[This Transcript is Unedited]


Subcommittee on Standards and Security

Conference Call

Subject: To discuss recommendation letter to the HHS Secretary on initial e-Prescribing standards.

August 30, 2004

9:00 a.m. CDT

Coordinator : I’d like to remind all participants this conference is being recorded. If you have any objections, you may disconnect at this time. You may begin.

Simon : Okay, thank you. Good morning. I want to call this meeting or this conference call to order. This is a two-hour conference call of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to HHS on health information policy. I’m Simon Cohen, Chairman of the Subcommittee, and the National Director for Health Information Policy for Kaiser Permanente.

I want to welcome our fellow subcommittee members, HH staff and others listening in. I want to remind everyone to speak clearly, since this is being taped. Obviously the purpose of this next two hours is to deliberate in open session, discussing the current status of our draft set of recommendations which will hopefully be going to the full committee for their deliberations on Wednesday regarding e-prescribing. As we’ve stated, this is the first set of recommendations and observations related to e-prescribing, and we’ll be having additional recommendations slated to come forward in March.

We obviously want to thank Jeff Blair, who I think is out getting dental work today, isn’t he?

Jeff : No, I’m enjoying the call here this morning.

Simon : Oh, you are? Good. That’s good. Are you excited to

Jeff : I was able to shift the dental appointment. So I hope that this helps to make the quorum.

Simon : I’m glad to hear that you’re there, Jeff. Thank you. Maria, are you there too?

Maria : I’m here, Simon.

Simon : Okay, obviously, thank you also. And Margaret A., hopefully you’re there also.

Margaret : I’m here.

Simon : So I was going to thank you all for your continued work in all of this. Obviously for everyone who’s on the call, we’ll go through introductions in just a second. I want to emphasize that this is an open session; however, as you know, it’s always a little difficult trying to run a conference call with both subcommittee members as well as in a complete open session. I would ask we’ll obviously try to keep this as open as possible. If you have comments to make, we’ll try to take you in turn. We ask you obviously to be brief and to the point.

As I would counsel for everyone, the point of this session is really much more along the lines of making sure we have recommendations right and major issues related to the way the letter is flowing. I think we do want to make sure to take wordsmithing changes offline; I think those can still be submitted to Margaret A. for inclusion. My understanding is also that we’re going to try to have this letter out a little later on today.

Now, with that, let’s have introductions by the subcommittee members and staff, and then others. Obviously, in your introduction if you would please indicate if there are any things upon which you need to recuse yourself for today.

Jeff : This is Jeff Blair, Vice Chair of the Subcommittee on Standards and Security. I’m Vice President of the Medical Records Institute. And I don’t think there’s anything in this letter which is a conflict of interest for me.

Harry : Harry Reynolds, Blue Cross/Blue Shield of North Carolina, member of the committee, and no conflicts.

Judy : Judy Warren, member of the committee. The only possible conflict I could have would be over the recommendation about HL7; and Simon, I’m going to need to leave at 11:30 this morning, so I’ll only be here for the first hour and a half.

Simon : Okay, so you’re in the Eastern time zone.

Judy : Yes.

Simon : Okay. Is Stan here today? No. Okay. Staff?

Maria : This is Maria Freidman, CMS, and lead staff to the subcommittee.

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

Steve : Steve Seindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee. And Simon, like Judy, I’m going to have to get off about 11:30.

Simon : Okay.

Randy : This is Randy Levin, FDA &.

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

Vivian : Vivian Aug, National Library of Medicine, staff to the subcommittee.

Gail : Gail Grand, Department of Veterans Affairs, staff to the subcommittee.

Margaret : Margaret Amadiyatin, independent consultant.

Simon : Others participating in the call?

Brent : Brent Buskowicz, NACDS.

Ken : Ken Wittemore, SureScripts.

Jeff : Jeff Brown, Rx Hub.

Shelly : Shelly Wooley, Rx Hub.

Mary : Mary Ryan, Medco.

Carrie : Carrie Swanson, Cigna Pharmacy Management.

Terri : Terri Byrne, Rx Hub.

Rob : Rob Tennen, MGMA.

Mark : Mark Brockle, the Academy of Managed Care Pharmacy.

Lynn : Lynn Gilbertson, NCPDP.

Simon : Anyone else? I want to thank you all for joining us. As you know, in California, it’s 7:00 a.m., so if I sound a little gravely, it’s because I am. Obviously I will also disclose in case there’s anything that comes up related to CPT that I am on the editorial panel and obviously will be recusing myself from any conversations on that.

Now, I obviously want to jump to the letter pretty quickly, but Jeff, do you have any introductory comments before we start moving into this?

Jeff : No, Simon. Why don’t you just go forward. I think that you’re doing great.

Simon : Okay.

(Parties speaking simultaneously.)

Jeff : The only piece that I might mention is that if people try to keep their phones on mute so they don’t hear the background noises. That’s it.

Simon : Okay. That’s fair. Now, obviously the purpose of this session I think is sort of two-fold. One is to as I looked at the letter, and obviously, Margaret, I want to thank you for further wordsmithing, and I know you’ve had assistance with I think what I almost would describe as light wordsmithing, since I personally didn’t find much different in terms of content as a result of that wordsmithing, but is to, A, review wordsmithing changes and make sure that the intent of the letter is as we left it.

Then, B, what I also realized is that we had gone through, from observation well forward only once, and we needed to make sure that the meaning, as has been more extensively edited, remains the same. And so I think what I’m going to suggest we do is, I guess assuming everybody’s in agreement, is basically start with the observations and recommendations, probably starting with I believe 12 is where we started our discussions on Friday. And we need to start from there, going through to the end, to make sure that we’re comfortable with how this has turned out; and then we’ll begin to look more globally through the letter for any things that we are either in disagreement with, believe need either further wordsmithing, or whether unintentionally meaning has been changed.

I think we will also, in that process, make sure that we have assigned the correct agency or organization within the government as being responsible when we talk about recommended actions, since that was an issue that came forward in e-mails. Is everyone agreeable with that process?

M : Yes.

Simon : Okay. So the first observation that we had worked on on Friday and Margaret, I am correct about these numbers, aren’t we?

Margaret : That’s right.

Simon : Okay, good. I sometimes wonder; I’ve looked at this thing so much, I’m having trouble separating my identity from this letter at this point. Anyway, observation 12, which is standard versioning Margaret, do you want to just read the recommended action here? Or actually, I should ask everyone: should she just read the whole the observation and the recommended actions on these couple of end items here? Actually, why don’t you do both.

Margaret : Simon, you had sent some suggested changes, so I’ve tried to pick up those, as many as I could. So I did

Simon : Only take them if you like them.

Margaret : Okay. For 12, I did accept them. For 13, I was having some difficulty, so I wanted to wait for the call. But for 12, I modified the observation to read: There are lessons learned from HIPAA regarding both the value of standards and the need for flexibility to respond to industry requirements and technology changes. There are a number of approaches that could be considered to provide the industry with greater flexibility and ability to advance, while maintaining standardization of messages and data. For example, the CHI has set precedents for this through adopting a version of its clinical information standards as a baseline from which new versions may be adopted by the industry when ready; although this process is different from the process required for standards adopted under HIPAA.

And the recommended action is, HHS should work with the industry in it’s &-making process to determine how best to afford flexibility, keeping standards in pace with the industry, including standards for HIPAA and
e-prescribing. For example, HHS might consider recognizing new versions of standards without a separate regulation, if they are backward- compatible.

Simon : Any comments on this one?

Jeff : This is Jeff. I feel very comfortable with that wording.

Harry : I agree, Simon. Harry.

Simon : Judy?

Judy : Me, too. I had to get the mute button off.

Simon : Okay, that’s fine, I understand. I think it actually reads a little better than it did before, so I guess we’re fine with that one. Any other comments? Move on to 13?

Margaret : Simon, I’m going to read this as it is, because you had several questions about whether this first paragraph was needed.

Simon : Let me just sort of introduce I mean, I think we need to read through it. I found myself now, of course, by the time I hit observation 13, since I gallantly started on page 1, and this is page 12, I was beginning to

Jeff : Simon, this is Jeff. I just have a question, and I don’t have a strong feeling about this, so this is just another question, all right?

Simon : Sure.

Jeff : On question 12, the way that we worded it

Simon : I’m sorry, you said 12 or 13?

Jeff : The one we just finished.

Simon : Okay.

Jeff : Which was 12. The way that we worded it, which I felt very comfortable with, is kind of a general practice or policies for all of the e-prescribing standards. So I would maybe ask you and/or the other subcommittee members whether you would all prefer to leave it as question 12, observation 12, with the recommendation, or to move it up onto the general section.

Simon : There’s only one thing in the general section at this point.

Jeff : Right, this would make the second.

Simon : I don’t know, I think I’m comfortable leaving this as 12, but I don’t have a strong feeling about this either.

Harry : Simon, this is Harry. Maybe the reason to keep it as an observation is that it would be dealt with as a subject, rather than just a comment in the general statement.

Jeff : Oh, it still would under the general section, it would still be just the way it is, with an observation and a recommendation. But anyway, doesn’t matter to me.

Simon : Yes; I think what Jeff was describing is moving this to observation 2 and recommendation 2.

Jeff : Right.

Harry : Observation 2, or observation 1?

Simon : Two, because the first one is

W : Observation 2 is prescription messages.

Simon : I know. It would not replace; it would be inserted between 1 and 2.

Harry : Okay, I got you, then. I’m finding the way, then. I thought it was a general I thought he meant a general statement, earlier in the letter. As long as it’s an observation, I’m fine, wherever you guys decide to position it.

Jeff : Simon, I would be happy moving it up.

Stan : This is Stan. I just joined the call. Sorry to be late. I would be in favor of moving it up as well.

Simon : Okay. It sounds like we have three people moving it up, and others who don’t care; so I’d say it’s probably just as well, because I was going to comment that we had mentioned the general as poor when we only had one general observation. So at least now we’re being honest.

Margaret : Simon?

Simon : Yes?

Margaret : Then, when I move it, I think it might be good to put General Standards Versioning, just so people know it’s a general issue.

Jeff : Yes.

Simon : Okay. Sounds good.

Margaret : So go on to 13, then?

Simon : Sure, why don’t we go on to 13. Why don’t you just read it, and then we can sort of talk about and Stan, we’re going through the observations, starting with 12, just to make sure we got these last ones right. And then we’re look through to see about wordsmithing other issues, and make sure that we’re okay with the recommendations and who we’ve assigned to be responsible for certain actions.

Stan : Great.

Margaret : Thirteen: Pilot Test Objectives. The NCVHS has observed that there were many impediments to full adoption and implementation of HIPAA transactions and code set standards. Implementation, sequencing, use of acknowledgements and guidance on when transactions should be rejected are examples of implementation issues. The NCVHS has previously recommended and applauds HHS in its regulatory intent to include pilot testing before adoption of new standards, such as for claims attachments and e-prescribing. The NCVHS further notes that while the foundation standards being recommended here are suitable for early industry adoption, there are several areas in the foundation standards that do not support all the MMA requirements. These requirements address these gaps and limitations. For example, the exchange of drug labeling and drug listing information should not be included in the NCBP script standard until supplied by the FDA and NLM. Another example is the incorporation of a structured, codified (cutting out) script.

Recommended action: 13.1: HHS should support the efforts of standard development organizations to incorporate in the foundation standards as many as possible of the additional requirements of MMA, as identified in these recommendations.

13.2: HHS should include the NCBP script standard with as many as possible of the additional requirements for MMA in the 2006 pilot test.

13.3: HHS should identify specific goals, objectives and metrics to guide the design and development of the 2006 pilot test, so that the resulting information from the pilot facilitates industry adoption and prescriber usability. The metrics should include economic and quality-of-care factors.

13.4: HHS should develop and widely promulgate information concerning the economic and quality-of-care benefits of e-prescribing, citing comprehensive education on implementation strategies, and address other elements (cutting out) widespread adoption.

13.5: HHS should ensure support for appropriate incentives to expedite interoperable e-prescription (cutting out).

Simon : That’s interoperable e-prescribing implementations, right?

Margaret : That’s what I said.

Simon : Okay, but you dropped off

Margaret : Oh, sorry.

Simon : — background. Okay, that’s fine. Okay, I think comments from everyone. This one is one that I sent out a note to everybody, saying I was particularly concerned about. Not that I in any way disagree with the recommendations; it was just that in the combining of things, and as I looked at how the observations related to the recommendations, I found myself getting increasingly confused, only because there seem to be a number of non sequiturs.

Jeff : We could put the non sequiturs in.

Simon : I think we already have.

Jeff : That was to be a joke.

Simon : That was, I think, my concern. I guess the question is here I mean, let me just start with sort of an easy one here, which is 13.5, which I fully support, which it says, HHS should ensure support for appropriate incentives to expedite interoperable e-prescribing implementations. I guess I looked at that one and I fully support that, though I found it a little odd at the end of pilot test objectives.

Now, I’m not sure whether we’re talking about here incentives to expedite piloting, of these pilot implementations, or whether it’s something else. I think I agree with some comments made by others, that this is probably a high priority one, but I didn’t I mean, what are we talking about there? And is that something that should be somewhere else?

Margaret : Simon, after I read this again, after your comments, I realized that I think actually this has lost its original intent. And at least when I wrote it, what I was trying to get across here was that after you have gone through the pilot testing with suitable metrics, you would use those results to apply those metrics to the incentives, so that you’re not just incentivizing because somebody says they have an e-prescribing application; but that there are metrics to demonstrate that they do have; or have the outcome from an e-prescribing application. It would be only then that you would get the incentive.

Jeff : So you were not thinking of general economic incentives.

Margaret : I was no; I was hoping that the metrics learned from the pilot test could be applied so that economic incentives would be fair.

Michael : Margaret, suppose we worded it something like this: HHS had used the pilot test results to develop appropriate incentives, etc.?

Simon : Well, though, as I read the MMA, you don’t need to wait for pilots to do incentives.

Jeff : I think maybe Margaret is talking about different types of incentives; and that was I think I tripped over the same thing. I think she’s specifically and I’m not sure that incentives might be the right word she’s basically saying, if we measure the pilot tests properly, where we identify barriers or impediments and let’s see if I’m saying this right then HHS might do things to address those barriers.

She used the word incentives ; I’m not sure incentives is the right word to address or overcome the barriers. Margaret, am I paraphrasing what your intent was?

Margaret : No; I think it really was to administer the incentives fairly. But if in fact there are going to be general incentives prior to the pilot test, just to get them started, then I would see this as being more of an ongoing incentive for use. Maybe more like a pay-for-performance type of thing.

Simon : I hear what you’re saying, though it certainly seems to be an odd placement for something that’s entitled Pilot Test Objectives.

Margaret : Well, it was the result of the pilot test that I thought and I could be entirely wrong; this may not have been your intent. But it was I thought the pilot test could be used to develop metrics that then would be applied to the fair provision of incentives.

Simon : Okay. What do people I’m trying to think of whether we

Jeff : I have no problem

(Parties speaking simultaneously.)

Simon : — feel like we’re getting in deep here and I’m

Jeff : — with what Margaret is trying to achieve. I think that maybe, if we either go to what Michael Fitzmaurice just suggested, or somehow more clearly define what those incentives are, so that we don’t get them confused with our general perception of the incentives that are in the MMA, which are somewhat different.

Margaret : Well, and maybe there is no need for this; and maybe that question needs to be asked first: Is that something you all agree with? If so, we can try to capture that. If not, then I would suggest removing this.

M : Margaret, based on what you’ve been saying, I would support removing it. Because I don’t think it fits in with the pilot objectives, and it’s pretty well covered under the two concerning metrics. Hopefully once you test metrics, you’re going to bring out ways to use them effectively. I don’t think we need to say that.

Jeff : This is Jeff. I would go along with removing it, because I’m assuming that HHS is going to attempt to do this anyway; and maybe if Maria says yes, then I would feel perfectly comfortable removing.

Maria : I say lets remove it, because I think we’re confusing apples and oranges here. And this letter is complicated enough. And I agree with others that the intent is covered elsewhere; so let’s flush it.

Simon : Okay.

Margaret : Gotcha.

Simon : Now, I guess I would ask everybody I’m struggling to figure out where to start in terms of our discussions of this one. I mean, is it reasonable for us to talk about the actions, then look back up to the objectives? Or do you want to all look at the objectives for a little bit first?

Margaret : Simon, usually the recommended action should follow from the observation, so if you do the actions first, then we can make sure we’re only addressing those in the observation.

Simon : Okay, so why don’t we stay with that one. Now, recommended action 13.1, which is, HHS should support the efforts of the standards development organizations to incorporate in the foundation standards as many as possible (cutting out) —

Jeff : I can’t hear you. There’s too much background noise. Could you repeat that?

Simon : Yes. HHS should support the efforts of standards development organizations to incorporate in the foundation somebody needs to put their phone on mute.

HHS should support the efforts of standards development organizations to incorporate in the foundation standards as many as possible of the additional requirements of MMA, as identified in these recommendations. Okay, comments or otherwise? Do you want me to read these other four overall, altogether? I mean, I looked at that one; I thought it was somewhat poorly worded. I guess I’m trying to figure out what we are are we talking about here in the I presume we’re talking about in the pilot; is that correct?

Margaret : Yes.

Simon : So basically, HHS should support the efforts of standard development organizations to incorporate for the in the foundation standards for the pilot tests, as many as possible of the additional requirements of MMA, as identified in these recommendations.

Jeff : Maybe you should incorporate as many additional requirements as possible in the pilot tests.

Stan : I think there are two things going on. I mean, the first thing you want to do is get the standard upgraded so that the standard supports MMA’s requirements, and then you use that upgraded standard in the pilots.

Jeff : And it does say it, but if you just move those words at the end so that they come before the words pilot test. So should incorporate as many new MMA requirements as possible in the pilot test. I think it reads better.

Stan : Well, but the second requirement or the second item is the one that says include the upgraded things in the pilot test. So you read ahead here, the second action says, HHS should include the NCBP standard in as many as possible of the additional requirements for MMA in the 2006 pilot test. So the first thing is concentrating on getting the standards upgraded; that’s its important statement. The second action is saying, and then include those upgraded standards in the pilot. Which flows, for me. I mean, that seems consistent and logical.

Steve : But Stan, that makes sense to me as long as we change the wording of 13.2 to make it a little bit more generic, and just don’t say NCPDP script.

Stan : Yes. I would agree with that.

Jeff : And change that to what; foundational standard?

Steve : Yes.

Stan : Yes.

Steve : Because I agree with Stan’s analysis of this. The first one is talking about letting the FTO’s do the work to develop some draft standards to try. And then testing them in 13.2. But I think the big problem that threw me in 13.2 was we just specify NCPDP script.

Jeff : If we do that, what if we move 13.2, so that becomes first? Because that’s upgrading the foundational standard. And then the next one is what was 13.1, which is everything else.

Steve : No; 13.1 is there’s a fundamental difference between the two, the way Stan just explained it. 13.1 is focusing on the actual pieces of paper that the FTO’s are developing. You can’t pilot anything until you have something to pilot. And then once those are developed, 13.2 is saying, go out telling HHS to go out and test them.

Jeff : Okay.

Simon : Okay. So 13.1 becomes helping the standards development organizations enhance their standards; and 13.2 becomes these enhanced standards are to be tested in the 2006 pilots.

Stan : Yes; and I agree with Steve, that this shouldn’t be limited to NCPDP script.

Simon : Yes.

Margaret : HHS should include foundation standards with as many as possible of the additional requirements for MMA in the 2006 pilot test.

Jeff : Good.

Simon : Yes. Now, let me just ask and this may be a wordsmithing piece but I don’t usually talk about adding additional about testing as many additional requirements. I mean, usually I talk about those as enhancements or new functionality. I don’t think I’ve ever used requirements in this frame before. Am I the only one?

Jeff : Well, actually, Simon this is Jeff I think that the focus that we have here is not enhancements. Our focus is on those requirements that are not covered in the foundation standards as they are now; but we want to get those foundation standards and the other standards being terminologies and identifiers and all we want to get them to come as close as possible as meeting the MMA requirements.

Simon : Yes.

Margaret : How about, HHS should include foundation standards with as many as possible of the additional functions required for MMA in the 2006 pilot test?

Stan : Yes, that’s better.

Simon : That sounds better. This is sort of wordsmithing; it’s just that I found myself sort of struggling with us throwing around these sort of requirements as though they were functions. So I mean, I think that’s fine, and you can obviously wordsmith 13.1, because it has some of the same terminology problems. So are we all okay with that so far?

M : Yes.

Simon : Okay. I mean, I don’t think we’re far off in terms of our as I found myself struggling with all this stuff, I think we’re all in favor of all the recommendations. It’s just sort of where and how we say them.

Recommended action 13.3, which is, HHS should identify specific goals, objectives and metrics to guide the design and assessment of the 2006 pilot test, so the resulting information from the pilots facilitate industry adoption and prescriber usability. The metrics should include economic and quality-of-care factors. I thought that was very good.

Jeff : Me, too.

Simon : Anybody have any changes to that one.

Jeff : This is Jeff. I’m fine.

Simon : Okay. Others okay?

W : Yes.

Simon : Then, 13.4 is, HHS should develop and widely promulgate information concerning economic and quality-of-care benefits of e-prescribing, provide comprehensive education on implementation strategies, and address other elements that contribute to successful and widespread adoption. I think we’re probably all fine with that too.

Jeff : This is Jeff. One of the pieces in there that I thought was especially important, and I am a little bit concerned it gets lost, because there’s two pieces in there that it’s recommending. One was the economic tests, but the other one is the education and information to improve adoption and acceptance. If I’m reading that correctly. That second piece, that HHS needs to take more be more proactive, let’s put it that way, be more proactive than during HIPAA to provide the education and the resources for implementation and removing barriers to acceptance. I feel like that’s a very important point, and I think it gets lost with having that be the second point in this single recommendation.

Simon : Actually, I’m not sure that I agree, but do others have comments? I think that it’s fine the way it is. Do others feel the need for I mean, Jeff, what are you proposing?

Jeff : Well, I hate to carve it in the first part of it seems like it goes in the recommendation that precedes it; and then the second part of it I thought could be a standalone recommendation.

Margaret : Simon, I think one of the points of this 13.4 is that in large measure, we didn’t know or understand the economic benefits of HIPAA; and I think that we were trying here to say, let’s establish those economic benefits as well as quality-of-care benefits up front for people, and provide education and implementation strategies. But I think really the ROI aspect is number one in people’s minds.

Jeff : I defer and I accept, Margaret. When you read it, I feel more comfortable with it.

Simon : Okay. So are we okay with this as it is, then?

Stan : Yes, I like it the way it is.

Steve : Yes, I think it looks fine.

M : Yes.

Simon : Okay, so we’re fine on that. Now, let’s go back up and look at the objectives, as well as a note that we probably need to say here somewhere and once again, I don’t know if this is an objective or it’s a recommendation but the issue of assuring appropriate resources, which is a note that I made about the NCVHS encourages the HHS to assure that appropriate resources are available to assure adequate pilot testing of new and enhanced e-prescribing standards.

This is sort of a it’s very obvious, but it still probably needs to be said. But Margaret, take us back up to the beginning of the observations. I guess I I think what you all saw as I looked at this one, I was having trouble connecting anything that we said in the observations to any of the recommended actions. And maybe you can all help me with this. Would you like me to read the first two paragraphs again?

Margaret : Simon, the first paragraph was intended to say there’s lessons learned from HIPAA; and you suggested dropping that paragraph. I would suggest that we perhaps don’t need all of it, but I think we do need some of it, because I think the actions in fact the last two, three and four specifically refer to the fact that we didn’t do right by HIPAA. So maybe that could be shortened.

Simon : Well, I guess the non sequitur I was having in the first paragraph had to do with the fact that we were talking about implementation, sequencing, use of acknowledgements and guidance as somehow errors in our HIPAA implementation, that we didn’t address those; and yet all of our recommendations are about pilot testing. But I thought that it was sort of like I had trouble sort of putting those all together.

(Parties speaking simultaneously.)

Margaret : Why don’t we

Jeff : What if we after we have the first piece, that first sentence in observation, there’s lessons to be learned we could wind up having an additional sentence after that that indicates that this time we have the opportunity to address many of those issues, via the pilot testing. And then our recommendations indicate what we include in those pilot testing, in order to improve acceptance and usability. Maybe that’s the missing sentence in the observation, is to say we could address the lessons learned with the pilot test.

Steve : So Simon, it sounds to me like you can achieve the objectives that Margaret and Jeff are talking about by just eliminating the middle sentence of the first paragraph. Because that’s the one that seems to disturb you the most.

Simon : Maybe it’s just because it seems to be off target, let’s say. Yes, though I think the last sentence needs to be wordsmithed

(Parties speaking simultaneously.)

Steve : — last sentence would have to be wordsmithed if you did drop it.

Simon : — because it doesn’t make much sense the way it is right now.

Steve : Yes, because if you say the & NCVHS, and obviously you want to change that; but that’s a simple wordsmithing.

Simon : Yes. So how would you want to wordsmith the last sentence, then? Or Margaret, do you want to take that offline and wordsmith the third sentence also?

Margaret : I guess, yes, I could. I guess I’m wondering if we even need it. Because if we say the NCVHS has observed that there were many impediments to full adoption and implementation of the HIPAA transactions and code set standards, with the requirements for pilot testing and e-prescribing, HHS has the opportunity to address these issues. And then that’s it.

Jeff : Right.

M : Sounds good.

M : I like that.

Simon : Okay, that sounds good. Does somebody else need to be on mute?

(Audio interrupted.)

Simon : Okay, well, that sounds good. So what do we do with the next paragraph, then?

Margaret : Simon, this is a paragraph that came from 14, and I did wordsmith it some; but it doesn’t look like it fits here anymore.

Lynn : This is Lynn Gilbertson from NCPDP. I had a question, because this is the first time we really call out the exchange of drug labeling and drug listing information in the script standard. And I went back to the other recommendations and we don’t ever call out that those things should be added to script.

Simon : Yes; I found all I mean, it was a funny sort of paragraph, Lynn, and I think we’re talking about I guess the question is whether we remove the whole paragraph.

Stan : I think what you’re trying to do in this paragraph is basically note that the foundation standards that we’ve suggested are incomplete; and I don’t think there’s any reason to call out NCPDP script here; much in the same way that we changed below that it’s not referring to NCPDP script, but just saying the foundation standards are deficient in these ways. Because I don’t think in fact that we necessarily want to change script. I mean, it might be an NCPDP standard that supports labeling and stuff, but I’m not sure that you want it to be the script standard necessarily even. Or there is HL7 work going on in this area too, so I mean, I think the thing that you’re really saying is that there are deficiencies, and two of the deficiencies are that the foundation standards don’t support right now the transmission of the drug listing information, drug labeling and drug listing information; and those are just examples of deficiencies, and that then justifies the additional work that needs to be done and the inclusion of those things in the pilots.

Simon : Okay. So, Stan, what is your recommendation for what we do with that paragraph?

Stan : I would say that in the second-to-the-last sentence and the last sentence, that we change that to refer to the foundational standards rather than to NCPDP script. So it would say something like, for example, the exchange of drug labeling and drug listing information is not supported in any of the foundation standards. And I would leave off that part about until supplied by FDA and NLM.

The second one, I actually well, let’s see. Another example is the incorporation of structured that one is actually probably appropriate, because that one is specific to NCPDP script. So I guess it’s just the second-to-the-last sentence.

Margaret : Simon, may I read this paragraph, then?

Simon : Sure.

Margaret : The NCVHS further notes that while the foundation standards being recommended here are suitable for early industry adoption, there are several areas in the foundation standards that do not support all the MMA requirements. For example, the exchange of drug labeling and drug listing information is not supported in any of the foundation standards. Another example is the incorporation of a structure and codified sig in the NCPDP script. Maybe we should say that it’s missing from, or not included in?

Stan : I think you could say, that last sentence, you might say, another example is the need to incorporate a structured and codified sig in the NCPDP script.

Simon : Margaret, have you got it?

Margaret : Yes.

Simon : Okay. Now, I guess my only question is, do we have a recommendation here that talks about a standard for the exchange of drug labeling and drug listing information? Or are we I mean, I’m trying to remember, is that in, what is it, eight or whatever, or

Lynn : It just says, this is being worked on, this is being worked on and this is being worked on.

Margaret : 8.2 refers to the FDA’s drug listing rule, and doesn’t directly link that to the need to then put and also the labeling, the structured product label. But doesn’t link that to then putting that into or associating it with the standards. The message standard.

Lynn : This is Lynn again. When I was reading through 8 again, I was trying to understand, is this a step one, then step two, then step three? It says, X needs to get this done before Y can then do the next step I was having trouble between what parts NRX norm, NDFRT, the SPL

Simon : Lynn, I don’t mean to stop you, but we’re actually talking about 13 right now. Is there something about this that relates specifically to 13?

Jeff : Simon, I think I’m back on, off of mute. You can hear me?

Simon : Yes.

Jeff : Okay. Although Lynn just referenced some of the other observations, I think she might be getting at what is our intent on this. And the way it had been worded, there was a phrase in there indicating that this couldn’t be done until FDA NRX norm were able to provide these capabilities. And I don’t know; does the subcommittee feel as if that’s a particular point that we want to make? Because if it is, I think that this is a separate observation with a separate recommendation.

Simon : That was certainly my question also, Jeff, thank you. Does anybody want to go there on this one, or is this one of those issues I think that was one of the ones we were talking about looking at in items not handled yet, isn’t it? Let me just see if it’s is that there, codification I thought we talked about SCL.

Margaret : Was that exchange of drug labeling and drug listing is the last item in the list of to-do’s?

Simon : Oh, that’s fair, okay. So

Margaret : And we already have a recommendation on the sig earlier. I don’t think you need you either don’t need to give these examples, or you give these examples only because they are examples and not because right here you’re going to recommend an action for them.

Jeff : And since it sounds like we don’t have an additional action to address that, and therefore if we don’t have an additional recommendation to address it, then I think we ought to remove it.

Stan : Yes. I think the last sentence could go, because it is addressed in the other recommendation.

Simon : Sounds like we’re getting rid of the last two sentences, actually.

Margaret : Yes.

Simon : Right?

Jeff : Yes.

Simon : And I guess the question here is I guess as I’m looking at this one, I’m trying to remember how many other times we’ve said here in this document that there are things that the foundation standards need to be tested for. So at a certain point I felt like I was reading the same sentence over and over again.

I guess, Margaret, if there’s some way for you to and we’re talking about pilot testing I mean, do we need that second paragraph at all?

Margaret : I think the only reason you might, and we could put we could try to work it into the first section there is to emphasize, because the foundation standards we’ve defined as not requiring testing, what we’re saying here is that there are some additions to the foundation standards that do need to be tested, but you can’t test those outside of the context of the foundation standards.

Simon : Okay, now, we have a whole paragraph where we’re saying that, right before our observations, right?

Jeff : Yes, but don’t we make that point elsewhere, Margaret? I thought we already made that point.

Margaret : Yes, I think we do, several times, actually.

Simon : Yes.

Jeff : Yes. So is there a reason why we would want to make it again here?

Simon : Yes; I mean, we could say, as has been previously mentioned, that making sure that at least we’re aware of the redundancy.

Margaret : That might be a good idea, only because you’ve got some recommendations that people may say, well, why emphasize that.

Simon : Sure. So they could just say, as previously mentioned, so at least we’re aware of that. Now, I guess so I think we’re getting pretty close here. Now, one other question, which was really just I guess notes that I made, assuming I can find them anymore. I put together a sentence, and I’m just wondering if this is actually maybe now a recommendation maybe this is the first one, which it says, HHS should assure that appropriate resources are available to ensure adequate pilot testing of new and enhanced
e-prescribing standards.

Jeff : So that would be the first recommendation?

Simon : I’m wondering. What do people think? I mean, it’s sort of obvious, but

M : Will you repeat that again, Simon?

Simon : Okay. HHS should assure that appropriate resources are available to ensure adequate pilot testing of new and enhanced e-prescribing standards.

Jeff : The only thing on the one hand, it’s an important recommendation. But the way we have it right now, it’s so simple we wound up backing it up to ensure appropriate resources, because we didn’t want to constrain or limit or be more specific. But in doing so, it’s almost like a bromide. And so I don’t feel as if it is as strong and specific as the other ones that we now have as one and two.

Simon : I don’t think it’s a replacement for one and two; I think it’s in addition. I mean, I guess I would ask others. I don’t feel strongly about this. I think we sort of talk around it, but we just don’t make the straight comment. And given that HHS has been notorious for under-funding a lot of these efforts

Harry : Simon, this is Harry. The thing that continues to bother me with this is that we are basically saying, go forward with the foundation standards, but we know there are holes; and even if you do a pilot testing, you have got to fill those holes as quickly as possible to really have a full e-prescribing environment.

Jeff : Correct.

Harry : That’s what we’re saying.

Jeff : Right.

Harry : But we don’t really hit that.

Jeff : Maybe, if we go back to what Simon was saying about the resources, and we strengthen that sentence with a few words that indicate that the resources really need to be sufficient to achieve the goals that we have in these other recommendations here.

Margaret : Simon, would you consider adding this to 13.3 and maybe making 13.3 a first one? Such as, HHS should ensure sufficient resources or the necessary resources to identify specific goals, objectives and metrics, blah, blah, blah?

Jeff : That’s better.

Stan : I think they’re saying two different things. I think it stands alone.

Simon : Yes, one of them is a metrics recommendation; the other is more generally that there’s enough implementations, etc., etc.

Margaret : Okay.

Harry : Simon, can I take what you recommended as a new first recommendation and give you a sentence that would replace a couple of sentences that would replace paragraph two, and see if it will tie together?

Simon : Okay, that would be great.

Harry : Let me do that.

Simon : Do you want to send those things over to Margaret A.?

Harry : Yes. Let me state it quickly, if I could, just to make sure that everybody agrees with the idea. So paragraph two would say something like, While NCVHS recommends foundation standards for pilot testing, the foundation standards in their current form do not support all MMA requirements. And then list a few of these examples. Then, if you listed what you said as the first recommendation, is that to ensure that these missing pieces or there’s much better words are included, HHS needs to supply the right resources, work with the industry, do whatever; and then we’ve got our other recommended actions to deal with it.

Simon : Well, I’ll let you play with it. It’s hard for me to know where you’re going. Now, you realize that they’re not going to be piloting the foundation standards; they’re going to be piloting enhanced foundation standards. Foundation standards don’t need piloting.

Harry : No, but without the inclusion of some of these things, we don’t meet the MMA requirements, right?

Simon : Right. Right. And that’s why we I call them enhanced foundation standards; whatever we’re I mean, that’s my shorthand terminology for that one.

Steve : Harry, we’ve already been told that we can pilot-test without meeting all the requirements of MMA, and also it’s been implied that we can introduce part of e-prescribing as part of Part D in Operation, without all of MMA.

Harry : Then, you answered my question, Steve. I’m

Simon : Okay, well, I would encourage I mean, once again, I don’t feel strongly about this one; it’s just sort of an obvious statement that we sort of don’t seem to say. So I mean, I would Harry, I would encourage you, if you can draft something, and we can look at it. It may not make it in before, in the version that goes out to everybody, but we can bring it forward by Tuesday, or if you get it done over the next little while, it may make it in as something italicized that we can all look at.

Harry : Oh, that’s fine; I’m not in other words, I wasn’t necessarily trying to grab the words as much as I what Steve added was good; what you added was good. I’m just trying to make sure if I sit here reading this as somebody it would come to, it doesn’t quite yet tell me what I should go do with it. And that’s all I was trying to mess with, but so

Simon : Yes, and I fully support what you’re trying to do. So are we in favor I mean, everybody’s comfortable with

Harry : But are we going to add are you going to add you recommended adding something. Are you withdrawing that, or was that added

Simon : I’m hearing mixed support on it, so that’s what I’m trying to figure out, what to do with that. What do people want to do with this one? Is this something where we’ll ask Carrie to put together some language to see, and then we’ll reflect on it? Do we like this wording? Do we think that it’s already incorporated in 13.1, 13.2, as we have it now?

Jeff : Could we ask Margaret what her thoughts are? Because she sometimes assimilates all this stuff and is able to see a way to include it. What are your thoughts, Margaret?

Margaret : I think that adding assurance that you have the necessary resources is good, and as 13.1. But I think that just saying to do the pilot, assure that you have the resources to do the pilot test, doesn’t sound quite right. So I’m wondering if you should say something like, HHS should assure that there are the necessary resources to fully test the additions to the foundation standards, or something like that.

Jeff : This is Jeff. I like that a lot.

Simon : Okay. Do we have any new standards that we’re promoting?

Margaret : Yes; and then we should add, and incorporate the new standards. Something to that effect. But just have resources as it seems like there’s not a reason for that.

Simon : Okay. Jeff, are you comfortable with letting Margaret wordsmith this one, knowing that we’ll

Jeff : I am. I feel like she’s captured the point you were trying to make, and I hope that she’s captured what Harry was trying to make. I feel like she’s doing it in a way where it is the minimal amount of changes, so we don’t

Simon : Sure, that’s

Steve : Simon, I have a problem with it.

Simon : Sure, please.

Steve : I think the more we talk about section 13, the more confused we get. And I think with some of the minor changes that we’ve made earlier, it makes sense. The idea of including resources at this point, HHS can throw all the resources they want at this and it’s not going to help the situation. A lot of this is temporal, within the standard development organizations. We have stated language that HHS should work with the standard development organizations. We have stated language that HHS should enforce the pilots going forward. I don’t think saying that HHS should throw resources at this is going to add anything. This is not really a resource or people issue.

Jeff : The only area where I thought resources this is Jeff, Steve is resources to assist with education and implementation. The types of things that Weede did for HIPAA because nobody else was doing it; that if HHS could provide that. And so maybe that becomes a different recommendation in a different place.

Steve : We already say that in 13.4.

Jeff : Yes. Okay.

Simon : Truthfully, I don’t feel terribly strongly about this one, and as long as we’re feeling that there’s enough resources, I guess I’m reflecting on how difficult it seemed to be to get pilot testing of the claims attachment standard.

Steve : But I think we have a fundamental difference here. There is already a commitment of HHS to do the pilot testing.

Simon : That probably is fair. This is

Steve : It’s in the law.

Simon : — sort of maybe saying the obvious.

Steve : Yes. This did not exist for the HIPAA process. And we already pointed out that this is good.

Jeff : This is Jeff. I accept Steve’s points.

Simon : Yes; it’s just that I think we need to sort of move on, as they say. So is everybody okay with leaving things I mean, we can keep this one in mind if it seems appropriate as we go through conversations with the full committee, but otherwise we’ll leave things as they are right now.

Harry : Yes; I’m fine.

Simon : Are we okay with 13?

W : Yes, I’m fine.

Simon : Stan?

Stan : Yes.

Simon : Jeff, you’re okay too, so we’re done with 13.

Jeff : Yes.

Stan : Unfortunately, I need to bop off to a meeting.

Simon : Okay. Before you bop off, was there anything that you discovered in your reading that you feel is either factual error, wordsmithing gone awry, or anything else that you need to tell us about versus e-mailing to Margaret?

Stan : No.

Simon : Okay. Stan, we will see you on Wednesday.

Stan : All right. Thanks a lot. See you.

Simon : Okay. Everybody, let’s keep going here. We’ve got about 56 minutes left, so we’re up to 14. Margaret, you want to just read that?

Margaret : Support for standards collaboration: A significant level of collaboration is occurring among standards development organizations and with vendors who have proprietary solutions, as there is growing momentum for
e-prescribing and other components of the National Health Information infrastructure. It is important to support the voluntary nature of standards development organizations while accelerating the process of standards development and coordination.

14.1: HHS should financially support the standards coordination activities to ensure a seamless e-prescribing process across provider domains. Example: Physician offices have the long-term care. Dispensers and payers PBM.

14.2: HHS should encourage standards development organizations to adopt a change management process that permits versions to maintain interoperability.

Jeff : This is Jeff. I only have one suggestion for word modification, and that is, where we say it’s important to support the voluntary nature of standards organizations, I don’t mind if voluntary is in there, but I felt that the most important thing was the consensus-based nature of standards development organizations. They tend to build consensus, industry consensus. And that I think is more important

(Parties speaking simultaneously.)

Simon : So Jeff, you want to do voluntary, comma, consensus-based nature?

Jeff : Pardon?

Simon : You want to do voluntary, comma, consensus-based?

Jeff : Voluntary and consensus-based, or I don’t even know if we need the word voluntary, but if people want to keep it, that’s fine. But I certainly would say consensus-based.

Simon : I’m fine with that.

Michael : Jeff, this is Mike Fitzmaurice. Would you also want to put in there openness, so that people who have a material interest can join

(Parties speaking simultaneously.)

Jeff : Yes, I would like open consensus-based; that would even be better.

Simon : Sounds good. Others? Are we all okay?

W : I’d like to keep the voluntary in there, because I think a lot of people misunderstand that one of the reasons this takes so long is not only developing consensus, but the voluntary nature of the people working at it.

Margaret : It is important to support the open, consensus-based and voluntary nature of standards development organizations.

W : I can go for that.

M : That sounds good.

Simon : Actually, I don’t mean to get into wordsmithing here, but I guess a question is, I think we’re all in favor of supporting the open and consensus-based. I mean, are we really making a firm statement here that we’re strong in support of the fact that it’s voluntary?

Jeff : I don’t see that voluntary is a

Simon : The critical factor there.

Jeff : — a strength. It’s something we just have to live with the fact that it is voluntary.

Maria : This is Maria. I think one of the I’d vote for keeping voluntary, because a lot of the people who are going to be reading this letter aren’t really familiar with the process.

W : That’s right.

Maria : So it’s a small thing to keep in, but it’s just another way of educating people. It’s one word; I vote to keep it.

Steve : Another aspect of it is, according to OMB, if we’re going to be looking for outside standard development organizations, they need to be voluntary.

Margaret : Simon

Simon : Okay, then leave it in.

Steve : Leave it in.

Simon : Leave it in.

Margaret : Would it help to say, it is important to support the open and consensus-based nature of the voluntary standards development organizations?

Jeff : Even better.

M : Are there non-voluntary standards organizations?

Steve : UL.

Jeff : Which doesn’t really is UL I’m not aware UL is really active in healthcare, but maybe, Steve, you know that it is.

Steve : No, not in healthcare; but actually, there are a bunch of non-voluntary that utilize a different type of standards process than what we’re familiar with in healthcare.

Jeff : Okay.

Margaret : Of the voluntary healthcare standards development organizations?

W : I liked the way you said it in the paragraph, the voluntary nature of the SDO’s.

Margaret : Okay. Open, consensus-based voluntary nature.

Simon : Okay. Let’s move on, then, okay? Anything else on 14?

Harry : Simon, Harry. Can I ask one question on 14.1?

Simon : Sure.

Harry : Can you concisely tell me what it means that they should financially support standards coordination activities?

Jeff : Could I jump in on that a little bit? Several years ago, I was active in ANSI HISB, and without some financial support for that coordination activity, it’s really I’d say it’s almost impossible to those coordinating efforts to be able to gather the voluntary people.

Harry : Well, the reason I asked the question, we go back to 13.1 which we argued about, pretty much discussed back and forth, debated on; and we just left support in there. But here, we really go into financial support.

Maria : This is Maria. We heard from Ross and Lynn about the HL7 SEPDP harmonization effort, how much that would be enhanced by having some financial support; in fact, they’ve given us some proposals a couple of times. And they were talking about financial support, but also some in-kind support. But I think if you want the federal government to pony up for this, then you should specifically say financial support.

Steve : Harry, this was what we used with the HL7 EHR process, where the government provided some money for HL7; and what it does is help facilitate meetings, etc.

Michael : Harry, this is Mike. There’s also another way of supporting that, is you don’t necessarily have to give the money to the SDO, but you pay for the meeting space. You might pay for travel of key experts. You might pay for having a recorder there or an industry expert to write down the agreement, so you have a document showing what was accomplished.

Jeff : But it’s still financial support.

Harry : No, I’m fine. I just questioned standards coordination activities versus standard development organizations, versus standards coordination and activities is kind of a fluff term to me.

Michael : It encompasses SDO’s and other coordinating bodies, to get a job done. It’s not just a particular SDO

Harry : All right. If you guys in the government consider that a key word, I will withdraw my concern.

Margaret : Simon?

Simon : Yes?

Margaret : I guess I would like to just do a double-check. On recommended action 13.1, I’m wondering if this is what Harry is referring to. We said, HHS should support the efforts of SDO’s to incorporate in the foundation standards as many of the additional requirements. Harry, are you suggesting we add financially support there, as well as here in 14?

Harry : Aren’t they the same groups? 13.1 and 14.1 are pretty close to the same people, aren’t they?

W : No. When I read 13.1, I see that you’re supporting the SDO’s to do their own standards. In 14.1, you’re trying to get the two groups together, like we are with HL7 and PD PC whatever the PCPDP.

Harry : I see that distinction too.

Simon : I guess the question I think Harry’s asking is, is the word financial here different than when we say support elsewhere? Isn’t that what you’re sort of asking, Harry?

Harry : Yes. I mean, if we believe we want to tell them in 14.1 to put in money, back to your earlier comment, Simon, on resources, then we should have them put in money in 13.1.

Steve : No; I think there’s a difference between what we’re talking about in 13 and what we’re talking about in 14. Fourteen, we’re talking about a very specific act we would like accomplished, and in 13, we’re talking more generally. And I think when we say financially support, we’re saying we’re going to financially support the creation of this specific act.

Jeff : This is Jeff. My perception on this is that existing standard development organizations already have a mechanism that’s in place to provide their own funding to some degree. But when we talk about coordination, we’re talking about creating essentially a new entity over and above, with additional meetings, additional documentation, additional travel. And because that is all new and additional, the financial support for those coordination activities isn’t there. And that’s why I thought that specifying financial support for coordination was necessary.

Simon : Okay. Are people comfortable with this? And Harry, we have the right to sort of further debate it when we get together on

Harry : Oh, no, no, I’m fine.

Simon : No, that’s fine; I’m just sort of saying we it seems like people have opinions, and when we look at this in the final version, we may decide that financial needs to show up more places; but probably find

Harry : No, I’m fine with the financial. I just struggle a little bit with the second part of that sentence, but that’s fine.

Simon : Okay. Are we okay? Can we move on to 15?

Margaret : Yes; and I notice I have two 15’s, but I have to renumber these anyway, so I’ll fix that. The first one, policies to remove barriers. Testimony identified widespread industry concerns relating to safe harbor preservation of provider patient choice, and freedom from commercial bias in messages received through e-prescribing applications.

Action 15.1: HHS should ensure that regulations define the parameters of safe harbor and ensure preservation of provider patient choice, and require the e-prescribing messages received through e-prescribing applications be free from commercial bias.

Jeff : This is Jeff. I feel comfortable with this.

Simon : Yes, fine.

Harry : Fine.

Simon : Judy?

Judy : Fine.

Simon : Okay. And Stan’s gone, so I think we’re fine. Okay, so we go on to observation 16.

Margaret : Conformance testing and certification. Testimony identified the need for testing conformance to standards and certification of e-prescribing systems, i.e., functionality and workflow. While conformance testing and certification are two distinct concepts, it should be recognized that some parts of the industry use the term certification’ in the limited sense of passing the conformance test.

16.1: HHS should support standards development organizations in their development of conformance tests for the e-prescribing standards and their implementation guides.

16.2: HHS should require that vendors use conformance tests to validate that their e-prescribing messages are interoperable.

16.3: HHS Office of the National Coordinator for Health Information Technology should investigate how e-prescribing applications might best be certified.

Jeff : This is Jeff. I feel comfortable with this.

Simon : Yes. I have one question, and I don’t mean it to be picky, but and Harry, help me with this one also. This is the i.e., where we’ve tried to describe certification. And I might have described it, if indeed i.e. means to me sort of is definitional; and I guess I’m wondering whether really certification of e-prescribing systems includes standards conformance, comma, functionality and workflow. I mean, isn’t that what certification generally means? It isn’t just functionality and workflow, but also includes functionality and workflow.

Jeff : Simon, that may be correct. But if you wind up doing that, then I think it makes it much more confusing, because it removes the barriers. We’re trying to use conformance in one way and certification in another, and then just recognize that the industry may have a broader definition of certification. And if we go beyond that, then I think we just make it confusing.

Simon : Well, I guess I

Harry : Simon, make your statement again, what you said originally.

Simon : Oh. I thought the i.e. for the certification included standards conformance, comma, functionality and workflow. And so I thought actually standards conformance was really part of the certification of e-prescribing. And what we had heard is that some parts of the industry use certification in the limited sense of passing a conformance test.

Jeff : Oh, I see what you’re saying, Simon.

Simon : Yes. So I think it does include all three, rather than just two. And we have a broader concept of

Harry : Let me ask you this: Do you also

Jeff : Simon, I defer to your suggestion. I understand it now.

Harry : Do you also add interoperability there, and then does that complete the whole circle? What you had, and then added interoperability also? Because that says you did the standard, you did the functionality, you did the workflow, and you’re interoperable. I think those are the four things you really want from someone.

Simon : That sounds good. So how do we describe this? Standards, conformance, comma, interoperable

Harry : Well, just say what you originally said, and just, before the end, put interoperability.

Jeff : Yes. And the other piece that changes with this change, Simon, is the beginning part of the sentence that says limited. This is now a broader definition of certification, not a limited one.

Margaret : No, the limited is in the second sentence of that.

Simon : And refers to how some of the rest of the industry describes it as just being standards conformance.

Jeff : Oh, maybe I’m in the wrong place, then. Are we changing because I though you were changing

Simon : Our definition of certification I’m talking about our definition of certification.

Jeff : — the industry. Because if you change where we are at top, then, it really gets confusing. At least to me.

Maria : I disagree, Jeff. This is Maria. I think the two suggestions about to broaden what we mean by certification of e-prescribing systems really helps, because if you say, what we really mean by that is, standards conformance, functionality, workflow and interoperability, Harry’s right, that shows the whole you’ve done the whole gamut there. You’ve done the whole circle.

Jeff : Okay. Well, go ahead and make all the changes, and then let’s have Margaret read it back, and then maybe I’ll understand it.

Margaret : Simon, may I ask one question?

Simon : Sure.

Margaret : I’m wondering if you need workflow in there. The reason is that standards conformance, you have a specific thing, you know what you’re certifying against. Functionality, you can come up with a specific list of functions so you know what you’re certifying against. Interoperability, the same way; you can test to make sure you can send from one to the other. But workflow is really internal to a prescriber or a dispenser organization, and I sort of think that’s outside the purview of

Simon : It’s hard to certify workflow?

Margaret : Yes. I don’t know how you do that.

Jeff : I agree.

Simon : Harry, you were the one who suggested workflow. Do we still have Harry there?

Harry : Yes, I’m here. I suggested interoperability.

Simon : No, but yesterday last time you suggested workflow.

Harry : Okay.

Simon : Do you have any issue with us taking it out? Because I agree with your interoperability, and I sort of agree with what Margaret just said.

Harry : Yes, I’m good with that now.

Simon : Okay.

W : But I think, if my memory is right from our discussion last time, wasn’t Harry’s point that a lot of these e-prescribing systems aren’t working because they didn’t consider the workflow of the prescriber?

Jeff : I don’t know if we could certify workflow.

Harry : Yes; we may need to say somewhere else that well, one thing we say in an earlier one we went over was this whole idea of prescriber usability, which was a key thing to me. And I think if we leave the three and take out workflow, and leave the in the pilot test and everything else, that the prescriber usability still remains. I would agree that we wouldn’t necessarily want to say what your workflow has to be, especially after my trip Friday.

W : Okay. So I’ll go with

Simon : So we’re okay

Harry : The real world will smack you in the mouth now and then.

Simon : Okay, so we’re good to go on this one?

Margaret : Let me read it. Testimony identified the need for testing conformance to standards and certification of

Jeff : Slower, because I can’t hear you.

Margaret : Testimony identified the need for testing conformance to standards and certification of e-prescribing systems, i.e., standards conformance, functionality, and interoperability. While conformance testing and certification are two distinct concepts, it should be recognized that some parts of the industry use the term certification’ in the limited sense of passing a conformance test.

Simon : I think that sounds fine. Others?

Jeff : I’m fine.

Harry : Fine.

Simon : Yes, okay. So we’re describing a certification of broader concept than conformance testing, is what we’re talking about. So we’re good to go on 16. Now, 17 is, as I’ve described before, not an observation; but it’s items not addressed in the initial set of recommendations. I don’t think we need to read through them; I think this is sort of a final set of paragraphs, and at the bottom we sort of say, thank you for your consideration of whatever. But I guess I would ask people offline if there are issues. Or actually, is there anything here that they have major conflicts or problems with? Can any of these issues is there anything here that you need to deal with verbally, or is it stuff that if there’s wordsmithing changes, you can submit them?

Jeff : At the bottom of the letter where it says love and kisses, John Lumpkin, I don’t think that’s very professional.

Simon : Okay, well Margaret, I guess you’re just going to have to clean that part up.

Margaret : I have added, based on Maria’s suggestion this morning, The NCVHS wishes to thank you for the opportunity to make these recommendations. Sincerely.

Simon : Sounds good. So are we okay with this last bit, which is this whole list of and I don’t think it’s 17.1 through 17.14, but they’re probably bulleted

Margaret : Right.

Simon : — things that we’re going to be looking at coming up.

Steve : Simon, I think the list should be alphabetized by the sixth letter.

Simon : I think you have to go and have some dental work done, Steve.

W : It would be less painful, that’s for sure.

Steve : I think there’s an attitude shift here, when we got to the bottom of the letter here.

Maria : This is Maria. If you don’t want to make this an observation, then you could just make this a new paragraph and just say, Further, there are several other message all this other stuff, and these topics include, and then just bullet them.

Simon : Yes, exactly. I think that was where I was trying to go. So thank you. So we’re good with this part, at least for sending out the draft version. Obviously we know we will have time to argue about this coming forward here. Now, I’m going to suggest we go back to the

Jeff : Could I one of the other piece? Because I think Maria just hit on a really good thought, where she said that 17 really isn’t an observation or recommendation. In fact, it’s

Simon : Jeff, I think that

Jeff : — a statement of what we’ll be looking at in the future?

Simon : Yes.

Jeff : Maybe it should not even be under the section of observations and recommendations. Maybe there should be a section title that that falls under?

Simon : Next steps?

Jeff : Next steps, or you could say next steps.

Simon : Jeff, I thought this was sort of towards the, basically, the ending of the letter.

Jeff : Yes.

Simon : So I mean, I guess we can Margaret, I guess I will let you and Jeff determine whether or not this needs to have a title to it, or whether it’s just a paragraph with some bullets.

Margaret : Okay.

Simon : With an extra line or two, so visually separating the rest of the document.

Jeff : Right.

Simon : Okay? Now, I’m going to suggest that we go back and start basically just quickly looking at the observations to make sure that we’re comfortable with them, and I’m getting out my notes too here recognizing that, as I said, we can wordsmith things until the cows come home, but we need to make sure that we’ve got the recommendations right to go off to the full committee. So is everyone game for this at this point?

Harry : Yes, sir.

Simon : Okay.

W : We’ve got half an hour.

Simon : Yes, exactly. I notice I’m beginning to talk a little faster here.

Marjorie : Simon, this is Marjorie and Debbie. Our intent is to send the well, when you tell us it’s ready to send send the letter to the full committee, but not the appendices. However, we will need the appendices for the meeting on Wednesday.

W : You have the appendices, Marjorie. I sent the

Marjorie : We have them all?

W : — the two, and then I sent you the revised participant list this morning.

Marjorie : Okay.

W : And the other two appendices are the work plan and the working document. So if you don’t have those

Marjorie : Okay. Marietta, are you on the call?

W : — let me know and I’ll resend them.

Marietta : Yes, and I have them all.

Marjorie : You have them all. Okay, fine. But would you agree that we will not send all of those to the members? I think it might just be a little overwhelming. I’d rather have them focus on the letter.

Simon : Yes.

Marjorie : Okay.

Simon : I don’t know what they would wordsmith on appendix C.

W : Oh, you don’t even want to go there.

Simon : Yes. I mean, I think that that’s just

Marjorie : So have the appendices available.

Simon : Yes. It will be available for the meeting, yes.

Marjorie : For the meeting. People like, when they approve a letter, they like to have the appendices, but

Simon : Yes, so we’ll expect that you’ll bring hard copies for everybody.

Marjorie : Thank you for providing them all.

Simon : Yes, okay. So let’s get into the observations here and just make sure that we’ll just sort of go from observation to observation. I will sort of read the title of the observation. I don’t think that we have time for Margaret to completely read through each of them, but I will assume that each of you has looked through them and can comment about whether you think there’s any problems or issue with them, especially in relationship to the wordsmithing that occurred over the weekend.

Now, observation one is general standards compatibility. Were there any issues that anyone discovered in terms of reviewing that? I guess a no will be sufficient?

Jeff : No.

W : No.

Simon : Okay. Now, obviously we have a new observation two, but we’ll talk with the old numbers for the moment, and we’ll just talk about prescription messages. Were there any major I think there was

Margaret : You had the suggestion that I tried to incorporate.

Simon : Oh, did you? Okay, good. How did you do that? Still, I was sort of befuddled on this one.

Margaret : Okay. The NCPP script standard provides for the exchange of new prescriptions, changes, renewals, cancellations and fill status notifications. Each function has varying degrees of industry experience. The NCPP script standard allows for both free text in certain fields, and choices of codes. It is critical to standardize on common interoperable terminologies to provide automated decision support required by portions of the MMA that related to patient safety and cost benefits. And then continue on.

Simon : Okay. I think there was one other sentence suggested where it says, These items are specifically addressed in later recommendations. You didn’t like that last sentence?

Margaret : I’m sorry, I didn’t see that.

Simon : Well, then, that wasn’t even my recommendation

Steve : That was in my wordsmithing changes, Simon.

Simon : Yes; I thought it was actually better I think she had read your wordsmithing changes.

Steve : Basically, yes.

Simon : And I actually sort of like them.

Margaret : Oh, These items are specifically addressed in later recommendations. You want me to add that too?

Simon : I think so.

Margaret : Okay, I can do that. I’m sorry, I just didn’t see it.

Simon : Maybe what you want to do is to do a new paragraph, where it says or actually, let me see whether this needs a new paragraph or not. I don’t know. It needs a little bit more wordsmithing, I think, in there.

Margaret : Where?

Simon : I guess if we put that additional it’s a transition from that back to the
“NCPP script, new prescription function, is most widely used.” And maybe just putting that as a new paragraph.

Margaret : I think that this section here where we talk about free text fields and choice of codes breaks up the flow, and I’m wondering if that section shouldn’t be moved to the end.

Simon : Okay. I think I would support that. I think that was part of the problem I was having, too. So you would put those areas at the very bottom.

Margaret : Yes.

Simon : As a separate paragraph

Margaret : Yes.

Simon : I would fully support that. So that’s wordsmithing. Is everybody comfortable with that?

W : Yes.

Jeff : This is Jeff. I don’t know what the changes are, but I at this stage, I feel like whatever you decide is fine.

Simon : Yes. I think we’re just doing some wordsmithing, moving things around; and I think it’s going to result in a better observation two. Does anybody have any issues with the recommendations, which I think are basically unchanged? I guess I’m hearing that as an okay?

Harry : Yes, correct.

Simon : Okay. Observation three, coordination of prescription message standards.

Judy : Simon, this is Judy. I need to leave.

Simon : Okay, Judy, thank you for joining us. Do you have any comments about any of the remaining sections?

Judy : No, I thought the remaining sections looked really great after all of our editing on Friday. So I’ll see you all on Wednesday.

Simon : Okay.

Judy : All right. Bye.

Simon : Bye bye. Okay, we still have a quorum: Harry, Jeff and I, right?

Harry : That’s correct.

Simon : Great, okay. So observation three, coordination of prescription message standards. Any issues or changes to be —

Margaret : Simon, 3.2, recommended action 3.2, you had suggested inserting the word e-prescribing before standard specifications. So it would read, are outside the scope of MMA e-prescribing standard specifications.

Simon : I presume that’s sort of a wordsmithing. Are people comfortable with that?

Jeff : That’s fine. By the way, Simon, I don’t have any problems with all of these that we’ve gone through before, unless there’s a change that you want to call our attention to.

Simon : I have notes that I made about possible changes. I want to just make sure, since part of the purpose here was to make sure that wordsmithing didn’t in any way change the meaning of all this; so I’m just sort of asking people as they go through. But thank you for that; so if I don’t hear your voice, I’ll assume that that’s assent with things that are going forward. So everybody’s

(Parties speaking simultaneously.)

Harry : I would do the same thing, Simon, so

Simon : — comfortable with e-prescribing

Harry : — if you take a break and don’t hear us, you can keep going.

Simon : Okay. So I think we’re okay with changing that to e-prescribing standard specifications, then. Observation four, formulary messages. Now, this is one where I think there’s been sort of an issue. 4.1, we talk about who did it, who we’re recommending. And this is one where we call out CMS as opposed to HHS, and I think Steve and others had questions about why in certain cases we might mention CMS

Jeff : This is Jeff. See, that’s my fault. I was the one that suggested to Margaret that wherever we know that specifically it’s going to be CMS that’s going to be doing this, that we specify CMS; and there’s a few that I think might have been FDA, and I think there was a few other where we could specify specific agencies; and some where we had to leave it as HHS. That was my suggestion.

Maria : This is Maria. I think it’s really, technically it’s globally HHS it should be globally HHS all the way through. Because you can’t assume, Jeff, that it’s going to be CMS in this case.

Jeff : Well, if I can’t assume it, then take it all to HHS.

Simon : Yes, I think that that will probably keep things better, or cleaner, anyway. So Margaret, I think you heard that notation?

Margaret : Yes.

Simon : And everybody’s in favor of those changes?

Harry : Yes, sir.

Jeff : I accept.

Simon : Okay. Any other changes to observation four? I think we’re comfortable with it. Observation five, which is eligibility and benefits messages.

Maria : This is Maria. If we’re going to make that change, then down in 5.3, the CMS should be changed to HHS.

Margaret : I’ll make a global change, Maria.

Simon : Yes, okay. Anything more on observation five? Okay. Observation six, prior authorization messages. I guess, again, we have a CMS change. Now, observation seven, which was medication history messages from payers, PBM’s to prescriber, I think I had suggested some wordsmithing in the observation.

Margaret : I’ve got that. Would you like me to read it?

Simon : Sure. And this is just, I think, parallels our recommendation in observation four, and that’s all I was just trying to do, but go forward.

Margaret : This is the second paragraph of medication history and messages from payer to prescriber. Medication history from payers, PBM’s to prescribers is currently communicated primarily with proprietary messages. Rx Hub has communicated its intent to submit its proprietary medication history message to NCPDP to establish industry consensus and ensure the protection for the industry afforded by becoming an ANSI-accredited standard. Development of an ANSI-accredited standard for medication history and messages between payers, PBM’s and prescribers appears to be possible in an accelerated time frame. The following recommended actions address only exchange of medication history from payers, PBM’s, to prescribers, hence VHS plans to address other medication history communication in its March 2005 recommendations.

Jeff : This is Jeff. I feel very comfortable with that.

Harry : This is Harry; I’m good.

Simon : Okay. And I’m good, so we’re fine with that. Anything else on seven? Let’s move to eight, which is clinical drug terminology. Any further recommendations on that? Then, I guess we fixed some of the wordsmithing around who’s responsible for their NDFRT and all of that here.

Margaret : Yes.

Simon : So, great, okay. I think we’re fine with that. Nine is the structured and codified sig, otherwise known as patient instructions.

Michael : Simon, this is Mike Fitzmaurice. I found out where sig comes from. It comes from the Latin, signatura, which is a part of the prescription, and is abbreviated sig. The signatura is the directions for the patient. And I’ve got a sheet of paper that I’ll bring with me to the meeting on Wednesday to let you take a look at it.

W : We believe you, Mike.

Simon : Can you just e-mail that to Margaret, and maybe Margaret could put that in a footnote.

W : Why?

Simon : Because I think people a lot of people seem to ask, what is sig; and so if it’s in a footnote

W : Well, we’ve defined what it is. I mean, do we have to go through all the history, the etymology of the whole thing?

Michael : I’ll just bring the page on Wednesday and you can decide.

Simon : That’s right, that sounds fine. But you can certainly also e-mail that to Margaret if you’d like to.

Michael : Okay.

Simon : Okay, so anything on observation nine? I think we may be good to go on that one. Observation ten is dispenser identifier.

Margaret : Simon, you had a question here?

Simon : Right, exactly, about how I think our recommendation 10.1 appeared that our the use of the NPI we’re only recommending for use in the NCPVP script standard, and I thought it might be sort of like more general.

Margaret : I wasn’t sure about that, because if you say, HHS should ensure that the NPI, when it becomes available, is incorporated as the primary identifier for dispensers, in the NCPDP script standard, if you leave that off, if you just say for e-prescribing, are you suggesting that the reason for that is that it could also be incorporated in HL7? Or I guess I thought

Simon : I just don’t know where else I mean, I don’t know what other what else may evolve, and it just seemed that we were being very proscriptive as did everybody sort of get this one, both on 10 and 11, we seem to be describing both dispenser identifier and prescriber identifier, and making recommendations that were very specific for prescribers or dispensers in the NCPVP script standard? I just thought there needed to be more general I guess I don’t feel strongly about that. I mean, are there any other uses for this that we might want to state, that we’d be using the NPI for?

Steve : I would prefer to leave it open, because there may be a lot of there may be things that develop in the future.

Simon : So how do we leave it open?

Steve : I liked it the way it was now.

Simon : Oh, so you mean so you’re not leaving it open. You’re basically being specific.

Steve : Yes; I think it says it’s very specific for use, and it doesn’t constrict use later.

Margaret : Simon, I think there’s one other point here, and that is that this is another good justification for pilot-testing this foundation standard. You want to make sure that when you put the NPI, they can actually get back to their database to be able to get the information they need.

Simon : Okay. So why don’t we leave that alone, then. I will withdraw that comment. So ten is dispenser identifier. Are we comfortable with the recommendations as they’ve come up? Okay. Eleven is prescriber identifier, with sort of basically parallel construction. Are we comfortable with that?

Harry : Yes.

Simon : Okay. I guess I should ask, and I’ll apologize: others have obviously been listening very patiently in all of this. Are there any comments from anyone who is not a member of the subcommittee or the staff, in terms of any of the recommendations that we’ve been through, before we go to the first couple of pages of introduction?

Margaret : Simon, I do have one question.

Simon : Sure.

Margaret : I know this is being really picky, but a couple of people had commented upon this, that in some cases we were using the NCVHS, but only referring to HHS, CMS, whatever, without the the in front of it. And the editor picked up that sometimes we have the in front of NCVHS and other times we didn’t; so she put the in front of all references to NCVHS, but to none of the other. Then people were saying that that’s inconsistent. And I would suggest that it would be easier to read if we remove the word the.

Maria : This is Maria. In previous letters, we’ve removed the.

Margaret : Thank you.

Simon : Fine. Such an editing, a global editing comment.

Margaret : Easy enough.

W : I think our general editor for the NCVHS, Susan Canaan, has also recommended that.

Margaret : Good.

Simon : Okay, great.

Jeff : And you just said, for the NCVHS.

W : I did. But we don’t censor spoken language.

Simon : Okay. That’s well said. So I’m fine, as long as it’s consistent; I don’t think I have a strong feeling about that. Okay, shall we go to the first couple of pages here, just to I mean, I think at this point everyone is comfortable with the recommendations and observations as they’re stated. Let’s just sort of look at our comments and other things related to the first bit here. I sent off some notes, some of which I didn’t have answers for

Margaret : Simon, in the current prescribing environment, I think you wanted to incorporate the notion that the dispenser has some information about contraindications and so forth in the pharmacy system.

Simon : Yes.

Margaret : You had proposed some wording, and Steve had proposed some wording which was different. Do you have a preference?

Simon : Actually, I don’t. It sounds like Steve’s might be simpler.

Margaret : Yes.

Simon : In fact, my comments took about 14 lines here, and Steve was able to put it in eight words. So you can tell where I go forward, it’s simplicity.

Margaret : I’ll work with Steve, then.

Simon : Okay, great. And this is just the observation that some of the edits and callbacks come from the initial from the pharmacist system itself, as opposed to everything coming through checking eligibility and interacting with the PBM’s and others, so it’s a sort of a reality check. Does anybody have any other comments about current prescribing environment?

Does anybody have any comments about the current e-prescribing capabilities?

Margaret : Simon, you had some comments here as well. It sounded like there were two things. One was very specific in the last sentence: I suggest NCPDP estimates that 75% of pharmacies have the capability to receive messages using the script standard, but fewer than 3% of all prescriptions are written by prescribers using an integrated e-prescribing system. Sounds like you wanted those reversed, to read that way?

Simon : I was struggling, because it isn’t quite the same thing. So

Margaret : I think the point here is that many of the pharmacies are ready, but the prescribers aren’t.

Simon : Steve, I’m looking at your notes about what you described here. What did you

Steve : The first thing I was reacting to was your comment about changing it from an and to a but. And I don’t like that change. But I see the point that you’re making, and I think it may be just easy to construct those two separate sentences.

Simon : Yes. In our last version, before our editor got that this was two separate sentences, believe it or not.

Jeff : This is Jeff. I don’t feel all that strongly about this, but I think it’s a very good point to show that 75% of the pharmacies have the capability, but only 3% of the prescribers are dispensing. My thought is to have the word however, rather than a but or an and.

W : You could make it a separate sentence and start it with however. Because it is an awful long sentence.

Jeff : That’s a good idea.

Simon : Yes —

Margaret : Simon, your other comment related to more of the full text of this bullet, in that you liked an earlier version better?

Simon : Well, that was two sentences.

Margaret : No; I’m referring now not to these two sentences. I’m referring to the entire content of the bullet. It sounded like, in addition to this issue, you had a problem with the entire content of this; am I right? Or was I reading this wrong?

Simon : Let’s see. I think this only referred to lines 5 through 8.

Margaret : Oh, okay. All right, that’s fine.

Simon : But let me see where I noted that.

Margaret : Okay, I think you’re right. I think it’s only this one section.

Simon : Yes, and so I would be I mean, any of the suggestions we’ve had I think are fine. I was struggling because I think in some ways we wanted I think there’s a point to be made here, and I think Jeff’s use of however I was not terribly satisfied with but. I thought and was sort of the wrong I mean, the sentence sort of left flat; so I would defer to you on how you want to

Margaret : I think splitting it and putting however in front is better.

Simon : Yes. That sounds fine. So is there anything else on then we go on to standards evaluation process.

Steve : Simon, I need to drop off.

Simon : Okay, Steve. Do you have any other comments?

Steve : No, I think everything has been covered in my responses to your comments. See you all Wednesday.

Simon: See you. So standards evaluation process, any changes? I think that the split actually looks very good.

Margaret : You put U.S. for U.S. healthcare delivery, and I changed enhancements to additions. In fact, I may go back and do a check on enhancements, and make sure we use additions in all cases.

Harry : I’m fine, Simon.

Simon : Okay, I think I’m fine, though I’m & for where you are.

Margaret : Okay. Under observations and recommended actions, that first paragraph. You said The NCVHS observes that the healthcare delivery system you wanted U.S. healthcare delivery system. And then

Simon : Actually, I think the U.S. healthcare system is what I wanted.

Margaret : Systems, plural?

Simon : U.S. healthcare system.

Jeff : U.S. healthcare system. He just took out the delivery.

Simon : Added U.S. and took out delivery.

Margaret : Oh, I’m sorry, okay. Gotcha. And then in the next paragraph, the second sentence, The recommended actions under each observation recognize first any foundation standards, then the actions to address I changed enhancements to additions. We had been using the word additions instead of enhancements.

Simon : I think the question read that sentence, because it sounds weird even if you change that.

Margaret : The recommended actions under each observation recognize first any foundation standards, then the actions to address additions, development, and pilot testing necessary to meet the MMA requirements.

Jeff : I like additions too, because enhancements sounds like that’s bells and whistles, whereas additions

Harry : Yes, that’s what we talked about the other day. I agree. I think it needs to be something other than enhancements.

Simon : Okay. I guess I’m still sort of struck with the development in the middle, because it sounds sort of weird. I mean, it probably will survive. So to address additions, development, and pilot testing

Margaret : Creation of new standards. That just makes it long.

Simon : Yes, it does. If you come up with something, fine; otherwise, why don’t we leave it alone, because this really is wordsmithing. Anyway, I think that does anybody have anything else in all of this? We’ve circled all the way around and we’re now back to the beginning of observation one. So I think we’ve gone through this; I’m hearing general agreement that, other than the changes we’ve just made, there hasn’t been in all of this, there have really not been any substantive changes.

As I want to remind everybody, there is still an opportunity to do additional wordsmithing. I’m sure the full committee will assist us with that. I would also have you reflect on really the question is, are there any very obvious recommendations that we’re missing. I know this sounds like a very funny comment to make, but sometimes it’s right in front of our nose and we can’t see it. So take a breath, don’t look at it for a day, and maybe on your flight out tomorrow or whatever, you’ll review it with a fresh eye and see if there’s something very obvious that we’re sort of missing from our recommendations. But certainly I think at this moment we’re good to go, for sending something out to the full committee.

Michael : Simon, this is Michael. You’ve been very good about giving the industry a chance to participate and keep us from going wrong. Do you want to give them one more chance to make any additions to the letter at this time, too?

Simon : Actually, that’s a very good comment. Are there any comments from anyone who’s on the line? You’ve obviously been very patient in all of this. Is there anybody out there?

W : Yes.

Margaret : Simon, I have a process question?

Simon : Yes?

Margaret : Okay. My plan, then, is to clean up whatever changes we’ve made here, remove the &, etc., and get a new version out, a clean version, which I will include Marietta, so that she can send that to the full committee. I will do so by 1:30 Central time today. If there are any other changes to be made, I will pick those up late Tuesday night.

Jeff : Margaret? I have a question.

Simon : Yes, Jeff.

Jeff : Is Marjorie on the phone?

Marjorie : Yes.

Jeff : This is my I don’t know what we have the freedom to do or not. Simon has shepherded us through these last several weeks I feel like it’s in a miraculous way. I mean, this was really hard to keep all of the industry participating as we went through the deliberations at every stage of the way, with tremendous patience and acceptance; and my concern is that on Wednesday, we will have two hours and 45 minutes for the full committee to review and make modifications and approve this letter. Is there a legal or procedural requirement during those two and three-quarter hours for us to accept further comments from the industry?

Marjorie : Well, I’m not quite sure I understand your question

(Parties speaking simultaneously.)

Simon : I think that’s a determination for John to make, Jeff.

Marjorie : Actually, in fact, there was not even a legal requirement to have these as open conference calls, but we all agreed that we should do it because, among other things, obviously the subcommittee has benefited tremendously from the input that it’s gotten from the industry, and wants to make sure that it’s got it right.

Jeff : I totally agree.

Marjorie : And I congratulate all of you on the work you’ve done. Now, the meeting will be an open meeting, of course, as all of our meetings are, on Wednesday. The chair of the committee will chair the meeting, and we’ll call on people as time permits. I believe the actual approval of the letter will probably take place on the next day; and of course people who are attending the meeting will also be free to attend the breakout session of the subcommittee, which I think is the following morning. So it’s possible you all will be working in the afternoon too, depending upon what you hear back from the committee. I’d say there’s always an opportunity for people to contribute, but hopefully we will have a final letter approved on Thursday.

I may not have answered your question, but that’s the process.

Simon : Marjorie, I think you’ve done a pretty good job responding to Jeff’s concern.

Jeff : That’s fine.

Harry : Simon, having heard Margaret’s logistics, if the letter is prepared by 1:30 Central, is given to the full committee, I would recommend that unless somebody finds a substantial omission, that you could include to the full committee in your report that any changes that we make be discussed after the full committee has seen it in our session, and then taken back to the full committee if they are accepted. Otherwise, we’re going to be making recommendations to something that, a new version might come out late Tuesday, which you trying to explain why that version is or isn’t different to the full committee could be pretty unwieldy.

W : Why would there be more changes?

Simon : Yes; I don’t know that there would be I actually short of agree with what you’re saying, Harry, though I think I would almost frame it differently, in the sense that once the document is sent out to the full committee, there are no more changes.

Harry : The reason I was making the point was you had mentioned maybe we’ll find something different as we look at it on the plane up. I’m saying that effective 1:30 Central today, we don’t make any changes until after the full committee sees it.

Simon : Oh, yes; and basically what I’m suggesting is that, given that we’re going to be asking the committee to look through this, but not to extensive wordsmithing. And indeed, what we’re most concerned about is that everyone is agreeable with both the content, as opposed to necessarily how every word sits in every sentence; but that if there are indeed recommendations that we didn’t see, that we need to note them and be prepared to bring them to the committee meeting.

Now, obviously, as I think Marjorie has commented, at the full committee we’re obviously a subcommittee, but we’re also individuals who’ve had a lot of expertise and knowledge of all of this, and certainly if there are additional recommendations that you want to bring forward at that point, in the full committee process, that’s really the time. So I’m just sort of suggesting to everybody, you should look at it again, make sure that there isn’t something obvious, an additional recommendation that you may need to bring forward and propose during the full committee discussion time, for their consideration and potentially having this included in the version, because that would really be the time. I mean, the time is not for us to hold back major recommendations and then bring them up in the subcommittee the day after. So is that sort of aligned with what you’re thinking also?

Harry : Yes, sir, that’s great.

Simon : Great, okay. Final comment we’re one minute to the ending I actually want to apologize Lynn, are you on the phone? Lynn Gilbertson? Maybe she isn’t.

Harry : She was earlier.

Simon : Because she had brought up some issues around 8.1 and then didn’t come back about them. I was just curious if there was anything that she had had, or any concerns that we need to be aware of. But we’ll ask her when we see her I’m sure on Wednesday and Thursday.

Marjorie : Simon, just one clarification. Obviously we’ve been posting these drafts, or we’ve attempted to, for these conference calls. Now, at the meeting, we will have copies of the version that we are sending out or whatever version you want to discuss

Simon : Well, the version that Margaret is sending out at 1:30 today.

Jeff : I think we ought to post this next version also, so that the industry can see it.

Marjorie : That’s what I wanted to ask; whether you want it posted as the draft that is going to be discussed on

Jeff : Yes.

(Parties speaking simultaneously.)

Marjorie : We’ve never done that before, but there may be people I guess participating on the listening on the Internet. They’re not going to be able to participate. There may be people who aren’t there. Anyone who is in the room will get a copy of the letter. But typically we do not post draft letters except for a particular call, in this case.

Jeff : The reason that I think we should is because clearly, when we look at the well, the last several months the interest and concern of the industry in this particular topic is very great. There’s a lot of sensitivities. And I think that it’s a good idea in this case for them to see what we finally came to. And although I express concern about having, in a limited amount of time, open-industry comment when we get there on Wednesday, the point that you made I also agree with, is that if, for example, the industry is upset with this letter in some way, we do need to hear it.

Margaret : May I ask a process question? Would that, then, still retain a footer that says Draft letter on e-prescribing 8/30/04, not valid after a specified time, such as not valid after Wednesday evening?

W : Yes.

Jeff : Yes.

Simon : Yes. Marjorie, this is one where I think I would defer to you and have it be through the regular I mean, I think that we’re talking about now moving back into routine and usual committee processes. So I don’t think I have a strong feeling one way or the other. I’m not sure of the value at this point of putting up a draft version for the next 36 hours, given that I think the intent would be for us to read the complete version in open session over the Internet.

Jeff : Oh time to really do that on Wednesday?

Simon : I think we need to read it. I don’t think we need to comment and do tremendous wordsmithing, but I think it needs to be read.

Jeff : Because when I looked at the numbers and I started to look at the time to review each of the 16 or 17 observations alone, and it start for the segments, and then the other six pages, there’s hardly any time for discussions and questions, if we read the whole thing through, every sentence.

Maria : Organizational dynamics of the full committee has been to wordsmith a lot on everything.

Simon : Well, no, that’s actually not true. It depends on what you’re asking them for. I think we’ve made it pretty clear we’re going to ask their permission at the beginning to basically have wordsmithing changes being handled offline or whatever, but substantive changes be discussed.

Maria : I think we should make that point quite strongly.

Simon : Yes.

(Parties speaking simultaneously.)

Simon : You’re right, we are talking about process here what?

Marjorie : My concern about posting it is that I really don’t want it to I just think it’s inappropriate when the letter, hopefully by the end of the day on Thursday a final letter will be approved that will be sent to the secretary, which means that the secretary will receive it maybe the following Monday or something, that for posting it

Jeff : Marjorie, I defer to you totally.

Marjorie : — is, I think, we

Jeff : Whatever your judgment is, you heard my thought, and your judgment I go with.

Marjorie : — raised the possibility of an earlier version ending up in the trade press.

Jeff : I totally defer to you, Marjorie. You heard my thoughts, and I accept whatever you decide.

Simon : Yes, and

Harry : Simon, I’ll step back and put my industry hat on. I feel that the industry has had ample opportunity to be involved, including today, and there were no comments of significance today. And I feel that if you don’t protect the standard process of the committee, then this will be setting a precedent

Marjorie : I have that concern also.

Harry : — that people could clearly start requiring this and use this committee as an example of what the new process ought to be.

Marjorie : I have that same concern, so

Harry : Now, if the full committee if that were a subject taken to the full committee and decided to do it that way, then I would feel much more comfortable.

Marjorie : Okay. I don’t intend to post it unless I hear otherwise that I another argument. But I think that we’ve followed, more than followed, the appropriate process, and I would rather stay with our current process as we move into the full committee. We’ll pull all the drafts off of the Internet.

Simon : I think that makes sense. I think things have sort of stabilized at this point. Okay, so I think we’re good to go. Basically, the copies go out to the full committee later on today. I was going to, probably on Wednesday, make a couple of introductory comments, but I’ve also been reminded that I think it’s very important that the letter be able to stand on its own. So my comments are going to be brief, and we’re going to launch pretty rapidly into the letter. I mean, recognizing that even if we just want to talk about the observations and recommendations, that’s all but two and a half pages of the letter anyway; so we might as well just read over the whole letter for the committee and make sure that they understand it as we go forward, and give them the chance if there’s some substantive issues or some major issues that they have, to bring them forward as we go forward.

Marjorie : I really wanted to get you guys T-shirts, but I don’t think I’m going to have a chance. But thanks for all your work.

Simon : Marjorie, thank you for hanging in there. Margaret, thank you. Maria, thank you. Jeff, thank you. Harry, thank you for hanging in to the end of this conference call, and obviously thanks to all of our experts who I think are probably trying to hang on the line here too.

We will adjourn the meeting. We will next convene with the full committee on Wednesday morning.

Marjorie : See you then.

Harry : Thanks, everyone.

Simon : Thank you all. Bye bye.