[This Transcript is Unedited]



Meeting of Subcommittee on Standards and Security

August 19, 2004

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
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P R O C E E D I N G S  [8:40 a.m.]

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

DR. COHN:  Okay, well welcome everyone, good morning, this is our final morning of this hearing schedule.  I want to call this meeting to order, this is the third day of three of meetings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.  The committee as you all know is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy.  I’m Simon Cohn, chairman of the subcommittee and the national director for health information policy for Kaiser Permanente.

I want to welcome our fellow subcommittee members who have made it through all three days, staff and I would say the same thing, obviously thank you for all your help and obviously others here in person.  I want to welcome those listening in on the internet and as always I want to remind everyone to speak clearly and into the microphone which is easy to forget.

Today the subcommittee will deliberate in open session, continuing to discuss observations and draft recommendations that we are fashioning to bring to the full national committee at their September meeting.  As we’ve stated this is our first set of recommendations, we will be having additional hearings and additional recommendations slated to come to the full committee in March 2005.  I do want to thank Jeff Blair again, our vice chair, without whom we would neither have a work plan nor have made it to this point in such an expeditious and I think exceptional fashion.  I think we’ve been able to move things forward relatively rapidly but I think we’ve really maintained subcommittee process and the integrity of things and I think that’s the important thing.

I guess I should also thank the other subcommittee members because the way we’ve done that is we’ve just added lots of days to the hearing schedules and so those of you who have been listening are probably aware that we’ve been meeting for three day sessions throughout the summer so that we can make sure that we have heard adequately from the industry and that this is indeed a collaborative and consensus based process.  Obviously I also want to thank Maria Friedman our lead staff for putting the hearings together and Margaret A our consultant who has been just instrumental in terms of helping to collect our thoughts and keeping things in order so that we can move forward.

As I mentioned before I do want to emphasize that this is an open session, as we move through the topics we do, we will obviously have subcommittee discussion, we do invite expert comments from those in attendance though we would ask that your comments be brief and to the point.  We do know that we are sort of moving forward, we are trying to complete these today but we obviously want to make sure that we’re not missing anything.  On the other hand please to the point as you make these comments.

Beyond that the hope would be is that we will be adjourning 12:30 or 1:00, I think that would be sort of the latest I would expect that we would be getting out today.  I won’t say keep my fingers crossed but that certainly is the intent.

With that let’s have introductions around the table and then around the room, for those on the national committee I would ask if you have any conflicts of interest related to any issues coming before us today would you please so state during your introduction.  Jeff.

MR. BLAIR:  Thank you Simon.  Jeff Blair, Medical Records Institute, member of AMIA, ASTM, HL7 and HIMSIS, there might be an apparent conflict of interest with respect to ASTM.

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

DR. COHN:  Steve thank you very much.

DR. HUFF:  You knew where you were sitting too, that’s great.

DR. HUFF:  This is Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City, a member of the committee and subcommittee, and I have a possible conflict of interest with HL7 if that should come up.

DR. FITZMAURICE:  Michael Fitzmaurice with the Agency for Healthcare Research and Quality, I’m liaison to the national committee and staff to the Subcommittee on Standards and Security.

DR. FERRER:  Jorge Ferrer, VA, staff to the subcommittee.

MS. AMATAYAKUL:  Margaret Amatayakul, independent consultant and assisting the committee.

MS. AULD:  Vivian Auld, National Library of Medicine, staff to the subcommittee.

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

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

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

DR. WARREN:  Judy Warren, University of Kansas School of Nursing, member of the committee and I may have a conflict of interest if we talk about HL7.

MS. FRIEDMAN:  Maria Friedman, CMS, lead staff to the subcommittee.

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

MS. WILLIE(?):  Shelly Willie, Rx-Hub.

MS. BURN(?):  Terrie Burn, Rx-Hub.

MR. BROWN:  Jeff Brown —

MS. BETHARO(?):  Patrice Betharo, Medco Health.

MS. BLOMM(?):  Laura Blomm, Joint Commission.

MR. ROTHERMICH:  Phil Rothermich, Express Scrips.

MR. DECARLO(?):  Michael DeCarlo, Blue Cross/Blue Shield Association.

MS. SHERWOOD:  Dana Sherwood, PCMA.

MS. WALKER:  Elizabeth Walker, reporter with the Pink Sheet.

MR. DABLE(?):  Ahib(?) Dable with Sure Scrips.

MR. WOODAMORE(?):  Ken Woodamore, Sure Scrips.

MS. WILLIAMSON:  Michelle Williamson, CDC, NCHS.

MR. ROBERTSON:  Scott Robertson, Kaiser Permanente representing HL7.

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

MS. ECKERT:  Karen Eckert with Medispan.

MR. BAMBERGER:  Brian Bamberger with Medi Media.

DR. COHN:  Well, thank you for all joining us.  Jeff, I’ll offer you some introductory comments and then let’s talk about how we’re going to proceed through the day.

MR. BLAIR:  I think that just about everybody here has been here for these last combination of three days so I’m not going to go through the same context background and I think we all know we’re about to hopefully finish off our recommendations piece and thank you all for being here.

DR. COHN:  Well let me just talk with the subcommittee and make sure that we’re sort of in agreement with the process.  What I’m proposing is that we jump back into the actual items and finish off the message format standard, open issues, then move to the other issues and at that point stop and just reflect on sort of are we missing things, what else do we need to put in here, and then what we’ll do is we’ll start out and make sure that we have the messages right.  Once again we’re not wordsmithing at this point but we want to make sure that we’re not missing any important messages or that things, we sort of need to make sure that the headlines are the right headlines, not headlines but the main bullet points are the right bullet points.  Is everyone agreeable with that approach?  Okay, well Margaret would you like to move us into the next message format standard issue that we have not yet addressed?

Agenda Item:  Draft Recommendation Letter – Dr. Cohn, Mr. Blair, and Ms. Amatayakul

MS. AMATAYAKUL:  Yes.  We didn’t address prior authorization, exchange of medication history, and exchange of medical history yesterday so those are numbered five, six, and seven now on the sheets that you were just distributed this morning.

DR. COHN:  Why don’t we start with prior authorization as opposed to handling them altogether.

MS. AMATAYAKUL:  Right, request for prior authorization from dispenser to prescriber exists in NCPDP although not widely used.  ASC X-12-N 278 provides for prior authorization in general but provides very limited support for prior authorization of drugs.  And the recommended action suggestion is support the facilitation of incorporating prior authorization for drug in ASC X-12-N 278.

DR. COHN:  Comments?

MR. BLAIR:  I’m sorry, maybe you have another recommendation there about the fact that they would hopefully participate in the demonstration project after they’ve added that capability?

MS. AMATAYAKUL:  The column checked is test and pilot.

DR. COHN:  Harry?

MR. REYNOLDS:  It’s a good point.

DR. COHN:  Oh, you’re happy with that.


DR. COHN:  Okay, I guess the only question I have is that, get back to where that this, I’d actually ask if you could —

MS. AMATAYAKUL:  I was just trying to get the top so we could see the columns.

DR. COHN:  I guess I’m not sure what’s, I think that this is the right direction but I’m a little unclear about what support the facilitation of incorporating prior authorization into the 278 means, and I guess I would ask the subcommittee what do we mean by that.  Are we talking about CMS doing something?  Standards groups doing something?  What are we talking about here?

DR. HUFF:  I have similar questions, I mean is it 278 going both ways?  Is it both the request for the authorization as well as an ability to notify so it flows both ways?

DR. COHN:  You can ask Margaret that one too, I think she’s agreeing that this —

MS. AMATAYAKUL:  Yes, it is both a request and a response.  Unlike the 270, 271 that has two different ones for inquiry and response, the 278 does both, both directions.

DR. HUFF:  And then I guess it’s vague in my mind too about what the content of this is, that is is it expected that this transaction would carry clinical data that would justify the prior authorization or is this —

DR. COHN:  The conversation that might occur, I mean I think that’s probably why more work needs to be done on it.  I want to just jump back for a second because I’m looking at how this is worded and I’ll ask Jeff to comment also but there’s a comment here that says request for prior authorization from dispenser to prescriber exists in NCPDP although it’s not widely used.  I think that’s a very misleading comment because as we understand from the industry the reason they don’t use prior authorization is that they use the claims in real time to find out whether it’s authorized or not and then go from there.  And so I’m not quite sure that that’s, and given that that’s between the prescriber, excuse me, the dispenser and the payer, or the PBM, am I wrong about that?

MS. AMATAYAKUL:  This request for prior authorization from dispenser to prescriber —

DR. COHN:  Oh, is this from dispenser to prescriber, okay —

MS. AMATAYAKUL:  So in other words the dispenser has determined a prior authorization is needed but they want the prescriber to get the prior authorization so they send a request for prior authorization to the prescriber notifying them you’ve got to get this.  And then the prescriber calls today, once that number is obtained they call the pharmacy.  278 provides the ability to electronically initiate a request from the prescriber to the payer to get the prior auth and that has very limited capability in terms of drug, any of the decision rationale and stuff we were talking about for prior auth, that needs to be greatly expanded.  So that’s why I had support facilitation of incorporating prior auth for drugs.

DR. STEINDEL:  Simon, this is Steve.  I have a question, does the X-12 transaction, will it support real time?

MR. BLAIR:  Very good question.  Nobody seems to know.

DR. STEINDEL:  Because I think this is an important part of the prior authorization that we’ve been hearing from multiple people that they don’t want to wait on the prior authorization, they want it to occur at the time they’re meeting with the patient if possible and I’m talking about this in both directions.

DR. COHN:  Let’s capture that thought because that’s an important one.

MS. AMATAYAKUL:  Theoretically the 278 should be able to be done in real time but really nobody is using this today, or hardly anybody is using this today so we don’t really have any experience.

DR. STEINDEL:  If we generally think of the HIPAA transactions as not being in real time so I think we need to make sure that it can support real time.

MR. BLAIR:  Apparently we really don’t know exactly what information the payers and PBMs will require in order to give that prior authorization and so, and I don’t know if we want to put this wording in the recommendation but I am thinking back a little bit to the way Health and Human Services tried to expedite the development of the HL7 EHR functionality model standard is basically the folks that normally have not been sitting at the table to develop that standard, and in this case it might be some PBMs, some other pharmacy payers, maybe even CMS, that they could help that by providing support or funding or something to convey an early meeting to discuss what needs to be in those messages to see if those messages can be enhanced either with some fields or specificity or whatever it takes in the hopes that it could be enhanced in time for the demonstration project.

DR. COHN:  I don’t know, Stan, were you next, or Harry?

DR. HUFF:  I think Harry was.

MR. REYNOLDS:  There’s nothing in the 278 that precludes it from being real time.  The reason, and you will see more and more of the HIPAA transactions go real time, as I stated yesterday everybody focused on the claim because that was the deal breaker.  We have some people showing an interest in the 278, the problem with the 278 and it’s the same thing you’re going to run into with the attachment and in some of the other things that are coming along is that we’re now getting into the art of discussion.  Because when you need prior authorization there’s usually not just, it’s not as simple as just saying I want to do this and somebody says well what’s going on, I mean it becomes a dialogue, it’s why people order medical records, because it’s more of a dialogue and it’s more of an evaluation.

So I don’t see any, there’s no reason that the 278 can’t be used, there’s no reason that if it works for anything it would not work less for here then it does for major cases when you’re getting prior authorization for other medical conditions or anything else.  So I don’t see a reason to move away from it but I think it will be inherent that whatever we recommend make sure that it is expedient, make sure that the industry agrees that that’s enough information to approve or disapprove the authorization, not to just kick it off and then it just creates another phone call.  That’s going to be the art of how you put whatever you put in the 278 to really make this process work.

DR. COHN:  And that’s obviously it needs to be piloted and further developed.

MR. REYNOLDS:  Right, absolutely.

DR. COHN:  Okay, Stan, comment?

DR. HUFF:  I was just saying, I was just thinking too and confirm that this would be the same transaction too that would normally be used from an inpatient environment to get authorization for surgery or for any other kind of expensive procedure, etc.

MR. BLAIR:  Good thinking.

DR. COHN:  Okay.  Do you want to read, I’m comfortable with what you’ve wordsmithed there —

MS. AMATAYAKUL:  Support the acceleration of incorporation functionality for prior authorization for drug in ASC X-12-N 278 and ensure that it supports real time transactions.

DR. COHN:  I see that Lynn Gilbertson came to the microphone, I presume it’s because you want to make a comment.

MS. GILBERTSON:  This is Lynn Gilbertson from NCPDP.  One of the things that came up just slightly during testimony but we didn’t want to hit on it real hard because we were quite sure where prior auth was going to go is to bear in mind that the pharmacy performs a lot of prior authorization today and there’s four sets of transactions for the pharmacy to do prior authorization checking and prior auth with a claim and other functions.  So when the recommendation goes to look at the prior auth process it needs to follow it all the way through to the end because we wouldn’t want to see that the prior auth works from the prescriber and then puts a real big gap in what the pharmacy has been or has not been doing and just to make sure, it’s a pretty big thing to chew off.

DR. COHN:  So it sounds like we need to make a comment that prior authorization works well between the PBMs and the dispenser, which is the other piece of the triangle here, and that any acceleration needs to incorporate an awareness or understanding of that functionality and those requirements.  Is that sort of Lynn what we’re talking about?

MS. GILBERTSON:  Just don’t stop halfway through prior auth, make sure it does the whole route.

MR. BLAIR:  There’s only one wrinkle in that and I’m in support of adding that but the communication between the PBM and the dispenser would probably be NCPDP whereas the communication between the PBM and the prescriber is likely to be X-12-N.  So we’re involving two different SDOs to get those two different things so I think we need to have those as two separate action items.

DR. COHN:  I think Marjorie may be helping us here.

MS. GREENBERG:  I have the same question, what I wondered is there, are you saying Lynn that sometimes the pharmacy goes directly, communicates directly with the health plan, the same —

MS. GILBERTSON:  Lots of times, basically the prescriber pushes it down to the pharmacy, you fulfill what needs for prior auth, call me with what you need, you fill in the missing pieces and you go get the prior auth because you want to dispense the drug.

MS. GREENBERG:  And Jeff is correct that that would be an NCPDP transaction —

MS. GILBERTSON:  Right, and I’m not trying to mix metaphors of standards, I’m just saying that when you’re considering the prior auth process don’t forget that the pharmacy is involved to the payer with some of the PA as well so hopefully you can fix things that are being pushed to the pharmacy that maybe don’t need to be but if you only consider the prescriber to the payer you will have lost some of the great analysis of the whole PA process.

MS. GREENBERG:  Do you see any problem with the fact that there are two different standards being used here between —

DR. COHN:  This is two different —

MS. GILBERTSON:  Because actually they’ll be a third one because the script, when the prescriber has gotten all the necessary information they need they’ll drop a new prescription down to the dispenser with whatever appropriate PA information might be necessary.

MS. GREENBERG:  So the dispenser would always use NCPDP standards and the prescriber would also use the X-12 standard?

MS. GILBERTSON:  If it works.

MS. GREENBERG:  And do they have comparable information on both of them?

DR. COHN:  That’s why this needs to be developed —

MS. GILBERTSON:  It needs to be analyzed, I mean this is a whole big business function.

DR. COHN:  Margaret do you just want to show us what you have here?

MS. AMATAYAKUL:  Okay, so I have 5.1, support the acceleration of incorporating functionality for prior authorization for drug in ASC X-12-N 278 and ensure that it supports real time transaction I think I’ll add between prescriber and payer, PBM.

DR. COHN:  Okay.

MS. AMATAYAKUL:  5.2, test the full flow of prior authorization through the entire process (Telecom 278 Script).

DR. COHN:  Okay, now Karen had a comment or question —

MS. TRUDEL:  No, I just wanted to contribute a fact, through the magic of Blackberries I checked with my staff and I’m told that the implementation guide has a specific discussion of how to do the 278 in real time.

DR. COHN:  Great, thank you.  That is just in time information so thank you.  And thank you all for your Blackberries.  Stan?

DR. HUFF:  Just a comment, if this is working right it would seem though that you would have diminishing need for the pharmacy to do this over time, right, because if it was working right when you pass the formulary information to the physician’s office the formulary indicates that this is a drug that needs prior authorization, and then it would be taken care of there and passed to the pharmacy so that the pharmacy didn’t have to independent, now I understand it may be quite a while before it really works that way but over time there would be a diminishing need for the pharmacist to directly request, I would think.

DR. COHN:  Hopefully the whole health care system will work better as a result of e-prescribing which is I think what you’re reflecting on and we would agree.  Jeff.

MR. BLAIR:  Margaret, could you reread your second item again there, your second recommendation again?

MS. AMATAYAKUL:  Actually I just modified 5.1 as well to say support the acceleration of incorporating functionality for real time prior authorization for drug in ASC X-12-N 278 from prescriber to payer PBM.

MR. BLAIR:  Right.

MS. AMATAYAKUL:  Two is test the full flow of prior authorization throughout the entire process (Telecom 278 Script.)  I’ll embellish that a bit.

MR. BLAIR:  The piece that I guess, I thought that Lynn’s point was that we also, I’m not sure that your second item, I tend to agree with the second recommendation from the standpoint that even if there’s a separate effort to accelerate the preauthorization to the dispensers a lot of that information from PBM standpoint is going to be dealing with the same algorithms for the preauthorization whether it’s to the dispenser or whether it’s to the prescriber so the coordination is a good idea so I like that item there.  But I’d just like to maybe ask Lynn whether that second recommendation achieves what you were suggesting, Lynn, that we don’t overlook the need to accelerate preauth, if it does then that’s fine.

MS. GILBERTSON:  The second of test the full flow of PA throughout the entire process?

MR. BLAIR:  Yeah, it just says test but it doesn’t do anything to wind up doing anything else.  Is that adequate?

MS. GILBERTSON:  It’s almost analyze or create business flows and test, or something to that effect, because I’m not quite sure, PA probably means ten different things to ten different people.

MR. BLAIR:  What words are missing from that second recommendation that you think we need?

MS. GILBERTSON:  Create business flows and test the full flow of PA throughout the entire process, that’s probably getting closer to make —

MR. BLAIR:  And who’s going to create them?  Is that NCPDP with X-12 and CMS together, all three?  Is that a meeting where all of them are getting together?

MS. GILBERTSON:  I think the PBMs need to be involved yeah, I’m mean definitely we have the payers well involved so I guess we could volunteer for another action.

DR. COHN:  There’s another comment, please introduce yourself.

MR. ROTHERMICH:  Phil Rothermich with Express Scripts, I just wanted to I guess ask a question.  There seems to be an underlying assumption that automating PA is a good thing and I understand that but I just want the committee to think about if we’re looking at this from a Medicare, in other words from a payer perspective, people use prior auth to manage cost so the assumption seems to be that automating PA is a good thing but that assumption is coming really from a physician’s perspective.

And looking at it from a Medicare or a payer perspective it may or may not be a good thing, in other words it hasn’t been shown necessarily that automating PA helps to reduce cost, it may increase cost, and so I just want to caution that as you’re looking at automating PA and testing that automation you ought to be sure you know what the goal is and if the goal as a payer is to reduce cost you want to make sure and keep your options open.  So as a payer Medicare may decide in certain instances as part of the benefit to implement PA and it may decide that automating that PA is a good thing and so one of the comments we made early on was you want to enable the automation of PA but it doesn’t necessarily mean you always want to do it and I just wanted people to keep that in mind.

DR. STEINDEL:  Simon, this is Steve, if I can comment.  The last two comments were very similar to thoughts that I was having in this area.  There are two parts to the PA process as I see it, one is the messaging part where we’re talking about enhancing and covering the 278 and the second part was the NCPDP script where it’s appropriate and I think that’s one aspect of the PA process.  The other aspect is the business case and business use of the PA process and whether we want to mention here that that needs to be investigated further in the world of e-prescribing or whether we want to mention it in the area of other recommended actions I’m not sure but I think that needs to be captured and recommended.  Because I just don’t think it’s involved with just messaging.

DR. COHN:  So you’re trying to capture a view here that we need to, that there should be an investigation maybe during the pilot of the business impacts —

DR. STEINDEL:  I’m thinking about that or even before the pilot to talk about various business cases so we know what to test in the pilot.

MR. ROTHERMICH:  And it may vary, in other words you can test the given PA in the pilot and you’ll have an answer about a given PA as to whether it helps to reduce cost but the next one might be different.  In each case I don’t think you can be heading toward automating PA as the panacea and it’s going to be there every time because there are certain instances where it may work very well and it may reduce cost and certain instances where you may not want to do it.

DR. COHN:  I want to make sure we don’t get ourselves involved with the argument about whether one should automate PA unless the subcommittee wants to revisit whether this indeed should be a recommendation.  But I do think that there is value to this issue around economic analysis and all of that so let’s make sure that we focus on that as opposed to the argument about whether or not there should be any automation applied to this.  Jeff, Marjorie, or Harry, Marjorie, I’m sorry.

MR. BLAIR:  Phil, I think your point is valid and I think the suggestion that if that demonstration project could also wind up showing what impact there might be on controlling costs that that’s valid, but it’s half the picture.  But I think that what we’re looking for in preauthorization is where’s the right balance so the other parts of the picture are if the, and I wouldn’t go all the way to saying automating because I guess in my mind sending the messages back and forth didn’t necessarily, it might mean automating the communication but not necessarily automating the process within a PBM of how that decision is made because that’s going to be pretty complex.  But it’s removing a barrier to try to level the playing field.

The other side of the picture is whether, if those messages are not available on an interactive basis is it effecting either patient safety or efficacy of the drug so if we’re going to wind up saying that the demonstration project should evaluate the business case and the cost benefit, which I think is valid, I think we also have to evaluate the other side which is whether when we don’t have that is it effecting either patient safety or the efficacy of what’s being prescribed.

MR. ROTHERMICH:  Just a quick comment, I don’t disagree with that but I’ll go back to a comment I made at another meeting which is when PAs are implemented it’s typically because there are other choices and this is an exception process and so I don’t think you can assume that patient care is effected because there’s a PA process in place.

MR. BLAIR:  And I don’t want to assume that, that’s why I’m saying that I think we need to test it, maybe it’s going to turn out that the process, maybe we’ve over estimated the concern about patient safety or efficacy, there’s people that are concerned about that but we don’t know for sure.  And the same thing about costs.

DR. COHN:  It was Harry and then Marjorie.

MR. REYNOLDS:  I have one specific comment and then a follow-up on Phil’s comment.  On 5.1 it should say, the last line it should say to and from the prescriber to the payer because it is a two way transaction.

But the other point, I think the whole thing about the industry and the 278 is that the jury is still out on how many answers can actually be automated, requests can always be automated but you want prior authorization.  But I don’t believe that the 278 restricts anyone from saying not authorizing it or saying you got to call or putting back a message.  There’s no transaction in HIPAA that doesn’t allow you to say yes or no.

The thing that needs to happen in the test in my opinion is to understand what percent, in the first place remember, prior authorization is a small, right now a very small percent of the drugs.  Now if 50 percent of them that would normally take a whole process can be handled through a 278, but then there’s another 50 percent of that small percentage again that doesn’t, we still may have some scrips that still go through the normal process, we may still have some phone calls going back and forth but that would be a message coming out of the 278 saying this isn’t going to happen right now, we need to talk or we need to do whatever.

So I think we’re getting into business process and business, I still have the right as a payer to say yes or no but this is the mechanism, if we’re going to allow electronic communication this is the mechanism that is already in place, already adopted, and should have the prescription drug stuff added to it, that’s my point.

DR. COHN:  Okay, Marjorie?

MS. GREENBERG:  I just want to reiterate, I think this is an important discussion because, and I do think, I completely agree with Jeff that I think we need to keep the consumer perspective in our recommendations and issues and in the test that we recommend as well as of course the payer and the prescriber perspective.  And of course expediting prior authorization does not mean as Harry said always saying yes, but there is to the consumer a benefit I think of trying to expedite a response whatever the response is and the response may be no, there’s a better drug or something like that.  But I really was struck as I think I mentioned at the executive subcommittee meeting by the last set of hearings where I don’t remember who it was but at least one presenter talked about how we go into exquisite detail in trying to identify the right message standard or the right technical solution but we don’t spend a lot of time evaluating what the impact actually is on care, quality, efficiency, cost, anything.  And I just think that’s where the national committee certainly can add value.

DR. COHN:  Margaret, would you like to, I think you’ve been wordsmithing while we’ve been talking, and then I just want to check in sort of an informal with the subcommittee because I’m assuming that we want to do something here but let’s make sure that everybody is comfortable with both that we want to do something and that we’re making the right recommendations.

MS. AMATAYAKUL:  So 5.1 is support the acceleration of incorporating functionality to enable real time messaging of prior authorization for drug in ASC X-12-N 278 between prescriber and payer PBM.  And 5.2 is SDOs and other industry participants should create businesses cases and flows and test the flows’ economic impact in  patient safety and quality of automated prior authorization messaging throughout the entire process (Telecom 278 Script.)

DR. COHN:  Does that sort of capture, I think Harry —

MR. REYNOLDS:  I struggle in the 278 with the, let me say this clearly.  I’m all for patient safety, let me say that straight up front, this is an open forum.  I don’t see what the automated prior approval has to do with anything different from patients, if a physician saying here’s what I want to do, you have a payer saying here’s what you need to give me before I’m going to pay for it, remember in the end, the physician can order it no matter what, it’s just whether it gets paid or not is what this, we’re in economics, and I’m struggling to see what this has to do, any different then anything else we’ve done because we’re putting medication histories down and we’re doing everything else so I’m not sure why zeroing this one in on patient safety whereas everything we’re dealing with should have that as an overriding theme.

DR. COHN:  Is it wordsmithing and once again I hate to get into wordsmithing but is it test the economic impact and any possible impacts on patient safety and quality, is that sort of what you’re talking about?

MR. BLAIR:  Could I clarify a little bit?

DR. COHN:  Jeff, go ahead.

MR. BLAIR:  And maybe we don’t need it, I’m just going to express my thoughts and then maybe some other folks can decide what the proper wording should be.  The thoughts that I have heard expressed to me was with respect to if we don’t have the messages it is so cumbersome and difficult for a busy prescriber to take the time to request the preauthorization that in many cases they felt that they just give up and don’t do it.  And if that’s the case then there’s where the thought was that the drug that’s being dispensed might meet the formulary and maybe cost effective but it may either have some patient safety concerns or efficacy concerns because the message is not there, because the message is not there.  I’m saying it that way because there’s some real complexities here because it’s almost saying that you have to test the case of what impacts to patient safety and efficacy exist today because the message is not there and then compare it against cost impacts when the message is there, and that becomes, I don’t know if we want to say that we want to do all that, that’s the only way that I know of to really answer the question but if we just do one or the other then we’re going to wind up getting an answer that favors one or the other so I don’t know how to craft this without asking for a complex expensive test.  But if we do one or the other then we’re going to obviously get information that’s going to support one case or the other without a balance.

MR. ROTHERMICH:  I think in both cases you need a control group and my point earlier was if you test a particular prior auth it tells you something about that prior auth, in other words the results for prior auth or a PPI over an H2 is probably a different result then a test of prior auth for growth hormone or something that’s more complex and so I’m not sure that you can over generalize that if you test automated PA in a given set of circumstances, a given drug, that you can generalize the result to every other PA.

MR. BLAIR:  Should we leave it to HHS to maybe sort that out, that it would be nice if all this could be done but it may turn out to be too big of a test?

MR. ROTHERMICH:  And HHS has to make the decision as to what they’re going to put on prior auth in the first place and it could be that the benefit that they implement they don’t use prior auth.

DR. COHN:  Phil, I’m going to ask you to hold for just a second here, but Marjorie, did you want to make a comment?  Or Margaret, I’m sorry.

MS. AMATAYAKUL:  In response to Harry’s concern we do have in important related issues an area where we address pilot testing in general and we could move the flow economic impact and patient safety effects of this one recommendation to the broader recommendation so it doesn’t look like you’re just focusing on this particular transaction for this but all transactions.

DR. COHN:  I guess I’ll ask the subcommittee, I think my own sense is that this has been a problematic enough area and it isn’t that I have a solution but I do think that this, to sort of meld it into well everything needs to be tested hasn’t been reflective of the ongoing discussions we’ve had.  Now I’m not saying that the answer here is to avoid the issue, I think it’s probably a second sentence on 5.2 rather then mushing everything together but I think that there needs to be a special focus here as you move forward, I’m looking at economic impact, I’m not sure about patient safety only because I’m having trouble with patient safety issues around this one but I do think that there’s certainly quality issues that need, quality of care issues that might need to be evaluated.  Luckily the good news is that even though I have an MPH and could certainly come up with a study design, and I know Jeff could come up with a work plan, the good news is that these are recommendations to CMS so we can leave them at a high enough level that we don’t have to specifically lay out whatever plan they’re going to do, or what they’re going to do with them after they decide.

I also, I’m just going to speak personally that I don’t think there’s any one solution, I think that this is an issue where we’re talking about tools, tools that may help some of the industry which is really what we’re talking about with all of this and it’s not a black and white, there’s a lot of gray here but I think there are some things here that actually might be of help to the industry.  But we need to understand those before we start implementing which is why we’re talking about pilots rather then this being ready to go and having adequate industry experience.  Marjorie?

MS. GREENBERG:  I was just thinking that maybe to kind of capture the ideas of cost, patient safety, quality of care, might say something like the efficiency and effectiveness of patient care, because I think it’s a combination, it’s the effectiveness but also it’s the efficiency and that’s not just from the perspective of the patient but also the payer, the prescriber, whatever.

MR. BLAIR:  I think that what Margaret was suggesting might hit the nail on the head, I mean at least I think from what I thought she’s suggesting.  I think all we need to achieve at this point is to have the message available and Harry pointed out that the PBMs can still say no and just because the message is there doesn’t stop the decisions that are made, it just winds up reducing the hassle from the prescriber so that that’s not an impediment.  Once we’ve done that then the whole question of cost effectiveness and patient safety and efficacy and efficiency, I don’t know that we need to wind up a whole series of tests of those aspects targeted towards this.  And I think Margaret wound up saying those are issues that are broad and that those should be moved to important related issues.

DR. COHN:  Well, Margaret has put a 5.3 here so do you want to read what you’ve done while we’ve been, while Jeff you’ve been commenting?

MS. AMATAYAKUL:  I’ll read 5.2 and 5.3, 5.1 is unchanged.  5.2, SDOs and other industry participants should create business cases and ensure proper flow throughout the entire messaging process (Telecom 278 Script.)  5.3, test the economic and quality of care impact of automating prior authorization messaging.

MR. BLAIR:  I’m kind of lost because now, didn’t you just put all that back with the prior auth instead of moving it to important related issues?

DR. COHN:  Yeah, and I was proposing that.

MR. BLAIR:  Okay.

DR. COHN:  I mean I just think this is an important enough specific issue that I think, I mean once again we can decide to move it further around but I guess I’m hearing very strongly that this is a specific area that really does need some in depth look at, I mean we can move it later on if it seems appropriate but I don’t certainly want to get this lost in the overarching view that everything needs to be tested.  Lynn and then we will hopefully move on to the next issue.

MS. GILBERTSON:  Just a question under 5.2, it almost, and I know NCPDP will volunteer to assist however but I wonder if this is something that should be a CMS directed item, that they bring the SDOs and the industry participants together.  Just a thought.

DR. COHN:  So you’re thinking that CMS should work with the SDOs and other industry participants, too, is what you’re saying.

MS. GILBERTSON:  Right, rather then for example NCPDP facilitating that, I’m wondering if it’s just more far reaching then NCPDP could go.

MR. BLAIR:  Maybe the piece that I don’t understand is if we’re going to test cost are we testing the cost of having the message or not having the message?  Because I thought we’ve kind of decided that we want to have the messages.

DR. COHN:  Jeff, this is actually the other one, I think, this is the process flow issue.  Is that what you’re referring to or —

MR. BLAIR:  No, let me keep quiet.

DR. COHN:  I just want to make sure that you knew which one we were, I think she’s talking about the business cases and proper flow through the entire messaging process which is now 5.2, to make sure it works and that no other part, and I think Lynn is commenting that because you’ve got X-12 and NCPDP involved in the process the question is how should it be sponsored, organized, enabled.

MS. FRIEDMAN:  That was my question, this is the first out of all of the sets of the recommendation that it’s been suggested that CMS or the government should convene the group and I’m wondering why this is different.

MS. GILBERTSON:  This one feels, this feels even bigger then sig and I just don’t want to reach too far with NCPDP facilitating.  We’ll be glad to but I’m just I guess looking for assistance to help facilitate because there’s only so many different ways we can chunk up so many different people as project managers.

MR. ROTHERMICH:  It seems beyond the scope of an SDO to take on that, I agree.

MS. GILBERTSON:  We’ll just pull everybody together.

DR. COHN:  I’m going to do Margaret and then I’m going to do Karen and then I’d like to see if we can wrap up this particular section.  Margaret?  No, Karen.

MS. TRUDEL:  I was just going to suggest that the who is not as important as the what and perhaps the what, which is the work ought to be done, is the recommendation and we can all sit down later and figure out who convenes and things like that.  I think Maria is right, that’s a level of specificity that we don’t have in the previous recommendations and in a sense we probably all should sit down together to figure out how to do it.

DR. COHN:  Are people comfortable with us leaving that a little ambiguous for the moment?  Though when we look back at our other recommendations we may have to reflect on this also.  I guess I should ask, how do we want to handle this one?  Michael?

DR. FITZMAURICE:  It’s always good to point in somebody’s direction but if somebody is overwhelmed then one can say that it has to be done and if everybody is overwhelmed then it ought to be supported by HHS, that is implying that there ought to be experts, maybe some funding for meetings and other things that the department can do, can use to help over burdened SDOs.

DR. COHN:  And right now we have facilitate as opposed to exactly who should facilitate which is the verb at this point.  Jeff?

MR. BLAIR:  Maybe I’m building a little bit on Michael’s point is if somebody isn’t responsible for seeing that this happen then it winds up having everybody pointing at everybody else to take the lead and this has to be done soon and if there isn’t somebody that has responsibility for then I’m concerned that it will languish and I think that the role CMS has is so important in this place because it’s the MMA and there’s the payer and they’re going to be making these decisions on these pieces so you sort of, well —

DR. COHN:  Jeff, the only question I have here is it looks to me like many of these recommendations are things that CMS is going to have to do so we ought to just look back because 5.1 looks like another CMS action too.  So I think we just probably need to hold the thought and it may be how we say the sentence before the recommendations in total that might solve our problem here because I absolutely agree with what you’re saying.  Marjorie and then Maria and then we will be try to finish this one up.

MS. GREENBERG:  Well, I just agree with what Karen said that I think we should focus on what needs to be done, make mostly high level kind of recommendations as to where the responsibility might lie and then what we need to do is a better job of following up to make, as to how the recommendations get implemented.

MS. FRIEDMAN:  My final thought on this is I agree with what’s been said and I think maybe the way to deal with this because there are so many of these is to make a very strong statement in the letter that HHS should provide the resources and the support to make these recommendations happen.  And do it in a more global way then try to nit pick through every single thing.

DR. COHN:  Well there’s certainly a lot of areas here where we’re asking for HHS to take leadership to help make this happen so let’s figure that one out.  Okay, are we done with this one?  Okay, are we comfortable with what we’ve got there?  Okay, well let’s move on to, and Phil thank you for your assistance and guidance, and Lynn also.  I think we’re into medication history, the next one is, Margaret do you want to lead us through this one?

MS. AMATAYAKUL:  Exchange of medication history may occur at multiple points among prescribers, between patients and prescribers, between payers and prescribers, between prescribers and dispensers.  Medication history from payers, PBMs to prescribers is currently performed in multiple proprietary formats.  Rx-Hub has a protocol based on NCPDP and HL7 and is submitting to NCPDP for balloting.  Medication history among prescribers may be performed using HL7 and ASTM CCR is a new standard that support the content for exchange between prescribers, such as in an electronic health record and with patients, such as in a personal health record.

Three suggestions for recommended actions, one, support the facilitation of a medication history transfer message between payer, PBM, and prescriber in NCPDP script in test and pilot.  Develop the business case for and support the facilitation of a medication history capability in NCPDP script to relay medication history from prescriber to dispenser when necessary.  And three, facilitate the harmonization of HL7 in ASTM CCR to support exchange of medication history between prescribers and with patients.

DR. COHN:  Comments, questions, statements?

MR. REYNOLDS:  I think the March 2005 sitting there is confusing, it seems to me that it almost reads like the CCR is going to be in March 2005.

MS. AMATAYAKUL:  This was just a placeholder to determine whether we wanted to move it down or not.

MR. REYNOLDS:  The rest of it’s fine.

DR. COHN:  So I guess one of the things we need to decide whether this is a March recommendation or a recommendation —

MR. REYNOLDS:  No, no, it looks like CCR is going to be ready in March.  That’s all I’m saying is it looks like that’s going to be available in March.

DR. COHN:  But I think that’s a placeholder there just to see whether we think if this is a recommendation ready to go or needs further.  Terrie, I think you’ve come and would like to ask questions and/or advise us and then Marjorie has a comment.  I’m sure others will probably also.

MS. BYRNE:  Okay, this is Terrie Byrne with Rx-Hub.  Just first of all one clarification, where it says Rx-Hub has a protocol based on NCPDP and HL7 and is submitting for balloting, I just want to clarify that.  Rx-Hub actually uses multiple formats to message for medication histories, one of them is an NCPDP based format that we developed using scripts, so that’s one format.  The other, we also use multiple HL7 message formats, so we won’t be submitting those to NCPDP, those are already accredited formats in HL7.  So there’s one standard that’s NCPDP based that the plan is to take through NCPDP.  Just to clarify that.

DR. COHN:  And the other one is already in HL7 approved format —

MR. BYRNE:  There are actually two formats we use that are HL7 messages and they’re already accredited.

DR. COHN:  Okay.  Marjorie?

MS. GREENBERG:  I had a question and then a comment related to it.  6.3, are we talking about the harmonization of HL7 and the ASTM CCR, or are we talking about harmonization of those as well with the NCPDP script?  And the reason for this question is that clearly medication history is a piece of the EHR and we’ve talked about this almost being kind of a pilot, this whole e-prescribing as being kind of a entrée or a pilot of an important aspect of EHR and all the issues that are relevant for EHR are relevant, many of them for this as well.  And yet we’re talking about, I’m concerned that since the whole EHR standard is HL7, that has been recommended at least in the past by this committee, how this kind of interdigitates(?) or whatever with NCPDP script because this is now not, we’re not talking so much about the e-prescribing mechanism, we’re talking about transferring or exchanging relevant EHR information here.

DR. STEINDEL:  Marjorie, this is Steve.  The present status of the HL7 EHR functional draft standard for trial use is to list functions but not say how those functions are being done.  So it doesn’t specifically say in there that that information will be transferred using this message protocol or that message protocol.

MS. GREENBERG:  I’m not sure I understand your point.  Well, maybe it answers my question first as to what 6.3 is talking about harmonizing.

DR. COHN:  Okay, we’ll why don’t we let HL7 since they’re at the table help clarify that because I think this needs considerable wordsmithing and I think that’s probably part of the confusion you have which is sort of like well what exactly are we talking about here.  That’s what I’m hearing from you anyway on a couple of these areas, so Scott why don’t you talk and then let’s talk about how this really needs to be fixed.

MR. ROBERTSON:  Scott Robertson from Kaiser Permanente representing HL7.  Yes, as Steve mentioned it’s a little bit different, you have to keep in mind that EHRS is a functional standard not a messaging standard, it’s saying what needs to be able to be support but it does not yet talk about how that information, or how the related information goes from one entity to another.  So in that way you don’t really want to say that EHR is an HL7 message, it’s a HL7 standard but it’s not an HL7 message, it gets a little confusing.

MS. GREENBERG:  Well I was actually not talking so much about the functional model as the recommendations that this committee has made about that HL7 should be the kind of core messaging standard vehicle.

MR. ROBERTSON:  And in terms of the messaging yes we can support a great range of things, in terms of 6.3 in particular I would suggest some revision because it’s not really a facilitation, it’s not really to facilitate the harmonization, it’s to facilitate the implementation of ASTM CCR in HL7 messaging.

DR. COHN:  Let’s just talk about this on a little bit because I actually think it’s an entirely different thing then that.  What I heard, let me just tell you what I heard in testimony, I may be completely off, Scott and Terrie you need to make sure that I’m describing this correctly and others in the audience.  But what I heard was is that ASTM had developed the CCR standard which is not a messaging standard, it’s a content standard, and that what I also heard is that HL7 is moving forward to develop messaging standards that may support that content standard.  That’s what I heard so far.  Now I’m not at all clear that we need to do anything as a committee regarding facilitating or otherwise enabling that because what I heard was that was sort of going on.  Now as a result I think what we’re talking about at least I begin to put this all together, we’re talking about medication history among providers being performed using HL7 and it may be being used by an HL7 current message or it may be a plan message that might include or leverage a CCR but it’s an HL7 message nevertheless.  So I think the ASTM CCR is sort of an off, I mean is a piece that needs to be referenced as one of the ways that an HL7 message might be constructed or occur but it’s not something we need to facilitate.  Now I do think the thing that we need to do in 6.3 potentially is maybe explore the applicability of that particular piece in the use of exchanging medication history and that would be more what I would think would be, what would be appropriate for a pilot as opposed to facilitating the work that at least what I was hearing is already about half done and may very well be done by the end of the year.  Now Stan, you’re a content expert, if I’m misstating HL7 on this one, or Scott if I’m misstating reality here —

MS. GREENBERG:  How does this then relate to the NCPDP script?

DR. COHN:  What?

MS. GREENBERG:  Then how does that all relate to the 6.1 and 6.2 which has to do with exchanging medication history through NCPDP script?

DR. COHN:  Well, I think what we’re describing is probably multiple different ways that medication history can be brought to the provider.

MS. GREENBERG:  That we’d like some kind of harmonization there?

DR. COHN:  I’m sorry, what?

MS. GREENBERG:  Wouldn’t we like some kind of harmonization?

DR. COHN:  Well, remember what we’ve talked about and this is the world that we live in is that different types of messages are standard between different sets of providers and obviously this is something that we need to talk about but when we’ve talked about for example NCPDP script or things coming, from the pharmacy to the provider back and forth we’ve talked about NCPDP, we haven’t talked about HL7.  The question is is this is a PBM to physician message and the question is is that an NCPDP message or is that an HL7 message.  Now we’ve postulated other uses here are HL7 messages and so is the question you’re bringing up is should this be an HL7 message —

MS. GREENBERG:  Well, or should at least the content between these two message be harmonized because the end of the day we want it to be exactly the same information I would think —

DR. COHN:  Okay, let’s let Judy comment and then Jeff, you have a question, and then others may comment because I know Terrie is sort of wondering about this question also.

DR. WARREN:  Well, when I looked at this I was getting very confused so I’m glad you brought up the confusion with the ASTM CCR because what the CCR is is a content standard about what needs to be passed to ensure continuity of care about a patient so it really passes much, much more then medication history, it’s also a medical history and a bunch of other things.  So I think for us to include that when we’re talking about medication history may be creating a lot of confusion, that that whole chunk may need to go down into seven instead of up in 6.3 and what we need to look at in 6.3 is the ability of HL7 to pass a medication history message and just leave it at that, not the whole continuity of care message.  I’d just like to clean it up a little bit so we know what we’re talking about and I know that Scott’s sig has been working on transferring messages, there’s also another format within HL7 called a working list message that can also roll up lists of things to message those, which could include medications and I don’t know if you’re using that facility in your group in working on messages or not.  But that would just be my plea is let’s pull out CCR from looking at medication history, if we want to look at it I think it belongs better down in the medical history.

DR. COHN:  Scott, actually I’m going to ask Stan as a content expert, or can you just comment about this one.

DR. HUFF:  Well, I think actually Judy I think is smarter then I am, well I think both of these guys are smarter then I am on that so I would defer to them.  I think what you said is accurate.

DR. COHN:  Okay.  Scott?

MR. ROBERTSON:  I have no difficulty with CCR being dropped down into seven because really CCR is a more global proposition then just medication history.  It will contain, or it can contain, medication history but it is not the focus of CCR to my knowledge.  And exploring or utilizing, I’m not going to actually say it the way 6.3 is worded right now but exploring the capabilities of HL7 messages to support medication history transmission as Terrie has mentioned from Rx-Hub, it exists and we can show it and there can be demonstrations made to show how it can do the same, potentially the same thing as the NCPDP messages, maybe something a little different, it depends on what you want to use it for.  Our design focus is slightly different then NCPDP so we might have some facilities that are not currently available at NCPDP, I don’t know that there’s a reason why they couldn’t — [microphone trouble] —

DR. COHN:  You need to repeat what you just said Scott.

MR. ROBERTSON:  I have to remember what I just said —

DR. COHN:  You were saying some about NCPDP.

MR. ROBERTSON:  I don’t want to say that NCPDP cannot do something or could not do something, HL7 and NCPDP have a slightly different focus so we might have some additional facilities in our message that are not currently available in NCPDP.  Whether that’s to the benefit of the overall exchange of this medication information might be something to be evaluated.

DR. COHN:  Okay, let me just stop a second because obviously we’re jumping back and forth between issues and there’s an issue that I really do want to bring up which is I think the Marjorie was bringing up, but let me make sure that we’re okay so far in how we’re going.  I think what we’ve done so far is we’ve said yes —

MR. BLAIR:  May I make a point —

DR. COHN:  Before I summarize?

MR. BLAIR:  Yes.

DR. COHN:  Okay, so you don’t want to know where we are, okay, please.

MR. BLAIR:  I’m a little uncomfortable here because this is an area where I really can’t make a comment.  Apparently there’s nobody here from ASTM to make a comment about this and this was an area where we did hear that ASTM was not only working with HL7 but was planning also to work with NCPDP and apparently there’s some open issues here.  And I had the impression that this was an area where we felt we needed additional information to make a pre-recommendation at this point and we were going to defer this until after September 1st and 2nd.  So I feel like we’re making a decision here without having all of the information to be able to lock it in.

DR. COHN:  Okay, well maybe Stan can make a comment.

DR. HUFF:  Well, I was just going to ask some questions, is 6.1 accurate?  Is it really script?  I mean I don’t remember a segment in script —

DR. COHN:  I was trying to hold that as a separate conversation to be held right after this but do you want to respond to what Jeff was saying?  I mean Jeff’s calling to hold this later on.

DR. HUFF:  Well, I thought I’d address that because I think that is pointing out other open questions that I don’t think are answered here and it would be hard for us to make a recommendation without some further information.

DR. STEINDEL:  Simon, I agree with Stan and Jeff on this, I think there’s a lot of questions open on how medication history should be transferred, should it be in  terms of the Rx-Norm code, the NDC codes, what it should look like, etc., and we haven’t explored it enough.

DR. HUFF:  Even if it’s being passed now I’d like to ask questions about whether it’s being passed as free text or how it’s being passed because to meet the goals of the regulation if it’s being passed as free text it’s not adequate.

DR. COHN:  Well, then let’s talk through this a little bit just to see where we are, I mean we may very well decide to hold this until March or we may make some beginning recommendations with the statement that we will be making further recommendations going on.  I think what we’re doing is beginning to move up towards the 6.1 issues which is exactly, I mean we’re all sort of reflecting on well geez, what do we know about the medication history information that has a been a proprietary, actually what I’m hearing is a couple of things, that there’s, that RX-Hub has been using various messages to get medication history down to the provider, to the physician level, and they use a proprietary standard in some cases that is sort of take off of an NCPDP transaction I think at least in the format, and Terrie, I’m looking at you to make sure I’m getting this right, that they do that.  But then they also are using currently existing HL7 message in other cases to get this information down, is that correct?

MS. BYRNE:  I’d like to kind of address Marjorie’s question because I think giving a little bit of history might help the committee.  Originally when we had a request to get medication history from the payer to the e-prescribing vendors we weren’t using any HL7 messaging nor were they so they were used to NCPDP script, these were the non-EMR e-prescribing vendors, the smaller vendors.  So we developed the NCPDP format, it’s like script, it uses all of the script segments, it had most of the information that we needed in it because it basically is a record of what was processed.  So we implemented that between the PBMs and the early technology vendors so the majority of our technology vendors are receiving medication history in the script like format.

And to answer the NDC question it is at an NDC level because the physicians want to know what medication was dispensed and the package, and then those vendors will roll it up where the physician can do the UR with the information, etc., so they want the detailed information.

Then we started working with EMR vendors and hospitals and within the hospital the physician didn’t want to see, nor did the applications want the detailed information, so we created a report format for them which is an ORU transaction which is an HL7 messaging format and it’s in a report, we also created the RDS format which is a discreet data format within HL7 for those hospitals or EMR vendors that wanted the detailed data to do DUR and roll it up themselves.

So that’s kind of the history why we had NCPDP.  And I do have a concern, we’re planning to take this transaction through NCPDP for approval as a new script type.  Now after hearing the committee’s decision on new prescriptions yesterday, the committee wants to recommend a specific transaction type for a specific entity, I have a big concern about that for medication history because we have vendors who want HL7 and we have some who want NCPDP formats.  You may have a payer who wants to talk in HL7 or one who wants to talk in NCPDP format and so I guess, I also had a concern about deferring this until March and if it is deferred until March I’m not sure I want to start the process of taking this through NCPDP yet because if that format doesn’t get approved or if it gets approved only for specific entities we would do it differently.

DR. COHN:  So Marjorie we have gone full circle and I think we may be addressing your question now.  Jeff, did you have a comment?

MR. BLAIR:  Yeah, was that Terrie speaking?  I think I feel somewhat the same way you do but instead of my thinking, and the messages are, which message it is is a valid way of looking at it but one of the reasons that I feel uncomfortable is because I’m looking at it from the standpoint of the source of the information for medication history.  And right now how are we going to pull together the fact that some of that information comes from the dispenser, some from the payers, some from the prescriber, and right now it’s in bits and pieces and not only do we not have clarity, well, I think we have the greatest clarity because Rx-Hub has taken the initiative and moved forward to provide the medication history they have to go forward and I think that’s the clearest area.

The other areas are not clear by themselves or how they will pull together to all three and then the other pieces here are going to be how the patients are going to feel about having this medication history, let alone the medical history, shared among folks and we haven’t really explored whether those exposures, or how much of an exposure there is in that area either.  Maybe if I come back full circle, if we have a recommendation in this I think we pretty well know what the payers can contribute and we understand that and could support that, but I think we have to wait for more information on what the dispensers and the prescribers can contribute and how that will all fit together.  Does hit the bottom line and still recognize what Rx-Hub can offer?

MS. BYRNE:  I would agree with that, Jeff, we really haven’t explored getting medication history information from the dispensers and the providers, or the prescribers give it to themselves, so we’ve only had a request to get information from the payers and from the payers to give it to the prescribers so I can’t really speak to whether dispensers can provide the information, how you would get that, that model is very complicated, it’s a little easier with the payers because you know where the patient has coverage.  There isn’t a really good way to know where the patient has had medications dispensed centrally.

DR. COHN:  Terrie, I was going to make a comment, are you done?

MS. BYRNE:  That’s it, I can’t speak to that model and that is going to be a difficult model to explore and I suspect we’ll be exploring it when we take this transaction through NCPDP because I know the dispensers want to be able to receive the history and potentially provide it as well.

DR. COHN:  This is one I’m having a little trouble with and I don’t know whether, I’m afraid first of all we’re not giving Terrie much direction other then that she should not do anything until we make a decision and I’m afraid, well, let me put this on the table.  We’re in a situation, there’s lots of information flows here some of which the information flow itself may be ambiguous or we may be uncertain about the business case or the ability of players to perform.  But the reality here is is that in most of these cases, and the NCPDP script is an exception, is what I’m hearing is that there are well developed standards in common use and maybe I’m wrong about the common use but well developed standards that through HL7 that can support this messaging coming down and so it’s not really a standards issue.  Terrie, am I wrong about that one?  People are using HL7 today to do this.

MS. BYRNE:  We’re using HL7 to transport the information to the physicians in some instances, in the hospital, and we’ve had EMR requests to do it as well.  We are not using HL7 to retrieve the information or request it from the payers, we’re using the NCPDP format in that case.  So we’re translating and to address your question Marjorie about translation we’ve actually done that and we have provided our maps to the HL7/NCPDP committee that’s working on that harmonization so we’re planning to participate in that and hopefully we’ll include medication history at some point if it becomes part of script.

DR. COHN:  Okay, maybe I am having to even retract, the point that I’m trying to make here is is that this actually may turn out to be one of those things that we can say is actually adopt as adequate with industry experience is sort of what I’m wondering and as I’m listening to you I’m trying to decide which parts of these  messages are actually in common use where we have adequate industry experience and I was not taking into account what sounds to me like your own Rx-Hub way of getting things from your PBM to where you are which then you send it to HL7.  I guess I’m sort of thinking, I may have to retract my comment that maybe there’s something very obvious here but on the other hand what I am thinking is that maybe we need to delve into this further and hear from some further players and participants in the industry, maybe as early as our October hearings because as I said we may come away concluding that there really is an HL7 message that we could say is adequate and appropriate for industry use as early as 2006 in all of this.  Am I missing something?

MS. BYRNE:  Simon?  My only concern with that would be, well two things.  First of all the majority of our participants are using our NCPDP format today.  Secondly if we do move to the model where the pharmacies are either receiving or providing information they’re used to talking NCPDP script, or NCPDP, so that’s the concern I have.  We don’t have that business model anywhere implemented today where the pharmacies are getting that information and are providing it but if that’s the model we want to move to then we should explore using NCPDP for sure.  And I don’t know the answer to that because we haven’t had a request for that.

DR. COHN:  And certainly my view is that you want to create the ability for players to participate but you don’t want to, I mean I can’t tell people how they will choose or not choose to send information.  Now Phil I’d like you to make a comment and then let’s sort of see where we are which may be deferring this until March —

MR. ROTHERMICH:  I just had a comment on the —

DR. STEINDEL:  Simon, I have a comment on this.

DR. COHN:  Okay, let Phil comment first please.

MR. ROTHERMICH:  I was just commenting on your statement about whether we need to hear from other people, I mean if we’re talking about creating a standard for the transaction for providing medication history from the PBM or payer to the prescriber, I was just going to suggest that’s what we’re doing today and in our testimony last month we said that we ought to use what we’re using and what the vendors are using today.  If you get into whether we’re going to get medication history from a pharmacy that isn’t something that exists today and I would suggest that’s a different issue, and whether we’re going to take that medication history and put it into EMRs and we start talking about how to translate to HL7 I’d suggest that’s a different animal, I mean we’re doing that today as Terrie mentioned and there’s a way to do it today that really sort of the issue has been solved but I just wanted to clarify that we ought to keep them as separate issues so that you could today say we recommend the adoption of this method that’s in use today and proven by the industry for provision of medication history from the PBM or payer to the prescriber because it exists, it works, it’s done, and as they take it through the NCPDP process to get sort of public validation of that then that solves that other issue that’s been identified.

DR. COHN:  Okay, then I will make a comment and then I’ll let Steve make a comment.  Phil, I hear what you’re saying and obviously where I was going was is that knowing that they use both HL7 and Rx-Hub transaction, I guess I was misunderstanding that the HL7 was a mature industry accepted transaction that might be good to go now.  The other one we know what’s happening, it’s going to be going through the NCPDP process and so I was obviously confusing genres here very clearly.  Steve, do you have a comment?

DR. STEINDEL:  Yeah, I kind of like the comment that was just made because that gives us something positive to point to in one direction but I also think that we do need to explore this further because one thing with medication history and medical history, going back to the idea of patient safety, this is intimately involved in the decision support system and we really haven’t explored that at all.  And I don’t want to lock us into a decision in September that might be counter indicated with what’s going on with the decision support systems.  So I would just like to defer it and look at it a little further.

DR. COHN:  Maybe I’ll let Karen comment and then Scott and Ross and we’ll try to wrap this issue up and then we’ll take a break.

MS. TRUDEL:  Just in case this provides any kind of context, in my reading of the MMA statute it’s clear that while Congress didn’t preclude exchanges of information between everybody involved in the prescribing process what they appeared to be concentrating on was enabling the sharing of information that the plan had with both the prescriber and the dispenser.  So if there’s, if that helps in determining priorities I just thought I’d pass that along.

DR. COHN:  Karen, thank you.  Scott.

MR. ROBERTSON:  Scott Robertson.  The comment was made that what’s working today in the industry is NCPDP, I want to point out that’s one segment of the industry, there are established messages in HL7 that are not common within the retail end PBM portions of the industry, they are done on an enterprise basis, in some other countries they are the basis for the interactions between payers but not in the United States.  So there are messages available in HL7.  Whether that means they need supplant, I’m not saying that, they are available, if they’re useful great, if not hey something’s working I’m all for going with what works.

DR. COHN:  Okay, Ross?

MR. MARTIN:  Ross Martin from Pfizer.  The business case that we’ve been able to establish through Rx-Hub is having a single hub doing that provision of information, I’m not sure that we’ve been able to establish any PDP who may not participate in that hub being able to also provide that.  And I don’t know that we want to say that there’s got to be one private methodology for doing that, there has to be a way for non-participating, there has to be a way for two Rx-Hubs to exist in other words, more then one Rx-Hub to exist if necessary in order to do this.  And of course as has already been mentioned we haven’t, we haven’t established a methodology for going from the pharmacy, which will have much of this information that won’t be provided through, even if all the PDPs were going through Rx-Hub, especially when you’re talking about somebody coming into Medicare for the first time they’re not going to have any previous medication history necessarily.

MR. ROTHERMICH:  Two points on that, in our testimony, I mean Cigna was with us, they’re not part of Rx-Hub, and they agreed that the way that Rx-Hub does it is a good way to do it and the point we made was we’re not suggesting Rx-Hub become the standard, we’re suggesting that the way Rx-Hub solved the problem become the standard so that what we’re doing today and what all of the vendors that are connected to Rx-Hub, which I think Terrie mentioned the other day is like 30 people now, 30 vendors that have built to that standard, are doing it.  So that if somebody comes in and doesn’t want to do it Rx-Hub’s way, if they use the same formatting for those messages then all the vendors who are out there doing it today could connect to them using the same thing and you don’t have to recreate the wheel.

MR. MARTIN:  I agree with that —

DR. COHN:  I think we’ve had some of this conversation yesterday also.

MR. MARTIN:  — I’m just suggesting that the focus of the pilots be that interoperability of there’s Rx-Hub doing it, there’s somebody else doing it, using the Rx-Hub methodology that’s fine, but we have to make sure that we’re doing that in the pilot and that’s not —

DR. COHN:  Well Terrie I think you have a final comment and then I’m going to ask the subcommittee what we would like to do at this point.

MS. BYRNE:  Yeah, I did want to comment just on the HL7 comment you made, Simon.  We did find through our research that there are other entities out there sharing medication history within hospital systems, etc., that are using HL7.  So I didn’t want to indicate that HL7 medication history is not mature, we’re just starting to use it in our implements but we used their experience in the development of our model.

DR. COHN:  Let me ask the subcommittee, do you want to try to make a disposition on this before we break or do you want to think about it over the break?  Okay, why don’t we take a ten minute break and we’ll come back hopefully ready to figure out what our next steps ought to be.

[Brief break.]

DR. COHN:  Okay everybody, we’re back together here.  I am reminded that I should never make comments either about when the meetings are going to end or how well we’re doing until we’ve already done it.  I do want to mention just as we start out, and we’re starting here, would everybody please be seated —

MR. BLAIR:  Steve, are you on?

DR. STEINDEL:  Yes, Jeff, I’m on.

DR. COHN:  I do just want to indicate that we are going to be having in follow-up of all of this two open conference calls which will be looking and revising and editing the actual document.  We’re clearly today getting the intellectual property in place and the basic thoughts and bullets and all of that but there is no intent to do extensive wordsmithing but we are going to be having two open conference calls to do wordsmithing hopefully and other comments at that point.  These will be occurring next week at, the first one will be on Wednesday, August 25th at 12:00 noon eastern time and we’ll be putting it on the website the call in information because as I said it will be an open call.  The other one will be at 12:00 noon on Friday if needed.  Marjorie?

MS. GREENBERG:  Eastern daylight time.  As you may be aware there is leave potentially the HHS Data Council meeting was, were you not planning to participate?  It was rescheduled to next Wednesday but I didn’t know what, and since you’re the representative, but —

DR. COHN:  I actually hadn’t been informed of the rescheduling though I was informed of the cancellation.

MS. GREENBERG:  And I don’t know if actually, I think it was like to hold that date if needed, it’s not been confirmed has it yet?  Okay, but I assume this call will last more then hour.

MR. BLAIR:  We really ought to schedule it for probably two, at least two.

MS. GREENBERG:  Okay, I just wanted to confirm that.  And the same on Friday?

DR. COHN:  Yes.  Okay, but anyway that will be posted on the website and all that.

Okay, now let’s go back to where we were, everybody okay with that?  Okay.

Now let’s go back and sort of see what we can do with item six here and I guess I’m going to suggest what we ought to do here and then see what the other subcommittee members think and see if there’s some way to get this resolved and move forward.  Now first of all the issue here is this includes a number of different information flows in the same recommendation and I am suggesting first of all that we talk specifically about the health plan, PBM to provider flow and deal with that specifically deferring comments on the other flows and the recommendation there would be that the rest of this will be deferred, the other parts will be deferred until March 2005 recommendations.  Are we okay with that first of all?

DR. HUFF:  Yeah, just one clarification, just a point of fact, I mean is that the common flow today, Terrie?  The common flow is from —

MS. BYRNE:  Yes, from the payer to the provider.

DR. HUFF:  From the payer to the provider.

MS. BYRNE:  Physician.

MR. BLAIR:  And provider meaning which since we have ambiguity about that word, to the prescriber or the dispenser?

MS. BYRNE:  Right, the physician, the prescriber —

MS. GREENBERG:  And that’s an NCPDP message?

MS. BYRNE:  We request and receive the information from the payer in an NCPDP format, we send some technology vendors the NCPDP format, we send a couple of them the HL7 format.

MR. BLAIR:  And Phil said something offline that made me feel a lot more comfortable about this and he indicated that there’s filters on that to try to minimize the possibility of privacy concerns and I think that’s a help.

MR. BYRNE:  And that’s the, the PBM determines that, what gets filtered.

DR. COHN:  And we will be having hearings and we’ll talk about that at the end about specific hearings with the Privacy and Confidentiality Subcommittee on the privacy concerns related to e-prescribing in November —

MR. REYNOLDS:  Let me ask one question of clarification.  Terrie, the same message also goes from the PBM to the pharmacy —


MR. REYNOLDS:  There’s no medication history going to the pharmacy?

MS. BYRNE:  No.  I don’t know of any implementation, Rx-Hub has not implemented that nor do I know of anyone —

MR. REYNOLDS:  But how are they doing drug/drug interaction or any of that?

MS. BYRNE:  Pardon me?

MR. REYNOLDS:  How are they doing the drug/drug interaction that we’ve heard so much testimony on?

MR. BYRNE:  With their own medication history I believe —

DR. COHN:  And then the PBM repeats it with their history —

MR. REYNOLDS:  But only their own —

MS. GREENBERG:  Which is only the stuff they filled —

MS. BYRNE:  I’m not the expert on that.

DR. COHN:  I like these councils of experts that we put together, please.

MR. WHITTEMORE:  Ken Whittemore from Sure Scripts.  Harry is right, the pharmacy gets the information when they submit the claim —

MR. REYNOLDS:  From the PBM —

MR. WHITTEMORE:  From the PBM, right, but that’s at the back end of the process rather the front end —

MR. REYNOLDS:  I understand that but they still get it —

MR. WHITTEMORE:  Excuse me, let me qualify.  It’s not a medication history, they’re basically passed if there’s a conflict with the medication history that the PBM might have so all they get would be that there is a conflict and what the conflict is with but if there are any other medications they wouldn’t get that.

MR. REYNOLDS:  Okay, that clears it up, I just needed to make sure —

MS. GREENBERG:  When you say when they submit the claim this is like in real time?  Before it’s actually given to, before the patient actually gets the drug?

MR. WHITTEMORE:  That’s correct.

DR. WARREN:  Could he repeat that again?  I’m having digestion problems.  Could you repeat the process?

MR. WHITTEMORE:  As I was saying to some folks yesterday we’re kind of getting in a process where this DUR can actually be done at four different points in the process.  Right now, well, let me just, I’ll highlight them all.  In theory with a physician system that they use to generate prescriptions when they create the prescription it will check against any medications that they’ve previously prescribed.  If they have a relationship with Rx-Hub then the next step would be to submit that information and Rx-Hub would bounce that information off of whatever payment claims history there was from the provider —

MS. BYRNE:  No, I’ll speak to the Rx-Hub model, the technology vendors receive the medication history from the payers through Rx-Hub, they start out locally.  We don’t have any history nor do we do DUR, we only provide the medication history to the technology vendors who then do, they have their own DUR logic within their systems.  And they do it, and just one other clarification, there are vendors out there who are also receiving medication history directly from other health plans and PBMs so they use the same model they just don’t get it through Rx-Hub.

MR. WHITTEMORE:  Then at the pharmacy when the prescription is received at the pharmacy and is input into the pharmacy system that system compares it with whatever medications are in that history and then once they’ve dealt with any conflicts that might occur and the claim is submitted to the PBM the PBM will bounce that off of all of the claims history that that PBM has in house and if there are any conflicts they send it back to the pharmacy.

MR. REYNOLDS:  Does the DUR message that comes back, is it in NCPDP format?


MR. REYNOLDS:  Thank you.

DR. COHN:  Yeah, it’s probably part of the NCPDP telecom messages.  Okay, I guess we’re going to try to keep this simple is the intent here and I guess what I was going to suggest for this particular message what we do now knowing that we heard yesterday from NCPDP that they were leading an effort to work with the currently existing proprietary message and I think Terrie is leading this effort up, to try to move this into an NCPDP process in much the same way as our discussions yesterday around the formulary message.

And so for this particular use case, particular information flow may be the better way to describe this, I was actually going to refer you to our previous recommendations to, which describe support of acceleration of NCPDP promulgating in this case a medication message between PBM/health plan and dispensing provider, prescribing provider, and as an ANSI standard using the Rx-Hub protocol as a basis to achieving the street consensus.

So basically once again mirroring that recommendation number one, number two is based upon the regular feedback on this from NCPDP, NCVHS will provide advice to the Secretary about readiness for adoption of this message format standard.  And sort of leave it at that and the other things will then be deferred then for further discussion and potential hearings or otherwise for the subcommittee.

Now are we comfortable with that, those sets of recommendations there?  This is once again just consistent with how we’ve handled other things that Rx-Hub has done, we’re obviously very thankful that they’re putting it into the NCPDP process and I think we’ve observed that A), this one is actually being used within the industry, we are going to need to look at this just as we will formulary to see whether it’s something that’s going to need piloting in 2006, or whether the view is either by the NCVHS and the rest of the industry that what comes out of the NCPDP process is sufficiently similar to what’s been there now and everybody feels comfortable going forward with this as one of the initial standards in 2006.

Margaret, do you have a question?

MS. AMATAYAKUL:  Yeah, I just want to check the wording on this about that?

DR. COHN:  Okay, why don’t you read it, I actually want to ask the subcommittee, are we okay with where we’re going here?  Okay.

DR. STEINDEL:  Simon?  I think I’m okay where we’re going here, I just have two questions.  One is does the Rx-Hub message transmit the medication history back to the prescriber using text or NDC codes?  And the next part of the question is how many prescribers actually receive that message and is there any problem?

MS. BYRNE:  This is Terrie Byrne.  To answer your first question we send back the NDC code so the actual package drug dispensed, and we haven’t heard of any problems as to, the question was are the physicians actually using the information, I guess that’d be a more appropriate question to ask the technology vendors who are using the information for DUR in presentation back to the physicians.

DR. STEINDEL:  I think I’m comfortable with it, I think that we may see some future twists in this after we relate the NDC codes to what’s required with decision support systems but I don’t think that’s really appropriate to comment here in this message.

DR. COHN:  Yeah, I don’t think that that’s an issue that we need to resolve right at the moment.  Is there an additional comment here before we try to move forward?

MS. HOME(?):  This is Jill Home from All Scripts, just as validation the Rx-Hub process does work well, we do receive information back in NDC codes and I think it is wise to make mention of an area of exploration would be the matching of the NDC codes back within the information that’s contained in the e-prescribing system.

MS. BYRNE:  Just to clarify on that, the reason we send the NDC is two-fold really, that is the drug dispensed and that’s necessary to know.  Secondly that is the key that all the other drug files use to match that drug so then the tech vendors can use the NDC code to get any therapy class, etc., information.

DR. COHN:  I think at this moment none of us are arguing about that approach.  Margaret, do you want to tell us what you have written up there so we can make sure that we’re comfortable with it?

MS. AMATAYAKUL:  So one would be to support acceleration of NCPDP promulgating a medication history message for communication between payer, PBM, and prescriber as an ANSI standard using the Rx-Hub message based on NCPDP.  The second piece of this and I have a question here, based on regular feedback from NCPDP and further exploration of HL7 messages, that should be —

DR. COHN:  No, there’s no, this is basically, look at 2.2 which you have which is based upon regular feedback from NCPDP NCVHS will provide advice to the Secretary about readiness for adoption of this message format standard and I would just leave it at that.

MS. AMATAYAKUL:  Then that’s what I’ve got here, you don’t want HL7 —

DR. COHN:  I don’t think that that’s something that we need to discuss right now.

MR. REYNOLDS:  So Simon we’re basically saying we’re recommending that they go off and do this and that we want regular updates and then we’ll tell the Secretary.

DR. COHN:  Exactly, exactly, once again this is I think what we said with the formulary standard, I think that this is something that it may be that as this moves through the NCPDP process we may all look at it and say the industry comes forward and says yes, this is great, this is really pretty much what we’ve been using or this is even better then what we’ve been using, this will be easy to implement, we’ve already had an adequate industry experience and therefore we can recommend to the Secretary that this is actually part of the standards that don’t need piloting.  Or based on what we’re hearing we may decide that this is a pilot issue.  Margaret?

MS. AMATAYAKUL:  So we can delete this adopt NCPDP script and HL7 message for medication history and respective domains, we can take that out —

DR. COHN:  Yes, everything else is going to be deferred, all the other issues we have here are going to be deferred until March.

MS. AMATAYAKUL:  Should I put this for March or should I just delete it entirely?

DR. COHN:  There’s another message here, I would delete it entirely but Jeff, what is your comment?

MR. BLAIR:  I think that we ought to have a statement so that somebody doesn’t think that we’re not looking at medication history which might come from prescribers, it might come, or it might be within the dispenser domain, that our silence doesn’t mean that we’re not planning on doing anything so I think that there ought to be a placeholder there indicating that we will be exploring those.

MS. AMATAYAKUL:  I do have placeholders for prescriber and dispenser and prescriber with patient for March, so I didn’t know if I should keep this for March or just delete it entirely.

MR. BLAIR:  Say it should be on the docket for March, that we plan to look at those.

DR. COHN:  Yes, but certainly not in this particular letter.  Harry, please.

MR. REYNOLDS:  Back to our, we made an earlier decision on the NCPDP that within an institution you can deal in HL7, if you went outside the institution you went to NCPDP, does the same premise exist in this as existed in that?

DR. HUFF:  I’m not sure we actually even, I don’t think we have to say because I think it’s understood that IHC talking to IHC can send whatever kind of messages it wants internally.

DR. COHN:  And that’s I think going to be a further message that we, I mean that’s a further transmission —

MS. GREENBERG:  Didn’t that decision relate to communicating with the retail pharmacies?  I thought that was —

MR. REYNOLDS:  Well, yeah, the whole decision in the past was if you’re in your own institution and you can do HL7 or NCPDP, whatever you want to do, as long as you’re already doing it.  If you go outside of that then you go to NCPDP, I mean I don’t want to belabor this, I just want to make sure that every time we reinstate that same decision, if it is a decision to make in this case —

MS. GREENBERG:  I think that’s a little broader because what if you as one institution wanted to send a medication history to another institution, does that have to be NCPDP?

MR. REYNOLDS:  Yes it does, we decided that yesterday.

DR. COHN:  Not medication history, a prescription.

MS. GREENBERG:  You mean two hospitals, they have to exchange medication history using NCPDP?

DR. COHN:  We haven’t talked about medication history, we’ve only talked about prescriptions.

MS. GREENBERG:  Right, so I’m saying it’s not the same decision when you’re talking about —

MR. REYNOLDS:  Wait a minute, that’s my whole question, are we using the same premise —

DR. COHN:  And I guess my point was is that we were deferring those other information flows to March is what I thought we were doing.  Stan, is that not what we’re doing?

DR. HUFF:  Yes, that’s what we’re doing, I just want to clarify, Harry’s question the way I understood it and the way we handled it in the first situation, the situation here would be for instance IHC’s health plans sending prescription, or medication lists to IHC prescribers, and we’re saying they can do that however they wanted to, we never addressed in either case when we were sending messages about the patient between two health care institutions.  We haven’t talked about that and I don’t think we should talk about that, I mean that’s really the EMRI standards that we talked about before, that’s where we already adopted HL7 for sending clinical information institution to institution.

DR. COHN:  I think the intent here just to keep the balance here as we were talking specifically about transmissions between health plan PBMs and providers, or prescribers in this case, and everything else we’re remaining silent and we will deal with in March is I think what we’re saying, and nothing should be in any way construed to mean anything else.  And I would be afraid to start picking away at those areas by making comments as opposed to giving a comprehensive statement.

MR. REYNOLDS:  Only making sure it’s clear —

DR. COHN:  Okay, are we all comfortable with this?

DR. STEINDEL:  Simon?  I think there’s some issues that may not even be resolved in March, like what Stan was talking about, we haven’t even discussed the idea of transmitting the patient’s history of their medical care from IHC to Mayo Clinic for instance, which is going to contain medication history.  That’s an entirely different issue and I think out of scope of this discussion with —

DR. COHN:  If we ever make it through this one that’s actually the next issue, Steve.

DR. STEINDEL:  It’s medical history with respect to e-prescribing but we were also talking about institution to institution transfer HL7 is now starting big discussions on.

DR. COHN:  Okay, well, so are we okay with where we are here?  Should we move to the next item?  Are we okay?  Going, going, okay, let’s move on to the next item.  The next item is I believe medication history from, Margaret help us with this one.

MS. AMATAYAKUL:  Medical history from prescriber to dispenser may be a desirable transaction but will require an electronic health record or other clinical computing capability that is not commonly existing in the industry today.  Early efforts are being made by HL7, ASTM CCR and others to promote this functionality.  ASTM CCR is a new standard that supports the content for exchange between prescribers, such as in an electronic health record, and with patients, such as in a personal health record.  The possible recommended actions are a medical history transaction for e-prescribing as a longer term action.  ASC X-12-N 275 additional information, common called the claims attachment, could be considered for interim use.

And second explore the applicability of using ASTM CCR content included, oh, I didn’t finish this, I’m sorry, because I moved this from up above —

DR. COHN:  Well I would ask the subcommittee, is this one that just in total other then the comment that we want to, that we’ll be looking at this further, is there any other comment that we want to make about this at this point?

MR. REYNOLDS:  Is ASTM CCR a standard?

DR. COHN:  It’s an ASTM standard —

MR. REYNOLDS:  Or a proposed standard?

MS. AMATAYAKUL:  It’s in final drafting ANSI standard.

DR. COHN:  ASTM, but there’s no transmission —

MR. BLAIR:  It was founded as a standard but the implementation guide will be validated in I don’t know, September or October, something like that.

DR. HUFF:  I would just suggest one wording change and say ASTM CCR is a new standard that specifies the content for exchange.

DR. COHN:  I guess my question is is do we need to say anything of this or do we just say the medical history issues are going to be further discussed in March, I mean that would be the question I’d have for the subcommittee.

DR. HUFF:  I second that —

MR. REYNOLDS:  I third that.

DR. COHN:  Judy, do you fourth that or do you have —

DR. WARREN:  I have a question about, I agree in principle with what you’re saying, up there with the ASTM we say it’s a new standard and yet it’s not completely through the process yet because the implementation guide is not done.  Can we say it’s a draft standard?  Isn’t that more accurate or am I missing something?

DR. FITZMAURICE:  It’s a balloted standard but to implement it you need an implementation guide, I don’t know, do we call that limbo?

DR. WARREN:  So I guess my question, is the word new appropriate there because it’s not completed yet.

DR. FITZMAURICE:  Why don’t they just say it’s a balloted standard and not talk about new or old.

DR. WARREN:  I would be happy with that.

MS. AMATAYAKUL:  How about ASTM CCR is a balloted standard with its implementation guide being balloted —

DR. COHN:  Being completed —

MS. AMATAYAKUL:  That specifies the content for exchange.

DR. COHN:  Okay, I think what we’ve heard, I’ve heard another person say yes, we should defer until March.  Okay I guess I would ask the subcommittee and I don’t mean to wordsmith, but since we’ve just been wordsmithing for the last three minutes the question is is do we want to include any of this in the letter or should we review that and see, I mean we can choose to include this as just sort of a statement and then we’ll say we’re going defer to looking at this entire area and provide recommendations in March, or we could not even include in this information.  Does the subcommittee want to review a letter that at least has a couple sentences here?

DR. FITZMAURICE:  My thought was that we don’t want to say that we’re looking at medical history but since we’re not making a specific recommendation at this point it’s kind of moot as to whether we mention CCR or not.  Judy, what do you think?

DR. WARREN:  That was my thing, I think we need to mention in the letter that we are still conducting hearings on medical history and leave it at that, I don’t think we need to mention any of this other stuff.

MR. REYNOLDS:  I agree with that.

DR. COHN:  Okay, so we’ll hold this wording for our potentially March letter updating it but we’ll just reference that this will be deferred to March.  Okay?  That was easier then the last one wasn’t it?  Now Margaret help me, is there anything else we have on message formats or do we now move to important related items?

MS. AMATAYAKUL:  No, there are no more issues.

DR. COHN:  Good, okay.  Do you want to lead us through the important related items?

MS. AMATAYAKUL:  Yes, okay, do you want me to identify what all I’ve got here and then go one by one?  Or one by one only?

DR. COHN:  Why don’t you go one by one?

MS. AMATAYAKUL:  MMA requires standards for e-prescribing for Medicare.  Because this will likely drive the industry in general standards adopted for e-prescribing should be universally acceptable.  And potential recommended actions might be ensure that e-prescribing standards are compatible with those adopted as HIPAA and CHI standards and two, ensure that e-prescribing standards are applicable for all of health care irrespective of payer.

DR. COHN:  Okay, comments?  I mean I think that looks pretty good.  Anything controversial there?

MR. BLAIR:  I’m sorry —

DR. COHN:  Jeff, do you have a controversial comment?

MR. BLAIR:  No, I don’t have a controversial comment, could you just reread it for me?

MS. AMATAYAKUL:  The whole thing Jeff?

MR. BLAIR:  Yeah, I’m sorry, that important related issue.

MS. AMATAYAKUL:  The observation is MMA requires standards for e-prescribing for Medicare.  Because this will likely drive the industry in general standards adopted for e-prescribing should be universally acceptable.  Recommended action one, ensure that e-prescribing standards are compatible with those adopted as HIPAA and CHI standards.  Two, ensure that e-prescribing standards are applicable for all of health care irrespective of payer.

DR. COHN:  Okay, I think we’re accepting that one, go forward.

MS. AMATAYAKUL:  There are lessons learned from HIPAA regarding both the need for standards and the flexibility to respond to industry needs and technology changes.  Pilot testing should ensure not only that new standards can be implemented with their implementation guidelines but provide ally(?) information, education, implementation recommendations and other elements that contribute to successful and widespread adoption.  I’ll clean up the typo.

The recommended actions might be one, incorporate the ability to respond to industry needs for revisions in e-prescribing standards that are regulated.  Two, identify specific goals, objectives and metrics to construct and evaluate pilots.  Three, test various enhancements to NCPDP script such as inclusion of decision rationale for drug choice, example, when a formulary drug is ordered or an allergy exists, Rx-Norm and structured and codified sig.  And four, support the development of educational material and explanation of return on investment benefits to facilitate adoption.

DR. COHN:  Comments?  Do you have a question or a comment?

MR. BLAIR:  Question.  This is an open question to anyone that may be able to clarify this.  I think it’s appropriate that we do have return on investment in there but it’s not clear to me what we’re referring to as the investment, and that if we’re comparing it to the proper context, because if it’s not compared in the proper context you could simply wind up indicating this is a cost, but if you don’t include all the parties that may benefit from the investment then you could easily say well, a payer had to pay this much to be able to do this standard but they didn’t get any benefit from it.  Where did the benefit go?  Maybe it went to the prescriber, maybe it went to the patient, and so what could we do so that the return on investment concept here includes all parties, and I’m hesitant on this because I sort of feel like it becomes hard to do and complex, and on the other hand if we don’t do it this way the return on investment may just simply come back and wind up saying to a prescriber, for example I’ll take another case, well it isn’t worth it for me to install e-prescribing because I don’t get my investment returned even though the returns may go to the system as a whole.  How do we do that?

DR. COHN:  I think Maria has a comment and then I have a comment, and Harry has a comment too.

MS. FRIEDMAN:  In responding to what Jeff said that’s going to be a challenge of the outreach and educational programs in general and I would like to modify 16.4 to say not just educational material because those of us who have been doing this knows you can throw a paper at people but getting them to act on it is a whole different thing and so I would like to modify that to educational program, broaden it, which would include developing materials, technical assistance, and all that, the kinds of things that we do.

And secondly I would like to just make that the benefits, an explanation of benefit of e-prescribing to facilitate adoption because it might not just be the ROI but there are patient safety and quality of care and other benefits that might be, that are first of all important to let people know about but that might be the other sales point for getting people to adopt.  It might not just be the ROI, it might be that people care more about patient safety or quality or whatever.

DR. COHN:  And of course incentives might help in all of this also, obviously incentives have a way of changing ROI.  Harry, do you have a comment?

MR. REYNOLDS:  I guess this is the area where if, when you read 16.3 it’s the philosophy of as this changes continue to evolve with it.  The current HIPAA standards, one of the problems with the HIPAA standards is it is a lockdown, it is clearly in the regulation, it is a lock down, your attention please you can only use this, this is it, have a nice day.  The issue that I hope we can figure a way to address is, and this was used for a long time in technology, IBM was a master at it, whereas they would give you system software and no matter how different the computer changed you could always continue to use it as you moved forward and then take advantage of the new functionality.

And if we could figure a way, and we’ll just use this NCPDP script as an example not as the only thing, so that we would say that whatever gets adopted only should the legislation get involved if people that implemented that are forced to change.  Let me give you an example, if you did NCPDP script and then you added something to it which people could use as an additional functionality, but if I didn’t want to use it I could continue, I being anybody, I could continue using what I already have, then you don’t want each one of those steps to have to go through this whole, once NCPDP said this is okay, you don’t have to change the legislation and you don’t have to go back through this whole magical process, then if people want to move to the next step and the next step and the next step, only when you force me because I implemented the first one to go in and change inherently what I’m doing, then you’re basically effecting the whole industry.  So I don’t know how that works, I don’t know the process —

DR. COHN:  It looks like Karen has a comment, it sounds like backward compatibility to me but Karen —

MS. TRUDEL:  Just wanted to point out that what we did to accommodate that concern in CHI, keeping in mind that these were voluntary standards required for federal use only, was to say for instance HL7 version 2.3 and up.

MR. REYNOLDS:  That then allows the industry to be progressive and it doesn’t tie people’s hands.

DR. COHN:  Jeff, do you have a comment?  Then Margaret has a question.

MR. BLAIR:  I’d like to propose a solution to the problem that I raised and Maria contributed part of it where she said benefits, so on the one hand if we indicated that there be an exploration of network wide or system wide benefits, so all parties looked at in the benefits, but if we, and I’d be eliminating the ROI words because that would be incorporated in the benefits plus this other phrase, and the other phrase is that we would also be examining to make sure that e-prescribing did not pose an undue burden, undue financial burden, okay, maybe financial time, an undue burden on any particular segment of this e-prescribing environment.  If you have both of those I think that that would put HHS in a position to identify any undue burdens, financial or time consuming burdens, but at the same time be able to measure it against the total picture.

DR. COHN:  Okay, do you want to have Margaret read what she has up there?

MS. AMATAYAKUL:  Support the development of educational programs and explanation of benefits and does not impose undue burden on any segment of e-prescribing environment for full adoption of e-prescribing for all beneficiaries.  I think the sequence could be better worded but —

DR. COHN:  Yeah, but it I think references those areas.  Okay, I think it incorporates what Jeff was just saying so it sounds good.

Now, Maria are you commenting on something yet different or are we closing the loop on 6.1, 16.1?

MS. FRIEDMAN:  I want to address 16.4 —

DR. COHN:  Okay, let’s finish off 16.4 then and then we’ll go back and deal with 16.1 since we skipped back and forth.  Go ahead.

MS. FRIEDMAN:  I’d like to take off the for full adoption of ERX for all beneficiaries because it makes it sound like the education programs only talk about the benefits for beneficiaries whereas there’s benefits for everybody in the chain.  I think eliminating that takes care of my problem with that.

MS. AMATAYAKUL:  I think as beneficiaries I meant all those who benefit, not the Medicare beneficiaries —

MS. FRIEDMAN:  Beneficiaries has a very specific meaning in the Medicare world so just to be clear.

MS. AMATAYAKUL:  From all who benefit would be better.

MS. FRIEDMAN:  And then I’m concerned about the undue burden because having lived in a regulatory environment there are always people who say I’m not going to do it because it’s going to be a burden, I’m not going to spend a nickel because that’s an undue burden and I’m just, I understand the intent of what you’re talking about that you don’t want to make this an onerous hasslesome process but I’m concerned that by stating it this way it just opens the door so wide for any, for a lot of people who won’t understand what the burden could be, they’re just not going to do it, they’re going to say it’s a burden I’m not going to do it.

MR. BLAIR:  Do you have any better language?  Because I don’t want to ignore the fact that there might be an undue burden and I think that there’s certain folks that are very concerned that as the path we take does place an undue burden so I sort of feel like some way, there should be some way to recognize and consider that and either help them with incentives or subsidies or something so maybe the words are not proper —

MS. FRIEDMAN:   I share your intent, I just don’t like the words.

DR. COHN:  Okay, well that’s wordsmithing and we can defer that one, but Margaret did you have a suggestion or a question on this one?

MS. AMATAYAKUL:  I wonder if there shouldn’t be a separate recommendation for incentives.

DR. COHN:  Okay.  Ross, do you have a comment?

MR. MARTIN:  I just wanted to point out that the language that is specifically in the bill talks about the undue burden on providers so it’s appropriate language for them at least and then maybe if you do do an incentives clause or another one that you could reflect on that.

DR. COHN:  Okay, thank you.  Now I realize that we are going to be wordsmithing after Margaret has a chance to wordsmith it herself so I don’t know that we need to do a whole lot.  Now I do think that 16.1 we did not close the loop on, did you have a suggestion?

MR. REYNOLDS:  As Karen mentioned CHI did what we’re talking about in 16.1, at least address it, I wouldn’t mind referencing that since it’s already been through all the process and it’s already been dealt with.  So I’d like you to add that to 16, okay, good.

MR. BLAIR:  I have another quick —

DR. COHN:  Jeff, are you doing wordsmithing or what?

MR. BLAIR:  Well, yes I am and I’ll wait.

DR. COHN:  Okay, Karen?  I’m just trying to keep everybody out of wordsmithing at this point.

MS. TRUDEL:  Again, just wanted to provide some context as far as incentives is concerned, the MMA does provide for a grant program beginning in 2007 for implementation of e-prescribing by providers.  And there is, I believe it’s $15 million dollars authorized for that year and then such other sums as necessary for the next two fiscal years after that but it is not appropriated money.

DR. COHN:  Well, actually there’s two pieces, there’s the grant program —

MS. TRUDEL:  And then there’s the incentives in section 102, exactly, for MA drug plans —

DR. COHN:  Which are made explicit in the NPRM, so I think we want to be supportive of both of those.  Okay, so I think we sort of have gotten the ideas up there and further wordsmithing.  Now are we okay with 16 at this point?  Margaret, you are not.

MS. AMATAYAKUL:  I have a question.  I just want to clarify that 16.1 and 16.3 I had a little bit different intent here and can I just check with you?  16.1 I think was the intent for this backward compatibility.  16.3 was really the notion that we were going to recommend in one the adoption of NCPDP in various functionality but that there would be testing of NCPDP once we got to these enhancements.  Maybe I didn’t say 16.3 quite correctly yet.

DR. COHN:  Well, I thought you did, I guess I’m, testing various enhancements to NCPDP script, is that —

MS. AMATAYAKUL:  Okay, yeah, okay.

DR. COHN:  I thought it was pretty clear what you were saying there.

Now are we okay generally with 16 knowing that we will wordsmith it like mad, I mean 16.1 needs a significant amount of wordsmithing and I don’t know whether it’s backwards compatibility or whether it’s HHS adopting the CHI model of standards identification and acceptance which is more like a version X and above rather then backward compatibility but they’re hopefully sort of similar concepts.  Now are we okay with 16?  Now I did receive a message —


DR. COHN:  Yes Steve, you have anything on 16 —

DR. STEINDEL:  I’m going to pull a Jeff trick could you read it again for me.

DR. COHN:  Sure, I think you want all of 16 read again?

DR. STEINDEL:  No, just the final part that we just went over, I think I have the gist of it but I want to make sure.

DR. COHN:  I don’t even know which 16 we just went over.

MS. AMATAYAKUL:  I’ll read the recommended actions for 16.  One, incorporate the ability to respond to industry needs for revisions in e-prescribing standards that are regulated through backward compatibility or adopt the CHI model such as version X and above.  Two, identify specific goals, objectives, and metrics to construct and evaluate pilots.  Three, test various enhancements to NCPDP script such as inclusion of decision rationale for drug choice, Rx-Norm, and structured and codified sig.  Four, support incentives for e-prescribing adoption, for example MMA provides through a grant program for adoption of e-prescribing by providers, we have to wordsmith on that, support the development of educational programs and explanation of benefits before adopting e-prescribing for all who benefit.

DR. STEINDEL:  Thank you, I’m fine.

DR. COHN:  Okay, so we’re okay with 16.  Now there’s been a request that we go back to 15 briefly, now are you okay?  I take back what I said.  Are we okay then?  I’m sorry, are you on 16?

MR. MARTIN:  Just about the versioning and this may apply to other ones as well, I think it’s good to say and above so that you don’t lock yourself and limit innovation but I think you also want to back into that in terms of sunsetting so that you say that you have to be, you can’t be more then X number of versions behind or say something like you can’t be more then three years behind in terms of what’s out there because you don’t want to be supporting forever that oldest version, so five, six years from now when we’ve gotten to being able to medication history and medical history and all those things you have to, you want people to be able to leapfrog it, you don’t want them to be developing to every single version each time because that gets expensive but you don’t want to be supporting somebody who’s ten years back.  And I would just suggesting thinking about how you can put that language in there.

MR. REYNOLDS:  What Karen and I had talked briefly about is the idea of rebasing at some point, at some point it would come back to the legislation and say okay now this is your starting point again and everybody has to move.  It’s kind of that idea you go for a while and then you say okay, this is now it and you’ve got X amount of time to implement it because you can’t just tell people to go, you can’t just have a free for all so you’ve got to set some process up.  That’s a way to consider it.

DR. COHN:  And I would suspect that rather then us giving the answer to CMS and HHS we’re suggesting some approaches because really what we want to do is provide some flexibility to the industry to enable people to move forward and so I think these are all examples.

MR. MARTIN:  The advantage to having a sunsetting clause in there is that you don’t have to go through regulations again to have some automatic advancement.

DR. COHN:  So we’re all okay with 16?

MS. AMATAYAKUL:  I’ll look at CHI and see what I can find from there.

DR. COHN:  Okay, great, I appreciate that.  Okay, let’s move on to 17 then.

MS. AMATAYAKUL:  A significant level of collaboration is occurring among SDOs and with vendors who have proprietary standards as there is growing momentum for e-prescribing and other components of the NHII.  It is important to support the voluntary nature of SDOs while accelerating the process of standards development.  One, recommended action, provide financial support to SDOs for facilitation of harmonization efforts to ensure a seamless prescribing process across provider domains, office, hospital, long term care.  Two, encourage SDOs to adopt a change management process that permits versions to remain in harmony.  Three, encourage the industry to adopt a policy that translation from one format to another be performed by sender so messages are ready for the receiver.

DR. COHN:  I see people nodding their heads, of course I know Jeff is going to have an issue here, but I’m sorry Jeff, would you like to comment?

MR. BLAIR:  I like it all, my only thought is a lot of this is coordination and integration and I just am a little concerned that we don’t really have an entity that would perform that function.  And I’m not sure that this requires another recommendation to be added to that but I’m fearful if we don’t have that that these will be nice words but they’ll be nobody to really go after this.  So how do we make this actionable?

DR. COHN:  I think Carol Bickford has a comment, do you have an answer to Jeff’s question?

DR. BICKFORD:  No, I have a different question, it’s in relation to 17.3, the way it’s written it would seem to me that if I’m in compliance with a specific standard that I’m being burdened to have to change the format for someone who was not, when it’s talking about the sender has to convert for the receiver so I’m asking for clarification on that.

MR. BLAIR:  We could do one thing at a time?  I think we’re jumping from one thought to another —

DR. COHN:  I think Margaret, let’s see if we can finish off Carol’s and then we will —

MS. AMATAYAKUL:  I think your point’s well taken and that wasn’t the intent so I’ll work on that.

DR. COHN:  We’ll wordsmith it, thank you Carol.

MS. GREENBERG:  I think you can just say translation from a non-standard format to a standard format is what you’re talking about right?

DR. BICKFORD:  My concern is that if I’m compliant with the standard why should I make —

MS. GREENBERG:  You wouldn’t have to, it’s only if you have a non-standard format and you’d be responsible to put it into standard format.  Right?  That’s what was meant?

DR. COHN:  Right, I think that’s —

MS. GREENBERG:  What I wanted, I had something else I wanted to say.  17.1, it would seem like we not only want this to be seamless across provider domains but also with the dispensing organization.

DR. COHN:  Oh, I see, you want to add in e.g. pharmacies.

MS. GREENBERG:  Well, no, yeah, I mean, and, not e.g. but and.

DR. COHN:  Okay, sounds good.  Now are these comments on, Margaret, okay, if you have an issue, Jeff has an issue that’s outstanding that we haven’t gotten to and I don’t know if there —

MS. AMATAYAKUL:  Can I follow-up on Marjorie’s?

DR. COHN:  Sure, please, let’s do each one by one.

MS. AMATAYAKUL:  Should we add provider, dispenser, and payer PBM domain?

MS. GREENBERG:  Whoever, but all of them, all of the above.

PARTICIPANT:  And wouldn’t it be anybody who’s involved in e-prescribing?

DR. COHN:  I’m sure you’ll come up with the right wording.  Okay, Terrie is this on this or is this on another thing?

MS. BYRNE:  Mine was back on 17.3.

DR. COHN:  Okay, let’s just stop for a second, I mean Jeff brought up an issue and I think that we’ve been sort of running forward, actually I thought we were going to talk about it for a second.  Jeff has brought the issue of well geez, all of these things need to happen, now obviously all of these recommendations go to HHS so the question is is it the expectation that HHS will enable, support, facilitate, whatever all of this harmonization, support, and otherwise, or does there need to be some other entity identified specifically and if so do we want to even, I mean do we want to go there now which is I think is sort of the question.   And Jeff, I think that’s the issue you brought up, right?  Am I expressing it appropriately?

MR. BLAIR:  Yeah, the only thing that I might add is I don’t want, everybody agrees that these are good things to do but I don’t want them to become platitudes and I sort of feel like if there’s not a little bit more actionable item to make it happen I’m afraid that it’s just going to be nice to have.

DR. COHN:  Other then, I guess my own view on this one and I’ll let the subcommittee, I mean first of all we obviously haven’t heard testimony from the industry as to a organization to do this.  I have heard SDOs individually stepping forward to work on all of this, I think we’ve also, many of these items are actually pointed at HHS to be the agency to, or the organization to make a lot of these things happen.  I’m not sure what to do beyond that in terms of our subcommittee.  Now I’ll look to others if you have better ideas or other suggestions, I see Harry is getting ready to comment, and Jeff you might actually have a suggestion.

MR. REYNOLDS:  I think Jeff’s got an excellent point, but if you look at it we are adopting standards and people that want to align to those standards are going to have to remain in sync, and this has a little more, now since we’re adopting standards it’s going to happen.  Any collaboration in anywhere where they have to align with each other, I don’t see a problem with that being a free enterprise and if it doesn’t exist so that things that are supposed to happen happen then that’s when somebody steps in.  So I don’t necessarily have a problem with that.

MR. BLAIR:  I have a possible suggestion —

DR. STEINDEL:  Simon, in a sense this section is somewhat directed at the Office of the National Coordinator, because that’s one of the tasks that he’s trying to do, is to put this whole system together and to make sure it stays together.

DR. COHN:  Jeff?

MR. BLAIR:  I’m not satisfied with the idea that I’m putting forward here because it’s problematical but I’m just trying to do something so that there’s some entity that has some responsibility for seeing that these things happen and lacking a better idea to some extent the DSMOs, that concept of designated standard maintenance organizations served a function of coordination so maybe it would not be DSMOs per se and that process had flaws and a lot of problems, but something analogous to that where all of the players had some way of trying to make sure that this does not, well all of those objectives is what we want to happen, to try to take action, to actually see that those recommendations are happening.

DR. COHN:  Jeff, I guess I will reiterate my comment that I feel uncomfortable without getting any input from the industry on either naming or otherwise identifying a coordinating body at this point to do these things.  I think if we’re happy to take testimony I’m obviously happy to go forward with it.  I think at the moment the area the issue that I’m concerned about because I am sensitive to your concerns, that as encouraging SDOs to do good things, or whatever, without any help is probably, I mean the verbs are wrong, and I guess I’m sort of thinking that we maybe, this is one of like many other recommendations, like most other recommendations, where we’re really tasking HHS to work with the SDOs to make this happen and that that’s really, and obviously there may be other groups that help make this happen but this is really once again a responsibility of the government working with these groups to help assure this outcome.  And I can’t think of a better response to that at this point, I mean there are obviously a lot of groups that we could talk to, we can hold hearings to try to identify the right group, we can’t for this letter though.

MR. BLAIR:  I accept that, maybe it’s a little bit out of our scope here, maybe there’s an SDO that could step forward in a leadership role that could provide some of these coordinating pieces and that’s outside of what we’re doing and then by October or December they could come forward and then HHS could provide support for that coordinating capability.

DR. COHN:  Well, I think I’d want to hear from the SDOs that they even wanted it from another SDO first, which would be, I mean when we want to hear about that now.  I’m going to ask for the moment because I’d like to finish this particular issue up before we move to others, Ross, is this on this topic?  Okay, and I presume your comment is on another topic.  Let’s just finish this, Ross and then Harry.

MR. MARTIN:  Just the example from the harmonization, or the coordination project we’re doing today with HL7 and NCPDP, in our memorandum of understanding between the two organizations they added an addendum and one of the things it said was that any grant monies or project coordination would be handled through NCPDP, they just chose one or the other, that would be one model to do, we have one instance of that now and I don’t know that there are others, but it is a good question to ask, you want to action it somewhere so you could perhaps just suggest talk amongst yourselves SDOs and if you think it should be just one of you, if you think it should be KAPARX(?), whatever that might be, that you’d say so and ask in that fashion when you ask for the coordination support, tell us who you want the project coordination to be done by.  Does that make sense?

DR. COHN:  I mean I appreciate that.

MR. REYNOLDS:  Just like WEDI stepped forward in some of the HIPAA, leaving it like this and knowing that we have another March, we have a March kind of stop line on some things.  This gives the industry between now and March to decide if they do or don’t want to step up, an SDO does or doesn’t want to step up, and that doesn’t preclude us from our March findings to either be more aggressive, less aggressive, or support what they have come forward to tell us that they would or wouldn’t do, just like we supported earlier the NCPDP everybody getting together and doing that.

DR. COHN:  Okay, so what I’m hearing is more action verbs which I think we’ve put in there now, and deferral of this particular issue until March 2005, is what I’m hearing for 17.5, which is exactly who should be working together.  Okay, are we done with this issue?  We’re almost done with this issue, Margaret has her hand up.

MS. AMATAYAKUL:  17.4 then is really not a recommended action, it’s just to make sure that we make more actionable verbs above.

DR. COHN:  I think it’s, exactly, actionable verbs above.  Okay, so let’s now, we have a couple people who have been waiting very patiently to talk about 17.3 and I saw Terrie up here and she left, it’s the same issue, oh I’m sorry, I thought you wanted to talk about a new issue —

MS. BYRNE:  No, no, 17.3 but Jeff and I both have the same issue so he’s going to talk about it.

DR. COHN:  Oh, Jeff, please introduce yourself.

MR. BROWN:  I’m Jeff Brown from Maher, Brown, Roe and Mau(?), attorney, outside counsel for Rx-Hub, and the concern we have is that the way that 17.3 is worded it sounds like the sender, whoever the sender is, has to do the work, and it could be done by a third party before it gets to the recipient.  And the second concern I had is when we talked about non-standard formats we may have two standards depending on which domain you’re in you use one standard or the other, so I have a suggestion for the language and let me just read it out to you which would be we would encourage the industry to adopt a policy that a receiver using a standard can require ERX messages in that standard regardless of the format used by the sender.

MR. REYNOLDS:  I like that a lot.

MS. AMATAYAKUL:  Could you repeat that or give it to me slowly?

MR. BROWN:  I’ll do it slowly.  Encourage the industry to adopt a policy that a receiver using a standard —

MS. GREENBERG:  An accepted standard.

MR. BROWN:  An accepted standard, absolutely, may require ERX messages in that standard, in that accepted standard, regardless of the format used by the sender.

MR. BLAIR:  I’m totally confused by that and it sounds like it is in opposition to what we agreed to before where we were focusing on NCPDP script is what, if you want to send something to a pharmacy it has to be an NCPDP script no matter who the sender is so I feel very uncomfortable, maybe your intent is right but the wording that you picked does not give me comfort.

MR. REYNOLDS:  Simon, I have a friendly amendment to that.  I think if you could come up with a word that says except where otherwise specified in the regulation, because we did, back to Jeff’s point, if   Simon, I have a friendly amendment to that.  I think if you could come up with a word that says except where otherwise specified in the regulation, because we did, back to Jeff’s point, if your wording sticks as it blows up what we said before because somebody was using HL7, somebody, so except where otherwise specified that there is only one way —

MR. BROWN:  You’re right and I was not here yesterday when you talked about script and I did hear that so that’s an absolutely valid exception —

DR. COHN:  I’m seconding, I was going to say the exact same thing as Marjorie is saying is I’m wondering the value of 17.3 and I think that this could certainly go forward very easily —

MS. AMATAYAKUL:  Take it out?

DR. COHN:  I’ll ask others, is there a particular value to having 17.3 in?

MR. BLAIR:  You’d have to read me 17.3, I don’t know what it is.

MS. GREENBERG:  I think that really has to be left for regulation.

DR. COHN:  This is the one we’ve just been talking about.

MR. BLAIR:  Yeah, but I don’t remember what 17.3 said.

MS. AMATAYAKUL:  This is the translation between standard and non-standard formats.

MR. BLAIR:  Oh, okay, I agree.

DR. COHN:  So I think we’re hearing everybody saying this one is problematic enough, it’s not so much that it’s problematic but it’s otherwise handled, I mean it’s sort of implicit in everything.

MR. REYNOLDS:  Let me see if you agree with this, there’s nothing in anything that we have recommended or in the standards that doesn’t already make that happen.

DR. COHN:  Exactly, that’s what, I think that’s what I was trying to say.

MR. REYNOLDS:  I can agree with that if that’s what we agreed to.

DR. COHN:  Okay, so are we covered?

DR. STEINDEL:  I agree Simon, it needs to go.

DR. COHN:  Okay, thank you all for your help on this particular issue.  Is there anything else on 17 before we move on to 18?  Okay, let’s move on to 18.

MR. BLAIR:  Is this the last one or how many more do we have?

DR. COHN:  No, we have about three or four more.

MS. AMATAYAKUL:  Okay, the rest of these I didn’t go into real specific detail because I felt like in some cases there wasn’t necessarily an observation or a recommendation, it was just sort of a statement.  The policies that provide safe harbors preserving provider patient choice and freedom from commercial bias are important.

DR. COHN:  Let me just ask because there’s about four of them here that look like they are things that we may want to, let me think about this one, that we may want to reaffirm the wording of the legislation, isn’t this sort of the wording of the legislation?  I’m not sure what to do with things because I don’t know if there’s any action items, but let’s talk, I mean we can go through and look at them because there actually is one around privacy which is 21, so should we just, is this something where we may want to at least provisionally think about this one, it’s just to reaffirm the wording of the legislation or —

DR. HUFF:  What does 19 mean?

DR. COHN:  Well, let’s talk about 18 first, what?

MS. GREENBERG:  Is that wording in the legislation?

DR. COHN:  Well, safe harbor, yeah, but it isn’t specific enough, gosh, maybe we should remove this one.  Phil, do you have a comment?

MR. ROTHERMICH:  I think you’re headed in the direction I was thinking is it’s so vague I don’t know what it means so it scares me.

MS. AMATAYAKUL:  It’s either something this vague or very, very much more elaborate which I didn’t —

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

MR. MARTIN:  I would think that you’d want to reflect that you’ve got a lot of commentary on it, and that’s what you’re trying to say is that there were a lot of people who wanted, it may not be your role to make those standards but to observe that there was a call for those policies to be made within the regulation —

MR. BLAIR:  Sensitivity to these things, issues —

DR. COHN:  Sort of like finally NCVHS heard testimony that made clear to us that there is, actually I don’t know what the verb is.

MR. REYNOLDS:  The fact that we would at least make a comment on them wouldn’t hurt because it would also reinforce to the Secretary that even as part of the NPRM process we heard a lot of testimony saying don’t back off some of these things, in other words protect some of those key things that are in the legislation, even if you get, and if significant comments comes in through the NPRM process maybe we should hear it again because we don’t want some of the advertising we heard, we don’t want transmission method constrained by the standard, we don’t want some of those so we heard enough testimony from the industry, the industry doesn’t want those either.  So maybe just this is further, back to the earlier comments.

MR. MARTIN:  It’s acknowledging that there aren’t policy standards out there to grab from that you could recommend and so in the absence of those they still have to be addressed so you took them into account but you couldn’t point to a standards development organization that had a standard about it.

DR. COHN:  I guess I’m looking at these things and I’m almost wondering if maybe there is a different way to handle this, I guess from my view yeah we heard testimony on safe harbor which is, and I’m not a lawyer, nor do I play one on TV, safe harbor is a big issue that’s going to have to be dealt with in the regs, I mean there’s not a policy, there’s not a standard that we would point to but it’s obviously an issue and I don’t know what we say about it other then we look forward to further clarification of safe harbor and all that in the NPRM.  We obviously also, and this was once again in the regulation, this preserving patient and provider choice.  Now the one piece here that I didn’t, that isn’t in the legislation but which is actually in the conference report is is that messages or whatever is this issue of freedom from commercial bias and I don’t know what, once again I don’t know what we want to say about that one, that was in the conference report and not in the regulation.

MS. TRUDEL:  It actually, it is in the MMA because it talks about commercial messaging.

DR. COHN:  Oh does it?  It’s actually in the MMA?

MS. TRUDEL:  So essentially the safe harbor and the provider patient choice and the commercial bias I think are all addressed in the law and will be addressed in the regulations so I guess the question is is there something more substantive about those things that the subcommittee wants to tell the Secretary.

DR. COHN:  Is there anything more substantive —

MR. ROTHERMICH:  In the context of standards —

DR. COHN:  In the context of standards, or in the context of the testimony that we’ve heard.  I guess I’ll ask the subcommittee, is there something more substantive about these things that we want to say or do we want to observe that this appeared to be major issues and concerns that we heard in testimony and we look for further definition in regulation.  Is that what, I’m looking, I’m not sure that, I heard enough things but I didn’t hear a single voice on any of these things, I heard a lot of, in these areas there was multiple different views and multiple different opinions and once again there’s a sensitivity but I don’t think I necessarily want to communicate a specific message about that.

MR. BLAIR:  Should we read down the rest?  Everybody might not even have comments on some of them so if we just read the next four if they’re short.

DR. COHN:  I guess I should ask, we have two people that want to comment —

MR. ROTHERMICH:  I have specific comments on 22.

DR. COHN:  Okay, I just wanted to make sure you didn’t have anything on 18 before we went to 19.  I don’t even understand 19 so maybe you can explain it to me.

MS. AMATAYAKUL:  Okay, 19, the transmission method should not be constrained by the standard.  There were several comments in the worksheet by people that said we definitely need this to be in XML, then other people said XML is a transmission method and we shouldn’t be constrained by that.  Then there were other people who said XML is not a transmission method but we shouldn’t constrained by the transmission method, that we should preserve dial up capability, lease lines, etc.

DR. COHN:  So Stan now that you understand it, I’d move for removing it but that’s my own opinion.

DR. HUFF:  I think a more proper word for that would be transmission format, transmission method would usually refer to whether you’re sending it over internet or whether you’re sending it over a synchronous line or that.  But beyond that —

DR. COHN:  Should it be there?

DR. HUFF:  No, I wouldn’t say anything about this even though —

DR. COHN:  Does anyone want to say anything about this one or can we safely remove this as, gone, okay.  Okay, 20.

MS. AMATAYAKUL:  Conformance testing should be required for all standards to be adopted.

DR. COHN:  What does that mean?  Are you referring to conformance testing of applications or are you referring to, I mean I don’t know that you can conformance test the standard —

MR. BLAIR:  The messages —

MS. AMATAYAKUL:  The message.

MR. BLAIR:  So somebody doesn’t wind up saying well I sent you the message and then the other folks said well I’ve got a system and it’s compliant but it can’t receive it.

MR. REYNOLDS:  Are you talking about a certifier?

MR. BLAIR:  Conformance to the standard for messages.

DR. COHN:  Okay, the way it reads is I guess I thought that maybe you needed to have conformance testing to enable a standard to be adopted and I don’t think that’s what we mean, are we saying conformance testing methodology should be implemented as part of standards adoption?

DR. HUFF:  Yeah, I mean the think that I think we should say is that we need, we need conformance testing, we need, somebody needs to provide a conformance testing place so that people who claim conformance to the standards can actually be tested as to whether they are conformant to the standard.

MR. REYNOLDS:  We’re trying to eliminate the whole interpretation free for all that went on with HIPAA so that two entities say they’re compliant and they can’t deal with each other in any reasonable way.

DR. COHN:  Well I guess a question is here and obviously we’re sort of wordsmithing on this one though I don’t know that, I mean I think we sort of know the idea here, we’re talking about someone, somehow to do conformance testing so that we know that the application conforms to the standard I think is what we’re talking about.

MR. BLAIR:  No, not the application but that the messages that we have designated as e-prescribing standards, that the folks that send those messages meet the conformance criteria and that both the sender and receiver can receive them.  So it’s the conformance to the message format standards.

DR. COHN:  Okay, so I guess a question I would ask is, Karen, do you want to make a comment?

MS. TRUDEL:  I think I’m hearing two different things —

DR. HUFF:  It’s just not the format, it’s obviously a big part of conformance would be whether there’s putting the standard codes in the right places and all that stuff too.

DR. COHN:  Right, and there’s two things we typically talk about when we talk about here, one is certification of systems, that they have the capability to produce a standard message and that’s something we’ve been hearing from ONCHIT and others working around certifying systems, around EHR systems and others.  And then there’s the issue of conformance testing, I’m not sure talking about one without the other is a useful concept only because conformance assumes that the system could even do it to begin with.  So I’m wondering do we need to have both of them in there and are these things that we need to be suggesting that ONCHIT take the leadership to identify a strategy to deal with these things.  Do you all know what ONCHIT means?  Okay, good.

DR. HUFF:  Well, one of the things, I mean you’re right in the full context if the system can’t produce it, but in the messaging standards for instance they don’t, they typically haven’t done conformance testing on the application, what they did is said okay, give me messages produced by your application so I guess in a sense they’re trusting them that they didn’t cheat and just mark them up but they say give me your messages and then they conform that the messages they produce, and so you can actually just go independently to a website and say here’s, so as I’m developing my application for instance I can take messages that are being produced and I can submit them to a service and the service will say oh, this is a conformant message or not this isn’t a conformant message.  So it’s a tool actually during development to ensure that you’re developing correctly which is a different thing from asserting that somebody has independently certified that my application produced that message —

MR. BLAIR:  Because that’s a whole, that would be huge to do the latter.

DR. COHN:  Ross and then Karen.

MR. MARTIN:  There is the development process that Stan was just referring to but then there’s also the certification so that a buyer of these systems can know that it’s got the Good Housekeeping seal of approval part and that’s the real benefit here, you can facilitate adoption by giving them some assurance that the thing that they’re buying really does what it’s supposed to do, meets all the requirements of MMA and the other component of this besides the messaging is should there be any policy standards around the application itself, the way it presents commercial messaging, somebody should be looking at that and be able to say it does or does not do any of the things that are required of a valid MMA e-prescribing system.  So it may be beyond just the message.

DR. COHN:  Karen has a comment and then Jeff has a suggestion and then we maybe can make some headway here.

MS. TRUDEL:  I just wanted to point out that there is an aspect of the national coordinator’s strategic plan and vision that talks about working collegially with private organizations to establish a certification authority, consortium, something like that.  And if that’s something that the subcommittee thinks is important perhaps the recommendation should be that e-prescribing software should be something because of deadlines and wanting to advance it should be given priority consideration.

MR. BLAIR:  Certification of software applications is really, it’s getting down to saying that we’re going to standardize the applications, that’s the vendors added value is how they do those things so I don’t think we want to get into conformance of the applications or conformance of the software, I think we need to keep it at the basic level for interoperability, is does their message, whether it’s the message format or the content, could be determined later, but does the message conform to the interoperability standards that, e-prescribing interoperability standards that we’re setting forth, that HHS will wind up setting forth, and we could word it very similar to the way that you worded it Karen and basically that I would modify in the way that you worded it is rather then saying that the software, that it either be, that the message conform or that the communication meet the e-prescribing standards.  Stan, maybe you can help with that.

DR. COHN:  Harry has a comment, Phil has a comment.

MR. REYNOLDS:  I guess a little different view and I guess I would pretty much second what Karen had to say.  One of the top five issues with HIPAA is that nobody ever even made a list of who the entities out there that if you tested through them and met their requirements and filled the fields and used some basic test cases or something that you basically were okay.  And I would hate to see us do another whole implementation because we have very disparate groups who identify this stuff totally different.  I agree with Jeff you don’t want to make this so that nobody can have their value add but there is a basic set of what is going on that all players have to play with and then people can value add on top of those fields all they want to.  And so I would concur with Karen, this may be one that we use Dr. Brailer’s group and we talk about a consortium that does it or whoever but as long as they were designated, not necessarily paid by anybody but designated, and we never designated them in HIPAA.  And so it just became everybody’s word against everybody’s else’s word and it created, and the people that get hurt most in this are the smallest players, they get jerked around by all the big players.  And so I just hope that we will learn from that one and try to come up with a way to get something in place that allows that to occur.

DR. COHN:  I think Phil has been waiting, Karen, and then I want to try to put this together recognizing that these are two separate issues, we’ve got certification and we’ve got conformance testing.

MR. ROTHERMICH:  A point of clarification, I think Jeff’s right, we’re not really talking about certifying a vendor and whether their application is the same as everyone else, we’re talking about certifying conformance to the standards and just to our frame of reference I mean Rx-Hub does that today with their provider partners where Terrie talked about vendors in productions and vendors who are certifying on transactions so you have eligibility transactions, you have drug history transactions, and basically the certification process, yes, you know how to do this, you do it right you get the right answer, so that’s different then saying everybody has to look the same.  But if you come out with standards I think Karen’s right, it makes sense to designate somebody as the referee to say yes, this vendor is complying with the standards, and if they have different value add then the next guy then so be it but it’s just conformance to the standards.

DR. COHN:  Yeah, okay, Karen, and then let me see if I can put this together.

MS. TRUDEL:  Again, I’m concerned that some of this goes beyond messaging and goes to functionality because we do talk, the MMA does talk about the fact that an e-prescribing system, a fully blown one, does a certain number of things.  And so rather then just testing what the message looks like on the way out there may be a need to test some other things as well and I’ll mention one from a HIPAA perspective, you can test the outbound transactions until the cows come home and you can test a plan’s ability to accept a compliant a claim, but everybody implemented the requirements for do I reject by the batch or do I reject by the claim in a different way, that’s functionality.  And the fact that that wasn’t tested for and it wasn’t standardized at least to a minimal degree caused a great deal of confusion.

DR. COHN:  Okay, let’s try to bring this back into scope and see if we can come sort of forward, out of the weeds, into the forests, or whatever.  There are two issues that we’re talking about that are somewhat overlapping but really different, one of them is the issue of certification of applications to sort of assure minimum functionality, make sure that they’re capable of performing the standards and all of that.  Now I guess I am reflecting having sat through the recent strategic summit on health information technology knowing that the Office of the National Coordinator for Health Information Technology felt, this is part of his strategic plan is to identify some sort of public/private group that could help with the certification process.  And I guess I’m sort of thinking that the recommendation, I think that it’s actually a good thing for there to be some certification going on, I don’t know exactly how to do it and I don’t know that we need to decide how to do it but I’m suggesting that we might want to recommend that the Office of the National Coordinator for Health Information Technology investigate how best the government should go about certifying e-prescribing systems for MMA and I would think that that would be a very reasonable recommendation to make.

DR. HUFF:  E-prescribing systems and messages I’d be happy.

DR. COHN:  Okay, is e-prescribing systems and messages?  Well, I guess I consider conformance to be a slightly different issue though.

MR. BLAIR:  I think he was trying to break it  out, going to be another recommendation —

DR. HUFF:  Oh, you were going to do another recommendation after that.

DR. COHN:  I thought that the other recommendation on conformance testing is is that, I mean it seems to me that there’s almost a utility, that the government should provide a utility upon which implementations could test to assure that they are in conformance with MMA e-prescribing standards was sort of what I was, is that a reasonable way of parsing, I knew somebody had a complaint here, come on.

MR. BLAIR:  Declare victory and gone.

MS. AMATAYAKUL:  Could we just review that one more time, the two components?

DR. COHN:  Okay, well one is certification of the application, and we’re saying it should investigate how best to certify applications.  And that the other one is conformance testing and we’re talking about that HHS should develop a utility upon which implementations can test their performance with e-prescribing standards.  I mean I’ve been through PMRI standards for too long —

MR. REYNOLDS:  I’d use select rather then develop.

DR. COHN:  Should develop, okay, should develop.

MS. BYRNE:  My only concern with this statement Simon is that, this is Terrie Byrne, we’re focusing on ERX applications, I think we should specify that it’s all players within electronic prescribing.

DR. COHN:  Okay, all systems used within electronic prescribing.

MS. BYRNE:  Right, so that all players have to participate in the certification effort.

DR. COHN:  Is that, are we okay —


DR. COHN:  Yes, Steve.

DR. STEINDEL:  If I can make a comment on this, with regard to the statement that the government should develop whatever words we’re using here for certification of e-prescribing, I think that that’s walking in the gray area but one the government might consider doing.  Generally speaking with regards to the Office of the National Coordinator they’re staying away from actually developing the conformance testing tool.

DR. COHN:  Conformance or certification?

DR. STEINDEL:  Both, they’re staying away from the certification process, they’re turning it over to a private sector body and they are looking to that body I believe to develop the actual mechanisms for doing it.  Now having said that I will say that within CDC for the PHIN(?) process we are both developing the certification process and the tools to do it with but that is a subset and I think HHS is comfortable with focusing on an area like we would be doing with e-prescribing.

DR. COHN:  Well Steve first of all for certification the verb was investigate how best to certify basically rather then telling them to do it, I think what I’m hearing, the second piece on conformance is that maybe we should say HHS should assure that a utility exists —

DR. STEINDEL:  That would probably be much more comfortable.

DR. COHN:  Is that better?

DR. STEINDEL:  Yeah, that would be much more comfortable because that’s neutral as to who actually does it.

DR. COHN:  Okay, are we okay with that?

MR. ROTHERMICH:  Yeah, I mean like I said, Rx-Hub is doing something like that today, they may be able to provide a function, there may be people who want to do it differently but that’s one way to do it.

DR. COHN:  Yeah, I don’t think we’re presupposing how all of this happens but I think we’ve learned from HIPAA that some of these things could be very useful as we go down the road.

MS. BYRNE:  It still says ERX applications though and that’s what I had an issue with.  All areas in electronic prescribing, so anybody who sends and receives messages in the electronic prescribing chain.

MR. MARTIN:  All applications involved in the e-prescribing process, and that could include like a knowledge database that’s not actually used in the transactions but for a vendor wanting to incorporate a knowledge database they need to know that it too complies with the MMA requirements.

DR. COHN:  Okay, so I think Margaret can do final wordsmithing on this one but I think we’re pretty much basically there, I think we’ve got the concept.  Something more Margaret on this one or can we move to the next?

MS. AMATAYAKUL:  I just want to ask do we want the conformance testing methodologies to be developed by the standards development groups?

DR. COHN:  I don’t think we want to say, we just want to assure that something like that exists.

Okay now the next one  and we actually have three, luckily the one is relatively mundane, the next one is actually on HIPAA privacy and security protections applied to ERX, and I guess my view is that we can make that statement, I think we also want to say that the NCVHS are going to be holding focused hearings on issues related to ERX and privacy and confidentiality in November and will report back —

MR. BLAIR:  You mean in December, oh, I’m sorry —

DR. COHN:  Actually it’s being led by the Privacy and Confidentiality, we’ll make sure we go through dates as we go along here but we’ll obviously be participating in that, it’s actually a November hearing but I think we’ll probably be coming, we’ll be given further communications as are warranted I would imagine on that one.  Is that a reasonable next step item on this?  And since we’re going to be doing hearings on it I don’t think we should make recommendations, do you have your hand up or are you just thinking?

MR. BROWN:  I actually had a comment on the observation.

DR. COHN:  Okay, observation, okay.

MR. BROWN:  Which is the protections apply to ERX but they apply differently depending on which player you’re talking about so that the tech vendors that work with the doctors are going to be business associates and the doctor or the physicians who are prescribing, the dispensers, are going to be covered entities.  And I think that the statutory language is that the standards have to be compatible with HIPAA security and privacy which is where I would expect that this would go.

DR. COHN:  Well I don’t know how to put that into an observation, I’m trying to think of what, I think what you’re saying is that the protections apply to ERX but there may be particular, or maybe peculiarities inherent in ERX that need to be further explored, is that what you’re saying?

MR. BROWN:  I think that ERX has to be compatible with HIPAA privacy and security but I don’t want, I know this is in the observations provision, it’s not in the observations, probably not in a recommendation column, but I want to make sure that we’re not suggesting to the Secretary that there should be new HIPAA regulations because I think that would —

DR. COHN:  No, no —

MR. BLAIR:  I think that’s the last thing the Secretary would ever want.

MR. REYNOLDS:  I totally agree with apply to, I mean I don’t see any difference in ERX coming in or something else coming in, I think exactly as it’s stated in the observation is correct.

DR. COHN:  I think what you are describing is that it, actually I’m not sure, I think you’re agreeing with that aren’t you basically except that you’re saying the way it applies varies —

MR. BROWN:  That’s fair.

DR. COHN:  But based on the person —

PARTICIPANT:  But at the end they still apply.

DR. COHN:  But it still applies.

MR. BROWN:  That’s fair.

DR. COHN:  Okay, so are we okay with that?  I mean I’m, okay.  And we’ll be obviously coming out with more on that so that’s, Jeff, did you have a comment on that or are you comfortable with that?

MR. BLAIR:  No, that’s fine.

DR. COHN:  Okay, now are next one is federal preemption of state regulations may be necessary to overcome impediments to ERX record retention and signature requirements.  Yeah.

MR. BLAIR:  Maybe this should be explore the need for federal preemption because a lot of folks recommended that it be done —

DR. COHN:  Well, it’s in the regulation so I don’t know what we’re exploring at this point.  Karen, maybe you can help me.

MS. TRUDEL:  Yeah, the question of preemption is not whether it’s needed, in some cases it will just simply occur —

DR. COHN:  It’s just how it applies.

DR. HUFF:  Is there any value in this committee taking on for March, no, I guess —

DR. COHN:  What were you going to suggest in our spare time?  Go ahead Stan, I’m being facetious.

DR. HUFF:  I was thinking of particular areas where, I’m trying to think how this happens —

MR. BLAIR:  I think HHS is better suited to do that.

DR. COHN:  Stan, I think the real question about federal preemption at least in my view and I’ll let Maria follow up is not federal preemption, it’s how federal preemption works when you’re talking about just MMA Medicare ERX prescriptions when the rest of the stuff is still subject to state rules.  And that’s I think really the issue here and that’s to be determined.

MS. FRIEDMAN:  I have a solution maybe.

DR. COHN:  Maybe Maria has a solution.

MS. FRIEDMAN:  I think the issue is that state regulations and laws have been, we heard testimony that there are barriers to e-prescribing, record retention, signature requirements and the recommendation, that’s the observation, the recommendation, that HHS explore preemption.

DR. COHN:  HHS explore —

MS. FRIEDMAN:  The preemption provisions of MMA need to be explored to see how these can be addressed, that’s one solution is preemption to this, there may be other solutions as well, there may be places where they just need to coordinate better.

DR. COHN:  Karen, what’s your comment?

MS. TRUDEL:  Again, preemption is not something that we have the choice, it’s not a solution, it is a fact, if there is a federal and state law that cannot coexist then preemption occurs, it’s a legal issue, so I think the recommendation may have less to do with preemption then it does to some sort of proactive relationship with state boards of pharmacy and their model laws to potentially remove or facilitate to remove barriers —

MR. ROTHERMICH:  It may be that the recommendation to the Secretary is to clarify that the statute says that any law, state law or regulation that’s contrary to the standards is preempted because that’s what the statute says.  And my concern was anything in this document that suggests otherwise is misleading and may be a disservice.  That was my comment on 15 because it’s sort of suggested that the reason to think more broadly was because industry is going to follow Medicare as opposed to the reason being that it’s preempted.  The statute is clear.

MR. BROWN:  And just following on what Karen said, I think that the observation is not so much about what preemption will or won’t do, it’s that there was testimony from the National Association of Boards of Pharmacy, as well from the PBMs, that I think the committee heard there are conflicting state regulations, there are state regulations and laws that will restrict the use of ERX.  That can be the observation and then I think it’s for HHS and for the legal folks to work out what should be done.

DR. COHN:  Actually in all of this I’m fine with the action, I’m just trying to figure out whether the observation is right here.

MR. ROTHERMICH:  I take issue with the action —

DR. COHN:  You don’t think that CMS should work with the state boards of pharmacy to align —

MR. ROTHERMICH:  They’ve been preempted —

DR. COHN:  Here’s the issue, and this is why maybe the observation is the wrong item, federal preemption will assure that for Medicare and Part D payments and for Part D Rx that the federal preemption exists.  However, if you are writing a prescription using electronic methodologies on a non-Part D covered person the state law exists.

MR. ROTHERMICH:  That’s the legal conclusion which I don’t happen to agree with.

DR. COHN:  You’re right, I am not a lawyer and it never occurred to me that anything would be different but then again I’m not a lawyer.  Jeff, do you have a comment and then Karen.

MR. BLAIR:  Yeah, I think what we’re hearing from Karen is that we’re not really adding a whole lot of value by having this included in our recommendations because they’re going to be going forth with this anyway, and we’re getting into areas where we don’t have either the legal expertise or the regulatory expertise and we’re just not well suited to really work through this issue but HHS is.

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

MS. TRUDEL:  That wasn’t the impression that I intended to leave and my thought about what the observation would be is that we heard from any number of people who testified that the, that state boards of pharmacy, laws and regulations, all handled electronic, either didn’t directly address electronic prescribing or may have, or they might have all addressed it in a different way which can be a barrier to e-prescribing especially for organizations that operate across state lines.  So my sense would be that’s the observation and the recommended action would be to work with state boards of pharmacy to coordinate to the extent possible state requirements through their model laws and rules.

DR. COHN:  To facilitate the implementation of e-prescribing for just not MMA but to all, beneficiaries is the wrong word here.  Okay —

MS. CANSOL(?):  This is Anne Cansol with Rx Benefits Coalition, I think that’s directly contrary to what the statute says.  The state boards of pharmacy are preempted in the statute and then the question is whatever laws are going to be preempted as well.  But anything that, there’s no reason to work through the state boards of pharmacy because the federal standards is going to be set.

MR. ROTHERMICH:  That was my point, that’s what preemption means is that the state boards no longer have the power to regulate those things so to the extent the Secretary can make a determination as to the extent of preemption then the action wouldn’t be to work with the states.  In other words if they’re preempted the states don’t regulate those areas anymore so there isn’t, you’re not talking about 50 states anymore.

DR. COHN:  And I guess the open question and not being a lawyer is whether that preemption applies to all electronic prescriptions —

MR. ROTHERMICH:  That’s the only reason I take issue with the recommendation because it assumes a legal conclusion that may not be accurate.

DR. COHN:  And once again as I comment, I don’t even pretend to play a lawyer even on TV, even with my children, so this is one that I said never occurred to me.  I guess the question is is whether or not given that we don’t even have clarity on the legal meaning of all of this I mean do we need to say anything or do we need to say —

MR. BLAIR:  We could defer until March, that’s another —

DR. HUFF:  I think I thought long enough to formulate my question better.  I wonder for instance if there’s any interplay between standards that we would suggest and anything to do with preemption, for example, if by testimony and by taking testimony we said gee, it seems sufficient for prescriptions, for controlled substances, that if those things are electronically signed then that’s sufficient, is a sufficiently rigorous method that digital signatures are not required for that purpose, and that conclusion conflicted with state laws that said you need to have, if this is done electronically you have to have a digital signature, does this come into play in any way, the preemption.  So by the standards we adopt do we get into —

DR. COHN:  Well luckily not so far on that one but, I mean let’s try to move this up a level, I think that there’s a couple things we can say maybe if we want to.  I mean one is is that the NCVHS strongly believes that e-prescribing is something that’s good and should apply, and that these capabilities should be available to the entire population or something on that level, I think that was observation one isn’t it, so we sort of said that.  And I think what we may want to say here is that we encourage the Secretary to with the power invested either through further clarification, a federal preemption, and/or as necessary working with state boards to help enable all citizens to have the opportunity to benefit from e-prescribing.  Is that what we sort of mean here?  Is that about the level, I mean I can’t think of anything much more specific then that that we can say.

MS. TRUDEL:  Is that worth recommending?

DR. COHN:  Well, now that’s a whole other question —

MS. TRUDEL:  And what’s the action again?

MR. BLAIR:  Encourage the Secretary to, those were the words that Simon used, I think that’s fine, I think it’s probably as far as we could go.

MR. BROWN:  This is Jeff Brown, if I could just make a suggestion.  Encourage the Secretary in light of the preemption provisions of MMA to consider solutions to conflicts between, what we talked about the conflicts and restrictions in state laws that will effect the ERX under Medicare.

MR. ROTHERMICH:  I’d say to clarify the scope of the preemption to enable a single nationwide system for electronic prescribing.

MR. BLAIR:  Those are good words.

DR. COHN:  Marjorie and I’m sure Karen has a comment too and then Harry, I feel as we dig into this one we may want to abandon it completely but Marjorie.

MS. GREENBERG:  On the one hand I feel like we’re getting kind of close to motherhood and apple pie here but I mean in saying what we think is a good idea but I think this goes a little beyond what’s appropriate at this point which is the standards recommendations.  I mean first of all there’s going to be, generally the committee has already come out in favor of electronic health records, come out in favor of decision support as part of that, the NHII vision and all of that so I think the committee is on record, the full committee on these issues.  But talking about having pilot tests and looking at various metrics and all of that so it might be a little premature for the committee to just make a blanket statement of supporting e-prescribing although certainly as I said the committee has already supported electronic health records, the NHII, etc.  So I just wouldn’t go there in these recommendations.

DR. COHN:  Okay, I think Karen has a comment, Harry has a comment, and then we will circle the wagons and do whatever we’re going to do on this one.

MS. TRUDEL:  I would strongly recommend if we’re talking about preemption let’s strike the observation and the recommended action because in fact preemption is a legal issue, our general counsel’s office will determine how and when it’s implemented.  It’s obviously, I’m hearing from right now that people have some very interesting views on it and it was a very hotly contended issue in the privacy regulation as well, you’ll see that the final rule has a lot of discussion about preemption and what it means.  So I would suggest striking it.

DR. COHN:  Okay, Harry?

MR. REYNOLDS:  I would strike it also because I don’t think we heard anything in testimony that says there’s anything wrong with the regulation.

MR. BLAIR:  Could I ask a question about that?  I guess it was about ten minutes ago when I suggested striking it also, however, Simon’s point here though was the law indicated preemption in terms of MMA which, what is it Part D only, and Simon was indicated that he would encourage the Secretary to expand it broader.  If we strike this is that going to be what HHS will likely to do or will we lose that point to encourage it to be broader?

DR. COHN:  Actually for the record I never said that first of all but basically, actually I think it just needs to be struck at this point.

DR. STEINDEL:  Simon?  I have a comment, I’m not in favor of striking it, I’m actually in favor of the last, not the last recommendation Karen made which was the one she made just a minute ago but the one before that with the observation tied to it that the Secretary investigate working with the state boards of pharmacy to create a new model law for this.  Because what I’m concerned about is first of all what you have brought up is will this just apply to Part D Medicare and not the other parts of e-prescribing, and also will it only preempt in the areas that are involved with the federal regulation overriding what the state may do, and we had a lot of states for instance that required written prescriptions in addition to the electronic prescriptions and would the federal preemption eliminate that requirement.  I don’t know, what would be nice is to create a new model law and jus task the Secretary to work with the groups to do that.

With regard to HIPAA privacy the problem came about not because there was federal preemption, federal preemption in MMA is very clear, is in HIPAA privacy it says federal preemption except when the state laws are more stringent and that’s where the issues came about.  So this one is a very clear case for federal preemption.

DR. COHN:  I think you’re losing the vote Steve. Maria, Harry, Karen, and then I want to, I mean if any of you have any other comments but I think we’re going to delete this whole area.

MS. FRIEDMAN:  I want to reemphasize what Karen said about are attorneys are looking at when and how the preemption will work.  And then secondly respond to Jeff’s question about urging the Secretary to broaden it around MMA, that’s probably beyond our statutory authority.  But again there are a whole host of legal issues here, it’s a real thicket.

DR. COHN:  As I said, I’ve heard this is going to be something that obviously will be discussed between lawyers for a while to come here.  Harry?

MR. REYNOLDS:  Chairman, I recommend we call this to a vote.

DR. COHN:  Okay, I do want to just offer in case, I mean since you’ve been sitting here so patiently we will let you both comment and then we will call a vote.

MR. ROTHERMICH:  I think if it’s stricken then it’s dealt with in the proper channels and the conclusions will be the conclusions, I’d rather see it stricken then see something dealing, recommending a model state law because a model state law is antithetical to preemption and so again it’s sort of presumes a conclusion.  So if you strike it and leave it to the general counsel I think that’s a good result.

MR. BLAIR:  What about the option of instead of striking it seeing if we could wind up coming up with more appropriate wording by March?

DR. COHN:  Okay, other comments from —

PARTICIPANT:  I would just make an observation that in our view the language in the MMA would allow preemption beyond just the Part D benefit —

DR. COHN:  Once again something to be determined by the lawyers.  Jeff, I think just to try to answer your question, I think striking this from this letter doesn’t in any way prejudice whether we decide to bring this back forward to the subcommittee as we move forward between now and March and I think there may be more information.  So I don’t know that we need to, once again, striking it from this letter, I mean I just don’t, what I think we do need to do is to not list this as an item that will be by definition at this point taken up between now and March, it may be something we come forward with, decide that there’s something that we need to say about it.  But I’m sort of reminded that if we’re going to get into this area we need our lawyers, we need lots of lawyers testifying to us.  Anyway Harry, you called the question, is there a second to calling the question on this one?

DR. HUFF:  I second the motion.

DR. COHN:  Okay, shall we just vote who’s in favor of deleting the section?  Okay, all in favor of deleting?  Okay, opposed?  One abstention, okay, so that is deleted.  Okay, well that was interesting.

MR. BLAIR:  Does Steve need to know what the vote was?

DR. COHN:  Steve, do you want to know what the vote was?

DR. STEINDEL:  I gather it was unanimous.

DR. COHN:  No, it was actually four to delete, zero against and one abstaining.

DR. STEINDEL:  Okay, thank you.

DR. COHN:  But again it’s without prejudice for bringing it up for the March stuff or putting it into the work plan.  Okay, e-signature, Margaret, do you have something before doing e-signature?

MS. AMATAYAKUL:  Just that e-signature will be addressed after September.

DR. COHN:  Sounds good.  Now, I guess I would ask at this moment are there things that we have missed in these recommendations?  I mean we’ve done everything now right?

MR. BLAIR:  I’m assuming that in the letter at some point you have e-signature being deferred, we have a list of items that we intend to consider between now and March and I’m assuming that that will be grouped together someplace in the letter as to the things we intend to look at by March, is that correct?

DR. COHN:  Including but not limited to.  Stan, please.

DR. HUFF:  Well I don’t know if this is appropriate so you can rule this out, on item three in reviewing what Margaret did overnight I wasn’t sure whether it reflected where we had ended up and the particular question was whether it was the consensus of the group that we were going to essentially grandfather HL7 things that were going outside the institution or whether the sense of the committee was that was a complication that —

MS. AMATAYAKUL:  Shall I read number three?  The recommended action is that NCPDP script should be the standard for new prescription, refills, cancels, changes, and fill status notification functions except that HL7 prescription message should be permitted in existing implementations between prescribers and dispensers so as not to negatively impact early adopters, new installations in which prescribers and dispensers are members of the same business entity, and if the prescriber with an HL7 message chooses to use bridging technology to convert HL7 to NCPDP to communicate to the individual’s choice of dispenser.

DR. HUFF:  It’s all one sentence, that’s part of the problem.

DR. COHN:  That is part of the problem.

MS. AMATAYAKUL:  Well, I mean I can chunk it up.

DR. COHN:  And Stan your issue on this one is you’re wondering —

DR. HUFF:  I’d raised the question, I guess my opinion is now that if you will allowing any existing HL7 interfaces that go out of the enterprise to continue to use HL7 seems like an inconsistency and antithetical to the purpose of the committee.  I would prefer to just say that within your enterprise you can do what you want, when you go outside the enterprise it needs to be in script for this particular set of transactions, again limited to this set of prescription related transactions.

MR. REYNOLDS:  I would second that.

DR. COHN:  Support three, okay, so I hear three supporting, Judy —


DR. COHN:  I’ll abstain so Scott, did you want to make a comment before we finish voting?

MR. ROBERTSON:  Well I realize you just voted but I thought it was fairly clear that in the recommended action that the purpose of doing this was so that existing implementations that are functioning today do not have to reengineer what they’re doing, I don’t quite understand why it is antithetical to the intent —

DR. HUFF:  Well, I think it confuses, it confuses things so who’s going to go around and check when people started doing it, who’s the enforcement authority that decides whether this existed before or after the standard was implemented and how many, for the confusion and language in this statement how many people are we actually effecting.

MR. BLAIR:  And the other thing Scott, I think the reason why Stan changed his position on this was the realization that this wouldn’t be enforced until like ’97 or ’98, maybe even, 2007 or 2008 or 2009 and by that time it shouldn’t be a burden to expect the transition to NCPDP.  Is that correct Stan, speaking for you?

DR. HUFF:  Yes.

DR. COHN:  Margaret, let’s talk about this because I have a question or two for Scott also but go forward.

MS. AMATAYAKUL:  So the wording would simply be NCPDP script should be the standard for new prescriptions, refills, cancels, changes, and fill status notification functions except when e-prescribing messages are conducted within the same business entity —

MR. BLAIR:  I’d end it at that.

MS. AMATAYAKUL:  Pardon me?

MR. BLAIR:  And I think that that’s where it ends, is that correct?

MR. ROBERTSON:  Are you also then taking out the —

DR. HUFF:  No, we still want a statement that allows bridging —

MR. BLAIR:  What is meant by bridging?

DR. COHN:  But isn’t that the same thing as, I mean in other words you can do whatever you want but if you send it out as an NCPDP message then it’s an NCPDP message right, is that what you’re saying there or is that something different?

DR. HUFF:  Well, I think all we were saying is that there are two ways that the sending thing can do it, their application could be changed to send it out natively or they have the option of contracting with somebody as an intermediary to do the conversion for them.  Now whether we need to say that or not, I think we want to allow that.

DR. COHN:  Oh, sure, I mean I just —

MR. BLAIR:  Okay, could we clarify the word bridging because that was the piece that I did not understand what was meant by that.

MR. ROBERTSON:  Translations functions provided by third party clearinghouses or switching, message switching services.

DR. COHN:  I guess Scott I see concern in your face obviously and I’m wondering if you can clarify for us, I mean obviously we’re trying to go towards simplicity rather then complexity, I’m obviously just trying to figure out in my own is there a significant part of the industry that will be impacted by —

MR. ROBERTSON:  Frankly I can’t say that there’s a significant part of the industry that would be effected by this, it was just I thought we had come to an agreement yesterday and I just wasn’t anticipating this change at this time but it really in the long term it won’t have a serious, I don’t believe it will have a serious impact on anybody.  I’m just —

MS. AMATAYAKUL:  The plan is to take this out.

DR. COHN:  Marjorie?

MS. GREENBERG:  I don’t know that that last parenthetical phrase is really appropriate or needed, I think you could say should be the standard for new whatever, maybe between external groups or something, I mean I don’t think HIPAA has ever specified, made requirements about what goes on within an organization have they?

MR. BLAIR:  This is a clarification.

MS. GREENBERG:  But this almost sounds like when it is within an organization it should be something different, I mean it could be NCPDP script within the organization or it could be HL7 or I guess it could be whatever you wanted —

MR. BLAIR:  With people that have made an investment within an organization and this clarifies that what we’re saying does not effect them.

DR. HUFF:  I think she’s just saying that we could say that more clearly instead of having it be a parenthetical, just have a sentence that says communication within an organization is outside the scope of this rule or whatever, outside the scope of these recommendations.

MS. GREENBERG:  This recommendation or a regulation or something.

DR. STEINDEL:  I’d like a clarification on the word, we used the word now organization, we used the word previously business entity, and is this just a corporation, a legally bound body, or does this also include the people they contract with where they may specify in the contract use my internal method?

DR. HUFF:  No, it’s the same company.

DR. STEINDEL:  So it has to be the same company?

DR. HUFF:  Yeah.

DR. STEINDEL:  Because this could have an impact on some people that are doing it this way, that are using proprietary message format to contracted entities today and it can be much broader then it would be if it’s just worded the way it was originally, an example would be Well Point.

DR. COHN:  I think we’re getting into trouble here with the wordsmithing, Scott, do you have any —

MR. ROBERTSON:  Well, that was, part of the effort that I tried to do yesterday morning was to come to something that reduced the vagueness of like business entity and I don’t claim that what I suggested yesterday was really all that great but it was an attempt to get out of that because when you talked about, if you want to talk about legal entities well there are legal entities that are collected under other legal entities and so do you, if you’re, yeah, I can say that these pharmacies are part of a legal entity and the doctors are part of a legal entity, turns out that there’s an overarching legal entity that they both belong to so which one do you have to then, that’s the problem that I was trying to get around, if there is some level at which you can describe them as belonging to the same entity that was sufficient to allow them —

DR. COHN:  I mean I do know that CMS obviously is going to have to eventually come up with the right wording but I don’t know that we need to have absolute legal precision here and I’m not quite myself quite comfortable with legal entity, but I’m trying to think, what did we have there before —

MS. AMATAYAKUL:  What we had before as in originally?

DR. COHN:  We had both organization and business right?

MS. AMATAYAKUL:  No, we had —

MR. ROBERTSON:  Business structure exists —

MS. AMATAYAKUL:  Existing implementations between prescribers and dispensers and also new installations in which prescribers and dispensers are members of the same business entity.

MR. ROBERTSON:  Well, the version prior to that talked about the existence of an organizational structure that at some point the two communicating players can be considered part of the same organization because there can be multiple, it’s confusing and actually you’re probably right, it starts to come down to how it’s actually drafted into regulation and that —

DR. HUFF:  I would be more comfortable with either just saying organization or enterprise, one or the other of those two.

DR. COHN:  Well, should we use enterprise?

DR. STEINDEL:  Enterprise I would be happier with.

PARTICIPANT:  I’m happy, that’s fine.

DR. COHN:  Should we go with that?  I mean once again it’s an area where —

MR. ROBERTSON:  It’s really going to be however it comes out in the NPRM and we have to wait and see how it comes out in the NPRM.

DR. COHN:  Is that okay?

MS. AMATAYAKUL:  E-prescribing communications within the same enterprise are permitted to use any message format standard or what —

DR. HUFF:  Or just outside the scope of this recommendation.

MS. AMATAYAKUL:  And then do we need any of the rest of this stuff?  Except for the translation function?

DR. COHN:  Well, I don’t know that we need the translation, is the translation function important here?

DR. HUFF:  I mean I think we agree with that, whether you need to say it, to me it’s just sort of understood that I can do it either those two ways —

MR. REYNOLDS:  The regulation doesn’t presuppose that you can’t.

MR. BLAIR:  I think the phrase gives comfort to those folks that are saying that they’re sending the message in a different form but there’s some entity there that could do the translation and it will still comply, so I think it helps people who wonder if they comply.

DR. STEINDEL:  I agree with Jeff, leave it in as a warm fuzzy.

DR. COHN:  Okay, let’s leave it in and I know that’s going to require significant wordsmithing, in fact one of the members is bristling at the wordsmithing but we will let her suggest an alternative wording offline to help with that knowing that we have to review all the wording anyway.

MR. ROBERTSON:  Actually my bigger concern is just that the idea of a third party translation is not precluded, so you can say it anyway you want, if you determine that it doesn’t really need to be said as long as there’s nothing explicitly excludes it.

DR. COHN:  I think we need to say it, I think we’re all hearing that we need to state it explicitly so we share your view on that so we will put that in.  So Stan are you okay?

DR. HUFF:  Yes.

DR. COHN:  Can we go to Terrie and her comment?  Stan?

DR. HUFF:  Where is the recommendation that it’s NCPDP for everything outside of an enterprise?

MS. AMATAYAKUL:  We could say e-prescribing functions should adopt NCPDP script —

DR. COHN:  That’s wordsmithing at this point, right?  No, that’s not wordsmithing?

MS. AMATAYAKUL:   What did I lose?  I’m sorry, I’m losing it, oh, okay, I gotcha —

MR. ROBERTSON:  We just lost a sentence that needs to be put back in.

MS. GREENBERG:  Stop with full status notification functions, period.

DR. COHN:  Obviously we did miss a sentence there didn’t we?  Terrie, while she’s working on that do you have a comment?

MS. BYRNE:  Yeah, actually I did some follow-up, I couldn’t speak to this yesterday but I did some follow-up on the authorized agent and I think one of the recommendations we made was inappropriate based on what I found out, it’s number 14.

DR. COHN:  Number 14, let’s see —

MS. BYRNE:  I wanted to help clarify what an authorized agent is, an authorized agent is either a submitter or a transmitter and the reason this came up when we were implementing script was we needed to understand the difference between a supervisor, a prescriber, and an authorized agent.  The authorized agent could be an administrative person who’s sitting at a desk and presses the button that hits send on a computer, so I’m not sure it’s appropriate it have to force an authorized agent to have an MPI, I guess that’s my issue.  And that’s why when we modified script to add the supervisor and the supervisor’s identifier we didn’t add one for the authorized agent because it typically is not a prescriber.

DR. COHN:  So you’re saying that an authorized agent really is probably not a PA or a nurse but a clerk.

MS. BYRNE:  Right, right, and the prescriber could be the PA or the nurse and the supervisor could be the physician but the authorized agent, and this only came up because there are some states that require to know every person who touched the prescription in the process.

DR. COHN:  So how are they identified currently?

MS. BYRNE:  By name.

DR. COHN:  Well, that is the ultimate way of doing things —

MS. BYRNE:  I guess my issue is I don’t think we want to be giving MPIs to every clerical person in a clinic.

DR. COHN:  Karen, can you clarify on that?

MS. TRUDEL:  And we wouldn’t because they’re not health care providers, they don’t meet the definition, so I think, and again, NCPDP might want to weigh in here but I don’t know that there’s any identifier that anyone uses to identify those people.

MS. BYRNE:  I think that’s why it’s just a text field on the script transaction today.

DR. COHN:  So you’re suggesting based on this additional information is that within 14 we strike authorized agents, is that —

MS. BYRNE:  Right, out of 14.1 I would strike authorized agents and I would remove 14.2 —

DR. COHN:  So you would remove everything?

DR. STEINDEL:  Simon my question here is HCID, are they planning to issue numbers to those types of people?  I would suspect no.

PARTICIPANT:  Lynn is saying no.

DR. STEINDEL:  Then it pays to strike it.

DR. COHN:  So I guess the question is do we delete this whole area?  It doesn’t look like there’s much left here in this recommendation, I think at this point, I guess the only thing that we’re suggesting at this point is that a supervisor should use MPI, that’s what’s left of this recommendation.

MS. BYRNE:  I think they typically would right?  And there’s room on script to provide the information so I don’t think there are any open issues then.

DR. WARREN:  Wasn’t the issue on this is that in some cases we need to have two prescriber identifiers, one for the person who wrote the prescription and then the other one for the person who provided provision?

DR. COHN:  Well, that’s right, NCPDP is balloting the supervisor qualifier.

DR. WARREN:  But that was the intent of 14 was to make sure that there was a spot for both of those.

MS. BYRNE:  And that is being adjudicated right now, that’s a derf(?) that we brought forward so there is a  space for both the supervisors, demographic information, and their identifier as well as the prescriber, and then there’s a space for their authorization agent which is just a text field.

DR. STEINDEL:  Simon, to bring up something that we just brought up earlier, that may be something that gets lots in preemption.

DR. COHN:  Huh?

DR. STEINDEL:  Something that’s required by state law, the federal regulations may not require it.

MS. BYRNE:  We already can do it so —

DR. COHN:  Well, the question is is there enough left here that needs to be a separate recommendation or is this really being sort of handled?  Margaret, I guess what I would say on this one is is that it doesn’t look to me that it stands on its own anymore, I think the only issue, and I’m just trying to think of it is that I think you’re right that there was a requirement at some point that NCPDP include an ability to represent both the authorization agent and the supervisor, is that —

MS. BYRNE:  Right, and I think that’s being handled.

DR. COHN:  And are they both being balloted?

MS. BYRNE:  Yes, all three of the entities can be handled on the new balloted script format.

DR. COHN:  Okay, well if that’s indeed the case then we should remove 14.  Okay?  Okay, thank you.

MS. BYRNE:  One more quick thing, really fast.  On number four I just wanted to make a clarification, I asked Margaret to change some wording on there because I didn’t want it to be perceived as though Rx-Hub testified that there were gaps in the X-12 transaction so I did ask Margaret to reword that because we do not believe there are any gaps.

MR. BLAIR:  Should they be limitations instead of gaps?

MS. BYRNE:  We don’t believe there are any limitations either, it was X-12 that testified that thought there were limitations for electronic prescribing in the 270, 271, but when I talked to Lisa she didn’t really have any basis for that testimony, I think she was talking more from a medical perspective but I just wanted to be on record that Rx-Hub does not believe there are any gaps.  And we’re the only ones utilizing it in electronic prescribing today.

DR. COHN:  So Margaret, I guess this is a question of I think wordsmithing four to recognize that there’s sort of an adversity of opinion, that some people thought there were some gaps but there have been successful implementations of all of this.  Is that —


DR. COHN:  Okay, so I think reflecting that for the record.  Okay, thank you.

Now what I was going to ask, we’ve got about 40 minutes and I wanted to first of all ask people the question of is there anything glaring that we’re completely missing here in these recommendations?  I mean is there something just sort of obvious that we didn’t capture, that we need to be reflecting on?  I guess the one thing that I’m wondering about and I think that this is handled, let me just ask you, is that we had heard earlier about this effort around harmonization between NCPDP and HL7 Rx messaging and we sort of talked about it, I think in the recommendations I think is at a high level that there needs to be harmonization, da, da, da, da, da, da, da, da, do we need to say anything more specifically about that this is a critical piece that needs to be happening?  Is that something we need to say or we want to say?

DR. HUFF:  I think it’s a great idea, I don’t know, again, I take this in the context of my HL7, I would like to see a future where basically there was one standard that covered e-prescribing and it was done jointly between HL7 and NCPDP as the main conveners and everybody else who wanted to to be involved.

DR. COHN:  I guess I’m wondering and once again I was just sort of thinking as I was having breakfast this morning as I was looking at this and saying well geez, did we actually really cover that.  And I’m wondering if there’s an action item in the harmonization, whatever number that is, where we say in particular we want to point out this particular harmonization effort that it is absolutely critical and that CMS or the federal government needs to pay particular focus to making sure that this is not only initially successful but that it is ongoing and may, I’m not sure if we want to start saying in this letter that everything should converge to one single standard or whatever, that may be a little extensive but I think having that, that could be a March discussion —

DR. HUFF:  I’m just expressing dreams, sir.

DR. COHN:  Yeah, I know, but I think it is an issue that we want to this sort of going on and that this harmonization or mapping be maintained as well as just done once.

DR. HUFF:  I think we could say that for sure.

DR. COHN:  And I only mention that because it’s a very particular case which I think is sort of critical to everything sort of happening the way we’d like it to happen.  Is that okay?

MS. GREENBERG:  I’d say to assure interoperability or something —

DR. COHN:  To assure, yeah, something, I vote for that.  Other things that people have mentioned, noticed or whatever?  Okay, Margaret has one question and then you have a comment.

MS. AMATAYAKUL:  I don’t really see a specific location where we’ve said this so do you want this in the messaging standards or in the terminology standards?

DR. COHN:  I thought that there were some harmonization —

MS. AMATAYAKUL:  We had pieces here and there but not as explicit as this.

DR. COHN:  No, actually in 17 —

MS. AMATAYAKUL:  So in important related instead?

DR. COHN:  Well, I don’t know, I guess we can consider it, 17 we were talking about supporting SDO facilitation of harmonization efforts, to ensure a seamless prescribing process across provider domains, and this appears to me to be, I mean it’s as good a place as any for the moment.  Is that okay?


DR. COHN:  Okay, Jeff.

MR. BLAIR:  My last comments, I want to recognize the leadership that Simon has taken during this period of time to have gotten us through something that I think a lot of us questioned whether we would get to this point by this time today and I also want to express appreciation to Margaret who I really questioned whether we could have gotten through these last three days without the way Margaret has organized information, captured it, and helped us through.

DR. COHN:  Hear, hear, oh ye of little faith.  Now Vivian has a comment, we’re not done yet.

MS. GREENBERG:  I wanted to really thank the whole subcommittee and the staff and the members also for just an incredible effort that I think is going to result in a letter in a week or two, which I think is quite remarkable.  And Jeff you’re certainly part of that.

DR. COHN:  Jeff your leadership is, I mean I helped make the trains run on time but obviously you’ve been providing the caboose and the engine on this one.  Vivian you had a comment?

MS. AULD:  A very quick one, the NCPDP and HL7 harmonization is talked about in number three.

DR. COHN:  Oh, is it number three?  Okay, so maybe number three would be the place to put it.

MS. AMATAYAKUL:  Is that part of the demonstration projects for new standards?  I think it’s different then that.

DR. COHN:  Margaret, we’ll defer to you to figure, this is not wordsmithing, we’re sort of section smithing now, okay let’s just think for a minute, basically is there any big issues that we’re sort of missing?  Anything that we really meant to say, anything that, I mean —

MR. BLAIR:  Declare a victory, you’ve done it!

DR. COHN:  Well, I’m not sure we’ve done it yet.  Now we’ve got about another 13 minutes, I think that rather then going through everything in 13 minutes which I think is unlikely I think we just need to talk about next steps for a second and just make sure that everybody is on board with all of the things that are going on.  Okay?

Now, what’s going to happen at this point is that I believe that Margaret and Jeff are going to take sort of their stabs at the next version of the letter and I would suspect that we will be seeing a draft version or a draft, draft version coming to us to make some initial suggestions, modifications, changes.  I mean what I think what we’re coming out of this is saying that certain things really are, have adequate industry experience and therefore could probably would not have to be piloted, I think a lot of other things we’re obviously saying having to be piloted, and then we’re saying other things, that there’s a whole bunch of process things that need to be put into place so I think that’s sort of how it sort of seems to make most sense.  But I suspect that we’ll be looking at a draft, giving some modifications or suggestions with the idea being that hopefully we’ll be able to look at a second version of this on Wednesday at 12:00 noon Eastern time during the conference call.

Now depending on how we’re doing at that point we’ll obviously be discussing it during, it’ll probably be a two hour conference call and Marjorie, do you have a question, comment?

MS. GREENBERG:  Yeah, so you’re going to have a draft to discuss, you’re going to do some drafting through email, etc., and then you’ll have a draft to discuss in the conference call?

DR. COHN:  Yes.

MS. GREENBERG:  So we should post that draft on the website —

DR. COHN:  So people have access to it and can make comments.

MS. GREENBERG:  Or tell people to, we may want to ask people to let us know if they are going to be participating in the call in the sense so I just want to make sure we have enough lines, then we could email them the draft because I don’t know quite when it’s going to be available.  But it doesn’t make sense for people to be able to participate in the call if they don’t have a copy of the draft letter.  So we have to work that out.

MR. BLAIR:  Would Maria be the point —

MR. ROTHERMICH:  [Off microphone.]

MS. GREENBERG:  Next time.

MS. AMATAYAKUL:  I have used Webax(?) and it’s quite effective.

MR. BLAIR:  Marjorie?  With respect to that do you want folks, so we get a feeling for how many folks are going to be on the call that that information goes to Maria or to somebody else?

DR. COHN:  I think on the web what we’ll do is we’ll post the information and ask people to RSVP to Maria Friedman so she knows how many —

MS. GREENBERG:  Or to Marietta.

DR. COHN:  Okay, whatever you’d like to do, we’ll let you guys —

MS. FRIEDMAN:  People have my email address and it’s also posted on the web.

MS. GREENBERG:  However, I’ll leave it between Marietta and Maria.

MS. FRIEDMAN:  I would venture to say that since we’ve had the same core people here for the set of hearings that maybe we should just look at the sign in sheets and kind of —

MS. GREENBERG:  That would be our working number but I’m also thinking —

DR. COHN:  And certainly if there are people on the internet that want to be involved they should send notes to Maria on that.

Okay, conference call 12:00 noon to 2:00 Eastern standard time on Wednesday, we’ll be reviewing it, if we need we will be having a conference call at 12:00 noon on Friday Eastern time to review if there’s a necessary additional draft.

MS. GREENBERG:  And we should point out that, you may have already, but of course this whatever is approved or decided by the subcommittee will be discussed in a full open meeting —

DR. COHN:  I was just going to, I haven’t gotten to that —

MS. GREENBERG:  September 1st and 2nd of the full committee which will I believe be in this building.

DR. COHN:  That’s the next step, is obviously bringing this to the full committee on September 1st for a first reading and discussion, the subcommittee will be having an early morning meeting on September 2nd which is Thursday to review changes and all of this, I have a feeling I know what that agenda is going to look like.  And then we’ll be bringing it forward again to the full committee for their consideration on September 2nd.  So that’s the way it’s sort of planned there.

MS. GREENBERG:  It will be presented on the 1st, further discussed the morning of the 2nd, finalized on the 2nd assuming —

DR. COHN:  Assuming that that happens.

MR. BLAIR:  Now is somebody going to go ahead and take action to get the e-health initiative document to the full committee?

MS. GREENBERG:  The e-health initiative document —

DR. COHN:  Maria and I will deal with that offline, I think what Jeff was asking for is the executive summary and the standards section to be distributed to the full committee as pre-reading just to make sure that they are —

MS. GREENBERG:  Didn’t we already do that?

DR. COHN:  Yes.

MS. GREENBERG:  It’s already gone to everybody.

DR. COHN:  Yeah, but that doesn’t mean that anybody’s looked at it.

MS. GREENBERG:  Oh, do you have a way to make them look at it?

DR. COHN:  No, I don’t, though I do have a front letter that I can stick on there.

Now beyond that we have hearings on October 12th and 13th which we’ll be talking about e-signature and the world of e-prescribing and probably e-signature in general will be the topic there.  There will be a joint hearing between the subcommittee and Privacy and Confidentiality on November 18th and 19th, one of the topics which will be security which of course is of interest to the subcommittee as well as the other topic will be e-prescribing and any privacy and confidentiality issues, so that will be happing in November.

In December we’ll be dealing with yet additional e-prescribing issues on the 8th and 9th of December, to be determined.  In January I think we’ve identified that there will be hearings, whoops, I don’t have them in my book here, it will be late January hearings that will likely also be focusing on various issues that we have yet to be resolved, maybe medical history or others, these are all sort of to be determined items with the idea being that we will come with a follow-up letter for the March timeframe.

MS. GREENBERG:  19, 20 potentially —

DR. COHN:  That’s right and we’re holding time in early February in case we need it.

Okay, now does anybody have any questions, comments or otherwise about where we are or our next steps?

Okay, well I really want to thank the subcommittee, I mean you’ve been real troopers, we’ve all spent the summer living in Washington, D.C., doing this or at least it feels that way, thankfully it wasn’t too hot this summer so we want to thank you.

I actually also want to just take an opportunity to really thank our experts, I mean you have been with us and I’m looking, I’m looking at all the people that have participated in the testimony, in terms of providing expert input and in terms of guidance and all of this stuff.  We want to thank you for joining us, we really want to thank you for your expertise in terms of assisting the subcommittee in terms of moving forward what hopefully will be some very valuable and well based recommendations, and technically accurate, exactly, so thank you all very much.

Okay, this meeting is adjourned.

[Whereupon at 1:00 p.m. the meeting was adjourned.]