of level of DUR – of course, that is not specified what that level is – and am aware of it, because I think – allergy there, but I already know about it or there is a contraindication, but I already know about it, which I think is really what we are talking about, isn t it?  I think.

Anyway, shall we move on?

MS. AMATAYAKUL: Drug knowledge base distribution.

DR. COHN: Okay.  Let s see.  We are on page – 8.  Thank you.

MS. AMATAYAKUL: This is under their mutual substitution classes, including lower-cost drug/therapy alternatives.  The drug-drug interactions, including severity, drug lab interactions, allergy groups, dosing, height and weight and age and overdose data, and then I didn t know where to put mapping to RxNorm, so I left it there, because it just wasn t – I probably could put that in in a standards gap, but it really applies to all of these.

DR. HUFF: Now, how do height and weight and – are those are under – that is indented again.  Okay.

MS. AMATAYAKUL: Yes, it is indented.

MS. BICKFORD: Carol Bickford, American Nurses Association.

You ll need to insert drug-food interaction here as well.

MS. AMATAYAKUL: Right.

DR. COHN: Okay.  Thank you.

MR. BIZZARO: Tom Bizzaro, First Data Bank.

I think Karen will agree with what I am going to be saying here.  Under drug knowledge base distribution, we can give you a whole list of clinical screening possibilities that you could have that are available from a knowledge basis, and it wouldn t be limited to just the things you have here.

My question would be do you want us to limit it when we reply to what you have here or would you like to know what the breadth of clinical capabilities are from the knowledge basis.

DR. COHN: Is there other –

MS. AMATAYAKUL: What I tried to do was include those things that were specified in MMA and not address the others.  So that was the distinction I used.

DR. HUFF: Yes, but I think – yes, I think we would like you to say – I mean, speaking for myself, I mean, I think what we talked about before is that somehow in filling this out, we want to make it clear to the people filling it out if they know about standards that we should be aware of, they should add rows to this table to indicate those – you know, either messages we didn t conceive of or other standards to supply the same need as rows that we already have.

MR. BIZZARO: Margret, I would ask that you indicate on this what is required by MMA –

MS. AMATAYAKUL: Okay.

MR. BIZZARO:  – for the clinical screening function, and then also ask for the additional information, and the knowledge bases will not be providing any lower-cost drug therapy.  We don t have information about – in the context you are talking about – what the actual cost of a drug is, either through a PBM or if it was even a cash prescription.  We don t collect that information.

DR. COHN: Okay.  Well, it s good that we didn t list you as one of the –

MR. BIZZARO: Yes.

DR. COHN:  – purveyors of that.  (Laughter).

SPEAKER: (Off mike).

DR. COHN: Well, that is true, but under lower-cost, drug-therapy alternatives, it is blank.

I think the issue – what you are describing is basically that when you think of knowledge-based distribution, you think of a proprietary vendor producing drug knowledge bases.  I think this is more meant as a generic information is I think what you refer this as, and it may be that we need to change the title here a little bit.

MS. AMATAYAKUL: Should that go under health plan instead?

MR. BIZZARO: Not if it is a formulary, and I do have a question for the committee.

DR. COHN: Or decision support.

MR. BIZZARO: A couple of days ago, the question came up about what therapeutic classification system is going to be mandated for use for classifying grouping of drug products, and we had been assuming that it was not going to be any of the proprietary classification systems, that it was going to be something being newly developed by USP, but I thought I heard a couple of days ago Kelly say that it is not going to be mandatory for use, and I would like to know – for our business, it is going to be very important to know what is going to be mandated as a – classification system.

DR. COHN: Yes, Karen, do you have a reference on that?  I mean, my understanding is that they are developing one, but that its use is optional, I think, in terms of use by PDPs.  Do you know this information or –

MS. TRUDEL: No, another question.

Yes, in the section on model guidelines, it says the Secretary shall request that the United States Pharmacopeia shall request USP to develop, in consultation with pharmaceutical benefit managers and other interested parties a list of categories and classes that may be used by prescription-drug plans under this paragraph.

MS. AMATAYAKUL: Shall I put that under terminologies?

DR. COHN: What?

MS. AMATAYAKUL: The USP, the therapeutic class.  To go under terminologies.  It is not a message.

DR. COHN: It is not a terminology either.

MS. AMATAYAKUL: It is a classification.

DR. COHN: Okay.  Help me with what – so, basically, the purpose – I mean, I am confused here a little bit.  We ve got –

MS. AMATAYAKUL: Okay.  There is a category – after we finish with the messages, there is a category and terminologies, including codes, classifications and vocabularies.

DR. COHN: Right, and I think classifications are actually part of formulary.

MS. AMATAYAKUL: So the therapeutic classification, the USP, should be listed under one of the classifications, is that correct?

MR. BIZZARO: What prompted my question was under drug knowledge base distribution, you have mutual substitution classes.  Now, we all have our own proprietary and some non-proprietary therapeutic classes that we can supply now.  The USP therapeutic classification system doesn t – as far as I know – exist yet is something else that we can also provide information on, so that it will allow you to do substitution of drug products.

I just was wondering what is going to be mandated, and are the PBMs or the other folks who are going to have to know what drugs are in a class and what drugs can I substitute within that class is a very big part, I think, of what MMA is trying to get to as they look at the proper – having the proper drug and the least costly drug and the most effective drug to dispense for that therapeutic class.  It is a real gap for us right now in knowing what are we going to have to do with the knowledge bases to accommodate a new therapeutic classification system.

MS. TRUDEL: I just want to mention that there was a press release sent out today that announced a public meeting on August 27th in Baltimore on the issue of formularies in drug classifications, a public meeting –

DR. COHN: That ll be timely.

MS. TRUDEL: Be there.

SPEAKER: I think it clashes with something else already.

DR. COHN: Yes.

Well, help me with this one.  I guess my sense is is that in the world of formulary this is one of the important things that gets brought down as part of formulary pieces, and I think what we are hearing is is that there ll be one, but there ll be many, and so is this different than formulary management?

MR. BIZZARO: No, it exactly isn t, and I guess – you know – from my point of view, having been in the PBM world at one time, I know how structured and dependent my formulary is on therapeutic classification systems, whatever system it is right now, and I am worried on how are those entities going to deal with a therapeutic classification system that doesn t exist yet if they have to start building formularies based on a new therapeutic classification system, and we want to be able to help them do that, if necessary, but you are right, Simon, it is exactly the way that formularies are built, so you know what drugs are in a class, what drugs are substitutable, what drugs have similar activity.

DR. COHN: Okay.  So I guess we reference this somehow as a formulary function.  I mean, I guess we need to find out what the – I mean, this is almost like it s a function of the formulary piece, and then I guess I am just trying to think if there is any particular data or terminology requirements that are somehow different than everything else we have been talking about.  I guess if you call your classifications different than something –

DR. HUFF: Well, yes.  I think, you know, at least as I was thinking about this particular section, see, I was thinking about – again, this would be helped a bunch by saying, you know, who is sending and receiving.  In my mind, this was sent – you know, the drug knowledge base vendors are sending this information to the system that was going to do the drug utilization review.  So that normally would have been the prescribing system, whatever the prescriber system was, and the goal of having this, basically, was so that you would have standards for loading this knowledge into the prescriber system, so that somebody could choose to use First Data Bank or Medispan or whoever they wanted for these – and you would have a standard format, and, regardless of which vendor you chose, you would have a standard way of loading that information from the drug knowledge base vendor into the prescribing system, and so, in the context of what you said, you know, that other thing, in terms of therapeutic class isn t – I don t think is being loaded there.  It is being loaded into the formulary or used in construction of the formulary for something – right? – or is it – would it be used in the prescribing system directly?

MR. BIZZARO:  Yes, it is used – it can be used in a prescribing system, because if a physician wants to know what other drugs are available in this therapeutic class, before he goes out to the PBM to see what drug he is going to – if the drug is covered on the formulary –

DR. HUFF: So then it would be appropriate to a line item in this section that was basically – you know – what is the format I would use if I wanted to transmit a particular therapeutic classification if I wanted to import it into a system.

MR. BIZZARO: Now, I am a little confused, because there are no standards that we have in the knowledge bases that would structure our content to be placed into an application in a uniform manner.

DR. HUFF: So you would say that.  That is what we want to know from you, and you could even say we don t think there is a value case for that, so don t do it.

MR. BIZZARO: Thank you, and I will do that.  (Laughter).

DR. COHN: Yes.  Okay.  Okay.  Are we comfortable with this section at this point?  Margret, are you comfortable with this section?

MS. AMATAYAKUL: Not so much –

DR. COHN: Okay.

MS. AMATAYAKUL:  – but I am hoping – (laughter).

DR. COHN: Okay.  Ross, did you have a comment?  I m sorry.

MR. MARTIN: I don t want to take up a lot of time on this, so we have made written comments that were an extension of our oral comments from yesterday that go into a little bit more detail on the therapeutic-classification issue here, and the challenge will be, I think, for the database companies, there is a special pressure on the classification schema within the Medicare setting, because the PDPs are required to cover drugs, as it is stated, within each class, which means two or more.  So in order to right-size their benefit, if you will, one of the things that they can do is kind of switch around the way that they identify what a class is to broaden that class, and that creates a lot of – because there is no obligation for them to cover – to follow the structure that USP is suggesting, it could create – it could be very difficult to translate how I think clinically as a prescriber and how the benefit is structured.

DR. STEINDEL: Ross, my comment is I think in the interest of time, perhaps, it is best to address this on the August 27th meeting that was just announced.

SPEAKER: Yes, we really need to stay focused, because we ve only got – less than an hour, I guess.

DR. COHN: Yes.  Okay.  Lynne.

MS. GILBERTSON: Lynne Gilbertson from NCPDP.

If this is now turning into the loading of drug database information within the systems, we ve got the DUR modules for the physicians, the pharmacies and the PBMs.  So there s three different entities in that environment and script would not be appropriate for that, because it is not a mechanism for loading information.  It is for relaying the results of your findings.

DR. HUFF: Right.  So NCPDP SCRIPT shouldn t be a choice in any of these.

MS. AMATAYAKUL: Gotcha.

DR. COHN: Well, I guess we need to think a little bit about what we mean by this, because, I mean, is it the loading?  Is it the transmission of the information?

DR. HUFF: It is a file format, so that I can have a standard file format to import from the drug knowledge base vendor into my prescribing system or into the other systems.

DR. COHN: Okay.  Okay.

Well, shall we move on?

MS. AMATAYAKUL: One second.

DR. COHN: Sure.  Well, I can actually handle the next area –

MS. AMATAYAKUL: Okay.

DR. COHN:  – which is e-signature standards.  Am I wrong?  Lab is the next one?  Oh, lab results.

DR. HUFF:  Where is this one flowing from and to?

MS. AMATAYAKUL: This is from an independent lab or wherever you are getting your lab results.  I didn t know for sure it should be in here, but I know there s –

DR. STEINDEL: I don t think it should be.

DR. HUFF: I don t think it should be in here.

DR. COHN: Yes.  That was simple.

Okay.  Now, shall I move on to e-signature standards?  Okay.  Discussion about authentication and non-repudiation in digital signatures.  Obviously, this is an area that we are deferring until October.  So I am not even sure that we should be asking people about that at this point.

MR. BLAIR: Well, here s my thought, Simon.  We ll probably be getting testimony on that.  A lot of the same folks that are going to be answering these other questions may have some thoughts here.  So if they have some thoughts I thought maybe they could give some feedback on there, but, you know, absolutely.  October is when we are really going to delve into that.  So if you want to delete it, that s okay, but it just may be an opportunity for people to express their thoughts.

DR. STEINDEL: I would prefer to delete it.

DR. COHN: Yes, I think this is long enough as it is.

DR. STEINDEL: Yes, just because if we address it in this questionnaire, it means we have to address it in the meeting.

MR. BLAIR: Oh, okay.

DR. COHN: Okay?

MR. BLAIR: Delete it.

DR. COHN: Hold it for the October.

Okay.  Now, the next section is terminologies.

MS. AMATAYAKUL: Terminologies.

DR. COHN: One of our favorite topics.  Actually, Margret, it sounds like you are back on stage here.  Do you want to –

MS. AMATAYAKUL: Okay.  All right.  So for the terminologies, we ve got the drug in various forms, packaged drug, clinical drug.

Now, Stan had originally set this section up with generic plus form, brand plus form, brand only, ingredients, and so I have tried to follow that, but it is not the same as the information I was getting from another source.  I just need some help here, because I don t know whether to use this type of standard classification here or a different one.

DR. HUFF: The other one – the other source –

MS. AMATAYAKUL: From Randy s information, from the FDA, Dr. Levin.

DR. HUFF: This might well, I think to make this really understandable, we probably need to indicate for these given – basically, for a given role here, we need to say the – sort of the message in the element, where we expect it to be used, because the –

DR. COHN: Is this the send-and-receive question also?

DR. HUFF: It is not quite send and receive.

DR. COHN: You re probably right.  Okay –

DR. HUFF: Because there are certain kinds of things even that we haven t – some of it is just terminology, and I don t care if you change generic form to be component or something or – you know –

MS. AMATAYAKUL: Okay.

DR. HUFF:  – so that that is – as long as it is the same thing, but the other thing is that I think we are even still missing some – well, no, we are probably fine, but you need to consider – it would be helpful at least to know that we are considering these sets of things as things that are orderable items, as opposed to terms that would be used, for instance, in reporting allergies, because there are things that you can report in allergies that you don t use as – you can t order.

MS. AMATAYAKUL: Can I put drug orderables here, and would that help?

DR. HUFF: Maybe I ought to think about it.  Let me –

DR. COHN: Yes, I d be happy to let Stan think about it.

MS. AMATAYAKUL: Over the weekend.

DR. HUFF: I ll bring back a proposal about how this section should look.

MS. AMATAYAKUL: Okay.

MR. BLAIR: Well, we are going to be sending it out – what? – Monday or Tuesday?

MS. AMATAYAKUL: Yes.

MR. BLAIR: So maybe you need to get it to Margret, you know, tomorrow sometime.

DR. HUFF: I ll do it on the plane.  (Laughter).

MR. BLAIR: There were two thoughts, and I am not sure whether the framework is structured to really get at these two areas of information.  I think it is, but I just want to verify it.  One is the mapping of the drug-reference terminologies to RxNorm.  That –

MS. AMATAYAKUL: Right.

MR. BLAIR: I think you have that in there.

MS. AMATAYAKUL: Yes.

MR. BLAIR: And I hope that is in a way that – and I am assuming that NLM and maybe Randy will also reply to that and maybe the drug knowledge base vendors will indicate the status of it.

The other pieces of this terminology area that I think is especially important is what are the dates of completion or at least readiness of the mappings and of RxNorm and the FDA codes?  Will they be ready to be folded into the demonstration project on January the 1st, and, somehow, I think we need to make sure that we are asking –

DR. COHN: Okay.

MR. BLAIR:  – for feedback in here.

MS. AMATAYAKUL: We do have the column – we continue the column that asks whether this is going to be near term, which we defined as ready for the demo.

MR. BLAIR: Good.  Okay.

MS. AMATAYAKUL: Okay.

DR. COHN: Okay.  Good.

MR. BLAIR: Thank you.

DR. COHN: Okay.  So shall we move on to SIG now and –

MS. AMATAYAKUL: Yes, so we ve got – well, we ve got drug.  We have over-the-counter drugs separate from drug.  We have therapeutic classification.  We have units of measure, which I didn t know where to put, but we heard yesterday we needed units of measure, and then we have the SIG, and under –

DR. COHN: I m sorry.  Do you have a comment on this?

DR. LEVIN: I mean, I could provide you with the different levels of the medications, the terminologies I have broken down from ingredient down to the levels that you are talking about, and then some of the control terminology that needs to go along with that, like dosage form and route of administration and classification, things along those lines, if you would like.  I mean, if I could work with Stan with that.

DR. COHN: Yes, I was hoping that you two would –

DR. HUFF: You ve got indication indented under the SIG?  That is not part of the SIG.

DR. COHN: Okay.  Have we made it through to SIG yet?

SPEAKER: I don t know.

DR. COHN: I think we were just getting ready to get to SIG.  Is there anything before we hit SIG that is an issue?

MR. BIZZARO: Tom Bizzaro with First Data Bank, and these are questions for clarification on how the knowledge bases can answer the questions.

Are you interested in us sending to you those proprietary elements that we have that would identify those drug elements that you have here?  Are you not interested in proprietary elements?

MS. AMATAYAKUL: Wouldn t we want to know that it is proprietary, but not what the element is necessarily?

MR. BIZZARO: Just that they exist?

MR. BLAIR: If it is proprietary, I think we still want feedback.  If it is proprietary or it is not proprietary, at this stage, we want the status and the information, and we haven t made our recommendations yet as to how we ll respond with that.

MR. BIZZARO: And the other comment I have – and Karen and I were just chatting for a moment – is that we are looking at being able to cross reference our ID s to RxNorm, but neither one of us is looking at NDFRT at all.  So –

DR. COHN: Okay.  So please indicate that in the response.  That would be helpful.

MS. ECKERT: Karen Eckert from Medispan.

Two points.  Jeff, you had asked for also the acknowledgment of the completioness (sic) or readiness of the mappings that would be available.  I guess I would ask the same thing about the references to daily med.  I know that as a communication tool that we have talked about with NLM, but I am still not sure when that is going to be available, and I think that would be helpful as we talk about this again in August.

And then towards the end of that page, we talk about therapeutic classification and we reference only that – VA s classification and NDFRT.  From our previous discussion, are we going to add the USP possible one there, too, that has been acknowledged in the – regs, even though it doesn t exist, but, at least, to acknowledge its existence?

MS. AMATAYAKUL: It s done.

DR. COHN: Great.

Okay.  Lynne, do you have a –

DR. STEINDEL: I have just a quick question of Gail Graham.  Gail, is VA planning to participate in that August 27th meeting, and you don t have to answer that question right now.

MS. GRAHAM: We will have a representative there.

DR. COHN: Okay.  Lynne.

MS. GILBERTSON: Just as a thought from the SDO perspective looking down this, I mean, what I guess I would have to respond, for example, RxNorm, NDFRT is unknown, because we wouldn t have any idea if it is near term, long term or what impact it would have on any of the standards.  So that would be all right –

DR. COHN: Oh, yes.  No –

MS. GILBERTSON:  – acceptable as responses?

SPEAKER: Sure.

DR. COHN:  Yes, if you are not the developer of this terminology, to know its status would be –

MS. GILBERTSON: Right.  We wouldn t know its impact on a standard.

DR. COHN: We would be pleased, but we would be surprised.  Yes.

SPEAKER: We really didn t expect that –

DR. COHN: Yes.  However, as I say that, I think the one question we would have for a standards developer is can you accommodate the data element?

MS. GILBERTSON: And I would have to respond back, tell me what it is you want, so I have a clue whether it s a code or it is 17 new data elements the industry would be populating.

DR. COHN: Thank you.

MS. GILBERTSON:  So we may need to change the SDO time line to the responders time line or something like that –

DR. COHN: Good point.

MS. GILBERTSON:  – so that you have – you know, because the SDO isn t going to have a time line for those –

DR. COHN: That is well said.

SPEAKER: Good point.

MS. GILBERTSON:  – but maybe the organization will.

DR. COHN: Okay.  Lynne, thank you.

Okay.  Are we ready for the SIG?

MS. AMATAYAKUL: SIG.

DR. COHN: Okay.

MS. AMATAYAKUL: So you said take indication out?

DR. HUFF: Well, yes, it shouldn t be inside the SIG.

MS. AMATAYAKUL: Do you want it –

DR. HUFF: So it should just be before or after as a – you know – an independent item in that terminology section.

MS. ECKERT: Can I ask one clarifying question?

DR. COHN: Sure.

MS. ECKERT: Karen Eckert from Medispan.

Stan, do you think the intent there was to say this is for fever or for hypertension that would part of the SIG, so it is a higher level of an indication?

MS. AMATAYAKUL: This was taken from a list of – from the testimony we heard –

DR. HUFF: We were thinking it would be like PRN, itching or something or –

MS. ECKERT: Yes, or pain?  To indicate if the drug has been used for pain versus for fever or such.

DR. HUFF: You re right.  In that context it could be inside the SIG, I guess.

MS. AMATAYAKUL: So I ll add an example, PRN for pain.  That ll clarify for us.  Okay.

But should I also add it separately?  Yes.  Okay.

DR. HUFF: Yes.

MS. AMATAYAKUL:  Yes.

DR. HUFF: Okay, then.

DR. HUFF: And then doesn t the FDA have at least internal standards for some of these things in the SIG, Randy?

DR. LEVIN: Yes.

DR. HUFF: And the drug knowledge base vendors, they have things they could put in here, too.

Rates of infusion, I think, is overlapping with units.  Rates of infusion is just a unit of measure, I think.

MS. AMATAYAKUL: This list was just from the testimony.  So I thought I would take it as it was.

SPEAKER: It s just there s different expressions of units of measures and how far down do you want to get?

DR. COHN: Okay.  You know, I don t think we should spend a whole lot of time on this one, since we know nobody has structured SIG.  So this is a requirement section for whoever it is that is doing the transmission standard to – or whoever group it is going to happen with this one.  Is that okay?

DR. HUFF: Well, see, that is where it is confusing.  HL7 does all of these things.

DR. COHN: Oh, does it?

DR. HUFF: Yes.

DR. COHN: Okay.

SPEAKER: Yes.

DR. COHN: Okay.

DR. HUFF: It does, but, I mean, it s a drug-order standard, not a prescription standard, and it is not – it hasn t been – I think the ideal situation was – you know, is that the collaboration between NCPDP and HL7 would come up with something that was standard across both of those standards for this.

DR. COHN: Well, that would certainly be an excellent result of collaboration and harmonization.

Scott, is that what we have to look forward to in next meeting?

MR. ROBERTSON: Well, I wanted to point out that – Scott Robertson with HL7.

Yes, HL7 supports – I wouldn t really call it a structured SIG, but you can pass the SIG and you can also break out functional elements of it, such as frequency, route, administration site, indication, almost everything that is on here, probably everything that is on here and maybe some more.

The question is whether those are actually implemented in any systems.  So the transmission standard, messaging standard can support it.  Whether an application can support that level of refinement is a different question –

DR. HUFF: There are some.

MR. ROBERTSON: There are some that do –

DR. COHN: The dirty secrets of SDOs.

MR. ROBERTSON: Well, I mean, the SDO supports it, but we can only – I mean, it is just – it is the same as the previous discussion.  You can pass information.  You can set things up to support information, but if the user interface isn t set up in such a way that that information can be derived, we support it, but we can t guarantee it is going to be there.

DR. STEINDEL: Yes, and I think, from that point of view, it is irrelevant.  We want to know whether you can support it or not.

MR. ROBERTSON: And we will be responding in terms of – I mean, the existing standards extent of use.  To the degree that we can say it is used, we will indicate that, and it might be infrequently.  I m probably not going to be coming back with specific percentages, but we can give a rough indication of the degree of use that we have based upon the participants in the committees.

DR. COHN: Okay.  Maria.

MS. FRIEDMAN: This, again, gets back to the conversation we have had all along about messaging standards versus content standards.  Now, you can send this along as a message, but what – the detail of each of these things is an entirely – is irrelevant for you, but it is important in another context in terms of the standard and what it contains.

MR. ROBERTSON: We support the transmission.

MS. FRIEDMAN: Right.

MR. ROBERTSON: We support – various terminologies that can be transmitted, but what the sending application sends and what the receiving application can understand are not really anything that we will have control over.  We can support a wide range of things.

MR. BLAIR: Just include that in your response.

DR. COHN: Yes.  I am sort of reminded of the world of interoperability and, in fact, we have a little ways to go on some of the stuff.

Okay.  Anything else on SIG?  I mean, obviously, people can give Margret some offline additions, changes or otherwise, but we can at least see what people respond back with.

So structured label is next?

MS. AMATAYAKUL: Yes, then I also added just for completion sake the structured label, the PDP drug card.

DR. COHN: Yes, I guess I m – is PDP drug card within the scope of this activity?  I am sort of struggling with that.

MS. AMATAYAKUL: We can take it out –

SPEAKER: And is that a terminology?

MR. BLAIR: I think – Maria and Karen, I think that you wanted to get some of that information feedback because you are going to be pulling together the requirements for the card and you figure that this leading information might help you to do that.  Is that correct?  So, in a sense, it may not be specific so much for our recommendations as it is useful for HHS.  Yes?  No?

MS. TRUDEL:  I am certainly not going to be one to say that I don t want information, but in terms of the subcommittee s role, you know, and mindful of wanting to streamline, you know, I don t think it is going to be relevant to the recommendations that you ll make.

MR. BLAIR: Okay.

DR. HUFF: What is the context of structured label here?  I wouldn t have thought of that as a terminology.  Were you thinking about transmitting it or – and from who to who?

DR. LEVIN: Well, it s – the structured product label, if that is what that – that will have the terminology that will include the terminologies of standards for the drug names and the other medication terminologies that will be transmitted to the – whoever is running the systems, the information suppliers.  So that is our communication to the information suppliers for all the standards.

DR. HUFF: So then I think that would be a – wouldn t that be a message type up in the – essentially drug knowledge?

DR. LEVIN: Yes, because it includes not only the standards, but it also includes the information about how to use the medication.

DR. COHN: So transmission of structured label.

DR. HUFF: Yes, so that –

DR. LEVIN: That makes it –

DR. COHN: Okay.  That helps.

DR. HUFF: Yes, so – and name it structured product label, so that it has its right name, and then that would be up in the drug knowledge base distribution.

MS. AMATAYAKUL: I got it.

DR. COHN: Okay.  Devices.

MS. AMATAYAKUL: Devices.

SPEAKER: Device codes.  Codes for medical devices?

DR. COHN: Now, these other things are not indented under – right?

MS. AMATAYAKUL: No, and then DME and supplies.

DR. COHN: Okay.  (Laughter).  What?

MS. AMATAYAKUL: And then DME and supplies.

DR. COHN: Okay.  Now, I m trying to think, the devices you are referring to are devices that would be prescribed as part of a – okay.  So we are not talking about – okay.  And so we are just asking people what they are doing for that.  Okay.

DR. LEVIN: I mean, there s something about devices in the previous – in the terminology section, too.

DR. COHN: I think this is the terminology section.

MS. AMATAYAKUL: This is terminology.

DR. LEVIN: Oh, I m sorry.  Okay.

DR. COHN: Yes.  Okay.

DR. LEVIN: It is repeated then, because there is something about –

DR. HUFF: Well, yes, they say drug-delivery devices, and then down here –

DR. LEVIN: Exactly.

DR. HUFF:  – there s just devices and then DME.

SPEAKER: You can group all – DME and supplies and devices –

DR. COHN: Yes.

SPEAKER: Right.

DR. COHN:  Thank you.

MR. MARTIN: May I make a suggestion about structure?

DR. COHN: Sure.

MR. MARTIN: This is Ross Martin.

DR. COHN: Structured label, you mean?

MR. MARTIN: No, just the structure of the questionnaire.

DR. COHN: Okay.

MR. MARTIN: It seems that for the vocabularies what you want to ask to the standards-development organizations is whether you support this in your transaction standard, as opposed to the other questions about the messaging itself.  Can your messaging standard handle this action, this kind of message.  It is a different flavor of the question for this section, and it is really pointed toward the standards organizations.  Is your standard able to send the medicine complaint structure?  Actually two –

DR. HUFF: We re actually – this was intended to actually ask vocabulary suppliers whether they supply this kind of terminology –

MR. BLAIR: And especially –

DR. HUFF:  – and that is an entirely different question from what you were suggesting.

MR. BLAIR: Right.  We want to make sure that these codes are available in time for these demonstration projects.

MR. MARTIN: Okay.  But then don t you also have to know if you are going to indicate that that is the vocabulary that you are going to use in this instance, that the messaging standard makers can use that vocabulary within their message?

MR. BLAIR: That s a good – question.

DR. HUFF: Well – because they are not – in HL7, the question is always yes.  That is never a question in HL7.  We may need to ask it of SCRIPT in some other standards.

MR. MARTIN:  In SCRIPT it may not always be yes, and, Lynne, would you nod your head at that or –

MS. GILBERTSON: This is Lynne.  Are we still back to the question of how do I know what to put in to support NDFRT when I don t know what the data elements might even be in NDFRT?

MR. MARTIN: NDFRT is simply – however it is used, it is a code.  So you have a code system and a code.  So if you support a coded field that has a code system and a code, you can support anything that is listed here.

MS. GILBERTSON: Right.  But I think it is just a little bit higher than that that says, what would you like?  And I can give you an answer.  So, for that particular terminology, all you need is a code and a field of support, a 50 by – value, then I can do that.  If it is lower than that or requires other things of the industry, then I need to know what it is you would like, and the answer will still be yes.  (Laughter).

MR. BLAIR: I think that Ross has identified an additional area that we failed to ask in the questionnaire, and I think that we do need to add that, and with the understanding, Lynne, that you may not be able, in the time frame that is here, to give an explicit answer of a yes or a no.  You may have to say it is conditional, based on.

MS. AMATAYAKUL: What I can do is add instructions before this section that relate to the SDO versus the vocabulary supplier.

DR. COHN: Great.

Scott –

MR. ROBERTSON: Just to reinforce Lynne s statement from the HL7 side, there is the requirement that we be able to identify the code system involved.  So that is the limiting factor.  As Stan said, we can support any code system you want, but we do have to – we may have to add into our standard an identifier for the code system, so that it would be known to both sides of the transaction.

MR. BLAIR: Just include that in your response.

MR. ROBERTSON: Yes, and – thank you.

DR. COHN: Okay.

MS. AMATAYAKUL: Okay.  So going on for terminology, complementary therapies, medical history.

DR. COHN: Can I just ask about complementary therapies?  I see you have identified an existing standard.  I should get some clearer – I believe that that is something that is being tested under –

DR. STEINDEL:  It s for HIPAA.

SPEAKER: It is a demonstration project.

DR. COHN: Yes, so is it an existing standard otherwise?

DR. STEINDEL: Simon, it is an existing standard.  It is being tested for use –

DR. COHN: Sure.

DR. STEINDEL:  – for HIPAA purposes, but this is different.

DR. HUFF: Well, I guess my question is where is the message that we contemplate that being a part of that is part of our projected use?  I don t know that we are transmitting therapies or are we talking about complementary drug therapies –

DR. STEINDEL: The alternative link includes complimentary drug therapies, and I think also SNOMED has some also.

DR. HUFF: Okay.  So it s –

DR. STEINDEL: You know, so – I mean, she s given an example, but I think there s other examples that could be used.

MS. AMATAYAKUL: I ll go back and make sure there is a message that complements the complementary therapy.

DR. COHN: Okay.

MS. AMATAYAKUL: Medical history, complaint, problem list, diagnosis, lab results, clinical findings –

DR. COHN: These are examples, now, or are these existing standards?

MS. AMATAYAKUL: Medcin, SNOMED.  These are the vocabularies, terminologies that may be suitable for use in medical history.

DR. COHN: Well, okay.  I guess – I had thought that SNOMED was the complaint terminology, and I think we – I agreed that – I mean, I think in previous communications, the Secretary – we had talked about Medcin is a very good interface terminology that needed to be mapped to SNOMED.  So I guess I was a little confused by that.

MS. AMATAYAKUL: So just put SNOMED?

SPEAKER: Um-hum.

DR. COHN: Yes.

SPEAKER: Yes.

MS. AMATAYAKUL: Okay.  That s fine.

DR. COHN: And I think – I guess as I look at all of this stuff I would like them to be connected or relate to recommendations that the committee has previously come up with, either that or we are identifying these as examples.  I m not sure which is which.

MR. BLAIR: Simon.

DR. COHN: Yes.

MR. BLAIR: There is going to – gee.  I don t know SDOs.  My thinking is there are some folks that are going to use Medcin, and as long as the mapping is there to SNOMED, I am just hesitant to – I would rather have us list all the different possible options, even though we know some –

DR. COHN: Oh, well, if we are being exhaustive, I don t disagree.  We have one per line, and so given that we have previously, where we talk about existing standards, where we put one, we mean that as likely the one we are considering, if what you are doing is using these as examples, that s a whole nother story.

MR. BLAIR: That s kind of what I was thinking of, because I didn t want to preclude any at this point.  It is not as if we have selected one at this point.  It is a matter of these are examples, so that the respondents can respond and either say, yes, that that is –

DR. STEINDEL:  Wait a minute –

SPEAKER: Wait.

DR. STEINDEL: Wait a minute, Jeff.  I have to disagree with that.

We have selected a set of standards in two phases last year, one with respect to approving the CHI standards and the other the PMRI terminology standards, and we can t go and select a third set of standards for e-prescribing.  They have to be in synch or we have to go back and change some of the other recommendations.

MR. BLAIR: Okay.  Yes, I concur with the point that you are making.  In the context of what we have here, it should note here what has been recommended previously by the NCVHS.

DR. COHN: Yes, I guess the question I would ask is almost more like a lot of things why we are asking them at all and that would be more to me more the question that we need to think about.  Are we asking these developers to come and testify to us in August about the status of their terminology?  Are we asking about – do we need an update on how SNOMED is doing?  Do we need to understand about ICD?  I mean that is – I mean, I guess that is sort of the question I have, given that we have been through a lot of this territory.  I guess the question is, in all of this stuff, what do we really need to ask?

MS. FRIEDMAN: Or is it here is a tool to help inform our thinking about here s –

DR. COHN: Yes.  Now –

MS. FRIEDMAN: It s not only a list to ask people about their status, but just a note to self about this is –

DR. COHN: Yes, I guess up until this area, I have been sort of tracking along.  So, I mean, I think we are recognizing that drug terminologies are a really key piece here, SIGs are a key issue, devices, maybe, except I think we already have a letter on that one, where we have sort of identified what we are doing, and then things sort of – sort of like it sounds like a rerun of our last –

DR. STEINDEL: Yes, and, Simon, on the drug terminologies, the recommendation, actually, on our drug terminologies, we were very specific, to a certain extent, but we also did note that they were in development, and, now, we are here where we are talking about a real rollout of that, and if we hear that they are not able to meet the needs of the development, I think that is a legitimate reason for us to revisit that.

DR. COHN: Okay.

DR. STEINDEL: But I don t think we have heard that with respect to the other terminologies.  They may not be in use, but they are deployed.

MR. BLAIR: So what will we list here?  Just SNOMED?

DR. STEINDEL: Well, we have – for complaints, we would list SNOMED, for problem list, SNOMED, for diagnosis, SNOMED, for lab results, LOINC and for clinical findings, SNOMED.

MR. BLAIR: Okay.

DR. STEINDEL: That s been our – that is the CHI recommendations.

MR. BLAIR: And what are the things we are eliminating that was there?

DR. STEINDEL: Well, LOINC was listed under clinical findings and Medcin was listed under complaint, and diagnosis ICD was listed.

DR. COHN: Yes, you know, I think that where there are – I guess – modification I might make to that is where there are other HIPAA code sets that have been mandated.

SPEAKER: Like ICD.

DR. COHN: Like ICD, we might want –

DR. STEINDEL: Okay –

DR. COHN:  – that as an additional.  What?  For example, diagnoses, there is a HIPAA code set, and so we might also want to mention ICD.

SPEAKER: And –

DR. COHN: And – well, I don t see a procedure –

SPEAKER: No, there s no procedures –

MS. AMATAYAKUL: Procedures are down further, I think.

DR. COHN: Okay.  Is that okay, Jeff?

MR. BLAIR: Yes.

DR. COHN: Okay.

SPEAKER: I am planning on leaving at 12:30.

SPEAKER: We all are.

DR. COHN: So are the rest of us.  We ve got 21 minutes.

DR. STEINDEL:  Yes, and manifestations of ADE, I – I am happy with putting Medra there.  It is just that Medra is not universally available.

MS. AMATAYAKUL: Indications, decision rationale, drug-allergy groups, drug interaction groups, claim rejection, reason codes.

DR. COHN: Well, yes, I guess I would, once again, just sort of make sure that these things relate to what we recommended previous, and I am not sure that I agree that what I am seeing there has been some recommended terminologies.

SPEAKER: I don t think indications exists in SNOMED.

DR. COHN: Yes, you know, I guess I would say in all of this stuff, one of the things that we may need to think about is how – I mean, once again, I would take this almost has to be sort of a subcommittee and maybe we ask Jeff and Margret and probably me to sort of think through this area and figure out what we really want to ask and who we really want to ask, in terms of – I mean, really the pertinent questions here, because, otherwise, it is going to be another terminology hearing, and I –

SPEAKER: It s not a good time?

DR. COHN: Yes.  I guess I hadn t perceived that we were going to be, in August, having terminology hearings.  I mean, there are a couple of areas that we really need to ask questions about and SIG is one, drug terminologies is another.  The rest of these, I m just not sure that we – I mean, I guess the question is what are we doing with all of this?

MS. AMATAYAKUL: I d be happy to take them out.  It just – you know, they were in the list before.  E had looked at them before, so I left them in.

MR. BLAIR: And, again, I – well, I hope I am not in the wrong place, but –

DR. COHN: Sure.  You are in the right place, Jeff.

MR. BLAIR: Our thought was – I m sorry – (laughter) – again, that some of these things were in here either for indications of either availability or compliance with other standards or mapping and stuff like that.  So, from that standpoint, you know, but I don t have strong feelings about this, you know, if you feel like we are getting to diminishing returns, it s okay.

DR. STEINDEL: Yes, and in many cases – talking about mapping, Jeff – we had the mapping requirements.

MR. BLAIR: You ve already got that there?

DR. STEINDEL: In the PMRI terminology letter.

MR. BLAIR: Okay.

DR. STEINDEL: You know, we have asked for those mappings.

DR. COHN: Yes, and I think one of the questions we could ask of NLM, since they are responsible for it, is what is the status of mapping –

MR. BLAIR: Exactly.

DR. COHN: And maybe that is the type of question –

DR. STEINDEL: Yes, and they are going to be here in August.

DR. COHN: Is that – Okay.  So, basically, I guess we should give strong consideration to having much of this area just sort of removed from the questionnaire, and we ll just have to think about what questions we really need to ask around all these things.  Mapping is one for the SDOs capability to handle clinical terminologies and I think those are the sorts of questions we probably need to ask.  People okay with that?  I see some heads nodding.

Okay.  Let s move –

MS. AMATAYAKUL: Okay.  This next section is medical history, functionality, and Jeff had asked that this be included separately.

MR. BLAIR: And the reason that I did was that this gets – it appears to be in content, you know, and, originally, it was folded under message formats and terminology, and it just seemed as if let s look at it individually, because it is, for the most part, content.

DR. COHN: Okay.  So, really, the responsibility here is to look through the sort of content and see –

DR. STEINDEL: Simon, we heard testimony yesterday from CCR, and I am looking down this list and I am looking at it with respect to what CCR showed us, and I don t know what is missing from CCR.  So we have an ASTM standard as defining this.

MS. AMATAYAKUL: And maybe we should ask ASTM are all of these things in the CCR.

DR. STEINDEL: I think that is basically it, and maybe we want comment, and we have heard about the CCR and ASTM and HL7 reconciling the use of the CCR within HL7.

MR. BLAIR: And the third thing would be are they there, and if they are not there, what is their target for when –

DR. STEINDEL: Right.

MR. BLAIR:  – they would be there.

DR. COHN: Yes.  I guess the other thing is is are we missing anything on this list.

MR. BLAIR: Right.  Yes.

DR. HUFF: Well –

DR. COHN: Stan.

DR. HUFF: The CCR, again, is basically specifying a set of content, and I am not sure what we gain by even referencing it here, because if we are going to transmit it as HL7, then you can transmit anything that can be transmitted by HL7.

DR. STEINDEL: And I agree with you.

MS. AMATAYAKUL: The primary value that I see in this category is really a functionality standard as opposed to a message standard or a terminology standard, but I honestly don t know how the SDOs or the vocabulary developers can respond to functionality.  This seems more like a question that you would ask the point-of-care developers.  I don t know that you need to or want to do that.

DR. HUFF: Well, I think the question is what message would this stuff flow in and who would it flow from and to?  This is data that, if I had it, I would access out of my electronic medical record.  If I didn t have an electronic medical record, then there is nowhere for this to go from and to.

MR. BLAIR: But that is not –

DR. HUFF: And so –

MR. BLAIR:  – consistent with the testimony we received, though, because it could go from NEHR, but, in addition, they were winding up testifying to us that there were several different modes of communication and a number of the ambulatory prescribers and the physician felt that it was especially important, because they didn t have any HR, and this gave them a vehicle.

DR. HUFF: To get it from where?

So, I mean, part of this, I guess, is sort of market readiness.  I agree that would be ideal, but do we know any vendor of e-prescribing systems that is requesting and receiving this data today?

MR. BLAIR: There were – what? – 30 vendors that apparently participated in the demonstration project.  So – and I don t want to get into this mode, because I feel like there s an –

DR. HUFF: Well, I m not talking about CCR in particular.  I am talking about – and I am not talking about demonstrations.  I am saying I don t know any real live e-prescribing systems that are asking and receiving this data today in their applications.

DR. STEINDEL: I think you are totally correct.  I mean, there may be the exception that proves the rule, but I think what is going to go on in the pilots is that they are going to ask to check various modes of this.

MR. BLAIR:  And the law said that this is an area of medical history that should be included in the e-prescribing.

DR. STEINDEL: And I think it is up to CMS on how they write the regs on – you know – how adamant this is going to be, and if it has to be handled on every prescription method, every e-prescription, then they ll figure out a way to get it into the systems.

MS. AMATAYAKUL: So should this be also going to system developers?

DR. STEINDEL: I don t think so.

DR. COHN: You know, I am, unfortunately – let me make a couple of comments here.

Number one is is that I am feeling like I need to go back and not only read the legislative language on this part as well as the comments by the conference referees – because this is an area where I think that there were some further clarifications that occurred about really what they meant by the scope of this, and I actually had thought that it was mostly medication history that they were really talking about, though, of course, we all –

MR. BLAIR: Two different things.  One is medication history – that was there – but, in addition to medication history they also asked for medical history.

DR. STEINDEL: Simon.

DR. COHN: Yes.

DR. STEINDEL: I think ,from the point of view of this committee, they have asked us to look at standards, whether standards exist for this or not, and I think we have identified that standards do exist for this.  They may not be 100 percent, but they do exist.

Now, the second question is can e-prescribing systems implement these standards?  They didn t ask us to look at that.

DR. COHN: Okay.  And certainly from the view of the role of the NHII, you actually talk about these things as sort of additional modules.

DR. STEINDEL: Um-hum.

DR. COHN: I mean, even though they may be part of one system, but, really, they are really functionally augmentations to all of that.

DR. STEINDEL: We might want to make a comment in the letter that we haven t seen this functionality, but – you know, we are not really asked to comment.

DR. COHN: Okay.

MS. AMATAYAKUL: So is the verdict to leave this in?

DR. STEINDEL: I think the standards – for everything under this, we have picked up the standards, and terminology, we have picked up in other sections, and the functionality part, we really were not asked to comment on.

MS. AMATAYAKUL: So I could take this out.

DR. STEINDEL: I personally think you can take it out, and I think we have probably – in doing due diligence, when we write up the letter, we probably should comment on it, you know, that we haven t investigated it, but –

DR. COHN: Well, is this a next phase –

DR. STEINDEL: Could very well be next phase.

DR. COHN: I guess that is really the question.  I mean – is that comfortable for everyone?

MS. AMATAYAKUL: Yes.

DR. COHN: Okay.  Now, let s look at the important related issues, and then we will talk about sort of the August hearing for a minute or two, and then we ll let Stan go.  (Laughter).

Okay.  And remember, important related issues are not necessarily standards.  They are things that we may want people to comment about, give us insights on, things that we may want to make policy recommendations or statements around.

And I see first one is patient safety.

MS. AMATAYAKUL: Let me tell you where this list came from.

DR. COHN: Okay.

MS. AMATAYAKUL: This list came from, in part, some of the language in MMA that they addressed need for patient safety quality, whatever quality means, et cetera, and then, as we heard testimony, we continued to add elements that appeared to be important related issues.  So some of them are like the work flow, the record retention, the state preemption, et cetera.

DR. COHN: Okay.  So, basically, we shouldn t take the titles here as having any relationship to anything.  These are more open-ended questions we would like them to comment on.

MS. AMATAYAKUL: Right.  Right.

DR. COHN: Okay.  And that includes patient safety, quality, formulary creation, policy standards, gosh, free of commercial bias.  (Laughter).  I guess, sort of make these all come up – we ll have to take a look through these.  Transmission, conformance testing, privacy, security.  Okay.

I guess what I would say is that if anybody – does anybody have any major issues with any of these particular questions?  If anybody has any additional questions that are sort of open-ended questions – I would, however, I think, probably – remember, we have already talked about e-signature as off the table for the moment.  That was identified before.

MS. AMATAYAKUL: Shall we take this off here?

DR. COHN: Yes, we ll ask that at a different time.

And I think, other than that, probably these are things that we need to carefully craft questions about.

Carol has a comment.  You have a comment.  Ross has a comment.  You all need to be brief, and then we will basically – okay.  Please, Carol.

MS. BICKFORD: Carol Bickford, American Nurses Association.  I have three questions.

One is inclusion of blood products and radio isotopes considered out of scope?

Number two, in this discussion, you have been talking about prescribers and benefits providers and – you know – suppliers, but where are the standards in relation to the consumer?

And then a third point is the discussion has sort of – you are focusing on MMA sort of as an instance or use case of e-prescribing, and I would encourage you to be thinking about the global issues rather than developing just another silo.

DR. COHN: Jeff, did you want to comment on that before others comment?  Go ahead.

MR. BLAIR: Yes, I have a comment, but it is not related to what was just said.

DR. COHN: Well, go forward.

MR. BLAIR: Hum?  Go ahead?

DR. COHN: Whatever comment you are going to make.

MR. BLAIR: Did we just eliminate, among everything we are going to consider, standards for medical history?  Because the law did delineate that we are to examine standards for medical history.

DR. STEINDEL: Margret, there is a section back further where you have medication history.  We don t have medical history, and we probably should add that as a tag line in the same fashion as we have medication history, and that addresses Jeff s point, which is totally correct.

MR. BLAIR: Well, the only piece that I am not sure of is when we are looking at medical history, I think under medication history, did you – you were thinking of that just as a message right?

MS. AMATAYAKUL: Right.

MR. BLAIR: And for medical history, I think the issue is what standards are there for the content of what should be in medical history?

DR. STEINDEL: But when she listed the content for medication history, she gave us examples, and one of the examples –

MR. BLAIR: Okay.

DR. STEINDEL: Um-hum.

MR. BLAIR: Okay.  So you want to put it back that way?

DR. STEINDEL: I think we should put it back that way and let the SDOs comment.

MR. BLAIR: Okay.

DR. COHN: Okay.  Ross, I think –

MR. MARTIN: One comment on medical history and that is that, in general, in MMA, it is all without – in as much as possible – without imposing an undue burden.  So identifying the standard and mandating its use – mandating that any e-prescription have a medication history or medical history in it is not the same.  So just identifying the standard, I think, is adequate.

And then I would have a suggestion about rather than removing e-signature acceptance from your important related issues, I would suggest that you put in there – put it in there and say, we ll receive comments on this later, just so you don t get people saying, hey, it s missing.  What about it, e-signatures?

DR. COHN: Fine.  Okay.

Please.

SPEAKER: My comment was the notation on there about formulary creation, and I just don t think that is really relevant here.  I don t think it belongs there.  I don t know how formulary creation has anything to do with the standards for electronic prescribing.

MS. AMATAYAKUL: You are talking about here formulary creation?

MR. BLAIR: Although, it was listed here as an important related issue –

SPEAKER: We received testimony from whoever the gentleman was about rules for good formulary creation –

SPEAKER: I just don t believe it is within the scope of this committee to regulate how formularies are created.

DR. COHN: Oh, but the comment, we might.

SPEAKER: Right.

DR. STEINDEL: It is not in the scope of the committee to regulate anything.

SPEAKER: Right.

SPEAKER: Well, that s why I said I don t know what it means, but I don t think it s –

DR. STEINDEL: It s in the scope of the committee to make recommendations to the Secretary in areas that it thinks is appropriate in this area.

MR. BLAIR: Yes, when folks testify to us that there s important issues that are related, I think it is something where we are obligated to pass that on, especially if a number of people were concerned about the same issue.

SPEAKER: What are we saying there about formulary creation?

MR. BLAIR: We are saying that it is an issue.  People are concerned about how that is done.  I don t know at this stage that we are elaborating on that.

DR. COHN: Yes, and I guess the question is is it formulary creation or is it just something slightly different?

DR. STEINDEL:  Well, I think the other comment is, Simon, we are asking for comments back on whether or not we should comment on formulary creation.  That is the purpose of this document.

DR. COHN: That is true.

DR. STEINDEL: So you can appropriately comment that way, and, you know, when we review this, we may find that we don t want to comment on it.

DR. COHN: Margret, and then I want to actually talk about the next –

MS. AMATAYAKUL: Yes, in sending this off to the SDOs and vocabulary developers and so forth, it might be appropriate to have a cover memo that clarifies that everything included in here is not necessarily something that is going to come out as a recommendation, that this is the full scope of what we are trying to understand, and recommendations will – maybe built upon some or all of it later or something –

DR. COHN: Okay.

SPEAKER: I guess that is part of my confusion is I don t really understand how HL7 or NCPDP, if that is the purpose of this document, are going to comment on formulary creation, and if it is intended for everyone to comment on –

MR. BLAIR: They don t have to.

SPEAKER: We seem to be going back and forth between whether this is for the SDOs or whether this is for everybody to talk about.

MR. BLAIR: Different people will comment on different sections.

DR. COHN: Yes.

MR. BLAIR: Whatever sections they –

DR. COHN: But, listen, I think we ll take your comment into consideration.  I mean, part of the next steps on this is obviously we look at the next version from Margret.  I think we are all going to cogitate on it a little bit, and we ll probably have even some further suggestions for improvements, modifications or whatever.

I think, Margret, you are hoping to get this out by early next week, is that –

MS. AMATAYAKUL: Yes.

MS. FRIEDMAN: Are you going to email it to me?  I need to have a conversation.  I m going to have two different email addresses, to make sure I get it, because we have been having some –

MS. AMATAYAKUL: Okay.

DR. COHN: Okay.  Now, let s just talk for a minute about the August 17th hearings.  Now, obviously, the actual hearings themselves, the structuring of them is sort of in process.  I am very concerned to make sure there is really enough time for subcommittee discussion of sort of what we are finding and what we are putting together, and I think we need to realize that there are some issues that are just going to be – we are going to, at the end of the day, have to say to people this is in our second set of recommendations, and that is just going to be the nature of the beast.

I mean, this is an initial set of recommendations of low-hanging fruit as well as gaps that we have identified, issues that are key issues that we are hearing that policymakers need to take into consideration, and unresolved issues that we haven t gotten to yet, but what we are obviously going to be doing is asking – and I think I am really sort of very focused on this.

We are going to be asking, obviously, the standards developers and the key terminology developers that we ll be supporting potentially or we have questions about in relationship to these standards, and, obviously, not to everybody, but the ones that we have questions about, we ll be asking them to come and testify to us about, among other things, the readiness, gaps, you know, trying to make sure, you know, is this thing really ready now or is it a year from now or is it longer than that.  I mean, I think these will be some of the questions that we ll be exploring as well as want to understand how things are being harmonized, where harmonization is necessary, because I think that ll be an important part of our recommendations.

I am suggesting that if there is background material, that generally what we will be doing is receiving that written in advance, and I ll be asking Margret and Jeff and I and Maria to sort of help make sure that the committee has appropriate background material if there is any particular standards that you are not familiar with, so that we are comfortable with that, but I don t think there will be time for us to do tutorials on various subjects at this session.

Now, is what I am describing, is this what all you thought we were going to be doing in August?

MR. REYNOLDS: The only question I would have, Simon, is whether or not that is two full days or we need more time the second day as far as formulating –

DR. COHN: Yes, I am actually hoping that we can limit the testimony to a day-and-a-half –

MR. REYNOLDS: That s where I was –

DR. COHN: And that s – my comment about enough time for us to really figure out what we are going to go through.

Ross, I see you have a comment or question.

MR. MARTIN: In that vein, in your draft, you have selected or you have listed two hours for the comments on harmonization between NCPDP and HL7, I would like to give you back an hour and 15 minutes of that.

(Applause).

DR. COHN: Oh, thank you.

SPEAKER: Thank you, Ross.

DR. COHN: Yes, so a 45-minute – okay.  Great.  I think that you ll have to realize that this is – I mean, looking at this list, there are, for example, background materials that we are going to be not doing and other things like this, but we will make sure that everybody has whatever background materials you think you need in advance.

Maria.

MS. FRIEDMAN: Just a side note.  We have a conference call the subcommittee members scheduled August 4th, and my question is do we still need it?

MR. BLAIR: Yes.

MS. FRIEDMAN: Okay.

DR. COHN: Yes.

MS. FRIEDMAN: I ll get out the call information.

DR. COHN: Okay.  And I should say on the internet that this obviously is a call that is –

MS. FRIEDMAN: It is a working session for the subcommittee.

DR. COHN: Okay.  Anyway, and then, obviously, we will have our next face-to-face meetings starting on the morning of the 17th, 18th, and I think we ll make sure that we are done at a reasonable hour on the 19th.

Does anybody have any parting comments here?  I think I am running about 120 seconds late, so I do want to apologize to everyone.  Does anybody have any parting comments on this one?

I think maybe I will make the parting comments.  This is a lot of work.  We really appreciate it.  Margret, thank you for walking us through that.  Jeff, thank you for beginning to put this together.  I think we ve got a lot of work ahead of us over the next two weeks, but, once again, recognizing that the definitive final recommendations are not for September.  It is just basically our first set of obvious recommendations.  Okay?

Actually, we also want to thank all of our experts meeting with us over the last two days.  You have been very helpful and we really appreciate that.

(The meeting is adjourned at 12:37 p.m.)